−Removed: CONTROLS AND PROCEDURES
−Removed: Evaluation of Disclosure Controls and Procedures
−Removed: We have evaluated, with the participation of
−Removed: our principal executive and our principle financial officer, the effectiveness of our disclosure controls and procedures as defined
−Removed: in Rules 13a-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) as of
−Removed: the end of the period covered by this Annual Report on Form 10-K.
−Removed: Based on this evaluation, our principal executive officer and
−Removed: our principal financial officer have concluded that our disclosure controls and procedures were effective to ensure that information
−Removed: 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 SEC’s rules and forms, and is accumulated and communicated to our
−Removed: management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate
−Removed: to allow timely decisions regarding required disclosure.
−Removed: Management’s Report on Internal Control Over Financial
−Removed: Our management is responsible for establishing
−Removed: and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange
−Removed: Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
−Removed: of any evaluation of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate
−Removed: because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate.
−Removed: supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we
−Removed: conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2020 using the criteria
−Removed: established in Internal Control Integrated Framework (“2013 Framework”) issued by the Committee of Sponsoring Organization
−Removed: of the Treadway Commission (“COSO”).
−Removed: Based on our evaluation using those criteria, our management has concluded that,
−Removed: as of June 30, 2020, our internal control over financial reporting was effective to provide reasonable assurance regarding the
−Removed: reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
−Removed: accepted accounting principles for the reasons discussed above.
−Removed: Changes in Internal Control Over Financial Reporting
−Removed: There were no changes in our internal controls over financial reporting
−Removed: during the fourth quarter of year ended June 30, 2020, that materially affected, or are reasonably likely to materially affect
−Removed: our internal controls over financial reporting.
−Removed: OTHER INFORMATION
−Removed: DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
−Removed: The following table sets forth certain information regarding our Board of Directors, our executive
−Removed: officers, and some of our key employees, as of the date of this Annual Report on Form 10-K.
−Removed: Director Since
−Removed: Terren Peizer
−Removed: Chairman of the Board & Chief Executive Officer
−Removed: Jonathan Adams
−Removed: President & Chief Operating Officer
−Removed: Joanne Wendy Kim
−Removed: Chief Financial Officer and Corporate Secretary
−Removed: Penelope Markham, PhD
−Removed: Chief Scientific Officer
−Removed: Independent Director
−Removed: Independent Director
−Removed: Michael Sherman
−Removed: Independent Director
−Removed: Independent Director
−Removed: Independent Director
−Removed: Robert Hariri, MD, PhD
−Removed: Independent Director
−Removed: Sigmund Rogich
−Removed: Independent Director
−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
−Removed: for attendance at each meeting.
−Removed: The Bylaws shall not be construed to preclude any director from serving the Company in any other
−Removed: capacity as an officer, agent or otherwise, and receiving compensation therefor.
−Removed: There are no familial relationships among any
−Removed: of our directors or officers.
−Removed: Terren Peizer, Chairman of the Board of Directors and Chief Executive Officer, is also the founder
−Removed: of Catasys, Inc.
−Removed: reporting company listed on Nasdaq on whose board Mr.
−Removed: Sherman also serves.
−Removed: Additionally, Jim Lang currently
−Removed: serves as a director at OptimizeRX, a U.S.
−Removed: reporting company that is listed on the Nasdaq stock exchange.
−Removed: None of our other directors
−Removed: or officers is or has been a Director or has held any form of directorship in any other U.S.
−Removed: reporting companies.
−Removed: None of our directors
−Removed: or officers has been affiliated with any Company that has filed for bankruptcy within the last five years.
−Removed: We are not aware of
−Removed: any proceedings to which any of our officers or directors, or any associate of any such officer or director, is a party that are
−Removed: adverse to the Company.
−Removed: We are also not aware of any material interest of any of our officers or directors that is adverse to our
−Removed: own interests.
−Removed: Terren Peizer, Chairman of the Board of
−Removed: Directors and Chief Executive Officer, is an entrepreneur, investor, and financier with a particular interest in healthcare, having
−Removed: founded and successfully commercialized several healthcare companies.
−Removed: Peizer is the founder of Catasys, Inc., a leader in behavioral
−Removed: and mental health management services, having served as the Chairman of the Board of Directors and CEO of Catasys since inception
−Removed: Peizer also is the Founder, Chairman and CEO and majority shareholder of NeurMedix, Inc., a biotechnology Company
−Removed: with a focus on inflammatory, neurological and neuro-degenerative diseases.
−Removed: Peizer is Chairman of Acuitas Group Holdings, LLC,
−Removed: his personal holding company that owns his portfolio Company interests.
−Removed: Through Acuitas, he owns Crede Capital Group, LLC, an industry
−Removed: leader in investing in micro and small capitalization public equities, having invested over $1.2 billion directly into portfolio
−Removed: Previously he was Chairman of Cray, Inc., the leading supercomputing Company, and held senior executive positions at
−Removed: various publicly-traded growth companies and with the investment banking firms Goldman Sachs, First Boston, and Drexel Burnham
−Removed: He received his B.S.E.
−Removed: in finance from The Wharton School of Finance and Commerce.
−Removed: Jonathan Adams has served as the Company's
−Removed: Chief Executive Officer and Chief Financial Officer from the time acquired LAT Pharma LLC on April 11, 2016 until July 2018.
−Removed: July 2018, he began serving as the Company's President and Chief Operating Officer.
−Removed: He founded LAT Pharma LLC and served as its
−Removed: Chief Executive Officer prior to its acquisition.
−Removed: Adams is a co-inventor of the Company's pending continuation-in-part patent
−Removed: application for the use of terlipressin to treat ascites patients and is a co-inventor of the pending US provisional and PCT filings
−Removed: for our novel liquid terlipressin formulations.
−Removed: He has over 30 years of biopharmaceutical industry experience, including corporate
−Removed: finance, company acquisitions and licensing deals, marketing and sales support.
−Removed: At Searle Pharmaceuticals he was a member of the
−Removed: global launch team for Celebrex, and he has worked on launching numerous new drugs and medical devices.
−Removed: Adams earned a BS at
−Removed: Cornell University and an MBA at the Tuck School at Dartmouth.
−Removed: Joanne Wendy Kim has served as the Company’s
−Removed: Chief Financial Officer since October 2018.
−Removed: Kim previously served as CFO for several companies throughout her career, most
−Removed: recently with Landmark Education Enterprises, and she has provided interim CFO services to various organizations through Group
−Removed: JWK from 2016 to 2018.
−Removed: In her various roles, Ms.
−Removed: Kim oversaw corporate finance and operational groups, closed eight acquisitions,
−Removed: secured bank financings, developed and implemented new business strategies, managed risk and implemented new financial policies
AND PROCEDURES
−Removed: As a CPA, Ms.
−Removed: Kim provided accounting, SEC filing review and other business consultative services to clients serving
−Removed: as a Director at BDO USA, LLP’s National Office SEC Department in 2008-2016 and as a Senior Manager at KPMG in earlier part
−Removed: of her career.
−Removed: She brings more than 30 years of accounting experience to this position.
−Removed: Kim earned her BBA in accounting and
−Removed: finance at California State University, Long Beach.
−Removed: Markham has served as the Company’s
−Removed: Chief Scientific Officer since November 2018.
−Removed: She was previously our Chief Scientist.
−Removed: Markham served as a Technical Consultant
−Removed: at LAT Pharma for 7 years prior to our acquisition of LAT Pharma.
−Removed: She has spent 15 years in immunology, infectious disease, bacteriology
−Removed: and drug discovery research.
−Removed: Markham was a co-founder and Research Director for Influx, Inc.
−Removed: involved in antibiotic drug discovery.
−Removed: She has been a member of NIH grant review panels and consulted for several pharmaceutical companies in a variety of therapeutic
−Removed: areas including Orphan Drug development.
−Removed: Markham has more than 20 publications in peer-reviewed journals and three patents.
−Removed: She holds a BS in Biochemistry from the University College Cork, Ireland, a Masters from Strathclyde University, Scotland, and
−Removed: a PhD from Rush University, Chicago.
−Removed: Cuong Do has been President, Global Strategy
−Removed: Group, at Samsung since February 2015.
−Removed: Do helps to set the strategic direction for Samsung Group’s diverse business portfolio.
−Removed: He was previously the Chief Strategy Officer for Merck from October 2011 to March 2014, Tyco Electronics, and Lenovo.
−Removed: a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate
−Removed: finance practices.
−Removed: He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth.
−Removed: Jim Lang is currently CEO of Water Street
−Removed: Capital’s and JLL Partner’s Global Life Sciences Services Platform.
−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
−Removed: Energy Research Associates (IHS CERA), a recognized leader in energy industry subscription information products, and formerly the
−Removed: President of Strategic Decisions Group (SDG), a leading global strategy consultancy.
−Removed: Lang holds a BS summa cum laude in electrical
−Removed: and computer engineering from the University of New Hampshire and an MBA with Distinction from the Tuck School of Business.
−Removed: Lang currently also serves as a Director at OptimizeRX, a Nasdaq listed Company.
−Removed: Berman was Chairman of National
−Removed: Investment Managers, a company with $12 billion pension administration assets from 2006-2011.
−Removed: Berman is a director of four
−Removed: other public healthcare companies:
−Removed: Catasys, Inc., Advaxis, Inc., Cryoport Inc.
−Removed: and Immuron Ltd.
−Removed: and a public fintech company, Cuentas,
−Removed: From 1998-2000, he was employed by Internet Commerce Corporation (now Easylink Services) as Chairman and CEO, and was a director
−Removed: from 1998-2012.
−Removed: Previously, Mr.
−Removed: Berman was Senior Vice President of Bankers Trust Company, where he started the M&A and Leveraged
−Removed: Buyout Departments;
−Removed: created the largest battery company in the world in the 1980’s by merging Prestolite, General Battery
−Removed: and Exide and advised on over $4 billion of M&transactions (completed over 300 deals).
−Removed: He is a past Director of the Stern School
−Removed: of Business of NYU where he obtained his BS and MBA.
−Removed: He also has US and foreign law degrees from Boston College and The Hague Academy
−Removed: of International Law, respectively.
−Removed: Michael Sherman JD retired from his position
−Removed: as a Managing Director at Barclays Plc in 2018, where he had worked since 2008.
−Removed: Previously he was a Managing Director at Lehman
−Removed: Brothers, Inc.
−Removed: He has worked in investment banking for 30 years.
−Removed: Sherman has significant experience in healthcare finance,
−Removed: most recently assisting on a $450 million convertible transaction for Neurocrine Biosciences.
−Removed: He has worked on successful financial
−Removed: transactions for Teva Pharmaceutical Industries, Amgen Inc., Cubist Pharmaceuticals, Merck & Co., and Cardinal Health, among
−Removed: other companies.
−Removed: After graduating from the University of Pennsylvania, Michael Sherman received his JD, cum laude, from the Harvard
−Removed: Steven Gorlin founded many biopharma companies
−Removed: including Hycor Biomedical, Theragenics, Medicis Pharmaceutical, EntreMed, MRI Interventions, DARA BioSciences, MiMedx, Medivation
−Removed: (sold to Pfizer for $14 billion) and NantKwest.
−Removed: Gorlin served for many years on the Business Advisory Council to the Johns
−Removed: Hopkins School of Medicine and on The Johns Hopkins BioMedical Engineering Advisory Board.
−Removed: He is currently a member of the Research
−Removed: Institute Advisory Committee (RIAC) of Massachusetts General Hospital.
−Removed: He started The Touch Foundation, a nonprofit organization
−Removed: for the blind, and was a principal contributor to Camp Kudzu for diabetic children.
−Removed: Robert Hariri MD, PhD, Chairman, founder, and
−Removed: CEO of Celularity, Inc., a leading cellular therapeutics company.
−Removed: He was the founder and CEO of Anthrogenesis Corporation, and
−Removed: after its acquisition served as CEO of Celgene Cellular Therapeutics.
−Removed: Hariri co-founded the genomic health intelligence company,
−Removed: Human Longevity, Inc.
−Removed: Hariri pioneered the use of stem cells to treat a range of life-threatening human diseases.
−Removed: acknowledged for his discovery of pluripotent stem cells and for assisting with discovering the physiological activities of tumor
−Removed: necrosis factor (TNF).
−Removed: He holds over 170 issued and pending patents and has authored over 150 publications.
−Removed: Sigmund Rogich CEO of President of The Rogich
−Removed: Communications Group and serves on the Board of Keep Memory Alive, a philanthropic organization which raises awareness about brain
−Removed: disorders and Alzheimer's disease.
−Removed: Keep Memory Alive funds clinical trials to advance new treatments for patients with Alzheimer’s,
−Removed: Huntington’s and Parkinson’s disease, as well as multiple sclerosis.
−Removed: Rogich was formerly the US Ambassador to Iceland.
−Removed: He has served as a senior consultant to Presidents Ronald Reagan and George H.W.
−Removed: Rogich serves on multiple boards of
−Removed: directors for charitable causes.
−Removed: Terren Peizer’s qualifications to serve
−Removed: on our Board of Directors are primarily based on his experience as an entrepreneur, investor, and financier with a particular interest
−Removed: in healthcare, having founded and successfully commercialized several healthcare companies.
−Removed: Peizer is the founder of Catasys,
−Removed: Inc., a leader in behavioral and mental health management services, having served as the Chairman of the Board of Directors and
−Removed: CEO of Catasys since inception in 2004.
−Removed: Peizer also is the Founder, Chairman and CEO and majority shareholder of NeurMedix,
−Removed: Inc., a biotechnology Company with a focus on inflammatory, neurological and neuro-degenerative diseases.
−Removed: Peizer is Chairman
−Removed: of Acuitas Group Holdings, LLC, his personal holding Company that owns his portfolio Company interests.
−Removed: Through Acuitas, he owns
−Removed: Crede Capital Group, LLC, an industry leader in investing in micro and small capitalization public equities, having invested over
−Removed: $1.2 billion directly into portfolio companies.
−Removed: Jonathan Adams’s qualifications to serve
−Removed: as our President and Chief Operating Officer are primarily based on his founding of LAT Pharma LLC and his over 30 years of biopharmaceutical
−Removed: industry experience.
−Removed: As Chief Executive of LAT Pharma LLC, Mr.
−Removed: Adams was a key contributor to inventing the BIV201 product candidate.
−Removed: He also helped to secure an Orphan Drug designation for a terlipressin analogue (a prior product candidate which is no longer in
−Removed: development).
−Removed: Adams’s biopharmaceutical experience includes work in corporate finance, company acquisitions and licensing
−Removed: deals, marketing and sales support.
−Removed: Wendy Kim’s qualifications to serve as
−Removed: our Chief Financial Officer are primarily based on her 35 years of accounting experience and having served as CFO for several companies
−Removed: and the provision of interim CFO services, accounting and business consultative services to various organizations through Group
−Removed: JWK, BDO USA, LLP and KPMG.
