−Removed: AND PROCEDURES
−Removed: of Disclosure Controls and Procedures
−Removed: have evaluated, with the participation of our principal executive and our principle financial officer, the effectiveness of our disclosure
−Removed: controls and procedures as defined in Rules 13a-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange
−Removed: Act) as of the end of the period covered by this Annual Report on Form 10-K.
−Removed: Based on this evaluation, our principal executive
−Removed: officer and our principal financial officer have concluded that our disclosure controls and procedures were effective to ensure that
−Removed: information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized
−Removed: and reported, within the time periods specified in the SECs rules and forms, and is accumulated and communicated to our management,
−Removed: including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow
−Removed: timely decisions regarding required disclosure.
−Removed: Report on Internal Control Over Financial Reporting
−Removed: management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f)
−Removed: and 15d-15(f) under the Exchange Act.
−Removed: Because of its inherent limitations, internal control over financial reporting may not prevent
−Removed: or detect misstatements.
−Removed: Projections of any evaluation of the effectiveness of internal control to future periods are subject to the
−Removed: risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures
−Removed: may deteriorate.
−Removed: Under the supervision and with the participation of our management, including our Chief Executive Officer and
−Removed: Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June
−Removed: 30, 2023 using the criteria established in Internal Control Integrated Framework (2013 Framework) issued by the Committee
−Removed: of Sponsoring Organization of the Treadway Commission (COSO).
−Removed: Based on our evaluation using those criteria, our management
−Removed: has concluded that, as of June 30, 2023, our internal control over financial reporting was effective to provide reasonable assurance
−Removed: regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
−Removed: generally accepted accounting principles for the reasons discussed above.
−Removed: in Internal Control Over Financial Reporting
−Removed: were no changes in our internal controls over financial reporting during quarter ended June 30, 2023, that materially affected, or are
−Removed: reasonably likely to materially affect our internal controls over financial reporting.
−Removed: REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
−Removed: EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
−Removed: The following table sets forth certain information
−Removed: regarding our Board of Directors, our executive officers, and some of our key employees, as of August 9, 2023.
−Removed: & President and Director
−Removed: Medical Officer
−Removed: Chairman of the Board
−Removed: Hariri, MD, PhD
−Removed: According to our Bylaws, the directors shall
−Removed: be elected at the annual meeting of the stockholders and each director shall be elected to serve until his successor shall be elected
−Removed: and shall qualify.
−Removed: A director need not be a stockholder.
−Removed: Directors shall not receive any stated salary for their services as directors
−Removed: or as members of committees, but by resolution of the Board of Directors a fixed fee and expenses of attendance may be allowed for attendance
−Removed: at each meeting.
−Removed: The Bylaws shall not be construed to preclude any director from serving the Company in any other capacity as an officer,
−Removed: agent or otherwise, and receiving compensation therefor.
−Removed: There are no familial relationships among
−Removed: any of our directors or officers.
−Removed: Biographical Information
−Removed: Cuong Do , has served on
−Removed: the Company’s Board of Directors since 2016 and effective April 27, 2021 was appointed the Company’s CEO and President.
−Removed: served as the President, Global Strategy Group, at Samsung from February 2015 to December 2020.
−Removed: Do helped set the strategic direction
−Removed: for Samsung Group’s diverse business portfolio.
−Removed: He was previously the Chief Strategy Officer for Merck from October 2011 to March
−Removed: 2014, and Tyco Electronics from June 2009 to October 2011, and Lenovo from December 2007 to March 2009.
−Removed: Do is a former senior partner
−Removed: at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate finance practices.
−Removed: a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth.
−Removed: We believe Mr.
−Removed: Do’s qualifications
−Removed: to serve on our Board of Directors and as the CEO are primarily based on his decades of experience as an executive in the pharma, biotech,
−Removed: and other high technology industries and his extensive experience in strategy, corporate finance practice and the development of companies
−Removed: in all stages.
−Removed: Joanne Wendy Kim has served
−Removed: as the Company’s Chief Financial Officer since October 2018.
−Removed: Kim previously served as CFO for several companies throughout her
−Removed: career, previously with Landmark Education Enterprises, and prior to that;
−Removed: other public entities in the entertainment and financial services
−Removed: industry sectors.
−Removed: She provided interim CFO services to various organizations from 2016 to 2018.
−Removed: In her various roles, Ms.
−Removed: corporate finance and operational groups, closed eight acquisitions, secured bank financings, developed and implemented new business strategies,
−Removed: managed risk and implemented new financial policies and procedures.
−Removed: As a CPA professional, she advised on accounting transactions, SEC
−Removed: reporting matters and other regulatory matters to clients serving as a Director at BDO USA, LLP’s National Office SEC Department
−Removed: and served on the U.S.
−Removed: desk in London for BDO LLP UK Firm in 2008-2016 and as a Senior Manager at KPMG in earlier part of her career.
−Removed: She brings more than 35 years of accounting and finance experience to this position.
−Removed: Kim earned her BSA in accounting and finance
−Removed: at California State University, Long Beach.
−Removed: Kims qualifications to serve as our Chief Financial Officer are primarily based on her 35 years of accounting and finance experience
−Removed: both as a CFO and as a CPA in major global accounting and consultancy firms.
−Removed: Palumbo has served as our Chief Medical Officer since November 2021.
−Removed: Formerly he served as the CMO at Zynerba Pharmaceuticals
−Removed: from July 2019 to October 2021, responsible for clinical operations, development, regulatory, and medical affairs.
−Removed: Prior to his time
−Removed: at Zynerba, Dr.
−Removed: Palumbo held senior worldwide governance roles at Mitsubishi Tanabe Pharma in both the United States and Japan from April
−Removed: 2012 to June 2019, where he led medical science and translational research across multiple therapeutic areas, and guided successful
−Removed: registrational programs for Radicava® (edaravone) for the treatment of Amyotrophic Lateral Sclerosis .
−Removed: From April 2003 to March 2012, Dr.
−Removed: Palumbo was Global Head and Franchise Medical Leader for Psychiatry, and the Interim Head of
−Removed: Global Neuroscience at Johnson & Johnson, where he led the medical teams who achieved successful global registrations for Risperdal®
−Removed: (risperidone);
−Removed: Concerta® (methylphenidate HCL);
−Removed: and Invega® (paliperidone).
−Removed: He was Head of Psychiatry and Neurology at Pharmanet
−Removed: for from April 2002 to April 2003.
−Removed: Dr Palumbo previously held industry positions in European Pharma with Sanofi-Synthelabo from April
−Removed: 1999 to April 2002, Biotech at Cephalon, from April 1997 to April 1998, and from July 1989 to April 2002, he held senior leadership and
−Removed: hospital administration roles at prestigious academic research institutions including Yale, Cornell, and the University of Pennsylvania.
−Removed: He holds a Bachelor of Arts at the University of Pennsylvania and received his Doctor of Medicine at the George Washington University
−Removed: School of Medicine.
−Removed: He was a Biological Sciences Training Program Fellow of the National Institutes of Health and Chief Resident for
−Removed: the Abraham Ribicoff Clinical Neuroscience Research Unit at Yale University.
−Removed: Dr Palumbo has received Board Certification in Psychiatry
−Removed: and Addiction Psychiatry.
−Removed: Palumbos qualifications to serve as our Chief Medical Officer is based on the decades and depth of experiences in the roles he
−Removed: has served in his medical profession and commercial experience in the healthcare industry and biopharma industries.
−Removed: Jim Lang has served as the Companys director since 2016 and as the Chairman of the Board since March 2023.
−Removed: He is currently
−Removed: CEO of EVERSANA, the leading commercialization services company for the life sciences industry.
−Removed: In five years since he founded EVERSANA,
−Removed: it is now over $1B in revenue, with >7000 employees across 40 global locations.
−Removed: He formerly served as the CEO of Decision Resources
−Removed: Group (DRG), which he transformed into a leading healthcare data and analytics firm.
−Removed: Prior to that, Jim was CEO of IHS Cambridge Energy
−Removed: Research Associates (IHS CERA), a recognized leader in energy industry subscription information products, and formerly the President
−Removed: of Strategic Decisions Group (SDG), a leading global strategy consultancy.
−Removed: Lang holds a BS summa cum laude in electrical and computer
−Removed: engineering from the University of New Hampshire and an MBA with Distinction from the Tuck School of Business.
−Removed: Jim Lang currently also
−Removed: serves as a Director at OptimizeRX (OPRX), a Nasdaq listed Company.
−Removed: Jim Lang’s qualifications to serve
−Removed: on our Board of Directors are primarily based on his decades of experience as a strategy consultant, broad industry expertise, and senior-level
−Removed: management experience running several healthcare and information technology companies.
−Removed: Berman has served
−Removed: as the Company’s director since June 2019.
−Removed: Berman has over 35 years of venture capital, senior management, and merger &
−Removed: acquisitions experience.
−Removed: He currently is a director of four public companies including;
−Removed: Cryoport Inc., Genius Group, Context Therapeutics,
−Removed: and over the last decade served on the boards of six companies that reached a market capitalization over one billion including Cryoport,
−Removed: Advaxis, EXIDE, Internet Commerce Corporation, Kapitus and Ontrak.
−Removed: From 1998-2000, he was employed by Internet Commerce Corporation (now
−Removed: Easylink Services) as Chairman and CEO and was a director from 1998-2012.
−Removed: Previously, Mr.
−Removed: Berman was Senior Vice President of Bankers
−Removed: Trust Company, where he started the M&A and Leveraged Buyout Departments;
−Removed: created the largest battery company in the world in the
−Removed: 1980’s by merging Prestolite, General Battery and Exide and advised on over $4 billion of M&A transactions (completed over 300
−Removed: He is a past Director of the Stern School of Business of NYU where he obtained his BS and MBA.
−Removed: He also has US and foreign law
−Removed: degrees from Boston College and The Hague Academy of International Law, respectively.
−Removed: We believe Richard J.
−Removed: Berman’s qualifications
−Removed: to serve on our Board of Directors include his experience in the healthcare industry, and his current and past experience in numerous
−Removed: private and publicly traded companies.
−Removed: Steven Gorlin has served
−Removed: as the Company’s director since June 2020.
−Removed: He has founded many biopharma companies including Hycor Biomedical, Theragenics, Medicis
−Removed: Pharmaceutical, EntreMed, MRI Interventions, DARA BioSciences, MiMedx, Medivation (sold to Pfizer for $14 billion) and NantKwest.
−Removed: Gorlin served for many years on the Business Advisory Council to the Johns Hopkins School of Medicine and on The Johns Hopkins BioMedical
−Removed: Engineering Advisory Board.
−Removed: He is currently a member of the Research Institute Advisory Committee (RIAC) of Massachusetts General Hospital.
−Removed: He started The Touch Foundation, a nonprofit organization for the blind, and was a principal contributor to Camp Kudzu for diabetic children.
−Removed: Steve Gorlin’s qualifications to serve
−Removed: on our Board of Directors are primarily based on his over 45 years of experience in founding and investing in several biopharma companies,
−Removed: leading multiple NASDAQ AND NYSE companies to their success.
−Removed: Robert Hariri MD, PhD ,
−Removed: has served as the Company’s director since June 2020.
−Removed: Dr Hariri is the Chairman, founder, and CEO of Celularity, Inc., a leading
−Removed: cellular therapeutics company.
−Removed: He was the founder and CEO of Anthrogenesis Corporation, and after its acquisition served as CEO of Celgene
−Removed: Cellular Therapeutics.
−Removed: Hariri co-founded the genomic health intelligence company, Human Longevity, Inc.
−Removed: Hariri pioneered the use
−Removed: of stem cells to treat a range of life-threatening human diseases.
−Removed: He is widely acknowledged for his discovery of pluripotent stem cells
−Removed: and for assisting with discovering the physiological activities of tumor necrosis factor (TNF).
−Removed: He holds over 170 issued and pending patents.
−Removed: Robert (Bob) Hariri’s qualifications
−Removed: to serve on our Board of Directors are primarily based on his decades of founding and leading several companies in the cellular therapeutic
−Removed: space, as well as pioneering in the use of stem cells to treat a range of life-threatening human diseases and discoveries in the physiological
−Removed: activities of tumor necrosis factor.
−Removed: He has authored over 150 publications and garnered numerous awards for contributions to the fields
−Removed: of biomedicine and aviation.
−Removed: Sigmund (Sig) Rogich has
−Removed: served as the Company’s director since June 2020.
−Removed: Sig is the CEO and President of The Rogich Communications Group and serves on
−Removed: the Board of Keep Memory Alive, a philanthropic organization which raises awareness about brain disorders and Alzheimer’s disease.
−Removed: Memory Alive funds clinical trials to advance new treatments for patients with Alzheimer’s, Huntington’s and Parkinson’s
−Removed: disease, as well as multiple sclerosis.
−Removed: Rogich was formerly the U.S.
−Removed: Ambassador to Iceland.
−Removed: He has served as a senior consultant
−Removed: to Presidents Ronald Reagan and George H.W.
−Removed: Rogich serves on multiple boards of directors for charitable causes.
−Removed: We believe Mr.
−Removed: Rogich’s qualifications
−Removed: to serve on our Board of Directors are based on his experience in the Communications sector and philanthropic organization raising awareness
−Removed: about brain disorders.
−Removed: His experience in service as a senior consultant to candidates of the highest office.
−Removed: Michael Sherman JD has
−Removed: served as the Company director since 2017.
−Removed: He retired from his position as a Managing Director at Barclays Plc in 2018, where he had worked
−Removed: Previously he was a Managing Director at Lehman Brothers, Inc.
−Removed: He has worked in investment banking for 30 years.
−Removed: has significant experience in healthcare finance, most recently assisting on a $450 million convertible transaction for Neurocrine Biosciences.
−Removed: He has worked on successful financial transactions for Teva Pharmaceutical Industries, Amgen Inc., Cubist Pharmaceuticals, Merck &
−Removed: Co., and Cardinal Health, among other companies.
−Removed: After graduating from the University of Pennsylvania, Michael Sherman received his JD,
−Removed: cum laude, from the Harvard Law School.
−Removed: Michael Sherman’s qualifications to
−Removed: serve on our Board of Directors are primarily based on his decades of finance industry experience and investment banking.
−Removed: has significant experience in healthcare finance including having worked on successful financial transactions for several pharmaceutical
−Removed: and healthcare focused companies.
−Removed: Delinquent Section 16(a) Reports
−Removed: Section 16(a) of the Securities Exchange
−Removed: Act of 1934, as amended (Exchange Act), requires our directors and executive officers, and persons who own more than 10% of our outstanding
−Removed: Common Stock, to file with the SEC, initial reports of ownership and reports of changes in ownership of our equity securities.
−Removed: are required by SEC regulations to furnish us with copies of all such reports they file.
−Removed: To our knowledge, based solely on a review
−Removed: of the copies of such reports furnished to us regarding the filing of required reports, we believe that, except for the reports filed
−Removed: by Clarence Ahlem (Form 4s filed on January 18, 2023 and February 22, 2023), Richard J.
−Removed: Berman (Form 4s filed on January 18, 2023, April
−Removed: 6, 2023 and June 15, 2023), Cuong Do (Form 4s filed on July 7, 2022, January 18, 2023, February 22, 2023 and June 26, 2023), Steve Gorlin
−Removed: (Form 4 filed on January 18, 2023), Robert J.
−Removed: Hariri (Form 4 filed on January 18, 2023), Wendy Kim (Form 4s filed on January 8, 2023
−Removed: and February 22, 2023), James Lang (Form 4 filed on January 18, 2023), Penelope Markham (Form 4s filed on January 18, 2023 and February
−Removed: 22, 2023), Joseph M Palumbo (Form 4s filed on January 18, 2023, February 22, 2023 and July 3, 2023), Terren Peizer (Form 3 filed on August
−Removed: 16, 2022 and Form 4s filed on August 26, 2022 and January 18, 2023), Christopher Reading (Form 4s filed on January 18, 2023 and February
−Removed: 22, 2023), Sigmund Rogich (Form 4 filed on January 18, 2023) and Michael Sherman (Form 4 filed on January 18, 2023), all Section 16(a)
−Removed: reports applicable to our directors, executive officers and greater-than-ten-percent beneficial owners with respect to fiscal 2023 were
−Removed: timely filed.
−Removed: Independence of the Board of Directors
−Removed: Our Common Stock is traded on the Nasdaq
−Removed: Capital Market.
−Removed: The Board of Directors has determined that six of the seven members of the Board of Directors qualify as “independent,”
−Removed: as defined by the listing standards of the Nasdaq.
−Removed: Consistent with these considerations, after review of all relevant transactions and
−Removed: relationships between each director, or any of the director’s family members, and the Company, its senior management and its independent
−Removed: auditors, the Board has determined further that Messrs.
−Removed: Lang, Sherman, Berman, Gorlin, Hariri and Rogich are independent under the listing
−Removed: standards of Nasdaq.
−Removed: In making this determination, the Board of Directors considered that there were no new transactions or relationships
−Removed: between its current independent directors and the Company, its senior management and its independent auditors since last making this determination.
−Removed: 2023 Meetings and Attendance
−Removed: During fiscal year 2023, the Board held four
−Removed: regular Board of Directors meetings and one special meeting of the Board of Directors, four Audit Committee meetings, six Compensation
−Removed: Committee meetings and one Nominating and Corporate Governance Committee meeting.
−Removed: All Directors attended at least 75% or more of the aggregate
−Removed: number of meetings of the Board and Board Committees on which they served.
−Removed: Committees of the Board of Directors
−Removed: Our Board of Directors has three standing
−Removed: an audit committee, a compensation committee and a nominating and corporate governance committee.
−Removed: Both our audit committee
−Removed: and our compensation committee will be composed solely of independent directors.
−Removed: The audit committee is comprised solely of independent
−Removed: directors, and the compensation committee and the nominating and corporate governance committee are comprised solely of independent directors.
−Removed: Each committee operates under a charter approved by our Board of Directors and have the composition and responsibilities described below.
−Removed: The charter of each committee is available on our website.
−Removed: Audit Committee
−Removed: We have established an audit committee of
−Removed: the Board of Directors.
−Removed: The members of our audit committee are Richard Berman, Michael Sherman, Jim Lang and Sigmund Rogich each of whom
−Removed: is an independent director within the meaning of the Nasdaq rules.
−Removed: Berman has served as chairman of the audit committee since October
−Removed: 2020 and qualifies as an “audit committee financial expert” as defined by Item 401(h)(2) of Regulation S-K.
−Removed: have adopted an audit committee charter, detailing the principal functions of the audit committee, including:
−Removed: board oversight of (1) the integrity of our financial statements, (2) our compliance
−Removed: with legal and regulatory requirements, (3) our independent auditors qualifications
−Removed: and independence, and (4) the performance of our internal audit function and independent
−Removed: the appointment, compensation, retention, replacement, and oversight of the work
−Removed: of the independent auditors and any other independent registered public accounting firm engaged
−Removed: ● pre-approving
−Removed: all audit and non-audit services to be provided by the independent auditors or any other
−Removed: registered public accounting firm engaged by us, and establishing pre-approval policies and
−Removed: reviewing and discussing with the independent auditors all relationships the
−Removed: auditors have with us in order to evaluate their continued independence;
−Removed: clear policies for audit partner rotation in compliance with applicable laws and regulations;
−Removed: and reviewing a report, at least annually, from the independent auditors describing (1) the
−Removed: independent auditors internal quality-control procedures and (2) any material issues
−Removed: raised by the most recent internal quality-control review, or peer review, of the audit firm,
−Removed: or by any inquiry or investigation by governmental or professional authorities, within the
−Removed: preceding five years respecting one or more independent audits carried out by the firm and
−Removed: any steps taken to deal with such issues;
−Removed: to review and discuss our annual audited financial statements and quarterly financial statements
−Removed: with management and the independent auditor, including reviewing our specific disclosures
−Removed: under Managements Discussion and Analysis of Financial Condition and Results
−Removed: of Operations;
−Removed: reviewing and approving any related party transaction required to be
−Removed: disclosed pursuant to Item 404 of Regulation S-K promulgated by the SEC prior to us entering
−Removed: into such transaction;
−Removed: with management, the independent auditors, and our legal advisors, as appropriate, any legal,
−Removed: regulatory or compliance matters, including any correspondence with regulators or government
−Removed: agencies and any employee complaints or published reports that raise material issues regarding
−Removed: our financial statements or accounting policies and any significant changes in accounting
−Removed: standards or rules promulgated by the Financial Accounting Standards Board, the SEC or other
−Removed: regulatory authorities.
