Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The Sarbanes-Oxley Act requires, among other things,
that we maintain effective disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) that are designed to ensure
that information required to be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is
recorded, processed, summarized and reported within the appropriate time periods, and that such information is accumulated and communicated
to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer has evaluated the effectiveness of our disclosure controls and procedures. Management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily
applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer has concluded that the Company’s disclosure controls and procedures were not effective
as of December 31, 2024, as a result of the material weaknesses described below.
Management’s Annual Report on Internal
Control Over Financial Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act). Our management
assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this assessment, our management
used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated
Framework (2013 framework).
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Based on our assessment under the framework in
Internal Control-Integrated Framework (2013 framework), our management concluded that our internal control over financial reporting was
not effective as of December 31, 2024, due to the existence of the material weaknesses described below.
A material weakness in internal control is a deficiency
in internal control, or combination of control deficiencies, that adversely affects the Company’s ability to initiate, authorize,
record, process, or report external financial data reliably in accordance with GAAP such that there is more than a remote likelihood that
a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected.
This Annual Report on Form 10-K does not include
an attestation report of our registered public accounting firm regarding internal control over financial reporting. Our auditors will
not be required to formally opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 until
we are no longer an “emerging growth company” as defined in the JOBS Act.
Material Weaknesses
in Internal Control Over Financial Reporting
We have identified the
following internal control deficiencies, which we believe to be material weaknesses as of December 31, 2024:
●
We did not maintain an effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements.
●
We do not have an effective risk assessment process and effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application of our controls.
●
Our controls over the approval and reporting of expense payments were not designed and maintained to achieve the Company’s objectives.
●
We do not yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions.”
●
We have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements.
●
The Company did not design, implement and
maintain effective controls to ensure information technology (“IT”) policies and procedures set the tone at the top, to mitigate
the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains. Specifically,
the design and implementation of user authentication, user access privileges, data backup and data recovery controls as well as the monitoring
controls of excessive user access and elevated privileged access to financial applications and data were not appropriately designed and
maintained. In addition, these inadequate ITGC controls combined with the use of personal devices to conduct business, can lead to an
IT control environment vulnerable to breaches and social engineering persuasion.
The above material weaknesses
did not result in a material misstatement of our previously issued financial statements but could have resulted in material misstatements
of our account balances or disclosures of our annual or interim financial statements that would not be prevented or detected. We have
developed a remediation plan for these material weaknesses which is described below in Remediation of Material Weaknesses .
Remediation of Material Weaknesses
As of the date of this
Annual Report on Form 10-K, management is re-assessing the design of controls and modifying processes designed to improve our internal
control over financial reporting and remediate the control deficiencies that led to the material weaknesses, including but not limited
to (a) improving consistency in change management supported by standard operating procedures to govern the authorization, testing and
approval of changes to information technology systems supporting all of the Company’s internal control processes, (b) enhancing
design and implementation of our control environment, including the expansion of formal accounting and IT policies and procedures and
financial reporting controls, (c) continuing to identify and design and implement effective review and approval controls, and (d) implementing
appropriate timely review and oversight responsibilities within the accounting and financial reporting functions and ensuring appropriate
segregation of duties.
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We will consider the
material weaknesses remediated after the applicable controls operate for a sufficient period of time, and management has concluded, through
testing, that the controls are operating effectively.
The process of designing
and implementing an effective accounting and financial reporting system is a continuous effort that requires us to anticipate and react
to changes in our business and the economic and regulatory environments and to expend significant resources to maintain an accounting
and financial reporting system that is adequate to satisfy our reporting obligations. As we continue to evaluate and take actions to improve
our internal control over financial reporting, we may determine to take additional actions to address control deficiencies or determine
to modify certain of the remediation measures described above. We cannot assure you that the measures we have taken to date, or any measures
we may take in the future, will be sufficient to remediate the material weakness we have identified or avoid potential future material
weaknesses.
Inherent Limitation
on the Effectiveness of Internal Control Processes
Our Interim Chief Executive
Officer and Interim Chief Financial Officer does not expect that our disclosure controls or our internal control over financial reporting
will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error
or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by
management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures
may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur
and not be detected.
Changes in Internal Control over Financial
Reporting
During the year ended December 31, 2024, there
were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange
Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
None .
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
None.
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PART III
Item 10. Directors, Executive Officers, and
Corporate Governance.
Directors and Executive Officers
The following table provides information regarding our executive officers
and directors as of May 30, 2025:
Name
Age
Position(s)
Executive Officers and Directors
Karina Fedasz
52
Interim Chief Executive Officer, Interim Chief Financial Officer
Non-Employee Directors
Andrew Oakley
62
Non-Executive Chairman
Simon Tarsh
63
Director
Timothy Ramdeen
33
Director
Thomas Meier
62
Director
Ajit Singh
61
Director
Executive Officers and Directors
Executive Officers and Directors
Karina Fedasz
Ms. Fedasz has helped companies raise capital,
model and forecast business, manage cash flow and conduct mergers and acquisitions. She is a dynamic, data-driven executive with a bold,
high-growth mindset. From January 2023 to June 2024, Ms. Fedasz worked with various clients, including a not-for-profit and an early-stage
artificial intelligence and data-driven health and wellness tracker. From February 2022 to December 2022, Ms. Fedasz served as Head of
Business Development for Evofem Biosciences, a Nasdaq-listed public biotech company developing innovative products for women's health.
From August 2019 to October 2021, Ms. Fedasz served in various positions of increasing responsibility, including Chief Financial Officer,
at IDW Media Holdings, a micro-cap media company, where she managed the company's initial public offering. From April 2018 to August 2019,
Ms. Fedasz served as Chief Financial Officer of MOCEAN, an integrated agency for entertainment, gaming, and brands. Ms. Fedasz's breadth
of experience has seen her lead teams in media, technology, services, manufacturing, and education, and she has worked with companies
whose clients and customers include Fortune 500 companies such as Netflix, Disney, Amazon, Apple, Activision, and EA. Ms. Fedasz received
an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los Angeles (UCLA). She holds
an inactive CPA in the state of California.
Non-Executive Directors
Andrew Oakley , our Non-Executive Chairman
since February 2025, is an experienced pharmaceutical and biotech industry professional. Previously, he held CFO positions at listed pharmaceutical
companies Autolus Therapeutics plc (NASDAQ: AUTL) from 2018 to 2022 and Sosei Group (TSE:4565) from 2017 to 2018, as well as Vectura Group
plc (LSE: VEC) and Actelion Ltd, where he led the finance function for over a decade. Additionally, he is a board member at a number of
privately held Biotech companies. Mr. Oakley holds a Bachelor of Economics Degree from Macquarie University and an MBA from London Business
School and has been a Member of the Australian Institute of Chartered Accountants since 1987.
Simon Tarsh , one of our directors since
August 2022, has more than 40 years of financial experience, working in both the UK and the U.S. He has recently retired from Deloitte
Consulting LLP, where he was a Senior Managing Director in Finance and Enterprise Performance Practice, where he had served global clients
since 2007. He led a growing global practice focused around Operational Transformation, including supporting Carve Out transactions, joint
ventures and hybrid structures, both in the US and in international locations, such as India, China, Eastern Europe and Latin America.
He supported high growth companies with their finance operations as they globalized, and was able to advise them on their expansion, while
balancing growth with appropriate controls. Prior to moving to the United States in 2007, Mr. Tarsh’s consulting career began with
PA Consulting Group, London in 1988, where he was elected as a Partner in 1997, and he built ISG’s business process outsourcing
advisory practice in Europe between 2001 and 2006. Mr. Tarsh’s early career was in finance, working with Marathon Oil and Dow Chemical,
and during this period, he qualified as a Chartered Accountant. Mr. Tarsh received a Bachelor of Science undergraduate degree in Business
and Administration from the University of Salford, Manchester, UK in 1981, and an MBA from City University Business School, London, UK
in 1988. He is a Fellow of the Chartered Institute of Management Accountants (1984), which is considered as a CPA equivalent. Mr. Tarsh’s
deep financial experience at Deloitte Consulting LLP for fifteen years offers valuable insights to our Board, particularly given the enhanced
accounting rules and regulations affecting public companies.
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Timothy Ramdeen , one of our directors since
January 2023, has nearly a decade of experience in private equity and hedge fund investing, capital markets, and company formation. Since
June 2022, Mr. Ramdeen has been founder and managing partner of Dharma Capital Advisors, an investment and advisory firm focused on early-stage
private and public companies. From March 2021 to March 2022, Mr. Ramdeen was co-founder, chief investment officer, and portfolio manager
at Sixth Borough Capital Management, a multi-stage, event-driven hedge fund focused on both private and public equities. Since 2022, Mr.
Ramdeen has been the co-founder of Amplexd Therapeutics, which is a women’s health/biotechnology company focused on providing low-cost,
effective, safe and accessible treatments for early cervical and HPV-related cancers worldwide. Mr. Ramdeen also serves as a corporate
advisor/board member to multiple early-stage companies and investment funds. Previously, Mr. Ramdeen was the fifth hire at Altium Capital
Management (“Altium”), a healthcare-focused investment firm, where from July 2019 to March 2021 he served as the sole investment
analyst on the private capital markets/special situations desk (privately-negotiated financings, direct investments, event-driven long/short,
and private to public investments in micro and small-cap companies). During his tenure at Altium, Mr. Ramdeen was instrumental in co-creating
the firm’s SPAC and reverse merger investment efforts and establishing extensive relationships with sell-side constituents, buy-side
counterparts, and hundreds of private and publicly traded companies across biotechnology, therapeutics, healthcare services, medical devices
and medtech. From 2017 to 2018, Mr. Ramdeen worked for Brio Capital Management, an event-driven hedge fund focused on small and micro
cap equities. Mr. Ramdeen received his B.S. in Biology from Temple University, where he conducted scientific research across neurology,
oncology, and developmental biology. In addition, Mr. Ramdeen earned his MBA in Finance from NYU Stern School of Business. Mr. Ramdeen
brings to our Board extensive experience in capital advisement and company development, specifically within the life science industry
and for publicly traded companies.
Thomas Meier , one of our directors since
February 1, 2024, has close to 25 years’ experience as a life-science and biotech entrepreneur, executive manager, and board member.
Since June 2022, Dr. Meier has served as Chairman of, and member of the Audit and Compensation Committees of, Santhera Pharmaceuticals
Holding AG (SIX: SANN), a publicly listed Swiss specialty pharmaceutical company focused on the development and commercialization of innovative
medicines for rare neuromuscular and pulmonary diseases. Dr. Meier has served on the board of Santhera since 2017 and stepped down as
the company’s CEO in November 2019 after having served 15 years as executive manager, the last 8 years as CEO. In 2020, Dr. Meier
became managing partner of Viopas Venture Consulting GmbH, a Swiss consultancy and advisory firm for the healthcare industry. Since 2020,
Dr. Meier has served as a board member of Novaremed AG, a privately held Swiss company developing innovative treatment options for the
management of chronic pain and alternatives to opioids. Dr. Meier has served on Novaremed’s Audit Committee since October 2021 and
became Executive Chairman of the company in January 2024. Since January 2022, Dr. Meier also serves on the board of Visgenx Inc. (USA).
In September 2021, he co-founded SEAL Therapeutics AG, a privately owned Swiss gene therapy company for which he also serves as Chairman.
Between July 2020 and November 2021, he served as Chairman of privately held Pharmabiome AG (Switzerland). Dr. Meier has a PhD in Biology
and qualified as lecturer in neurosciences at the Biozentrum, University of Basel (Switzerland). Dr. Meier brings to our board experience
as an internationally recognized scientist with track record in clinical research of orphan diseases.
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Ajit Singh, one of our directors since
February 7, 2024, is a Partner at Silicon Valley based Artiman Ventures, focused on early-stage technology and life science investments,
with over $1 billion in assets under management. Besides serving on the board of directors of Artiman portfolio companies, he has served
on the boards of Sofie Biosciences, a PET radiopharmaceuticals company focused on Oncology and Neurology, Leo Cancer Care, focused on
radiation oncology since 2013, Artidis, an oncology diagnostics company with nanomechanical biomarkers for cancer, and Chronus Health,
in the area of Point-of-Care diagnostics since 2023. He also serves on the Board of Trustees of American Association for Cancer Research
(AACR) Foundation, the oldest and the largest cancer research organization globally. Dr. Singh is an Adjunct Professor in the School of
Medicine at Stanford where he teaches clinical diagnostics and entrepreneurship. In the past, Dr. Singh has served as a Lead Director
on the board of directors of Max Healthcare, and as a Senior Advisor to the Tata Trusts Cancer program, which developed a “plan
centrally, deliver locally” platform for cancer care, and delivered it via comprehensive cancer centers built bespoke with funding
from the Tata Group. Until 2023, he also served on the board of directors of Cadila Pharmaceuticals. Prior to joining Artiman, Dr. Singh
was the President and CEO of BioImagene, a company specializing in AI-based Cancer Diagnostics, based in California. BioImagene was acquired
by Roche Pharmaceuticals in September 2010. Before BioImagene, Dr. Singh spent nearly twenty years at Siemens in various roles, in the
United States and Germany, most recently as the global CEO of Siemens Oncology, and Siemens Digital Imaging Systems. Before transitioning
to these executive responsibilities, Dr. Singh spent several years in R&D at Siemens Research in Princeton, responsible for research
in the areas of artificial intelligence and robotics. During this time, he concurrently served as an adjunct faculty at Princeton University.
Dr. Singh has a Ph.D. in Computer Science from Columbia University, a Master’s degree in Computer Engineering from Syracuse University,
and a Bachelor’s in Electrical Engineering from Indian Institute of Technology (IIT) in Varanasi, India. He has published two books
and numerous refereed articles and holds five patents. His Top-10 Book Review is carried by various blogs and reading journals in December
every year. Mr. Singh brings to our board significant experience in the biotech industry and diagnostic field, particularly in a commercial
execution capacity.
Board of Directors and Corporate Governance
General
Our business and affairs are organized under the
direction of our Board, which currently consists of five members. Our Board is divided into three classes, Class I, Class II and Class
III, with members of each class serving staggered three-year terms. Our directors are divided among the three classes as follows:
●
the Class I directors are Simon Tarsh and Thomas Meier, and their term will expire at our 2025 annual meeting of stockholders;
●
the Class II director is Andrew Oakley, and his term will expire at our 2026 annual meeting of stockholders; and
●
the Class III directors are Timothy Ramdeen and Ajit Singh, and their term will expire at our 2025 annual meeting of stockholders.
Our Amended and Restated Certificate of Incorporation
and our Amended and Restated Bylaws provide that the authorized number of directors may be changed only by resolution of the Board. Our
directors hold office until the earlier of their death, resignation, removal, or disqualification, or until their successors have been
elected and qualified. Our board of directors does not have a formal policy on whether the roles of Chief Executive Officer and Chairman
of our Board should be separate. The primary responsibilities of our Board are to provide oversight, strategic guidance, counselling,
and direction to our management.
We have no formal policy regarding board diversity.
Our priority in selection of board members is identification of members who will further the interests of our stockholders through his
or her established record of professional accomplishment, the ability to contribute positively to the collaborative culture among board
members, knowledge of our business and understanding of the competitive landscape.
Directors and Executive Officers Qualifications
We believe that the collective skills, experiences,
and qualifications of our directors provide our Board with the expertise and experience necessary to advance the interests of our stockholders.
In selecting directors, the Board considers candidates that possess qualifications and expertise that will enhance the composition of
the Board. Nominees for director will be selected on the basis of, among other things, leadership experience, knowledge, skills, expertise,
integrity, diversity, ability to make independent analytical inquiries, understanding of the Company’s business environment and
willingness to devote adequate time and effort to Board responsibilities. The Nominating & Corporate Governance Committee may require
certain skills or attributes, such as financial or accounting experience, to meet specific board needs that arise from time to time and
will also consider the overall experience and makeup of its members to obtain a broad and diverse mix of board members. We believe that
our directors should have the highest professional and personal ethics and values, consistent with our longstanding values and standards.
They should have broad experience at the policy-making level in business, exhibit commitment to enhancing stockholder value and have sufficient
time to carry out their duties and to provide insight and practical wisdom based on their past experience.
97
Committees of the Board
Our Board has established three standing committees—audit,
compensation and nominating and corporate governance—each of which operates under a charter that has been adopted by our Board.
Copies of each committee’s charter are posted on the “Investor Relations” section of our website, which is located at
https://onconetix.com/corporate-governance/governance-overview . Each committee has the composition and responsibilities described
below. Our Board may from time to time establish other committees.
Audit Committee
Our audit committee (“ Audit Committee ”)
consists of Simon Tarsh, who is the chair of the committee, Timothy Ramdeen, and Andrew Oakley. Our Board has determined that each of
the members of our Audit Committee satisfies the Nasdaq Marketplace Rules and SEC independence requirements. The functions of this committee
include, among other things:
●
evaluating the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors;
●
reviewing and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services;
●
reviewing our annual and quarterly financial statements and reports, including the disclosures contained under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and discussing the statements and reports with our independent auditors and management;
●
reviewing with our independent auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy, and effectiveness of our financial controls;
●
reviewing and approving, in accordance with the Company’s policies, any related party transaction as defined by applicable rules and regulations
●
reviewing our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented; and
●
reviewing and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.
The Board has determined
that Simon Tarsh qualifies as an “audit committee financial expert” within the meaning of applicable SEC regulations and meets
the financial sophistication requirements of the Nasdaq Marketplace Rules. In making this determination, the Board has considered Mr.
Tarsh’s extensive financial experience and business background. Both our independent registered public accounting firm and management
periodically meet privately with our Audit Committee.
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Compensation Committee
Our compensation committee (“ Compensation
Committee ”) consists of Thomas Meier, who is the chair of the committee, Simon Tarsh, and Timothy Ramdeen. Our board of directors
has determined that each of the members of our Compensation Committee is an outside director, as defined pursuant to Section 162(m) of
the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence requirements. The
functions of this committee include, among other things:
●
reviewing, modifying, and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation strategy and policies;
●
reviewing and approving the compensation, the performance goals, and objectives relevant to the compensation, and other terms of employment of our executive officers;
●
reviewing and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending, or terminating existing plans and programs;
●
reviewing and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements for our executive officers;
●
reviewing with management and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic reports or proxy statements to be filed with the SEC; and
●
preparing the report that the SEC requires in our annual proxy statement.
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee
(“ Nominating Committee ”) consists of Timothy Ramdeen, who is the chair of the committee, and Simon Tarsh. Our Board
has determined that each of the members of this committee satisfies the Nasdaq Marketplace Rules independence requirements. The functions
of this committee include, among other things:
●
identifying, reviewing, and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;
●
evaluating director performance on the board and applicable committees of the board and determining whether continued service on our board is appropriate;
●
evaluating, nominating, and recommending individuals for membership on our board of directors; and
●
evaluating nominations by stockholders of candidates for election to our board of directors.
Board Leadership Structure
Our board of directors is free to select the Chairman
of the board of directors and the Chief Executive Officer in a manner that it considers to be in the best interests of our company at
the time of selection. Currently, Karina Fedasz serves as our Interim Chief Executive Officer and Interim Chief Financial Officer. All
five members of our board of directors have been deemed to be “independent” by the board of directors, which we believe provides
sufficient independent oversight of our management.
Our board of directors, as a whole and also at
the committee level, plays an active role overseeing the overall management of our risks. Our Audit Committee reviews risks related to
financial and operational items with our management and our independent registered public accounting firm. Our board of directors is in
regular contact with our Chief Executive Officer, who reports directly to the board of directors and supervises day-to-day risk management.
99
Role of Board in Risk Oversight Process
We face a number of risks, including those described
under the caption “Risk Factors” contained elsewhere in this Report. Our board of directors believes that risk management
is an important part of establishing, updating, and executing our business strategy. Our board of directors has oversight responsibility
relating to risks that could affect the corporate strategy, business objectives, compliance, operations, and the financial condition and
performance of our Company. Our board of directors focuses its oversight on the most significant risks facing us and, on our processes
to identify, prioritize, assess, manage, and mitigate those risks. Our board of directors receives regular reports from members of our
senior management on areas of material risk to us, including strategic, operational, financial, legal and regulatory risks. While our
board of directors has an oversight role, management is principally tasked with direct responsibility for management and assessment of
risks and the implementation of processes and controls to mitigate their effects on us.
Our board is generally responsible for the oversight
of corporate risk in its review and deliberations relating to our activities. Our principal source of risk falls into two categories,
financial and product commercialization. Our Audit Committee oversees management of financial risks; our board regularly reviews information
regarding our cash position, liquidity, and operations, as well as the risks associated with each. The board regularly reviews plans,
results and potential risks related to our product offerings, growth and strategies. Our Compensation Committee oversees risk management
as it relates to our compensation plans, policies and practices for all employees including executives and directors, particularly whether
our compensation programs may create incentives for our employees to take excessive or inappropriate risks which could have a material
adverse effect on our company.
Board Member Attendance at Annual Stockholder Meetings
Although we do not have a formal policy regarding director attendance
at annual stockholder meetings, directors are encouraged to attend these annual meetings. All of our directors attended our 2024 virtual
annual meeting of stockholders held on September 5, 2024
Number of Meetings
During the fiscal year ended December 31, 2024,
our Board met eighteen times, the audit committee met five times, the compensation committee met four times, and the nominating and corporate
governance committee met two times. In the fiscal year ended December 31, 2024, each of our directors attended at least 75% of the meetings
of the Board and committees on which he served as a member.
Code of Business Conduct and Ethics
We have adopted a written code of business conduct
and ethics that applies to our directors, officers, and employees, including our principal executive officer, principal financial officer,
principal accounting officer or controller, or persons performing similar functions. The code of business conduct and ethics is posted
on our website at www.onconetix.com . We expect that any amendments or waivers to the code that are required by law or Nasdaq Marketplace
Rules will be disclosed on our website.
Insider Trading Policy
We have adopted insider trading policies and procedures
governing the purchase, sale, and/or other dispositions of our securities by directors, officers, and employees, which are reasonably
designed to promote compliance with insider trading laws, rules and regulations, and applicable Nasdaq listing standards (the “ Insider
Trading Policy ”).
The foregoing
description of the Insider Trading Policy does not purport to be complete and is qualified in its entirety by the terms and conditions
of the Insider Trading Policy, a copy of which is attached hereto as Exhibit 19 and is incorporated herein by reference.
Compensation Recovery Policy
On January 17, 2024, our Board adopted a policy
(commonly known as a “clawback” policy) which provides for the recovery of erroneously awarded incentive compensation to certain
of our officers in the event that we are required to prepare an accounting restatement due to material noncompliance by us with any financial
reporting requirements under the federal securities laws. This policy is designed to comply with Section 10D of the Securities Exchange
Act of 1934, as amended, related rules and the listing standards of Nasdaq Stock Market or any other securities exchange on which our
shares are listed in the future. The policy is administered by our Board or, if so designated by the Board, the Compensation Committee.
Any determinations made by the Board shall be final and binding on all affected individuals.
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The individuals covered by the policy (the “Covered
Executives”) are any current or former employee who is or was identified as our president, principal financial officer, principal
accounting officer (or if there is no such accounting officer, the controller), any vice-president in charge of a principal business unit,
division, or function (such as sales, administration, or finance), any other officer who performs a policy-making function, or any other
person (including any executive officer of our subsidiaries or affiliates) who performs similar policy-making functions for us.
The policy covers our recoupment of “Incentive-Based
Compensation” (as defined in the policy) received by a person after beginning service as a Covered Executive and who served as a
Covered Executive at any time during the performance period for that Incentive-Based Compensation. In the event we are required to prepare
an accounting restatement, the policy requires us to recover, reasonably promptly, any excess incentive compensation (as determined by
our Board or Compensation Committee) received by any Covered Executive during the three completed fiscal years immediately preceding the
date on which we are required to prepare such accounting restatement.
The foregoing description of our clawback does
not purport to be complete and is qualified in its entirety by the terms and conditions of such policy, a copy of which is filed as an
exhibit to the registration statement filed on October 8, 2021 and is incorporated herein by reference.
Communications with the Board
Any stockholder or any other interested party
who desires to communicate with our Board, our non-management directors, or any specified individual director, may do so by directing
such correspondence to the attention of the Interim Chief Executive Officer, Onconetix, Inc., 201 E. Fifth Street, Suite 1900, Cincinnati,
OH. The Interim Chief Executive Officer will forward the communication to the appropriate director or directors as appropriate.
Delinquent Section 16(a) Reports
Section 16(a) of the Exchange Act requires the
Company’s directors, executive officers, and persons who own more than 10% of a registered class of the Company’s equity securities,
to file with the SEC reports of beneficial ownership and reports of changes in beneficial ownership in the Company’s securities.
Based solely upon a review of Forms 3, 4 and 5, and amendments thereto, filed electronically with the SEC during the year ended December
31, 2024, the Company believes that all Section 16(a) filings applicable to its directors, officers, and 10% stockholders were filed on
a timely basis during the year ended December 31, 2024, except that due to an administrative oversight, a Form 4 was not timely filed
to report a transaction that occurred in December 2024 by each of Christian Brühlmann and Ralph Schiess.
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Item 11. Executive Compensation.
Summary Compensation Table
The following table sets forth total compensation
paid to our named executive officers for the years ended December 31, 2024 and 2023. Individuals we refer to as our “named executive
officers” include (i) all individuals serving as our Chief Executive Officer during the fiscal year ended December 31, 2024; (ii)
our two most highly compensated executive officers other than our Chief Executive Officer who were serving as executive officers at the
end of the fiscal year ended December 31, 2024, whose salary and bonus for services rendered in all capacities exceeded $100,000 during
the fiscal year ended December 31, 2024 and (iii) up to two of our most highly compensated executive officers other than our Chief Executive
Officer who served as executive officers during the fiscal year ended December 31, 2024 but not at the end of the fiscal year ended December
31, 2024 whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2024.
Name and Principal Position
Year
Salary
($)
Bonus
($)
Stock
Awards
($) (1)
Option
Awards
($) (1)
All
Other
Compensation
($)
Total
($)
Ralph Schiess (2)
2024
265,176
40,000 (3)
-
-
-
305,176
Former Chief Executive Officer and Former Chief Science Officer
2023
11,228
94,317
-
-
-
105,545
Neil Campbell (4)
2024
5,481
-
-
-
158,333 (5)
163,814
Former Chief Executive Officer
2023
114,792
75,000
-
186,377
-
376,169
Bruce Harmon (6)
2024
166,491
-
-
-
66,153 (7)
232,644
Former Chief Financial Officer
2023
78,542
24,375
-
62,126
-
165,043
Christian Brühlmann (8)
2024
265,176
-
-
-
-
265,176
Former Chief Strategy Officer
2023
11,228
94,317
-
-
81,250
186,795
Karina Fedasz (9)
2024
197,125
-
-
-
-
197,125
Interim Chief Executive Officer and Interim Chief Financial Officer
2023
-
-
-
-
-
-
(1)
This figure represents the aggregate grant date fair value of stock-based awards granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. Assumptions used in the calculation of these amounts are included in the notes to our consolidated financial statements included elsewhere in this Report. Does not include restricted stock units (“RSUs”) granted to Ralph Schiess and Christian Brühlmann, as such RSUs were granted in exchange for options to purchase shares of Proteomedix AG (“PMX”), pursuant to the Share Exchange Agreement, dated December 13, 2023, between the Company and PMX, and not as compensation for services rendered to the Company.
(2)
Mr. Schiess was appointed as Interim Chief Executive Officer on January 12, 2024 and as Chief Science Officer on December 15, 2023. His salary for 2023 is noted as pro-rata for such time as effective in 2023. The bonus for Mr. Schiess noted in 2023 is for the amount earned in 2023 but paid in full in 2024.
(3)
Mr. Schiess was awarded a bonus of $40,000 for his role as Interim Chief Executive Officer. A 2024 bonus for services rendered as Chief Science Officer during the fiscal year ended December 31, 2024 is omitted as it cannot be calculated because it has not yet been determined. If and when such amount becomes calculable in whole or part, the Company will disclose such amounts on a Current Report on Form 8-K
(4)
Mr. Campbell was appointed by the Board to serve as Chief Executive Officer on October 4, 2023, and resigned on January 10, 2024.
(5)
Mr. Campbell received a severance payment of $158,333,
(6)
Mr. Harmon was appointed by the Board to serve as Chief Financial Officer on October 4, 2023 and resigned as Chief Financial Officer on June 8, 2024.
(7)
Mr. Harmon received a severance of $66,153 upon his resignation.
(8)
Mr. Brühlmann was appointed as Chief Strategy Officer on December 15, 2023. His salary for 2023 is noted as pro-rata for such time as effective in 2023. The bonus for Mr. Brühlmann noted in 2023 is for the amount earned in 2023 but paid in full in 2024. A 2024 bonus for services rendered as Chief Strategy Officer during the fiscal year ended December 31, 2024 is omitted as it cannot be calculated because it has not yet been determined. When such amount becomes calculable in whole or part, the Company will disclose such amounts on a Current Report on Form 8-K.