−Removed: Markham’s qualifications to serve
−Removed: as our Scientific Officer are primarily based on her years of experience with LAT Pharma, as well as having been a member of NIH
−Removed: grant review panels and consulted for several pharmaceutical companies in a variety of therapeutic areas including Orphan Drug
−Removed: Cuong Do’s qualifications to serve on
−Removed: our Board of Directors are primarily based on his decades of experience as an executive in the pharma, biotech, and other high
−Removed: technology industries.
−Removed: He was previously the Chief Strategy Officer for Merck, a leading U.S.
−Removed: pharmaceuticals Company, Tyco Electronics,
−Removed: Do is a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare,
−Removed: high tech and corporate finance practices.
−Removed: Jim Lang’s qualifications to serve on
−Removed: our Board of Directors are primarily based on his decades of experience as a strategy consultant, broad industry expertise, and
−Removed: senior-level management experience running several healthcare and information technology companies.
−Removed: This includes his experience
−Removed: as CEO of Decision Resources Group, CEO of IHS Cambridge Energy Research Associates (IHS CERA), and President of Strategic Decisions
−Removed: Group (SDG), a leading global strategy consultancy.
−Removed: Berman’s qualifications to
−Removed: 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: Michael Sherman’s qualifications to serve
−Removed: on our Board of Directors are primarily based on his decades of finance industry experience including as a Managing Director at
−Removed: Barclays Plc and as a Managing Director at Lehman Brothers, Inc.
−Removed: He has worked in investment banking for 30 years.
−Removed: has significant experience in healthcare finance including having worked on successful financial transactions for several pharmaceutical
−Removed: and healthcare focused companies.
−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
−Removed: companies, leading multiple NASDAQ AND NYSE companies to their success.
−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
−Removed: therapeutic space, as well as pioneering in the use of stem cells to treat a range of life-threatening human diseases and discoveries
−Removed: in the physiological activities of tumor necrosis factor.
−Removed: He has authored over 150 publications and garnered numerous awards for
−Removed: contributions to the fields of biomedicine and aviation.
−Removed: Sigmund (Sig) Rogich’s qualifications
−Removed: to serve on our Board of Directors are based on his experience in the Communications sector and philanthropic organization raising
−Removed: awareness about brain disorders.
−Removed: Rogic was formerly the US Ambassador to Iceland.
−Removed: He has served as a senior consultant to candidates
−Removed: for the highest office, including Presidents Ronald Reagan and George H.W.Bush.
−Removed: Rogich serves on the Board of Directors for
−Removed: many charitable causes.
−Removed: Section 16(a) beneficial ownership
−Removed: reporting compliance
−Removed: Committees of the Board of Directors
−Removed: Upon the effective date of the registration
−Removed: statement pm FormS-1 originally filed on April 30,2019, a part,
−Removed: our Board of Directors will have three standing committees:
−Removed: an audit committee, a compensation committee and a nominating and corporate
−Removed: governance committee.
−Removed: Both our audit committee and our compensation committee will be composed solely of independent directors.
−Removed: Subject to phase-in rules, the rules of Nasdaq and Rule 10A-3 of the Exchange Act require that the audit committee of a listed
−Removed: company be comprised solely of independent directors, and the rules of Nasdaq require that the compensation committee and the nominating
−Removed: and corporate governance committee of a listed company be comprised solely of independent directors.
−Removed: Each committee operates under
−Removed: a charter approved by our Board of Directors and will have the composition and responsibilities described below.
−Removed: The charter of
−Removed: each committee will be available on our website following the closing of this offering.
−Removed: AUDIT COMMITTEE
−Removed: We have established an audit committee of the
−Removed: Board of Directors.
−Removed: The members of our audit committee are Michael Sherman, Jim Lang and Richard J.
−Removed: Berman, each of which is an
−Removed: independent director within the meaning of the Nasdaq rules.
−Removed: Sherman serves as chairman of the audit committee.
−Removed: We have adopted an audit committee charter,
−Removed: detailing the principal functions of the audit committee, including:
−Removed: assisting board oversight of (1) the integrity of our financial statements, (2) our compliance with legal and regulatory requirements, (3) our independent auditor’s qualifications and independence, and (4) the performance of our internal audit function and independent auditors;
−Removed: the appointment, compensation, retention, replacement, and oversight of the work of the independent auditors and any other independent registered public accounting firm engaged by us;
−Removed: pre-approving all audit and non-audit services to be provided by the independent auditors or any other registered public accounting firm engaged by us, and establishing pre-approval policies and procedures;
−Removed: reviewing and discussing with the independent auditors all relationships the auditors have with us in order to evaluate their continued independence;
−Removed: setting clear policies for audit partner rotation in compliance with applicable laws and regulations;
−Removed: obtaining and reviewing a report, at least annually, from the independent auditors describing (1) the independent auditor’s internal quality-control procedures and (2) any material issues raised by the most recent internal quality-control review, or peer review, of the audit firm, or by any inquiry or investigation by governmental or professional authorities, within the preceding five years respecting one or more independent audits carried out by the firm and any steps taken to deal with such issues;
−Removed: meeting to review and discuss our annual audited financial statements and quarterly financial statements with management and the independent auditor, including reviewing our specific disclosures under “Management’s Discussion and Analysis of Financial Condition and Results of Operations”;
−Removed: reviewing and approving any related party transaction required to be disclosed pursuant to Item 404 of Regulation S-K promulgated by the SEC prior to us entering into such transaction;
−Removed: reviewing with management, the independent auditors, and our legal advisors, as appropriate, any legal, regulatory or compliance matters, including any correspondence with regulators or government agencies and any employee complaints or published reports that raise material issues regarding our financial statements or accounting policies and any significant changes in accounting standards or rules promulgated by the Financial Accounting Standards Board, the SEC or other regulatory authorities.
−Removed: COMPENSATION COMMITTEE
−Removed: We have established a compensation committee
−Removed: of the Board of Directors.
−Removed: The members of our Compensation Committee are Mr.
−Removed: Sherman and Mr.
−Removed: Berman serves
−Removed: as chairman of the compensation committee.
−Removed: We have adopted a compensation committee charter,
−Removed: which details the principal functions of the compensation committee, including:
−Removed: reviewing and approving on an annual basis the corporate goals and objectives relevant to our Chief Executive Officer’s compensation, evaluating our Chief Executive Officer’s performance in light of such goals and objectives and determining and approving the remuneration (if any) of our Chief Executive Officer based on such evaluation;
−Removed: reviewing and making recommendations to our Board of Directors with respect to the compensation, and any incentive-compensation and equity-based plans that are subject to board approval of all of our other officers;
−Removed: reviewing our executive compensation policies and plans;
−Removed: implementing and administering our incentive compensation equity-based remuneration plans;
−Removed: assisting management in complying with our proxy statement and annual report disclosure requirements;
−Removed: approving all special perquisites, special cash payments and other special compensation and benefit arrangements for our officers and employees;
−Removed: producing a report on executive compensation to be included in our annual proxy statement;
−Removed: and reviewing, evaluating and recommending changes, if appropriate, to the remuneration for directors.
−Removed: The charter also provides that the compensation
−Removed: committee may, in its sole discretion, retain or obtain the advice of a compensation consultant, independent legal counsel or other
−Removed: adviser and will be directly responsible for the appointment, compensation and oversight of the work of any such adviser.
−Removed: before engaging or receiving advice from a compensation consultant, external legal counsel or any other adviser, the compensation
−Removed: committee will consider the independence of each such adviser, including the factors required by Nasdaq and the SEC.
−Removed: Nominating and Corporate Governance Committee
−Removed: We have established a nominating and corporate
−Removed: governance committee of the Board of Directors.
−Removed: The members of our nominating and corporate governance committee are Mr.
−Removed: Do serves as chair of the nominating and corporate governance committee.
−Removed: We have adopted a nominating and corporate
−Removed: governance committee charter, which details the purpose and responsibilities of the nominating and corporate governance committee,
−Removed: identifying, screening and reviewing individuals qualified to serve as directors, consistent with criteria approved by the Board of Directors, and recommending to the Board of Directors candidates for nomination for election at the annual meeting of stockholders or to fill vacancies on the Board of Directors;
−Removed: developing and recommending to the Board of Directors and overseeing implementation of our corporate governance guidelines;
−Removed: coordinating and overseeing the annual self-evaluation of the Board of Directors, its committees, individual directors and management in the governance of the company;
−Removed: reviewing on a regular basis our overall corporate governance and recommending improvements as and when necessary.
−Removed: The charter also provides that the nominating
−Removed: and corporate governance committee may, in its sole discretion, retain or obtain the advice of, and terminate, any search firm
−Removed: to be used to identify director candidates, and will be directly responsible for approving the search firm’s fees and other
−Removed: retention terms.
−Removed: We have not formally established any specific,
−Removed: minimum qualifications that must be met or skills that are necessary for directors to possess.
−Removed: In general, in identifying and evaluating
−Removed: nominees for director, the Board of Directors considers educational background, diversity of professional experience, knowledge
−Removed: of our business, integrity, professional reputation, independence, wisdom, and the ability to represent the best interests of our
−Removed: stockholders.
−Removed: Prior to our initial business combination, holders of our public shares will not have the right to recommend director
−Removed: candidates for nomination to our Board of Directors.
−Removed: Compensation Committee Interlocks and Insider
−Removed: Participation
−Removed: None of our officers currently serves, or in
−Removed: the past year has served, as a member of the compensation committee of any entity that has one or more officers serving on our
−Removed: Board of Directors.
−Removed: CODE OF ETHICS
−Removed: We have adopted a code of conduct and ethics
−Removed: meeting the requirements of Section 406 of the Sarbanes-Oxley Act of 2002.
−Removed: We believe our code of conduct and ethics is reasonably
−Removed: designed to deter wrongdoing and promote honest and ethical conduct;
−Removed: provide full, fair, accurate, timely and understandable disclosure
−Removed: in public reports;
−Removed: comply with applicable laws;
−Removed: ensure prompt internal reporting of violations;
−Removed: and provide accountability for
−Removed: adherence to the provisions of the code of ethic.
−Removed: Our code of conduct and ethics is available on our website .
−Removed: of our code of conduct and ethics is filed as an exhibit to this Form 10-K.
−Removed: EXECUTIVE COMPENSATION
−Removed: Summary Compensation Table
−Removed: We did not pay any compensation to any of our
−Removed: executive officers prior to the start of our fiscal year ending June 30, 2020;
−Removed: however, we did accrue salary for Mr.
−Removed: Adams in accordance
−Removed: with his related employment agreements for all periods subsequent to their effective dates.
−Removed: Summary Compensation Table
−Removed: Annual Compensation
−Removed: Name and Principal Position
−Removed: Option Awards(1)
−Removed: All Other Compensation
−Removed: Terren Peizer
−Removed: Chief Executive Officer and Chairman(2)
−Removed: Jonathan Adams
−Removed: President and Chief Operating Officer(2)
−Removed: aggregate grant date fair value of such awards were computed in accordance with Financial Accounting Standards Board ASC Topic
−Removed: 718, Stock Compensation (ASC Topic 718), and do not take into account estimated forfeitures related to service-based vesting conditions,
−Removed: The valuation assumptions used in calculating these values are discussed in Note 9 of the Notes to Consolidated Financial
−Removed: Statements appearing elsewhere herein.
−Removed: These amounts do not represent actual amounts paid or to be realized.
−Removed: Amounts shown are
−Removed: not necessarily indicative of values to be achieved, which may be more or less than the amounts shown as awards may subject to
−Removed: time-based vesting.
−Removed: Peizer became our Chief Executive Officer and Chairman in July 2018 at which time Mr.
−Removed: Adams became President and Chief Operating
−Removed: Officer, having previously served as our Chief Executive Officer and Chief Financial Officer, Treasurer and Corporate Secretary.
−Removed: The stock awards received by Mr.
−Removed: Peizer and Mr.
−Removed: Adams represented 1,600 shares of common stock and vested in full upon grant.
−Removed: Narrative Disclosures to Summary of Compensation
−Removed: Employment Agreements
−Removed: On April 11, 2016, we entered into an employment
−Removed: agreement with Mr.
−Removed: Adams, pursuant to which Mr.
−Removed: Adams was entitled to receive $250,000 as annual salary.
−Removed: The agreement was effective
−Removed: beginning April 11, 2016 and expired on July 2, 2019.
−Removed: On July 9, 2018, Mr.
−Removed: Adams, our President and
−Removed: Chief Operating Officer, entered into an Accord and Debt Satisfaction Agreement with us, pursuant to which he agreed to release
−Removed: us from all liabilities (including the original contract dated March 23, 2017 to defer payment of his accrued salary, the promissory
−Removed: note issued by us to defer payment of accrued salary and subsequent unpaid salary), for an aggregate amount of $534,722, and received
−Removed: a cash payment of $25,694 in satisfaction.
−Removed: The gain of $509,028 on the settlement of debt was reflected as additional paid in capital.
−Removed: Compensation of Directors
−Removed: There are no arrangements pursuant to which
−Removed: our directors are or will be compensated in the future for any services provided to the Company, except that each director shall
−Removed: receive stock options and common share grants as remuneration for their service in lieu of cash compensation.
−Removed: For the fiscal year
−Removed: ended June 30, 2020, each director received 800 stock options on the one-year anniversary of his or her service to the Company with an exercise price equal to the closing stock price on the day of the option grant.
−Removed: total value of the options granted to directors for the fiscal year ended June 30, 2020 was $13,684 based on the Black-Scholes
−Removed: option value method.
−Removed: Each director also receives a stock grant of 1,600 common shares for every year of service.
−Removed: On January 2,
−Removed: 2020, our directors received a combined grant of 11,200 shares of common stock with a face value of $39,200 based on the closing
−Removed: stock price of $3.50 on the grant date.
−Removed: Long-Term Incentive Plans and Awards
−Removed: Other than the options granted as described
−Removed: above and our recently adopted 2019 Omnibus Equity Incentive Plan (the “2019 Plan”), we do not currently have any long-term
−Removed: incentive plans that provide compensation intended to serve as incentive for performance.
−Removed: Since prior to such grants, no individual
−Removed: grants or agreements regarding future payouts under non-stock price-based plans had been made to any executive officer or any director
−Removed: or any employee or consultant since our inception, no future payouts under non-stock price-based plans or agreements had been granted
−Removed: or entered into or exercised by our officer or director or employees or consultants.
−Removed: 2019 Omnibus Equity Incentive Plan
−Removed: On April 30, 2019, our Board of Directors and
−Removed: our stockholders approved and adopted the 2019 Plan, subject to complying with the notification requirements of Regulation 14C
−Removed: of the Exchange Act which were complied with effective May 29, 2019.
−Removed: The 2019 Plan allows us, under the direction of our Board
−Removed: of Directors or a committee thereof, to make grants of stock options, restricted and unrestricted stock and other stock-based awards
−Removed: to employees, including our executive officers, consultants and directors.
−Removed: The 2019 Plan allows for the issuance of up to 253,163
−Removed: shares of common stock pursuant to new awards granted under the 2019 Plan.