−Removed: We have established a compensation committee
−Removed: of the Board of Directors.
−Removed: The members of our Compensation Committee are Richard Berman, Michael Sherman and Steve Gorlin.
−Removed: has served as chairman of the compensation committee since October 2020.
−Removed: have adopted a compensation committee charter, which details the principal functions of the compensation committee, including:
−Removed: and approving on an annual basis the corporate goals and objectives relevant to our Chief
−Removed: Executive Officers compensation, evaluating our Chief Executive Officers performance
−Removed: in light of such goals and objectives and determining and approving the remuneration (if
−Removed: any) of our Chief Executive Officer based on such evaluation;
−Removed: and making recommendations to our Board of Directors with respect to the compensation, and
−Removed: any incentive-compensation and equity-based plans that are subject to board approval of all
−Removed: of our other officers;
−Removed: our executive compensation policies and plans;
−Removed: ● implementing
−Removed: and administering our incentive compensation equity-based remuneration plans;
−Removed: assisting management
−Removed: in complying with our proxy statement and annual report disclosure requirements;
−Removed: all special perquisites, special cash payments and other special compensation and benefit
−Removed: arrangements for our officers and employees;
−Removed: a report on executive compensation to be included in our annual proxy statement;
−Removed: and reviewing,
−Removed: evaluating and recommending changes, if appropriate, to the remuneration for directors.
−Removed: charter also provides that the compensation committee may, in its sole discretion, retain or obtain the advice of a compensation consultant,
−Removed: independent legal counsel or other adviser and will be directly responsible for the appointment, compensation and oversight of the work
−Removed: of any such adviser.
−Removed: However, before engaging or receiving advice from a compensation consultant, external legal counsel or any other
−Removed: adviser, the compensation committee will consider the independence of each such adviser, including the factors required by Nasdaq and
−Removed: Committee Interlocks and Insider Participation
−Removed: of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one
−Removed: or more officers serving on our Board of Directors.
−Removed: and Corporate Governance Committee
−Removed: have established a nominating and corporate governance committee of the Board of Directors.
−Removed: The members of our nominating and corporate
−Removed: governance committee are, Jim Lang, Michael Sherman and Robert Hariri.
−Removed: Lang has served as chair of the nominating and corporate governance
−Removed: committee since August 2021.
−Removed: have adopted a nominating and corporate governance committee charter, which details the purpose and responsibilities of the nominating
−Removed: and corporate governance committee, including:
−Removed: ● identifying,
−Removed: screening and reviewing individuals qualified to serve as directors, consistent with criteria
−Removed: approved by the Board of Directors, and recommending to the Board of Directors candidates
−Removed: for nomination for election at the annual meeting of stockholders or to fill vacancies on
−Removed: the Board of Directors;
−Removed: and recommending to the Board of Directors and overseeing implementation of our corporate
−Removed: governance guidelines;
−Removed: ● coordinating
−Removed: and overseeing the annual self-evaluation of the Board of Directors, its committees, individual
−Removed: directors and management in the governance of the company;
−Removed: on a regular basis our overall corporate governance and recommending improvements as and
−Removed: when necessary.
−Removed: charter also provides that the nominating and corporate governance committee may, in its sole discretion, retain or obtain the advice
−Removed: of, and terminate, any search firm to be used to identify director candidates, and will be directly responsible for approving the search
−Removed: firms fees and other retention terms.
−Removed: have not formally established any specific, minimum qualifications that must be met or skills that are necessary for directors to possess.
−Removed: In general, in identifying and evaluating nominees for director, the Board of Directors considers educational background, diversity of
−Removed: professional experience, knowledge of our business, integrity, professional reputation, independence, wisdom, and the ability to represent
−Removed: the best interests of our stockholders.
−Removed: Prior to our initial business combination, holders of our public shares will not have the right
−Removed: to recommend director candidates for nomination to our Board of Directors.
−Removed: forth below is information concerning the gender and demographic background of each of our current directors, as self-identified and
−Removed: reported by each director.
−Removed: This information is being provided in accordance with Nasdaqs board diversity rules.
−Removed: Diversity Matrix (As of August 11, 2023)
−Removed: Number of Directors:
−Removed: Gender Identity
−Removed: Demographic Background
−Removed: American or Black
−Removed: Native or Native American
−Removed: Hawaiian or Pacific Islander
−Removed: or More Races or Ethnicities
−Removed: Not Disclose Demographic Background
−Removed: have adopted a code of conduct and ethics meeting the requirements of Section 406 of the Sarbanes-Oxley Act of 2002.
−Removed: We believe our code
−Removed: of conduct and ethics is reasonably designed to deter wrongdoing and promote honest and ethical conduct;
−Removed: provide full, fair, accurate,
−Removed: timely and understandable disclosure in public reports;
−Removed: comply with applicable laws;
−Removed: ensure prompt internal reporting of violations;
−Removed: and provide accountability for adherence to the provisions of the code of ethic.
−Removed: Our code of conduct and ethics is available on our website .
−Removed: copy of our code of conduct and ethics is filed as an exhibit to this Form 10-K.
−Removed: have adopted an insider trading policy that includes a provision restricting trading of any interest or provision relating to the future
−Removed: price of our securities, such as a put, call or short sale.
−Removed: Compensation Table
−Removed: following table sets forth the total compensation paid during the last two fiscal years ended June 30, 2023 and 2022 to the following
−Removed: executive officers of the Company, who are referred to as our named executive officers:
−Removed: Do, our President and Chief Executive Officer
−Removed: Wendy Kim, our Chief Financial Officer and Corporate Secretary
−Removed: Palumbo, our Chief Medical Officer
−Removed: Name and Principal
−Removed: Incentive Plan Compensation
−Removed: Deferred Compensation Earnings
−Removed: Other Compensation
−Removed: Executive Officer and President
−Removed: Wendy Kim (3)
−Removed: Financial Officer, Treasurer and Corporate Secretary
−Removed: Medical officer
−Removed: The aggregate grant date fair value of such awards were computed in accordance with Financial Accounting Standards Board ASC Topic 718, Stock Compensation (ASC Topic 718), and do not take into account estimated forfeitures related to service-based vesting conditions, if any.
−Removed: The valuation assumptions used in calculating these values are discussed in Note 10 of our Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended June 30, 2023.
−Removed: These amounts do not represent actual amounts paid or to be realized.
−Removed: Amounts shown are not necessarily indicative of values to be achieved, which may be more or less than the amounts shown as awards may subject to time-based vesting.
−Removed: The stock awards in form of RSUs and Stock Option Awards were awarded pursuant to the 2019 Omnibus Incentive Plan, (the “2019 Plan”).
−Removed: Do’s salary from April 27, 2021 (date of his appointment as CEO) through December 31, 2021 was paid through RSUs.
−Removed: The aggregate grant date fair value of the award was $454,794 and the total 58,759 RSUs awarded allows Mr.
−Removed: Do to receive one shares of Common Stock for each RSU.
−Removed: Kim served as the Chief Financial Officer and Corporate Secretary and Treasurer on a full
−Removed: time basis effective July 1, 2021.
−Removed: Palumbo joined the Company on November 1, 2021 and served as the Chief Medical Officer.
−Removed: employment arrangements are at will agreements.
−Removed: Equity Awards at Fiscal Year-End
−Removed: following table sets forth all outstanding equity awards held by our named executive officers as of June 30, 2023:
−Removed: of securities underlying unexercised options exercisable
−Removed: of securities underlying unexercised options unexercisable
−Removed: incentive plan awards:
−Removed: number of securities underlying unexercised unearned options
−Removed: exercise price
−Removed: expiration date
−Removed: of shares or units of stock that have not vested
−Removed: value of shares or units of stock that have to vested
−Removed: incentive plan awards:
−Removed: number of unearned shares, units or other rights that have not vested
−Removed: incentive plan awards:
−Removed: market or payout value of unearned shares, units or other right that have not vested
−Removed: Named executive officers held stock options
−Removed: to purchase a total of 1,371,729 shares of Common Stock as of June 30, 2023, with an aggregate grant date fair value of approximately
−Removed: $5.4 million, the last of which vests in 2027.
−Removed: Stock options granted prior to August 20, 2021, vested on the grant date;
−Removed: the stock options
−Removed: granted on August 20, 2021 vested 20% on the grant date, with the remaining stock options vesting in five equal annual installments beginning
−Removed: on the first grant date anniversary;
−Removed: the stock options granted on June 7, 2023, vested 25% on the grant date, with the remaining stock
−Removed: options vesting in four equal annual installments beginning on the first grant date anniversary;
−Removed: and the stock options and stock awards
−Removed: in the form RSUs granted to the CEO on June 21, 2022 and June 29, 2023 vests in three equal annual installments beginning on the first
−Removed: grant date anniversary.
−Removed: The RSU awarded on November 23, 2022 vested 25% on the grant date with the remaining RSU vesting in three equal
−Removed: annual installments beginning on the first grant date anniversary.
−Removed: The total RSUs outstanding awarded to the named executive officers
−Removed: totaled 351,386 with a market value totaling approximately $1.5 million as of June 30, 2023.
−Removed: Potential Payments Upon Termination or Change
−Removed: There are no arrangements with the named
−Removed: executive officers or our equity incentive plan or individual award agreements thereunder providing for certain payments to our named
−Removed: executive officers at or following or in connection with a termination of their employment or a change of control of the Company.
−Removed: are no arrangements pursuant to which our directors are or will be compensated in the future for any services provided to the Company.
−Removed: following table provides information regarding compensation that was earned or paid to the individuals who served as non-employee directors
−Removed: during the year ended June 30, 2023.
−Removed: Except as set forth in the table, during the fiscal year 2023, directors did not earn nor receive
−Removed: cash compensation or compensation in the form of stock awards, options awards or any other form.
−Removed: Stock awards (1)
−Removed: Option awards(1)
−Removed: Non-equity incentive plan compensation
−Removed: Change in pension value and nonqualified deferred compensation
−Removed: All other compensation
−Removed: Michael Sherman
−Removed: Richard Berman
−Removed: Robert Hariri MD, Phd
−Removed: Sigmund Rogich
−Removed: Terren Piezer (2)
−Removed: aggregate grant date fair value of such awards were computed in accordance with Financial
−Removed: Accounting Standards Board ASC Topic 718, Stock Compensation (ASC Topic 718), and do not
−Removed: take into account estimated forfeitures related to service-based vesting conditions, if any.
−Removed: The valuation assumptions used in calculating these values are discussed in Note 10 of our
−Removed: Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended
−Removed: June 30, 2023.
−Removed: These amounts do not represent actual amounts paid or to be realized.
−Removed: shown are not necessarily indicative of values to be achieved, which may be more or less
−Removed: than the amounts shown as awards may subject to time-based vesting.
−Removed: Piezer resigned from the Board of Directors effective March 2, 2023.
−Removed: Our directors are eligible to participate
−Removed: in our equity incentive plans, which are administered by our Compensation Committee under authority delegated by our Board of Directors.
−Removed: The terms and conditions of the option grants to our non-employee directors under our equity incentive plans are and will be determined
−Removed: in the discretion of our Compensation Committee, consistent with the terms of the applicable plan.
−Removed: The fiscal year 2023 annual compensation
−Removed: granted to existing board members consisted of either an award of RSUs at one unit per share of Common Stock, a total of 155,636 RSU at
−Removed: a grant date market value of $952,492 or stock options to purchase a total of 195,000 shares of commons stock with a grant date fair value
−Removed: totaling $791,700.
−Removed: The former chairman of the Board of Directors, the chairman of the compensation committee and a member of the audit
−Removed: committee received stock options to purchase 65,000, 75,000 and 55,000 shares of Common Stock, respectively.
−Removed: The chairmen of the audit
−Removed: committee and the corporate governance and nominating committee each received 43,578 RSUs and the members of those committees each received
−Removed: following tables sets forth the outstanding equity awards held by non-employee directors as of June 30, 2023:
−Removed: of securities underlying unexercised options exercisable
−Removed: of securities underlying unexercised options unexercisable
−Removed: incentive plan awards:
−Removed: number of securities underlying unexercised unearned options
−Removed: exercise price
−Removed: expiration date
−Removed: of shares or units of stock that have not vested
−Removed: value of shares or units of stock that have to vested
−Removed: incentive plan awards:
−Removed: number of unearned shares, units or other rights that have not vested
−Removed: incentive plan awards:
−Removed: market or payout value of unearned shares, units or other right that have not vested
−Removed: There was a total of 1,483,300 stock options outstanding to directors as of June 30, 2023, with an aggregate grant date fair value of approximately $13.2 million, the last of which vest in 2027.
−Removed: Stock options granted on December 18, 2020 and April 5, 2022 vest 25% on grant date with the remaining stock options vesting in three annual equal installments beginning on the first grant date anniversary.
−Removed: Stock options granted on November 23, 2022 vest in four equal quarterly installments beginning February 9, 2023.
−Removed: Equity awards granted the Board of Directors on November 23, 2022 were in the form of RSUs, one unit for one share of Common Stock, vest in four equal quarterly installments beginning February 9, 2023.
−Removed: There were 77,460 RSUs outstanding as of June 30, 2023, with an aggregate market value of approximately $335,000.
−Removed: Incentive Plans and Awards
−Removed: than the options granted and RSU awards as described above, we do not currently have any long-term incentive plans that provide compensation
−Removed: intended to serve as incentive for performance.
−Removed: Since prior to such grants, no individual grants or agreements regarding future payouts
−Removed: under non-stock price-based plans had been made to any executive officer or any director or any employee or consultant since our inception,
−Removed: no future payouts under non-stock price-based plans or agreements had been granted or entered into or exercised by our officer or director
−Removed: or employees or consultants.
−Removed: Omnibus Equity Incentive Plan
−Removed: On April 20, 2019, our Board of Directors
−Removed: and our stockholders approved and adopted the 2019 Plan.
−Removed: The 2019 Plan allows us, under the direction of our Board of Directors or a committee
−Removed: thereof, to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive
−Removed: officers, consultants and directors.
−Removed: The 2019 Plan allows for the issuance of up to 6,540,000 shares of common pursuant to new awards
−Removed: granted under the 2019 Plan and as of June 30, 2023, there were 2,269,952 shares of Common Stock available for new awards granted under
−Removed: the 2019 Plan.
−Removed: Compensation Plan Information [1]
−Removed: following table provides certain aggregate information with respect to all of the Companys equity compensation plans in effect
−Removed: as of June 30, 2023:
−Removed: Plan Category
−Removed: Number of securities to be issued upon exercise of outstanding
−Removed: options, warrants and rights
−Removed: Weighted-average exercise price of outstanding options,
−Removed: warrants and rights
−Removed: Number of securities remaining available for future
−Removed: issuance under equity compensation pans (excluding securities reflected in column (a))
−Removed: Equity compensation plans approved by security holders
−Removed: Equity compensation not approved by security holders
−Removed: VERSUS PERFORMANCE
−Removed: required by Item 402(v) of Regulation S-K, we are providing the following information regarding the relationship between executive compensation
−Removed: and our financial performance for each of the last two completed calendar years.
−Removed: In determining the “compensation actually paid”
−Removed: to our named executive officers (“NEOs”), we are required to make various adjustments to amounts that have been previously
−Removed: reported in the Summary Compensation Table in previous years, as the SEC’s valuation methods for this section differ from those
−Removed: required in the Summary Compensation Table.
−Removed: Versus Performance Table
−Removed: table below summarizes compensation values both previously reported in our Summary Compensation Table, as well as the adjusted values
−Removed: required in this section for fiscal years 2022 and 2023.
−Removed: Note that for our NEOs other than our principal executive officer (the “PEO”),
−Removed: compensation is reported as an average.
−Removed: Compensation Table Total for PEO
−Removed: Actually Paid to PEO
−Removed: Summary Compensation Table Total for Non-PEO Named Executive Officers
−Removed: Compensation Actually Paid to Non-PEO Named Executive Officers
−Removed: of Initial Fixed $100 Investment Based on Total Shareholder Return
−Removed: (1) During fiscal years 2023 and 2022, the PEO was Cuong Do.
−Removed: During fiscal years 2023 and 2022, the non-PEO NEOs were Joanne W Kim and Joseph M Palumbo M.D.
−Removed: dollar amounts reported are the amounts of total compensation reported for Mr.
−Removed: average total compensation reported for Non-PEO Named Executive Officers for the applicable
−Removed: fiscal year in the “Total” column of the Summary Compensation Table (SCT).
−Removed: following table sets forth the adjustments made to the SCT total for each year represented
−Removed: in the pay versus performance table to arrive at “compensation actually paid”
−Removed: to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:
−Removed: Total for PEO
−Removed: Amount reported under the “Stock Awards” column in the SCT
−Removed: Fair value as of fiscal year-end of awards granted during the fiscal year that are outstanding and unvested as of the end of the
−Removed: Change in fair value as of fiscal year-end, compared to prior fiscal year-end, of awards granted in any prior fiscal year that are
−Removed: outstanding and unvested as of the end of the fiscal year
−Removed: Fair value as of vest date of awards granted and vested in the fiscal year
−Removed: Change in fair value as of vesting date, compared to prior fiscal year-end, of awards granted in any prior fiscal year for which
−Removed: all vesting conditions were satisfied at fiscal year-end or during the fiscal year
−Removed: Forfeitures during fiscal year equal to prior fiscal year-end value
−Removed: Actually Paid to PEO
−Removed: following table sets forth the adjustments made to the SCT total for each year represented
−Removed: in the pay versus performance table to arrive at “compensation actually paid”
−Removed: to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:
−Removed: SCT Total for Non-PEO NEOs
−Removed: Amount reported under the “Stock Awards” column in the SCT
−Removed: Fair value as of fiscal year-end of awards granted during the fiscal year that are outstanding and unvested as of the end of the
−Removed: Fair value as of vest date of awards granted and vested in the fiscal year
−Removed: change in fair value as of vesting date, compared to prior fiscal year-end of awards granted in any prior fiscal year for which all vesting conditions were satisfied at fiscal year-end or during the fiscal year
−Removed: Forfeitures during fiscal year equal to prior fiscal year-end value
−Removed: Compensation Actually Paid to Non-PEO NEOs
−Removed: amounts reported represent the measurement period value of an investment of $100 in our stock
−Removed: on June 30, 2021 (the last trading day before the 2022 fiscal year), and then valued again
−Removed: on each of June 30, 2022 (the last trading day of the 2022 fiscal year) and June 30, 2023
−Removed: (the last trading day of the 2023 fiscal year), based on the closing price per share of the
−Removed: Company’s common stock as of such dates and assuming the reinvestment of dividends.
−Removed: amounts reported represent net loss for the applicable fiscal year calculated in accordance
−Removed: with generally accepted accounting principles in the United States.
−Removed: Between CAP Amounts and Performance Measures
−Removed: following charts show graphically the relationships over the past two years of the CAP Amounts for the PEO and the Other NEOs as compared
−Removed: to our (i) cumulative total shareholder return and (ii) net loss.
−Removed: the Compensation Committee makes executive compensation decisions in consideration of a variety of factors, including corporate and individual
−Removed: performance, the decisions of the Compensation Committee and Board of Directors in 2022 and 2023 were made independently of these disclosure
−Removed: requirements.