(9)
Ms. Fedasz was appointed Interim Chief Financial Officer effective June 10, 2024 and Interim Chief Executive Officer effective April 2, 2025.
102
Employment Agreements of Named Executive Officers
Set forth below is a summary of many of the material
provisions of the employment agreements with our named executive officers and other executive officers, of which summaries do not purport
to contain all of the material terms and conditions of each such agreement.
Neil Campbell
In connection with Dr. Campbell’s appointment,
the Company and Dr. Campbell entered into an employment agreement (the “Campbell Employment Agreement”), pursuant to which
Dr. Campbell served as President and Chief Executive Officer of the Company and was paid a signing bonus of $75,000 and an annual base
salary of $475,000. In addition, Dr. Campbell was entitled to receive, subject to employment by the Company on the applicable date of
the bonus payout, an annual target discretionary bonus of up to 50% of his annual base salary, payable at the discretion of the Compensation
Committee of the Board. Dr. Campbell was also eligible to receive healthcare benefits as may be provided from time to time by the Company
to its employees generally, and to receive paid time off annually.
Pursuant to the Campbell Employment Agreement,
Dr. Campbell was granted a long-term equity incentive grant in the form of an option to purchase 3% of the total outstanding shares of
the Company’s common stock as of the Effective Date. Such award vests in quarterly increments over a period of three years from
the Effective Date, subject to Dr. Campbell’s continued employment by the Company on the applicable vesting date. Dr. Campbell’s
option grant has an exercise price per share equal to $0.4305, which was the closing price of the Company’s common stock on Nasdaq
on the grant date.
Pursuant to the Campbell Employment Agreement,
Dr. Campbell agreed to be bound by certain non-compete and non-solicitation covenants contained therein.
Effective as of January 10, 2024, Dr. Campbell resigned as President
and Chief Executive Officer and a member of the Board. The Company entered into a Release of Claims with Dr. Campbell, pursuant to which
Dr. Campbell will receive a severance payment of $158,333 in two equal payments.
Bruce Harmon
In connection with Mr. Harmon’s appointment,
the Company and Mr. Harmon entered into an employment agreement (the “Harmon Employment Agreement”), pursuant to which Mr.
Harmon will serve as Chief Financial Officer of the Company and will be paid an annual base salary of $325,000. In addition, Mr. Harmon
is entitled to receive, subject to employment by the Company on the applicable date of bonus payout, an annual target discretionary bonus
of up to 30% of his annual base salary, payable at the discretion of the Compensation Committee of the Board. Pursuant to the Harmon Employment
Agreement, Mr. Harmon is also eligible to receive healthcare benefits as may be provided from time to time by the Company to its employees
generally, and to receive paid time off annually.
Pursuant to the Harmon Employment Agreement, Mr.
Harmon was granted a long-term equity incentive grant in the form of an option to purchase 1% of the total outstanding shares of the Company’s
common stock as of the Effective Date. Such award vests in quarterly increments over a period of three years from the Effective Date,
subject to Mr. Harmon’s continued employment by the Company on the applicable vesting date. Mr. Harmon’s option grant has
an exercise price per share equal to $0.4305, which was the closing price of the Company’s common stock on the Nasdaq Stock Market
on the grant date.
Pursuant to the Harmon Employment Agreement, Mr.
Harmon agreed to be bound by certain non-compete and non-solicitation covenants contained therein.
Mr. Harmon resigned as Chief Financial Officer
of the Company effective as of June 8, 2024. On June 10, 2024, the Company entered into a Release Agreement with Mr. Harmon, which provides
for two months of severance payment.
103
Christian Brühlmann
In November 2011, Christian Brühlmann entered
into an employment agreement with Proteomedix (as amended, the “Brühlmann Employment Agreement”), pursuant to which Mr.
Brühlmann serves as Chief Financial Officer of Proteomedix and was paid a base salary of 233,100 Swiss francs (“CHF”)
in the fiscal year ended December 31, 2024. Mr. Brühlmann is also eligible to participate in the stock option plan sponsored by Proteomedix
(the “PMX Option Plan”) and to receive accident insurance, sick pay insurance, a pension plan, and certain government-mandated
child allowance benefits.
Pursuant to the Brühlmann Employment Agreement,
Mr. Brühlmann agreed to be bound by certain non-compete and non-solicitation covenants contained therein.
The Brühlmann Employment Agreement may be
terminated with notice in writing by either Proteomedix or Mr. Brühlmann. In the event of a change of control, either party must
give twelve months’ notice, but for a period starting six months prior to and two years after a change of control becomes effective,
Proteomedix must, upon request of Mr. Brühlmann, release him from his working obligations (“Garden Leave”) within 30
days after receipt of such request. During the Garden Leave, Mr. Brühlmann may enter into consulting arrangements and accept board
positions, provided that Mr. Brühlmann’ statutory and contractual confidentiality, non-competition and non-solicitation obligations
remain unchanged and in effect. If the termination of the Brühlmann Employment Agreement is for any other reason than a change of
control, then either party must give five months’ notice.
On February 18, 2025, Christian Brühlmann
resigned from his position as Chief Strategy Officer of the Company, effective immediately. Mr. Brühlmann will remain in his position
as Chief Business Officer of Proteomedix AG.
Ralph Schiess
In November 2011, Ralph Schiess entered into an
employment agreement with Proteomedix (as amended, the “Schiess Employment Agreement”), pursuant to which Dr. Schiess serves
as Chief Executive Officer of Proteomedix and was paid a base salary of CHF 233,100 in the fiscal year ended December 31, 2023. Dr. Schiess
is also eligible to participate in the PMX Option Plan and to receive accident insurance, sick pay insurance, a pension plan, and certain
government-mandated child allowance benefits. Dr. Schiess received a bonus of CHF 90,804 for 2023.
Pursuant to the Schiess Employment Agreement,
Dr. Schiess agreed to be bound by certain non-compete and non-solicitation covenants contained therein.
The Schiess Employment Agreement may be terminated
with notice in writing by either Proteomedix or Dr. Schiess. In the event of a change of control, either party must give twelve months’
notice, but for a period starting six months prior to and two years after a change of control becomes effective, Proteomedix must, upon
request of Dr. Schiess, must provide Garden Leave within 30 days after receipt of such request. During the Garden Leave, Dr. Schiess may
enter into consulting arrangements and accept board positions, provided that Dr. Schiess’ statutory and contractual confidentiality,
non-competition and non-solicitation obligations remain unchanged and in effect. If the termination of the Schiess Employment Agreement
is for any other reason than a change of control, then either party must give five months’ notice.
On February 24, 2025, Dr. Schiess resigned from
his positions as the Interim Chief Executive Officer and Chief Science Officer of the Company, effective immediately, and from his position
as Chief Executive Officer of Proteomedix, effective May 31, 2025.
Karina Fedasz
On June 10, 2024, the Company appointed Karina
M. Fedasz as Interim Chief Financial Officer of the Company, effective immediately. In connection with Ms. Fedasz’s appointment
as Interim Chief Financial Officer, on June 10, 2024, the Company and Ms. Fedasz entered into a consulting agreement (the “Fedasz
Consulting Agreement”), pursuant to which Ms. Fedasz will serve as Interim Chief Financial Officer of the Company and will be paid
$15,000 per month for up to 80 hours of monthly service to the Company and will provide signatory services for $2,500 per month. The Fedasz
Consulting Agreement is for a term of one year, subject to early termination by either party upon thirty (30) days’ written notice.
104
On April 2, 2025, Ms. Fedasz was appointed Interim
Chief Executive Officer of the Company. No additional compensation was granted in connection with this appointment.
Potential Payments Upon Termination or Change-in-Control
See “Employment Agreements of Named Executive Officers”
above.
Outstanding Equity Awards at Fiscal Year-End
None of our named executive officers had any outstanding equity incentive
plan awards as of December 31, 2024.
Director Compensation
The Board has approved cash and equity compensation
of directors, such that we pay each of our non-employee directors an annual cash retainer for service on the Board and for service on
each committee on which the director is a member. The chair of each committee receives an additional annual retainer for such service.
All retainers are payable in arrears in four equal quarterly installments. The retainers paid to non-employee directors for service on
the Board and for service on each committee of the Board on which the director is a member are as follows:
Annual Board Service Retainer
All non-employee directors
$ 45,000
Annual Committee Member Service Retainer
Member of the Audit Committee
$ 10,000
Member of the Compensation Committee
$ 7,500
Member of the Nominating and Corporate Governance Committee
$ 5,000
Annual Committee Chair Service Retainer
(in addition to Committee Member Service Retainer above):
Chair of the Audit Committee
$ 15,000
Chair of the Compensation Committee
$ 7,500
Chair of the Nominating and Corporate Governance Committee
$ 5,000
Certain members of our Board have voluntarily
elected to waive payment of their annual cash retainers.
Additionally, each non-director will receive an
annual grant of restricted stock awards equal to 0.04% of the shares of Common Stock outstanding as of the date of the Company’s
annual meeting, such restricted stock vesting approximately one year from the grant dates and upon the director’s death or disability
or upon a change of control of the Company.
Our Compensation Committee will continue to review
and make recommendations to the Board regarding compensation of directors, including equity-based plans. We will reimburse our non-employee
directors for reasonable travel expenses incurred in attending board and committee meetings.
105
Director Compensation Table
The following table sets forth information concerning
the compensation of our directors for the year ended December 31, 2024:
Fees
Earned or
Paid In
Cash
Stock
Awards
Option
Awards
All Other
Compensation
Total
Name
($)
($) (1)
($) (1)
($)
($)
Thomas Meier
11,250 (2,4)
5,120 (3)
—
40,067 (4)
56,437
Timothy Ramdeen
72,500 (5)
5,120 (3)
—
—
77,620
James Sapirstein (9)
176,250 (6)
5,120 (3)
—
—
181,370
Ajit Singh
45,000 (2)
5,120 (7)
—
—
50,120
Simon Tarsh
82,500 (8)
5,120 (3)
—
—
87,620
(1)
This figure represents the aggregate grant date fair value of stock-based awards granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. Assumptions used in the calculation of these amounts are included in the notes to our consolidated financial statements included elsewhere in this Report.
(2)
Represents fees earned for serving as a member of the Board.
(3)
These directors were each granted 3,318 shares of restricted stock on September 26, 2024, which vest on August 31, 2025. All such shares are unvested and remain outstanding as of December 31, 2024.
(4)
Represents fees earned for serving as a seller’s representative in connection with the PMX merger.
(5)
Represents fees earned by Mr. Ramdeen, for serving as a member of the Board, Audit Committee, and Compensation Committee, as well as Chairman of the Nominating Governance Committee totaling $72,500.
(6)
Represents fees earned by Mr. Sapirstein, for serving as a member of the Board, Audit Committee, and Nominating Governance Committee, as well as Chairman of the Compensation Committee, totaling $75,000. This figure also includes $101,250 of fees earned by Mr. Sapirstein for his role as Lead Independent Director and non-executive Chairman of the Board.
(7)
Mr. Singh was granted 3,318 shares of restricted stock, which vest on August 31, 2025. All such shares are unvested and remain outstanding as of December 31, 2024. Mr. Sing was also granted 78 shares on February 14, 2024 when he joined the Board, which vested in full on June 30, 2024.
(8)
Represents fees earned by Mr. Tarsh for serving as a member of the Board, Compensation Committee, and Nominating Governance Committee, as well as Chairman of the Audit Committee, totaling $82,500.
(9)
As of March 28, 2025, James Sapirstein resigned as Executive Chairman and a member of the Board.
Securities Authorized for Issuance under
Equity Compensation Plans
The following table provides information as of
December 31, 2024, regarding our common stock that may be issued under the Company’s 2019 Equity Incentive Plan (the “2019
Plan”) and the Company’s 2022 Equity Incentive Plan (the “2022 Plan”).
Plan category:
Number of
Securities to
be issued
Upon
Exercise of
Outstanding
Options,
Warrants,
and Rights (a)
Weighted
Average
Exercise
Price of
Outstanding
Options (b)
Number of
Securities
Remaining
Available for
Future
Issuance
Under Equity
Compensation
Plans
(Excluding
Securities
Reflected in
column (a)) (c)
Equity compensation plans approved by stockholders
2019 Plan (1)
-
-
-
(1)(2)
2022 Plan (3)
13,674
$
156.96
719,660
Total
13,674
$
156.96
719,660
(1)
The 2019 Plan permits grants of equity awards to employees, directors, consultants, and other independent contractors. Our board of directors and stockholders have approved a total reserve of 35,000 shares for issuance under the 2019 Plan.
(2)
Once the 2022 Plan became effective, no further grants were made under the 2019 Plan and all shares that remained available for the issuance of awards under our 2019 Plan as of immediately prior to the time our 2022 Plan became effective were rolled over into the 2022 Plan.
(3)
The 2022 Plan permits grants of equity awards to employees, directors, consultants, and other independent contractors. Our board of directors and stockholders have approved a total reserve of 1,450,000 shares for issuance under the 2022 Plan, of which 719,660 are remaining.
106
The following table provides
information as of December 31, 2024, regarding common stock of Proteomedix that may be issued under a stock option plan sponsored by Proteomedix
(the “PMX Option Plan”).
Plan category:
Number of
Securities to
be issued
Upon
Exercise of
Outstanding
Options
(a)
Weighted
Average
Exercise
Price of
Outstanding
Options (b)
Number of
Securities
Remaining
Available for
Future
Issuance
Under Equity
Compensation
Plans
(Excluding
Securities
Reflected in
column (a)) (c)
Equity compensation plans approved by Proteomedix board of directors
PMX Option Plan (1)
58,172
3.46
n/a (1)(2)
Total
58,172
3.46
(1)
The PMX Option Plan permits grants of equity awards to employees and consultants. The board of directors of Proteomedix approves shares issued under this plan and there is no maximum number of shares that may be issued.
(2)
The PMX Option Plan does not have a maximum number of shares that may be issued.
2022 Equity Incentive Plan
Our board of directors adopted, and our stockholders
approved, our 2022 Plan effective upon the completion of our initial public offering. Our 2022 Plan is a successor to and continuation
of our 2019 Plan. Our 2022 Plan became effective on the date of the completion of our initial public offering. Once the 2022 Plan became
effective, no further grants will be made under the 2019 Plan.
Awards. Our 2022 Plan provides for the
grant of incentive stock options, or ISOs, within the meaning of Section 422 of the Internal Revenue Code, or the Code, to employees,
including employees of any parent or subsidiary, and for the grant of nonstatutory stock options, or NSOs, stock appreciation rights,
restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants,
including employees and consultants of our affiliates.
107
Authorized Shares. Initially, the maximum
number of shares of our common stock that may be issued under our 2022 Plan was 40,000 shares of our common stock, which is the sum of
(i) 5,000 new shares, plus (ii) an additional number of shares not to exceed 35,000 (calculated after giving effect to the Pre-IPO Stock
Split), consisting of (A) shares that remain available for the issuance of awards under our 2019 Plan as of immediately prior to the time
our 2022 Plan becomes effective and (B) shares of our common stock subject to outstanding stock options or other stock awards granted
under our 2019 Plan that, on or after the 2022 Plan becomes effective, terminate or expire prior to exercise or settlement; are not issued
because the award is settled in cash; are forfeited because of the failure to vest; or are reacquired or withheld (or not issued) to satisfy
a tax withholding obligation or the purchase or exercise price, if any, as such shares become available from time to time.
On August 22, 2022, at the Company’s 2022
annual meeting of stockholders, the Company’s stockholders approved an additional 25,000 shares of common stock that may be issued
under the 2022 Plan. On May 31, 2023, at the Company’s 2022 annual meeting of stockholders, the Company’s stockholders approved
an additional 13,750 shares of common stock that may be issued under the 2022 Plan. On September 5, 2024, at the Company’s 2024
annual meeting of stockholders, the Company’s stockholders approved an additional 1,371,250 shares of common stock that may be issued
under the 2022 Plan.
The number of shares of common stock available
for issuance under our 2022 Plan will be reduced by: one share for each share of common stock issued pursuant to a stock option or stock
appreciation right with respect to which the exercise or strike price is at least 100% of the Fair Market Value of the Common Stock subject
to the stock option or appreciation right on the grant date; and (ii) 1.20 shares for each share of common stock issued pursuant to any
restricted stock unit or other “full value award.” The maximum number of shares of our common stock that may be issued on
the exercise of ISOs under our 2022 Plan is equal to the number of shares reserved under the 2022 Plan at any time.
Shares subject to stock awards granted under our
2022 Plan that expire or terminate without being exercised in full or that are paid out in cash rather than in shares do not reduce the
number of shares available for issuance under our 2022 Plan. Shares withheld under a stock award to satisfy the exercise, strike, or purchase
price of a stock award or to satisfy a tax withholding obligation do not reduce the number of shares available for issuance under our
2022 Plan. If any shares of our common stock issued pursuant to a stock award are forfeited back to or repurchased or reacquired by us
(i) because of a failure to meet a contingency or condition required for the vesting of such shares, (ii) to satisfy the exercise, strike
or purchase price of an award or (iii) to satisfy a tax withholding obligation in connection with an award, the shares that are forfeited
or repurchased or reacquired will revert to and again become available for issuance under the 2022 Plan. Any shares previously issued
which are reacquired in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of a stock
award will again become available for issuance under the 2022 Plan. The number of shares available for issuance under our 2022 Plan will
increase by 1.20 shares for each share subject to restricted stock units or other full value awards (not including stock options or stock
appreciation rights) which are forfeited or reacquired for the reasons described in the preceding two sentences.
Plan Administration. Our Board of Directors
has assigned the authority to administer the 2022 Plan to our Compensation Committee, but may, at any time, re-vest in itself some or
all of the power delegated to our Compensation Committee. The Compensation Committee may delegate to one or more of our officers the authority
to (i) designate employees (other than officers) to receive specified stock awards and (ii) determine the number of shares subject to
such stock awards. Under our 2022 Plan, our Compensation Committee has the authority to determine award recipients, grant dates, the numbers
and types of stock awards to be granted, the applicable fair market value, and the provisions of each stock award, including the period
of exercisability and the vesting schedule applicable to a stock award.
Stock Options. ISOs and NSOs are granted
under stock option agreements in a form approved by the Compensation Committee. The Compensation Committee determines the exercise price
for stock options, within the terms and conditions of the 2022 Plan, provided that the exercise price of a stock option generally cannot
be less than 100% of the fair market value of our common stock on the date of grant. Options granted under the 2022 Plan vest at the rate
specified in the stock option agreement as determined by the Compensation Committee.
108
The Compensation Committee determines the term
of stock options granted under the 2022 Plan, up to a maximum of 10 years. Unless the terms of an option holder’s stock option agreement,
or other written agreement between us and the recipient approved by the Compensation Committee, provide otherwise, if an option holder’s
service relationship with us or any of our affiliates ceases for any reason other than disability, death or cause, the option holder may
generally exercise any vested options for a period of three months following the cessation of service. This period may be extended in
the event that exercise of the option is prohibited by applicable securities laws. If an option holder’s service relationship with
us or any of our affiliates ceases due to death, or an option holder dies within a certain period following cessation of service, the
option holder or a beneficiary may generally exercise any vested options for a period of 18 months following the date of death. If an
option holder’s service relationship with us or any of our affiliates ceases due to disability, the option holder may generally
exercise any vested options for a period of 12 months following the cessation of service. In the event of a termination for cause, options
generally terminate upon the termination date. In no event may an option be exercised beyond the expiration of its term.
Acceptable consideration for the purchase of common
stock issued upon the exercise of a stock option will be determined by the Compensation Committee and may include (i) cash, check, bank
draft or money order, (ii) a broker-assisted cashless exercise, (iii) the tender of shares of our common stock previously owned by the
option holder, (iv) a net exercise of the option if it is an NSO or (v) other legal consideration approved by the Board of Directors.
Unless the Compensation Committee provides otherwise,
options or stock appreciation rights generally are not transferable except by will or the laws of descent and distribution. Subject to
approval of the Compensation Committee or a duly authorized officer, an option may be transferred pursuant to a domestic relations order,
official marital settlement agreement or other divorce or separation instrument.
Tax Limitations on ISOs. The aggregate
fair market value, determined at the time of grant, of our common stock with respect to ISOs that are exercisable for the first time by
an award holder during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that exceed
such limit will generally be treated as NSOs. No ISO may be granted to any person who, at the time of the grant, owns or is deemed to
own stock possessing more than 10% of our total combined voting power or that of any of our parent or subsidiary corporations unless (i)
the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant and (ii) the
term of the ISO does not exceed five years from the date of grant.
Restricted Stock Unit Awards. Restricted
stock unit awards are granted under restricted stock unit award agreements in a form approved by the Compensation Committee. Restricted
stock unit awards may be granted in consideration for any form of legal consideration that may be acceptable to our board of directors
and permissible under applicable law. A restricted stock unit award may be settled by cash, delivery of stock, a combination of cash and
stock as deemed appropriate by the Compensation Committee or in any other form of consideration set forth in the restricted stock unit
award agreement. Additionally, dividend equivalents may be credited in respect of shares covered by a restricted stock unit award. Except
as otherwise provided in the applicable award agreement, or other written agreement between us and the recipient approved by the Compensation
Committee, restricted stock unit awards that have not vested will be forfeited once the participant’s continuous service ends for
any reason.
Restricted Stock Awards. Restricted stock
awards are granted under restricted stock award agreements in a form approved by the Compensation Committee. A restricted stock award
may be awarded in consideration for cash, check, bank draft or money order, past or future services to us or any other form of legal consideration
that may be acceptable to our board of directors and permissible under applicable law. The Compensation Committee determines the terms
and conditions of restricted stock awards, including vesting and forfeiture terms. If a participant’s service relationship with
us ends for any reason, we may receive any or all of the shares of common stock held by the participant that have not vested as of the
date the participant terminates service with us through a forfeiture condition or a repurchase right.
Stock Appreciation Rights. Stock appreciation
rights are granted under stock appreciation right agreements in a form approved by the Compensation Committee. The Compensation Committee
determines the strike price for a stock appreciation right, which generally cannot be less than 100% of the fair market value of our common
stock on the date of grant. A stock appreciation right granted under the 2022 Plan vests at the rate specified in the stock appreciation
right agreement as determined by the Compensation Committee. Stock appreciation rights may be settled in cash or shares of common stock
or in any other form of payment as determined by the Board and specified in the stock appreciation right agreement.
109
The Compensation Committee determines the term
of stock appreciation rights granted under the 2022 Plan, up to a maximum of 10 years. If a participant’s service relationship with
us or any of our affiliates ceases for any reason other than cause, disability or death, the participant may generally exercise any vested
stock appreciation right for a period of three months following the cessation of service. This period may be further extended in the event
that exercise of the stock appreciation right following such a termination of service is prohibited by applicable securities laws. If
a participant’s service relationship with us, or any of our affiliates, ceases due to disability or death, or a participant dies
within a certain period following cessation of service, the participant or a beneficiary may generally exercise any vested stock appreciation
right for a period of 12 months in the event of disability and 18 months in the event of death. In the event of a termination for cause,
stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the termination of the individual
for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term.
Performance Awards. The 2022 Plan permits
the grant of performance awards that may be settled in stock, cash, or other property. Performance awards may be structured so that the
stock or cash will be issued or paid only following the achievement of certain pre-established performance goals during a designated performance
period. Performance awards that are settled in cash or other property are not required to be valued in whole or in part by reference to,
or otherwise based on, the common stock.
The performance goals may be based on any measure
of performance selected by the board of directors or the Compensation Committee. The performance goals may be based on company-wide performance
or performance of one or more business units, divisions, affiliates, or business segments, and may be either absolute or relative to the
performance of one or more comparable companies or the performance of one or more relevant indices. Unless specified otherwise by the
board of directors at the time the performance award is granted, the board or Compensation Committee will appropriately make adjustments
in the method of calculating the attainment of performance goals as follows: (i) to exclude restructuring and/or other nonrecurring charges;
(ii) to exclude exchange rate effects; (iii) to exclude the effects of changes to generally accepted accounting principles; (iv) to exclude
the effects of any statutory adjustments to corporate tax rates; (v) to exclude the effects of items that are “unusual” in
nature or occur “infrequently” as determined under generally accepted accounting principles; (vi) to exclude the dilutive
effects of acquisitions or joint ventures; (vii) to assume that any portion of our business which is divested achieved performance objectives
at targeted levels during the balance of a performance period following such divestiture; (viii) to exclude the effect of any change in
the outstanding shares of our common stock by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization,
merger, consolidation, spin-off, combination or exchange of shares or other similar corporate change or any distributions to common stockholders
other than regular cash dividends; (ix) to exclude the effects of stock based compensation and the award of bonuses under our bonus plans;
(x) to exclude costs incurred in connection with potential acquisitions or divestitures that are required to be expensed under generally
accepted accounting principles; (xi) to exclude the goodwill and intangible asset impairment charges that are required to be recorded
under generally accepted accounting principles; and (xi) to exclude the effects of the timing of acceptance for review and/or approval
of submissions to the U.S. Food and Drug Administration or any other regulatory body.
Other Stock Awards. The Compensation Committee
may grant other awards based in whole or in part by reference to our common stock. The Compensation Committee will set the number of shares
under the stock award (or cash equivalent) and all other terms and conditions of such awards.
Non-Employee Director Compensation Limit. The
aggregate value of all compensation granted or paid to any non-employee director with respect to any calendar year, including awards granted
and cash fees paid by us to such non-employee director, will not exceed $150,000 in total value; provided that such amount will increase
to $200,000 for the first year for newly appointed or elected non-employee directors.
Changes to Capital Structure. In the event
there is a specified type of change in our capital structure, such as a stock split, reverse stock split or recapitalization, appropriate
adjustments will be made to (i) the class and maximum number of shares reserved for issuance under the 2022 Plan, (ii) the class and maximum
number of shares by which the share reserve may increase automatically each year, (iii) the class and maximum number of shares that may
be issued on the exercise of ISOs and (iv) the class and number of shares and exercise price, strike price or purchase price, if applicable,
of all outstanding stock awards.
Corporate Transactions. The following applies
to stock awards under the 2022 Plan in the event of a corporate transaction (as defined in the 2022 Plan), unless otherwise provided in
a participant’s stock award agreement or other written agreement with us or one of our affiliates or unless otherwise expressly
provided by the Board or Compensation Committee at the time of grant.
110
In the event of a corporate transaction, any stock
awards outstanding under the 2022 Plan may be assumed, continued, or substituted for by any surviving or acquiring corporation (or its
parent company), and any reacquisition or repurchase rights held by us with respect to the stock award may be assigned to the successor
(or its parent company). If the surviving or acquiring corporation (or its parent company) does not assume, continue or substitute for
such stock awards, then (i) with respect to any such stock awards that are held by participants whose continuous service has not terminated
prior to the effective time of the corporate transaction, or current participants, the vesting (and exercisability, if applicable) of
such stock awards will be accelerated in full to a date prior to the effective time of the corporate transaction (contingent upon the
effectiveness of the corporate transaction), and such stock awards will terminate if not exercised (if applicable) at or prior to the
effective time of the corporate transaction, and any reacquisition or repurchase rights held by us with respect to such stock awards will
lapse (contingent upon the effectiveness of the corporate transaction), and (ii) any such stock awards that are held by persons other
than current participants will terminate if not exercised (if applicable) prior to the effective time of the corporate transaction, except
that any reacquisition or repurchase rights held by us with respect to such stock awards will not terminate and may continue to be exercised
notwithstanding the corporate transaction.
In the event a stock award will terminate if not
exercised prior to the effective time of a corporate transaction, the board of directors may provide, in its sole discretion, that the
holder of such stock award may not exercise such stock award but instead will receive a payment equal in value to the excess (if any)
of (i) the per share amount payable to holders of common stock in connection with the corporate transaction over (ii) any per share exercise
price payable by such holder, if applicable. In addition, any escrow, holdback, earn out or similar provisions in the definitive agreement
for the corporate transaction may apply to such payment to the same extent and in the same manner as such provisions apply to the holders
of common stock.
Plan Amendment or Termination. Our board
of directors has the authority to amend, suspend or terminate our 2022 Plan, provided that such action does not materially impair the
existing rights of any participant without such participant’s written consent. Certain material amendments also require the approval
of our stockholders. No ISOs may be granted after the tenth anniversary of the date our board of directors adopts our 2022 Plan. No stock
awards may be granted under our 2022 Plan while it is suspended or after it is terminated.
2019 Equity Incentive Plan
Our board of directors adopted, and our stockholders
approved our 2019 Equity Incentive Plan (the “2019 Plan”) in July 2019 for grants of awards to employees, directors, officers,
and consultants of us or any of our subsidiaries. Once the 2022 Plan became effective, no further grants will be made under the 2019 Plan.
However, the 2019 Plan will continue to govern the terms and conditions of the outstanding awards previously granted under the 2019 Plan.
Awards. Our 2019 Plan provides for the
grant of stock awards (collectively, “Stock Awards”) to employees, directors, officers and consultants of us or any of our
subsidiaries, consisting of (i) incentive stock options, (“ISOs”), within the meaning of Section 422 of the Internal Revenue
Code (the “Code”); (ii) nonstatutory stock options (“NSOs”); (iii) stock appreciation rights; (iv) restricted
stock awards; (v) restricted stock unit awards, and (vi) other forms of awards.