−Removed: This description is qualified in its entirety by reference
−Removed: to the actual terms of the 2019 Plan, a copy of which is attached as Appendix D to our Definitive Information Statement on Schedule
−Removed: 14C, filed with the SEC on May 8, 2019.
−Removed: SECURITY 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 3, 2020 regarding the beneficial ownership
−Removed: of our common stock by:
−Removed: each person known by us to be the beneficial owner of more than 5% of our outstanding shares of common stock;
−Removed: each of our named executive officers and directors;
−Removed: all our executive officers and directors as a group.
−Removed: The percentage ownership information shown
−Removed: in the table is based upon 5,204,392 shares of common stock outstanding as of August 3, 2020.
−Removed: Beneficial ownership is determined in accordance
−Removed: with the rules of the SEC and includes voting or investment power with respect to the securities.
−Removed: Except as otherwise indicated,
−Removed: each person or entity named in the table has sole voting and investment power with respect to all shares of our capital shown as
−Removed: beneficially owned, subject to applicable community property laws.
−Removed: In computing the number and percentage of shares
−Removed: beneficially owned by a person as of a particular date, shares that may be acquired by such person (for example, upon the exercise
−Removed: of options or warrants) within 60 days of such date are counted as outstanding, while these shares are not counted as outstanding
−Removed: for computing the percentage ownership of any other person.
−Removed: The address of each holder listed below, except
−Removed: as otherwise indicated, is c/o BioVie Inc., 2120 Colorado Avenue, #230, Santa Monica, California 90404.
−Removed: Name and Address of Beneficial Owner
−Removed: Number of Common Shares of Beneficial Ownership (1)
−Removed: Percentage of Beneficial Ownership
−Removed: Terren Peizer(2)
−Removed: Jonathan Adams(3)
−Removed: Joanne Wendy Kim(4)
−Removed: Robert Hariri, MD, PhD
−Removed: Penolope Markham, PhD(5)
−Removed: James Lang(7)
−Removed: Michael Sherman(8)
−Removed: Sigmund Rogich
−Removed: All directors and executive officers as a group (eight persons):
−Removed: _________________________________
−Removed: *Less than 1%
−Removed: Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities.
−Removed: In accordance with SEC rules, shares of common stock issuable upon the exercise of options or warrants which are currently exercisable or which become exercisable within 60 days following the date of the information in this table are deemed to be beneficially owned by, and outstanding with respect to, the holder of such option or warrant, however none of the persons listed hereinabove has the right to acquire beneficial ownership in any other shares of the Company.
−Removed: Subject to community property laws where applicable, to our knowledge, each person listed is believed to have sole voting and investment power with respect to all shares of common stock owned by such person.
−Removed: All shares and warrants are held of record by Acuitas Group Holdings, LLC, a limited liability company 100% owned by Terren S.
−Removed: Peizer, and as to which, Mr.
−Removed: Peizer may be deemed to beneficially own or control.
−Removed: Peizer disclaims beneficial ownership of any such securities.
−Removed: Excludes shares issuable upon conversion of the Debenture, which is expected to be repaid in cash with the net proceeds of this offering, and includes an aggregate of 6,813,082 shares expected to be issued to Acuitas upon completion of this offering in connection with the automatic exercise of the Bridge Financing Warrants and the committed exercise of its purchase option granted in connection with its initial investment in the Company.
−Removed: After giving effect to such issuance and the completion of this offering, Acuitas is expected to beneficially own 11,072,038 shares in total, or __%of the outstanding shares of common stock.
−Removed: Includes warrants to purchase 8,564 shares of common stock and options to purchase 24,800 shares of common stock, all of which are exercisable within the next 60 days.
−Removed: Common stock beneficially owned by Mr.
−Removed: Adams includes 1,120 and 1,200 shares of common stock held of record by Mr.
−Removed: Adams, as custodian for Elliott P.
−Removed: Adams and Jeremy P.
−Removed: Adams, respectively;
−Removed: and 2,924 shares of common stock held of record by Elliott P.
−Removed: Each of Elliott P.
−Removed: Adams and Jeremy P.
−Removed: Adams are family members of Mr.
−Removed: Adams and, as a result, Mr.
−Removed: Adams may be deemed to beneficially own shares held by (or for the benefit of) such family members.
−Removed: Represents options to purchase 1,600 shares of common stock exercisable in the next 60 days.
−Removed: Includes options to purchase 3,200 shares of common stock exercisable in the next 60 days.
−Removed: Includes warrants to purchase 70,667 shares of common stock and options to purchase 3,200 shares of common stock, all of which are exercisable within the next 60 days.
−Removed: All shares of common stock, warrants and options are held of record by Do & Rickles 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 own or control.
−Removed: Includes warrants to purchase 18,788 shares of common stock and options to purchase 3,200 shares of common stock, all of which are exercisable in the next 60 days.
−Removed: Includes warrants to purchase 13,606 shares of common stock and options to purchase 3,200 shares of common stock, all of which are exercisable within the next 60 days.
−Removed: Common stock held by Michael Sherman includes 13,333 shares of the common stock held of record by Sherman Children’s Trust Brian Krisber, Trustee.
−Removed: All shares of common stock, warrants and options are deemed to be beneficially owned or controlled by Michael Sherman.
−Removed: Includes options to purchase 800 shares of common stock, which are exercisable within the next 60 days.
−Removed: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
−Removed: During the period commencing July 1, 2018 and through the date of this Annual Report on Form 10-K,
−Removed: we have not engaged in any transactions with any officer, director or holder of more than 5% of our common stock, except as follows:
−Removed: Purchase of Preferred Stock
−Removed: On July 3, 2018, we entered into a Securities
−Removed: Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holdings, LLC (“Acuitas”) and certain
−Removed: other purchasers identified in the Purchase Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i)
−Removed: the Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred
−Removed: Stock”) at a price per share of $1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to
−Removed: issue warrants (the “Warrants”) to purchase 1,706,666 shares of common stock, each subject to the terms and conditions
−Removed: set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million.
−Removed: We received $160,000 of the $3.2 million in
−Removed: April and May 2018 as prepaid equity.
−Removed: Acuitas also received an additional 6,667 Warrants in connection with the payoff of a note
−Removed: issued by us in favor of Acuitas.
−Removed: The Initial Sale and issuance of the Warrants occurred on July 3, 2018.
−Removed: In addition, Acuitas
−Removed: had the option to purchase up to an additional 1,600,000 shares of common stock at a price per share of $1.88, and warrants on
−Removed: the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the “Subsequent
−Removed: Sale”) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year
−Removed: anniversary of the closing of the Initial Sale, less any federal or FDA grant funding received by the Company.
−Removed: Acuitas is controlled
−Removed: by our Chairman and Chief Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuang Do and
−Removed: Michael Sherman, who are members of our Board of Directors.
−Removed: The Purchase Agreement contained customary representations
−Removed: and warranties.
−Removed: In connection with the disclosure schedule associated with the representations and warranties, we also disclosed
−Removed: customary information, including the following:
−Removed: (i) the existence of the Mallinckrodt petition before the PTAB, (ii) our capitalization,
−Removed: (iii) our obligation to pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared
−Removed: among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge, Inc.
−Removed: pursuant to the Agreement and Plan of Merger, dated
−Removed: April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation to pay a low single digit royalty on net sales of all
−Removed: terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement,
−Removed: dated July 25, 2016, by and between us and the University of Padova (Italy), and (v) certain recent issuances of common stock by
−Removed: Each share of Preferred Stock automatically converted
−Removed: into 1 shares of common stock upon the filing with the Secretary of State of the State of Nevada of a Certificate of Amendment
−Removed: to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized shares
−Removed: of common stock to 800,000,000.
−Removed: The Amendment was approved by the written consent of the holders of more than a majority of our
−Removed: issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20 calendar
−Removed: days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on July 13,
−Removed: Pursuant to a letter agreement dated June 24,
−Removed: 2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:
−Removed: - Acuitas agreed to immediately exchange its
−Removed: existing Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless exercise
−Removed: thereof at an assumed current market price of $45.00 per share and, as a result received an aggregate of 95% of the shares covered
−Removed: thereby, or 1,526,094 shares of common stock;
−Removed: - Acuitas agreed to (i) waive its rights to a
−Removed: 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price
−Removed: per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights,
−Removed: and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase”
−Removed: at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of our common stock
−Removed: on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later
−Removed: than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of
−Removed: the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent
−Removed: Sale upon the issuance by us of an aggregate of 1,339,958 shares of common stock (the “Subsequent Sale Shares”) to
−Removed: Acuitas, which is expected to occur concurrently with the closing of this offering;
−Removed: - Acuitas shall in exchange for the foregoing
−Removed: agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common
−Removed: stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective
−Removed: purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant
−Removed: to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of
−Removed: its rights to purchase securities in a Subsequent Sale mentioned above.
−Removed: On September 24, 2019, the Company, entered into
−Removed: a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed to
−Removed: purchase a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 for an aggregate commitment
−Removed: amount of up to $2.0 million, and (ii) the Company issued 1,125,000 shares (the “Commitment Shares”) of the Company’s
−Removed: common stock and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each subject to the terms
−Removed: and conditions set forth in the 2019 Purchase Agreement.
−Removed: The Debenture accrues additional principal at the rate of 6% per annum
−Removed: and interest at the rate of 10% per annum, is convertible into shares of common stock at $4.00 per share prior to the completion
−Removed: of this offering or, subsequent to the closing of this offering, the lower of $4.00 or 80% of the offering price per unit to the
−Removed: public in this offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest
−Removed: to the date of redemption.
−Removed: The Commitment Warrants are five year warrants, exercisable at an amount equal to the lower of $4.00
−Removed: or 80% of the offering price per unit to the public in this offering.
−Removed: Upon entering into the 2019 Purchase Agreement, the Company
−Removed: drew an initial $500,000 under the Debenture and in accordance with the 2019 Purchase Agreement, Acuitas received an additional
−Removed: 125,000 warrants (the “Bridge Warrants”) having the same terms as the Commitment Warrants.
−Removed: Any future draws under the
−Removed: Debenture, which may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000
−Removed: each, will entitle Acuitas to receive additional Bridge Warrants in equal amount upon such funding.
−Removed: In addition, the 2019 Purchase
−Removed: Agreement provides that, should the underwriters in this offering exercise their option to purchase additional securities during
−Removed: the 45 days following closing and the issuance of such securities would result in Acuitas’
−Removed: beneficial ownership (on a fully
−Removed: diluted basis) of shares of common stock being below 60%, Acuitas shall be issued a number of additional shares of common stock
−Removed: and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis)
−Removed: of shares of common stock equaling 60%.
−Removed: The issuance of 1,125,000 shares of the Company’s
−Removed: commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing
−Removed: was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the excess of the fair value
−Removed: of the consideration given for the financing, net of debt discount;
−Removed: was recorded in accumulated deficit for the year ended June
−Removed: 30,2020, accordingly.
−Removed: (See accompanied Statements of Changes in Stockholders’
−Removed: (Deficit) Equity).
−Removed: A debt discount of $500,000
−Removed: against the debenture was recorded which will be amortized over the term of the debenture using the effective interest method.
−Removed: The Company recognized amortization of the discount the year ended June 30, 2020 was $37,136.
−Removed: The Company received
−Removed: draws under the Debenture that totaled $1.3 million during the year ended June 30, 2020, The total interest expense related
−Removed: to the draws under the Debenture was approximately $99,000 for the year ended June 30, 2020.
−Removed: On April 1, 2020 the Company
−Removed: entered into an amendment to modify the payment of accrued interest amounts under the original terms of the Debenture to
−Removed: capitalize all such amounts as would otherwise accrue on the Debenture.
−Removed: On January 4, 2020, payment of $13,487 accrued
−Removed: interest due was paid through the issuance of 4,422 shares of the Company’s common stock.
−Removed: Acuitas and the Company
−Removed: continue to discuss the need and timing for some or all the remaining draws under the Debenture Agreement.
−Removed: Subsequent to the initial $500,000 draw on September 24, 2019, the Company received draws that totaled $813,000 as July 13,
−Removed: 2020, and accordingly;
−Removed: the Company issued additional Bridge Warrants to purchase 203,250 shares of common stock to its
−Removed: controlling stockholder under the terms of the Bridge Financing.
−Removed: On July 14, 2020, the Company, entered into a
−Removed: further extension of its letter agreements dated April 8, 2020, that furthered extended its letter agreement dated February 10,
−Removed: 2020 with Acuitas regarding Acuitas’
−Removed: previous agreement to modify its existing rights under the Purchase Agreement dated
−Removed: July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase price applicable to
−Removed: its initial investment in the Company and the exercise price of the warrants received in such transaction and the price per share
−Removed: should it exercise certain rights to purchase additional securities in the event of certain reductions in the useful life of the
−Removed: Company’s intellectual property rights and commitment to purchase such securities upon the closing of the Company’s
−Removed: planned public offering of shares of Class A common stock (the “Common Stock”) as described in its Registration Statement
−Removed: on Form S-1 (File No.
−Removed: 333-231136) and commitment to purchase such additional securities would remain effective until October 31,
−Removed: 2020, and accordingly Acuitas shall be entitled to receive an aggregate of 5,359,832 shares of Common Stock at such closing.
−Removed: addition, the parties agreed that certain draws under the Company’s current bridge financing with Acuitas were to be made
−Removed: based with respect to the Company’s ongoing capital requirements and current market conditions, notwithstanding certain scheduled
−Removed: availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued in connection therewith.
−Removed: The letter agreement
−Removed: of July 14, 2020 also confirmed the understanding between the Company and Acuitas regarding certain amounts funded to BioVie that
−Removed: were intended as “partial draws”
−Removed: of credit available under the Debenture which, as of the date hereof aggregated $813,000
−Removed: in aggregate principal amount in additional to amounts initial funded under the Debenture.
−Removed: Accordingly, such “partial draws”
−Removed: shall accrue additional principal as amounts otherwise funded pursuant to the original schedule of draws included in the Debenture
−Removed: (as modified by the letter agreement between BioVie and Acuitas dated April 1, 2020 regarding the capitalization of interest otherwise
−Removed: payable) and shall entitle Acuitas to receive a pro rata amount of Bridge Warrants.
−Removed: Pursuant to the 2019 Purchase Agreement, Acuitas
−Removed: has agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’
−Removed: previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July
−Removed: 2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event
−Removed: of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase
−Removed: securities in a Subsequent Sale pursuant to a “cashless purchase”
−Removed: at an assumed current market price of approximately
−Removed: $11.25 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0
−Removed: million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that
−Removed: Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale
−Removed: and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an
−Removed: aggregate of 2,679,916 shares of common stock and 2,679,916 warrants having the same terms as the Commitment Warrants to Acuitas,
−Removed: which is currently expected with the closing of this offering.