−Removed: OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
−Removed: Based solely upon information made available
−Removed: to us, the following table sets forth information as of August 9, 2023 regarding the beneficial ownership of our Common Stock by:
−Removed: person known by us to be the beneficial owner of more than 5% of our outstanding shares of
−Removed: Common Stock;
−Removed: of our named executive officers and directors;
−Removed: our executive officers and directors as a group.
−Removed: The percentage ownership information shown in
−Removed: the table is based upon 36,765,035 shares of Common Stock outstanding as of August 9, 2023.
−Removed: ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
−Removed: Except as otherwise indicated, each person or entity named in the table has sole voting and investment power with respect to all shares
−Removed: of our capital shown as beneficially owned, subject to applicable community property laws.
−Removed: computing the number and percentage of shares beneficially owned by a person as of a particular date, shares that may be acquired by
−Removed: such person (for example, upon the exercise of options or warrants) within 60 days of such date are counted as outstanding, while these
−Removed: shares are not counted as outstanding for computing the percentage ownership of any other person.
−Removed: address of each holder listed below, except as otherwise indicated, is c/o BioVie Inc., 680 W Nye Lane, Suite 201, Carson City, Nevada
−Removed: Name and Address of Beneficial Owner
−Removed: Number of Common Shares of Beneficial Ownership
−Removed: Percentage of Beneficial Ownership
−Removed: executive officers and directors:
−Removed: James Lang (1)
−Removed: Richard Berman (2)
−Removed: Steve Gorlin (3)
−Removed: Robert Hariri (4)
−Removed: Sigmund Rogich (5)
−Removed: Michael Sherman (6)
−Removed: Joanne Wendy Kim (8)
−Removed: Joseph Palumbo (9)
−Removed: All directors and executive officers as a group (9)
−Removed: 5% Stockholders
−Removed: Acuitas Group Holdings (10)
−Removed: * Less than 1%
−Removed: (1) Includes warrants
−Removed: to purchase 17,333 shares of Common Stock and options to purchase 134,636 shares of Common Stock, all of which are exercisable
−Removed: within 60 days of August 9, 2023.
−Removed: (2) Includes options
−Removed: to purchase 109,138 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
−Removed: (3) Includes options
−Removed: to purchase 102,788 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
−Removed: 50,000 shares of
−Removed: common stock is held by Mr.
−Removed: Gorlin’s wife.
−Removed: (4) Includes options to
−Removed: purchase 102,775 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
−Removed: (5) Includes options
−Removed: to purchase 145,175 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
−Removed: (6) Includes warrants
−Removed: to purchase 13,333 shares of Common Stock and options to purchase 168,513 shares of Common Stock, all of which are exercisable
−Removed: within 60 days of August 9, 2023.
−Removed: Common stock held of record by Sherman Children’s Trust Brian Krisber, Trustee.
−Removed: of common stock, warrants and options are deemed to be beneficially owned or controlled by Michael Sherman.
−Removed: (7) Includes warrants to
−Removed: purchase 70,666 shares of Common Stock and options to purchase 455,681 shares of Common Stock, all of which are exercisable within
−Removed: 60 days of August 9, 2023.
−Removed: 211,965 shares of Common Stock and warrants are held of record by Do & Rickles
−Removed: Investments, LLC, a limited liability company 100% owned by Cuong Do and his wife, and as such, Mr.
−Removed: Do may be deemed to beneficially
−Removed: own or control.
−Removed: (8) Include options
−Removed: to purchase shares 70,967of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
−Removed: (9) Includes options
−Removed: to purchase 30,833 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
−Removed: (10) Includes warrants
−Removed: to purchase 7,272,728 shares of Common Stock and options to purchase 65,000 shares of Common Stock, all of which are exercisable
−Removed: within 60 days of August 9, 2023.
−Removed: All shares held of record by Acuitas Group Holdings, LLC, a limited liability company 100%
−Removed: owned by Terren Peizer, and as which Mr.
−Removed: Peizer may be deemed to beneficially own or control.
−Removed: Peizer disclaims beneficial
−Removed: of any such securities.
−Removed: RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
−Removed: following includes a summary of transactions since June 30, 2022, to which we have been a party in which the amount involved exceeded
−Removed: or will exceed the lesser of (i) $120,000 and (ii) one percent (1%) of the average of our total assets at year-end for the prior two
−Removed: fiscal years, and in which any of our directors, executive officers or beneficial owners of more than 5% of our capital stock or any
−Removed: member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest.
−Removed: On July 15, 2022, the Company, entered into
−Removed: a Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas, pursuant to which Acuitas agreed to purchase from
−Removed: the Company, in a private placement (the “Private Placement”), (i) an aggregate of 3,636,364 shares of the Company’s
−Removed: Class A Common Stock, par value $0.0001 per share at a price of $1.65 per share, and (ii) a warrant to purchase 7,272,728 shares of Common
−Removed: Stock, at an exercise price of $1.82, with a term of exercise of five years;
−Removed: (collectively, the “Securities”).
−Removed: The aggregate
−Removed: purchase price for the Securities sold in the Private Placement was $6 million.
−Removed: The Private Placement closed on August 15, 2022.
−Removed: Review and Approval of Transactions with
−Removed: Related Persons
−Removed: Either the audit committee or the Board of
−Removed: Directors approves all related party transactions.
−Removed: The procedure for the review, approval or ratification of related party transactions
−Removed: involves discussing the proposed transaction with management, discussing the proposed transaction with the external auditors, reviewing
−Removed: financial statements and related disclosures, and reviewing the details of major deals and transactions to ensure that they do not involve
−Removed: related party transactions.
−Removed: Members of management have been informed and understand that they are to bring related party transactions
−Removed: to the audit committee or the Board of Directors for pre-approval.
−Removed: These policies and procedures are evidenced in the audit committee
−Removed: charter and our code of ethics.
−Removed: ACCOUNTANT FEES AND SERVICES
−Removed: following table shows what the auditor billed for the audit and other services for the years ended June 30, 2023 and 2022.
−Removed: Audit - Related Fees
−Removed: All other Fees
−Removed: Fees —This category includes the audit of the Companys annual financial statements, review of financial statements included
−Removed: in the Companys Form 10-Q Quarterly Reports and services that are normally provided by the independent auditors in connection
−Removed: with engagements for those years.
−Removed: Audit-Related
−Removed: on Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Public Accountant
−Removed: with SEC policies regarding auditor independence, the Audit Committee has responsibility for appointing, setting compensation and overseeing
−Removed: the work of our independent registered public accounting firm.
−Removed: In recognition of this responsibility, the Audit Committee has established
−Removed: a policy to pre-approve all audit and permissible non-audit services provided by our independent registered public accounting firm.
−Removed: to engagement of an independent registered public accounting firm for the next years audit, management will submit an aggregate
−Removed: of services expected to be rendered during that year for each of four categories of services to the Audit Committee for approval.
−Removed: services include audit work performed in the preparation of financial statements,
−Removed: as well as work that generally only an independent registered public accounting firm can
−Removed: reasonably be expected to provide, including comfort letters, statutory audits, and attest
−Removed: services and consultation regarding financial accounting and/or reporting standards.
−Removed: Audit-Related
−Removed: services are for assurance and related services that are traditionally performed
−Removed: by an independent registered public accounting firm, including due diligence related to mergers
−Removed: and acquisitions, employee benefit plan audits, and special procedures required to meet certain
−Removed: regulatory requirements.
−Removed: services include all services performed by an independent registered public accounting
−Removed: firms tax personnel except those services specifically related to the audit of the
−Removed: financial statements, and includes fees in the areas of tax compliance, tax planning, and
−Removed: Fees are those associated with services not captured in the other categories.
−Removed: Company generally does not request such services from our independent registered public accounting
−Removed: to engagement, the Audit Committee pre-approves these services by category of service.
−Removed: The fees are budgeted and the Audit Committee
−Removed: requires our independent registered public accounting firm and management to report actual fees versus the budget periodically throughout
−Removed: the year by category of service.
−Removed: During the year, circumstances may arise when it may become necessary to engage our independent registered
−Removed: public accounting firm for additional services not contemplated in the original pre-approval.
−Removed: In those instances, the Audit Committee
−Removed: requires specific pre-approval before engaging our independent registered public accounting firm.
−Removed: Audit Committee may delegate pre-approval authority to one or more of its members.
−Removed: The member to whom such authority is delegated must
−Removed: report, for informational purposes only, any pre-approval decisions to the Audit Committee at its next scheduled meeting.
−Removed: AND FINANCIAL STATEMENT SCHEDULES
+Added: CONTROLS AND PROCEDURES
+Added: Evaluation of Disclosure Controls and Procedures
+Added: We have evaluated, with the participation of our principal
+Added: executive and our principle financial officer, the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e)
+Added: and 15(d)-15(e) under the Exchange Act as of the end of the period covered by this Annual Report on Form 10-K.
+Added: Based on this evaluation,
+Added: our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective
+Added: to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed,
+Added: summarized and reported, within the time periods specified in the Commission’s rules and forms, and is accumulated and communicated
+Added: to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate
+Added: to allow timely decisions regarding required disclosure.
+Added: Management’s Report on Internal Control
+Added: Over Financial Reporting
+Added: Our management is responsible for establishing and
+Added: maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act.
+Added: of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
+Added: Projections of any evaluation
+Added: of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate because of changes
+Added: in conditions, or that the degree of compliance with policies or procedures may deteriorate.
+Added: Under the supervision and with the
+Added: participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the
+Added: effectiveness of our internal control over financial reporting as of June 30, 2024 using the criteria established in Internal Control
+Added: Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission.
+Added: Based on our evaluation using those
+Added: criteria, our management has concluded that, as of June 30, 2024, our internal control over financial reporting was effective to provide
+Added: reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
+Added: in accordance with generally accepted accounting principles for the reasons discussed above.
+Added: Changes in Internal Control Over Financial Reporting
+Added: There were no changes in our internal controls over
+Added: financial reporting during the quarter ended June 30, 2024, that materially affected, or are reasonably likely to materially affect our
+Added: internal controls over financial reporting.
+Added: OTHER INFORMATION
+Added: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
+Added: Not applicable.
+Added: DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
+Added: The information required by this item is
+Added: included in our 2024 Proxy Statement and is
+Added: incorporated herein by reference.
+Added: EXECUTIVE COMPENSATION
+Added: The information required by this item is
+Added: included in our 2024 Proxy Statement and is
+Added: incorporated herein by reference.
+Added: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
+Added: The information required by this item is
+Added: included in our 2024 Proxy Statement and is
+Added: incorporated herein by reference.
+Added: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
+Added: The information required by this item is
+Added: included in our 2024 Proxy Statement and is
+Added: incorporated herein by reference.
+Added: PRINCIPAL ACCOUNTANT FEES AND SERVICES
+Added: The information required by this item is
+Added: included in our 2024 Proxy Statement and is
+Added: incorporated herein by reference.
+Added: EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1),(2) Financial Statements
−Removed: Financial Statements listed on page F-1 of this document are filed as part of this filing.
−Removed: following is a list of exhibits filed as a part of this report:
+Added: The Financial Statements listed on page F-1 of this
+Added: document are filed as part of this filing.
+Added: (a)(3) Exhibits
+Added: The following is a list of exhibits filed as a part
+Added: of this report:
Description of Document
7 unchanged sentences
First Amendment to the Amended and Restated Bylaws of the Company, dated March 12, 2023 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March 13, 2023).
+Added: Certificate of Change (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on August 1, 2024)
+Added: Termination of Amendment/Certificate (incorporated by reference to Exhibit 3.1 to the Company’s Current Report, as amended, on Form 8-K/A filed on August 6, 2024)
+Added: Certificate of Amendment (incorporated by reference to Exhibit 3.1 to the Company’s Current Report, as amended, on Form 8-K/A filed on August 6, 2024)
Specimen Certificate representing shares of Class A Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 filed on April 26, 2019, File No.
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
+Added: Form of Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
Form of 10% OID Convertible Delayed Draw Debenture (incorporated by reference to Exhibit 4.1 the Company’s Current Report on Form 8-K filed on September 25, 2019).
−Removed: Description of Securities (incorporated by reference to Exhibit 4.4 to the Company’s Annual Report on Form 10-K filed on August 30, 2021).
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K/A filed on July 18, 2022).
Form of Warrant to Purchase Shares of Class A Common Stock of the Company (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on December 1, 2021).
+Added: Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on March 4, 2024).
+Added: Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on March 4, 2024).
2019 Omnibus Equity Incentive Plan (incorporated by reference to Appendix D to the Definitive Information Statement on Schedule 14C, filed on May 8, 2019).
4 unchanged sentences
and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 2.2 to the Company’s Current Report on Form 8-K filed on May 10, 2021).
−Removed: 2 to the Asset Purchase Agreement, dated January 13, 2023, among the Company, Acuitas Group Holdings, LLC and Acuitas Group
−Removed: Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on May 12,
+Added: Amendment No.
+Added: 2 to the Asset Purchase Agreement, dated January 13, 2023, among the Company, Acuitas Group Holdings, LLC and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2023).
Employment Offer & Agreement, between Chris Reading and the Company, dated June 18, 2021 (incorporated by reference to Exhibit 10.14 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
10 unchanged sentences
Securities Purchase Agreement, dated July 15, 2022, by and between the Company and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K/A filed on July 18, 2022).
−Removed: Equity Offering SM Sales Agreement, dated August 31, 2022, among the Company, Cantor Fitzgerald & Co.
−Removed: Securities, Inc.
+Added: Controlled Equity Offering SM Sales Agreement, dated August 31, 2022, among the Company, Cantor Fitzgerald & Co.
+Added: Riley Securities, Inc.
(incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on August 31, 2022).
3 unchanged sentences
(incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1, File No.
+Added: Insider Trading Policy
Consent of Independent Registered Public Accounting Firm - EisnerAmper LLP
+Added: Power of Attorney (included on signature page to this registration statement)
Rule 13a-14(a) Certification
2 unchanged sentences
Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
+Added: Clawback Policy
XBRL Instance Document
4 unchanged sentences
XBRL Taxonomy Extension Definition Linkbase Document
−Removed: Indicates a management contract or compensatory plan or arrangement
−Removed: 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
−Removed: on its behalf by the undersigned, thereunto duly authorized.
−Removed: Executive Officer
+Added: # Indicates a management contract or compensatory
+Added: plan or arrangement
+Added: * Filed herewith.
+Added: ** Furnished herewith.
+Added: Pursuant to the requirements of Section 13 or 15(d)
+Added: of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto
+Added: duly authorized.
+Added: September 30, 2024
+Added: Chief Executive Officer
(Principal Executive Officer)
−Removed: to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and
−Removed: on the dates indicated.
−Removed: Executive Officer
−Removed: Executive Officer)
+Added: POWER OF ATTORNEY
+Added: Each person whose signature appears below constitutes
+Added: and appoints Cuong Do and Joanne Wendy Kim, and each of them acting individually and without the other, as his or her true and lawful
+Added: attorneys-in-fact and agents, with full power of substitution and re-substitution, for him or her and in his or her name, place, and stead,
+Added: in any and all capacities, to sign any and all amendments (including post-effective amendments, exhibits thereto and other documents in
+Added: connection therewith) to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with
+Added: the Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and
+Added: every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might
+Added: or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or either of them individually, or
+Added: their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
+Added: Pursuant to the requirements of the Securities Exchange
+Added: Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
+Added: Chief Executive Officer
+Added: September 30, 2024
+Added: (Principal Executive Officer)
+Added: /s/ Joanne Wendy Kim
+Added: Chief Financial Officer
+Added: September 30, 2024
Joanne Wendy Kim
−Removed: Financial Officer
−Removed: Financial Officer)
+Added: (Principal Financial Officer)
+Added: September 30, 2024
+Added: /s/ Michael Sherman
+Added: September 30, 2024
Michael Sherman
+Added: /s/ Richard J.
+Added: September 30, 2024
+Added: /s/ Robert Hariri
+Added: September 30, 2024
Robert Hariri
+Added: /s/ Sigmund Rogich
+Added: September 30, 2024
Sigmund Rogich
−Removed: to Financial Statements
+Added: Index to Financial Statements
Report of Independent Registered Public Accounting Firm – EisnerAmper LLP (PCAOB Number 274 )
+Added: Financial Statements:
Balance Sheets
3 unchanged sentences
Notes to Financial Statements
−Removed: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Board of Directors and Stockholders of
−Removed: on the Financial Statements
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: To the Board of Directors and Stockholders of
+Added: Opinion on the Financial Statements
We have audited the accompanying balance sheets of
3 unchanged sentences
In our opinion, the financial statements present fairly, in all material respects, the financial
−Removed: position of the Company as of June 30, 2023 and 2022, and the results of its operations and its cash flows for each of the years then
−Removed: ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: position of the Company as of June 30, 2024 and 2023, and the results of its operations and its cash flows for of the years then ended,
+Added: in conformity with accounting principles generally accepted in the United States of America.
Going Concern
3 unchanged sentences
losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue as a going
−Removed: Management’s plans in regard to these matters are also described in Note 2.
−Removed: The financial statements do not include any
−Removed: adjustments that might result from the outcome of this uncertainty.
+Added: Management’s plans regarding these matters are also described in Note 2.
+Added: The financial statements do not include any adjustments
+Added: that might result from the outcome of this uncertainty.
Basis for Opinion
23 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matter
The critical audit matter communicated below is a
8 unchanged sentences
As described in Note 3 to the accompanying financial
−Removed: statements, research and development expenses consists primarily of costs associated with the preclinical and/or clinical trials of drug
−Removed: candidates, compensation and other expenses for research and development, supplies and development materials, costs for consultants and
−Removed: related contract research and third-party facility costs.
+Added: statements, research and development expenses consist primarily of costs associated with the preclinical and/or clinical trials of drug
+Added: candidates, compensation and other expenses for research and development, personnel, supplies and development materials, costs for consultants
+Added: and related contract research and third-party facility costs.
The amounts recorded for clinical trial expenses represent the Company’s
1 unchanged sentence
and accurate reporting of contract research organizations and other third-party vendors.
−Removed: We identified the accounting for the research
−Removed: and development expenses and related accruals to be a critical audit matter due to the degree of management judgement in ensuring they
−Removed: are complete and accurate, their significance, their increase from the prior year, and the risk of material misstatement due to the nature
−Removed: and timing of these costs and accruals.
−Removed: This in turn led to a high degree of auditor judgment, subjectivity, and effort in applying the
−Removed: procedures related to their accounting.
+Added: We identified the accounting for the research and
+Added: development expenses and related accruals to be a critical audit matter due to the degree of management judgement in ensuring they are
+Added: complete, accurate and classified correctly, their significance, and the risk of material misstatement due to the nature and timing of
+Added: these costs and accruals.
+Added: This in turn led to a high degree of auditor judgment, subjectivity, and effort in applying the procedures related
+Added: to their accounting.
Addressing the matter involved performing procedures
1 unchanged sentence
These procedures included, obtaining
−Removed: an understanding of management’s process and evaluating the design of controls over research and development expenses and the completeness
−Removed: and accuracy of related accruals, reading the terms of the master service agreements and statements of work for significant vendors and
−Removed: making selections of transactions to determine the adequacy of the support, their mathematical accuracy and their recording as research
−Removed: and development expenses.
−Removed: We also made inquiries of management and reviewed subsequent payments of major research and development expenses
−Removed: to ensure that accruals were complete as of June 30, 2023.
+Added: an understanding of management’s process and evaluating the design of controls over research and development expense classification
+Added: and the completeness and accuracy of related accruals, independently researching vendors, testing a selection of research and development
+Added: expense transactions to determine, based on the underlying supporting documents, the mathematical accuracy of the expense and the appropriateness
+Added: of the expense classification.