Authorized Shares . Once the 2022 Plan became
effective, no further grants were made under the 2019 Plan and all shares that remained available for the issuance of awards under our
2019 Plan as of immediately prior to the time our 2022 Plan became effective were rolled over into the 2022 Plan.
Plan Administration. The 2019 Plan may
be administered by our board of directors, and our board of directors may delegate such administration to a committee of the board of
directors (as applicable, the “Administrator”). The Administrator, in its discretion, selects the individuals to whom awards
may be granted, the time or times at which such awards are granted and the terms and conditions of such awards.
111
Stock Options. Stock options entitle the
holder to purchase a specified number of shares of common stock at a specified price (the exercise price), subject to the terms and conditions
of the stock option grant. Our board of directors may grant either incentive stock options, which must comply with Code Section 422, or
non-qualified stock options. ISO’s may only be granted to employees of the Company or a “parent corporation” or “subsidiary
corporation” thereof (as such terms are defined in Sections 424(e) and 424(f) of the Code). Our Administrator sets exercise prices
and terms and conditions; except that stock options must be granted with an exercise price not less than 100% of the fair market value
of our common stock on the date of grant. Unless our Administrator determines otherwise, fair market value means, as of a given date,
the closing price of our common stock. At the time of grant, our board of directors determines the terms and conditions of stock options,
including the quantity, exercise price, vesting periods, term (which may not exceed 10 years) and other conditions on exercise. Pursuant
to the 2019 Plan, we may only issue 35,000 ISOs.
Eligibility. Awards may be granted under the 2019 Plan to officers,
employees, directors, officers and of us and our subsidiaries. Incentive stock options may be granted only to employees of us or our subsidiaries.
Restricted Stock, Restricted Stock Units and Other
Stock-Based Awards. Our board of directors may grant awards of restricted stock, which are shares of common stock subject to specified
restrictions, and restricted stock units, or RSUs, which represent the right to receive shares of our common stock in the future. These
awards may be made subject to repurchase, forfeiture or vesting restrictions at the discretion of our board of directors’ discretion.
The restrictions may be based on continuous service with us or the attainment of specified performance goals, as determined by the board
of directors. Stock units may be paid in stock or cash or a combination of stock and cash, as determined by the board of directors. Other
stock awards valued in whole or in part by reference to, or otherwise based on, Common Stock, including the appreciation in value thereof
(e.g., options or stock rights with an exercise price or strike price less than one hundred percent (100%) of the fair market value of
the common stock at the time of grant) may be granted either alone or in addition to stock awards provided for under the 2019 Plan.
Stock Appreciation Rights. Upon exercise,
SARs entitle the holder to receive payment per share in stock or cash, or in a combination of stock and cash, equal to the excess of the
share’s fair market value on the date of exercise over the aggregate strike price of the number of Common Stock equivalents with
respect to which the Participant is exercising the SAR on such date (the “grant price”. Exercise of a SAR issued in tandem
with a stock option will reduce the number of shares underlying the related stock option to the extent of the SAR exercised. The term
of a SAR cannot exceed 10 years.
Changes to Capital Structure. In the event
there is a specified type of change in our capital structure, such as a stock split, reverse stock split or recapitalization, appropriate
adjustments will be made to (i) the class and maximum number of shares subject to the 2019 Plan, (ii) the class and maximum number of
shares that may be issued on the exercise of ISOs and (iii) the class and number of shares and exercise price, strike price or purchase
price, if applicable, of all outstanding stock awards.
Corporate Transactions. The following applies
to Stock Awards under the 2019 Plan in the event of a corporate transaction (as defined in the 2019 Plan), unless otherwise provided in
a participant’s stock award agreement or other written agreement with us or one of our affiliates or unless otherwise expressly
provided by the Board at the time of grant.
In the event of a corporate transaction, the board
of directors may take one of the following actions, contingent on the completion of the corporate transaction: (i) arrange for the surviving
or acquiring corporation (or its parent company) to assume, continue or substitute the Stock Award for a similar stock award; (ii) arrange
for the assignment of any reacquisition or repurchase rights held by the Company in respect of common stock issued pursuant to the Stock
Award to the surviving or acquiring corporation (or its parent company); (iii) accelerate the vesting (in whole or in part) of the Stock
Award; (iv) arrange for the lapse, in whole or in part, of any reacquisition or repurchase rights held by the Company with respect to
the Stock Award; (v) cancel or arrange for the cancellation of the Stock Award, to the extent not vested or not exercised prior to the
effective time of the corporate transaction, in exchange for such cash consideration that the Board; and (vi) make a payment equal to
the excess, if any, of (A) the value of the property the participant would have received upon the exercise of the Stock Award immediately
prior to the effective time of the corporate transaction, over (B) any exercise price payable by such holder in connection with such exercise
The Board need not take the same action or actions with respect to all Stock Awards or portions thereof or with respect to all participants.
The Board may also take different actions with respect to the vested and unvested portions of a Stock Award.
112
Additionally, under the 2019 Plan, a Stock Award
may be subject to additional acceleration of vesting and exercisability upon or after a Change in Control (as defined in the 2019 Plan)
as may be provided in the Grant Agreement for such Stock Award or as may be provided in any other written agreement between the participant
and the Company or any of its subsidiaries which may employ the participant, but in the absence of such provision, no such acceleration
will occur.
Plan Amendment or Termination. Our board
of directors has the authority to amend, suspend or terminate our 2019 Plan, subject to certain conditions, including that such action
does not materially impair the existing rights of any participant without such participant’s written consent. Certain material amendments
also require the approval of our stockholders. No ISOs may be granted after the tenth anniversary of the date our board of directors adopted
our 2019 Plan.
Proteomedix Stock Option Plan
The PMX Option Plan was approved by Proteomedix’s
board of directors as of July 1, 2015, and provides for the grant of options to acquire shares in Proteomedix. The terms of the PMX Option
Plan are described in more detail below.
The PMX Option Plan is administered by a plan
administrator (one or several persons) elected by Proteomedix’s board of directors (the “Proteomedix Board”) from time
to time. The plan administrator acts within the guidelines set and approved by Proteomedix’s board of directors or a committee thereof
and is authorized to, among others, determine (i) which eligible persons are to receive awards under the PMX Option Plan, (ii) the time
or times when such options grants are to be made, (iii) the nature and the number of options covered by each such grant, (iv) the time
or times at which each option right is to become exercisable, (v) the vesting conditions applicable to the options, (vi) the maximum term
for which the options are to remain outstanding, and (vii) any terms and conditions of the options granted, in each case, subject to the
guidelines set and approved by Proteomedix’s board of directors or a committee thereof. Persons eligible to participate in the PMX
Option Plan are employees, members of Proteomedix’s board of directors and consultants of Proteomedix or a subsidiary. The plan
administrator determines within the guidelines set and approved by Proteomedix’s board of directors or a committee which eligible
persons are to receive rights to acquire options under the PMX Option Plan.
The number of shares that may be issued under
the PMX Option Plan is determined by the Proteomedix’s board of directors. In the event common shares that otherwise would have
been issuable under the PMX Option Plan are withheld by Proteomedix in payment of the exercise price or withholding obligations, such
shares shall remain available for issuance under the PMX Option Plan. In the event that an outstanding award expires or is cancelled,
forfeited or terminated for any reason, the shares allocable to the unexercised or unsettled portion shall remain available for issuance
under the PMX Option Plan.
A participant may only exercise an option or stock
appreciation right to the extent that the option or stock appreciation right has vested and has not lapsed under the PMX Option Plan.
Unless otherwise determined by Proteomedix’s board of directors at the grant date or set forth in the grant notice, an option or
an award in the form of a restricted stock unit or stock appreciation right granted under the PMX Option Plan typically vests as to 25.0%
of the award at the end of the first year following the vesting start date, with the remaining 75.0% of the award vesting monthly over
the 3 years after the first year following the vesting start date.
If indicated in the grant notice or otherwise
resolved by Proteomedix’s board of directors, upon the occurrence of a “Corporate Transaction” (as defined in the PMX
Option Plan), all options (i) shall fully vest and (ii) may be immediately exercised, except if such options are canceled by the plan
administrator in exchange for compensation equivalent to the economic value of the option under the PMX Option Plan.
Proteomedix has complete and exclusive power and
authority to amend or modify the PMX Option Plan in any or all respects. No such amendment or modification shall, without the consent
of the grantee, adversely affect his/her rights and obligations under the PMX Option Plan.
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Item 12. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters.
The following table sets forth certain information
concerning the ownership of our common stock, with respect to: (i) each person, or group of affiliated persons, known to us to be the
beneficial owner of more than five percent of our common stock; (ii) each of our directors; (iii) each of our named executive officers;
and (iv) all of our current directors and executive officers as a group.
Applicable percentage ownership is based on 44,358,422 shares of common
stock outstanding as of May 30, 2025.
We have determined beneficial ownership in accordance
with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting
or investment power with respect to such securities. In addition, pursuant to such rules, we deemed outstanding shares of common stock
subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days of May 30, 2025. We did
not deem such shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Except as indicated
by the footnotes below, we believe, based on the information furnished to us, that the beneficial owners named in the table below have
sole voting and investment power with respect to all shares of our common stock that they beneficially own, subject to applicable community
property laws.
Shares of Common
Stock Owned
Name and Address of Beneficial Owner (1)
Number of
Shares
Percentage
Executive Officers and Directors
James Sapirstein
3,477 (10)
*
Simon Tarsh
3,477 (2)
*
Timothy Ramdeen
3,477 (3)
*
Thomas Meier
3,318 (4)
*
Ajit Singh
3,396 (5)
*
Karina M. Fedasz
-
-
Ralph Schiess
673,365 (6)
1.5 %
Christian Brühlmann
611,372 (7)
1.4 %
Bruce Harmon
29,574 (8)
*
Neil Campbell
- (9)
*
Andrew Oakley
1,709 (11)
All directors and named executive officers as a group (11 persons)
1,333,165
3 %
5% Stockholders
Altos Venture AG
2,695,931 (12)
6 %
*
Represents beneficial ownership of less than 1%.
(1)
Unless otherwise noted, the business address of each of the following entities or individuals is c/o Onconetix, Inc., 201 E. Fifth Street, Suite 1900, Cincinnati, Ohio 45202.
(2)
Includes 3,477 restricted stock awards of which 3,318 do not vest until August 31, 2025 and 101 shares of common stock underlying options that are currently exercisable within 60 days of November 1, 2024.
(3)
Includes 3,477 restricted stock awards of which 3,318 do not vest until August 31, 2025 and 59 shares of common stock underlying options that are currently exercisable within 60 days of November 1, 2024.
(4)
Includes 3,318 restricted stock awards of which 3,318 do not vest until August 31, 2025.
(5)
Includes 3,396 restricted stock awards of which 3,318 do not vest until August 31, 2025.
(6)
Includes 177,462 shares of common stock issuable upon settlement of RSUs. Dr. Schiess resigned as Chief Science Officer and Interim Chief Executive Officer on February 24, 2025.
(7)
Includes 177,462 shares of common stock issuable upon settlement of RSUs. Mr. Brühlmann resigned as Chief Strategy Officer on February 18, 2025.
(8)
Consists of 29,574 shares of common stock. Mr. Harmon resigned as Chief Financial Officer on June 8, 2024.
(9)
Mr. Campbell resigned as Chief Executive Officer on January 10, 2024.
(10)
Consists of 3,477 shares of common stock underlying options that are currently exercisable within 60 days of April 5, 2024.
(11)
Includes 1,709 restricted stock awards of which 1,709 do not vest until August 31, 2025.
(12)
Per Schedule 13D filed on September 26, 2024, Altos Venture AG (“Altos”) is the beneficial owner of 2,695,931 shares of Common Stock. The address of Altos is Obertorweg 64, CH-4123, Allschwil, Switzerland.
114
Item 13. Certain Relationships and Related
Transactions, and Director Independence.
The following is a description of transactions
since January 1, 2023 to which we were a party in which (i) the amount involved exceeded or will exceed the lesser of $120,000 of one
percent (1%) of our average total assets at year-end for the last two completed fiscal years and (ii) any of our directors, executive
officers or holders of more than 5% of our capital stock, or any member of the immediate family of, or person sharing the household with,
any of the foregoing persons, who had or will have a direct or indirect material interest, other than equity and other compensation, termination,
change in control and other similar arrangements, which are described under “Executive and Director Compensation.”
Debenture
On January 23, 2024, the Company issued a non-convertible
debenture (the “Debenture”) in the principal sum of $5.0 million, in connection with a Subscription Agreement, to Altos Ventures,
a stockholder of the Company. The Debenture has an interest rate of 4.0% per annum, and the principal and accrued interest are payable
in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. Additionally, the $5.0 million subscription
amount under the Subscription Agreement shall be increased by the amount of interest payable under the Debenture.
Related party advances
During the year ended December 31, 2023, the Company’s
Audit Committee completed a review of the Company’s expenses due to certain irregularities identified with regards to the related
party balance. Based on the results of the review, it was determined that the Company paid and recorded within selling, general and administrative
expenses, personal expenditures of the Company’s former CEO and an accounting employee who was also the former CEO’s assistant,
during 2022 and during the first three quarters of 2023. The Company evaluated the receivable, which was approximately $363,000, after
recording a recovery of approximately $159,000, and which represented the total of the items identified as personal in nature for which
the Company did not anticipate recovery from the related party. During 2023, the Company recorded a corresponding reserve for the full
amount, resulting in a net related party receivable balance of $0 as of December 31, 2023. There were no such transactions during the
year ended December 31, 2024.
Lease Agreements
The Company entered into a short-term lease in
Palm Beach, Florida with an unrelated party, with a commencement date of May 1, 2022, for approximately $14,000 per month. The lease,
which was personally guaranteed by the Company’s former CEO, ended on April 30, 2023. During the year ended December 31, 2023, the
Company incurred rent expense on this lease of approximately $51,000, and variable lease expense of approximately $4,000.
Consulting Agreement
On February 6, 2024,
the Company appointed Thomas Meier, PhD, as a member of the Company’s board of directors. Dr. Meier provides consulting services
to Proteomedix, through a consulting agreement that was effective January 4, 2024. The Company recorded approximately $58,000 in related
expenses during the year ended December 31, 2024, of which approximately $11,000 is included in accrued expenses in the accompanying consolidated
financial statements as of December 31, 2024.
115
On February 28, 2025, the Company and James Sapirstein
entered into a consulting agreement, pursuant to which Mr. Sapirstein will be compensated on an hourly basis at a rate of $400 per hour
for up to twenty hours per week. As of March 28, 2025, James Sapirstein resigned as Executive Chairman and a member of the Board.
Director Independence
The Board has evaluated each of its directors’
independence from the Company based on the definition of “independence” established by Nasdaq and has determined that each
of Simon Tarsh, Timothy Ramdeen, Andrew Oakley and Ajit Singh are independent directors, constituting a majority of the Board. The Board
has further determined that each member of our Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee
is “independent” under applicable Nasdaq rules.
The Board has also determined that each member
of our audit committee is “independent” for purposes the Exchange Act.
In its evaluation of each director’s or
nominee’s independence from the Company, the Board reviewed whether any transactions or relationships currently exist or existed
during the past year between each director or nominee and the Company and its subsidiaries, affiliates, equity investors, or independent
registered public accounting firm, and whether there were any transactions or relationships between each director or nominee and members
of the senior management of the Company or their affiliates.
Item 14. Principal Accounting Fees and Services.
Audit and Non-Audit Fees
EisnerAmper served as the independent registered
public accounting firm to audit our books and accounts for the fiscal year ended December 31, 2023. Malone-Bailey served as the independent
registered public accounting firm to audit our books and accounts for the fiscal year ended December 31, 2024.
The table below presents the aggregate fees billed
for professional services rendered by Malone-Bailey and EisnerAmper (prior auditor) for the years ended December 31, 2024 and
2023, respectively.
EiEisnerAmper
2024
2023
Audit fees
$ 742,827
$ 951,818
Audit-related fees
—
—
Tax fees
—
—
All other fees
—
—
Total fees
$ 742,827
$ 951,818
Malone-Bailey
2024
2023
Audit fees
$ 267,800
$ —
Audit-related fees
—
—
Tax fees
—
—
All other fees
—
—
Total fees
$ 267,800
$ —
In the above table, “audit
fees” are fees billed for services provided related to the audit of our annual consolidated financial statements, quarterly reviews
of our interim condensed financial statements, and services normally provided by EisnerAmper and Malone-Bailey in connection with regulatory
filings or engagements for that fiscal period.
Pre-Approval Policy
It is the Audit Committee’s policy to approve
in advance the types and amounts of audit, audit-related, tax, and any other services to be provided by our independent registered public
accounting firm. In situations where it is not practicable to obtain full Audit Committee approval, the Audit Committee has delegated
authority to the Chair of the Audit Committee to grant pre-approval of audit and permissible non-audit services and any associated fees.
Any pre-approved decisions by the Chair are required to be reviewed with the Audit Committee at its next scheduled meeting.
Our Audit Committee was formed upon the consummation
of our initial public offering. As a result, the audit committee did not pre-approve all of the foregoing services, although any services
rendered prior to the formation of our audit committee were approved by our board of directors. Since the formation of our Audit Committee,
and on a going-forward basis, the Audit Committee has and will pre-approve all auditing services and permitted non-audit services to
be performed for us by our auditors, including the fees and terms thereof (subject to the de minimis exceptions for non-audit services
described in the Exchange Act which are approved by the audit committee prior to the completion of the audit).
116
PART IV
Item 15. Exhibit and Financial Statement Schedules.
ONCONETIX, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID 206) F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID 274 ) F-3
Consolidated Balance Sheets as of December 31, 2024 and 2023 F-4
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023 F-5
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2024 and 2023 F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023 F-7
Notes to Consolidated Financial Statements F-8
F- 1
Report
of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Onconetix, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of Onconetix Inc. and its subsidiary (collectively, the “Company”) as of December 31, 2024, and the related
consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit), and
cash flows for the year then ended, and the related notes (collectively referred to as the “financial statements”). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024,
and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted
in the United States of America.
Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has
suffered recurring losses from operations and has a net capital deficiency that raises substantial doubt about its ability to continue
as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include
any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ MaloneBailey, LLP
www.malonebailey.com
We have served as the Company’s auditor
since 2025.
MALONEBAILEY LLP
Houston, Texas
May 30, 2025
F- 2
Report
of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Onconetix, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of Onconetix Inc. and Subsidiary (the “Company”) as of December 31, 2023, and the related consolidated statements
of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit), and cash flows for the year
then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial
statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023, and the
consolidated results of their operations and their cash flows for the year then ended, in conformity with accounting principles generally
accepted in the United States of America.
Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has
incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable
future, which raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters
are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ EisnerAmper LLP
We served as the Company’s auditor from
2023 to 2024.
EISNERAMPER LLP
Iselin, New Jersey
April 11, 2024, except for the effects of the reverse stock split discussed
in Note 1 to the financial statements, as to which the date is May 30, 2025.
F- 3
ONCONETIX, INC.
Consolidated Balance Sheets
December 31,
December 31,
2024
2023
ASSETS
Current assets
Cash
$ 646,500
$ 4,554,335
Accounts receivable, net
25,717
149,731
Inventories
64,079
364,052
Prepaid expenses and other current assets
213,971
770,153
Total current assets
950,267
5,838,271
Prepaid expenses, long-term
-
17,423
Deferred offering costs
-
366,113
Property and equipment, net
62,896
60,654
Operating right of use asset
119,427
148,542
Intangible assets, net
-
25,410,887
Goodwill
27,048,973
55,676,142
Total assets
$ 28,181,563
$ 87,518,032
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable
$ 3,787,564
$ 5,295,114
Accrued expenses
888,988
2,199,867
Notes payable, net of debt discounts of $ 4,966 and $ 381,627 at December 31, 2024 and 2023, respectively
9,328,061
9,618,373
Operating lease liability, current
119,427
74,252
Subscription agreement liability - Related Party
4,123,000
-
Contingent warrant liabilities
43,089
2,641
Total current liabilities
18,290,129
17,190,247
Note payable, net of current portion
-
118,857
Subscription agreement liability, long-term related party
-
864,000
Pension benefit obligation
280,879
556,296
Operating lease liability, net of current portion
-
74,290
Deferred tax liability, net
-
3,073,781
Total liabilities
18,571,008
21,877,471
Commitments and Contingencies (see Note 10)
Series B Convertible Redeemable Preferred stock, $ 0.00001 par value, 2,700,000 shares authorized at December 31, 2024 and 2023, 0 and 2,696,729 shares issued and outstanding at December 31, 2024 and 2023, respectively
-
64,236,085
Series C Redeemable Preferred Stock, $ 0.00001 par value, 10,000 shares authorized, 3,499 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively
1,067,928
-
Stockholders' equity
Series A Convertible Preferred stock, $ 0.00001 par value, 10,000 shares authorized at December 31, 2024 and 2023; 0 and 3,000 shares issued and outstanding at December 31, 2024 and 2023, respectively; Liquidation preference of $ 0 and $ 3,000,000 at December 31, 2024 and 2023, respectively.
-
-
Common stock, $ 0.00001 par value, 250,000,000 shares authorized at December 31, 2024 and 2023; 11,767,443 and 571,033 the shares issued at December 31, 2024 and 2023, respectively; 11,754,509 and 558,099 shares outstanding at December 31, 2024 and 2023, respectively
118
6
Additional paid-in capital
127,825,626
49,429,031
Treasury stock, at cost; 12,934 shares of common stock at December 31, 2024 and 2023
( 625,791 )
( 625,791 )
Due from shareholders
( 250,308 )
-
Accumulated deficit
( 115,683,621 )
( 56,786,194 )
Accumulated other comprehensive income (loss)
( 2,723,397 )
2,380,920
Total Onconetix, Inc. stockholders’ equity (deficit)
8,542,627
( 5,602,028 )
Non-controlling interest
-
7,006,504
Total stockholders’ equity
8,542,627
1,404,476
Total liabilities, convertible preferred stock, and stockholders’ equity
$ 28,181,563
$ 87,518,032
The accompanying notes are an integral part
of these consolidated financial statements.
F- 4
ONCONETIX, INC.
Consolidated Statements of Operations and Comprehensive Loss
December 31,
2024
December 31,
2023
Revenue
$ 2,524,116
$ 58,465
Cost of revenue
1,469,018
1,185,630
Gross profit
1,055,098
( 1,127,165 )
Operating expenses
Selling, general, and administrative
11,231,982
14,770,678
Research and development
154,359
1,949,406
Impairment of ENTADFI
3,530,716
14,687,346
Impairment of intangibles
10,279,796
-
Impairment of goodwill
32,347,000
-
Impairment of deposit on asset purchase agreement
-
3,500,000
Total operating expenses
57,543,853
34,907,430
Loss from operations
( 56,488,755 )
( 36,034,595 )
Other (expense) income
Loss on extinguishment of note payable
-
( 490,000 )
Interest expense - related party
( 534,245 )
-
Interest expense
( 873,433 )
( 671,625 )
Interest income
18
-
Change in fair value of subscription agreement liability
( 3,259,000 )
( 134,100 )
Change in fair value of contingent warrant liabilities
1,250,466
( 91,967 )
Other
168,746
-
Total other (loss)
( 3,247,448 )
( 1,387,692 )
Loss before income taxes
( 59,736,203 )
( 37,422,287 )
Income tax benefit
1,045,180
12,593
Net loss
$ ( 58,691,023 )
$ ( 37,409,694 )
Deemed dividend Series C preferred stock
( 206,404 )
-
Net loss applicable to common stockholders
( 58,897,427 )
( 37,409,694 )
Net loss per share, basic and diluted
$ ( 21.45 )
$ ( 87.45 )
Weighted average number of common shares outstanding, basic and diluted
2,745,564
427,784
Other comprehensive income (loss)
Net loss
$ ( 58,691,023 )
$ ( 37,409,694 )
Foreign currency translation
( 5,342,327 )
2,374,957
Change in pension benefit obligation
238,010
5,963
Total comprehensive loss
$ ( 63,795,340 )
$ ( 35,028,774 )
The accompanying notes are an integral part
of these consolidated financial statements.
F- 5
ONCONETIX, INC.
Consolidated Statements of Convertible Preferred
Stock and Stockholders’ Equity (Deficit)
Series
A Preferred Stock
Common
Stock
Additional
Paid-in
Treasury
Stock
Accumulated
Accumulated
Other
Comprehensive
Due
from
Total
Onconetix
Equity
Non-controlling
Equity
Total
Stockholders'
Equity
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Income
Shareholders
(Deficit)
(Deficit)
(Deficit)
Balance at December 31, 2023
3,000
—
571,033
$ 6
49,429,031
( 12,934 )
( 625,791 )
$ ( 56,786,194 )
$ 2,380,920
$ -
$ ( 5,602,028 )
7,006,504
$ 1,404,476
Issuance of common stock
and warrants from exercise of preferred investment options, net of issuance costs
—
—
186,466
2
765,027
—
—
—
—
—
765,029
—
765,029
Grant and immediate exercise
of warrants
—
—
154,027
2
6,153
—
—
—
—
—
6,155
—
6,155
Issuance of shares in connection
with related party subscription agreement
—
—
513,424
5
5,134,242
—
—
—
—
—
5,134,247
—
5,134,247
Conversion of Series A Preferred
Stock to common stock
( 3,000 )
—
142,749
1
( 1 )
—
—
—
—
—
—
—
—
Conversion of Series B Preferred
Stock to common stock
—
—
6,741,820
67
64,236,018
—
—
—
—
—
64,236,085
—
64,236,085
Exercise of stock options
—
—
406
—
163
—
—
—
—
—
163
—
163
Stock-based compensation
—
—
—
—
260,406
—
—
—
—
—
260,406
178,247
438,653
Issuance of restricted common
stock
—
—
16,668
—
—
—
—
—
—
—
—
—
—
Forfeitures of restricted stock
—
—
( 312 )
—
—
—
—
—
—
—
—
—
—
Cash in lieu of shares
—
—
( 227 )
—
( 719 )
—
—
—
—
—
( 719 )
—
( 719 )
Foreign currency translation
adjustment
—
—
—
—
—
—
—
—
( 5,342,327 )
—
( 5,342,327 )
—
( 5,342,327 )
Issuance of common stock
in connection with the ELOC
—
—
2,757,933
28
935,562
—
—
—
—
( 250,308 )
685,282
—
685,282
Issuance of restricted common
stock in exchange in exchange for options
—
—
683,456
7
7,184,744
—
—
—
—
—
7,184,751
( 7,184,751 )
—
Adjustment to redeemable
Series C preferred Stock
—
—
—
—
( 125,000 )
—
—
( 206,404 )
—
—
( 331,404 )
—
( 331,404 )
Changes in pension benefit
obligation
—
—
—
—
—
—
—
—
238,010
—
238,010
—
238,010
Net
loss
—
—
—
—
—
—
—
( 58,691,023 )
—
—
( 58,691,023 )
—
( 58,691,023 )
Balance
at December 31, 2024
—
—
11,767,443
118
$ 127,825,626
( 12,934 )
( 625,791 )
$ ( 115,683,621 )
$ ( 2,723,397 )
$ ( 250,308 )
$ 8,542,627
—
$ 8,542,627
Series A
Accumulated
Non-
Total
Preferred
Additional
Other
Total
controlling
Stockholders'
Stock
Common
Stock
Paid-in
Treasury
Stock
Accumulated
Comprehensive
Onconetix
Equity
Equity
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Income
Deficit
(Deficit)
(Deficit)
Balance at December 31, 2022
—
—
393,107
$ 4
42,331,308
( 11,493 )
( 566,810 )
$ ( 19,376,500 )
$ —
$ 22,388,002
$ —
$ 22,388,002
Issuance of common stock
from exercise of preferred investment options
—
—
62,155
—
2,272,838
—
—
—
—
2,272,838
—
2,272,838
Issuance of warrants for
settlement of contingent warrants
—
—
—
—
129,184
—
—
—
—
129,184
—
129,184
Issuance of Series A Preferred
Stock
3,000
—
—
—
3,490,000
—
—
—
—
3,490,000
—
3,490,000
Issuance of common stock
and Series B Preferred Stock in connection with PMX Transaction
—
—
91,885
2
875,482
—
—
—
—
875,484
—
875,484
Assumption of stock-based
compensation plan awards in connection with PMX Transaction
—
—
—
—
—
—
—
—
—
—
7,006,504
7,006,504
Exercise of stock options
—
—
1,148
—
459
—
—
—
—
459
—
459
Exercise of pre-funded warrants
—
—
16,166
—
—
—
—
—
—
—
—
—
Issuance of restricted stock
—
—
12,823
—
—
—
—
—
—
—
—
—
Forfeitures of restricted
stock
—
( 6,251 )
—
—
—
—
—
—
—
—
—
Stock-based compensation
—
—
—
—
329,760
—
—
—
—
329,760
—
329,760
Purchase of treasury shares
—
—
—
—
—
( 1,441 )
( 58,981 )
—
—
( 58,981 )
—
( 58,981 )
Foreign currency translation
adjustment
—
—
—
—
—
—
—
—
2,374,957
2,374,957
—
2,374,957
Changes in pension benefit
obligation
—
—
—
—
—
—
—
—
5,963
5,963
—
5,963
Net loss
—
—
—
—
—
—
—
( 37,409,694 )
—
( 37,409,694 )
—
( 37,409,694 )
Balance at December 31,
2023
3,000
—
571,033
$ 6
$ 49,429,031
( 12,934 )
$ ( 625,791 )
$ ( 56,786,194 )
$ 2,380,920
$ ( 5,602,028 )
$ 7,006,504
$ 1,404,476
The accompanying notes are an integral part
of these consolidated financial statements.