−Removed: Pursuant to an amendment to the 2019 Purchase
−Removed: Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:
−Removed: The Commitment Warrants (and related warrants issued
−Removed: upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised
−Removed: upon the closing of this offering at an exercise price equal to the par value of the common stock;
−Removed: Acuitas' existing rights under the Purchase Agreement
−Removed: dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four
−Removed: (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement);
−Removed: The provisions of the 2019 Purchase Agreement providing
−Removed: that, should the underwriters in this offering exercise their option to purchase additional securities during the 45 days following
−Removed: closing and the issuance of such securities would result in Acuitas’
−Removed: beneficial ownership (on a fully diluted basis) of shares
−Removed: of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same
−Removed: terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling
−Removed: 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number
−Removed: of securities that will result in Acuitas’
−Removed: fully diluted beneficial ownership after the exercise of such option being the
−Removed: same as prior thereto.
−Removed: Issuance of Shares in Settlement of Debt
−Removed: During the fiscal year ended June 30, 2019, we
−Removed: settled $1,475,765 of debt including $1,313,765 owed to related parties, by issuing 7,803 shares of common stock with a fair value
−Removed: of $1,150,135.
−Removed: See Notes 5 and 6 to the financial statements for the fiscal years ended June 30, 2019 and 2018, appearing elsewhere in this annual report.
−Removed: PRINCIPAL ACCOUNTANT FEES AND SERVICES
−Removed: The following table shows what the auditor billed for the audit
−Removed: and other services for the years ended June 30, 2020 and 2019.
−Removed: June 30, 2020
−Removed: June 30, 2019
−Removed: Audit-Related Fees
−Removed: All Other Fees
−Removed: Audit Fees —This
−Removed: category includes the audit of the Company’s annual financial statements, review of financial statements included in the
−Removed: Company’s Form 10-Q Quarterly Reports and services that are normally provided by the independent auditors in connection with
−Removed: engagements for those years.
−Removed: Audit-Related Fees —N/A
−Removed: Tax Fees —N/A
+Added: of Disclosure Controls and Procedures
+Added: have evaluated, with the participation of our principal executive and our principle financial officer, the effectiveness of our disclosure
+Added: 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
+Added: Act) as of the end of the period covered by this Annual Report on Form 10-K.
+Added: Based on this evaluation, our principal executive
+Added: officer and our principal financial officer have concluded that our disclosure controls and procedures were effective to ensure that
+Added: information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized
+Added: and reported, within the time periods specified in the SECs rules and forms, and is accumulated and communicated to our management,
+Added: including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow
+Added: timely decisions regarding required disclosure.
+Added: Report on Internal Control Over Financial Reporting
+Added: management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f)
+Added: and 15d-15(f) under the Exchange Act.
+Added: Because of its inherent limitations, internal control over financial reporting may not prevent
+Added: or detect misstatements.
+Added: Projections of any evaluation of the effectiveness of internal control to future periods are subject to the
+Added: risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures
+Added: may deteriorate.
+Added: Under the supervision and with the participation of our management, including our Chief Executive Officer and
+Added: Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June
+Added: 30, 2021 using the criteria established in Internal Control Integrated Framework (2013 Framework) issued by the Committee
+Added: of Sponsoring Organization of the Treadway Commission (COSO).
+Added: Based on our evaluation using those criteria, our management
+Added: has concluded that, as of June 30, 2021, our internal control over financial reporting was effective to provide reasonable assurance
+Added: regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
+Added: generally accepted accounting principles for the reasons discussed above.
+Added: in Internal Control Over Financial Reporting
+Added: were no changes in our internal controls over financial reporting during quarter ended June 30, 2021, that materially affected, or are
+Added: reasonably likely to materially affect our internal controls over financial reporting.
+Added: REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
+Added: EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
+Added: information required by this item will be included in our Proxy Statement for the 2021 Annual Meeting of Stockholders to be filed with
+Added: the SEC within 120 days of the fiscal year ended June 30, 2021 and is incorporated herein by reference.
+Added: information required by this item will be included in our Proxy Statement for the 2021 Annual Meeting of Stockholders to be filed with
+Added: the SEC within 120 days of the fiscal year ended June 30, 2021 and is incorporated herein by reference.
+Added: OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
+Added: information required by this item will be included in our Proxy Statement for the 2021 Annual Meeting of Stockholders to be filed with
+Added: the SEC within 120 days of the fiscal year ended June 30, 2021 and is incorporated herein by reference.
+Added: RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
+Added: information required by this item will be included in our Proxy Statement for the 2021 Annual Meeting of Stockholders to be filed with
+Added: the SEC within 120 days of the fiscal year ended June 30, 2021 and is incorporated herein by reference.
+Added: ACCOUNTANT FEES AND SERVICES
+Added: information required by this item will be included in our Proxy Statement for the 2021 Annual Meeting of Stockholders to be filed with
+Added: the SEC within 120 days of the fiscal year ended June 30, 2021 and is incorporated herein by reference.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
5 unchanged sentences
Description of Document
−Removed: Agreement and Plan of Merger, dated April 11, 2016, among the Company, LAT Acquisition Corp and LAT Pharma, LLC (incorporated by reference to Exhibit 2.1 the Company’s Current Report on Form 8-K filed on April 15, 2016).
−Removed: Articles of Incorporation of the Company as filed with the Secretary of State of Nevada (incorporated by reference to Exhibit 3.1 to the Company’s registration statement on Form S-1 filed on August 15, 2013, File No.
−Removed: Certificate of Amendment to Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 22, 2016).
−Removed: Certificate of Amendment to Articles of Incorporation (incorporated by reference to Appendix A to the Company’s Information Statement on Schedule 14C filed on July 13, 2018).
−Removed: Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 3, 2018).
−Removed: Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s registration statement on Form S-1 filed on August 15, 2013, File No.
+Added: Agreement and Plan of Merger, dated April 11, 2016, among the Company, LAT Acquisition Corp and LAT Pharma, LLC (incorporated by reference to Exhibit 2.1 the Companys Current Report on Form 8-K filed on April 15, 2016).
+Added: Articles of Incorporation of the Company as filed with the Secretary of State of Nevada (incorporated by reference to Exhibit 3.1 to the Companys registration statement on Form S-1 filed on August 15, 2013, File No.
+Added: Certificate of Amendment to Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Companys Current Report on Form 8-K filed on July 22, 2016).
+Added: Certificate of Amendment to Articles of Incorporation (incorporated by reference to Appendix A to the Companys Information Statement on Schedule 14C filed on July 13, 2018).
+Added: Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Companys Current Report on Form 8-K filed on July 3, 2018).
+Added: Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Companys registration statement on Form S-1 filed on August 15, 2013, File No.
Certificate of Amendment to Articles of Incorporation
Specimen Certificate representing shares of Class A Common Stock.
−Removed: (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1, File No.
−Removed: 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).
−Removed: 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).
+Added: (incorporated by reference to Exhibit 4.1 to the Companys Registration Statement on Form S-1, File No.
+Added: Form of Warrant (incorporated by reference to Exhibit 4.2 to the Companys Current Report on Form 8-K filed on September 25, 2019).
+Added: Form of 10% OID Convertible Delayed Draw Debenture (incorporated by reference to Exhibit 4.1 the Companys Current Report on Form 8-K filed on September 25, 2019).
Description of Securities
−Removed: Securities Purchase Agreement, dated as of July 3, 2018, by and among BioVie Inc., Acuitas Group Holdings, LLC and the Purchasers identified therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 3, 2018).
+Added: Securities Purchase Agreement, dated as of July 3, 2018, by and among BioVie Inc., Acuitas Group Holdings, LLC and the Purchasers identified therein (incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on July 3, 2018).
Employment Agreement between Jonathan Adams and the Company dated, April 11, 2016.
−Removed: (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1, File No.
+Added: (incorporated by reference to Exhibit 10.3 to the Companys Registration Statement on Form S-1, File No.
Amendment No.
1 to Employment Agreement between Jonathan Adams and the Company dated July 3, 2018.
−Removed: (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1, File No.
+Added: (incorporated by reference to Exhibit 10.4 to the Companys Registration Statement on Form S-1, File No.
Letter Agreement between Acuitas Group Holdings, LLC and the Company dated June 24, 2019.
−Removed: (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1, File No.
+Added: (incorporated by reference to Exhibit 10.5 to the Companys Registration Statement on Form S-1, File No.
2019 Omnibus Equity Incentive Plan (incorporated by reference to Appendix D to the Definitive Information Statement on Schedule 14C, filed on May 8, 2019)
Securities Purchase Agreement dated as of September 24, 2019 by and among BioVie Inc.
−Removed: and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 25, 2019)
+Added: and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on September 25, 2019)
Amendment to Securities Purchase Agreement, dated as of October 9, 2019, by and between the Company and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on October 9, 2019)
3 unchanged sentences
(incorporated by reference to Exhibit 10.11 to the Companys Registration Statement on Form S-1, File No.
−Removed: Code of Conduct and Ethics of BioVie Inc.
−Removed: (incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1, File No.
−Removed: Rule 13a-14(a) Certification
−Removed: Rule 13a-14(a) Certification
−Removed: Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
−Removed: Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
+Added: Purchase Agreement by and Among BioVie,Inc - Buyer and Neurmedix, Inc - Seller and Acuitas Group Holdings as Gauarantor of April
+Added: 27, 2021 filed on Form 8-K on April 27, 2021
+Added: 1 of the Asset Purchase Agreement dated May 9, 2021 filed on Form 8-K on May 10, 2021
+Added: of Conduct and Ethics of BioVie Inc.
+Added: (incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on
+Added: Form S-1, File No.
+Added: of Independent Registered Public Accounting Firm - EisnerAmper LLP*
+Added: 13a-14(a) Certification
+Added: 13a-14(a) Certification
+Added: Certification
+Added: Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
+Added: Certification
+Added: Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
XBRL Instance Document
4 unchanged sentences
XBRL Taxonomy Extension Definition Linkbase Document
−Removed: Pursuant to the requirements of Section 13
−Removed: or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned,
−Removed: thereunto duly authorized.
−Removed: /s/ Terren Peizer
−Removed: Terren Peizer
−Removed: Chief Executive Officer
−Removed: (Principal Executive Officer)
−Removed: Pursuant to the requirements of the Securities
−Removed: Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
−Removed: /s/ Terren Peizer
−Removed: Chairman and Chief Executive Officer
−Removed: August 6, 2020
−Removed: Terren Peizer
+Added: 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
+Added: on its behalf by the undersigned, thereunto duly authorized.
+Added: Executive Officer
(Principal Executive Officer)
−Removed: Chief Financial Officer and Corporate Secretary
−Removed: August 6, 2020
−Removed: (Principal Financial Officer)
−Removed: /s/ Jonathan Adams
−Removed: President and Chief Operating Officer
−Removed: August 6, 2020
−Removed: Jonathan Adams
−Removed: August 6, 2020
−Removed: August 6, 2020
−Removed: /s/ Michael Sherman
−Removed: August 6, 2020
+Added: to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and
+Added: on the dates indicated.
+Added: Executive Officer
+Added: Executive Officer)
+Added: Joanne Wendy Kim
+Added: Financial Officer
+Added: Financial Officer)
+Added: Terren Piezer
Michael Sherman
−Removed: /s/ Richard J.
−Removed: August 6, 2020
−Removed: /s/ Steve Gorlin
−Removed: August 6, 2020
−Removed: /s/ Robert Hariri
−Removed: August 6, 2020
Robert Hariri
−Removed: /s/ Sigmund Rogich
−Removed: August 6, 2020
Sigmund Rogich
Index to Financial Statements
−Removed: Report of Independent Registered Public Accounting Firm –
−Removed: EisnerAmper LLP
+Added: Report of Independent Registered Public Accounting Firm – EisnerAmper LLP
Financial Statements:
1 unchanged sentence
Statements of Operations
−Removed: Statements of Changes in Stockholders’
−Removed: Equity (Deficit)
+Added: Statements of Changes in Stockholders Equity (Deficit)
Statements of Cash Flows
Notes to Financial Statements
−Removed: REPORT OF INDEPENDENT
−Removed: REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: To the Board of Directors and Stockholders
−Removed: Opinion on the Financial Statements
−Removed: We have audited the accompanying balance sheets
−Removed: of BioVie, Inc.
−Removed: (the “Company") as of June 30, 2020 and 2019 and the related statements of operations, changes in stockholders’
−Removed: equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of
−Removed: June 30, 2020 and 2019, and the results of its operations and its cash flows for the years then ended in conformity with accounting
−Removed: principles generally accepted in the United States of America.
−Removed: Going Concern
−Removed: The accompanying financial statements have
−Removed: been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 2 to the financial statements,
−Removed: the Company’s recurring losses from operations and negative cash flows from operating activities raise substantial doubt
−Removed: about its ability to continue as a going concern.
−Removed: Management’s plans in regard to these matters are also described in Note
+Added: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: the Board of Directors and Stockholders of
+Added: on the Financial Statements
+Added: have audited the accompanying balance sheets of Biovie Inc.
+Added: (the Company) as of June 30, 2021 and 2020, and the related
+Added: statements of operations, changes in stockholders equity (deficit), and cash flows for each of the years then ended, and the related
+Added: notes (collectively referred to as the financial statements).
+Added: In our opinion, the financial statements present fairly,
+Added: in all material respects, the financial position of the Company as of June 30, 2021 and 2020, and the results of its operations and its
+Added: cash flows each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note
+Added: 2 to the financial statements, the Companys recurring losses from operations and negative cash flows from operating activities
+Added: raise substantial doubt about its ability to continue as a going concern.
+Added: Managements plans in regard to these matters are also
+Added: described in Note 2.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based
−Removed: on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
−Removed: and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable
−Removed: rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with
−Removed: the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
−Removed: the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have,
−Removed: nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audit, we are required
−Removed: to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the
−Removed: effectiveness of the Company's internal control over financial reporting.
+Added: financial statements are the responsibility of the Companys management.
+Added: Our responsibility is to express an opinion on the Companys
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain
+Added: reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits
+Added: we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Companys internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to
−Removed: assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures
−Removed: that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
−Removed: in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made
−Removed: by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audits provide a
−Removed: reasonable basis for our opinion.
−Removed: /s/ EisnerAmper LLP
−Removed: We have served as the Company’s auditor
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
+Added: critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
+Added: or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial
+Added: statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter
+Added: does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
+Added: matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Party Transactions
+Added: described in note 5 to the financial statements, the Company has entered into agreements with a related party.
+Added: As part of these agreements,
+Added: the Company is required to issue common stock and, at times, warrants to the related party.
+Added: The purchase option to the related party
+Added: for the additional securities resulted in a deemed dividend of approximately $53 million recorded on the June 30, 2021 balance sheet.
+Added: Additionally, in accordance with the Asset Purchase Agreement identified in note 5, the Company recorded approximately $130.6 million
+Added: of in-process research and development expenses on the June 30, 2021 statement of operations and $124.3 million of common stock and additional
+Added: paid-in-capital and cash paid to related party of approximately $2.3 million on the June 30, 2021 balance sheet.