+Added: In addition, we made inquiries of management and reviewed subsequent payments, invoices and agreements
+Added: relating to certain research and development expenses to ensure that accruals were properly recorded as of June 30, 2024.
+Added: /s/ EisnerAmper LLP
+Added: We have served as the Company’s auditor since
EISNERAMPER LLP
−Removed: have served as the Company’s auditor since 2019.
−Removed: CURRENT ASSETS:
−Removed: cash equivalents
−Removed: Investments in U.S.
−Removed: Treasury Bills
−Removed: and other assets
+Added: Iselin , New Jersey
+Added: September 30, 2024
+Added: Balance Sheets
+Added: and cash equivalents
+Added: Treasury Bills (available-for-sale)
+Added: and other current assets
current assets
−Removed: Operating lease right-of-use
−Removed: Intangible assets,
−Removed: Other assets, non-current
−Removed: LIABILITIES AND
−Removed: STOCKHOLDERS EQUITY
+Added: lease right-of-use assets, net
+Added: AND STOCKHOLDERS' EQUITY
+Added: payable and accrued expenses
current liabilities
−Removed: Accounts payable and
−Removed: accrued expenses
−Removed: Current portion of
−Removed: other liabilities
−Removed: Current portion of
−Removed: operating lease liabilities
−Removed: Current portion of
−Removed: Note payable, net of financing cost, unearned premium and discount of $ 894,926 at June 30, 2023
−Removed: Warrant liabilities
+Added: portion of operating lease liabilities
+Added: portion of note payable, net of financing cost, unearned premium and discount of $ 701,210 at June 30, 2024 and $ 894,926 at June 30,
derivative liability
current liabilities
−Removed: Other liabilities,
−Removed: net of current portion
−Removed: Operating lease liabilities,
−Removed: net of current portion
−Removed: payable, net of current portion, financing cost, unearned premium and discount of $ 227,268 at June 30, 2023 and $ 2,861,314
−Removed: at June 30, 2022
+Added: lease liabilities, net of current portion
+Added: Note payable,
+Added: net of current portion, financing cost, unearned premium and discount of $ 0 and $ 227,268 at June 30, 2024 and June 30,
+Added: 2023, respectively.
Commitments and contingencies
STOCKHOLDERS'
−Removed: Preferred stock;
+Added: $ 0.001 par value;
10,000,000 shares authorized;
0 shares issued and outstanding
−Removed: Common stock, $ 0.0001
+Added: Common stock, $ 0.0001 par
800,000,000 shares authorized at June 30, 2024 and June 30, 2023, respectively;
6,216,398 shares issued of which 6,190,072
−Removed: shares outstanding at June 30, 2023 and 24,984,083 issued and outstanding at June 30, 2022;
−Removed: Additional paid in capital
−Removed: Accumulated other comprehensive
−Removed: Accumulated deficit
+Added: shares are outstanding at June 30, 2024;
+Added: and 3,645,183 shares issued of which 3,642,895 shares outstanding at June 30, 2023
+Added: paid in capital
+Added: other comprehensive income
( 334,232,661 )
2 unchanged sentences
LIABILITIES AND STOCKHOLDERS' EQUITY
−Removed: accompanying notes are an integral part of the financial statements.
−Removed: of Operations and Comprehensive Loss
+Added: The accompanying notes are an integral part of the
+Added: financial statements.
+Added: Statements of Operations and Comprehensive Loss
June 30, 2024
1 unchanged sentence
OPERATING EXPENSES:
+Added: Amortization of intangible assets
Research and development expenses
4 unchanged sentences
( 45,080,448 )
−Removed: OTHER EXPENSE (INCOME):
+Added: OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
2 unchanged sentences
Interest income
−Removed: TOTAL OTHER EXPENSE (INCOME), NET
( 1,136,703 )
+Added: TOTAL OTHER (INCOME) EXPENSE, NET
$ ( 32,120,533 )
$ ( 50,255,815 )
+Added: Deemed dividend related to ratchet adjustment to warrants
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
3 unchanged sentences
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
+Added: NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 33,006,956 )
$ ( 50,255,815 )
−Removed: Other comprehensive income
−Removed: Unrealized gain on investments for available-for-sale
−Removed: Other comprehensive income
+Added: Other comprehensive (loss) income
+Added: Unrealized gain on available-for-sale investments
+Added: Reclassification of unrealized gains on available-for-sale investments upon settlement
+Added: Total other comprehensive (loss) income
Comprehensive loss
1 unchanged sentence
$ ( 50,079,224 )
−Removed: accompanying notes are an integral part of the financial statements.
−Removed: of Changes in Stockholders Equity
+Added: The accompanying notes are an integral part of the
+Added: financial statements.
+Added: Statements of Changes in Stockholders’ Equity
For the Years Ended June 30, 2024 and 2023
+Added: Treasury Stock
+Added: Treasury Stock
Comprehensive
Stockholders'
−Removed: June 30, 2021
+Added: Balance, June 30, 2022
$ 254,638,329
$ ( 250,969,890 )
−Removed: option-based compensation
−Removed: from issuance of common stock, net costs of $2,224,992
−Removed: based compensation – restricted stock
+Added: Stock option-based compensation
+Added: Stock-based compensation - restricted stock units
+Added: Stock-based compensation - issuance of common stock for services rendered
+Added: Cashless exercise of options
+Added: Cashless exercise of warrants
+Added: Proceeds from exercise of options
+Added: Proceeds from issuance of common stock, net costs of $2,008,898
+Added: Proceeds from issuance of common stock, net of costs of $94,160
+Added: - Related Party
+Added: Unrealized gain on available-for-sale investments
( 50,255,815 )
( 50,255,815 )
−Removed: June 30, 2022
+Added: Balance, June 30, 2023
( 301,225,705 )
−Removed: option-based compensation
−Removed: compensation – restricted stock units
−Removed: compensation – issuance of common stock
−Removed: exercise of options
−Removed: exercise of warrants
−Removed: from exercise of options
−Removed: from issuance of common stock, net costs of $2,008,898
−Removed: from issuance of common stock, net of costs of $94,160 – Related Party
−Removed: gain on available-for-sale securities
+Added: Stock - based compensation - stock options
+Added: Stock-based compensation - restricted stock units
+Added: Proceeds from issuance of common stock, net of costs of $2,908,141
+Added: Issuance of common stock from vesting of restricted stock units
+Added: Stock-based compensation - issuance of common stock for services rendered
+Added: Deemed dividend for ratchet adjustment to warrants
+Added: Relcassification of unrealized gains on available-for-sale investments
+Added: upon settlement
+Added: Issuance of additional shares for fractional shares effected by the reverse
( 32,120,533 )
( 32,120,533 )
−Removed: June 30, 2023
+Added: Balance, June 30, 2024
$ 349,732,674
$ ( 334,232,661 )
−Removed: accompanying notes are an integral part of the financial statements.
−Removed: of Cash Flows
+Added: The accompanying notes are an integral part of the
+Added: financial statements.
+Added: Statements of Cash Flows
June 30, 2024
3 unchanged sentences
$ ( 50,255,815 )
−Removed: Adjustments to reconcile net loss to net cash used in operating
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible assets
5 unchanged sentences
Accretion of loan premium
−Removed: Change in operating lease right-of-use assets
+Added: Realized gain on maturity of available-for sale
+Added: Non-cash lease expense from right-of-use assets
+Added: Gain on termination of operating lease
Change in fair value of derivative liabilities
1 unchanged sentence
Changes in operating assets and liabilities:
−Removed: Prepaids and other assets
+Added: Prepaid and other assets
Accounts payable and accrued expenses
Operating lease liabilities
−Removed: Other liabilities
+Added: Other current liabilities
( 1,304,925 )
3 unchanged sentences
CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Purchases of U.S.
−Removed: Treasury Bills
+Added: Proceeds from (purchases of) U.S.
+Added: Treasury Bills (available-for-sale)
( 14,301,135 )
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
( 14,301,135 )
1 unchanged sentence
Net proceeds from issuance of common stock
−Removed: Proceeds from note payable net of financing costs
+Added: Payments of note payable
+Added: ( 10,000,000 )
Proceeds from exercise of stock options
−Removed: Net proceeds from issuance of common
−Removed: stock – Related Party
+Added: Net proceeds from issuance of common stock - Related Party
Net cash provided by financing activities
Net increase in cash and cash equivalents
−Removed: Cash and cash equivalents,
−Removed: beginning of period
−Removed: Cash and cash equivalents,
−Removed: end of period
+Added: Cash and cash equivalents, beginning of period
+Added: Cash and cash equivalents, end of period
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
−Removed: SCHEDULE OF NON-CASH
−Removed: FINANCING AND INVESTING ACTIVITIES:
−Removed: Right of use assets
−Removed: obtained in exchange for lease obligations
−Removed: Unrealized gain on
−Removed: Treasury Bills
−Removed: accompanying notes are an integral part of the financial statements.
−Removed: to Financial Statements
−Removed: the Years Ended June 30, 2023 and 2022
−Removed: (the Company or we or our) is a clinical-stage company developing innovative drug therapies
−Removed: to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease.
−Removed: Company acquired the biopharmaceutical assets of NeurMedix, Inc.
−Removed: (NeurMedix), from a related party privately held clinical-stage
−Removed: pharmaceutical company, in June 2021.
−Removed: The acquired assets included NE3107, a potentially selective inhibitor of inflammatory extracellular
−Removed: single-regulated kinase(ERK) signaling that, based on animal studies and is believed to reduce neuroinflammation.
−Removed: is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological
−Removed: inflammatory cascades with a novel mechanism of action.
−Removed: There is emerging scientific consensus that both inflammation and insulin resistance
−Removed: may play fundamental roles in the development of Alzheimers Disease (AD) and Parkinsons Disease (PD), and NE3107 could,
−Removed: if approved represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans
−Removed: suffering from AD and 1 million Americans suffering from PD.
−Removed: Company is conducting a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
−Removed: evaluate NE3107 in patients who have mild to moderate Alzheimers disease (NCT04669028).
−Removed: The Company is targeting primary completion
−Removed: of this study in the fourth quarter of calendar year 2023.
−Removed: Company completed its Phase 2 study assessing NE3107 in Parkinsons disease patients in the fourth quarter of calendar year 2022.
−Removed: The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinsons
−Removed: disease (PD) participants treated with carbidopa/levodopa and NE3107.
−Removed: The study was primarily designed to assess safety (general safety
−Removed: in the patient population and potential for drug-drug interactions of NE3107 with levodopa);
−Removed: and secondary, to look for indications of
−Removed: promotoric activity akin to promotoric activity and apparent enhancement of levodopa activity observed in preclinical models.
−Removed: safety and efficacy objectives of the study were met.
−Removed: Neuroinflammation,
−Removed: insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including Alzheimers Disease
−Removed: (AD), Parkinsons Disease (PD), frontotemporal lobar dementia, and Amyotrophic lateral sclerosis (ALS).
−Removed: an orally bioavailable, blood-brain permeable, small molecule, with potential anti-inflammatory, insulin sensitizing, and ERK-binding
−Removed: properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
−Removed: NE3107s potential to inhibit
−Removed: neuroinflammation and insulin resistance forms the basis for the Companys work testing the molecule in AD and PD patients.
−Removed: is patented in the United States, Australia, Canada, Europe and South Korea.
−Removed: The Company’s Orphan Drug candidate BIV201
−Removed: (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a U.S.
−Removed: Phase 2b study (NCT04112199) for the treatment
−Removed: of refractory ascites due to liver cirrhosis.
−Removed: BIV201 is administered as a patent-pending liquid formulation.
−Removed: The study was closed before
−Removed: full enrollment, without clinically meaningful adverse effects associated with BIV201 treatment.
−Removed: While the active agent is approved in
−Removed: and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these
−Removed: authorizations.
−Removed: Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in
−Removed: annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.
+Added: SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
+Added: Right-of-use assets obtained in exchange for lease obligations
+Added: Unrealized gain on U.S.
+Added: Treasury Bills (available-for-sale)
+Added: Reclassification of unrealized gains on U.S.
+Added: Treasury Bills (available-for-sale investments) upon settlement
+Added: Deemed dividend of ratchet adjustment to warrants
+Added: The accompanying notes are an integral part of the
+Added: financial statements.
+Added: Notes to Financial Statements
+Added: Background Information
+Added: (the “Company” or “we”
+Added: or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including
+Added: neurological and neuro-degenerative disorders and liver disease.
+Added: The Company acquired the biopharmaceutical assets
+Added: of NeurMedix, Inc.
+Added: (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021 .
+Added: acquired assets included NE3107.
+Added: NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven
+Added: insulin resistance and major pathological inflammatory cascades with a novel mechanism of action.
+Added: There is emerging scientific consensus
+Added: that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”)
+Added: and Parkinson’s disease (“PD”), and NE3107 could, if approved by the U.S.
Food and Drug Administration (“FDA”),
−Removed: has not approved any drug to treat refractory ascites.
−Removed: The BIV201 development program was initiated by
−Removed: LAT Pharma LLC (LAT Pharma).
−Removed: On April 11, 2016, the Company acquired LAT Pharma and the rights to its BIV201 development
−Removed: The Company currently owns all development and marketing rights to this drug candidate.
−Removed: Pursuant to the Agreement and Plan of
−Removed: Merger entered into on April 11, 2016, between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated
−Removed: to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin), if approved, to be shared by the members
−Removed: of LAT Pharma, PharmaIn Corporation and The Barrett Edge, Inc.
−Removed: to Financial Statements
−Removed: the Years Ended June 30, 2023 and 2022
−Removed: and Going Concern
−Removed: The Company’s operations are subject to
−Removed: a number of factors that can affect its operating results and financial conditions.
+Added: represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering
+Added: from AD and 1 million Americans suffering from PD.
+Added: Neurodengenerative Disease Program
+Added: In neurodegenerative disease, the Company’s
+Added: drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear
+Added: factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”)
+Added: signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
+Added: NE3107 does not interfere with
+Added: their homeostatic functions (e.g., insulin signaling and neuron growth and survival).
+Added: Both inflammation and insulin resistance are drivers
+Added: of AD and PD.
+Added: Alzheimer’s Disease (NCT05083260)
+Added: On November 29, 2023, the Company announced the analysis
+Added: of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
+Added: The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
+Added: 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
+Added: Patients were randomly assigned, 1:1 versus placebo, to receive
+Added: sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
+Added: Upon trial completion, as the Company began the
+Added: process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices
+Added: (“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area).
+Added: This highly unusual level
+Added: of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of
+Added: Scientific Investigations (“OSI”) for potential further action.
+Added: After the patient exclusions, 81 patients remained in
+Added: the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial
+Added: and were verified to take study drug from pharmacokinetic data.
+Added: The trial was originally designed to be 80% powered
+Added: with 125 patients in each of the treatment and placebo arms.
+Added: The unplanned exclusion of so many patients has left the trial underpowered
+Added: for the primary endpoints.
+Added: In the Per-Protocol population, which included those patients who completed the trial and who were further
+Added: verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest
+Added: a slowing of cognitive loss;
+Added: these same patients experienced an advantage in age deceleration vs.
+Added: placebo as measured by DNA epigenetic
+Added: Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this
+Added: case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
+Added: was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
+Added: Additional DNA methylation
+Added: data continues to be collected and analyzed.
+Added: Parkinson’s Disease (NCT05083260)
+Added: The Phase 2 study of bezisterim (NE3107) for the treatment
+Added: of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
+Added: in PD participants treated with carbidopa/levodopa and bezisterim (NE3107).
+Added: Forty-five patients with a defined L-dopa “off state”
+Added: were randomized 1:1 to placebo:
+Added: bezisterim (NE3107) 20 mg twice daily for 28 days.
+Added: This trial was launched with two design objectives:
+Added: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
+Added: of bezisterim (NE3107) with carbidopa/ levodopa;
+Added: and 2) the secondary objective was to determine if preclinical indications of promotoric
+Added: activity and apparent enhancement of levodopa activity could be seen in humans.
+Added: Both objectives were met.
+Added: Background Information (continued)
+Added: Long COVID Program
+Added: In April 2024, the Company announced the grant of
+Added: a clinical trial award of up to $13.1 million from the DOD, awarded through the Peer Reviewed
+Added: Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”).
+Added: can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment
+Added: of neurological symptoms that are associated with long COVID.
+Added: The Company anticipates the trial to commence by early 2025.
+Added: Liver Disease Program
+Added: In liver disease, our investigational drug candidate
+Added: BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
+Added: being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
+Added: treatment of ascites due to chronic liver cirrhosis.
+Added: BIV201 is administered as a patent-pending liquid formulation.
+Added: In June 2021, the Company initiated a Phase 2 study
+Added: (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
+Added: cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites.
+Added: endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
+Added: to a pre-treatment period.
+Added: In March 2023, the Company announced enrollment was
+Added: paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
+Added: during the 28 days after treatment initiation compared to the 28 days prior to treatment.
+Added: The change in ascites volume was significantly
+Added: different from those patients receiving SOC treatment.
+Added: Patients who completed the treatment with BIV201 experienced a 53% reduction in
+Added: ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
+Added: In June 2023, the Company requested and subsequently
+Added: received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
+Added: due to chronic liver cirrhosis.
+Added: The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
+Added: of ascites due to chronic liver cirrhosis.
+Added: The BIV201 development program was initiated by LAT
+Added: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.
+Added: The Company currently
+Added: owns all development and marketing rights to this drug candidate.
+Added: Pursuant to the Agreement and Plan of Merger entered into on April 11,
+Added: 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty
+Added: on net sales of BIV201 (continuous infusion terlipressin).
+Added: to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett
+Added: Liquidity and Going Concern
+Added: The Company’s operations are subject to a number
+Added: of factors that can affect its operating results and financial conditions.
Such factors include, but are not limited to:
−Removed: results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval
−Removed: to market its products;
−Removed: competition from products manufactured and sold or being developed by other companies;
−Removed: the price of, and demand
−Removed: for, Company products;
−Removed: the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for
+Added: the results of
+Added: clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market
its products;
+Added: competition from products manufactured and sold or being developed by other companies;
+Added: the price of, and demand for, Company
+Added: the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products;
and the Company’s ability to raise capital.
−Removed: The Company’s financial statements have been prepared assuming the
−Removed: Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
−Removed: course of business.
−Removed: As of June 30, 2023 the Company had working capital of approximately $ 19.5 million, cash and cash equivalents and
−Removed: US treasury bills totaling of approximately $ 33.9 million, stockholders’ equity of approximately $ 15.3 million, and an accumulated
−Removed: deficit of approximately $ 301 million.
+Added: The Company’s financial statements have been prepared assuming the Company will
+Added: continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of
+Added: As of June 30, 2024, the Company had working capital of approximately $ 14.7 million, cash and cash equivalents of approximately
+Added: $ 23.8 million, stockholders’ equity of approximately $ 15.5 million, and an accumulated deficit of approximately $ 334.2 million.
The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future.
−Removed: The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts,
−Removed: as well as its ability to secure additional financing as needed.
−Removed: Although our cash balance may possibly sustain operations over the next
−Removed: 12 months from the balance sheet date if measures are taken to delay planned expenditures in our research protocols and slow the progress
−Removed: in the Company’s development of next phase clinical programs, the Company’s current planned operations to meet certain goals
−Removed: and objectives, project cash flows to be depleted within that period of time.
−Removed: future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations.
−Removed: expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.
−Removed: The Impact of COVID-19 pandemic created a widespread
−Removed: labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the potential patient participation
−Removed: in our studies, which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.
−Removed: management continues to pursue the Companys strategic plans, there is no assurance that the Company will be successful in obtaining
−Removed: sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations.
−Removed: These circumstances raise substantial
−Removed: doubt on the Companys ability to continue as a going concern.
−Removed: The financial statements do not include any adjustments that might
−Removed: result from the outcome of this uncertainty.