F- 6
ONCONETIX, INC.
Consolidated Statements of Cash Flows
For the year
ended
December 31,
2024
For the year
ended
December 31,
2023
Cash flows from operating activities
Net loss
$ ( 58,691,023 )
$ ( 37,409,694 )
Adjustments to reconcile net loss to net cash used in operating activities:
Impairment of deposit on asset purchase agreement
-
3,500,000
Impairment of other long-lived assets
-
267,019
Loss on impairment of goodwill
32,347,000
-
Loss on impairment of ENTADFI
3,530,717
14,687,346
Loss on impairment of intangibles
10,279,796
-
Amortization of debt discount
376,660
671,373
Amortization of debt discount - related party
400,000
-
Loss on related party receivable
-
265,648
Loss on extinguishment of note payable
-
490,000
Depreciation and amortization
731,345
43,937
Fair value of subscription agreement liability
-
729,900
Net periodic pension benefit cost
( 48,423 )
13,875
Stock-based compensation
438,653
329,760
Loss on impairment of inventory of ENTADFI
356,637
-
Change in fair value of contingent warrant liabilities
( 1,250,466 )
91,967
Change in fair value of subscription agreement liability
3,259,000
134,100
Recovery of related party receivable
-
( 159,000 )
Provision for excess inventory
-
1,152,369
Deferred tax benefit
( 1,045,181 )
( 12,593 )
Amortization of deferred offering costs
366,113
-
Gain on settlement of contingent warrant liabilities
( 5,282 )
-
Changes in assets and liabilities:
Accounts receivable
116,676
( 62,286 )
Inventory
( 62,273 )
( 315,828 )
Prepaid expenses and other assets
1,018,109
( 412,601 )
Prepaid expenses, LT
( 7,749 )
( 16,883 )
Accounts payable
( 1,477,075 )
3,372,648
Accrued expenses
( 1,129,050 )
( 942,075 )
Net cash used in operating activities
( 10,495,816 )
( 13,581,018 )
Cash flows from investing activities
Acquisition of assets
-
( 6,079,771 )
Cash acquired through business combination
-
1,056,578
Deposit made in connection with asset purchase agreement
-
( 3,500,000 )
Purchase of other long-lived assets
-
( 51,744 )
Receivable from related party
-
( 70,798 )
Purchase of property and equipment
( 28,471 )
( 3,300 )
Net cash used in investing activities
( 28,471 )
( 8,649,035 )
Cash flows from financing activities
Proceeds from issuance of notes payable - related party
5,000,000
-
Payment of financing costs
( 400,000 )
-
Payment on note payables
( 1,345,521 )
( 1,000,000 )
Proceeds from exercise of preferred investment options, net
922,749
2,298,675
Proceeds from exercise of stock options
163
459
Proceeds from exercise of warrants
6,155
-
Proceeds from issuance of Series C Preferred Stock and warrants
1,875,000
-
Proceeds from purchases of common stock
685,282
-
Cash in lieu of shares
( 718 )
-
Deferred financing costs
-
( 205,093 )
Purchase of treasury shares
-
( 58,981 )
Net cash provided by financing activities
6,743,110
1,035,060
Effect of exchange rate changes on cash
( 126,658 )
( 3,331 )
Net (decrease) in cash
( 3,907,835 )
( 21,198,323 )
Cash, beginning of period
4,554,335
25,752,659
Cash, end of period
$ 646,500
$ 4,554,335
Cash paid for interest
$ 379,409
$ -
Noncash investing and financing activities:
Inventory and intangible assets acquired through issuance of notes payable
$ -
$ 12,947,000
Incremental fair value of exchanged preferred investment options
$ -
$ 2,613,011
Deferred offering costs included in accounts payable and accrued expenses
$ -
$ 150,000
Recognition of contingent warrant liability
$ 157,720
$ 25,837
Warrants issued for settlement of contingent warrants
$ -
$ 129,184
Deferred offering costs previously included in prepaid expenses
$ -
$ ( 11,020 )
Effect of business combination (Note 5)
$ -
$ 64,054,991
Conversion of Series B Preferred Stock to common stock
$ 64,236,085
$ -
Settlement of related party note payable and accrued interest through issuance of common stock
$ 5,134,247
$ -
Settlement of note payable through issuance of Series A convertible preferred stock
$ -
$ 3,490,000
Exercise of pre-funded warrants
$ -
$ 7
Issuance of restricted stock
$ -
$ 5
Restricted stock forfeitures
$ -
$ ( 3 )
Establishment of operating right-of-use asset
$ 87,864
$ -
Conversion to equity of non-controlling interest
$ 7,184,751
$ -
D&O insurance premium financed
$ 678,548
$ -
Receivable from shareholders for shares issued
$ 250,308
$ -
Measurement Period Adjustments from Proteomedix acquisition
$ 10,321,000
$ -
Adjustment to redeemable Series C preferred stock
$ 125,000
$ -
Deemed dividend Series C preferred stock
$ 206,404
$ -
The accompanying notes are an integral part
of these consolidated financial statements.
F- 7
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 1 — Organization and Basis of Presentation
Organization and Nature of Operations
Onconetix, Inc. (formerly known as Blue Water
Biotech, Inc. and Blue Water Vaccines Inc.) (the “Company” or “Onconetix”) was formed on October 26, 2018, and
is a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men’s
health and oncology.
On December 15, 2023, Onconetix acquired
100 % of the issued and outstanding voting equity interests in Proteomedix AG, a Swiss company (“Proteomedix”), and its related
diagnostic product Proclarix. As a result of this transaction, Proteomedix became a wholly owned subsidiary of Onconetix (see Note 5).
Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis. Proteomedix has identified novel biomarker
signatures with utility in prostate cancer diagnosis, prognosis and therapy management.
In April 2023, the Company acquired ENTADFI®,
a Food and Drug Administration (“FDA”)-approved, once daily pill that combines finasteride and tadalafil for the treatment
of benign prostatic hyperplasia.
Historically, the Company’s focus was on
the research and development of transformational vaccines to prevent infectious diseases worldwide, until the third quarter of 2023, at
which time the Company halted its efforts on vaccine development activities to focus on commercialization activities for ENTADFI and pursue
other potential acquisitions. However, in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI,
and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is still working
with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to
resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets,
we may abandon the assets and destroy our inventory of the product. Based on the circumstances surrounding ENTADFI, the ENTADFI assets
were fully impaired at June 30, 2024 (see Notes 4 and 5).
On April 21, 2023, the Company filed an amendment
to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to change its corporate name from “Blue
Water Vaccines Inc.” to “Blue Water Biotech, Inc.” The name change was effective as of April 21, 2023. On December 15,
2023, the Company filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware
to change its corporate name from “Blue Water Biotech, Inc.” to “Onconetix, Inc.” In connection with each of the
name changes, the Company also amended the Company’s bylaws to reflect the new corporate name.
Reverse Stock Split
On September 24, 2024, the Company effected a
reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted
for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification (“ASC”) 260, Earnings
Per Share . All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise prices and per share
data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all
periods presented. The number of authorized shares and par value of the preferred stock and common stock were not adjusted because of
the reverse stock split.
Basis of Presentation and Principles of Consolidation
The Company’s consolidated financial statements
have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”)
and include the accounts of Onconetix and its 100 % wholly owned subsidiary, Proteomedix, since the acquisition date of December 15, 2023.
All significant intercompany balances and transactions have been eliminated in consolidation.
The non-controlling interest recorded in the accompanying
consolidated financial statements as of December 31, 2023 relates to currently outstanding stock-based awards issued by Proteomedix, which
were assumed by Onconetix in connection with the acquisition of Proteomedix (see Note 5). During the year ended December 31, 2024, the
non-controlling interest converted to equity with the issuance of restricted common stock in exchange for PMX options.
F- 8
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 2 — Going Concern and Management’s
Plans
The Company’s operating activities to date
have been devoted to seeking licenses, engaging in research and development activities, potential asset and business acquisitions, and
expenditures associated with the previously planned commercial launch of ENTADFI, and the commercialization of Proclarix.
The Company has incurred substantial operating
losses since inception and expects to continue to incur significant operating losses for the foreseeable future.
As of December 31, 2024, the Company had cash
of approximately $ 0.6 million, a working capital deficit of approximately $ 17.3 million and an accumulated deficit of approximately $ 115.7
million. During the year ended December 31, 2024, the Company used approximately $ 10.5 million in cash for operating activities. In addition,
as of May 30, 2025, the Company’s cash balance was approximately $ 0.5 million. The Company’s current cash balance is not sufficient
to fund its operations through the end of December 2025. In December 2024, the Company began drawing on the Equity Financing Line of Credit
(“ELOC”), which it entered into on October 2, 2024, referred herein as the ELOC Purchase Agreement; however, projections are
indicative that it will be unable to meet its contractual commitments and obligations as they come due in the ordinary course of business.
Effective in 2025, the Company has redeemed the preferred stock of approximately $ 1.71 million. The Company will require significant additional
capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the funds
needed to support the Company’s working capital needs and business activities. These business activities include the commercialization
of Proclarix, and the development and commercialization of the Company’s future product candidates. These factors raise substantial
doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these consolidated
financial statements.
Management’s plans for funding the Company’s
operations include generating product revenue from sales of Proclarix, which may still be subject to further successful commercialization
activities within certain jurisdictions. Management also intends to secure additional required funding through equity or debt financings
if available, and to utilize the ELOC entered into in October 2024 (see Note 9) on an as-needed basis to assist with the paydown of notes
issued to Veru and to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based
on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will
not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there
any assurance that such financing will be available to the Company on favorable terms, if at all. This creates significant uncertainty
whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix. If the
Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development, and/or commercialization
of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient
to sustain operations and meet its obligations.
Because of historical and expected operating losses
and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for
one year from the issuance of the consolidated financial statements, which is not alleviated by management’s plans. The consolidated
financial statements have been prepared assuming the Company will continue as a going concern. These consolidated financial statements
do not include any adjustments that might be necessary from the outcome of this uncertainty.
F- 9
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies
Use of Estimates
The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported
amounts of revenue and expenses during the reporting periods. The most significant estimates in the Company’s consolidated financial
statements relate to accounting for acquisitions, valuation of inventory, the useful life of the amortizable intangible assets, estimates
of future cash flows used to evaluate impairment of intangible assets, accrued research and development expenses, assumptions related
to the pension benefit obligation, stock-based compensation, the valuation of preferred stock, valuation of subscription agreement liability,
and the valuation allowance of deferred tax assets. These estimates and assumptions are based on current facts, historical experience
and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual
results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and
actual results, the Company’s future results of operations will be affected.
Concentration of Credit Risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist of cash accounts in financial institutions, which, at times, exceed the Federal Depository
Insurance Coverage limit for those maintained in the United States and exceed the Swiss Financial Market Supervisory Authority for those
maintained in Switzerland. As of December 31, 2024 and 2023, the Company has not experienced losses on these accounts and management believes
the Company is not exposed to significant risks on such accounts.
Foreign Currency Translation
The financial statements of Proteomedix, the Company’s
foreign subsidiary, are measured using the local currency, which is the Swiss Franc, as the functional currency. Assets and liabilities
of this subsidiary are translated into U.S. dollars at exchange rates as of the consolidated balance sheet date. Equity is translated
at historical exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the
period. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ equity, as
accumulated other comprehensive income or loss. Foreign currency transaction gains and losses are included in the results of operations.
For the years ended December 31, 2024 and 2023, foreign currency translation gain (loss) was approximately $( 5.3 ) million and $ 2.4 million.
Accounts receivable
The Company
performs periodic credit evaluations of its customers’ financial condition and extends credit to virtually all of its customers
on an uncollateralized basis. Credit losses to date have been insignificant and within management’s expectations. The Company provides
an allowance for credit losses that is based upon a review of outstanding receivables, historical collection information, expected future
losses, and existing economic conditions. As of December 31, 2024, there was no allowance for credit losses. As of December 31,
2024, substantially all of the Company’s accounts receivable are due from a single customer.
Inventories
Inventories consist of product acquired in the
Proteomedix transaction. Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out
basis, aside from inventories acquired in an asset acquisition or business combination, which are recorded at fair value. The Company
periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable
items are observed and there are no alternative uses for the inventory, the Company records a write-down to net realizable value in the
period that the decline in value is first recognized.
Property and Equipment
Property and equipment consists of laboratory
equipment, computers, and office furniture and fixtures, all of which are recorded at cost. Depreciation is recorded using the straight-line
method over the respective useful lives of the assets ranging from two to ten years . Depreciation expense was approximately $ 22,000 and
$ 7,000 for the years ended December 31, 2024 and 2023 and is included in selling, general and administrative expenses in the accompanying
consolidated statements of operations and comprehensive loss.
F- 10
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Acquisitions
The Company evaluates acquisitions to first
determine whether a set of assets acquired constitutes a business and should be accounted for as a business combination. If the assets
acquired are not a business, the transaction is accounted as an asset acquisition in accordance with Accounting Standards Codification
(“ASC”) 805-50, Asset Acquisitions (“ASC 805-50”), which requires the acquiring entity to recognize
assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, except for non-qualifying assets including
financial assets such as inventory. Further, the cost of the acquisition includes the fair value of consideration transferred and direct
transaction costs attributable to the acquisition. Goodwill is not recognized in an asset acquisition and any excess consideration transferred
over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration
payments in asset acquisitions are recognized when the contingency is determined to be probable and reasonably estimable. If the assets
acquired are a business, the Company accounts for the transaction as a business combination. Business combinations are accounted for by
using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their
respective fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded
as goodwill. Acquisition related expenses are expensed as incurred, and are included in selling, general and administrative expense in
the consolidated statements of operations and comprehensive loss.
Goodwill and Other Intangible Assets
Goodwill represents the excess of the cost
of a business combination over the fair value of the net assets acquired. Goodwill and intangible assets deemed to have
indefinite lives are not amortized but are subject to impairment tests on an annual basis, and whenever events or changes in circumstances
indicate that the carrying value may not be recoverable. Goodwill is allocated to the reporting unit from which it was
created. A reporting unit is an operating segment or sub-segment to which goodwill is assigned when initially recorded. The
Company tests indefinite lived intangible assets for impairment, on an annual basis in the fourth quarter, or more frequently if an event
occurs or circumstances indicate that the indefinite lived assets may be impaired. The Company may perform a qualitative assessment to
determine whether it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. If the Company
determines this is the case, the Company then performs further quantitative analysis to identify and measure the amount of goodwill impairment
loss to be recognized, if any. To perform its quantitative test, the Company compares the fair value of the reporting unit to its carrying
value. If the fair value of the reporting unit exceeds the carrying value of its net assets, goodwill is not impaired, and no
further testing is required. If the fair value of the reporting unit is less than the carrying value, the Company measures the amount
of impairment loss, if any, as the excess of the carrying value over the fair value of the reporting unit. The Company did not test
its goodwill or indefinite lived assets for impairment during the year ended December 31, 2023, given that the acquisition date occurred
after the annual testing date and given that there were no impairment indicators from the date of acquisition through the end of the reporting
period. For the year ended December 31, 2024, the Company recorded losses on impairment of goodwill of approximately $ 32.3 million.
Intangible assets with finite lives are reported
at cost, less accumulated amortization, and are amortized over their estimated useful lives, starting when sales for the related product
begin. Amortization is calculated using the straight-line method, and recorded within selling, general, and administrative expenses, or
cost of revenue, depending on the nature and use of the asset.
During the ordinary course of business, the Company
has entered into certain license and asset purchase agreements. Potential milestone payments for development, regulatory, and commercial
milestones are recorded when the milestone is probable of achievement. Upon a milestone being achieved, the associated milestone payment
is capitalized and amortized over the remaining useful life for approved products, or expensed as research and development expense for
milestones relating to products whose FDA approval has not yet been obtained.
Impairment of Long-Lived Assets
The Company reviews long-lived assets, including
intangible assets with finite useful lives, for impairment whenever events or changes in business circumstances indicate that the carrying
amount of the assets may not be fully recoverable (a “triggering event”). Factors that the Company considers in deciding when
to perform an impairment review include significant underperformance of the long-lived asset in relation to expectations, significant
negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is
performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result
from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated
undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would
be based on the excess of the carrying value of the impaired asset over its fair value. During the years ended December 31, 2024 and 2023,
the Company determined that there were certain triggering events that indicated that the carrying amount of the assets recorded in connection
with the ENTADFI acquisition (see Note 5) may not be fully recoverable. Impairment losses of $ 3.5 million and $ 14.7 million were recorded
during the years ended December 31, 2024 and 2023, respectively (see Note 4). The Company also recorded an impairment loss of approximately
$ 267,000 during the year ended December 31, 2023, related to implementation costs incurred under cloud computing hosting arrangements
that were capitalized during the year.
During the year ended December 31, 2024, the Company
determined there were certain triggering events that indicated the carrying amounts of the assets recorded in connection with the PMX
acquisition (see Note 5) may not be fully recoverable. Impairment losses of approximately $ 10.3 million related to the Company’s
intangible assets were recorded during the year ended December 31, 2024 resulting in a zero balance of the intangible assets as of December
31, 2024. See Note 4 for further details.
F- 11
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Fair Value Measurements
Fair value is defined as the price that would
be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement
date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
●
Level 1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;
●
Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
●
Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
In some circumstances, the inputs used to measure
fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is
categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.
Financial instruments, including cash, inventory, accounts receivable, receivables from related party, accounts payable, accrued liabilities,
operating lease liabilities, and notes payable are carried at cost, which management believes approximates fair value due to the short-term
nature of these instruments.
The fair value of the contingent warrant liability
and the related party subscription agreement liability are valued using significant unobservable measures and other fair value inputs
and are therefore classified as Level 3 financial instruments.
The fair value of financial instruments measured on a recurring basis
is as follows as of December 31, 2024 and 2023:
As of December 31, 2024
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Contingent warrant liabilities
$ 43,089
—
—
$ 43,089
Subscription agreement liability – related party
4,123,000
—
—
4,123,000
Total
$ 4,166,089
$ —
$ —
$ 4,166,089
As of December 31, 2023
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Contingent warrant liability
$ 2,641
—
—
$ 2,641
Subscription agreement liability – related party
864,000
—
—
864,000
Total
$ 866,641
—
—
866,641
During the year ended December 31, 2023, in connection
with the acquisition of Proteomedix, the Company recorded intangible assets, which were recognized at fair value (see Note 5). Additionally,
as a result of the impairment losses recorded on the Company’s ENTADFI asset group during the year ended December 31, 2024, the
related assets were recorded at fair value as of December 31, 2024. These non-financial assets were valued using significant unobservable
measures and other fair value inputs and are therefore classified as Level 3 measurements.
None of the Company’s other non-financial
assets or liabilities are recorded at fair value on a non-recurring basis as of December 31, 2024 and 2023. There were
no transfers between levels during the periods presented.
The following table summarizes the activity for
the related party subscription agreement liability, using unobservable Level 3 inputs, for the years ended December 31, 2024 and 2023:
Subscription
Agreement
Liability
Balance at December 31, 2022
$ —
Fair value upon issuance
729,900
Change in fair value
134,100
Balance at December 31, 2023
864,000
Change in fair value
3,259,000
Balance at December 31, 2024
$ 4,123,000
F- 12
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Valuation of Subscription Agreement Liability
The Subscription Agreement is accounted for as a liability in accordance
with ASC 480, Distinguishing Liabilities from Equity, (“ASC 480”), as the make-whole provision could result in a variable
number of shares being issued upon settlement. The related party subscription agreement liability is measured at fair value at the commitment
date and at each subsequent reporting period, with changes in fair value recorded as a component of other income (expense), net in the
consolidated statements of operations and comprehensive loss. As of December 31, 2024 and December 31, 2023, the fair value of the related
party subscription agreement liability is estimated to be approximately $ 4,123,000 and $ 864,000 , respectively, and the change in fair
value of the related party subscription agreement liability for the year ended December 31, 2024 was an increase of approximately $ 3,259,000 .
The fair value was determined using a Monte-Carlo option pricing model, and as of December 31, 2024 and 2023, the Company utilized 100 %
and 55 % probability, respectively, that the Subscription Agreement will close.
The following table summarizes the activity for
the contingent warrant liabilities, using unobservable Level 3 inputs, for the years ended December 31, 2024 and 2023:
Contingent
Warrant
Liabilities
Balance at December 31, 2022
$ 14,021
Fair value at issuance
25,837
Reclassification to equity
( 129,184 )
Change in fair value
91,967
Balance at December 31, 2023
2,641
Fair value at issuance
1,296,196
Change in fair value
( 1,250,466 )
Gain on settlement of contingent warrant liability
( 5,282 )
Balance at December 31, 2024
$ 43,089
Deferred Offering Costs
The Company capitalizes certain legal, professional
accounting and other third-party fees that are directly associated with in-process equity financing as deferred offering costs until such
financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity as a reduction
of proceeds generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will
be expensed immediately as a charge to expenses in the consolidated statements of operations and comprehensive loss.
Leases
The Company accounts for leases in accordance
with ASC 842, Leases . The Company has one lease agreement for office space, which contains an initial term of two years with renewal
options. The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement
conveys to the Company the right to control the use of an explicitly or implicitly identified asset for a period of time in exchange for
consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to
obtain substantially all of the economic benefits from using the underlying asset.
Operating lease right of use assets and operating
lease liabilities are recognized on the lease commencement date. Operating lease right of use assets represent the Company’s right
to use an underlying asset for the estimated lease term and operating lease liabilities represent the Company’s present value of
its future lease payments. In assessing its lease and determining its lease liability at lease commencement or upon modification, the
Company was not able to readily determine the rate implicit for its lessee arrangements and thus has used its incremental borrowing rate
on a collateralized basis to determine the present value of the lease payments. The Company’s right of use asset is measured as
the balance of the lease liability plus or minus any prepaid or accrued lease payments and any unamortized initial direct costs. The operating
lease payments are recognized as lease expense on a straight-line basis over the lease term, and are included in selling, general and
administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. Lease payments included in the
measurement of the lease liability are comprised of fixed payments. If the Company’s lease agreements include renewal option periods,
the Company includes such renewal options in its calculation of the estimated lease term when it determines whether the options are reasonably
certain to be exercised. When such renewal options are deemed to be reasonably certain, the estimated lease term determined under ASC
842 will be greater than the non-cancellable term of the contractual arrangement.
Leases with an initial term of 12 months or less
are not recorded on the consolidated balance sheet and the Company recognizes lease expense for these leases on a straight-line basis
over the lease term. The Company applies this policy to all underlying asset categories.
The Company additionally evaluates leases at their
inception to determine if the leases are to be accounted for as an operating lease or a finance lease. Lease expense for operating leases
is recognized on a straight-line basis over the lease term. Variable lease payments are recognized in the period in which the obligations
for those payments are incurred. Lease expense for finance leases is bifurcated into two components, with the amortization expense component
of the right-of-use asset recognized on a straight-line basis and the interest expense component recognized using the effective interest
method over the lease term. The Company has no financing leases as of December 31, 2024 or 2023.
F- 13
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Defined Benefit Pension Plan
Proteomedix sponsors
a defined benefit pension plan (the “Swiss Plan”) covering its eligible Swiss employees. The Swiss Plan is government-mandated
and provides retirement benefits based on employees’ years of service and compensation levels. The Company recognizes an asset for
the Swiss Plan’s overfunded status or a liability for underfunded status in its consolidated balance sheets. Additionally, the Company
measures its plan’s assets and obligations that determine its funded status as of the end of the year and recognizes the changes
in the funded status in the year in which the changes occur. Those changes are reported in accumulated other comprehensive loss in the
accompanying consolidated statements of convertible preferred stock and stockholders’ equity. The Company uses actuarial valuations
to determine its pension and postretirement benefit costs and credits. The amounts calculated depend on a variety of key assumptions,
including discount rates and expected return on plan assets. Current market conditions are considered in selecting these assumptions.
Collaborative Agreements
The Company periodically enters into strategic
alliance agreements with counterparties to produce products and/or provide services to customers. Alliances created by such agreements
are not legal entities, have no employees, no assets and have no true operations. These arrangements create contractual rights and the
Company accounts for these alliances as a collaborative arrangement by reporting costs incurred and reimbursements received from transactions
within research and development expenses within the consolidated statements of operations and comprehensive loss.
Revenue Recognition
Development Services
Proteomedix
provides a range of services to life sciences customers referred to as “Development Services” including testing for biomarker
discovery, assay design and development. These Development Services are performed under individual statement of work (“SOW”)
arrangements with specific deliverables defined by the customer. Development Services are generally performed on a time and materials
basis. During the performance and through completion of the service to the customer in accordance with the SOW, the Company has the right
to bill the customer for the agreed upon price and recognizes the Development Services revenue over the period estimated to complete the
SOW. The Company generally identifies each SOW as a single performance obligation.
Completion
of the service and satisfaction of the performance obligation under a SOW is typically evidenced by access to the data or test made available
to the customer or any other form or applicable manner of delivery defined in the SOW. However, for certain SOWs under which work is performed
pursuant to the customer’s highly customized specifications, the Company has the enforceable right to bill the customer for work
completed, rather than upon completion of the SOW. For those SOWs, the Company recognizes revenue over a period of time during which the
work is performed based on the expended efforts (inputs). As the performance obligation under the SOW is satisfied, any amounts earned
as revenue and billed to the customer are included in accounts receivable
F- 14
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Product Sales
The Company derives revenue through sales of its
products, which includes Proclarix, its diagnostic product, directly to end users, including laboratories, hospitals, and medical centers,
and to distributors. As of the year ended December 31, 2024, the majority of the Company’s product revenue was generated from sales
of Proclarix assays to LabCorp for review and testing in connection with the Company’s license agreement with LabCorp (see Note
6). The Company considers customer purchase orders, which in some cases are governed by master sales agreements or standard terms and
conditions, to be the contracts with a customer. For each contract, the Company considers the promise to transfer products, each of which
is distinct, to be the identified performance obligations. In determining the transaction price, the Company evaluates whether the price
is subject to a refund or adjustment to determine the net consideration to which it expects to be entitled. The Company fulfills its performance
obligation applicable to product sales once the product is transferred to the customer.
The Company’s revenue was generated from
the following geographic regions during the year ended December 31, 2024:
European
Union
Non-European
Union (UK)
United
States
Development services
100 %
-
%
-
%
Product sales
65 %
10 %
25 %
European
Union
Non-European
Union (UK)
United
States
Total Revenue
Development services
$ 2,275,088
$ -
$ -
$ 2,275,088
Product sales
162,071
23,842
$ 63,115
249,028
Total
$ 2,437,159
$ 23,842
$ 63,115
$ 2,524,116
The Company’s revenue was generated from
the following geographic regions during the year ended December 31, 2023:
European
Union
Non-European
Union (UK)
United
States
Development services
100 %
-
%
-
%
Product sales
0 %
-
%
-
%
European
Union
Non-European
Union (UK)
United
States
Total Revenue
Development services
$ 58,465
$ -
$ -
$ 58,465
Total
$ 58,465
$ -
$ -
$ 58,465
The Company had the following customer concentrations
for its revenue during the years ended December 31, 2024 and 2023:
For
the Year Ended
December 31, 2024
For
the Year Ended
December 31, 2023
Development
Services
Product
Sales
Development
Services
Product
Sales
Customer A
100 %
65 %
100 %
— %
Customer B
— %
25 %
— %
— %
Customer C
— %
5 %
— %
— %
Customer D
— %
5 %
— %
— %
F- 15
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Any revenues earned but not yet billed to the
customer as of the date of the consolidated financial statements are recorded as contract assets and are included in prepaid expenses
and other current assets in the accompanying consolidated financial statements. The Company had no unbilled accounts receivable as of
December 31, 2024 and an insignificant balance as of December 31, 2023. Amounts recorded in contract assets are reclassified to accounts
receivable in our consolidated financial statements when the customer is invoiced according to the billing schedule in the contract. Accounts
receivable was approximately $ 26,000 and $ 150,000 as of December 31, 2024 and December 31, 2023, respectively.
In relation to customer contracts, the Company
incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria
for capitalization and are expensed as incurred.
In circumstances where a SOW includes a variable
consideration component, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing
either the expected value method or the most likely amount method, depending on which method is expected to better predict the amount
of consideration to which the Company will be entitled. The value of variable consideration is included in the transaction price if, and
to the extent, it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur when the uncertainty
associated with the variable consideration is subsequently resolved. These estimates are reassessed each reporting period, as required,
and any adjustment required is recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.