+Added: identified managements related party transactions as a critical audit matter due to the significance of transactions occurring
+Added: throughout the year and managements process to ensure all transactions are recorded and disclosed accurately.
+Added: This in turn led
+Added: to a high degree of auditor judgment, subjectivity and effort in applying the procedures related to those transactions.
+Added: the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial
+Added: We obtained an understanding and evaluated the design of the controls over the Companys process to identify, account
+Added: for and disclose related party transactions.
+Added: We performed procedures to test the common stock, additional paid-in-capital, deemed dividend
+Added: and in-process research and development expenses balances related to related parties transactions at the balance sheet date.
+Added: procedures also included, among others, reading agreements and subsequent amendments, and testing invoices to related parties to ensure
+Added: expenses are accurate and proper approval from management and audit committee was received.
+Added: We also made direct inquiries of financial
+Added: personnel on the status of all agreements to ensure the population of amendments or new agreements entered into was complete and that
+Added: these items were properly accounted for and disclosed.
+Added: Additionally, we reviewed all board minutes to ensure completeness of related
+Added: party transactions.
EisnerAmper LLP
−Removed: Iselin, New Jersey
−Removed: August _ 2020
−Removed: Balance Sheets
+Added: have served as the Companys auditor since 2019.
CURRENT ASSETS:
3 unchanged sentences
Total other assets
−Removed: LIABILITIES AND STOCKHOLDERS' EQUITY
+Added: LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)
CURRENT LIABILITIES:
2 unchanged sentences
Derivative liability - conversion option on convertible debenture
−Removed: Convertible debenture - related party, net of
−Removed: unearned discount $462,864 and capitalized accrued interest of $48,407 and $0 at June 30, 2020 and June 30, 2019,
+Added: Convertible debenture - related party, net of unearned discount of $ 0 and $ 462,864 and capitalized accrued interest of $ 0 and $ 48,407 at June 30, 2021 and June 30, 2020, respectively
Total current liabilities
−Removed: LONG TERM LIABILITIES:
TOTAL LIABILITIES
Commitments and contingencies (Note 8)
−Removed: STOCKHOLDERS' (DEFICIT) EQUITY
+Added: STOCKHOLDERS EQUITY (DEFICIT):
Preferred stock;
8 unchanged sentences
( 224,885,422 )
−Removed: Total stockholders' (deficit) equity
( 41,037,898 )
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
−Removed: The accompanying notes are an integral part
−Removed: of the financial statements.
+Added: Total stockholders equity (deficit)
+Added: ( 21,498,636 )
+Added: TOTAL LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)
+Added: accompanying notes are an integral part of the financial statements.
Statements of Operations
June 30, 2021
+Added: June 30, 2020
OPERATING EXPENSES:
3 unchanged sentences
LOSS FROM OPERATIONS
−Removed: OTHER EXPENSE (INCOME):
+Added: ( 138,054,139 )
+Added: ( 2,692,888 )
+Added: OTHER EXPENSE (INCOME) EXPENSE:
Change in fair value of derivative liabilities
−Removed: Gain on settlement of debt
+Added: ( 8,279,919 )
+Added: Gain on extinguishment of debt
Interest expense
Interest income
−Removed: TOTAL OTHER EXPENSE (INCOME), NET
+Added: TOTAL OTHER (INCOME) EXPENSE, NET
( 7,804,935 )
$ ( 130,249,204 )
−Removed: Deemed dividends for commitment shares and rachet adjustments
+Added: $ ( 16,676,768 )
+Added: Deemed dividends - related party
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
3 unchanged sentences
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
−Removed: The accompanying notes are an integral part
−Removed: of the financial statements.
−Removed: Statements of Changes in Stockholders’
−Removed: Equity (Deficit)
+Added: accompanying notes are an integral part of the financial statements.
+Added: Statements of Changes in Stockholders Equity (Deficit)
For the Years Ended June 30, 2021 and 2020
3 unchanged sentences
$ ( 7,262,072 )
−Removed: Issuance of preferred stock in a private placement
−Removed: Conversion of preferred stock to common stock
−Removed: Issuance of shares in exchange for debt settlement
−Removed: Issuance of shares for services
−Removed: Stock option compensation
−Removed: Cashless exercise of warrants
−Removed: Deemed dividends for ratchet adjustment to warrants
−Removed: Net loss for the three months ended September 30, 2018
−Removed: Balance, June 30, 2019
−Removed: $ (7,262,072 )
Issuance of commitment shares
11 unchanged sentences
$ ( 21,498,636 )
−Removed: The accompanying notes are an integral part
−Removed: of the financial statements.
+Added: Proceeds from issuance of common stock
+Added: Redemption of warrants - related party
+Added: Deemed dividend for purchase option - related party
+Added: ( 53,598,320 )
+Added: Cashless exercise of options and warrants
+Added: Stock-based compensation
+Added: Proceeds from exercise of warrants
+Added: Issuance of shares for purchase of in process research and development expenses - related party
+Added: ( 130,249,204 )
+Added: ( 130,249,204 )
+Added: Balance, June 30, 2021
+Added: $ 229,933,505
+Added: $ ( 224,885,422 )
+Added: accompanying notes are an integral part of the financial statements.
Statements of Cash Flows
8 unchanged sentences
Common shares issued for interest payment
+Added: Common shares issued for asset acquisition
Stock based compensation expense
−Removed: Gain on settlement of debt
+Added: Gain on extinguishment of loan payable
Interest expense from convertible debenture
Change in fair value of derivative liabilities
+Added: ( 8,279,919 )
Changes in operating assets and liabilities:
1 unchanged sentence
Net cash used in operating activities
+Added: ( 10,453,047 )
+Added: ( 1,628,228 )
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Repayment of debt
−Removed: Proceeds from issuance of preferred shares
+Added: Net proceeds from issuance of common stock
+Added: Proceeds from exercise of warrants
+Added: Payment of convertible debenture - related party
+Added: ( 1,821,818 )
Proceeds from convertible debenture - related party
1 unchanged sentence
Net cash provided by financing activities
−Removed: Net (decrease) increase in cash
+Added: Net increase (decrease) in cash
Cash, beginning of period
4 unchanged sentences
SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
−Removed: Conversion of preferred shares to common stock
−Removed: Settlement of debt by issuance of common stock and forgiveness of debt
−Removed: Cashless exercise of warrants
−Removed: Deemed dividends for ratchet adjustments to warrants
−Removed: Deemed dividends for commitment shares
+Added: Deemed dividends - related party
Stock warrants classified as derivative liability
−Removed: The accompanying notes are an integral part
−Removed: of the financial statements.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Background Information
−Removed: (the “Company”) is
−Removed: a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies.
−Removed: We are currently
−Removed: focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites
−Removed: due to chronic liver cirrhosis.
−Removed: Our therapy BIV201 is based on a drug that is approved in about 40 countries to treat related complications
−Removed: of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the United States.
−Removed: BIV201’s active
−Removed: agent is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world.
−Removed: is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.
−Removed: BioVie began administering BIV201 to patients
−Removed: in a Phase 2a clinical trial in patients with refractory ascites due to advanced liver cirrhosis at the McGuire Research Institute
−Removed: in Richmond, VA in September 2017.
−Removed: In April 2019, we announced top-line results and in June met with representatives of the
−Removed: FDA for a Type C Guidance Meeting to discuss the study results and plan our next clinical study.
−Removed: In July 2019, the FDA provided
−Removed: meeting minutes for the Company’s proposed randomized and controlled study design.
−Removed: In September we requested a Type B Meeting
−Removed: and subsequently submitted an extensive pre-meeting information package.
+Added: accompanying notes are an integral part of the financial statements.
+Added: (the Company or we or our) is a company developing innovative drug
+Added: therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders and
+Added: certain cancers.
+Added: We are currently focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel investigational
+Added: approach to the treatment of ascites due to chronic liver cirrhosis.
+Added: Our therapy BIV201 is based on a drug that is approved in
+Added: about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet
+Added: available in the United States.
+Added: BIV201s active agent is a potent vasoconstrictor and has shown efficacy for reducing portal
+Added: hypertension in studies around the world.
+Added: The goal is for BIV201 to interrupt the ascites disease pathway, thereby halting the
+Added: cycle of accelerating fluid generation in ascites patients.
+Added: BioVie completed a Phase 2a clinical trial of BIV201 in six patients with refractory ascites due to advanced liver
+Added: cirrhosis at the McGuire Research Institute in Richmond, VA in 2019.
+Added: The Company met with representatives of the Food and Drug Administration
+Added: (FDA) in a Type C Guidance Meeting to discuss the study results and plan our next clinical study.
+Added: Subsequently, we requested
+Added: a Type B Meeting and submitted an extensive pre-meeting information package.
In April 2020, the FDA provided a written response that
1 unchanged sentence
of the clinical trial design.
−Removed: In May 2020 they answered certain follow-up questions enabling the Company to complete the Phase
−Removed: 2 clinical trial protocol which will be finalized soon.
−Removed: The Phase 2 study will be used to guide the design of a pivotal Phase 3
−Removed: clinical trial.
−Removed: We are developing a patent-pending novel liquid formulation of terlipressin for use in this study that is intended
−Removed: to improve convenience for outpatient administration and avoid potential formulation errors that may occur when pharmacists reconstitute
−Removed: the powder version.
−Removed: BIV201 has the potential to improve the health
−Removed: of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis
−Removed: (NASH), and alcoholism.
−Removed: It has FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites,
−Removed: which represents a significant unmet medical need.
−Removed: An Orphan drug that is first-to-market typically receives 7 years of market
−Removed: exclusivity in the United States for the designated use(s).
+Added: After further communications, the Company completed the clinical trial design protocol and was cleared
+Added: to begin a Phase 2 clinical study.
+Added: We activated the first trial sites in the first calendar quarter of 2021 and as of July 2021, seven
+Added: of nine planned US study centers have been activated and are actively screening patients, and two patients have been enrolled in the
+Added: We plan to follow this study with a larger potentially pivotal Phase 3 clinical trial expected to begin in 2022.
+Added: The Phase 2 study
+Added: results will be used to guide the design of a potentially pivotal Phase 3 clinical trial.
+Added: We have developed a patent-pending novel liquid
+Added: formulation of BIV201 for use in this study that is intended to improve convenience for outpatient administration and avoid potential
+Added: formulation errors that may occur when pharmacists reconstitute the powder version of terlipressin.
+Added: BIV201 has the potential to improve the health of thousands of patients suffering
+Added: from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism.
+Added: FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites, which represents a significant
+Added: unmet medical need.
+Added: The first-approved orphan drug may receive 7 years of market exclusivity in the United States for the specific drug
+Added: for the specific orphan indication.
The FDA has never approved any drug specifically for treating ascites.
−Removed: addition, the Company has a pending patent application directed to proprietary liquid formulations of terlipressin for use in its
−Removed: planned Phase 2 and Phase 3 clinical trials, subject to FDA clearance, which could eventually provide up to 20 years of patent
−Removed: coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues according
−Removed: to the patent laws of the issuing country.
−Removed: The BIV201 development program began at LAT
−Removed: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.
−Removed: currently owns all development and marketing rights to its drug candidate.
−Removed: The Company and PharmaIN, Corp.
−Removed: (“PharmaIN”),
−Removed: LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but
−Removed: not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development
−Removed: programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues.
−Removed: On December 24,
−Removed: 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously
−Removed: paid the remaining balance due on a related debt.
−Removed: PharmaIN, Corp.’s rights to our program remain unchanged.
−Removed: The Company’s activities are subject
−Removed: to significant risks and uncertainties including failure to secure additional funding to properly execute the Company’s business
−Removed: On November 22, 2019, the Company effected the reverse stock split
−Removed: of 125 common stock for every 1 common stock.
−Removed: All share amounts have been updated to reflect the reverse stock split.
−Removed: split was related to the Company’s planned up listing to NASDAQ Stock Market and potential future issuance and sales of our
−Removed: equity securities for ordinary corporate finance and general corporate purposes.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Liquidity and Going Concern
−Removed: The Company’s operations are subject
−Removed: to a number of factors that can affect its operating results and financial conditions.
−Removed: Such factors include, but are not limited
−Removed: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain
−Removed: regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies,
−Removed: the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing
−Removed: and marketing agreements for its products, and the Company’s ability to raise capital.
−Removed: The Company’s financial statements
−Removed: have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the
−Removed: satisfaction of liabilities in the normal course of business.
−Removed: As of June 30, 2020, the Company had an accumulated deficit of approximately
−Removed: In addition, the Company has not generated any revenues 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
−Removed: effort, as well as continuing to secure additional financing.
−Removed: On September 24, 2019, the Company
−Removed: entered into a Securities Purchase Agreement with its controlling stockholder regarding bridge financing (the “Bridge Financing”)
−Removed: in the form of up to $2.0 million in convertible debt and warrants, of which approximately $1.3 million has been drawn and reflected
−Removed: in the amount of $848,543, net of unearned discount of $462,864 as Convertible debenture - related party in the accompanying balance
−Removed: sheet at June 30, 2020 Amounts borrowed under the Bridge Financing must be repaid with the proceeds of our potential public offering
−Removed: of equity securities referred to below.
−Removed: The availability of additional draws under the Bridge Financing is under further discussion
−Removed: with the controlling stockholder in light of delays in the timing of the potential public offering.
−Removed: As further discussed below,
−Removed: the Company is pursuing various options to raise further financing to continue the testing and development of its product.
−Removed: the Company is not successful in raising additional funds it may reduce its monthly spend and potentially delay the implementation
−Removed: of the larger scale Phase 2 and Phase 3 clinical trials until sufficient funding is secured.
−Removed: The future viability of the Company
−Removed: is largely dependent upon its ability to raise additional capital to finance its operations.
−Removed: Management expects that future sources
−Removed: of funding may include sales of equity, obtaining loans, or other strategic transactions The emergence of widespread health emergencies
−Removed: or pandemics, such as coronavirus ("COVID-19"), may lead to continued regional quarantines, business shutdowns, labor
−Removed: shortages, disruptions to supply chains, and overall economic instability, including the duration and spread of the outbreak and
−Removed: restrictions and the impact of COVID-19 on the financial markets and the overall economy, all of which are highly uncertain and
−Removed: cannot be predicted.
−Removed: If the financial markets and/or the overall economy continue to be impacted for an extended period, the Company’s
−Removed: ability to raise funds may be materially adversely affected.
−Removed: Although management continues to pursue
−Removed: these plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to
−Removed: the Company, if at all, to fund continuing operations.
−Removed: These circumstances raise substantial doubt on the Company’s ability
−Removed: to continue as a going concern.
−Removed: The financial statements do not include any adjustments that might result from the outcome of this
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Significant Accounting Policies
−Removed: Basis of Presentation
−Removed: The Company’s financial statements
−Removed: have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include
−Removed: all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
−Removed: Use of Estimates
−Removed: The preparation of financial statements
−Removed: in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial
−Removed: statements and accompanying notes.
−Removed: The Company bases its estimates on historical experience and on various assumptions that are
−Removed: believed to be reasonable under the circumstances.