−Removed: Accounting Policies
−Removed: of Presentation
−Removed: Companys financial statements have been prepared in accordance with accounting principles generally accepted in the United States
−Removed: (GAAP) and include all adjustments necessary for the fair presentation of the Companys financial position for the
−Removed: periods presented.
−Removed: preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts
−Removed: reported in the financial statements and accompanying notes.
−Removed: The Company bases its estimates on historical experience and on various
−Removed: assumptions that are believed to be reasonable under the circumstances.
−Removed: The amounts of assets and liabilities reported in the Companys
−Removed: balance sheet and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which
−Removed: are used for, but not limited to, accounting for clinical accruals, share-based compensation, accounting for derivatives, assumptions used in leases and recoverability of intangible assets, the inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and accounting for income taxes.
+Added: The Company’s future operations
+Added: are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure
+Added: additional financing as needed.
+Added: Projected cash flows could be extended if further measures are taken to delay planned expenditures in
+Added: our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
+Added: The future viability of the Company is largely dependent
+Added: upon its ability to raise additional capital to finance its operations.
+Added: Management expects that future sources of funding may include
+Added: sales of equity, obtaining loans, or other strategic transactions.
+Added: Liquidity and Going Concern (continued)
+Added: Although management continues to pursue the Company’s
+Added: strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the
+Added: Company, if at all, to fund continuing operations.
+Added: These circumstances raise substantial doubt on the Company’s ability to continue
+Added: as a going concern.
+Added: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: Significant Accounting Policies
+Added: Basis of Presentation
+Added: The Company’s financial statements have been
+Added: prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments
+Added: necessary for the fair presentation of the Company’s financial position for the periods presented.
+Added: Use of Estimates
+Added: The preparation of financial statements in conformity
+Added: with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying
+Added: The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the
+Added: circumstances.
+Added: The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
+Added: for each of the periods presented in the statements of operations and comprehensive loss are affected by estimates and assumptions, which
+Added: are used for, but not limited to, accounting for clinical accruals, share-based compensation, accounting for derivatives, assumptions
+Added: used in recording leases, the inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and
+Added: accounting for income taxes.
Actual results could differ from those estimates.
−Removed: and cash equivalents
+Added: Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits
2 unchanged sentences
Treasury Bills with original maturities of three months or less.
−Removed: to Financial Statements
−Removed: the Years Ended June 30, 2023 and 2022
−Removed: Accounting Policies (continued)
+Added: Investments in U.S.
Treasury Bills
4 unchanged sentences
comprehensive income in the accompanying statements of operations and comprehensive loss.
−Removed: Concentration of Credit Risk in the Financial
−Removed: Service Industry
+Added: Concentration of Credit Risk in the Financial Service
As of June 30, 2024, the Company had cash deposited
10 unchanged sentences
arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
−Removed: value measurement of assets and liabilities
−Removed: determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use
−Removed: of observable inputs and minimize the use of unobservable inputs when measuring fair value.
−Removed: Fair value is defined as the price that would
−Removed: be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
−Removed: The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous
−Removed: market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions
−Removed: that market participants would use in pricing the asset or liability.
−Removed: The classification of a financial asset or liability within the
−Removed: hierarchy is based upon the lowest level input that is significant to the fair value measurement.
−Removed: The fair value hierarchy prioritizes
−Removed: the inputs into three levels that may be used to measure fair value:
−Removed: 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
−Removed: 2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability,
−Removed: either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
−Removed: 3 - Inputs are unobservable inputs based on our assumptions.
+Added: Significant Accounting Policies (continued)
+Added: Fair value measurement of assets and liabilities
+Added: We determine the fair values of our financial instruments
+Added: based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable
+Added: inputs when measuring fair value.
+Added: Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability
+Added: in an orderly transaction between market participants at the measurement date.
+Added: The fair value assumes that the transaction to sell the
+Added: asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the
+Added: fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset
+Added: or liability.
+Added: The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant
+Added: to the fair value measurement.
+Added: The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
+Added: Level 1 - Inputs are unadjusted quoted prices in active
+Added: markets for identical assets or liabilities.
+Added: Level 2 - Inputs are quoted prices for similar assets
+Added: and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market
+Added: corroboration, for substantially the full term of the financial instrument.
+Added: Level 3 - Inputs are unobservable inputs based on
+Added: our assumptions.
The Company’s financial instruments include
4 unchanged sentences
lease liabilities approximate their fair values since they bear interest at rates which approximate market rates for similar debt instruments.
−Removed: and other Assets
−Removed: and other assets consist of prepayments of certain expenses and direct costs related to capital raise which will offset proceeds upon
−Removed: Assets, non-current
−Removed: assets consist of a security deposit for an office lease.
−Removed: to Financial Statements
−Removed: the Years Ended June 30, 2023 and 2022
−Removed: Accounting Policies (continued)
−Removed: Company determines whether an arrangement contains a lease at inception.
−Removed: Operating leases are included in operating lease right-of-use
−Removed: (ROU) assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion on
−Removed: our balance sheets.
−Removed: ROU assets represent the Companys right to use an underlying asset for the lease term and lease liabilities
−Removed: represent an obligation to make lease payments arising from the lease.
−Removed: Lease ROU assets and lease liabilities are recognized based on
−Removed: the present value of the future minimum lease payments over the lease term at the commencement date.
−Removed: As the Companys leases do
−Removed: not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement date in determining
−Removed: the present value of lease payments.
−Removed: The Company does not include options to extend or terminate the lease term in its calculation unless
−Removed: it is reasonably certain that the Company will exercise any such options.
−Removed: Rent expense is recognized under the operating leases on a
−Removed: straight-line basis.
−Removed: The Company does not recognize right of-use assets or lease liabilities for short-term leases, which have a lease
−Removed: term of 12 months or less at inception, and instead will recognize lease payments as expense on a straight-line basis over the lease term.
−Removed: and Development
−Removed: and development expenses consist primarily of costs associated with the preclinical and/ or clinical trials of drug candidates, compensation
−Removed: and other expenses for research and development, personnel, supplies and development materials, costs for consultants and related contract
−Removed: research and facility costs.
−Removed: Company uses the asset and liability method of accounting for deferred income taxes.
−Removed: Deferred income taxes are measured by applying enacted
−Removed: statutory rates to net operating loss carryforwards and to the differences between the financial reporting and tax bases of assets and
−Removed: Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion
−Removed: or all of the deferred tax assets will not be realized.
−Removed: Company recognizes uncertainty in income taxes in the financial statements using a recognition threshold and measurement attribute
−Removed: of a tax position taken or expected to be taken in a tax return.
−Removed: The Company applies the more-likely-than-not
−Removed: recognition threshold to all tax positions, commencing at the adoption date of the applicable accounting guidance, which resulted in
−Removed: no unrecognized tax benefits as of such date.
−Removed: Additionally, there have been no unrecognized tax benefits subsequent to adoption.
−Removed: Company has opted to classify interest and penalties that would accrue, if any, according to the provisions of relevant tax law as
−Removed: general and administrative expenses, in the Statements of Operations and Comprehensive Loss.
−Removed: For the years ended June 30, 2023 and 2022, there was no
−Removed: such interest or penalty.
−Removed: Loss per Common Share
−Removed: Basic net loss per common share is computed by
−Removed: dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during
−Removed: Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted
−Removed: average number of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the
−Removed: potential dilution that could occur from common shares issuable through stock options, warrants, and convertible debentures.
−Removed: For the years
−Removed: ended June 30, 2023 and 2022, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to
−Removed: the net loss for the periods.
−Removed: table below shows the number of outstanding stock options, warrants and restricted stock units as of June 30:
+Added: Prepaid and other assets
+Added: Prepaid and other assets consist of prepayments of
+Added: certain expenses and a security deposit paid in connection with a lease agreement.
+Added: The Company determines whether an arrangement contains
+Added: a lease at inception.
+Added: Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating
+Added: lease liabilities, and operating lease liabilities, net of current portion on our balance sheets.
+Added: ROU assets represent the Company’s
+Added: right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from
+Added: ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease
+Added: term at the commencement date.
+Added: As the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based
+Added: on the information available at the commencement date in determining the present value of lease payments.
+Added: The Company does not include
+Added: options to extend or terminate the lease term in its calculation unless it is reasonably certain that the Company will exercise any such
+Added: Rent expense is recognized under the operating leases on a straight-line basis.
+Added: The Company does not recognize right-of-use assets
+Added: or lease liabilities for short-term leases, which have a lease term of 12 months or less at inception, and instead will recognize lease
+Added: payments as expense on a straight-line basis over the lease term.
+Added: Research and Development
+Added: Research and development expenses consist primarily
+Added: of costs associated with the preclinical and/or clinical trials of drug candidates, compensation and other expenses for research and development,
+Added: personnel, supplies and development materials, costs for consultants and related contract research and facility costs.
+Added: The Company uses the asset and liability method of
+Added: accounting for deferred income taxes.
+Added: Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards
+Added: and to the differences between the financial reporting and tax bases of assets and liabilities.
+Added: Deferred tax assets are reduced, by a
+Added: valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
+Added: decided to apply a full valuation allowance against its deferred tax assets due to the continuing losses.
+Added: Significant Accounting Policies (continued)
+Added: The Company recognizes uncertainty in income taxes
+Added: in the financial statements using a recognition threshold and measurement attribute of a tax position taken or expected to be taken in
+Added: a tax return.
+Added: The Company applies the “more-likely-than-not” recognition threshold to all tax positions, commencing at the
+Added: adoption date of the applicable accounting guidance, which resulted in no unrecognized tax benefits as of such date.
+Added: Additionally, there
+Added: have been no unrecognized tax benefits subsequent to adoption.
+Added: The Company has opted to classify interest and penalties that would accrue,
+Added: if any, according to the provisions of relevant tax law as general and administrative expenses, in the Statements of Operations and Comprehensive
+Added: For the years ended June 30, 2024 and 2023, there was no such interest or penalty.
+Added: Net Loss per Common Share
+Added: Basic net loss per common share is computed by dividing
+Added: the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during the period.
+Added: Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number
+Added: of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the potential dilution
+Added: that could occur from common shares issuable through stock options, warrants, and convertible debentures.
+Added: For the years ended June 30,
+Added: 2024 and 2023, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for
+Added: the periods presented.
+Added: The table below shows the potential shares of common stock, presented based on amounts outstanding
+Added: at each year end, that were excluded from the computation of diluted net loss per share attributable to common stockholders because including
+Added: them would have had an anti-dilutive effect:
Schedule of dilutive securities were excluded from the computation of diluted loss per share
5 unchanged sentences
Restricted Stock Units
−Removed: to Financial Statements
−Removed: the Years Ended June 30, 2023 and 2022
−Removed: Accounting Policies (continued)
−Removed: Company has accounted for stock-based compensation under the provisions of FASB ASC 718 – Stock Compensation which
−Removed: requires the use of the fair-value based method to determine compensation for all arrangements under which employees and others receive
−Removed: shares of stock or equity instruments (stock options and Common Stock purchase warrants).
−Removed: For employee awards, the fair value of each
−Removed: stock option award is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility,
−Removed: expected dividends, expected term, and the risk-free interest rate.
−Removed: For non-employees, the fair value of each stock option award is estimated
−Removed: on the measurement date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected
−Removed: term, and the risk-free interest rate.
−Removed: For non-employees, the Company utilizes the graded vesting attribution method under which the
−Removed: entity treats each separately vesting portion (tranche) as a separate award and recognizes compensation cost for each tranche over its
−Removed: separate vesting schedule.
−Removed: Expected volatilities are based on historical volatility of peer companies and other factors estimated over
−Removed: the expected term of the stock options.
−Removed: For employee awards, the expected term of options granted is derived using the simplified
−Removed: method which computes expected term as the average of the sum of the vesting term plus the contract term.
−Removed: The risk-free rate is
−Removed: based on the U.S.
−Removed: Treasury yield curve in effect at the time of grant for the period of the expected term.
−Removed: The Company recognizes forfeitures
−Removed: as they occur.
−Removed: is recorded when the purchase price paid for an acquisition exceeds the fair value of net identified tangible and intangible assets acquired.
−Removed: The Company performs an annual impairment test of goodwill and further periodic tests to the extent indicators of impairment develop
−Removed: between annual impairment tests.
−Removed: The Companys impairment review process compares the fair value of the reporting unit to its carrying
−Removed: value, including the goodwill related to the reporting unit.
−Removed: To determine the fair value of the reporting unit, the Company may use various
−Removed: approaches including an asset or cost approach, market approach or income approach or any combination thereof.
−Removed: These approaches may require
−Removed: the Company to make certain estimates and assumptions including future cash flows, revenue and expenses.
−Removed: These estimates and assumptions
−Removed: are reviewed each time the Company tests goodwill for impairment and are typically developed as part of the Companys routine business
−Removed: planning and forecasting process.
−Removed: While the Company believes its estimates and assumptions are reasonable, variations from those estimates
−Removed: could produce materially different results.
−Removed: The Company did no t recognize any goodwill impairments for the years ended June 30, 2023
−Removed: of Long-Lived Assets
−Removed: assets, including intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
−Removed: amount of an asset may not be recoverable.
−Removed: Recoverability of assets to be held and used is measured by a comparison of the carrying amount
−Removed: of an asset to estimated undiscounted future cash flows expected to be generated by the asset.
−Removed: the carrying amount of an asset exceeds its undiscounted estimated future cash flows, an impairment review is performed.
−Removed: An impairment
−Removed: charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset.
−Removed: Generally, fair value
−Removed: is determined using valuation techniques such as expected discounted cash flows or appraisals, as appropriate.
−Removed: Assets to be disposed
−Removed: of would be separately presented in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell,
−Removed: and are no longer depreciated or amortized.
−Removed: The assets and liabilities of a disposed group classified as held for sale would be presented
−Removed: separately in the appropriate asset and liability sections of the balance sheets.
−Removed: Accounting Pronouncements
−Removed: Company considers the applicability and impact of all Accounting Standards Updates (ASUs).
−Removed: There were no recent
−Removed: ASUs that are expected to have a material impact on our balance sheets or statements of operations and comprehensive loss.
−Removed: In June 2016, the Financial Accounting Standards
−Removed: Board (“FASB”) issued ASU No.
−Removed: 2016-13, “Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses
−Removed: on Financial Instruments.” This amendment replaces the incurred loss impairment methodology in current GAAP with a methodology
−Removed: that reflects expected credit losses on instruments within its scope, including trade receivables.
−Removed: This update is intended to provide
−Removed: financial statement users with more decision-useful information about the expected credit losses.
−Removed: In November 2019, the FASB issued No.
−Removed: 2019-10, Financial Instruments --Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842), which deferred
−Removed: the effective date of ASU 2016-13 for Smaller Reporting Companies for fiscal years beginning after December 15, 2022, including interim
−Removed: periods within those fiscal years.
−Removed: The Company does not expect a material impact from the adoption of ASU 2016-13 on the financial statements.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
+Added: Notes payable conversion option
+Added: Stock-based Compensation
+Added: The Company has accounted for stock-based compensation
+Added: under the provisions of Accounting Standards Codification (“ASC”) Topic 718 – “Stock Compensation” (“ASC
+Added: 718”) which requires the use of the fair-value based method to determine compensation for all arrangements under which employees
+Added: and others receive shares of stock or equity instruments (stock options and Common Stock purchase warrants).
+Added: For employees and non-employees
+Added: awards, the fair value of each stock option award is estimated on the date of grant using the Black-Scholes valuation model that uses
+Added: assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate.
+Added: For non-employees, the Company
+Added: utilizes the graded vesting attribution method under which the entity treats each separately vesting portion (tranche) as a separate award
+Added: and recognizes compensation cost for each tranche over its separate vesting schedule.
+Added: Expected volatilities are based on historical volatility
+Added: of peer companies and other factors estimated over the expected term of the stock options.
+Added: For employee and non-employee awards, the expected
+Added: term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of
+Added: the vesting term plus the contract term.
+Added: The risk-free rate is based on the U.S.
+Added: Treasury yield curve in effect at the time of grant for
+Added: the period of the expected term.
+Added: The Company recognizes forfeitures as they occur.
+Added: Goodwill is recorded when the purchase price paid
+Added: for an acquisition exceeds the fair value of the net identified tangible and intangible assets acquired.
+Added: The Company performs an annual
+Added: impairment test of goodwill and further periodic tests to the extent indicators of impairment develop between annual impairment tests.
+Added: The Company’s impairment review process compares the fair value of the reporting unit to its carrying value, including the goodwill
+Added: related to the reporting unit.
+Added: To determine the fair value of the reporting unit, the Company may use various approaches including an
+Added: asset or cost approach, market approach or income approach or any combination thereof.
+Added: These approaches may require the Company to make
+Added: certain estimates and assumptions including future cash flows, revenue and expenses.
+Added: These estimates and assumptions are reviewed each
+Added: time the Company tests goodwill for impairment and are typically developed as part of the Company’s routine business planning and
+Added: forecasting process.
+Added: While the Company believes its estimates and assumptions are reasonable, variations from those estimates could produce
+Added: materially different results.
+Added: The Company did not recognize any goodwill impairments for the years ended June 30, 2024 and 2023.
+Added: Significant Accounting Policies (continued)
+Added: Impairment of Long-Lived Assets
+Added: Long-lived assets, including intangible assets, are
+Added: reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
+Added: Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted
+Added: future cash flows expected to be generated by the asset.
+Added: If the carrying amount of an asset exceeds its undiscounted
+Added: estimated future cash flows, an impairment review is performed.
+Added: An impairment charge is recognized in the amount by which the carrying
+Added: amount of the asset exceeds the fair value of the asset.
+Added: Generally, fair value is determined using valuation techniques such as expected
+Added: discounted cash flows or appraisals, as appropriate.
+Added: Assets to be disposed of would be separately presented in the balance sheet and reported
+Added: at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated or amortized.
+Added: The assets and liabilities
+Added: of a disposed group classified as held for sale would be presented separately in the appropriate asset and liability sections of the balance
+Added: The Company did not recognize any long-lived asset impairments for the years ended June 30, 2024 and 2023.
+Added: Reverse stock split up
+Added: The company effected a 1:10 reverse split of the issued and outstanding
+Added: shares of its Class A commons stock which was approved by the board of director after the approval obtained from shareholders at a special
+Added: meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’ approval was
+Added: All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
+Added: Recent Accounting Pronouncements
+Added: The Company considers the applicability and impact
+Added: of all Accounting Standards Updates (“ASU’s”).
+Added: There were no recent ASU’s that are expected to have a material
+Added: impact on our balance sheets or statements of operations and comprehensive loss.
+Added: In June 2016, the Financial Accounting Standards Board
+Added: (“FASB”) issued ASU No.
+Added: 2016-13, “Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on
+Added: Financial Instruments” (“ASU 2016-13”).
+Added: This amendment replaces the incurred loss impairment methodology in current
+Added: GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables.
+Added: is intended to provide financial statement users with more decision-useful information about the expected credit losses.
+Added: The Company adopted
+Added: ASU 2016-13 effective July 1, 2023 and the adoption had an insignificant impact on the accompanying financial statements.
+Added: In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, "Segment Reporting (Topic 280):
+Added: Improvements to Reportable
+Added: Segment Disclosures," to enhance disclosures for significant segment expenses for all public entities required to report segment information
+Added: in accordance with ASC 280.
+Added: The standard did not change the definition of a segment, the method for determining segments or the criteria
+Added: for aggregating operating segments into reportable segments.
+Added: The amendments are effective for fiscal years beginning after December 15,
+Added: 2023, and interim periods within fiscal years beginning after December 15, 2024.
+Added: Retrospective adoption is required for all prior periods
+Added: presented in the financial statements.
+Added: The adoption is not expected to have a material impact to our financial statements or disclosures.