Research and Development
The Company expenses the cost of research and
development as incurred. Research and development expenses include costs incurred in funding research and development activities, license
fees, and other external costs. Advance payments for goods and services that will be used in future research and development activities
are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and
milestone payments due to third parties that perform research and development services on the Company’s behalf will be expensed
as services are rendered or when the milestone is achieved. When billing terms under research and development contracts do not coincide
with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations as of period end to
those third parties. Accrual estimates are based on several factors, including the Company’s knowledge of the progress towards completion
of the research and development activities, invoicing to date under the contracts, communication from the research institution or other
companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant
judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ
from the estimates made by the Company. The historical accrual estimates made by the Company have not been materially different from the
actual costs (see Note 6).
In accordance with the Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 730-10-25-1, Research and Development, costs
incurred in obtaining licenses and patent rights are charged to research and development expense if the technology licensed has not reached
commercial feasibility and has no alternative future use. The licenses purchased by the Company (see Note 6) require substantial completion
of research and development, regulatory and marketing approval efforts to reach commercial feasibility and have no alternative future
use. Accordingly, the total purchase price for the licenses acquired is reflected as research and development on the Company’s consolidated
statements of operations and comprehensive loss.
Contingencies
Accruals are recorded for loss contingencies when
it is probable that a liability has been incurred, and the amount of the related loss can be reasonably estimated. The Company evaluates,
on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the
liability that has been accrued previously. Considering facts known at the time of the assessment, the Company determines whether potential
losses are considered reasonably possible or probable and whether they are estimable. Based upon this assessment, the Company carries
out an evaluation of disclosure requirements and considers possible accruals in the consolidated financial statements.
Stock-Based Compensation
The Company expenses stock-based compensation
to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards. Stock-based
awards to employees with graded-vesting schedules are recognized, using the accelerated attribution method, on a straight-line basis over
the requisite service period for each separately vesting portion of the award.
F- 16
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
The Company estimates the fair value of stock
option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards
represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
Expected Term — The expected
term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the simplified
method, which is the half-life from vesting to the end of its contractual term. The simplified method is used as the Company has insufficient
historical information to provide a basis for an estimate of the expected term.
Expected Volatility —
Volatility is a measure of the amount by which the Company’s share price has historically fluctuated or is expected to fluctuate
(i.e., expected volatility) during a period. Due to the lack of an adequate history of a public market for the trading of the Company’s
common stock and a lack of adequate company-specific historical and implied volatility data, the Company computes stock price volatility
over expected terms based on comparable companies’ historical common stock trading prices. For these analyses, the Company has selected
companies with comparable characteristics, including enterprise value, risk profiles, and position within the industry.
Common Stock Fair Value —
The fair value of the common stock underlying the Company’s stock options is based on the closing price of the Company’s common
stock, as reported by the Nasdaq Capital Market, on the grant date of the award.
Risk-Free Interest Rate —
The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury securities with a remaining term commensurate
with the estimated expected term.
Expected Dividend — The
Company has never declared or paid any cash dividends on its shares of common stock and does not plan to pay cash dividends in the foreseeable
future, and, therefore, uses an expected dividend yield of zero in its valuation models.
The Company recognizes forfeitures
of equity awards as they occur.
Income Taxes
Income taxes are accounted for under the asset
and liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax
credit carryforwards.
Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the jurisdictions and years in which those temporary differences are expected
to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rate is recognized in operations in the
period that includes the enactment date. Deferred tax assets are reduced to estimated amounts expected to be realized by the use of a
valuation allowance.
Comprehensive Loss
The Company is required to report all components
of comprehensive loss, including net loss, in the accompanying consolidated financial statements in the period in which they are recognized.
Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner
sources. The Company’s comprehensive losses for the years ended December 31, 2024 and 2023 are comprised of net loss, the effect
of currency translation adjustments, and the change in pension benefit obligation.
F- 17
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Financial instruments
The Company determines the accounting classification
of financial instruments that are issued, including its warrants and a subscription agreement, as either liability or equity, by first
assessing whether the financial instruments are freestanding financial instruments, and if they meet liability classification in accordance
with ASC 480, Distinguishing Liabilities from Equity , (“ASC 480”), and then in accordance with ASC 815-40, Derivatives
and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 480-10, financial instruments are
considered liability-classified if the instruments are mandatorily redeemable, obligate the issuer to settle the instruments or the underlying
shares by paying cash or other assets, or must or may require settlement by issuing a variable number of shares.
If the instruments do not meet liability classification
under ASC 480, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer
to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that
triggers the net cash settlement feature. If the financial instruments do not require liability classification under ASC 815-40, in order
to conclude equity classification, the Company assesses whether the instruments are indexed to the Company’s common stock and whether
the instruments are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company
concludes whether the instruments are classified as liability or equity. Liability-classified instruments are required to be accounted
for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after
the issuance date recorded as a component of other income (expense), net in the consolidated statements of operations and comprehensive
loss. Equity-classified instruments are accounted for at fair value on the issuance date with no changes in fair value recognized after
the issuance date.
Preferred Stock
The Company applies the guidance enumerated in
ASC 480, when determining the classification and measurement of preferred stock. Preferred stock subject to mandatory redemption, if any,
is classified as a liability and is measured at fair value. The Company classifies conditionally redeemable preferred stock, which includes
preferred stock that features redemption rights that are either within the control of the holder or subject to redemption upon the occurrence
of uncertain events not solely within the Company’s control, as temporary equity. At all other times, the Company classifies
its preferred stock in stockholders’ equity.
Treasury Stock
The Company records treasury stock activities under the cost method
whereby the cost of the acquired stock is recorded as treasury stock.
F- 18
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 3 — Summary of Significant Accounting Policies (cont.)
Recently Adopted Accounting Standards
Effective with the 2024 consolidated financial
statements, the Company adopted Accounting Standards Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable
Segment Disclosures , which requires disclosure of significant segment expenses and other segment items on an annual and interim basis.
The standard expanded disclosures that are required on an interim basis. Additionally, it requires a public entity to disclose the title
and position of the Chief Operating Decision Maker (“CODM”). The ASU does not change how a public entity identifies its operating
segments, aggregates them, or applies the quantitative thresholds to determine its reportable segments. The adoption of this standard
only impacted the Company’s disclosures, which were made on a retrospective basis, with no impact to the results of operations,
cash flows or financial condition.
Recent Accounting Pronouncement s Not Yet Adopted
In December 2023, the FASB issued ASU No. 2023-09,
Income Taxes (Topic 740 ): Improvements to Income Tax Disclosures . This ASU requires disclosure of specific categories in the rate
reconciliation and additional information for reconciling items that meet a quantitative threshold. The amendment also includes other
changes to improve the effectiveness of income tax disclosures, including further disaggregation of income taxes paid for individually
significant jurisdictions. This ASU is effective for annual periods beginning after December 15, 2024. Adoption of this ASU should be
applied on a prospective basis. Early adoption is permitted. The Company is currently evaluating the impact that this guidance will have
on its consolidated financial statements.
In November 2024, the FASB issued ASU No. 2024-03,
Disaggregation of Income Statement Expenses . This guidance will require additional disclosures and disaggregation of certain costs
and expenses presented on the face of the income statement. The amendments are effective for annual reporting periods beginning after
December 15, 2026 and interim reporting period beginning after December 15, 2027 with early adoption permitted. The Company is currently
evaluating the impact of this new guidance to our consolidated financial statements.
The Company’s management does not believe
that any other recently issued, but not yet effective, accounting standards, if currently adopted, would have a material effect on the
accompanying consolidated financial statements.
Note 4 — Balance Sheet Details
Inventories
Inventories, which primarily relate to Proclarix
product as of December 31, 2024 and ENTADFI product as of December 31, 2023, consisted of the following:
December 31,
2024
December 31,
2023
Raw materials
$ 57,446
$ 139,208
Work-in-process
—
194,805
Finished goods
6,633
30,039
Total
$ 64,079
$ 364,052
The Company recorded an impairment on the ENTADFI
inventory in the amount of approximately $ 0.4 million during the year ended December 31, 2024. During the year ended December 31, 2023,
$ 1.2 million of an impairment was recorded (see Note 5).
F- 19
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 4 — Balance Sheet Details (cont.)
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following
as of December 31, 2024 and 2023:
December 31,
2024
December 31,
2023
Prepaid insurance
$ 101,999
$ 122,004
Prepaid regulatory fees
—
312,551
Prepaid research and development
—
89,195
Prepaid professional fees
7,487
70,708
VAT taxes receivable
28,756
—
Prepaid other
33,894
175,695
Other Receivable
41,835
—
Total
$ 213,971
$ 770,153
Intangible Assets
Intangible assets, which were recorded during
the year ended December 31, 2023 in connection with the ENTADFI and Proteomedix acquisitions (see Note 5), is comprised of customer relationships,
product rights for developed technology and a trade name, and consisted of the following as of December 31, 2024 and 2023:
Trade name
Product rights
for developed
technology
Customer
relationships
Total intangible
assets, net
Balance at January 1, 2023
$ -
$ -
$ -
$ -
Additions
9,018,000
28,447,771
1,891,000
39,356,771
Impairment
-
( 14,610,128 )
-
( 14,610,128 )
Amortization
-
( 31,213 )
( 5,599 )
( 36,812 )
Effect of Foreign Currency Translation
294,739
344,514
61,803
701,056
Balance at December 31, 2023
$ 9,312,739
$ 14,150,944
$ 1,947,204
$ 25,410,887
Measurement period adjustments related to the Proteomedix acquisition (Note 5)
( 6,239,000 )
( 3,264,000 )
( 818,000 )
( 10,321,000 )
Impairment
( 2,676,441 )
( 9,912,392 )
( 987,607 )
( 13,576,440 )
Amortization
( 185,396 )
( 457,144 )
( 66,502 )
( 709,042 )
Effect of Foreign Currency Translation
( 211,902 )
( 517,408 )
( 75,095 )
( 804,405 )
Balance at December 31, 2024
$ -
$ -
$ -
$ -
The finite lived intangible assets held by the
Company, which includes trade name, customer relationships and product rights for developed technology, were being amortized over their
estimated useful lives, which is 15 years. Amortization expense related to intangible assets was approximately $ 0.7 million for the year
ended December 31, 2024, of which approximately $ 457,000 and $ 252,000 was recorded as cost of revenue and selling, general, and administrative
expenses, respectively, in the accompanying consolidated statements of operations and comprehensive loss. Amortization expense related
to intangible assets was approximately $ 37,000 for the year ended December 31, 2023, of which approximately $ 31,000 and $ 6,000 was recorded
as costs of revenue and selling, general, and administrative expenses, respectively.
F- 20
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 4 — Balance Sheet Details (cont.)
ENTADFI Intangible Asset Impairment
During the three months ended March 31, 2024,
the Company became aware of a new competitor that received approval by the FDA for a combined finasteride-tadalafil capsule, which is
a direct competitor product to ENTADFI. This was determined to be a triggering event that could result in a decrease in future expected
cash flows, and thus indicated the carrying amount of the ENTADFI asset group may not be fully recoverable. The Company performed an
undiscounted cash flow analysis over the ENTADFI asset group and determined that the carrying value of the asset group is not recoverable.
The Company then estimated the fair value of the asset group to measure the impairment loss for the period. Significant assumptions used
to determine this non-recurring fair value measurement included projected sales driven by market share and product sales price estimates,
associated expenses, growth rates, the discount rate used to measure the fair value of the net cash flows associated with this asset
group, as well as Management’s estimates of an expected sales price for the asset group, and the probability of each potential
strategic alternative taking place.
During the three months ended June 30, 2024, the
Company reevaluated the probability of each potential strategic alternative occurring and determined that the change in probabilities
is a triggering event that could result in a decrease in future expected cash flows. Based on the Company’s evaluation, there was
no plan to resume commercialization of ENTADFI, the Company had not identified any buyers interested to consummate a sale or other transaction
of the ENTADFI assets and was considering abandoning the product, all of which indicated the carrying amount of the ENTADFI asset group
may not be fully recoverable. The Company further determined that the asset group was fully impaired at June 30, 2024, and recorded a
corresponding impairment charge during the three months ended June 30, 2024, thus resulting in no remaining carrying value for the assets
in the ENTADFI asset group. The Company further determined that the asset group was fully impaired at June 30, 2024, and recorded a corresponding
impairment charge during the three months ended June 30, 2024, thus resulting in no remaining carrying value for the assets in the ENTADFI
asset group. There were no additional impairments for the remainder of the year ending December 31, 2024.
Proteomedix Intangible Assets Impairment
The Company assesses the recoverability of its
intangible with definite lives whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
During the three months ended March 31, 2024, June 30, 2024 and September 30, 2024, the Company did identify certain impairment indicators
such as the decrease in the Company’s stock price; however, the Company concluded the intangible assets’ values were recoverable
based on its quantitative analyses to assess the projected future undiscounted cash flows associated with the intangible assets compared
to their carrying value. Therefore, the Company recorded no impairment charges on its intangible assets during the three months
ended March 31, 2024, June 30, 2024 and September 30, 2024.
During the three months ended December 31, 2024,
the Company identified indicators of impairment related to the intangible assets acquired in connection with the PMX acquisition. Although
the Company continued to view the underlying technologies as strategically important, it determined that it no longer possessed the operational
or financial resources required to advance their development. This conclusion was based on several factors including the Company experiencing
a substantial decline in market capitalization and share price during the three months ended December 31, 2024. The decrease in market
capitalization and share price was driven by significant recurring net losses and a decrease in the Company’s liquidity position.
The Company’s updated financial forecasts reflected continued and increasing net losses associated with the development and commercialization
of the PMX-related assets; however, the Company’s weakened financial condition constrained its ability to raise the capital necessary
to support the continued investment in the PMX assets. This limited access to capital raise led the Company to conclude it no longer has
the ability to support the continued operation and commercialization efforts associated with the PMX assets. As a result of these factors,
the Company recorded a full impairment charge on the remaining balance of its intangible assets resulting in a zero balance at December
31, 2024.
F- 21
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 4 — Balance Sheet Details (cont.)
Goodwill
During the three months ended March 31, 2024,
the Company’s stock price and market capitalization declined, and the Company determined that this was an indicator of a potential
impairment of its goodwill, and accordingly, as of March 31, 2024, the Company performed a quantitative analysis to identify and
measure the amount of impairment loss to be recognized, if any. To perform its quantitative test, the Company compared the fair value
of the Proteomedix reporting unit to its carrying value and determined that the fair value of the reporting unit was less than its carrying
value. The Company determined the amount of impairment charges to its goodwill for the three months ended March 31, 2024 to be approximately
$ 5.2 million.
Historically, the Company was organized in two
reporting units, Proteomedix and ENTADFI. The goodwill arising from the Proteomedix acquisition was assigned solely to the Proteomedix
reporting unit. The Company reevaluated its reporting units during the three months ended June 30, 2024, and determined that as of April
30, 2024, ENTADFI no longer qualified as a separate reporting unit. As a result, since that date, the Company’s goodwill is assigned
to a single reporting unit. Accordingly, the Company performed a quantitative analysis immediately prior to the change in reporting units,
and immediately after the change in reporting units, to identify and measure the amount of impairment loss to be recognized, if any.
To perform its quantitative tests, the Company compared the fair value of the reporting unit to its carrying value and determined that
the fair value of the reporting unit was less than its carrying value. The Company determined the amount of impairment charges to its
goodwill for the three months ended June 30, 2024 to be approximately $ 10.3 million.
During the three months ended September 30, 2024,
the Company’s re-evaluation of market conditions and anticipated timing of projected sales prompted the Company to determine that
there was an indicator of a potential impairment of its related intangible assets and goodwill, and accordingly, as of September 30, 2024,
the Company performed a quantitative analysis to identify and measure the amount of impairment loss to be recognized, if any. It was determined
no further impairment on goodwill was required for the three months ended September 30, 2024.
During the three months ended December 31, 2024,
the Company identified a measurement period adjustment relating from the Proteomedix acquisition resulting in an increase to the acquired
goodwill of approximately $ 8.4 million (see Note 5). In addition, the Company performed a re-evaluation of market conditions and anticipated
timing of projected sales which prompted the Company to determine that there was an indicator of a potential impairment of its related
goodwill. Accordingly, as of December 31, 2024, the Company performed a quantitative analysis to identify and measure the amount of impairment
loss to be recognized. It was determined there was an additional impairment on goodwill of $ 16.8 million for the three months ended December
31, 2024.
The Company has recorded a cumulative $ 32.3 million
in impairment charges related to its goodwill for the year ended December 31, 2024.
The fair value estimate of the reporting units
for the quarters ended March 31, 2024 and June 30, 2024 was derived from a combination of an income approach and a market approach, and
a reconciliation to the Company’s market capitalization. The fair value estimate of the reporting units for the quarter ended September
30, 2024 was derived from the income approach and reconciled to the Company’s market capitalization. The method was changed for
the quarter ended September 30, 2024 to reflect the disparity between the Company and the guideline transactions that were previously
selected in prior quarters. The fair value estimate of the reporting units for the quarter ended December 31, 2024 was derived from the
Company’s market capitalization. Under the income approach, the Company estimated the fair value of the reporting unit based on
the present value of estimated future cash flows, which the Company considers to be a Level 3 unobservable input in the fair value hierarchy.
The Company prepared cash flow projections based on management’s estimates of future revenue and operating costs, taking into consideration
the historical performance and the current macroeconomic, industry, and market conditions. The Company based the discount rate on the
weighted-average cost of capital considering Company-specific characteristics and changes in the reporting unit’s projected cash
flows. Under the market approach, the Company estimated the fair value of the reporting unit based on revenue market multiples derived
from comparable companies with similar characteristics as the reporting unit, as well as an estimated control premium.
F- 22
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 4 — Balance Sheet Details (cont.)
Goodwill consisted of the following as of December
31, 2024 and 2023:
Balance as of January 1, 2023
$ -
PMX transaction goodwill
53,914,055
Foreign currency translation
1,762,087
Balance as of December 31, 2023
55,676,142
Measurement period adjustment related to the Proteomedix acquisition
8,393,843
Impairment loss
( 32,347,000 )
Foreign currency translation
( 4,674,012 )
Balance as of December 31, 2024
$ 27,048,973
Accrued Expenses
Accrued expenses consisted of the following as of December 31,
2024 and 2023:
December 31,
2024
December 31,
2023
Accrued compensation
$ 186,956
$ 487,579
Accrued research and development
320,096
616,707
Accrued professional fees
161,981
550,415
Accrued implementation fees
—
93,787
Accrued franchise taxes
40,000
60,530
Accrued interest
139,409
—
Accrued deferred offering costs
—
125,000
Accrued license fees
14,705
—
Other accrued expenses
25,841
265,849
Total
$ 888,988
$ 2,199,867
Note 5 — Acquisitions
ENTADFI ®
On April 19, 2023, the Company and Veru,
Inc. (“Veru”) entered into an Asset Purchase Agreement (the “Veru APA”). Pursuant to, and subject to the terms
and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru’s ENTADFI product (“ENTADFI”)
(the “Transaction”) for a total possible consideration of $ 100 million.
In accordance with the Veru APA, the Company agreed
to provide Veru with initial consideration totaling $ 20.0 million, consisting of (i) $ 6.0 million paid upon the closing of the Transaction
on April 19, 2023, (ii) an additional $ 4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii)
an additional $ 10.0 million in the form of two $ 5.0 million non-interest bearing notes payable, each due on April 19, 2024 and September
30, 2024.
F- 23
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
Additionally, the terms of the Veru APA require
the Company to pay Veru up to an additional $ 80.0 million based on the Company’s net sales of ENTADFI after closing (the “Milestone
Payments”). The Milestone Payments are payable as follows: (i) $10.0 million is payable upon the first time the Company achieves
net sales from ENTADFI® of $100.0 million during a calendar year, (ii) $20.0 million is payable upon the first time the Company
achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $50.0 million is payable upon the first time the Company
achieves net sales from ENTADFI of $500.0 million during a calendar year.
In connection with the Transaction, the Company
also assumed royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered into
by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017 (the “Camargo Obligations”). The Camargo Obligations
assumed by the Company include a 6 % royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $ 22.5 million,
payable to Camargo as follows: (i) $5.0 million is payable upon the first time the Company achieves net sales from ENTADFI of $100.0
million during a calendar year, (ii) $7.5 million is payable upon the first time the Company achieves net sales from ENTADFI of $200.0
million during a calendar year, and (3) $10.0 million is payable upon the first time the Company achieves net sales from ENTADFI of $300.0
million during a calendar year.
On September 29, 2023, the Company entered into
an amendment to the Veru APA (the “Veru APA Amendment”), which provides that the $ 4.0 million note payable originally due
on September 30, 2023 was deemed paid and fully satisfied upon (1) the payment to the Seller of $ 1.0 million in cash on September 29,
2023, and (2) the issuance to the Seller by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock (the “Series
A Preferred Stock”) of the Company (see Note 9). Pursuant to the Veru APA Amendment, the Series A Preferred Stock will convert to
common stock of the Company one year from the date of issuance if the required stockholder approval is obtained. The Series A Preferred
Stock, which was issued to the Seller on October 3, 2023 is initially convertible, in the aggregate, into 142,479 shares of the Company’s
common stock, subject to adjustment and certain stockholder approval limitations specified in the Certificate of Designations. Pursuant
to the Veru APA Amendment, the Company agreed to use commercially reasonable efforts to obtain such stockholder approval by December 31,
2023, however, such shareholder approval was not obtained as of December 31, 2023. The Company also agreed to include the shares of common
stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the SEC.
On April 24, 2024, the Company entered into a
Forbearance Agreement with Veru in connection with the Company’s default on the $ 5.0 million non-interest bearing note payable that
was due on April 19, 2024 (see Note 7).
On September 19, 2024, the Company entered into
an Amended and Restated Forbearance Agreement with Veru, which further modified the terms of both the April and September Veru notes outstanding
(see Note 7).
Also, in connection with, and at the time of the
Transaction, and pursuant to the Veru APA, the Company entered into non-competition and non-solicitation agreements (the “Non-Competition
Agreements”) with two of Veru’s key stockholders and employees (the “Restricted Parties”). The Non-Competition
Agreements generally prohibit the Restricted Parties from either directly or indirectly engaging in the Restricted Business (as such term
is defined in the Veru APA) for a period of five years from the closing of the Transaction.
The acquisition of ENTADFI was accounted
for as an asset acquisition in accordance with ASC 805-50 because substantially all of the fair value of the assets acquired is concentrated
in a single asset, the ENTADFI product rights. The ENTADFI products rights consist of trademarks, regulatory approvals, and other records,
and are considered a single asset as they are inextricably linked.
The following table summarizes the aggregate consideration
transferred for the assets acquired by the Company in connection with the Veru APA:
Consideration
Transferred
Consideration transferred at closing
$ 6,000,000
Fair value of notes payable issued
12,947,000
Transaction costs
79,771
Total consideration transferred
$ 19,026,771
The fair value of the non-interest bearing notes
payable was estimated using a net present value model using discount rates averaging 8.2 %. The resulting fair value is being accreted
to the face value of the notes, through the respective maturity dates. Management evaluated the Milestone Payments and determined that
at the close of the Transaction, they are not considered probable, and as such, the Company did not recognize any amount related to the
Milestone Payments in the consideration transferred.
Management evaluated the Camargo Obligations and
determined that at the close of the Transaction, the related sales milestone payments are not considered probable, and as such, the Company
did not recognize any related liability at the date of the Transaction.
F- 24
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
The following table summarizes the assets acquired with the Veru APA:
Assets Recognized
Inventory
$
1,120,000
ENTADFI Intangible
17,906,771
Total fair value of identifiable assets acquired
$
19,026,771
In accordance with ASC 805-50, the acquired inventory
was recorded at fair value. The remaining consideration transferred was allocated to the ENTADFI® intangible asset, which will be
amortized over its estimated useful life, starting when ENTADFI® sales begin. Acquired inventory is comprised of work-in-process
and raw materials. The fair value of work-in-process inventory was determined based on an estimated sales price of the finished goods,
adjusted for costs to complete the manufacturing process, costs of the selling effort, a reasonable profit allowance for the
remaining manufacturing and selling effort, and an estimate of holding costs, and resulted in a fair value adjustment of approximately
$ 0.3 million. The fair value of raw materials was determined to approximate replacement cost.
The Company recorded an impairment charge on the
ENTADFI asset group of $ 3.5 million during the year ended December 31, 2024 (see Note 4), and an impairment charge on the ENTADFI inventory
of approximately $ 0.4 million during the year ended December 31, 2024. In addition, during the fourth quarter of 2023, the Company recorded
an impairment charge of approximately $ 14.7 million on the ENTADFI asset group, as well as an impairment charge on the ENTADFI acquired
inventory of approximately $ 1.2 million, which included impairment of 100 % of the acquired work-in-progress inventory.
WraSer:
On June 13, 2023 (the “Execution Date”),
the Company entered into an asset purchase agreement with WraSer, LLC, and affiliates (the “WraSer Seller”) (the “WraSer
APA”). Pursuant to, and subject to the terms and conditions of, the WraSer APA, on the WraSer Closing Date (as defined below) the
Company was to purchase six FDA-approved pharmaceutical assets across several indications, including cardiology, otic infections, and
pain management (the “WraSer Assets”).
Under the terms of the WraSer APA, the Company
was to purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA; (ii) $4.5 million in cash on the later of
(x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the WraSer APA are met or otherwise
waived (the “WraSer Closing Date”); (iii) 25,000 shares of the Company’s common stock (the “Closing Shares”)
issuable on the WraSer Closing Date, and (iv) $500,000 in cash one year from the WraSer Closing Date.
In conjunction with the WraSer APA, the Company
and the WraSer Seller entered into a Management Services Agreement (the “MSA”) on the Execution Date. Pursuant to the terms
of the MSA, the Company will act as the manager of the WraSer Seller’s business during the period between the Execution Date and
the WraSer Closing Date. During this period, the Company will make advances to WraSer, if needed. If, on the WraSer Closing Date, the
WraSer Seller’s cash balance is in excess of the target amount (“Cash Target”) specified in the MSA, the Company will
apply that excess to the $ 4.5 million cash payment due upon closing. Conversely, if there is a shortfall, the Company will be required
to remit the difference to the WraSer Seller over time.
The WraSer APA could be terminated prior to the
closing upon agreement with all parties or upon breach of contract of either party, uncured within 20 days of notice. If the WraSer APA
was terminated upon agreement with all parties or upon uncured breach of contract by the Company, the initial $ 3.5 million payment would
be retained by the WraSer Seller. If it is determined that there is an uncured breach of contract by the WraSer Seller, and the WraSer
APA was terminated, the Company will have an unsecured claim against WraSer for the $ 3.5 million payment made by the Company upon execution
of the WraSer APA. The closing of the transaction is subject to certain customary closing conditions, including submission of the FDA
transfer documentation to transfer ownership of the acquired product regulatory approvals to the Company.
F- 25
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
Management evaluated the terms of the WraSer APA
and the WraSer MSA, and determined that, at the Execution Date, control under the provisions of ASC 805, Business Combinations (“ASC
805”), did not transfer to the Company; if the transaction closes, control will transfer then, and the acquisition date will be
the closing date. Management further evaluated the requirements pursuant to ASC 810, Consolidations , and determined based on the
terms of the MSA, and the Company’s involvement in the WraSer Seller’s business, that the WraSer Seller is a variable interest
entity (“VIE”) to the Company. Management determined that the Company is not the primary beneficiary of the VIE as the WraSer
APA and MSA do not provide the Company with the power to direct the activities of the VIE that most significantly impact the VIE’s
economic performance. While the Company was involved in the day-to-day business activities of the VIE until WraSer filed for relief under
Chapter 11 of the U.S. Bankruptcy Court (see below), the WraSer Seller had to approve substantially all business activities and transactions
that significantly impact the economic performance of WraSer during the term of the MSA. Additionally, the Company is not required to
absorb the losses of WraSer if the WraSer APA does not close. As such, the Company was not required to consolidate WraSer in the Company’s
financial statements as of the years ended December 31, 2024 and 2023.
The Company recorded the initial $ 3.5 million
payment as a deposit. The Company does not have any liabilities recorded as of December 31, 2024 and 2023 associated with its variable
interest in the WraSer Seller, and its exposure to the WraSer Seller’s losses is limited to no more than the shortfall, if any,
of the Cash Target amount of approximately $ 1.1 million compared to the WraSer Seller’s cash balance on the WraSer Closing Date.
On September 26, 2023, WraSer and its affiliates
filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court. On October 4, 2023, the parties agreed to amend
the WraSer APA, which was subject to court approval. Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the
WraSer APA as amended. The amendment, among other things, eliminates the $ 500,000 post-closing payment due June 13, 2024 and
staggers the $ 4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to
be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares
of Series A Preferred Stock to be paid at closing . The amendment also reduced the number of products the Company was acquiring by
excluding pain medications and including only (i) Ciprofloxacin 0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL
and its Authorized Generic Version approved under US FDA NDA No. 208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark
CETRAXAL, and (iii) Vorapaxar Sulfate tablets under the trademark Zontivity approved under US FDA NDA N204886.