−Removed: The amounts of assets and liabilities reported in the Company’s balance
−Removed: sheet and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are
−Removed: used for, but not limited to, accounting for share-based compensation, accounting
−Removed: for derivatives and accounting for income taxes.
+Added: In addition, the Company
+Added: is applying for global patent coverage of a proprietary liquid formulation of terlipressin which could eventually provide up to 20 years
+Added: of patent protection in countries where the Company seeks patent issuance according to local patent laws.
+Added: BIV201 development program began at LAT Pharma LLC.
+Added: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights
+Added: to its BIV201 development program.
+Added: The Company currently owns all development and marketing rights to its drug candidate.
+Added: Company and PharmaIN, Corp.
+Added: (PharmaIN), LAT Pharmas former partner focused on the development of new modified
+Added: drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future
+Added: net sales of each companys ascites drug development programs, or if such program is licensed to a third party, less than 5% of
+Added: each companys net license revenues.
+Added: On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified
+Added: terlipressin development program and simultaneously paid the remaining balance due on a related debt.
+Added: PharmaIN, Corp.s
+Added: rights to our program remain unchanged.
+Added: April 27, 2021, the Company entered into an Asset Purchase Agreement (the APA) with NeurMedix, Inc.
+Added: (NeurMedix)
+Added: and Acuitas Group Holdings, LLC (Acuitas), which are related party affiliates, pursuant to which the Company acquired
+Added: certain assets from NeurMedix and assumed certain liabilities of NeurMedix, in exchange for the consideration of cash and shares
+Added: of common stock.
+Added: (collectively, the Transaction).
+Added: The acquired assets include, among others, those related to certain
+Added: drug candidates being developed by NeurMedix, including NE3107, a small molecule orally administered inhibitor of insulin resistance
+Added: and the pathological inflammatory cascade, with a novel mechanism of action that has potential applications for treatment against
+Added: Alzheimers Disease and Parkinsons Disease.
+Added: total cost of the asset purchase of the In Process Research and Development (IPR&D) was approximately $ 130.6
+Added: The Company issued 8,361,308 shares of the Companys common stock, valued at $ 14.87 per share, the closing price
+Added: on June 10, 2021 (the closing date);
+Added: and was required to make cash payments totaling approximately $6.3 million, of which approximately
+Added: $2.3 million was paid to Acuitas and approximately $ 4.0 million to others for due diligence, legal fees, transaction fees and
+Added: the fairness opinion.
+Added: to the terms and conditions of Amendment No.
+Added: 1 to the APA dated May 9, 2021, (the Amendment and the APA as so amended,
+Added: the Asset Purchase Agreement);
+Added: following the closing, the Company may be obligated to deliver contingent stock consideration
+Added: to NeurMedix (or its successor) consisting of up to 18.0 million shares of BioVies common stock, with 4.5 million shares
+Added: issuable upon the achievement of each of the four milestones set forth in the Asset Purchase Agreement, subject to a cap limiting
+Added: the issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5%
+Added: of BioVies issued and outstanding common.
+Added: (See Note 5 Related Party Transactions - Equity Transactions with Acuitas
+Added: and Going Concern
+Added: Companys operations are subject to a number of factors that can affect its operating results and financial conditions.
+Added: Such factors include, but are not limited to:
+Added: the results of clinical testing and trial activities of the Companys products,
+Added: the Companys ability to obtain regulatory approval to market its products, competition from products manufactured and sold
+Added: or being developed by other companies, the price of, and demand for, Company products, the Companys ability to negotiate
+Added: favorable licensing or other manufacturing and marketing agreements for its products, and the Companys ability to raise
+Added: The Companys financial statements have been prepared assuming the Company will continue as a going concern, which
+Added: contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
+Added: As of June 30, 2021,
+Added: the Company had working capital of approximately $ 3.6 million, cash of approximately $4.5 million, stockholders equity
+Added: of approximately $5.1 million, and an accumulated deficit of approximately $224.9 million.
+Added: In addition, the Company has not generated
+Added: any revenues to date and no revenues are expected in the foreseeable future.
+Added: The Companys future operations are dependent
+Added: on the success of the Companys ongoing development and commercialization effort, as well as continuing to secure additional
+Added: The cash payments required to close on the purchase of the biopharmaceutical assets from NeurMedix had a significant
+Added: impact on the Companys cash position.
+Added: On August 11, 2021, the Company closed a capital raise issuing 2.5 million shares
+Added: of commons stock at $8.00 per share and increased cash by the net proceeds of approximately $17.8 million.
+Added: Although the increase
+Added: in the cash balance could possibly sustain operations over the next 12 months if measures are taken to delay planned expenditures
+Added: in our research protocols and slow the progress in the Companys clinical programs, the Companys current planned
+Added: operations to meet certain goals and objectives, project cash flows to be depleted within that period of time.
+Added: future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations.
+Added: expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.
+Added: The emergence
+Added: of widespread health emergencies or pandemics such as coronavirus (COVID-19) and its variants, may lead to continued
+Added: regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability, including
+Added: the duration and spread of the outbreak and restrictions and the impact of COVID-19 and its variants on the financial markets
+Added: and the overall economy, all of which are highly uncertain and cannot be predicted.
+Added: If the financial markets and/or the overall
+Added: economy are impacted for an extended period, the Companys ability to raise funds may be materially adversely affected.
+Added: management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient
+Added: financing on terms acceptable to the Company, if at all, to fund continuing operations.
+Added: These circumstances raise substantial
+Added: doubt on the Companys ability to continue as a going concern.
+Added: The financial statements do not include any adjustments that
+Added: might result from the outcome of this uncertainty.
+Added: Accounting Policies
+Added: of Presentation
+Added: Companys financial statements have been prepared in accordance with accounting principles generally accepted in the United
+Added: States (GAAP) and include all adjustments necessary for the fair presentation of the Companys financial position
+Added: for the periods presented.
+Added: preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect
+Added: the amounts reported in the financial statements and accompanying notes.
+Added: The Company bases its estimates on historical experience
+Added: and on various assumptions that are believed to be reasonable under the circumstances.
+Added: The amounts of assets and liabilities reported
+Added: in the Companys balance sheet and the amounts of expenses reported for each of the periods presented are affected by estimates
+Added: and assumptions, which are used for, but not limited to, accounting for share-based compensation, accounting for derivatives and
+Added: accounting for income taxes.
Actual results could differ from those estimates.
−Removed: The Company considers all highly liquid instruments
−Removed: with original maturities of three months or less to be cash equivalents.
−Removed: Cash is maintained at one financial institution and, at
−Removed: times, balances may exceed federally insured limits.
−Removed: The Company has never experienced any losses related to these balances.
−Removed: Other assets consists of direct costs related
−Removed: to capital raise and filing of the registration statement legal fees and investment banking fees incurred to raise capital.
−Removed: costs will be offset against proceeds received once the Company raises the capital.
−Removed: Fair Value of Financial Instruments
−Removed: Fair value is defined as the price
−Removed: that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants
−Removed: at the measurement date.
−Removed: When determining the fair value for applicable assets and liabilities, we consider the principal or most
−Removed: advantageous market in which we would transact and we consider assumptions market participants would use when pricing the asset
−Removed: or liability, such as inherent risk, transfer restrictions, and risk of nonperformance.
−Removed: This guidance also establishes a fair value
−Removed: hierarchy to prioritize inputs used in measuring fair value as follows:
+Added: Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents.
+Added: is maintained at two financial institutions, and, at times, balances may exceed federally insured limits.
+Added: The Company has never
+Added: experienced any losses related to these balances.
+Added: assets consist of direct costs related to capital raise and filing of the registration statement legal fees and investment banking
+Added: fees incurred to raise capital.
+Added: The costs will be offset against proceeds received once the Company raises the capital.
+Added: Value of Financial Instruments
+Added: value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction
+Added: between market participants at the measurement date.
+Added: When determining the fair value for applicable assets and liabilities, we
+Added: consider the principal or most advantageous market in which we would transact and we consider assumptions market participants
+Added: would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance.
+Added: guidance also establishes a fair value hierarchy to prioritize inputs used in measuring fair value as follows:
Observable inputs such as quoted prices in active markets;
1 unchanged sentence
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Significant Accounting Policies (continued)
−Removed: The Company’s financial instruments
−Removed: include cash, accounts payable, related party loans and a demand promissory note.
−Removed: The carrying amounts of cash and accounts payable
−Removed: approximate their fair value, due to the short-term nature of these items.
−Removed: Loan Pursuant to Paycheck Protection Program
−Removed: The Company received $62,500 in loan proceeds pursuant to the Paycheck
−Removed: Protection Program (“PPP”), under the Coronavirus Aid
−Removed: Relief and Economic Security (CARES) Act.
+Added: Companys financial instruments include cash, accounts payable, related party loans and a demand promissory note.
+Added: amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items.
+Added: Pursuant to Paycheck Protection Program
+Added: Company received $ 62,500 in loan proceeds pursuant to the Paycheck Protection Program (PPP), under the Coronavirus
+Added: Aid Relief and Economic Security (CARES) Act.
The PPP Loan is evidenced by a loan application and payment agreement by and between
4 unchanged sentences
interest at an annual rate of 1%.
−Removed: The PPP is subject to 100% forgiveness.
−Removed: Currently, the application process to apply forgiveness
−Removed: occurs 24 weeks after the funding date.
−Removed: The Company intends to file the application for forgiveness, accordingly, unless the pending
−Removed: outcome of a new ruling is approved that forgives all the PPP loans under $160,000.
−Removed: There can be no assurance that such forgiveness
−Removed: The Company is accounting for the loan as debt and if forgiveness is granted the Company will recognize a gain on extinguishment.
−Removed: Research and Development
−Removed: Research and development expenses
−Removed: consist primarily of costs associated with the preclinical and/ or clinical trials of drug candidates, compensation and other expenses
−Removed: for research and development, personnel, supplies and development materials, costs for consultants and related contract research
−Removed: and facility costs.
+Added: On June 28, 2021, the Company received confirmation that the Small Business Administrations
+Added: PPP loan was forgiven and recognized the loan forgiveness as gain on extinguishment of debt in the accompanying Statements of
+Added: and Development
+Added: and development expenses consist primarily of costs associated with the preclinical and/ or clinical trials of drug candidates,
+Added: compensation and other expenses for research and development, personnel, supplies and development materials, costs for consultants
+Added: and related contract research and facility costs.
Expenditures relating to research and development are expensed as incurred.
−Removed: The Company uses the asset and liability
−Removed: method of accounting for deferred income taxes.
−Removed: Deferred income taxes are measured by applying enacted statutory rates to net operating
−Removed: loss carryforwards and to the differences between the financial reporting and tax bases of assets and liabilities.
−Removed: assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred
−Removed: tax assets will not be realized.
−Removed: The Company recognizes uncertainty
−Removed: in income taxes in the financial statements using a recognition threshold and measurement attribute of a tax position taken or
−Removed: expected to be taken in a tax return.
−Removed: The Company applies the “more-likely-than-not”
−Removed: recognition threshold to all tax
−Removed: positions, commencing at the adoption date of the applicable accounting guidance, which resulted in no unrecognized tax benefits
−Removed: as of such date.
+Added: In the fiscal year ended June 30, 2021 the company recorded the assets acquired totaling approximately $130.6 million from NeurMedix,
+Added: a controlled affiliate of Acuitas, our majority shareholder, that were under development as research and development expenses
+Added: in the accompanying Statements of Operations.
+Added: See Note 1 - Background Information.
+Added: Company uses the asset and liability method of accounting for deferred income taxes.
+Added: Deferred income taxes are measured by applying
+Added: enacted statutory rates to net operating loss carryforwards and to the differences between the financial reporting and tax bases
+Added: of assets and liabilities.
+Added: Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not
+Added: that some portion or all of the deferred tax assets will not be realized.
+Added: Company recognizes uncertainty in income taxes in the financial statements using a recognition threshold and measurement attribute
+Added: of a tax position taken or expected to be taken in a tax return.
+Added: The Company applies the more-likely-than-not
+Added: recognition threshold to all tax positions, commencing at the adoption date of the applicable accounting guidance, which resulted in
+Added: no unrecognized tax benefits as of such date.
Additionally, there have been no unrecognized tax benefits subsequent to adoption.
−Removed: The Company has opted to classify
−Removed: interest and penalties that would accrue, if any, according to the provisions of relevant tax law as general and administrative
−Removed: expenses, in the statements of operations.
−Removed: For the years ended June 30, 2020 and 2019 there was no such interest or penalty.
−Removed: Net Loss per Common Share
−Removed: Basic net loss per common share is computed
−Removed: by dividing the net loss before deemed dividend by the weighted average number of shares of common stock outstanding during the
−Removed: Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock
−Removed: outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur
−Removed: from common shares issuable through stock options, warrants, convertible preferred stock and convertible debentures.
−Removed: net loss for the period, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Significant Accounting Policies (continued)
−Removed: The table below shows the number of
−Removed: outstanding stock options and warrants as of June 30, 2020 and June 30, 2019:
+Added: Company has opted to classify interest and penalties that would accrue, if any, according to the provisions of relevant tax law as
+Added: general and administrative expenses, in the Statements of Operations.
+Added: For the years ended June 30, 2021 and 2020, there was no such
+Added: interest or penalty.
+Added: Loss per Common Share
+Added: 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 during the period.
+Added: Diluted net loss per common share is computed by dividing the net loss
+Added: attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding
+Added: shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through
+Added: stock options, warrants, and convertible debentures.
+Added: For the years ended June 30, 2021 and 2020, such amounts were excluded from
+Added: the diluted loss since their effect was considered anti-dilutive due to the net loss for the year.
+Added: table below shows the number of outstanding stock options and warrants as of June 30, 2021 and June 30, 2020:
+Added: Schedule of Dilutive securities were excluded from the computation of diluted loss per share
June 30, 2021
June 30, 2020
−Removed: Number of Shares
−Removed: Number of Shares
Stock Options
−Removed: Stock-based Compensation
−Removed: The Company has accounted for stock-based
−Removed: compensation under the provisions of FASB ASC 718 –
−Removed: “Stock Compensation”
−Removed: which requires the use of the fair-value
−Removed: based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity
−Removed: instruments (stock options and common stock purchase warrants).
−Removed: For employee awards, the fair value of each stock option award
−Removed: is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected
−Removed: 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,
−Removed: expected term, and the risk-free interest rate.
−Removed: For non-employees, the Company utilizes the graded vesting attribution method under
−Removed: which the entity treats each separately vesting portion (tranche) as a separate award and recognizes compensation cost for each
−Removed: tranche over its separate vesting schedule.
−Removed: Expected volatilities are based on historical volatility of peer companies and other
−Removed: factors estimated over the expected term of the stock options.