+Added: In December 2023, the FASB issued ASU 2023-09, "Income
+Added: Taxes (Topic 740):
+Added: Improvements in Income Tax Disclosures" to enhance the transparency and decision usefulness of income tax disclosures.
+Added: This amendment requires public companies to disclose specific categories in the rate reconciliation and provide additional information
+Added: for reconciling items that meet a quantitative threshold.
+Added: Additionally, under the amendment entities are required to disclose the amount
+Added: of income taxes paid disaggregated by federal, state and foreign taxes, as well as disaggregated by material individual jurisdictions.
+Added: Finally, the amendment requires entities to disclose income from continuing operations before income tax expense disaggregated between
+Added: domestic and foreign and income tax expense from continuing operations disaggregated by federal, state and foreign.
+Added: The new rules are
+Added: effective for annual periods beginning after December 15, 2024.
+Added: We will adopt this standard on a prospective basis as allowed by the standard.
+Added: The adoption of this standard is not expected to have a material impact on our financial statements.
Investments in U.S.
Treasury Bills available-for-sale
−Removed: following is a summary of the U.S.
−Removed: Treasury Bills held at June 30, 2023:
+Added: The following is a summary of the U.S.
+Added: Treasury Bills
+Added: held at June 30, 2023:
Schedule of U.S.
3 unchanged sentences
Accumulated Other Comprehensive Income
−Removed: Treasury Bills due is 3 - 6 months
−Removed: The Company purchased a total of approximately $ 46 million of U.S.
−Removed: Treasury Bills during the year ended June 30, 2023.
−Removed: The U.S Treasury Bills that matured were approximately $ 18 million and none were
−Removed: sold before maturity.
−Removed: Companys intangible assets consist of intellectual property acquired from LAT Pharma, Inc.
−Removed: and are amortized over their estimated
−Removed: useful lives.
−Removed: The following is a summary of the intangible assets as of June 30, 2023 and 2022:
+Added: Bills due in 3 - 6 months
+Added: During the fiscal year ended June 30, 2023, the Company
+Added: purchased a total of approximately $ 46 million of U.S.
+Added: Treasury Bills.
+Added: All outstanding investments in U.S.
+Added: Treasury Bills available-for-sale
+Added: held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain of $ 223,865
+Added: recorded as a component of interest income on the accompanying statement of operations and comprehensive loss.
+Added: Intangible Assets
+Added: The Company’s intangible assets consist of intellectual property
+Added: acquired from LAT Pharma, Inc.
+Added: and are amortized over their estimated useful lives.
+Added: The following is a summary of the intangible assets
+Added: as of June 30, 2024 and 2023:
Schedule of intangible assets
2 unchanged sentences
Intellectual Property
−Removed: Less Accumulated Amortization
+Added: Accumulated Amortization
( 1,886,052 )
1 unchanged sentence
Intellectual Property, Net
−Removed: expense amounted to $ 229,377 for each of the years ended June 30, 2023 and 2022, respectively.
−Removed: The Company amortizes intellectual property
−Removed: over the expected original useful lives of 10 years .
−Removed: future amortization expense is as follows:
+Added: Amortization expense amounted to $ 229,377 for each
+Added: of the years ended June 30, 2024 and 2023, respectively.
+Added: The Company amortizes intellectual property over the expected original useful
+Added: lives of 10 years.
+Added: Estimated future amortization expense is as follows:
Schedule of future amortization expense
Year ending June 30,
−Removed: Party Transactions
−Removed: Transactions with Acuitas
−Removed: July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (Acuitas), the Companys
−Removed: majority stockholder, pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364
−Removed: shares of the Companys Common Stock, at a price of $1.65 per share (the PIPE Shares), and (ii) a warrant to purchase
−Removed: 7,272,728 shares of Common Stock (PIPE Warrant Shares), at an exercise price of $1.82, with a term of exercise of five
−Removed: The warrant has a down round feature that reduces the exercise price of the warrant if the Company sells stock at a price lower
−Removed: than the exercise price of the warrant.
−Removed: On August 15, 2022, the Company received net proceeds of approximately $5.9 million, net of costs
−Removed: of approximately $94,000, and entered into an amended and restated registration agreement with Acuitas, which amended and restated that
−Removed: certain registration rights agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the Existing Registration
−Removed: Rights Agreement), to amend the definition of Registrable Securities in the Existing Registration Rights Agreement
−Removed: to include the PIPE Shares and the PIPE Warrant Shares as Registrable Securities thereunder.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Party Transactions (continued)
−Removed: Acquisition with NeurMedix
−Removed: On April 27, 2021, the Company entered into an
−Removed: Asset Purchase Agreement (“APA”) with NeurMedix and Acuitas, which are related party affiliates, pursuant to which the Company
−Removed: acquired certain assets from NeurMedix and assumed certain liabilities of NeurMedix.
−Removed: The acquired assets include, among others, certain
−Removed: assets related to the drug candidates then being developed by NeurMedix, including NE3107.
−Removed: On June 10, 2021, and pursuant to the terms
−Removed: of the APA, the Company issued to Acuitas (as NeurMedix’s assignee) 8,361,308 shares of the Company’s Common Stock and made
−Removed: a cash payment to Acuitas of approximately $2.3 million.
−Removed: Since the transaction was between entities under common control, there were no
−Removed: fair value adjustments of the purchased assets, and the historical cost basis of the purchased assets was zero.
−Removed: The total consideration
−Removed: paid was expensed as in process research and development expense in the year ended June 30, 2021.
−Removed: Subject to the terms and conditions of APA, as
−Removed: amended on May 9, 2021, the Company may be obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting
−Removed: of up to 18 million shares of the Company’s Common Stock, with 4.5 million shares issuable upon the achievement of each of the
−Removed: four milestones related to certain clinical, regulatory and commercial milestones set forth in the APA, subject to a cap limiting the
−Removed: issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of the
−Removed: Company’s issued and outstanding Common Stock.
−Removed: current portion of other liabilities at June 30, 2023 and June 30, 2022 were approximately $ 48,400 and $ 1.3 million, and included $ 48,400 and $ 580,614 ,
−Removed: respectively, of a retention bonus payable for arrangements with certain employees.
−Removed: The payment terms of the total retention bonus arrangements
−Removed: of $ 1,161,000 recognized in August 2021 provided for equal monthly installments over a 24-month period and began in August 2021.
−Removed: November 30, 2021 (the Closing Date), the Company entered into a Loan and Security Agreement and the Supplement to the
−Removed: Loan and Security Agreement and Promissory Notes (together, the Loan Agreement) with Avenue Venture Opportunities Fund,
−Removed: (AVOPI) and Avenue Venture Opportunities Fund II, L.P.
−Removed: (AVOPII, and together with AVOPI, Avenue)
−Removed: for growth capital loans in an aggregate commitment amount of up to $20 million (the Loan).
−Removed: On the Closing Date, $15 million
−Removed: of the Loan was funded (Tranche 1).
−Removed: The Loan provided for an additional $5 million to be available to the Company on or
−Removed: prior to September 15, 2022, subject to the Companys achievement of certain milestones with respect to certain of its ongoing
−Removed: clinical trials, which were not achieved.
−Removed: The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00 % plus
−Removed: the prime rate as reported in The Wall Street Journal and (b) 10.75%.
+Added: Finite lived intangible assets, net
+Added: Related Party Transactions
+Added: Equity Transactions with Acuitas
+Added: On July 15, 2022, the Company entered into a securities
+Added: purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which
+Added: Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 363,636 shares of the Company’s Common
+Added: Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE
+Added: Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years.
+Added: The down round feature reduced the exercise
+Added: price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 in connection with the offering further described in Note 9 as the
+Added: Company sold stock at a price lower than its initial exercise price.
+Added: The Company calculated the difference in fair value of the PIPE Warrant
+Added: Shares between the stated exercise price and the reduced exercise price and recorded $ 886,423 as a deemed dividend.
+Added: The fair value of
+Added: the PIPE Warrant Shares were estimated using the Black Scholes Method with the following inputs, the stock price of $ 10.65 , exercise price
+Added: of $ 18.20 and $ 10.00 , remaining term of 3.5 years, risk free rate of 4.4 % and volatility of 95.0 % .
+Added: On August 15, 2022, the Company received net proceeds of approximately
+Added: $5.9 million, net of costs of approximately $94,000, and entered into an amended and restated registration agreement with Acuitas, which
+Added: amended and restated that certain registration rights agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the
+Added: “Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities” in the Existing
+Added: Registration Rights Agreement to include the PIPE Shares and the PIPE Warrant Shares as Registrable Securities thereunder.
+Added: Notes Payable
+Added: On November 30, 2021 (the “Closing
+Added: Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and
+Added: Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P.
+Added: (“AVOPI”) and
+Added: Avenue Venture Opportunities Fund II, L.P.
+Added: (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital
+Added: loans in an aggregate commitment amount of up to $20 million (the “Loan”).
+Added: On the Closing Date, $15 million of the Loan
+Added: was funded (“Tranche 1”).
+Added: The Loan provided for an additional $5 million to be available to the Company on or prior to
+Added: September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical
+Added: trials, which were not achieved.
+Added: The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00 %
+Added: plus the prime rate as reported in The Wall Street Journal and (b) 10.75%.
The prime rate at June 30, 2024 was 8.50 % .
−Removed: The Loan is secured
−Removed: by a lien upon and security interest in all of the Companys assets, including intellectual property, subject to agreed exceptions.
+Added: The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property,
+Added: subject to agreed exceptions.
The maturity date of the Loan is December 1, 2024.
−Removed: Loan Agreement requires monthly interest-only payments during the first eighteen months of the term of the Loan.
−Removed: Following the interest-only
−Removed: period, the Company will make equal monthly payments of principal, plus accrued interest, until the Loans maturity date when all
−Removed: remaining principal and accrued interest is due.
−Removed: If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in
−Removed: an amount equal to 3.0% of the principal amount of the Loan that is prepaid during the interest-only period;
−Removed: and (b) a prepayment fee
−Removed: in an amount equal to 1.0% of the principal amount of the Loan that is prepaid after the interest-only period.
−Removed: At the Loans maturity
−Removed: date, or on the date of the prepayment of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment
−Removed: amount, the sum of Tranche 1 and Tranche 2.
−Removed: Loan Agreement includes a conversion option to convert up to $5.0 million of the principal amount of the Loan outstanding at the option
−Removed: of Avenue, into shares of the Companys Common Stock at a conversion price of $6.98 per share.
−Removed: the Closing Date, the Company issued to Avenue warrants to purchase 361,002 shares of Common Stock of the Company (the Avenue
−Removed: Warrants) at an exercise price per share equal to $5.82.
+Added: The Loan Agreement required monthly interest-only
+Added: payments during the first eighteen months of the term of the Loan.
+Added: Following the interest-only period, on July 1, 2023, the Company pays
+Added: equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued
+Added: interest is due.
+Added: If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal
+Added: amount of the Loan that is prepaid during the interest-only period;
+Added: and (b) a prepayment fee in an amount equal to 1.0% of the principal
+Added: amount of the Loan that is prepaid after the interest-only period.
+Added: At the Loan’s maturity date, or on the date of the prepayment
+Added: of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and
+Added: Tranche 2, which amounts to $850,000 (the “Loan Premium”).
+Added: The Loan Agreement includes a conversion option to
+Added: convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s
+Added: Common Stock at a conversion price of $69.80 per share (the “Conversion Option”).
+Added: On the Closing Date, the Company issued to Avenue
+Added: warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal
The Avenue Warrants are exercisable until November 30, 2026.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Payable (continued)
−Removed: amount of the carrying value of the notes payable was determined by allocating portions of the outstanding principal of the notes;
−Removed: approximately
−Removed: $ 1.4 million to the fair value of the Avenue Warrants and approximately $ 2.2 million to the fair value of the embedded conversion option.
−Removed: Accordingly, the total amount of unearned discount of approximately $ 3.7 million, the total direct financing cost of approximately $ 390,000
−Removed: and premium of $ 850,000 are recognized on an effective interest method over the term of the Loan.
−Removed: The adjusted effective interest rate
−Removed: The total interest expense of approximately $ 4.3 million for the year ended June 30, 2023, was recognized in the accompanying
−Removed: statements of operations and comprehensive loss and included the interest only payments totaling approximately $ 2.1 million, the amortization of financing costs
−Removed: of approximately $ 170,000 , unearned discount of approximately $ 1.6 million and the accretion of loan premium of approximately $ 422,000 .
−Removed: total interest expense of approximately $ 2.2 million for the year ended June 30, 2022;
−Removed: was recognized in the accompanying statements
−Removed: of operations and comprehensive loss and included the interest only payments totaling approximately $ 952,000 , the amortization of financing costs of approximately
−Removed: $ 99,000 , unearned discount of approximately $934,000 and the accretion of loan premium totaled of approximately $ 165,000 .
−Removed: of June 30, 2023, the remaining principal balance of $15 million under the Loan is payable in 18 monthly equal installments beginning
−Removed: July 1, 2023;
−Removed: for a total of $10.0 million and $5.0 million in the fiscal years ended June 30, 2024 and 2025 respectively.
−Removed: following is a summary of the Note Payable as of June 30, 2023 and June 30, 2022:
−Removed: portion of Notes Payable
+Added: The amount of the carrying value of the notes payable
+Added: was determined by allocating portions of the outstanding principal of the notes, approximately $ 1.4 million, to the fair value of the
+Added: Avenue Warrants, and approximately $ 2.2 million to the fair value of the embedded Conversion Option.
+Added: Accordingly, the total amount of
+Added: unearned discount of approximately $ 3.6 million, the total direct financing cost of approximately $ 390,000 and the Loan Premium of $ 850,000
+Added: are being amortized using the effective interest method over the term of the Loan.
+Added: The adjusted effective interest rate is 27%.
+Added: Total interest expense for the year ended June 30,
+Added: 2024 was approximately $ 2.9 million on the accompanying statement of operations and comprehensive loss.
+Added: Interest expense was comprised
+Added: of interest incurred on the outstanding principal of the loan of approximately $ 1.5 million, amortization of financing costs of approximately
+Added: $ 109,000 , amortization of the unearned discount of $ 1.0 million, and the accretion of the Loan Premium of approximately $ 237,000 .
+Added: Total interest expense for the year ended June 30,
+Added: 2023 was approximately $ 4.3 million on the accompanying statement of operations and comprehensive loss.
+Added: Interest expense was comprised
+Added: of interest incurred on the outstanding principal of the loan of approximately $ 2.1 million, amortization of financing costs of approximately
+Added: $ 170,000 , amortization of the unearned discount of $1.6 million, and the accretion of the Loan Premium of approximately $ 422,000 .
+Added: As of June 30, 2024, the remaining principal balance
+Added: of $ 5.0 million under the Loan is payable in 6 monthly equal installments.
+Added: For the year ended June 30, 2024, the Company paid back $ 10
+Added: million, of the original loan of $15 million.
+Added: Notes Payable (continued)
+Added: The following is a summary of the Notes Payable as of June 30, 2024 and
+Added: Current portion of Notes Payable
Schedule of note payable
2 unchanged sentences
Current portion of Notes Payable
−Removed: Less debt financing costs
−Removed: Less unearned discount
+Added: debt financing costs
+Added: unearned discount
( 1,023,145 )
−Removed: Plus accretion of loan premium
−Removed: Current portion of Notes Payable, net of financing costs, unearned premiums and
−Removed: portion of Notes Payable
+Added: accretion of Loan Premium
+Added: Current portion of Notes Payable, net of financing costs, unearned premium and discount
+Added: Non-current portion of Notes Payable
June 30, 2024
1 unchanged sentence
Notes Payable
−Removed: Less debt financing costs
−Removed: Less unearned discount
−Removed: ( 2,735,802 )
−Removed: Plus accretion of loan premium
−Removed: Notes Payable, net of the current portion financing costs, unearned premiums
−Removed: future amortization expense and accretion of premium is as follows:
+Added: debt financing costs
+Added: unearned discount
+Added: accretion of Loan Premium
+Added: Notes Payable, net of the current portion financing costs, unearned premium and discount
+Added: Estimated future amortization expense and accretion of Loan Premium is
Schedule of estimated future amortization expense and accretion of premium
1 unchanged sentence
Debt Financing Costs
−Removed: Loan accretion Premium
Year ending June 30,
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Value Measurements
−Removed: June 30, 2023 and 2022, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:
+Added: Fair Value Measurements
+Added: At June 30, 2024 and 2023, the estimated fair value of derivative liabilities
+Added: measured on a recurring basis are as follows:
Schedule of derivative liabilities at fair value
2 unchanged sentences
Derivative liability - Warrants
−Removed: Derivative liability - Conversion option on notes payable
−Removed: Total derivatives
+Added: Derivative liability - Conversion Option
+Added: Total derivative liabilities
Fair Value Measurements at
1 unchanged sentence
Derivative liability - Warrants
−Removed: Derivative liability - Conversion option on note payable
−Removed: Total derivatives
−Removed: following table presents the activity for liabilities measured at fair value using unobservable inputs for the years ended June 30, 2023
+Added: Derivative liability - Conversion option
+Added: Total derivative liabilities
+Added: The following table presents the activity for level 3 liabilities measured
+Added: at fair value using unobservable inputs for the years ended June 30, 2024 and 2023:
Fair value, liabilities measured on recurring basis
−Removed: Derivative liabilities - Warrants
−Removed: Derivative liability - Conversion Option on Convertible Debenture
−Removed: Balance at July 1, 2021
+Added: Derivative liability - Warrants
+Added: Derivative liability - Conversion Option
+Added: Balance at June 30, 2022
Additions to level 3 liabilities
−Removed: Change in fair value of level 3 liability
−Removed: ( 1,261,982 )
−Removed: ( 2,025,436 )
+Added: Change in in fair value of level 3 liabilities
Transfer in and/or out of level 3
1 unchanged sentence
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liability
+Added: Change in in fair value of level 3 liabilities
Transfer in and/or out of level 3
Balance at June 30, 2024
−Removed: fair values of derivative liabilities for the Avenue Warrants and conversion option at June 30, 2023 in the accompanying balance sheet,
−Removed: were approximately $894,000 and approximately $926,000, respectively.
−Removed: The total change in the fair value of the derivative liabilities
−Removed: totaled approximately $1.4 million and $3.3 million for the year ended June 30, 2023, and 2022, respectively;
−Removed: and accordingly, was recorded
−Removed: in the accompanying statements of operations and comprehensive loss.
−Removed: The assumptions used in the Black Scholes model to value the derivative liabilities at June
−Removed: 30, 2023 included the closing stock price of $ 4.31 per share;
−Removed: for the Avenue Warrants, the exercise price of $ 5.82 , remaining term 3.4
−Removed: year, risk free rate of 4.4 % and volatility of 92.0 % ;
−Removed: and for the embedded derivative liability of the conversion option, the conversion
−Removed: price of $ 6.98 ;
−Removed: remaining term 1.4 years, risk free rate of 5.18 % and volatility of 92.0 % .
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Value Measurements (continued)
−Removed: liability – Avenue Warrants
−Removed: Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms
−Removed: of the warrant agreements.
−Removed: Under applicable accounting guidance, stock warrants that are precluded from being indexed to the
−Removed: Companys own stock because of full-rachet and anti-dilution provisions or adjustments to the strike price due to an occurrence
−Removed: of a future event are accounted for as derivative financial instruments.
−Removed: The Avenue Warrants were not considered to be indexed to
−Removed: the Companys own stock, and accordingly, were recorded as a derivative liability at fair value in the accompany balance sheets at June 30, 2023 and 2022.
−Removed: Black Scholes model was used to calculate the fair value of the warrant derivative to bifurcate the warrant derivative amount from the
−Removed: Avenue Loan amount funded.
−Removed: The Avenue Warrants are recorded at their fair values at the date of issuance and remeasured at June 30, 2023.