In October 2023, WraSer alerted the Company
that its sole manufacturer for the active pharmaceutical ingredient (“API”) for Zontivity, the key driver for the WraSer acquisition,
would no longer manufacture the API for Zontivity. The Company believes that this development constituted a Material Adverse Effect under
the WraSer APA and the WraSer MSA, enabling the Company to terminate the WraSer APA and the WraSer MSA. On October 20, 2023, the Company
filed a motion for relief from the automatic stay in the Bankruptcy Court so that the Company can exercise the termination rights under
the WraSer APA, as amended. On December 18, 2023, the Bankruptcy Court entered into an Agreed Order lifting the automatic stay to
enable the Company to exercise its rights to terminate the WraSer APA and the WraSer MSA. On December 21, 2023, the Company
filed a Notice with the Bankruptcy Court terminating the WraSer APA and the WraSer MSA. WraSer has advised the Company that it does
not believe that a Material Adverse Effect occurred. Due to the WraSer bankruptcy filing and the Company’s status as an unsecured
creditor of WraSer, it is unlikely that the Company will recover the $ 3.5 million initial payment made, or any costs and resources in
connection with services provided by the Company under the WraSer MSA, and therefore the Company recorded a loss on impairment for the
$ 3.5 million deposit during the year ended December 31, 2023.
F- 26
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
Proteomedix
On December 15, 2023 (the “Acquisition Date”), Onconetix
entered into a Share Exchange Agreement (the “Share Exchange Agreement”) with Proteomedix and each of the holders of outstanding
capital stock or Proteomedix convertible securities (other than Proteomedix stock options) (collectively the “Sellers”), pursuant
to which the Company acquired 100 % of the outstanding common shares and voting interest of Proteomedix, through the issuance of
91,885 shares of common stock and 2,696,729 shares of Series B Convertible Preferred Stock (the
“PMX Transaction”) convertible into 6,741,820 shares of Common Stock .
Upon approval by
the requisite vote of stockholders of Onconetix at the Special Meeting of the Stockholders (“Stockholder Approval”), each
share of Series B Convertible Redeemable Preferred Stock (“Series B Preferred Stock”) was automatically convertible into 100 shares
of common stock in accordance with the terms of the Series B Certificate of Designation (the “Conversion”). If Stockholder
Approval was not obtained by January 1, 2025, Onconetix was, at the option of the holders, obligated to cash settle the Series B Preferred
Stock at the option of the holders. The Series B Preferred Stock outstanding as a result of the PMX Transaction was convertible into 6,741,820 shares
of common stock. Stockholder Approval was obtained on September 5, 2024 and the Conversion occurred subsequently on September 24, 2024
(see Note 9).
The consummation (the “Closing”)
of the PMX Transaction was subject to customary closing conditions and the agreement to enter into a subscription agreement (see Note
8) with Altos Ventures, a shareholder of Proteomedix, prior to the closing of the PMX Transaction (the “PMX Investor”).
In addition, each option to purchase
shares of Proteomedix (each, a “Proteomedix Stock Option”) outstanding immediately before the Closing, whether vested or unvested,
remains outstanding until the Conversion unless otherwise terminated in accordance with its terms. At the Conversion, each outstanding
Proteomedix Stock Option, whether vested or unvested, shall be assumed by Onconetix and converted into the right to receive (a) an option
to acquire shares of common stock (each, an “Assumed Option”) or (b) such other derivative security as Onconetix and Proteomedix
may agree, subject in either case to substantially the same terms and conditions as were applicable to such Proteomedix Stock Option immediately
before the Closing. Each Assumed Option shall: (i) represent the right to acquire a number of shares of common stock equal to the product
of (A) the number of Proteomedix common shares that were subject to the corresponding Proteomedix Option immediately prior to the Closing,
multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement”); and (ii) have an exercise price (as rounded
down to the nearest whole cent) equal to the quotient of (A) the exercise price of the corresponding Proteomedix Option, divided by (B)
the Exchange Ratio. The Company completed the Conversion on September 24, 2024, and the Company is in process of exchanging
the Proteomedix Stock Options into Onconetix restricted stock units as of the date of this filing. As of December 31, 2024, the PMX option
holders continue to own Proteomedix Stock Options.
Management determined
that the PMX Transaction was a business combination as defined within ASC 805 , and that Onconetix was the accounting acquirer.
The Company determined that Onconetix was the accounting acquirer based on the guidance contained within ASC 805-10. The significant factors
that led to the Company’s conclusion were ( i) the Company obtained 100% of the outstanding common stock and voting interest of PMX,
(ii) at closing of the PMX Transaction, the PMX shareholders were issued approximately 17% of Onconetix’s outstanding common stock
and none of the former PMX shareholders held more than 5% of Onconetix’s common stock individually, (iii) the composition of executive
management and the governing body did not change sufficiently to give PMX or its former shareholders control over these functions within
Onconetix, and (iv) Onconetix was significantly larger when considering both total assets and operations. As a result, the
Company has applied purchase accounting as of the Closing of the PMX Transaction. The assets, liabilities, and non-controlling interest
of Proteomedix were recognized at fair value as of the Closing and the results of its operations have been included within Onconetix’s
consolidated statements of operations and comprehensive loss from that date forward.
F- 27
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
The acquisition-date fair value of the consideration
transferred totaled approximately $ 65.1 million, which consisted of the following:
Consideration
Transferred
Common stock
$ 875,484
Series B convertible preferred stock
64,236,085
Total consideration transferred
$ 65,111,569
The fair value of the Company’s common shares
issued as consideration was based on the closing price of the Company’s common stock as of the Acquisition Date. The fair value
of the Series B Preferred Stock issued as consideration was based on the underlying fair value of the number of common shares that the
Series B Preferred Stock converts into, also based on the closing price of the Company’s common stock as of the Acquisition Date.
The fair value of the Proteomedix stock options
assumed as part of the PMX Transaction was determined using a Black-Scholes option pricing model with the following significant assumptions:
Exercise price
$ 1.15 – 28.83
Stock price
$ 128.11
Term (years)
0.17 – 3.59
Expected stock price volatility
90 %
Risk-free rate of interest
4.07 % – 5.47 %
We finalized the purchase price allocation on
December 15, 2024. The following table summarizes the fair values of the assets acquired, and liabilities assumed at the acquisition date:
As Initially
Reported
Measurement
Period
Adjustments
As
Adjusted
Cash
$ 1,056,578
$ -
$ 1,056,578
Accounts receivable
87,445
-
87,445
Inventories
80,593
-
80,593
Prepaid expenses and other current assets
114,615
-
114,615
Right of use asset
149,831
-
149,831
Property and equipment, net
39,779
-
39,779
Trade name
9,018,000
( 6,239,000 )
2,779,000
Customer relationships
1,891,000
( 818,000 )
1,073,000
Product rights for developed technology
10,541,000
( 3,264,000 )
7,277,000
Goodwill
53,914,055
8,393,843
62,307,898
Total assets acquired
76,892,896
( 1,927,157 )
74,965,739
Accounts payable
( 234,029 )
-
( 234,029 )
Accrued expenses
( 732,814 )
-
( 732,814 )
Operating lease liability
( 149,831 )
-
( 149,831 )
Deferred tax liability
( 2,994,669 )
1,927,157
( 1,067,512 )
Pension benefit obligation
( 548,384 )
-
( 548,384 )
Note payable
( 115,096 )
-
( 115,096 )
Total liabilities assumed
( 4,774,823 )
1,927,157
( 2,847,666 )
Net assets
72,118,073
-
72,118,073
Less non-controlling interest
( 7,006,504 )
-
( 7,006,504 )
Net assets acquired
$ 65,111,569
$ -
$ 65,111,569
F- 28
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
During the year ended December 31, 2024, we recorded
measurement period adjustments to decrease intangible assets, specifically the trade name, customer relationships, and product rights
for developed technology, as a result of revised future cash flow estimates and to decrease deferred tax liability as a result of changes
in net operating loss estimates from the initial purchase price allocation. In addition, the measurement period adjustment included a
change in the useful life determination of the tradename from indefinite to 15-years. These measurement period adjustments were made to
reflect facts and circumstances that existed as of the acquisition date. The net effect of these adjustments would have resulted in an
insignificant decrease in amortization expense recorded during the year ended December 31, 2024. The measurement period adjustments were
recorded in our consolidated financial statements as of and for the year ended December 31, 2024.
The goodwill recognized as a result of the PMX
Transaction is attributable primarily to expected synergies and the assembled workforce of Proteomedix. None of the goodwill is expected
to be deductible for income tax purposes.
The fair values of the acquired tangible and intangible
assets were determined using variations of the cost, income approach using the excess earnings, lost profits and relief from royalty methods.
The income approach valuation methodology used for the intangible assets acquired in the PMX Transaction makes use of Level 3 inputs.
The trade name intangible asset represents the
value of the Proclarix™ brand name and was valued using a relief from royalty method under an income approach. A royalty rate of
6 % was utilized in determining the fair value of this intangible asset. The fair value of this asset was determined based on a cash flow
model using forecasted revenues and expenses specifically tied to Proclarix™. Those cash flows were then discounted at 10 % determined
by the use of a weighted average return on assets analysis The estimated useful life of the trade name of 15-years was determined based
on the underlying patent’s remaining life.
The customer relationship intangible assets represent
the value of the existing customer contract with LabCorp (see Note 5) and was valued using the lost profits method under the income approach.
The fair value of this asset was determined based on a cash flow model using forecasted revenues specifically tied to Proteomedix’s
LabCorp contract. Those cash flows were then discounted at 10 % determined by the use of a weighted average return on assets analysis.
The estimated useful life of this asset was determined by reference to the estimated life of the product rights associated with the LabCorp
contract.
The product rights for developed technology acquired
in the PMX Transaction represents know-how and patented intellectual property held by PMX pertaining to its commercial-ready prostate
cancer diagnostic system, Proclarix™. The fair value of this asset was determined based on a cash flow model based on forecasted
revenues and expenses specifically tied to Proclarix™. Those cash flows were then discounted at 7 % for the period prior to patent
expiration and 14 % for the period thereafter. The discount rates were determined by the use of a weighted average return on assets analysis.
The estimated useful life of the product rights was determined based on the underlying patent’s remaining life.
F- 29
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 5 — Acquisitions (cont.)
The fair value of the non-controlling interest
in Proteomedix was estimated to be $ 7.0 million and represented the fair value of the vested Proteomedix stock options outstanding as
of the Acquisition Date. The fair value of the non-controlling interest was valued using the methodology applicable to the Proteomedix
stock options disclosed above. As Proteomedix was a private company as of the Acquisition Date, the fair value measurement is based on
significant inputs that are not observable in the market and thus represents a Level 3 measurement as defined in ASC 820, Fair Value
Measurement .
The Company recognized approximately $ 1.5 million
of acquisition related costs that were expensed during 2023, including the fair value of the subscription agreement liability, which was
a closing condition for the PMX Transaction (see Note 8).
The amounts of revenue and loss of Proteomedix,
included in the Company’s consolidated statements of operations and comprehensive loss from the Acquisition Date through December
31, 2023 are as follows:
Revenue
$ 58,465
Net loss
$ 315,688
The following summary, prepared on a pro forma
basis, presents the Company’s unaudited consolidated results of operations for 2023 and 2022 as if the PMX Transaction had been
completed as of January 1, 2022. The pro forma results below include the impact of amortization of intangible assets. This pro forma
information is presented for illustrative purposes only, is not necessarily indicative of future results of operations and does not include
any impact of transaction synergies. In addition, the pro forma results are not necessarily indicative of the results of operations that
actually would have been achieved had the PMX Transaction been consummated as of that date:
Unaudited
For the Years Ended
December 31,
2023
2022
Revenue
$ 2,601,310
$ 392,460
Net loss
$ 38,577,046
$ 16,326,247
Note 6 — Significant Agreements
Services Agreement
On July 21, 2023, the Company, entered into a
Licensing and Services Master Agreement (“Master Services Agreement”) and a related statement of work with a vendor, pursuant
to which the vendor was to provide to the Company commercialization services for the Company’s products, including recruiting, managing,
supervising and evaluating sales personnel and providing sales-related services for such products, for fees totaling up to $ 29.1 million
over the term of the statement of work. The statement of work had a term through September 6, 2026, unless earlier terminated in accordance
with the Master Services Agreement and the statement of work. On July 29, 2023, a second statement of work was entered into with the same
vendor for certain subscription services providing prescription market data access to the Company. The fees under the second statement
of work totaled approximately $ 800,000 , and the term was through July 14, 2025 . On October 12, 2023, the Company terminated the Master
Services Agreement and the statements of work. During 2023, the Company recognized a termination fee of approximately $ 1.4 million included
in selling, general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. Subsequently
during 2024, the Company agreed with the vendor to pay a reduced termination fee of approximately $ 0.9 million and recorded net credits
of $0.5 million for the difference in the termination fee related to this contract during the year ended December 31, 2024, which is included
in selling, general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. The Company
had approximately $ 1.1 million and $ 1.8 million recorded in related accounts payable as of December 31, 2024 and 2023, respectively, which
includes amounts due for early termination of the contract.
F- 30
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 6 — Significant Agreements (cont.)
Laboratory Corporation of America
On March 23, 2023, Proteomedix
entered into a license agreement with LabCorp, pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix,
and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States (“Licensed
Products”). In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee of in the mid-six
figures upon signing of the contract. Additionally, Proteomedix is entitled to royalty payments of between 5 % and 10 % on the net sales
recognized by LabCorp of any Licensed Products plus milestone payments as follows:
●
after the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures,
●
after LabCorp achieves a certain amount in the low seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures,
●
after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures.
The total milestone payments available under the
terms of this contract are $ 2.5 million. An additional $ 0.5 million was paid to Proteomedix as an initial license fee in 2023.
LabCorp is wholly responsible for the cost, if
any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of
those costs against future royalty and milestone payments. Additionally, LabCorp may deduct royalties or other payments made to third
parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix. There
was no such activity under the agreement for the year ended December 31, 2024.
The license agreement and related royalty payment
provisions expire during 2038, which approximates the expiration of the last patent covered by the license agreement. LabCorp has the
right to terminate the license agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate
the license agreement due to a material reach of the terms of the license agreement with 40 days’ notice, provided such breach is
not cure within the foregoing 30-day period. Finally, Proteomedix may terminate the license agreement with 60 days’ notice in the
event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day period.
As of December 31, 2024, the sale of Licensed
Products by LabCorp under the license agreement has not commenced. The Company has sold product to LabCorp for their use in internal trials
of the test.
Note 7 — Notes Payable
Veru Notes Payable
In connection with the Veru APA (see Note 5),
the Company executed three non-interest bearing notes payable (the “Notes”) in the principal amounts of $ 4.0 million, $ 5.0
million and $ 5.0 million with initial maturity dates of September 30, 2023 , April 19, 2024 , and September 30, 2024 , respectively. In accordance
with the Notes, no principal payments are due until maturity, however, the Company may voluntarily prepay the Notes with no penalty. Additionally,
in an Event of Default, as defined in the Notes, the unpaid principal amount of the Notes will accrue interest at a rate of 10.0 % per
annum.
The Company imputed interest on the Notes using
an average discount rate of 8.2 % and recorded a debt discount of approximately $ 1.1 million at the issuance date. The debt discount is
reflected as a reduction in the carrying amount of the Notes and amortized to interest expense through the respective maturity dates,
using the effective interest method.
F- 31
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 7 — Notes Payable (cont.)
On September 29, 2023, the Company and the note
holder entered into an amendment to the Veru APA, which provided that the $ 4.0 million note payable originally due on September 30, 2023
was deemed paid and fully satisfied upon (1) the payment to the Seller of $ 1.0 million in cash on September 29, 2023, and (2) the issuance
to the Seller by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company (see Note 5). In connection with the Veru
APA Amendment, the Company recorded an extinguishment loss on the note payable of approximately $ 490,000 , which represents the difference
between the fair value of the Series A Preferred Stock that was issued to settle the debt and the carrying value of the note payable as
of September 29, 2023. Pursuant to the Veru APA Amendment, the Series A Preferred Stock would convert to common stock of the Company one
year from the date of issuance if the required stockholder approval was obtained. The Series A Preferred Stock, which was issued to the
Seller on October 3, 2023 was initially convertible, in the aggregate, into 142,749 shares of the Company’s common stock, subject
to adjustment and certain stockholder approval limitations specified in the Certificate of Designations. Stockholder approval was obtained
during September 2024 and therefore subsequent conversion of the Series A Preferred Stock to common stock was consummated by the Company
during the quarter ended September 30, 2024 (see Note 9). The Company also agreed to include the shares of common stock issuable upon
conversion of the Series A Preferred Stock in the next resale registration statement filed with the SEC. To that end, the Company registered
130,321 shares of common stock, out of the 142,749 shares issued to Veru, in a registration statement filed with the SEC on November 1,
2024. Of the 142,749 shares issued to Veru originally, 12,428 shares were sold prior to registration. As a result, the remaining unsold
shares of 130,321 were registered.
On April 24, 2024, the Company entered into a
forbearance agreement with Veru (the “Original Forbearance Agreement”) due to the Company’s failure to repay the principal
balance on the $ 5.0 million note payable that had a maturity date of April 19, 2024 (the “April Veru Note”). Pursuant to the
Original Forbearance Agreement, Veru will forbear from exercising its rights and remedies under the April Veru Note as a result of this
default, until March 31, 2025 (the “April 2024 Forbearance Period”).
Interest will accrue on any unpaid principal balance
of the April Veru Note at a rate of 10 % per annum, commencing on April 20, 2024 through the date that the outstanding principal balance
under the April Veru Note is paid in full. Any such accrued interest will become immediately due and payable upon the earlier of (i)certain
events of default under the April Veru Note or the $ 5.0 million note payable that matures on September 30, 2024 (the “September
Veru Note”), (ii) a payment default under the September Veru Note and (iii) the final payment of any principal amount payable under
the September Veru Note. No interest was to accrue under the September Veru Note during the April 2024 Forbearance Period unless an Event
of Default (as defined in the Original Forbearance Agreement) occurs, in which case interest will accrue from and after the date on which
such default occurs.
In consideration for Veru’s entrance into
the Original Forbearance Agreement, the Company agreed to pay Veru:
● $ 50,000 of the principal due under the April Veru Note, which was paid on April 25, 2024, and up to $ 10,000 of out-of-pocket expenses incurred by Veru in connection with the Original Forbearance Agreement;
● 15 % of (i) the monthly cash receipts of Proteomedix for the licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from LabCorp; and
● 10 % of the net proceeds from any financing or certain asset sale, transfer or licensing transactions that are consummated prior to March 31, 2025.
The Company also agreed to a general release of
claims against Veru and its representatives arising out of or relating to any act or omission thereof prior to April 24, 2024.
The Company determined that the Original Forbearance
Agreement should be accounted for as a modification of the April Veru Note and the September Veru Note in accordance with ASC 470-50,
Debt - Modifications and Extinguishments (“ASC 470”), as the change in cash flows expected under the April Veru Note
and the September Veru Note was not substantial. A new effective interest rate was established based on the carrying value of the original
Notes and the revised cash flows and no gain or loss was recorded.
On September 19, 2024, the Company entered into
an Amended and Restated Forbearance Agreement with Veru (the “Amended and Restated Forbearance Agreement” or “A&R
Forbearance Agreement”), which amends and restates the Original Forbearance Agreement in its entirety. Pursuant to the A&R Forbearance
Agreement, Veru will forbear from exercising its rights under both the April Veru Note and the September Veru Note, subject to the terms
and conditions set forth below.
F- 32
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 7 — Notes Payable (cont.)
The A&R Forbearance Agreement extends the
due date for the April 2024 and September 2024 Veru Notes until the earlier to occur of (i) June 30, 2025 or (ii) the occurrence of any
Event of Default. The Amended and Restated Forbearance Agreement also effected certain modifications to the payment terms in the Original
Forbearance Agreement and amended certain terms of the September Veru Note as summarized below.
Pursuant to the A&R Forbearance Agreement,
the Company agreed to make the following required payments (the “Required Payments”) during the April 2024 Forbearance Period,
first to accrued and unpaid interest under the April Veru Note and then any remainder to the outstanding principal amount of the April
Veru Note:
● Interest at the rate of 10 % per annum shall accrue on any unpaid principal balance of the April Veru Note commencing on April 20, 2024 through the date that the outstanding principal balance under the April Veru Note is paid in full;
● Monthly payments equal to 25 % (increased from 15 % in the Original Forbearance Agreement) of (i) the monthly cash receipts of Proteomedix for the licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from LabCorp cash receipts of the Company or any of its subsidiaries from certain sale or licensing revenues or payments (the “Ordinary Cash Revenue”), which increased amount began October 20, 2024 for cash receipts in September 2024;
● Payment of 20 % (increased from 10 % in the Original Forbearance Agreement) of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by the Company or any of its subsidiaries during the April 2024 Forbearance Period, which increased amount will begin for any net proceeds received after September 19, 2024; and
●
The remaining balance of the April Veru Note will be due at the end of the April 2024 Forbearance Period.
The Company
and Veru also agreed to the following amendments to the September Veru Note in the A&R Forbearance Agreement:
●
As noted above, an extension of the maturity date to June 30, 2025;
● The accrual of interest at the rate of 10 % per annum on any unpaid principal balance of the September Veru Note commencing on October 1, 2024 through the date that the outstanding principal balance under the September Veru Note is paid in full;
●
Any amounts owed on the September Veru Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of Veru and the Company, in shares of the Company’s Common Stock or a combination of cash and the Company’s Common Stock;
●
Following full repayment of all principal and interest under the April Veru Note, the Company will make the Required Payments first towards accrued and unpaid interest under the September Veru Note and then towards the remaining principal balance payable under the September Veru Note;
● If the aggregate unpaid principal outstanding under the April Veru Note and the September Veru Note and all accrued and unpaid interest thereon is repaid in cash on or before December 31, 2024, then the total principal balance under the September Veru Note that will be payable by the Company in satisfaction of its obligations under the September Veru Note will be reduced from $ 5.0 million to $ 3.5 million.
The Company determined the A&R Forbearance
Agreement should be accounted for as a modification of both the April and September Veru Notes in accordance with ASC 470-50, Debt
- Modifications and Extinguishments (“ASC 470”), as the change in cash flows expected under the April Veru Note and the
September Veru Note was not substantial. A new effective interest rate was established based on the carrying value of the original Notes
and the revised cash flows and no gain or loss was recorded.
On November 26, 2024, the Company entered into
another Amended and Restated Forbearance Agreement with Veru (the “November Amended and Restated Forbearance Agreement” or
“November A&R Forbearance Agreement”), which amends and restates certain terms of the Amended and Restated Forbearance
Agreement. Pursuant to the November A&R Forbearance Agreement, Veru agreed to waive the due date for payment of applicable Cash Receipt
Payments (as such term is defined in the A&R Forbearance Agreement) generated in October 2024 until the Company receives funds of
at least $ 97,000 pursuant to its equity line of credit facility with Keystone Capital Partners LLC. In exchange, the Company agreed to
increase its payments to be made to Veru out of future financing and strategic transactions through June 30, 2025, from 20 % to 25 % of
net proceeds generated from such transactions. All other terms of the A&R Forbearance Agreement with Veru remain the same. Management
has evaluated and concluded that there is no accounting impact from the A&R Forbearance Agreement with Veru.
During the year ended December 31, 2024 and 2023,
the Company recorded approximately $ 1.4 million and $ 0.7 million of associated interest expense, respectively, which includes accrued
interest and amortization of the debt discount. The unamortized debt discount as of December 31, 2024 and 2023 was $ 5,000 and $ 0.4 million.
As of December 31, 2024, the Company has recorded accrued interest of approximately $ 0.1 million on the Notes, which is included in accrued
expenses in the accompanying consolidated balance sheets.
Future minimum principal payments on the Notes
as of December 31, 2024 include $ 4.3 million in principal payments that are due in March 2025 and $ 5.0 million principal payments that
are due in June 2025.
F- 33
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 7 — Notes Payable (cont.)
Related Party Debenture
On January 23, 2024, the Company issued a non-convertible
debenture (the “Debenture”) to the PMX Investor, a related party, in the principal sum of $ 5.0 million, in connection with
the Subscription Agreement discussed in Note 8. The Debenture has an interest rate of 4.0 % per annum, and the principal and accrued interest
was originally payable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. Additionally,
the $ 5.0 million subscription amount under the Subscription Agreement shall be increased by the amount of interest payable under the Debenture.
On April 24, 2024, the maturity date of the related
party debenture was extended to October 31, 2024, through the execution of an extension agreement (the “Extension Agreement”)
between the Company and the PMX investor. No other terms of the Debenture were modified in connection with the Extension Agreement.
The Company considered the guidance of ASC 470-60,
Troubled Debt Restructuring by Debtors , and concluded that the Extension Agreement should be accounted for as a troubled debt restructuring
as the Company is experiencing financial difficulty and since the effective borrowing rate under the Extension Agreement is less than
the effective borrowing rate under the original agreement, which indicates that a concession is deemed to have been granted. This did
not result in a gain on restructuring as the future undiscounted cash outflows required under the Extension Agreement exceed the carrying
value of the Debenture immediately prior to the extension. A new effective rate was established based on the carrying value of the original
Debenture and the revised cash flows.
In connection with the issuance of the Debenture,
the Company incurred approximately $ 0.4 million in financing fees, which was recorded as a debt discount, and reflected as a reduction
in the carrying amount of the Debenture. The debt discount is being amortized to interest expense through the maturity date. The Company
did not incur any financing fees in connection with the Extension Agreement.
On September 24, 2024, the Company converted all
unpaid principal and accrued interest due under the Debenture into 500,000 units, attributable to principal, and 13,424 units, attributable
to accrued interest, upon the closing of the Subscription Agreement. Each unit consisted of 1 share of common stock and 0.30 pre-funded
warrants at an exercise price of $ 0.04 per share. As a result of the transaction, 513,424 shares of common stock were issued, and 154,027
pre-funded warrants were issued. As of December 31, 2024, there is no outstanding balance or accrued interest remaining on the Debenture.
The remaining unamortized debt discount was immediately expensed upon settlement.
The Company recorded approximately $ 0.5 million
of interest expense on the Debenture during the year ended December 31, 2024, respectively, which includes accrued interest and amortization
of the debt discount.
Insurance Financing
During the year ended December 31, 2024, the Company
obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns the lender a first priority
lien on and security interest in the financed policies and any additional premium required in the financed policies.
The total premiums, taxes and fees financed are
approximately $ 0.7 million, with an annual interest rate of 7.79 %. In consideration of the premium payment by the lender to
the insurance companies or the agent or broker, the Company unconditionally promised to pay the lender the amount financed plus interest
and other charges permitted under the agreement. As of December 31, 2024, the company had paid off the insurance financing note payable.
The Company paid the insurance financing through monthly installment payments of approximately $ 78,000 , the last payment for the note
was paid on November 17, 2024 .
PMX Note Payable
The Company also assumed an obligation in the
amount of 100,000 CHF, in connection with the Proteomedix acquisition. This obligation relates to a loan from an investor that was advanced
to Proteomedix in March 2010. This loan bears no interest, is unsecured and may be cancelled by the Company at its discretion. The loan
was terminated in the fourth quarter of 2024. The long term note payable has no outstanding balance as of December 31, 2024.
F- 34
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 8 — Subscription Agreement
On December 18, 2023, the Company entered into
a subscription agreement (the “Subscription Agreement”) with the PMX Investor, who became a stockholder of Onconetix at the
closing of the PMX Transaction (see Notes 5 and 11), for the sale of 500,000 units, each comprised of 1 share of common stock and 0.30
pre-funded warrants (the “Units”) at $ 10 per Unit. The Subscription Agreement includes a make-whole provision which requires
the issuance of additional shares of common stock in the event that the 270-day volume weighted average price after the closing of the
Subscription Agreement, is below $ 10 , and the PMX Investor still holds the common shares acquired upon closing of the Subscription Agreement
270 days after such closing. The Subscription Agreement would only close upon obtaining Stockholder Approval for certain transactions
involving the Company’s Series B Preferred Stock, as further described in Note 5. The Subscription Agreement was amended on January
23, 2024 to include a provision for interest on the $ 5 million debenture, accruing at a rate of 4 %, to be included in the calculation
of the units to be issued upon the Conversion. Stockholder approval was obtained on September 5, 2024, and as a result, the Conversion
and the issuance of 500,000 units, attributable to the Subscription Agreement, and 13,424 units, attributable to additional accrued interest
under the debenture to the PMX Investor took place on September 24, 2024. Due to the issuance, the make-whole took effect and remains
in place until June 24, 2025.