−Removed: For employee awards, the expected term of options granted is derived
−Removed: using the “simplified method”
−Removed: which computes expected term as the average of the sum of the vesting term plus the contract
+Added: Company has accounted for stock-based compensation under the provisions of FASB ASC 718 – Stock Compensation
+Added: which requires the use of the fair-value based method to determine compensation for all arrangements under which employees and
+Added: others receive shares of stock or equity instruments (stock options and common stock purchase warrants).
+Added: For employee awards,
+Added: 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
+Added: fair value of each stock option award is estimated on the measurement date using the Black-Scholes valuation model that uses assumptions
+Added: for expected volatility, expected dividends, expected term, and the risk-free interest rate.
+Added: For non-employees, the Company utilizes
+Added: 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
+Added: volatility of peer companies and other factors estimated over the expected term of the stock options.
+Added: For employee awards, the
+Added: expected term of options granted is derived using the simplified method which computes expected term as the average
+Added: of the sum of the vesting term plus the contract term.
The risk-free rate is based on the U.S.
−Removed: Treasury yield curve in effect at the time of grant for the period of the expected
−Removed: We recognize forfeitures as they occur.
−Removed: Goodwill is recorded when the purchase price
−Removed: paid for an acquisition exceeds the fair value of net identified tangible and intangible assets acquired.
−Removed: The Company performs
−Removed: an annual impairment test of goodwill and further periodic tests to the extent indicators of impairment develop between annual
−Removed: impairment tests.
−Removed: The Company’s impairment review process compares the fair value of the reporting unit to its carrying value,
−Removed: 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
−Removed: may require the Company to make certain estimates and assumptions including future cash flows, revenue and expenses.
−Removed: These estimates
−Removed: and assumptions are reviewed each time the Company tests goodwill for impairment and are typically developed as part of the Company’s
−Removed: routine business planning and forecasting process.
−Removed: While the Company believes its estimates and assumptions are reasonable, variations
−Removed: from those estimates could produce materially different results.
−Removed: The Company did not recognize any goodwill impairments for the
−Removed: years ended June 30, 2020 and 2019.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Significant Accounting Policies (continued)
−Removed: Impairment of Long-Lived Assets
−Removed: Long-lived assets, including intangible
−Removed: assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may
−Removed: not be recoverable.
−Removed: Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset
−Removed: to estimated undiscounted future cash flows expected to be generated by the asset.
−Removed: If the carrying amount of an asset exceeds
−Removed: its undiscounted estimated future cash flows, an impairment review is performed.
−Removed: An impairment charge is recognized in the amount
−Removed: by which the carrying amount of the asset exceeds the fair value of the asset.
−Removed: Generally, fair value is determined using valuation
−Removed: techniques such as expected discounted cash flows or appraisals, as appropriate.
−Removed: Assets to be disposed of would be separately presented
−Removed: in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated
−Removed: or amortized.
−Removed: The assets and liabilities of a disposed group classified as held for sale would be presented separately in the appropriate
−Removed: asset and liability sections of the balance sheet.
−Removed: Reclassifications
−Removed: Certain prior year amounts have been reclassed for consistency with current year presentation.
−Removed: These reclassifications
−Removed: had no effect on the reported results of operations.
−Removed: Recent accounting pronouncements
−Removed: The Company considers the applicability and
−Removed: impact of all Accounting Standard Updates (“ASU’s”).
−Removed: ASU’s not discussed below were assessed and determined
−Removed: to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.
−Removed: In June 2018, the FASB issued ASU 2018-07,
−Removed: “Compensation –
−Removed: Stock Compensation (Topic 718):
−Removed: Improvements to Non-employee Share-Based Accounting”.
−Removed: This guidance
−Removed: aligns the accounting for share-based payment transactions with non-employees to accounting for share-based payment transactions
−Removed: with employees.
−Removed: Companies are required to record a cumulative-effect adjustment (net of tax) to retained earnings as of the beginning
−Removed: of the fiscal year of the adoption.
−Removed: Upon transition, non-employee awards are required to be measured at fair value as of the adoption
−Removed: This standard will be effective for fiscal years beginning December 15, 2018, including interim periods within those fiscal
−Removed: Early adoption is permitted.
−Removed: The Company’s adoption of this ASU as of July 1, 2019 had no impact on the financial statements.
−Removed: In August 2018, the FASB issued ASU 2018-13,
−Removed: “Fair value measurement (Topic 820):
−Removed: Disclosure Framework –
−Removed: Changes to the Disclosure Requirements for Fair Value Measurement”.
−Removed: The new guidance modifies the disclosure requirements on fair value measurements.
−Removed: ASU 2018-13 is effective for fiscal years beginning
−Removed: after December 15, 2019.
−Removed: Early adoption is permitted.
−Removed: The Company does not expect ASU 2018-13 to have a significant impact to its
−Removed: financial statements and related disclosures.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Intangible Assets
−Removed: The Company’s
−Removed: intangible assets consist of intellectual property acquired from LAT Pharma, Inc.
−Removed: and are amortized over their estimated useful
−Removed: The following is a summary of the intangible assets as of June 30, 2020 and 2019:
+Added: Treasury yield curve in effect
+Added: at the time of grant for the period of the expected term.
+Added: The Company recognizes forfeitures as they occur.
+Added: is recorded when the purchase price paid for an acquisition exceeds the fair value of net identified tangible and intangible assets
+Added: The Company performs an annual impairment test of goodwill and further periodic tests to the extent indicators of impairment
+Added: develop between annual impairment tests.
+Added: The Companys impairment review process compares the fair value of the reporting
+Added: unit to its carrying value, including the goodwill related to the reporting unit.
+Added: To determine the fair value of the reporting
+Added: unit, the Company may use various approaches including an asset or cost approach, market approach or income approach or any combination
+Added: These approaches may require the Company to make certain estimates and assumptions including future cash flows, revenue
+Added: and expenses.
+Added: These estimates and assumptions are reviewed each time the Company tests goodwill for impairment and are typically
+Added: developed as part of the Companys routine business planning and forecasting process.
+Added: While the Company believes its estimates
+Added: and assumptions are reasonable, variations from those estimates could produce materially different results.
+Added: The Company did not
+Added: recognize any goodwill impairments for the years ended June 30, 2021 and 2020.
+Added: of Long-Lived Assets
+Added: assets, including intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the
+Added: carrying amount of an asset may not be recoverable.
+Added: Recoverability of assets to be held and used is measured by a comparison of
+Added: the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset.
+Added: the carrying amount of an asset exceeds its undiscounted estimated future cash flows, an impairment review is performed.
+Added: An impairment
+Added: charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset.
+Added: Generally, fair
+Added: value is determined using valuation techniques such as expected discounted cash flows or appraisals, as appropriate.
+Added: be disposed of would be separately presented in the balance sheet and reported at the lower of the carrying amount or fair value
+Added: less costs to sell, and are no longer depreciated or amortized.
+Added: The assets and liabilities of a disposed group classified as held
+Added: for sale would be presented separately in the appropriate asset and liability sections of the balance sheets.
+Added: Accounting for Transactions with Related Party
+Added: accounting for transactions with related party, entities under common control, are recorded at the historical carrying cost with
+Added: no step up in basis to the fair market value of the asset or liability are recognized.
+Added: Accounting Pronouncements
+Added: Company considers the applicability and impact of all Accounting Standards Updates (ASUs).
+Added: There were no
+Added: recent ASUs that are expected to have a material impact on our balance sheets or statements of operations.
+Added: Companys intangible assets consist of intellectual property acquired from LAT Pharma, Inc.
+Added: and are amortized over their
+Added: estimated useful lives.
+Added: The following
+Added: is a summary of the intangible assets as of June 30, 2021 and 2020:
June 30, 2021
2 unchanged sentences
Less Accumulated Amortization
+Added: ( 1,197,921 )
Intellectual Property, Net
−Removed: Amortization expense
−Removed: amounted to $229,377 for each of the years ended June 30, 2020 and
−Removed: 2019, respectively.
−Removed: The Company amortizes intellectual property over the expected original useful lives of 10 years.
−Removed: Estimated future amortization
−Removed: expense is as follows:
+Added: expense amounted to $229,377 for each of the years ended June 30, 2021 and 2020, respectively.
+Added: The Company amortizes intellectual
+Added: property over the expected original useful lives of 10 years.
+Added: future amortization expense is as follows:
+Added: Schedule of Future expected Amortization of intangible assets
Year ending June 30,
−Removed: Renegotiated Debt
−Removed: On July 19, 2018, Geis-Hides Consulting
−Removed: LLC entered into an Accord and Debt Satisfaction Agreement with the Company in which the consulting
−Removed: firm agreed to release the Company from all liabilities arising from the Original Contract and Debt Repayment Plan dated December
−Removed: 15, 2013 totaling $132,000 and received cash of $65,000 and 2,080 common shares in satisfaction.
−Removed: The common shares were valued
−Removed: at the market price on the date of settlement at $7.50 per common share.
−Removed: The gain of $51,400 on the settlement of debt was reflected
−Removed: on the Statements of Operations as “other income”
−Removed: for the year ended June 30, 2019.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Related Party Transactions
−Removed: On March 23, 2017,
−Removed: Barrett Ehrlich agreed to defer the payment of his consulting fee debt of $173,333 until December 31, 2019, through the issuance
−Removed: of a Promissory note.
−Removed: The promissory note does not carry any interest charge as long as the amount is paid in full before December
−Removed: The consulting fee debt was reclassified from a current liability to a long-term liability on the balance sheet.
−Removed: portion of the balance due under the note that remains unpaid after December 31, 2019 will accrue interest at a rate
−Removed: of 5% per annum until paid in full.
−Removed: On August 8, 2018, Barrett Ehrlich (Independent
−Removed: contractor, related party to Elliot Ehrlich and shareholder) on behalf of The Barrett Edge Inc.
−Removed: (“Barrett”) entered into an Accord and Debt Satisfaction Agreement with the Company in which Barrett agreed to release
−Removed: the Company from all liabilities including the original contract to defer payment of accrued consulting fees dated March 23, 2017,
−Removed: the promissory note issued by the Company to defer payment of accrued consulting fees;
−Removed: loan to the Company for $14,000, and subsequent
−Removed: unpaid consulting fees, totaling $543,014, and received cash of $131,333 and 3,947 common shares in satisfaction.
−Removed: The common shares
−Removed: were valued at the market price on the date of settlement at $16.25 per common share.
−Removed: The gain of $361,548 on the settlement of
−Removed: debt was reflected in the additional paid in capital for the year ended June 30, 2019.
−Removed: On March 23, 2017,
−Removed: Elliot Ehrlich agreed to forgive 50% of his salary debt of $444,056.
−Removed: The adjusted salary debt is $222,028.
−Removed: Elliot Ehrlich
−Removed: also agreed to defer the payment of his salary debt of $222,028 until December 31, 2019, through the issuance of a Promissory
−Removed: The promissory note does not carry any interest charge as long as the amount is paid in full before December 31,
−Removed: The salary debt was reclassified from a current liability to a long-term liability on the balance sheet and the salary
−Removed: debt forgiven had been reflected on the income statement as other income.
−Removed: Any portion of the balance due under the note that
−Removed: remains unpaid after December 31, 2019 will accrue interest at a rate of 5% per annum until paid in full.
−Removed: On July 9, 2018, Elliot Ehrlich (former
−Removed: CEO and shareholder) entered into an Accord and Debt Satisfaction Agreement with the
−Removed: Company in which he agreed to release the Company from all liabilities including the original contract to defer payment of accrued
−Removed: salary dated March 23, 2017, totaling the amount of $222,028 the promissory note issued by the Company to defer payment of accrued
−Removed: and received cash of $22,273 and 1,777 common shares in satisfaction.
−Removed: The common shares were valued at the market price
−Removed: on the date of settlement at $7.50 per common share.
−Removed: The gain of $186,503 on the settlement of debt was reflected in the additional
−Removed: paid in capital for the year ended June 30, 2019.
−Removed: On March 23, 2017,
−Removed: Jonathan Adams agreed to defer the payment of his salary debt of $180,555 until December 31, 2019, through the issuance of
−Removed: a Promissory note.
−Removed: The promissory note does not carry any interest charge as long as the amount is paid in full before December
−Removed: The salary debt was reclassified from a current liability to a long-term liability on the balance sheet.
−Removed: portion of the balance due under the note that remains unpaid after December 31, 2019 will accrue interest at a rate
−Removed: of 5% per annum until paid in full.
−Removed: On July 9, 2018, Jonathan
−Removed: Adams (COO) entered into an Accord and Debt Satisfaction Agreement with the Company in which he agreed to release the Company from
−Removed: all liabilities including the original contract to defer payment of his accrued salary dated March 23, 2017, the promissory note
−Removed: issued by the Company to defer payment of accrued salary;
−Removed: and subsequent unpaid salary, totaling the amount of $534,722, and received
−Removed: cash of $25,694 in satisfaction.
−Removed: The gain of $509,028 on the settlement of debt was reflected in the additional paid in capital
−Removed: for the year ended June 30, 2019.
−Removed: The outstanding balance of the long-term
−Removed: note payable at June 30, 2019 was $0.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Related Party Transactions (continued)
−Removed: Equity Transactions with Acuitas
−Removed: On July 3, 2018, we entered into a Securities
−Removed: Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holding, LLC (“Acuitas”) and certain other
−Removed: purchasers identified in the Purchase Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the
−Removed: Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred
−Removed: Stock”) at a price per share of $1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to
−Removed: issue warrants (the “Warrants”) to purchase 1,706,666 shares of common stock, each subject to the terms and conditions
+Added: Intellectual Property, Net
+Added: Party Transactions
+Added: Acquisition with NeurMedix
+Added: April 27, 2021, the Company entered into an APA with NeurMedix and Acuitas, which are related party affiliates, pursuant to which
+Added: the Company acquired certain assets from NeurMedix and assumed certain liabilities of NeurMedix, in exchange for consideration
+Added: of cash and shares of common stock.
+Added: The acquired assets include, among others, those related to certain drug candidates being
+Added: developed by NeurMedix, including NE3107, a small molecule orally administered inhibitor of insulin resistance and the pathological
+Added: inflammatory cascade, with a novel mechanism of action that has potential applications for treatment against Alzheimers
+Added: Disease and Parkinsons Disease.
+Added: to the terms and conditions of the Asset Purchase Agreement, following the closing, the Company may be obligated to deliver contingent
+Added: stock consideration to NeurMedix (or its successor).
+Added: Previously, the Company was obligated to deliver contingent stock consideration
+Added: to NeurMedix (or its successor) consisting of shares of the Companys common stock having an aggregate value of up to $3.0
+Added: billion, subject to the achievement of certain clinical, regulatory and commercial milestones related to the drug candidates to
+Added: be acquired by the Company from NeurMedix, and subject to a cap limiting each issuance of shares if such issuance would result
+Added: in the beneficial ownership of NeurMedix and its affiliates exceeding 89.9999% of the Companys issued and outstanding common
+Added: Pursuant to the Amendment No.