−Removed: The assumptions used for the fair value calculation at November 30, 2021 included:
−Removed: the closing stock price of $ 6.44 per share;
−Removed: price of $ 5.82 ;
−Removed: a risk free rate of 1.14 % and volatility of 74.4 % .
−Removed: derivative liability – Conversion Option
−Removed: embedded derivative liability represents the optional conversion feature of up to $5.0 million of the outstanding Loan, which meets the
−Removed: definition of a derivative and requires bifurcation from the loan amount.
−Removed: Black Scholes model was used to calculate the fair value of the embedded derivative to bifurcate the embedded derivative amount representing
−Removed: the conversion option from the Loan amount funded.
−Removed: The assumption used for the fair value calculation at November 30, 2021 included:
+Added: The fair values of derivative liabilities for the
+Added: Avenue Warrants and Conversion Option at June 30, 2024 in the accompanying balance sheet, were approximately $3,800 and approximately
+Added: zero, respectively.
+Added: The total change in the fair value of the derivative liabilities totaled approximately $(1.8) million and $1.4 million
+Added: for the years ended June 30, 2024, and 2023, respectively;
+Added: and accordingly, was recorded in the accompanying statements of operations
+Added: and comprehensive loss.
+Added: The assumptions used in the Black Scholes model to value the derivative liabilities at June 30, 2024 included
the closing stock price of $ 4.00 per share;
−Removed: the conversion price of $ 6.98 ;
−Removed: risk free rate of 0.81 % and volatility of 76.85 % .
−Removed: of June 30, 2023, investments in U.S.
−Removed: Treasury Bills were valued through use of quoted prices and are classified as Level 1.
−Removed: The following
−Removed: table presents information about our assets that are measured at fair value on a recurring basis using the above input categories.
+Added: for the Avenue Warrants, the exercise price of $ 58.20 , remaining term 2.4 year, risk free
+Added: rate of 4.6 % and volatility of 82.0 % ;
+Added: and for the Conversion Option, the conversion price of $ 69.80 ;
+Added: remaining term of 5 months, risk
+Added: free rate of 5.38 % and volatility of 91.0 % .
+Added: Derivative liability – Avenue Warrants
+Added: The Avenue Warrants were not considered to be indexed
+Added: to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying balance sheets
+Added: at June 30, 2024 and 2023.
+Added: The Black Scholes model was used to calculate the
+Added: fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded.
+Added: The Avenue Warrants
+Added: are recorded at their fair values at the date of issuance and remeasured at each subsequent reporting period end date.
+Added: Fair Value Measurements (continued)
+Added: Embedded derivative liability – Conversion
+Added: The Conversion Option is accounted for as an embedded
+Added: derivative liability and required bifurcation from the Loan amount.
+Added: The Black Scholes model was used to calculate the fair value of the
+Added: Conversion Option to bifurcate it from the Loan.
+Added: Financial assets
+Added: As of June 30, 2024, investments in U.S.
+Added: Treasury Bills were valued through
+Added: use of quoted prices and are classified as Level 1.
+Added: The following table presents information about our assets that are measured at fair
+Added: value on a recurring basis using the above input categories.
Measured at fair value on a recurring basis
1 unchanged sentence
June 30, 2024
−Removed: Treasury Bills due in 3 months or less
−Removed: Treasury Bills due in 3 - 6 months
+Added: Treasury Bills due in 3 months or less at purchase
Fair Value Measurements at
June 30, 2023
−Removed: Treasury Bills due in 3 months or less
−Removed: Treasury Bills due in 3 - 6 months
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: following table summarizes the activity relating to the Companys stock options for the years ended June 30, 2023 and 2022:
+Added: Treasury Bills due in 3 months or less at purchase
+Added: Treasury Bills due in 3 - 6 months at purchase
+Added: Equity Transactions
+Added: Issuance of common stock for cash
+Added: On August 31, 2022, the Company entered into a Controlled
+Added: Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
+Added: Riley Securities, Inc.
+Added: (collectively,
+Added: the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock
+Added: through the Agents, subject to the terms and conditions of the Sales Agreement.
+Added: On April 6, 2023, the Company and B.
+Added: Riley Securities,
+Added: mutually agreed to terminate B.
+Added: Riley Securities, Inc.’s role as a sales agent under the Sales Agreement.
+Added: During the year ended
+Added: June 30, 2024, the Company sold 333,749 shares of common stock under the Sales Agreement for total net proceeds of approximately $ 9.3
+Added: million after deducting 3 % commissions and expenses of approximately $ 377,000 .
+Added: During the year ended June 30, 2023, the Company sold 753,925
+Added: shares of common stock under the Sales Agreement for total net proceeds of approximately $ 49.5 million after 3 % commissions and expenses
+Added: of approximately $ 2.0 million.
+Added: On March 6, 2024, the Company closed a best efforts
+Added: public offering (the “Offering”) of 1,500,000 shares (the “Shares”) of its common stock, par value $ 0.001 per
+Added: share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 600,000 shares of Common
+Added: Stock, and warrants to purchase up to 1,050,000 shares of Common Stock (the “Common Warrants”) at a combined public offering
+Added: price of $ 10.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
+Added: Warrants have an exercise price of $15.00 per share and are immediately exercisable upon issuance for a period of five years following
+Added: the date of issuance.
+Added: The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement
+Added: agent fees and offering expenses of approximately $2.5 million, resulting in net proceeds of approximately $18.5 million.
+Added: Additionally,
+Added: upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 105,000 shares
+Added: of Common Stock exercisable at a per share price of $12.50, which was equal to 125% of the public offering price per share.
+Added: The Placement
+Added: Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.
+Added: The Pre-Funded Warrants were
+Added: exercised shortly after issuance and the 600,000 shares of Common Stock were issued during the year ended June 30, 2024.
+Added: Equity Transactions (continued)
+Added: Issuance of common stock for services
+Added: On April 6, 2023, the Company awarded 5,000 shares
+Added: of Common Stock to a vendor as part of their fees in exchange for services.
+Added: The fair value of the Common Stock at the date of issuance
+Added: was $ 74.50 per share.
+Added: The stock-based compensation expense related to this Common Stock issuance was $ 372,500 .
+Added: On May 10, 2024, the Company awarded 15,000 shares
+Added: of Common Stock to a vendor as part of their fees in exchange for services.
+Added: The fair value of the Common Stock at the date of issuance
+Added: was $ 4.86 per share.
+Added: The stock-based compensation expense related to this Common Stock issuance was $ 72,900 .
+Added: Stock Options
+Added: The following table summarizes the activity relating to the Company’s
+Added: stock options for the years ended June 30, 2024 and 2023:
Schedule of summarizes the activity relating to the Company’s stock options
−Removed: Weighted-Average
−Removed: Exercise Price
−Removed: Remaining Average Contractual Term
−Removed: Intrinsic Value
−Removed: at June 30, 2021
−Removed: at June 30, 2022
−Removed: at June 30, 2023
−Removed: at June 30, 2023
−Removed: fair value of each option grant on the date of grant is estimated using the Black-Scholes option.
−Removed: The pricing model reflects the following
−Removed: weighted-average assumptions for the years ended June 30, 2023 and 2022:
+Added: Weighted-Average Exercise Price
+Added: Weighted Remaining Average Contractual Term
+Added: Aggregate Intrinsic Value
+Added: Outstanding at June 30, 2022
+Added: Options Expired
+Added: Options Canceled
+Added: Options Exercised
+Added: Outstanding at June 30, 2023
+Added: Options Expired
+Added: Options Canceled
+Added: Outstanding at June 30, 2024
+Added: Exercisable at June 30, 2024
+Added: The fair value of each option grant on the date of
+Added: grant is estimated using the Black-Scholes model.
+Added: The following weighted-average assumptions were utilized for the years ended:
Schedule of assumptions used
5 unchanged sentences
Dividend Yield
−Removed: volatility is based on the historical volatilities of three comparable companies of the daily closing price of their respective Common
−Removed: Stock and the expected life of options is based on historical data with respect to employee exercise periods.
−Removed: The Company accounts for
−Removed: forfeitures as they are incurred.
−Removed: Company recorded stock option-based compensation expense of approximately $ 4.2 million and $ 5.8 million for the years ended June 30,
−Removed: 2023 and 2022, respectively.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Transactions (continued)
−Removed: following is a summary of stock options outstanding and exercisable by exercise price as of June 30, 2023:
−Removed: Schedule of summary of stock options outstanding and exercisable
−Removed: Average Contract Life
−Removed: of Common Stock through exercise of Stock Options and Warrants
−Removed: In December 2022, the Company issued 22,082 shares of Common Stock pursuant to a cashless exercise of stock options
−Removed: to purchase 99,300 shares at an average exercise price of $ 7.64 .
−Removed: November 2022, the Company issued 800 shares of Common Stock pursuant to a cash exercise of stock options to purchase 800 shares at an
−Removed: average exercise price of $ 2.80 per share.
−Removed: October 2022, the Company issued 3,590 shares of Common Stock pursuant to a cashless exercise of warrants to purchase 8,000 shares at
−Removed: an average exercise price of $ 2.25 .
−Removed: May 2023, the Company issued 481 shares of Common Stock pursuant to a cashless exercise of stock options to purchase 800 shares at an
−Removed: average exercise price of $ 3.13 .
−Removed: Issuance of common stock for cash
−Removed: During the three months ended September 30, 2021,
−Removed: the Company issued 2,592,000 of its Class A common stock at $8.00 per share in connection with its registered public offering of approximately
−Removed: $ 18.5 million, net of issuance costs of approximately $ 2.2 million.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Transactions (continued)
−Removed: On August 31, 2022, the Company entered into a
−Removed: Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
−Removed: Riley Securities,
−Removed: (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s
−Removed: common stock through the Agents, subject to the terms and conditions of the Sales Agreement.
−Removed: On April 6, 2023, the Company and B.
−Removed: Securities, Inc.
−Removed: mutually agreed to terminate B.
−Removed: Riley Securities, Inc.’s role as a sales agent under the Sales Agreement.
−Removed: the year ended June 30, 2023, the Company sold 7,539,254 shares of common stock under the Sales Agreement for total net proceeds of $ 49.5
−Removed: million after 3% commissions and expenses of approximately $ 2.0 million.
−Removed: of restricted stock units for services
−Removed: August 20, 2021, the Company awarded 58,759 RSUs to the Companys President and CEO under
−Removed: the Companys 2019 Omnibus Incentive Equity Plan (the 2019 Omnibus Plan) as his salary for the period from April
−Removed: 27, 2021, the date of his appointment, through December 31, 2021.
−Removed: The number of RSUs awarded was based on a prorated annual base salary
−Removed: of $600,000 at a 10% discount to the grant date fair value of $ 7.74 per share of the Companys Common Stock.
−Removed: Each RSU awarded to
−Removed: the CEO entitled him to receive one share of Common Stock upon vesting.
−Removed: A total of 15,339 RSUs (representing the pro rata portion of
−Removed: the RSU award for the period from April 27, 2021 to June 30, 2021) vested at the grant date, 21,710 vested at September 30, 2021 and
−Removed: the remaining 21,710 vested at December 31, 2021.
−Removed: Accordingly, the CEO was issued an aggregate of 58,759 shares of Common Stock over
−Removed: the vesting period of the RSUs.
−Removed: The stock-based compensation expense related to these RSUs was $ 384,456 for the year ended June 30, 2022.
−Removed: June 21, 2022, the Company awarded 124,520 RSUs to the President and CEO under the Companys 2019 Omnibus Plan.
−Removed: Each RSU awarded
−Removed: to the CEO entitles him to receive one share of Common Stock upon vesting.
−Removed: The RSUs vest in three equal annual installments beginning on the first grant anniversary date.
−Removed: 41,506 RSUs vested in June 2023 at a fair value of $ 5.90 per share of the Companys Common
−Removed: The stock-based compensation expense related to these RSUs was approximately $ 243,000 and $ 1,754 for the years ended June 30, 2023, and 2022, respectively.
−Removed: November 23, 2022, the Company awarded 381,976 RSUs to certain employees and a consultant, with a grant date fair value of $ 6.12 per
−Removed: 25% of these RSUs vested on the grant date and the remaining RSUs vest in three equal installments over three years
−Removed: beginning on the first anniversary of the grant date.
−Removed: For the year ended June 30, 2023, the stock-based compensation expense
−Removed: related to these RSUs was $ 584,424 .
−Removed: On February 16, 2023, the Company delivered the vested portion of the RSUs and issued 72,612
−Removed: shares of Common Stock net of 25 % withholding.
−Removed: 22,880 shares issued to employees were withheld in Treasury stock in exchange for payment
−Removed: of withholding tax on behalf of the employees.
−Removed: November 23, 2022, the Company issued equity awards for the Board of Directors annual compensation.
−Removed: Four directors received RSUs
−Removed: to purchase a total of 155,636 shares of Common Stock at the grant date fair value of $ 6.12 per share, a total cost of $ 952,492 recognized
−Removed: as stock compensation in the year ended June 30, 2023.
−Removed: Three directors received stock options to purchase 195,000 shares
−Removed: of Common Stock at an exercise price of $ 6.12 per share, the grant date fair value.
−Removed: The total stock compensation cost of stock options
−Removed: of $ 791,700 was recognized in the year ended June 30, 2023.
−Removed: The equity awards vest every three months beginning from the
−Removed: last annual shareholders meeting on November 9, 2022, on February 9, 2023, May 9, 2023, August 9, 2023 and earlier of November
−Removed: 9, 2023 or the next annual shareholders meeting.
−Removed: While the agreements contain certain contractual vesting terms, there are circumstances
−Removed: where the vesting can be accelerated that is not within the Companys control and as a result, for accounting purposes, the awards
−Removed: are assumed to have been fully vested on the grant date, accordingly, the Company recognized the total compensation cost of $ 1,744,192
−Removed: on November 23, 2022.
−Removed: On February 9, 2023, the Company delivered the vested portion and issued 39,088 shares of Common Stock.
−Removed: On May 9, 2023, the Company delivered the vested portion and issued 39,088 shares of Common Stock.
−Removed: June 20, 2023, the Company awarded 149,500 RSUs to the President and CEO under the Companys 2019 Omnibus Plan.
−Removed: Each RSU awarded
−Removed: to the CEO entitles him to receive one share of Common Stock upon vesting.
−Removed: The RSUs vest in three equal annual installments beginning on the first grant date anniversary.
−Removed: Compensation expense related to vested RSUs for
−Removed: the year ended June 30, 2023 was approximately $1.8 million.
−Removed: following table summarizes vesting of restricted common stock:
+Added: The Company recorded stock based compensation expense
+Added: relating to the vesting of stock options of approximately $ 2.8 million and $ 4.2 million for the years ended June 30, 2024 and 2023, respectively.
+Added: Issuance and modification of restricted stock units and options:
+Added: On June 21, 2022, the Company awarded 12,452 restricted
+Added: stock units (“RSUs”) to the President and CEO under the Company’s 2019 Omnibus Plan.
+Added: Each RSU awarded to the CEO entitles
+Added: him to receive one share of Common Stock upon vesting.
+Added: The RSUs vest in three equal annual installments beginning on the first anniversary
+Added: 4,151 and 4,151 RSUs vested in June 2023 and 2024, respectively.
+Added: On November 23, 2022, the Company awarded 38,198 RSUs
+Added: to certain employees and a consultant, with a grant date fair value of $ 61.20 per share.
+Added: 25% of these RSUs vested on the grant date and
+Added: the remaining RSUs vest in three equal installments over three years beginning on the first anniversary of the grant date.
+Added: year ended June 30, 2023, 9,550 of these RSUs vested, of which 2,288 shares were withheld in Treasury stock in exchange for payment of
+Added: withholding tax on behalf of the employees.
+Added: Equity Transactions (continued)
+Added: On November 23, 2022, the Company issued equity awards
+Added: for the board of directors’ annual compensation.
+Added: Four directors received 15,564 RSUs with a grant date fair value of $ 61.20 per
+Added: In addition, three directors received stock options to purchase 19,500 shares of common stock at an exercise price of $ 61.20 per
+Added: share with a grant date fair value of $40.60 per share.
+Added: The equity awards vest quarterly on February 23, 2023, May 23, 2023, August 23,
+Added: 2023 and earlier of November 23, 2023 or the next annual shareholders’ meeting.
+Added: During the year ended June 30, 2024, 7,746 of these
+Added: These RSUs and options contain certain contractual vesting terms where the vesting can be accelerated outside the Company’s
+Added: control and as a result, for accounting purposes, are assumed to have been fully vested on the grant date, and accordingly, the Company
+Added: recognized the total compensation cost of $ 1,744,192 on November 23, 2022.
+Added: On November 9, 2023, the Company issued equity awards
+Added: for the board of directors’ annual compensation.
+Added: Four directors received 18,270 RSUs with a grant date fair value of $ 30.10 per
+Added: In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $ 30.10 per
+Added: share with a grant date fair value of $18.30 per share.
+Added: The equity awards vest quarterly on February 9, 2024, May 9, 2024, August 9, 2024
+Added: and earlier of November 9, 2024 or the next annual shareholders’ meeting.
+Added: During the year ended June 30, 2024, 4,568 of these RSUs
+Added: In December 2023, the Company terminated five employees
+Added: and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
+Added: The modifications
+Added: included the acceleration of certain stock option awards to purchase a total of 5,623 shares of common stock (“Accelerated Options”),
+Added: effective on the December Separation Date, as defined in severance agreement (“Separation Date”), and extended the expiration
+Added: date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options held by the terminated
+Added: employees as of the Separation Date.
+Added: Accordingly, the Company remeasured the Accelerated Options based on the stock price of $15.40 per
+Added: share at the close on the Separation Date and a one-year extension of the term.
+Added: The net adjustment for the modification was a net credit
+Added: of $127,199 and was recognized as an adjustment to stock compensation expense during the year ended June 30, 2024.
+Added: Additionally, 1,030 vesting RSUs were accelerated
+Added: as of the Separation date.
+Added: The modified RSUs were remeasured based on the stock price of $15.40 per share at close on the Separation Date
+Added: and $15,865, was recorded to additional in stock-based compensation for the year ended June 30, 2024 as a result of the modification.
+Added: In connection with the separation, the Company canceled
+Added: 18,396 unvested stock options and 1,030 unvested RSUs.
+Added: Additionally, the Company canceled an additional 13,416 unvested stock options
+Added: for employees that voluntarily left the company.
+Added: In June 2023, the Company issued 14,950 RSUs with
+Added: a grant date fair value of $ 41.10 per share to the President and CEO under the Company’s 2019 Omnibus Plan.
+Added: The RSUs vest in three
+Added: equal annual installments beginning on the first anniversary grant date.
+Added: 4,983 RSUs vested in June 2024.
+Added: In June 2024, the Company issued 85,800 RSUs to employees,
+Added: with a grant date fair value of $ 4.74 per share.
+Added: The RSUs vested on the grant date.
+Added: The Company delivered the vested portion of the RSU’s
+Added: and issued 85,800 shares of Common Stock, of which 21,450 shares were withheld in Treasury stock in exchange for payment of withholding
+Added: tax on behalf of the employees.
+Added: The following table summarizes vesting of restricted
Schedule of vesting of restricted common stock
4 unchanged sentences
Unvested at June 30, 2024
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Transactions (continued)
−Removed: of Shares for Services
−Removed: April 6, 2023, the Company awarded 50,000 shares of Common Stock to a vendor as part of their fees in exchange for services.
−Removed: value of the Common Stock at the date of issuance was $ 7.45 per share.
−Removed: The stock-based compensation expense related to this Common Stock
−Removed: issuance was $ 372,500 .
−Removed: of Stock Options under the 2019 Omnibus Plan.
−Removed: August 20, 2021, the Company granted stock options to purchase 1,365,835 shares of Common Stock to the executive management team.