The Subscription Agreement is accounted for as
a liability in accordance with ASC 480, Distinguishing Liabilities from Equity , (“ASC 480”), as the make-whole provision
could result in a variable number of shares being issued upon settlement. The related party subscription agreement liability is measured
at fair value at the commitment date and at each subsequent reporting period, with changes in fair value recorded as a component of other
income (expense), net in the consolidated statements of operations and comprehensive loss. As of December 31, 2024 and December 31, 2023,
the fair value of the related party subscription agreement liability is estimated to be approximately $ 4,123,000 and $ 864,000 , respectively,
and the change in fair value of the related party subscription agreement liability for the year ended December 31, 2024 was an increase
of approximately $ 3,259,000 . The fair value was determined using a Monte-Carlo option pricing model, and as of December 31, 2024 and 2023,
the Company utilized 100 % and 55 % probability, respectively, that the Subscription Agreement will close. The significant assumptions used
in the Monte-Carlo model, which utilizes Level 3 inputs (see Note 3), are as follows as of December 31, 2024 and 2023:
December 31,
2024
December 31,
2023
Exercise price
$ 10
$ 10
Term (years)
0.48
1.2
Expected stock price volatility
100 %
95 %
Risk-free rate of interest
4.25 %
4.64 %
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity
Authorized Capital
As of December 31, 2024 and 2023, the Company
is authorized to issue 250,000,000 shares and 10,000,000 shares of common stock and preferred stock, respectively, with a par value of
$ 0.00001 for both common stock and preferred stock.
At December 31, 2024, the Company had designated 1,150,000 shares,
10,000 shares, 2,700,000 shares, and 10,000 shares of Series Seed Preferred Stock, Series A Preferred Stock, Series B Preferred Stock
and Series C Preferred Stock, respectively.
At December 31, 2023, the Company had designated and authorized the
issuance of up to 1,150,000 shares, 10,000 shares, 2,700,000 shares, and 0 shares of Series Seed Preferred Stock, Series A Preferred Stock,
Series B Preferred Stock and Series C Preferred Stock, respectively.
Preferred Stock
Series Seed Convertible Preferred Stock
The Company has 1,150,000 shares of preferred
stock designated as Series Seed Preferred Stock (“Series Seed”) and there are no shares of Series Seed outstanding as of December
31, 2024 and 2023.
F- 35
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Series A Convertible Preferred Stock
On September 29, 2023, the Company filed a Certificate
of Designations of Rights and Preferences of Series A Preferred Stock of the Company (the “Series A Certificate of Designations”)
with the State of Delaware to designate and authorize the issuance of up to 10,000 shares of Series A Preferred Stock.
On October 3, 2023, the Company issued 3,000 shares
of Series A Convertible Preferred Stock in exchange for the settlement of $ 3.0 million in notes payable due to Veru, Inc. (see Notes 5
and 7).
On September 24, 2024, Veru converted all 3,000
shares of Series A Convertible Preferred Stock into 142,749 shares of the Company’s common stock per the stated conversion ratio.
There were 0 and 3,000 shares of Series A Convertible Stock outstanding as of December 31, 2024 and 2023, respectively.
Series B Convertible Preferred Stock
On December 15, 2023, the Company filed a Certificate
of Designations of Rights and Preferences of Series B Convertible Preferred Stock of the Company (the “Series B Certificate of Designations”)
with the State of Delaware to designate and authorize the issuance of up to 2,700,000 shares of Series B Preferred Stock.
On December 15, 2023, in connection with the PMX
Transaction, as part of the purchase consideration, the Company issued 2,696,729 shares of Series B Convertible Preferred Stock (see Note
5). The Series B Preferred Stock was initially convertible into approximately 6,741,820 shares of the Company’s common stock,
upon Stockholder Approval as defined in the Series B Certificate of Designation.
The Company evaluated the terms of the Series
B Preferred Stock, and in accordance with the guidance of ASC 480, the Series B Preferred Stock was classified as temporary equity in
the accompanying consolidated balance sheets, as the shares may be redeemable by the holders for cash, upon certain conditions that are
not within the control of the Company. Additionally, the Company does not control the actions or events necessary to deliver the number
of required shares upon exercise by the holders of the conversion feature. The Series B Preferred Stock was recorded at its fair value
as of the issuance date (see Note 5). The Series B Preferred Stock was not previously redeemable or probable of becoming redeemable because
it was subject to, among other things, Stockholder Approval as described above, and therefore the carrying amount was not accreted to
its redemption value in prior periods.
On September 5, 2024, Stockholder Approval was
obtained, and on September 24, 2024, the Company effected the conversion of all 2,696,729 shares of Series B Preferred Stock into 6,741,820
shares of the Company’s common stock.
Series C Convertible Preferred Sock
On October 1, 2024, the Board of Directors authorized
the Company to create a series of 10,000 shares of preferred stock designated as “Series C Convertible Preferred Stock”, with
a par value of $ 0.00001 , pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible
Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends
actually paid on shares of Common Stock, when and if actually paid. In addition, from and after the occurrence and during the continuance
of any Triggering Event, dividends (“Default Dividends”) will accrue on the Stated Value of each Preferred Share at a rate
of fifteen percent ( 15.0 %) (the “Default Rate”) per annum. Each holder is entitled to convert any portion of the outstanding
Preferred Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which
can be determined by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $ 4.5056 , subject to adjustment
as provided in the Certificate of Designations.
F- 36
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
After the Stockholder Approval Date, if a Triggering
Event occurs and is continuing at any time after the earlier of the holders’ receipt of a Triggering Event Notice and such holder
becoming aware of such Triggering Event (such earlier date, the “Alternate Conversion Right Commencement Date”) and ending
on the twentieth (20 th ) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder’s
receipt of a Triggering Event Notice (such ending date, the “Alternate Conversion Right Expiration Date”), and each such period,
an “Alternate Conversion Right Period”), such holder may, at such holder’s option, by delivery of a Conversion Notice
to the Company (the date of any such Conversion Notice, each an “Alternate Conversion Date”), convert all, or any number of
Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an “Alternate Conversion”).
Alternate Conversion Price means, with respect to any Alternate Conversion that price will be the lowest of (i) the applicable Conversion
Price as in effect on the applicable Conversion Date of the applicable Alternate Conversion, and (ii) the greater of (x) the Floor Price
and (y) 80% of the lowest VWAP of the Common Stock during the five (5) consecutive Trading Day period ending and including the Trading
Day immediately preceding the delivery or deemed delivery of the applicable Conversion Notice (such period, the “Alternate Conversion
Measuring Period”).
At any time, the Company has the right to redeem
in cash all, but not less than all, of the Preferred Shares then outstanding at a price (the “Company Optional Redemption Price”)
equal to 125% of the greater of (i) the Conversion Amount being redeemed and (ii) the product of (1) the Conversion Rate with respect
to the Conversion Amount being redeemed multiplied by (2) the greatest closing sale price of the Company’s Common Stock on any Trading
Day during the period commencing on the date immediately preceding the date the Company notifies the holders of its elections to redeem
and the date the Company makes the entire payment required. Upon the occurrence of a Bankruptcy Triggering Event, the Company will immediately
redeem, in cash, each of the Preferred Shares then outstanding at a redemption price equal to the greater of (i) the product of (A) the
Conversion Amount to be redeemed multiplied by (B) 125% and (ii) the product of (X) the Conversion Rate with respect to the Conversion
Amount in effect immediately following the date of initial public announcement of such Bankruptcy Triggering Event multiplied by (y) the
product of (1) 125% multiplied by (2) the greatest closing sale price of the Common Stock on any Trading Day during the period commencing
on the date immediately preceding such Bankruptcy Triggering Event and ending on the date the Company pays the entire payment required.
The holders of the Series C Preferred Stock are entitled to be paid a cash amount equal to 30% of the gross proceeds in the event of any
sale of common stock under the ELOC in accordance with the terms stated below within the ELOC securities purchase agreement.
In no event may any Preferred Shares be converted
(or Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common
Stock upon such conversion of the Preferred Shares (or exercise of the Warrants), the holder (together with its affiliates, if any) would
beneficially own more than 4.99 % of the outstanding shares of Common Stock, which we refer to herein as the “PIPE Blocker”.
The PIPE Blocker may be raised or lowered to any percentage not in excess of 9.99 % at the option of the applicable holder of the Preferred
Shares (or Warrants), except that any raise will only be effective upon 61-days’ prior notice to the Company.
F- 37
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Securities Purchase Agreement and ELOC
On October 2, 2024, the Company entered into a
Securities Purchase Agreement (the “Securities Purchase Agreement”) with six institutional and accredited investors. The Company
sold an aggregate of i) 3,499 Series C Preferred Stock, par value $ 0.00001 per share (the “Series C Redeemable Preferred
Stock”), and (ii) a warrants to purchase 591,856 shares of common stock (the “Series C PIPE Warrants”), for
aggregate cash proceeds of $ 2,000,000 . The Warrants have an exercise price of $ 4.38 per share, subject to adjustment therein, and
expire on the third anniversary of the initial exercisability date. The warrants issued with the Series C Redeemable Preferred Stock are
accounted for as liabilities in accordance with ASC 815.
Concurrently, on October 2, 2024, the Company
entered into a Common Stock Equity Line of Credit Purchase Agreement (the “ELOC Purchase Agreement”) with an institutional
investor, whereby the Company may sell up to $ 25,000,000 of the Company’s new issued Common Stock. Pursuant to the ELOC Purchase
Agreement, the investor shall purchase from the Company up to the lesser of (i) $ 25.0 million in shares of our Common Stock and (ii) 1,658,525
shares, representing 19.99 % of the total number of shares of Common Stock outstanding immediately prior to the execution of the ELOC Purchase
Agreement. Pursuant to the ELOC Purchase Agreement, 30 % of the gross proceeds to the Company from any sale of common stock thereunder
must be applied towards the redemption of the Series C Redeemable Preferred Stock.
Based on the terms of
the Series C Redeemable Preferred Stock and the Company’s Certificate of Designation, and in accordance with ASC 480, the Series
C Redeemable Preferred Stock is accounted for as mezzanine equity due to the contingent redemption feature upon any sale of common
stock under the ELOC Purchase Agreement. The initial cash proceeds of $ 2,000,000 were allocated between the Series C Preferred Stock
and derivative liability warrants, with the amount initially recorded in mezzanine equity based on the guidance in ASC 815 (i.e. the value
of the derivative liability warrant is allocated its full fair value, and the residual is allocated to the Series C Redeemable Preferred
Stock). The derivative liability warrants were measured at fair value at inception in the amount of $ 1,138,476 and the Series C Redeemable
Preferred stock was measured at residual value of $ 861,524 . The Series C Redeemable Preferred Stock is subsequently measured at redemption
value as they occur, with the difference between the basis per share of $ 246.22 and redemption value per share recorded as a deemed dividend
in the statements of operations.
During the year ended
December 31, 2024, the Company received proceeds of $ 935,625 and recorded approximately $ 250,000 of shareholder receivable under the ELOC
and the Company recorded a deemed divided in the amount of $ 206,404 in the statements of operations for the year ended December 31, 2024.
The Company did not have
the Series C PIPE warrant liabilities at December 31, 2023. The following table presents information about the Company’s Series
C PIPE warrant liabilities that are measured at fair value on a recurring basis with changes in fair value presented in the statements
of operations:
Description
Level
December 31,
2024
Contingent warrant liabilities – Series C PIPE warrants*
3
$ 32,892
Total
$ 32,892
* Included within contingent warrant liabilities of the accompanying
consolidated balance sheet as of December 31, 2024.
The following table presents the changes in the
fair value of the Series C PIPE warrants:
Series C
PIPE
warrants*
Fair value as of October 2, 2024 (inception)
$ 1,138,476
Change in fair value
( 1,105,584 )
Fair value as of December 31, 2024
$ 32,892
* Included within Change in Fair Value of Contingent Warrant
Liabilities in the accompanying consolidated statement of operations for the year ended December 31, 2024.
The following table provides quantitative information
regarding the fair value measurements for the derivative liability warrants using the Monte Carlo pricing model:
At Inception
December 31,
2024
Strike price
$ 4.38
$ 4.38
Expected annual volatility
90 %
90 %
Risk-free rate
3.55 %
4.31 %
Expected term, years
3.50
3.25
There were no transfers in or out of
Level 3 from other levels in the fair value hierarchy during the year ended December 31, 2024.
F- 38
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Common Stock
As of December 31, 2024 and 2023 there were 11,767,443
and 571,033 shares of common stock issued, respectively, and 11,754,509 and 558,099 shares of common stock outstanding, respectively.
Warrant Inducements:
July 2024 Inducement
On July 11, 2024, the Company entered into common
stock preferred investment options exercise inducement offer letters (the “Inducement Letters”) with certain holders of existing
preferred investment options to purchase shares of the Company’s common stock at the original exercise prices of $ 101.84 and $ 43.60
per share, issued on August 11, 2022 and August 2, 2023, respectively (collectively, the “Existing PIOs”), pursuant to which
the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 186,466 shares of the Company’s common stock,
at a reduced exercise price of $ 6.00 per share, in consideration for the Company’s agreement to issue new preferred investment options
(the “Inducement PIOs”) to purchase up to an aggregate of 559,397 shares of the Company’s common stock. Of the 559,397
PIOs issued, 186,465 have a contractual term of 5 years, while the remaining 372,932 have a contractual term of 2 years. Aside from the
contractual terms, the Inducement PIOs have substantially the same terms as the Existing PIOs.
On July 11, 2024, the Company consummated the
transaction contemplated by the Inducement Letters upon unanimous written consent of the Board of Directors (the “Warrant Inducement”).
The Company received aggregate net proceeds of approximately $ 0.9 million from the Warrant Inducement, after deducting placement agent
fees and other offering expenses payable by the Company.
The Company agreed to file a registration statement
covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the “Resale Registration
Statement”) within 30 days after the date of the Inducement Letter and to use commercially reasonable efforts to cause such Resale
Registration Statement to be declared effective by the SEC within 60 days following the date of the Inducement Letter (or within 90 days
following the date of the Inducement Letter in the case of full review of the Resale Registration Statement by the SEC).
The Company engaged H.C. Wainwright & Co.,
LLC (“Wainwright”) to act as its exclusive placement agent in connection with the transactions summarized herein and paid
Wainwright a cash fee equal to 7.5 % of the gross proceeds received form the exercise of the Existing PIOs as well as a management fee
equal to 1.0 % of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its expenses
in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOS, up to $ 50,000 for fees and expenses of legal
counsel and other out-of-pocket expenses and paid Wainwright for non-accountable expenses in the amount of $ 35,000 . The Company also issued
to Wainwright or its designees warrants (the “Placement Agent Warrants”), and as such shares of common stock issuable thereunder,
(the “Placement Agent Warrant Shares”) to purchase (i) 13,054 shares of common stock which have the same terms as the Inducement
PIOs except for an exercise price equal to $ 7.50 per share and a term of five (5) years following the date of stockholder approval and
(ii) upon any exercise for cash of the Inducement PIOs, 7.5 % of the aggregate exercise price and that number of shares of common stock
equal to 7.0 % of the aggregate number of such shares of common stock underlying the Inducement PIOs that have not been exercised, which
will have substantially the same terms as the Placement Agent Warrants.
The Company evaluated the terms of the Inducement
PIOs and the Wainwright Inducement Warrants (collectively, the “August 2023 Inducement Warrants”), and determined that they
should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40.
The Warrant Inducement, which resulted in the
lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing
PIOs under the guidance of Accounting Standards Update (“ASU”) No. 2021-04, Issuer’s Accounting for Certain Modifications
or Exchanges of Equity Classified Written Call Options . The modification is consistent with the “Equity Issuance” classification
under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants,
resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately
$ 0.9 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as
the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $ 1.9
million as an equity issuance cost.
In addition, the change in fair value of the contingent
warrant liability associated with 3,729 of the August 2022 Contingent Warrants and 7,459 of the August 2023 Contingent Warrants was decreased
to $ 0 upon the agreement with Wainwright that all prior contingent warrants were no longer issuable or due upon the Warrant Inducement
Transaction. The fair value of the contingent warrant liability of approximately $ 2,700 was derecognized as of the settlement date, with
the corresponding amount, representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid-in capital.
The Company evaluated the terms of the 39,158
Inducement Contingent Warrants (equivalent to 7.0 % of the aggregate number of such shares of common stock underlying the Inducement PIOs
that have not been exercised), which are issuable upon a future inducement, and determined that they should be classified as a liability
based upon accounting guidance provided in ASC 815-40. Since the Inducement Contingent Warrants are a form of compensation to Wainwright,
the Company recorded the value of the liability of approximately $ 158,000 as a reduction of additional paid in capital, with subsequent
changes in the value of the liability recorded in other income (expense) in the accompanying statements of operations. The fair value
was determined using a Monte-Carlo option pricing model, and as of December 31, 2024 and 2023
F- 39
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
August 2023 Inducement
On July 31, 2023, the Company entered into a common
stock preferred investment option exercise inducement letter (the “Inducement Letter”) with a certain holder of existing preferred
investment options to purchase shares of the Company’s common stock at the original exercise price of $ 101.84 per share, issued
on August 11, 2022 (the “Existing PIOs”). Pursuant to the Inducement Letter, the Holder agreed to exercise for cash its Existing
PIOs to purchase an aggregate of 62,155 shares of the Company’s common stock (the “Inducement PIO Shares”), at a reduced
exercise price of $ 43.6 per share, in exchange for the Company’s agreement to issue new PIOs (the “Inducement PIOs”)
to purchase up to 124,311 shares of the Company’s common stock. The Inducement PIOs have substantially the same terms as the Existing
PIOs.
On August 2, 2023, the Company consummated the
transactions contemplated by the Inducement Letter (the “Warrant Inducement”). The Company received aggregate net proceeds
of approximately $ 2.3 million from the Warrant Inducement, after deducing placement agent fees and other offering expenses payable by
the Company.
Upon close of the transaction, the Company issued
the Holder 39,375 of the 62,155 shares of common stock that were issuable upon exercise of the Existing PIOs. Due to the beneficial ownership
limitation provisions in the Inducement Letter, the remaining 22,780 shares were initially unissued, and held in abeyance for the benefit
of the Holder until notice from the Holder that the shares may be issued in compliance with such limitation is received. These shares
were issued to the Holder in October 2023.
The Company agreed to file a registration statement
covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs, as soon as practicable,
and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC within 90 days following
the date of the Inducement Letter, and to keep the Resale Registration Statement effective at all times until there are no Inducement
PIO Shares. The provision to register the underlying shares in the Warrant Inducement does not require payment related to the registration
rights provided. As such, while the shares were not registered within 90 days of the date of the Inducement Letter, there is no accounting
impact for this provision.
The Company engaged Wainwright to act as its placement
agent in connection with the Warrant Inducement and paid Wainwright a cash fee equal to 7.5 % of the gross proceeds received from the exercise
of the Existing PIOs as well as a management fee equal to 1.0 % of the gross proceeds from the exercise of the Existing PIOs. The Company
also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement
PIOs, up to $ 50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable
expenses in the amount of $ 35,000 . In addition, the exercise for cash of the Existing PIOs triggered the issuance to Wainwright or its
designees, warrants to purchase 3,729 shares of common stock (“Wainwright Inducement Warrants”), which were issuable in accordance
with the terms of the August Contingent Warrants, and have the same terms as the Inducement PIOs except for an exercise price equal to
$ 54.50 per share. The Company also agreed to issue warrants to Wainwright upon any exercise for cash of the Inducement PIOs, that number
of shares of common stock equal to 6.0 % of the aggregate number of such shares of common stock underlying the Inducement PIOs that have
been exercised, also with an exercise price of $ 54.50 (the “Inducement Contingent Warrants”). The maximum number of Inducement
Contingent Warrants issuable under this provision is 7,459 .
The Company evaluated the terms of the Inducement
PIOs and the Wainwright Inducement Warrants (collectively, the “August 2023 Inducement Warrants”), and determined that they
should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40. The Company also evaluated
the unissued shares held in abeyance, which represent a prepaid forward contract, and determined that it is an equity instrument based
on the guidance provided in ASC 480 and ASC 815-40.
The Warrant Inducement, which resulted in the
lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing
PIOs under the guidance of Accounting Standards Update (“ASU”) No. 2021-04, Issuer’s Accounting for Certain Modifications
or Exchanges of Equity Classified Written Call Options . The modification is consistent with the “Equity Issuance” classification
under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants,
resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately
$ 2.3 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as
the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $ 2.6
million as an equity issuance cost.
In addition, the change in fair value of the contingent
warrant liability associated with 3,729 of the August Contingent Warrants that were settled through issuance of the Wainwright Inducement
Warrants, of approximately $ 122,000 , was recognized in other income(expense) in the accompanying statements of operations, and the fair
value of the contingent warrant liability of approximately $ 129,000 was derecognized as of the settlement date. The corresponding amount,
representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid in capital.
The Company evaluated the terms of the Inducement
Contingent Warrants and determined that they should be classified as a liability based upon accounting guidance provided in ASC 815-40.
Since the Inducement Contingent Warrants are a form of compensation to Wainwright, the Company recorded the value of the liability of
approximately $ 26,000 as a reduction of additional paid in capital, with subsequent changes in the value of the liability recorded in
other income (expense) in the accompanying statements of operations.
F- 40
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Treasury Stock
On November 10, 2022, the Board approved a stock
repurchase program (the “Repurchase Program”) to allow the Company to repurchase up to 125,000 shares of common stock with
a maximum price of $ 1.00 per share, with discretion to management to make purchases subject to market conditions. On November 18, 2022,
the Board approved an increase to the maximum price to $ 2.00 per share. There was no expiration date for this program and prices are not
adjusted for the reverse stock split to comply with the program.
There were no repurchases of common stock during
the year ended December 31, 2024. During the year ended December 31, 2023, the Company repurchased 1,441 shares of common stock, for an
aggregate of approximately $ 59,000 , at an average price of $ 40.80 (adjusted on a post-reverse stock split basis). Shares that are repurchased
are classified as treasury stock pending future use and reduce the number of shares outstanding used in calculating earnings per share.
On November 13, 2024, the Board terminated the
Repurchase Program.
At the Market Offering Agreement
On March 29, 2023, the Company entered into an
At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (the “Agent”),
to create an at-the-market equity program under which it may sell up to $ 3,900,000 of shares of the Company’s common stock (the
“Shares”) from time to time through the Agent (the “ATM Offering”). Under the ATM Agreement, the Agent will be
entitled to a commission at a fixed rate of 3.0 % of the gross proceeds from each sale of Shares under the ATM Agreement. The Company has
no obligation to sell, and the Agent is not obligated to buy or sell, any of the Shares under the Agreement and may at any time suspend
offers under the Agreement or terminate the Agreement. The ATM Offering will terminate upon the termination of the ATM Agreement
as permitted therein.
Deferred offering costs associated with the ATM
Agreement are reclassified to additional paid in capital on a pro-rata basis when the Company completes offerings under the ATM Agreement.
Any remaining deferred costs will be expensed to the statements of operations should the planned offering be abandoned.
As of December 31, 2024, no shares have been sold
under the ATM Offering, and the Company wrote off approximately $ 0.3 million of deferred offering costs in its consolidated balance sheets
as of December 31, 2024.
F- 41
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Warrants
The following summarizes activity related to the
Company’s outstanding warrants, excluding contingent warrants issuable upon exercise of the preferred investment options, for the
years ended December 31, 2024 and 2023:
Weighted
Average
Weighted Remaining
Average Contractual
Number of Exercise Life
Shares Price (in years)
Outstanding as of December 31, 2022 147,773 $ 94.8 4.7
Granted 128,040 44.0 -
Exercised ( 78,321 ) 34.6 -
Cancelled -
-
-
Outstanding as of December 31, 2023 197,492 $ 67.20 4.3
Granted 1,318,334 4.59 -
Exercised ( 340,493 ) 34.53 -
Cancelled -
-
-
Outstanding as of December 31, 2024 1,175,333 6.72 2.92
Warrants vested and exercisable as of December 31, 2024 583,475 $ 9.10 2.57
As of December 31, 2024, the Company had outstanding
warrants, which are exercisable into 583,475 shares of common stock. The shares of common stock underlying the warrants outstanding had
an exercise price of $ 6.72 per share, based on the closing trading price on December 31, 2024.
Contingent Warrant Liabilities
Additionally, as of December 31, 2024, the fair
value of contingent warrant labilities includes the Series C PIPE warrants (see Note 9) of $ 32,982 and those issuable upon exercise of
the Inducement PIOs of approximately $ 10,200 (see Note 9) totaling $ 43,089 included as contingent warrant liabilities in the accompanying
consolidated balance sheets.
As of December 31, 2023, the fair value of contingent
warrants issuable upon exercise of the August 2022 private placement and August 2023 inducement warrants was approximately $ 3,000 . Upon
the PIO inducement in July 2024, the August 2022 and August 2023 contingent warrants were settled and replaced for no consideration.
The maximum number of warrants issuable upon settlement
of the contingent warrants was 39,158 for the Inducement PIOs contingent warrants and 591,856 for the Series C PIPE warrants as of December
31, 2024. The maximum number of warrants issuable upon settlement of the Inducement contingent warrants was 11,188 as of December 31,
2023.
Onconetix Equity Incentive Plans
The Company’s 2019 Equity Incentive Plan
(the “2019 Plan”) was adopted by its board of directors and by its stockholders on July 1, 2019. On February 23, 2022 the
Company’s board of directors adopted the Company’s 2022 Equity Incentive Plan (the “2022 Plan”), which is the
successor and continuation of the Company’s 2019 Plan. Under the 2022 Plan, the Company may grant stock options, restricted stock,
restricted stock units, stock appreciation rights, and other forms of awards to employees, directors, and consultants of the Company.
In May 2023, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to 78,750 , and in September
2024, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to 1,450,000 . Stock-based awards granted
during the year ended December 31, 2024 and 2023 were all granted under the 2022 Plan. As of December 31, 2024, there are 719,660 shares
available for issuance under the 2022 Plan.
F- 42
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Stock Options
The following summarizes activity related to
the Company’s stock options under the 2019 Plan and the 2022 Plan for the years ended December 31, 2024 and 2023:
Weighted
Average
Weighted Remaining
Average Total Contractual
Number of Exercise Intrinsic Life
Shares Price Value (in years)
Outstanding as of December 31, 2022 34,816 $ 132.0 $ 670,161 8.2
Granted 24,054 19.2 —
—
Forfeited / cancelled ( 10,103 ) 194.80 —
—
Exercised ( 1,148 ) 0.4 1,148 —
Outstanding as of December 31, 2023 47,619 65.20 94,239 8.4
Granted —
—
—
—
Forfeited / cancelled ( 33,539 ) 28.35 —
—
Exercised ( 406 ) 0.5 2,512 —
Outstanding as of December 31, 2024 13,674 156.96 —
7.87
Options vested and exercisable as of December 31, 2024 9,336 $ 189.15 7.65
There were no stock options granted during the
year ended December 31, 2024. The fair value of options granted during the year ended December 31, 2023 was estimated using the following
assumptions:
For the Year
Ended December 31,
2023
Exercise price
$ 10.40 – 51.60
Term (years)
5.00 – 10.00
Expected stock price volatility
101.1 % – 119.5 %
Risk-free rate of interest
3.5 % – 4.7 %
The weighted average grant date fair value of
stock options granted during the year ended December 31, 2023 was $ 16.40 . The aggregate fair value of stock options that vested during
the years ended December 31, 2024 and 2023 was approximately $ 0.7 million and $ 0.7 million, respectively.
On October 4, 2023, the Company’s board
of directors granted an aggregate of 17,744 stock options in connection with the appointment of the Company’s newly hired Chief
Executive Officer and Chief Financial Officer. The options granted have an exercise price of $ 17.22 per share, vest quarterly over
a three-year period, and have a grant date fair value of approximately $ 0.2 million. The Company recognized less than $ 0.1 million of
stock-based compensation expense related to these awards during the year ended December 31, 2023. Subsequent to December 31, 2023, in
connection with the resignation of the newly hired Chief Executive Officer, 12,199 of these options were forfeited.
F- 43
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 9 — Convertible Redeemable Preferred Stock and Stockholders’
Equity (cont.)
Restricted Stock
On May 9, 2023, the Board’s Compensation
Committee approved the issuance of restricted stock, granted under the Company’s 2022 Plan, to the Company’s executive officers,
employees, and certain of the Company’s consultants. The restricted shares granted totaled 12,188 , of which 3,750 , 1,875 , and 3,750
were granted to the Company’s former CEO, former CFO, and former CBO, respectively. All of the restricted shares granted vest as
follows: 50 % in January 2024, 25 % in August 2024, and 25 % in August 2025. In addition, on May 31, 2023, the Board’s Compensation
Committee approved the issuance of 636 shares of restricted stock, granted to the Company’s non-executive Board members, with full
vesting on May 31, 2024. On February 14, 2024, in connection with the appointment of a non-executive Board member, the Company issued
78 shares of restricted stock, which vested in full on June 14, 2024. Furthermore, on September 26, 2024, the Company issued its
Board members a total of 16,590 restricted stock, with full vesting August 31, 2025.
Weighted
Average
Number of
Grant Date
Shares
Fair Value
Nonvested as of December 31, 2023
6,414
$ 41.20
Granted
700,124
0.42
Vested
( 688,308 )
0.62
Forfeited
( 313 )
40.93
Nonvested as of December 31, 2024
17,917
$ 6.15
Proteomedix Stock Option Plan
Proteomedix sponsors a stock option plan (the
“PMX Option Plan”) which provides common stock option grants to be granted to certain employees and consultants, as was determined
by the board of directors of Proteomedix. In connection with the PMX Transaction, the Company assumed the PMX Option Plan (see Note 5).