−Removed: 20% of the shares underlying the options awarded vested on the grant date, and the remaining 80% will vest equally over a 5 -year
−Removed: period, on the first, second, third, fourth and fifth anniversary of the grant date.
−Removed: The exercise price of the options is $ 7.74 per share,
−Removed: the grant date fair value of the stock, and the options terminate on the earlier of the tenth anniversary of the grant date or the date
−Removed: on which the options have been fully exercised.
−Removed: April 5, 2022, the Company granted stock options to purchase 755,000 shares of Common Stock to the independent directors of the board
−Removed: as compensation for services at an exercise price of $ 5.04
−Removed: per share, the grant date fair value.
−Removed: of the shares underlying the options awarded
−Removed: vested on the grant date, and the remaining 75 %
−Removed: vest ratably over three 3
−Removed: years on the first, second, and third anniversary
−Removed: of the grant date.
−Removed: The options terminate on the earlier of the fifth anniversary of the grant date or the date as of Xwhich the options
−Removed: are fully exercised.
−Removed: to a former employee Separation Agreement, dated April 11, 2022, the Company modified a former employees stock option award granted
−Removed: on August 20, 2021, pursuant to the 2019 Omnibus Plan (2021 Options Grant).
−Removed: Pursuant to the terms of the Separation Agreement,
−Removed: effective on July 8, 2022 (the Separation Date), the Company accelerated the vesting of options scheduled to vest on the
−Removed: first and second anniversary of the grant date as deemed vested (Accelerated Options) and after giving effect to the Accelerated
−Removed: Options, extended the exercise period of the total vested outstanding and unexercised options (totaling 74,500 options) to one year following
−Removed: the Separation Date.
−Removed: The unvested portion of the 2021 Option Grant (totaling 49,667 options) was canceled.
−Removed: The modification was remeasured
−Removed: as of July 8, 2022, and the incremental difference totaled $181,154, net credit, due to the original exercise price of $7.74 being greater
−Removed: than the stock price of $1.80 on the remeasurement date, and accordingly was recognized on July 8, 2022.
−Removed: June 21, 2022, the Company granted stock options to purchase 124,520
−Removed: shares of Common Stock to the CEO.
−Removed: The options vest in three equal annual installments beginning on the first grant date anniversary.
−Removed: The exercise price is $ 1.69
−Removed: per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.
−Removed: the fiscal year ended June 30, 2022, the Company granted stock options to purchase a total of 479,334 shares of Common Stock in connection
−Removed: with compensation packages of seven new employees.
−Removed: The exercise prices were based on each of respective the grant date fair values with
−Removed: vesting terms over a five years period and the options terminate on the earlier of tenth grant date anniversary or the date of which
−Removed: the options are fully exercised.
−Removed: June 7, 2023, the Company granted stock options to purchase 148,000 shares of Common Stock to the certain employees.
−Removed: the shares underlying the options awarded vested on the grant date, and the remaining 80 % will vest in four equal annual installments
−Removed: beginning, on the first grant date anniversary.
−Removed: The exercise price of the options is $ 5.78 per share, the grant date fair value of the
−Removed: stock, and the options terminate on the earlier of the tenth grant date anniversary or the date of which the options are fully exercised.
−Removed: the fiscal year ended June 30, 2023, the Company granted stock options to purchase a total of 286,167 share of Common Stock in connection
−Removed: with compensation packages of three new employees.
−Removed: The exercise prices were as of each respective grant date fair value with vesting
−Removed: terms over five year period and the options terminate on the earlier of tenth grant date anniversary or the date of which the options
−Removed: are fully exercised.
−Removed: of Stock Options
−Removed: August 27, 2021, the Chief Executive Officer forfeited unvested stock options to purchase up to 73,125 shares of Common Stock that were
−Removed: previously granted to him as compensation as an independent director of the Board of Directors.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: Transactions (continued)
−Removed: following table summarizes the warrants activity during the years ended June 30, 2023 and 2022:
+Added: Equity Transactions (continued)
+Added: The total stock-based compensation expense from restricted
+Added: stock units for the year ended June 30, 2024 and 2023 was approximately $ 1.8 million and $ 1.8 million, respectively.
+Added: Issuance of Common Stock through exercise of Stock Options and Warrants
+Added: In December 2022, the Company issued 2,209 shares
+Added: of Common Stock pursuant to a cashless exercise of stock options to purchase 9,930 shares at an average exercise price of $ 76.40 .
+Added: In November 2022, the Company issued 80 shares of
+Added: Common Stock pursuant to a cash exercise of stock options to purchase 80 shares at an average exercise price of $ 28.00 per share.
+Added: In October 2022, the Company issued 359 shares of
+Added: Common Stock pursuant to a cashless exercise of warrants to purchase 800 shares at an average exercise price of $ 22.50 .
+Added: In May 2023, the Company issued 48 shares of Common
+Added: Stock pursuant to a cashless exercise of stock options to purchase 80 shares at an average exercise price of $ 31.30 .
+Added: Issuance of Stock Options under the 2019 Omnibus Plan.
+Added: Pursuant to a former employee’s Separation Agreement,
+Added: dated April 11, 2022, the Company modified their stock option award granted on August 20, 2021, pursuant to the 2019 Omnibus Plan (“2021
+Added: Options Grant”).
+Added: Pursuant to the terms of the Separation Agreement, effective July 8, 2022 (the “Separation Date”),
+Added: the Company accelerated the vesting of options scheduled to vest on the first and second anniversary of the grant date as deemed vested
+Added: (“Accelerated Options”) and after giving effect to the Accelerated Options, extended the exercise period of the total vested
+Added: outstanding and unexercised options (totaling 7,450 options) to one year following the Separation Date.
+Added: The unvested portion of the 2021
+Added: Option Grant (totaling 4,967 options) was canceled.
+Added: The modification was remeasured as of July 8, 2022, and the incremental difference
+Added: in fair value resulted in a net credit to stock based compensation expense of $181,154, due to the original exercise price of $77.40 being
+Added: greater than the stock price of $18.00 on the remeasurement date, and accordingly was recognized on July 8, 2022.
+Added: On June 7, 2023, the Company granted stock options
+Added: to purchase 14,800 shares of Common Stock to certain employees.
+Added: 20 % of the shares underlying the options awarded vested on the grant date,
+Added: and the remaining 80 % will vest in four equal annual installments beginning, on the first grant date anniversary.
+Added: The exercise price of
+Added: the options is $ 57.80 per share, the grant date fair value and the options terminate on the earlier of the tenth grant date anniversary
+Added: or the date of which the options are fully exercised.
+Added: During the fiscal year ended June 30, 2023, the Company
+Added: granted stock options to purchase a total of 28,617 shares of Common Stock in connection with compensation packages of three new employees.
+Added: The exercise prices were set at the grant date fair value with vesting terms over a five year period and the options terminate on the
+Added: earlier of tenth grant date anniversary or the date of which the options are fully exercised.
+Added: On October 3, 2023, the Company granted stock options
+Added: to purchase 21,117 shares of Common Stock to new hire employees.
+Added: 20 % of the shares underlying the options awarded vest on the one-year
+Added: anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter.
+Added: exercise price of the options is $ 34.10 , the grant date fair value, and the options terminate on the earlier of the tenth grant date anniversary
+Added: or the date of which the options are fully exercised.
+Added: In June 2024, the Company granted stock options to
+Added: purchase 115,800 shares of Common Stock to employees.
+Added: 33 % of the shares underlying the options awarded vest on the grant date, and the
+Added: remaining 67 % will vest over 2 years on first and second anniversary of the grant date.
+Added: The exercise price of the options is $ 4.70 , the
+Added: grant date fair value, and the options terminate on the earlier of the tenth grant date anniversary or the date of which the options are
+Added: fully exercised.
+Added: Equity Transactions (continued)
+Added: Stock Warrants
+Added: The following table summarizes the warrants activity during the years ended
+Added: June 30, 2024 and 2023:
Summary of warrants activity
6 unchanged sentences
Outstanding and exercisable at June 30, 2024
−Removed: total warrants outstanding at June 30, 2023 expire in the following fiscal years ending June 30 as follows:
−Removed: 101,380 in 2025;
−Removed: 35,175 expire
−Removed: and 7,633,730 in 2027.
−Removed: Company paid an annual rent of $2,200 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 897603.
−Removed: The rental agreement
−Removed: is for a one-year term and commenced on October 1, 2022.
−Removed: February 26, 2022, the Companys San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122.
−Removed: The term for the new office
−Removed: lease is 38 months and commenced on March 1, 2022.
−Removed: The monthly base rate of $4,175 began June 1, 2022, with annual increases of
−Removed: three percent.
−Removed: operating lease expense of approximately $ 52,000 and $ 89,000 for the year ended June 30, 2023 and 2022, respectively;
−Removed: were included in
−Removed: the accompanying statements of operations and comprehensive loss.
−Removed: right-of-use asset, net and current and non current portion of the operating lease liabilities included in the accompany balance sheets
−Removed: at June 30 follows:
−Removed: Schedule of balance sheet information related to leases
−Removed: lease, right-of-use asset, net
−Removed: portion of operating lease liabilities
−Removed: lease liabilities, net of current portion
−Removed: operating lease liabilities
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
+Added: Of the above warrants outstanding at June 30, 2024,
+Added: 10,138 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the fiscal
+Added: year ending June 30, 2027 and 1,155,000 expire in the fiscal year ending June 30, 2029.
+Added: Office Leases
+Added: The Company pays an annual rent of $2,200 for its
+Added: headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
+Added: The rental agreement was for a one-year term, commenced on October
+Added: 1, 2022 and has been subsequently renewed for another year at the same rate.
+Added: The Company’s San Diego office lease at 5090
+Added: Shoreham Place Suite 212, San Diego, CA 92122 which commenced on March 1, 2022, was for a term of 38 months with a base monthly rate of
+Added: $4,300, and annual increases of three percent.
+Added: In February 2024, the Company amended the lease agreement which allowed the Company to
+Added: vacate the then current space and move to a larger space at Suite 206.
+Added: The current monthly base rate for the new office space is $9,685,
+Added: with an annual increase of four percent.
+Added: The term for the new office lease is 60 months and commenced on February 12, 2024.
+Added: that was in place for the 5090 Shoreham Place Suite 212 office was effectively extinguished upon the commencement of the new office space
+Added: lease on February 12, 2024, resulting in the write off of the corresponding remaining right-of-use asset and operating lease liability
+Added: of $ 56,909 and $ 62,124 , respectively, and a gain to selling, general and administrative expenses of $ 5,215 for the year ended June 30,
+Added: Total operating lease expense for the years ended
+Added: June 30, 2024 and 2023 of approximately $ 78,000 and $ 52,000 , respectively were included in the accompanying statements of operations and
+Added: comprehensive loss as a component of selling, general and administrative expenses.
+Added: The right-of-use asset, net and current and non-current
+Added: portion of the operating lease liabilities included in the accompanying balance sheets are as follows:
Leases (continued)
−Removed: June 30, 2023, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
−Removed: Schedule of future estimated minimum lease payments under non-cancelable operating leases
−Removed: ending June 30, 2023
−Removed: minimum lease payments
−Removed: amount representing interest
−Removed: value of future minimum lease payments
−Removed: current portion of operating lease liabilities
−Removed: lease liabilities, net of current portion
−Removed: cash paid for amounts included in the measurement of lease liabilities were $ 50,600 and $ 4,175 for the years ended June 30, 2023 and
−Removed: 2022, respectively.
−Removed: weighted average remaining lease term and discount rate as of June 30, 2023, and 2022 were as follows:
+Added: Schedule of deferred tax assets
+Added: June 30, 2024
+Added: June 30, 2023
+Added: Operating lease, right-of-use asset, net
+Added: Current portion of operating lease liability
+Added: Operating lease liability, net of current portion
+Added: Total operating lease liability
+Added: At June 30, 2024, the future estimated minimum lease payments under non-cancelable
+Added: operating leases are as follows:
+Added: Schedule of future estimated minimum lease payments
+Added: under non-cancelable operating leases
+Added: Year ending June 30,
+Added: Total minimum lease payments
+Added: Less amount representing interest
+Added: Present value of future minimum lease payments
+Added: Less current portion of operating lease liability
+Added: Operating lease liability, net of current portion
+Added: Total cash paid for amounts included in the measurement of lease liabilities
+Added: were $ 83,910 and $ 50,600 for the years ended June 30, 2024 and 2023, respectively.
+Added: The weighted average remaining lease term and discount
+Added: rate as of June 30, 2024 and 2023 were as follows:
Schedule of weighted average remaining lease term and discount rate
−Removed: average remaining lease term (Years)
−Removed: average discount rate
−Removed: and Contingencies
−Removed: to the Agreement and Plan of Merger entered into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics,
−Removed: Inc., the Company is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared
−Removed: by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
−Removed: to the Technology Transfer Agreement entered into on July 25, 2016, by and between the Company and the University of Padova (Italy),
−Removed: the Company is obligated to pay a low single digit royalty on net sales of all terlipressin products covered by U.S.
−Removed: and any future foreign issuances, capped at a maximum of $200,000 per year.
−Removed: August 1, 2021, the Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code
−Removed: (the 401K Plan) pursuant to which, all employees meeting eligibility requirements are able to participate.
−Removed: to certain limitations in the Internal Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax
−Removed: salary reduction basis and the Company will match 5% of the first 5% of an employees contributions to the 401K Plan., The Company
−Removed: made contributions of approximately $ 171,900 and $ 121,000 , for the years ended June 30, 2023 and 2022, respectively.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2023 and 2022
−Removed: components of the Companys deferred tax assets (liabilities) are as follows:
+Added: June 30, 2024
+Added: June 30, 2023
+Added: Weighted average remaining lease term (Years)
+Added: Operating lease
+Added: Weighted average discount rate
+Added: Operating lease
+Added: Commitments and Contingencies
+Added: Royalty Agreements
+Added: Pursuant to the Agreement and Plan of Merger entered
+Added: into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated to pay
+Added: a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members,
+Added: PharmaIn Corporation, and The Barrett Edge, Inc.
+Added: Pursuant to the Technology Transfer Agreement entered
+Added: into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company is obligated to pay a low single digit
+Added: royalty on net sales of all terlipressin products covered by US patent no.
+Added: 9,655,645 and any future foreign issuances, capped at a maximum
+Added: of $200,000 per year.
+Added: Shareholder class action complaint
+Added: On January 19, 2024, a purported shareholder class action complaint,
+Added: captioned Eric Olmstead v.
+Added: 3:24-cv-00035, was filed in the U.S.
+Added: District Court for the District of
+Added: Nevada, naming the Company and certain of its officers as defendants.
+Added: On February 22, 2024, a second, related putative securities class
+Added: action was filed in the same court asserting similar claims against the same defendants, captioned Way v.
+Added: 2:24-cv-00361.
+Added: On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc.
+Added: Securities Litigation ,
+Added: 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.
+Added: On June 21, 2024, the lead plaintiff filed
+Added: an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the
+Added: Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of
+Added: bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a)
+Added: of the Exchange Act, and Rule 10b-5 promulgated thereunder.
+Added: The class action is on behalf of purchasers of the Company’s
+Added: securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages on behalf of the putative
+Added: class and an award of costs and expenses, including attorney’s fees.
+Added: The defendants filed a motion to dismiss the amended complaint
+Added: on August 21, 2024.
+Added: The Company believes the lawsuit is without merit
+Added: and intends to defend the case vigorously.
+Added: At this early stage of the proceedings, the Company is unable to make any prediction regarding
+Added: the outcome of the litigation.
+Added: No adjustment or accruals have been reflected in the accompanying financial statements.
+Added: Employee Benefit Plan
+Added: On August 1, 2021, the Company began sponsoring an
+Added: employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which,
+Added: all employees meeting eligibility requirements are able to participate.
+Added: Subject to certain limitations in the Internal Revenue Code, eligible employees
+Added: are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the first 5%
+Added: of an employee’s contributions to the 401K Plan.
+Added: The Company made contributions into the plan of approximately $ 153,200 and $ 171,900 ,
+Added: for the years ended June 30, 2024 and 2023, respectively.
+Added: Significant components of the Company’s deferred tax assets (liabilities)
+Added: are as follows:
Schedule of deferred tax assets
−Removed: tax assets (liabilities):
−Removed: loss carryforward
−Removed: based compensation
+Added: June 30, 2024
+Added: June 30, 2023
+Added: Deferred tax assets (liabilities):
+Added: Tax loss carryforward
+Added: Intangible assets
+Added: Stock based compensation
+Added: R&D capitalized
+Added: Valuation Allowance
( 69,643,154 )
( 60,637,938 )
−Removed: deferred tax assets
−Removed: June 30, 2023 and 2022, the Company has recorded a full valuation against its net deferred tax assets of approximately $ 13.6 million
−Removed: and $ 8.0 million, respectively, since in the judgement of management, these assets are not more than likely than not to be realized.
−Removed: The increase in the valuation allowance during the years ended June 30, 2023 and 2022 were approximately, $ 5.6 million and $ 6.0 million, respectively.
−Removed: June 30, 2023, the Company had a Net Operating Loss (NOL) carryforward of approximately $ 168 million.
−Removed: NOLs generated
−Removed: prior to 2018 have expiration dates ranging from 2032 to 2037 .
−Removed: The Company has no current tax expense due to its net losses and a
−Removed: full valuation allowance.
−Removed: Reconciliation
−Removed: of the differences between income tax benefit computed at the federal and state statutory tax rates and the provision for income tax
−Removed: benefit for the years ended June 30, 2023 and 2022 is as follows:
+Added: Net deferred tax assets
+Added: At June 30, 2024 and 2023, the Company has recorded a full valuation
+Added: against its net deferred tax assets of approximately $ 69.6 million
+Added: and $ 60.6 million,
+Added: respectively, since in the judgement of management, these assets are not more than likely to be realized.
+Added: The increase in the
+Added: valuation allowance during the year ended June 30, 2024 was approximately $ 9.0 million.
+Added: At June 30, 2024, the Company had a Net Operating
+Added: Loss (“NOL”) carryforward of approximately $ 184 million.
+Added: NOL’s generated prior to 2018 have expiration dates ranging
+Added: from 2032 to 2037 .
+Added: The Company has no current tax expense due to its net losses and a full
+Added: valuation allowance.
+Added: Reconciliation of the differences between income tax
+Added: benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended June 30, 2024
+Added: and 2023 is as follows:
Schedule of effective income tax rate reconciliation
3 unchanged sentences
Effective tax rate
−Removed: Subsequent to June 30, 2023 the Company sold
−Removed: 336,089 shares of common stock for net proceeds of $ 1.6 million net of 3% commission and expenses totaling approximately $ 50,000 under
−Removed: the Sales Agreement with the Agent.
+Added: Subsequent Events
+Added: On September 25, 2024, the Company closed a best
+Added: efforts public offering (the “September 2024 Offering”) of 1,360,800
+Added: shares of its common stock, par value $ 0.0001
+Added: per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000
+Added: shares of Common Stock, and warrants to purchase up to 1,960,800
+Added: shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 1.53
+Added: per Share, or September Pre-funded Warrant, and the associated September Common Warrant.
+Added: The September Common
+Added: Warrants have an exercise price of $ 1.53
+Added: per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.
+Added: gross proceeds to the Company from the September 2024 Offering were approximately $ 3.0
+Added: million, before deducting placement agent fees and offering expenses of approximately $ 560,000 .
+Added: Additionally, upon closing the Company issued the placement agent warrants (“September Placement Agent’s
+Added: Warrants”) to purchase 98,040
+Added: shares of Common Stock exercisable at a per share price of $ 1.91 ,
+Added: which was equal to 125% of the public offering price per share.
+Added: The September Placement Agent’s Warrants are exercisable
+Added: during a five-year period commencing 180 days from September 25, 2024.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.