Generally, options issued under the PMX Option
Plan have a term of less than 11 years and provide for a four -year vesting period during which the grantee must remain in the service
of Proteomedix. Stock options issued under the PMX Option Plan are measured at fair value using the Black-Scholes option pricing model.
On April 16, 2024, the board of directors of Proteomedix
approved a two-year extension of 12,257 vested stock options that were set to expire in April 2024. The extended expiration date for these
options is April 18, 2026. The Company recorded approximately $ 18,000 of expense associated with this modification during the year ended
December 31, 2024.
There was no other activity under the PMX Option
Plan for the year ended December 31, 2024. In October 2024, 58,172 stock options were converted to shares with a weighted average exercise
price of $ 3.46 . As of December 31, 2024, there were no outstanding stock options.
Stock-Based Compensation
Stock-based compensation expense for the years ended December 31, 2024
and 2023 was as follows:
For the Years Ended
December 31,
2024
2023
Selling, general and administrative
$ 483,226
$ 234,298
Research and development
( 44,573 )
95,462
Total
$ 438,653
$ 329,760
During the year ended December 31, 2024, in connection
with the termination of three Company employees, outstanding stock options and restricted stock awards to these individuals were modified
to allow continued vesting during the term of their respective new consulting agreements. The Company recognized a net credit of approximately
$ 58,000 to stock-based compensation expense as a result of these modifications, primarily due to the decrease in the Company’s
stock price.
F- 44
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 10 — Commitments and Contingencies
Leases
The Company entered into a short-term lease in
Palm Beach, Florida with an unrelated party, with a commencement date of May 1, 2022, for approximately $ 14,000 per month. The lease,
which was personally guaranteed by the Company’s former CEO, ended on April 30, 2023. During the year ended December 31, 2023, the
Company incurred rent expense on this lease of approximately $ 51,000 , and variable lease expense of approximately $ 4,000 .
Proteomedix leases office and lab space in Zurich
Switzerland. On April 1, 2024, the original lease was amended to add additional office and laboratory space. The lease amendment was
accounted for as a separate lease, resulting in an additional right-of-use asset and lease liability of approximately $ 88,000 . The lease,
as amended, requires payments of approximately $ 129,000 for the year ended December 31, 2025.
Litigation
From time to time, the Company may be subject
to various legal proceedings and claims that arise in the ordinary course of its business activities. As of December 31, 2024, the Company
is not a party to any material legal proceedings and is not aware of any pending or threatened claims. However, as discussed in Note 5,
on December 21, 2023, the Company filed a notice with the Bankruptcy Court terminating the WraSer APA and the WraSer MSA, after having
determined that a Material Adverse Effect had occurred. WraSer has advised the Company that it does not believe that a Material Adverse
Effect occurred, and they recently filed a plan of reorganization that indicates it may seek damages from the Company due to the termination
of the WraSer APA and WraSer MSA.
Registration Rights Agreements
In connection with private placements consummated
in April 2022 and August 2022, the Company entered into Registration Rights Agreements with the purchasers. Upon the occurrence of any
Event (as defined in each Registration Rights Agreement), which, among others, prohibits the purchasers from reselling the securities
for more than ten consecutive calendar days or more than an aggregate of fifteen calendar days during any 12-month period, and should
the registration statement cease to remain continuously effective, the Company would be obligated to pay to each purchaser, on each monthly
anniversary of each such Event, an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 2.0 % multiplied
by the aggregate subscription amount paid by such purchaser in the private placements. As of December 31, 2024, and as a result of the
consummation of the remaining warrants associated with the April 2022 and August 2022 private placements, the Company has no further obligations
pertaining to the Registration Rights Agreements.
Indemnification
In the normal course of business, the Company
enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications.
The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the
future but have not yet been made. To date, the Company has not been required to defend any action related to its indemnification obligations.
However, during the third quarter of 2023, the Company received a claim from its former CEO and a former accounting employee requesting
advancement of certain expenses. The Company recorded approximately $ 209,000 in related expenses during the year ended December 31, 2023,
of which approximately $ 159,000 was paid through reduction of the outstanding related party receivable due from the former CEO (see Note
11). The Company recorded a related accrual of approximately $ 50,000 , which was included in accrued expenses at December 31, 2023, and
which was paid during 2024, and accordingly there is no related accrual as of December 31, 2024. The maximum potential amount of future
payments the Company could be required to make under these indemnification agreements is not estimable at this time.
F- 45
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 11 — Related Party Transactions
During 2022, the Company entered into a lease
agreement that was personally guaranteed by the Company’s former CEO. The lease expired on April 30, 2023 (see Note 10).
During the year ended December 31, 2023, the Company’s
Audit Committee completed a review of the Company’s expenses due to certain irregularities identified with regards to the related
party balance. Based on the results of the review, it was determined that the Company paid and recorded within selling, general and administrative
expenses, personal expenditures of the Company’s former CEO and an accounting employee who was also the former CEO’s assistant,
during 2022 and during the first three quarters of 2023. The Company evaluated the receivable, which was approximately $ 363,000 , after
recording a recovery of approximately $ 159,000 , and which represented the total of the items identified as personal in nature for which
the Company did not anticipate recovery from the related party. During 2023, the Company recorded a corresponding reserve for the full
amount, resulting in a net related party receivable balance of $0 as of December 31, 2024 and December 31, 2023.
On December 18, 2023, the Company entered into
the Subscription Agreement with the PMX Investor, a 5 % stockholder of the Company as of December 31, 2024 (see Note 8). During the year
ended December 31, 2024, the Company issued a non-convertible debenture in the principal amount of $ 5.0 million to the PMX Investor, in
connection with the Subscription Agreement and has settled the principal and accrued interest through the issuance of shares (see Notes
7 and 8).
On February 6, 2024, the Company appointed Thomas
Meier, PhD, as a member of the Company’s board of directors. Dr. Meier provides consulting services to Proteomedix, through a consulting
agreement that was effective January 4, 2024. The Company recorded approximately $ 58,000 in related expenses during the year ended December
31, 2024, of which approximately $ 0 is included in accounts payable in the accompanying consolidated balance sheets as of December 31,
2024.
F- 46
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 12 — Income Taxes
The components of loss before income taxes are as follows:
For the Years Ended
December 31,
2024
2023
U.S.
$ ( 58,988,309 )
$ ( 37,106,599 )
Foreign
( 747,894 )
( 315,688 )
Total loss before income taxes
$ ( 59,736,203 )
$ ( 37,422,287 )
The Company’s major tax jurisdictions are
the United States, Switzerland, and various state jurisdictions, and the Company does not have any pending tax audits. The income tax
benefit recorded for the years ended December 31, 2024 and December 31, 2023 related to the Company’s deferred foreign taxes. Generally,
the Company’s federal returns from 2019 on and state returns from 2018 on, and foreign returns from 2018 on, are subject to examination
by the United States, state, and foreign tax authorities; however, to the extent allowed by law, tax authorities have the ability to adjust
the Company’s carryforwards of unutilized net operating losses and research and development credits for all years.
At December 31, 2024, the Company had a net operating
loss (“NOL”) carryforward for federal, foreign, and state income tax purposes totaling approximately $ 42.8 million, $ 15.2
million, and $ 35.7 million, respectively, available to reduce future taxable income. The federal NOL and certain state NOLs of $ 28.6 million
are carried forward indefinitely subject to a limitation of 80 % of taxable income. State NOLs of approximately $ 15.2 million will begin
to expire in 2024 if not utilized, and foreign NOLs of approximately $ 7.1 million will begin to expire in 2024 if not utilized.
The NOL carry forward is subject to review and
possible adjustment by the Internal Revenue Service and state tax authorities. Under the Internal Revenue Code (“IRC”) Sections
382 and 383, annual use of the Company’s net operating loss carryforwards and research credit carryforwards to offset taxable income
and tax, respectively, may be limited based on cumulative changes in ownership. The Company has not completed an analysis to determine
whether any such limitations have been triggered as of December 31, 2024. The amount of the annual limitation, if any, will be determined
based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation
in future years.
The tax effects of the temporary differences and
carryforwards that give rise to deferred tax assets and liabilities consist of the following:
As of
December 31,
2024
2023
Deferred tax assets:
Net-operating loss carryforward
$ 13,309,416
$ 10,214,760
Intangibles
3,887,855
3,349,919
Capitalized research and development
1,001,916
1,171,320
Stock-based compensation
645,113
690,760
Deposit on WraSer APA
854,896
854,896
Accrued compensation
55,193
150,099
License agreement
45,493
49,157
Other
667,065
520,207
Gross deferred tax assets
20,466,947
17,001,118
Valuation allowance
( 20,441,833 )
( 15,697,701 )
Deferred tax assets, net of allowance
$ 25,114
$ 1,303,417
Deferred tax liabilities:
Intangible assets
-
( 4,345,449 )
Fixed assets
( 1,378 )
( 2,560 )
Other
( 23,736 )
( 29,189 )
Total deferred tax liabilities
$ ( 25,114 )
$ ( 4,377,198 )
Net deferred tax liability
$ -
$ ( 3,073,781 )
F- 47
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 12 — Income Taxes (cont.)
The Company has evaluated the positive and negative
evidence bearing upon the realizability of its deferred tax assets. The Company has recorded a valuation allowance against its United
States and foreign deferred tax assets in each of the years ended December 31, 2024 and 2023, because the Company’s management believes
that it is more likely than not that these assets will not be realized. During the years ended December 31, 2024 and 2023, the valuation
allowance increased by approximately $ 4.7 million and $ 11.2 million, respectively.
The provision for income taxes on earnings subject
to income taxes differs from the statutory Federal rate at December 31, 2024 and 2023, due to the following:
For the Years Ended
December 31,
2024
2023
Expected income tax benefit at Federal statutory tax rate
$ ( 12,488,416 )
$ ( 7,858,680 )
State and local taxes, net of Federal tax benefit
( 339,155 )
( 1,192,605 )
Research credits
( 37,810 )
—
Foreign NOL expirations
—
315,927
Stock-based compensation
29,088
196,025
Subscription agreement liability
684,390
181,440
Officer’s compensation
—
( 126,337 )
Acquisition related costs
10,500
164,073
Goodwill Impairment
6,792,870
—
Permanent items
( 244,395 )
55,486
State rate adjustment
—
( 23,135 )
Foreign rate differential
7,205
—
Currency translation adjustment
49,773
—
Other
( 253,362 )
60,599
Change in valuation allowance
4,744,132
8,214,614
Income tax benefit
$ ( 1,045,180 )
$ ( 12,593 )
Under U.S. GAAP, the impact of an uncertain income
tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit
by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, U.S. GAAP provides guidance on derecognition, classification, interest and penalties, accounting for interim
periods, disclosure, and transition.
A reconciliation of the beginning and ending amount of unrecognized
tax benefits is as follows:
For the Years Ended
December 31,
2024
2023
Beginning balance
$ 17,010
$ 17,010
Increases related to prior year tax positions
—
—
Increases related to current year tax positions
9,452
—
Ending balance
$ 26,462
$ 17,010
At December 31, 2024 and 2023, the Company’s
unrecognized tax benefits were $ 26,462 and $ 17,010 , respectively. Due to the existence of the valuation allowance, future changes in the
Company’s unrecognized tax benefits will not impact the effective tax rate. The Company does not expect its unrecognized tax benefits
to change significantly over the next 12 months.
The Company’s policy is to recognize interest
and penalties related to uncertain tax positions in income tax expense. As of December 31, 2024 and 2023, there were no accrued interest
and penalties associated with uncertain tax positions.
F- 48
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 13 — Net Loss Per Share
Basic net loss per share is computed by dividing
the net income or loss applicable to common shares by the weighted average number of common shares outstanding during the period. The
weighted average number of shares of common stock outstanding includes pre-funded warrants because their exercise requires only nominal
consideration for delivery of shares; it does not include any potentially dilutive securities or any unvested restricted shares of common
stock. Certain restricted shares, although classified as issued and outstanding at December 31, 2024, are considered contingently returnable
until the restrictions lapse and will not be included in the basic net loss per share calculation until the shares are vested. Unvested
shares of the Company’s restricted stock do not contain non-forfeitable rights to dividends and dividend equivalents.
The two-class method is used to determine earnings
per share based on participation rights of participating securities in any undistributed earnings. Each share of preferred stock that
includes rights to participate in distributed earnings is considered a participating security and the Company uses the two-class method
to calculate net income available to the Company’s common stockholders per common share — basic and diluted.
The following securities were excluded from the
computation of diluted shares outstanding due to the losses incurred in the periods presented, as they would have had an anti-dilutive
impact on the Company’s net loss:
For the Years Ended
December 31,
2024
2023
Options to purchase shares of common stock
13,674
47,619
Warrants
1,175,333
197,492
Unvested shares of restricted stock
17,917
6,414
Common stock issuable upon conversion of Series A Preferred Stock
-
142,749
Common stock issuable upon conversion of Series C Redeemable Preferred Stock
776,589
-
Total
1,983,513
394,274
Note 14 — Defined Benefit Plan
Proteomedix sponsors a defined benefit pension
plan (the “Swiss Plan”) covering certain eligible employees. The Swiss Plan provides retirement benefits based on years of
service and compensation levels.
The following significant actuarial assumptions
were used in calculating the benefit obligation and the net periodic benefit cost as of December 31, 2024 and 2023:
December 31,
2024
December 31,
2023
Discount rate
1.00 %
1.45 %
Expected long-term rate of return on plan assets
1.00 %
1.45 %
Rate of compensation increase
1.50 %
3.00 %
Changes in these assumptions may have a material
impact on the plan’s obligations and costs.
The components of net periodic benefit cost
for the year ended December 31, 2024 and for the period from December 15, 2023 to December 31, 2023 are as follows:
For the year ended
December 31,
2024
For the period
December 15,
2023
through December 31,
2023
Service cost
$ 97,964
$ 4,278
Interest cost
30,032
1,943
Expected return on plan assets
( 23,343 )
( 1,581 )
Amortization of net (gain) loss
( 15,346 )
( 1,534 )
Settlements (gain) loss
-
( 1,157 )
Total
$ 89,307
$ 1,949
During the year ended December 31, 2024 and for
the period ended December 15, 2023 through December 31, 2023, the Company made pension contributions of approximately $ 89,404 and $ 0 ,
respectively.
F- 49
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 14 — Defined Benefit Plan (cont.)
The components of accumulated comprehensive loss
attributable to the Company’s pension plan for the year ended December 31, 2024 and for the period from December 15, 2023 to December
31, 2023 are as follows:
For the year ended December 31,
2024
For the period
December 15,
2023
through
December 31,
2023
Net loss (gain)
$ ( 190,064 )
$ 7,277
Prior service cost (credit)
( 63,292 )
-
Amortization of net gain
15,346
1,534
Effect of settlement
-
1,157
Other adjustments
-
( 4,005 )
Total recorded during the period
$ ( 238,010 )
$ 5,963
As of December 31, 2024 and 2023, the funded status
of the plan and the amounts recognized in the accompanying consolidated balance sheet are as follows:
December 31,
2024
2023
Projected benefit obligation
$ 2,593,360
$ 2,299,970
Fair value of plan assets
2,312,481
1,743,674
Overfunded (underfunded) status
$ ( 280,879 )
$ ( 556,296 )
A reconciliation of the beginning and ending balances
of the accumulated benefit obligation is provided in the table below:
As of December 31, 2023
$ 2,299,970
Service cost
97,964
Interest cost
30,032
Actuarial (gain) loss
72,031
Benefits paid
( 20,824 )
Ordinary contributions paid by employees
89,404
Contributions paid by plan participants
125,553
Plan amendments
( 100,770 )
Projected benefit obligation as of December 31, 2024
2,593,360
Actuarial (gain)/loss due to assumption changes
( 37,727 )
Actuarial (gain)/loss due to plan experience
109,758
Accumulated benefit obligation as of December 31, 2024
$ 2,665,391
A reconciliation of the beginning and ending balances
of the plan assets is provided in the table below:
As of December 31, 2023
$ 1,743,674
Actual return on plan assets
285,270
Contributions paid by employer
89,404
Ordinary contributions paid by employees
89,404
Contributions paid by plan participants
125,553
Benefits paid
( 20,824 )
Settlements
-
As of December 31, 2024
$ 2,312,481
F- 50
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 14 — Defined Benefit Plan (cont.)
Projected benefit payments for the next five years
as of December 31, 2024 are as follows:
Years ending December 31,
2025
$ 113,000
2026
111,000
2027
108,000
2028
106,000
2029
104,000
Thereafter
464,000
Total
$ 1,006,000
Note 15 – Segment Information
The Company conducts its business activities and
reports financial results as one business segment. The presentation of financial results as one reportable segment is consistent with
the way the Company operates its business and is consistent with the manner in which the Chief Operating Decision Maker ("CODM")
evaluates performance and makes resource and operating decisions for the business. The Company’s CODM is the Chief Executive Officer.
Furthermore, the Company notes that monitoring financial results as one reportable segment helps the CODM manage costs on a consolidated
basis, consistent with the integrated nature of the operations. The CODM uses net loss, as reported on the Consolidated Statements of
Operations and Comprehensive Loss, in evaluating performance of the Company and determining how to allocate resources of the Company as
a whole. As the CODM evaluates performance on a consolidated basis, all required financial segment information is included in the consolidated
financial statements.
Geographic Information
The distribution of revenue by geographical area
was as follows:
Years Ended
December 31,
2024
2023
United States
$ 63,115
$ —
United Kingdom
23,842
—
Switzerland
2,437,159
58,465
Total
$ 2,524,116
$ 58,465
The distribution of long-lived assets by geographical
area, which includes property and equipment and the Company’s right of use asset, was as follows:
Years Ended
December 31,
2024
2023
United States
$ 5,864
$ 10,956
Switzerland
176,459
198,240
Total
$ 182,323
$ 209,196
F- 51
ONCONETIX, INC.
Notes to Consolidated Financial Statements
Note 16 — Subsequent Events
IQVIA Settlement:
As previously disclosed
in Current Reports on Form 8-K filed on July 21, 2023 and October 18, 2023, Onconetix, Inc. (the “Company”) entered into a
Licensing and Services Master Agreement (“Master Services Agreement”) and a related statement of work with IQVIA, Inc. (“IQVIA”)
on July 21, 2023, and a second statement of work on July 29, 2023, which were terminated on October 12, 2023. On January 15, 2025, the
Company and IQVIA entered into a Settlement Agreement (the “Settlement Agreement”) concerning potential termination payments
under the Master Services Agreement and statements of work. Pursuant to the Settlement Agreement, the Company agreed to pay to IQVIA an
aggregate of $ 150,000 in exchange for a mutual release of all claims in connection with the Master Services Agreement. As a result of
the Settlement Agreement, the Company will record an adjustment of approximately $( 0.9 ) million in accounts payable.
Potential Business
Combination:
On April 8, 2025, the
Company issued a press release announcing the execution of a “Non-Binding Letter of Intent contemplating a potential business combination
transaction with Ocuvex Therapeutics, Inc. (“Ocuvex”), a privately held biopharmaceutical company focused on the development
and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. The
Company and Ocuvex intend to continue negotiations to enter into a definitive agreement. Upon closing of the proposed transaction, the
Company will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of common stock of
the Company. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will own approximately
90 % of the equity interests in the Company.
ELOC Draws and Series
C Preferred Stock Redemption:
As of April 15, 2025,
the Company has redeemed approximately 1,369 Series C preferred shares for an aggregate amount of $ 1.71 million. An additional amount
of $ 150,531 is due to the PIPE Series C investors for 120 Series C preferred shares that remain due from the most recent ELOC draw. These
120 shares remain subject to future redemption.
On May 30, 2025, the
Company has sold approximately 33,256,563 shares under the ELOC Purchase Agreement for aggregate proceeds of approximately $ 5.3 million,
for a total of 36,014,496 shares sold under the ELOC Purchase Agreement for gross proceeds of approximately $ 6.2 million.
Veru Agreement Waivers:
On March 31, 2025, Veru
and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024
Promissory Note to April 14, 2025.
On April 23, 2025, Veru
and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024
Promissory Note to June 30, 2025.
F- 52
Exhibit No.
Description
2.1
Share Exchange Agreement, dated December 15, 2023, by and among the Company, Proteomedix, Thomas Meier and the Sellers. (19)
3.1
Amended and Restated Certificate of Incorporation filed. (3)
3.2
Certificate of Amendment to the Company’s Second Amended and Restated Certificate of Incorporation (9)
3.3
Certificate of Amendment to the Company’s Second Amended and Restated Certificate of Incorporation. (19)
3.4
Fourth Amended and Restated Bylaws of the Company. (19)
3.5
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation (12)
3.6
Certificate of Amendment to the Amended and Restated Certificate of Incorporation (14)
3.7
Certificate of Designations authorizing the issuance of the Series C Preferred Stock (15)
4.1
Specimen Common Stock Certificate. (1)
4.2
Description of Registered Securities*
4.3
Form of Inducement PIO (10)
4.4
Form of Altos Warrants (14)
4.5
Form of Warrant (15)
10.1
2019 Equity Incentive Plan. (1)
10.2
2022 Equity Incentive Plan. (8)
10.3
2019 Equity Incentive Plan Form of Stock Option Grant Agreement. (1)
10.4
2022 Equity Incentive Plan Form of Incentive Stock Option Agreement (Employee). (24)
10.5
2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Consultant). (24)
10.6
2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Non-Employee Director). (24)
10.7
2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Employee). (24)
10.8
Form of Employment Agreement with Neil Campbell. (13)
10.9
Form of Employment Agreement with Bruce Harmon. (13)
10.10
Form of Employment Agreement with Ralph Schiess. (2)
10.11
Amendment to Employment Agreement, dated October 15, 2020, by and between Proteomedix and Ralph Schiess. (2)
10.12
Amendment to Employment Agreement by and between Proteomedix and Ralph Schiess. (2)
10.13
Form of Employment Agreement with Christian Brühlmann. (2)
10.14
Amendment to Employment Agreement, dated October 16, 2020, by and between Proteomedix and Christian Brühlmann. (2)
10.15
Amendment to Employment Agreement by and between Proteomedix and Christian Brühlmann. (2)
10.16
Release, dated January 10, 2024, by and between the Company and Dr. Neil Campbell. (20)
10.17
Form of Indemnification Agreement for Directors and Officers. (13)
10.18
Asset Purchase Agreement, dated April 19, 2023, between the Company and Veru Inc. (11) †
10.19
Amendment to Asset Purchase Agreement, dated September 29, 2023, between the Company and Veru Inc. (26)
10.20
Form of Non-Competition and Non-Solicitation Agreement, dated April 19, 2023. (11)
10.21
Form of Lock-Up Agreement, dated December 15, 2023, by and among the Company and certain stockholders of Proteomedix. (19)
117
10.22
Form of Non-Competition and Non-Solicitation Agreement, dated December 15, 2023, by and among the Company and certain stockholders of Proteomedix. (19)
10.23
Form of Stockholder Support Agreement, dated December 15, 2023, by and among the Company, Proteomedix, and certain stockholders of Proteomedix. (19)
10.24
Form of Subscription Agreement, dated December 15, 2023, by and among the Company, Proteomedix, and the Investor. (19)
10.25
Separation Agreement, dated January 17, 2024, between the Company and Erin Henderson. (21)
10.26
Consulting Agreement, dated January 17, 2024, between the Company and The Aetos Group. (21)
10.27
Debenture, dated January 23, 2024 issued to the Investor. (22)
10.28
Consulting Agreement, dated January 4, 2024, by and between the Company and Thomas Meier. (23)
10.29
Forbearance Agreement, dated April 24, 2024, between the Company and Veru (4)
10.30
Amendment to Non-Convertible Debenture, dated April 24, 2024, between the Company and Altos. (4)
10.31
Master Research Services Agreement, dated October 1, 2022, by and between Proteomedix AG and Immunovia, AB (5)
10.32
Collaboration Agreement, dated July 19, 2021, by and between Proteomedix AG and New Horizon Health Limited (5)
10.33
Amendment No. 1, dated June 26, 2023, to Collaboration Agreement, dated July 19, 2021, by and between Proteomedix AG and New Horizon Health Limited (5)
10.34
Release Agreement, dated June 10, 2024, between the Company and Bruce Harmon. (6)
10.35
Consulting Agreement, dated June 10, 2024, between the Company and Karina Fedasz. (7)
10.36
Form of Inducement Letter (10)
10.37
Amended and Restated Forbearance Agreement between the Company and Veru, dated September 19, 2024 (12)
10.38
Form of Securities Purchase Agreement dated October 2, 2024 relating to the sale of the Series C Preferred Stock and Warrants (15)
10.39
Form of Registration Rights Agreement dated as of October 2, 2024 relating to the resale of the shares of Common Stock underlying the Series C Preferred Stock and Warrants (15)
10.40
Form of ELOC Purchase Agreement dated October 2, 2024 (15)
10.41
Form of ELOC Registration Rights Agreement dated October 2, 2024 (15)
10.42
Waiver and Amendment No. 1 to Forbearance Agreement, dated November 26, 2024, between the Company and Veru (18)
14
Code of Ethics. (25)
16.1
Letter from EisnerAmper LLP, dated October 21, 2024. (17)
19
Insider Trading Policy, adopted August 7, 2023*
21
List of Subsidiaries.*
23.1
Consent of Malone Bailey*
23.2
Consent of EisnerAmper LLP.*
31.1
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
32.1
Certification of the Principal Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
97
Policy Related to Recovery of Erroneously Awarded Compensation, adopted January 17, 2024.*
101.INS*
XBRL Instance Document.*
101.SCH*
XBRL Taxonomy Schema Linkbase Document.*
101.CAL*
XBRL Taxonomy Calculation Linkbase Document.*
101.DEF*
XBRL Taxonomy Definition Linkbase Document.*
101.LAB*
XBRL Taxonomy Labels Linkbase Document.*
101.PRE*
XBRL Taxonomy Presentation Linkbase Document.*
104*
Cover Page Interactive Data File (Embedded as Inline XBRL document and contained in Exhibit 101).
* Filed herewith.
** Furnished herewith.
† Certain of the exhibits and
schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Company agrees to furnish a copy
of all omitted exhibits and schedules to the SEC upon its request.
# Certain portions of this exhibit
(indicated by “[***]” have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K as we have determined they (1)
are not material and (2) are the type that the Company treats as private or confidential. The Registrant hereby agrees to furnish a copy
of any omitted portion to the SEC upon request.
118
(1) Incorporated by reference to
the Company’s Registration Statement on Form S-1, filed with the SEC on October 8, 2021.
(2) Incorporated by reference to
the Company’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024.
(3) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on February 24, 2022.
(4) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on April 26, 2024.
(5) Incorporated by reference to
the Company’s Registration Statement on Form S-1/A filed with the SEC on June 5, 2024.
(6) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on June 13, 2024.
(7) Incorporated by reference to
the Company’s Amendment to Current Report on Form 8-K, filed with the SEC on June 14, 2024.
(8) Incorporated by reference to
the Company’s Registration Statement on Form S-1/A, filed with the SEC on January 6, 2022.
(9) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on April 24, 2023.
(10) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on July 11, 2024.
(11) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on April 20, 2023.
(12) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on September 20, 2024.
(13) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on October 10, 2023.
(14) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on September 24, 2024.
(15) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on October 3, 2024.
(16) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on September 20, 2024.
(17) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on October 21, 2024.
(18) Incorporated by reference to
the Company’s Current Report on Form 8-K, filed with the SEC on December 3, 2024.
(19) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on December 21, 2023.
(20) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on January 12, 2024.
(21) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on January 19, 2024.
(22) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on January 29, 2024.
(23) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on February 12, 2024.
(24) Incorporated by reference to
the Company’s Registration Statement on Form S-1/A filed with the SEC on January 6, 2022.
(25) Incorporated by reference to
the Company’s Registration Statement on Form S-1/A, filed with the SEC on November 5, 2021.
(26) Incorporated by reference to
the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2023.
Item 16. Form 10-K Summary.
We have elected not to include a summary pursuant to this Item 16.
119
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Onconetix, Inc.
Date: May 30, 2025
By:
/s/ Karina Fedasz
Karina Fedasz
Interim Chief Executive Officer and
Interim Chief Financial Officer
Pursuant to the requirements
of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in
the capacities indicated on May 30, 2025.
Signature
Title
/s/ Karina Fedasz
Interim Chief Executive Officer and Interim Chief Financial Officer
Karina Fedasz
/s/ Andrew Oakley
Non-Executive Chairman of the Board
Andrew Oakley
/s/ Thomas Meier
Director
Thomas Meier
/s/ Timothy Ramdeen
Director
Timothy Ramdeen
/s/ Ajit Singh
Director
Ajit Singh
/s/ Simon Tarsh
Director
Simon Tarsh
Our common stock is traded on The Nasdaq Capital
Market under the trading symbol “ONCO.”
120