+Added: 1 to the APA, dated May 9, 2021, the Company may now be obligated to deliver contingent stock
+Added: consideration to NeurMedix (or its successor) consisting of up to 18 million shares of BioVies common stock, with 4.5 million
+Added: shares issuable upon the achievement of each of the four milestones set forth in the APA, subject to a cap limiting the issuance
+Added: of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of the Companys
+Added: issued and outstanding common stock.
+Added: June 10, 2021, and pursuant to the Asset Purchase Agreement, the Company issued to Acuitas (as NeurMedixs assignee) 8,361,308
+Added: shares of the Companys common stock and made a cash payment of approximately $2.3 million, representing NeurMedixs
+Added: direct and documented cash expenditures to advance certain programs from March 1, 2021 through the closing date and cash payments
+Added: to other third parties for expenses totaling approximately $4.0 million for due diligence, legal fees, transaction fees and the
+Added: fairness opinion.
+Added: Since the transaction was between entities under common control, there were no fair value adjustments of the
+Added: purchased assets and the historical cost basis of the purchased assets was zero .
+Added: The total consideration paid was expensed as
+Added: research and development expense.
+Added: Transactions with Acuitas
+Added: September 22, 2020, concurrent with the closing of the Companys Offering, approximately $1.8 million was paid to Acuitas
+Added: satisfying all amounts owed on the Debenture due September 24, 2020 held by the Companys controlling stockholder, Acuitas.
+Added: Additionally,
+Added: in connection with the close of the public offering on September 22, 2020, the Company issued an aggregate of 6,909,582 shares
+Added: of Common Stock to Acuitas, representing (i) 5.4 million shares issuable pursuant to Acuitas rights under the Purchase
+Added: Agreement dated July 3, 2018, as amended on June 24, 2019 and October 9, 2019;
+Added: and the various extension letters as more fully
+Added: described below;
+Added: which resulted in a deemed dividend at the close of the public offering at price of $10 per share, consistent
+Added: with the Companys accounting policy;
+Added: and (ii) the automatic exercise of 1.5 million warrants issued to Acuitas in connection
+Added: with the Debenture financing at the par value of the Common Stock.
+Added: the year ended June 30, 2021, the Company received additional draws under the Debenture totaling $436,000.
+Added: The total draws as
+Added: of September 22, 2020 were $1.7 million and the related total number of warrants issuable at $4.00 per share of common stock was
+Added: 424,750 of which 328,250 warrants had been issued.
+Added: In accordance with the Debenture agreements, as more fully described below;
+Added: at September 22, 2020 upon the Companys close of its public offering, all the warrants issued related to the debenture
+Added: totaling 1,453,250 were mandatorily redeemed along with the additional 96,500 shares common stock issued to Acuitas.
+Added: following paragraphs summarize the background of those financings and arrangements which were settled and redeemed on September
+Added: July 3, 2018, we entered into a Securities Purchase Agreement (the Purchase Agreement) with Acuitas and certain
+Added: other purchasers identified in the Purchase Agreement (together with Acuitas, the Purchasers) pursuant to which
+Added: (i) the Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the Preferred
+Added: Stock) at a price per share of $1.50 per share of Preferred Stock (the Initial Sale) and (ii) we agreed to
+Added: issue warrants (the Warrants) to purchase 1,706,666 shares of common stock, each subject to the terms and conditions
set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million.
−Removed: We received $160,000 of the $3.2 million in
−Removed: April and May 2018 as prepaid equity.
−Removed: Acuitas also received an additional 6,667 Warrants in connection with the payoff of a note
−Removed: issued by us in favor of Acuitas.
+Added: We received $160,000 of the $3.2 million
+Added: in April and May 2018 as prepaid equity.
+Added: Acuitas also received an additional 6,667 Warrants in connection with the payoff of a
+Added: note issued by us in favor of Acuitas.
The Initial Sale and issuance of the Warrants occurred on July 3, 2018.
1 unchanged sentence
had the option to purchase up to an additional 1,600,000 shares of common stock at a price per share of $1.88, and warrants on
−Removed: the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the “Subsequent
−Removed: Sale”) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year
+Added: the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the Subsequent
+Added: Sale) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year
anniversary of the closing of the Initial Sale, less any federal or FDA grant funding received by the Company.
−Removed: Acuitas is controlled
−Removed: by our Chairman and Chief Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuong Do and
−Removed: Michael Sherman, who are members of our Board.
−Removed: The Purchase Agreement contained customary
−Removed: representations and warranties.
−Removed: In connection with the disclosure schedule associated with the representations and warranties,
−Removed: we also disclosed customary information, including the following:
−Removed: (i) the existence of the Mallinckrodt petition before the U.S.
−Removed: Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales
−Removed: of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge,
−Removed: pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation
−Removed: to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000
−Removed: per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy),
−Removed: and (v) certain recent issuances of common stock by us.
−Removed: Each share of Preferred Stock automatically converted into 1 share of common stock upon the filing
−Removed: with the Secretary of State of the State of Nevada of a Certificate of Amendment to our Articles of Incorporation (the “Amendment”)
−Removed: on August 13, 2018 that increased the number of authorized shares of common stock to 800,000,000.
−Removed: The Amendment was approved by
−Removed: the written consent of the holders of more than a majority of our issued and outstanding common stock on July 3, 2018 and was filed
−Removed: with the Secretary of State of the State of Nevada 20 calendar days following the distribution of our Definitive Information Statement
−Removed: on Schedule 14 that was filed with the SEC on July 13, 2018.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Related Party Transactions (continued)
−Removed: Pursuant to a letter agreement dated
−Removed: June 24, 2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:
−Removed: Acuitas agreed to immediately exchange its existing 1,606,667 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless exercise thereof at an assumed current market price of $45.00 per share and, as a result received an aggregate of 95% of the shares covered thereby, or 1,526,094 shares of common stock;
−Removed: Acuitas agreed to (i) waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase”
−Removed: at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of our common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 1,339,958 shares of common stock (the “Subsequent Sale Shares”) to Acuitas, which is expected to occur concurrently with the closing of our potential public offering and listing on Nasdaq;
−Removed: Acuitas shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned above.
−Removed: Convertible Debenture Transaction with Acuitas
−Removed: On September 24, 2019, the Company entered
−Removed: into a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed
−Removed: to purchase a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 for an aggregate
−Removed: commitment amount of up to $2.0 million, and (ii) the Company issued 1,125,000 shares (the “Commitment Shares”) of
−Removed: the Company’s common stock and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each
−Removed: subject to the terms and conditions set forth in the 2019 Purchase Agreement.
−Removed: The Debenture accrues additional principal at the
−Removed: rate of 6% per annum and interest at the rate of 10% per annum, is convertible into shares of common stock at $4.00 per share prior
−Removed: to the completion of the company’s planned public offering of units (the “Public Offering”) or, subsequent to
−Removed: the closing of the Public Offering, the lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering
−Removed: and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption.
−Removed: The Commitment Warrants are five-year warrants, exercisable upon the earlier of the effectiveness of the Company’s current
−Removed: reverse stock split or December 1, 2019, at an amount equal to the lower of $4.00 or 80% of the offering price per unit to the
−Removed: public in the Public Offering.
−Removed: Upon entering into the 2019 Purchase Agreement, the Company drew an initial $500,000 under the Debenture
−Removed: and in accordance with the 2019 Purchase Agreement, Acuitas received an additional 125,000 warrants (the “Bridge Warrants”)
−Removed: having the same terms as the Commitment Warrants.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Related Party Transactions (continued)
−Removed: Any future draws under the Debenture, which
−Removed: may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000 each, will entitle
−Removed: Acuitas to receive additional Bridge Warrants in equal amount upon such funding.
−Removed: In addition, the 2019 Purchase Agreement provides
−Removed: that, should the underwriters in the Public Offering exercise their option to purchase additional securities during the 45 days
−Removed: following closing and the issuance of such securities would result in Acuitas' beneficial ownership (on a fully diluted basis)
−Removed: of shares of common stock being below 60%, Acuitas shall be issued a number of additional shares of common stock and warrants having
−Removed: the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common
−Removed: stock equaling 60%.
−Removed: The issuance of 1,125,000 shares of the Company’s
−Removed: commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing
−Removed: was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the excess of the fair value
−Removed: of the consideration given for the financing, net of debt discount;
−Removed: was recorded in accumulated deficit for the year ended June
−Removed: 30,2020, accordingly.
−Removed: A debt discount of $500,000 against the debenture was recorded which will be amortized over the term of the
−Removed: debenture using the effective interest method.
−Removed: The Company recognized amortization of the discount for the year ended June 30,
−Removed: 2020 of $37,136.
−Removed: The Company received draws under the Debenture that totaled approximately $1.3 million during the year
−Removed: ended June 30, 2020.
−Removed: The total interest expense related to the draws under the Debenture was approximately $99,000 for the year
−Removed: ended June 30, 2020.
−Removed: On April 1, 2020 the Company entered into an amendment to modify the payment of accrued interest amounts under
−Removed: the original terms of the Debenture to capitalize all such amounts as would otherwise accrue on the Debenture.
−Removed: On January 4, 2020,
−Removed: payment of $13,487 accrued interest due was paid through the issuance of 4,422 shares of the Company’s common stock.
−Removed: and the Company continue to discuss the need and timing for some or all the remaining draws under the Debenture Agreement.
−Removed: Subsequent to the initial $500,000 draw on September 24, 2019, the Company received draws that totaled $813,000 as July 13, 2020,
−Removed: and accordingly;
−Removed: the Company issued additional Bridge Warrants to purchase 203,250 shares of common stock to its controlling stockholder
−Removed: under the terms of the Bridge Financing.
−Removed: Accordingly, on April 16, 2020, the Company recorded the warrants to purchase 125,000
−Removed: common stock related to the second $500,000 draw under the debenture as a derivative warrant liability as of June 30, 2020.
−Removed: Company recorded the warrants related to the draws totaling $313,000 to purchase 78,250 common shares as derivative liabilities.
−Removed: The draws under the Debenture received subsequent to September 24, 2019 were previously reflected as note payable –
−Removed: party in the previous filed 10-Q for the fiscal year ended June 30, 2020.
−Removed: During the fourth quarter the note payable -related party,
−Removed: were reclassified as the Debenture in the accompanying balance sheet at June 30, 2020, in accordance with the letter agreement
−Removed: of July 14, 2020 which re-confirmed the understanding between the Company and Acuitas regarding the certain amounts funded to BioVie
−Removed: that were intended as “partial draws”.
−Removed: See below for discussion regarding the letter agreement of July 14, 2020.
−Removed: Pursuant to the 2019 Purchase Agreement, Acuitas
−Removed: has agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’
−Removed: previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July
−Removed: 2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event
−Removed: of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase
−Removed: securities in a Subsequent Sale pursuant to a “cashless purchase”
−Removed: at an assumed current market price of approximately
−Removed: $11.25 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0
−Removed: million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that
−Removed: Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale
−Removed: and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an
−Removed: aggregate of 2,679,916 shares of common stock and 2,679,916 warrants having the same terms as the Commitment Warrants to Acuitas,
−Removed: upon the closing of the Public Offering.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Related Party Transactions (continued)
−Removed: Pursuant to an amendment to the 2019 Purchase
−Removed: Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:
−Removed: The Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the common stock;
−Removed: Acuitas' existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement);
−Removed: The provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas’
−Removed: beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas’
−Removed: fully diluted beneficial ownership after the exercise of such option being the same as prior thereto.
−Removed: On July 14, 2020, the Company, entered into
−Removed: a further extension of its letter agreements dated April 8, 2020, that furthered extended its letter agreement dated February 10,
−Removed: 2020 with Acuitas regarding Acuitas’
−Removed: previous agreement to modify its existing rights under the Purchase Agreement dated
−Removed: July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase price applicable to
−Removed: its initial investment in the Company and the exercise price of the warrants received in such transaction and the price per share
−Removed: should it exercise certain rights to purchase additional securities in the event of certain reductions in the useful life of the
−Removed: Company’s intellectual property rights and commitment to purchase such securities upon the closing of the Company’s
−Removed: planned public offering of shares of Class A common stock (the “Common Stock”) as described in its Registration Statement
−Removed: on Form S-1 (File No.
−Removed: 333-231136) and commitment to purchase such additional securities would remain effective until October 31,
−Removed: 2020, and accordingly Acuitas shall be entitled to receive an aggregate of 5,359,832 shares of Common Stock at such closing.
−Removed: addition, the parties agreed that certain draws under the Company’s current bridge financing with Acuitas were to be made
−Removed: based with respect to the Company’s ongoing capital requirements and current market conditions, notwithstanding certain scheduled
−Removed: availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued in connection therewith.
−Removed: The letter agreement
−Removed: of July 14, 2020 also confirmed the understanding between the Company and Acuitas regarding certain amounts funded to BioVie that
−Removed: were intended as “partial draws”
−Removed: of credit available under the Debenture which, as of the date hereof aggregated $813,000
−Removed: in aggregate principal amount in additional to amounts initial funded under the Debenture.
−Removed: Accordingly, such “partial draws”
−Removed: shall accrue additional principal as amounts otherwise funded pursuant to the original schedule of draws included in the Debenture
−Removed: (as modified by the letter agreement between BioVie and Acuitas dated April 1, 2020 regarding the capitalization of interest otherwise
−Removed: payable) and shall entitle Acuitas to receive a pro rata amount of Bridge Warrants.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Commitments and Contingencies
−Removed: On July 1, 2019, the Company’s office
−Removed: moved with Acuitas’
−Removed: new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404.
−Removed: There is no lease agreement for
−Removed: the new premises and the Company continues to accrue monthly lease payments of $1,000 for the new office under the terms of the
−Removed: previous month-to-month lease for the previous premises which may be cancelled upon 30 days’
−Removed: written notice.
−Removed: Challenge to US Patent
−Removed: On April 30, 2018, we received notice that
−Removed: Mallinckrodt had petitioned the U.S.
−Removed: Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our
−Removed: 9,655,945 titled “Treatment of Ascites”
−Removed: (the “’945 patent”).
−Removed: Inter Partes Review
−Removed: is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more
−Removed: claims of a patent.
−Removed: Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents
−Removed: and printed publications.
−Removed: On November 13, 2019, the Patent Trial and
−Removed: Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter
−Removed: partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”)
−Removed: against BioVie Inc.
−Removed: (“BioVie”
−Removed: or “Company”).
−Removed: In that action, Mallinckrodt sought to invalidate BioVie’s
−Removed: 9,655,945, “Treatment of Ascites”) (the “’945 Patent”).
−Removed: In its decision, the
−Removed: Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in
−Removed: light of prior art.
−Removed: The Board also denied BioVie’s Motion to Amend the claims on similar grounds.
−Removed: The result of the Board’s
−Removed: decision is that the ‘945 patent is no longer valid or enforceable.
−Removed: Acuitas Group Holdings, LLC was aware of this patent
−Removed: challenge when it purchased a majority ownership interest in the company in July 2018.
−Removed: This ruling is unrelated to the Company’s
−Removed: Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged.
−Removed: An Orphan drug that
−Removed: is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s).
−Removed: the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations
−Removed: of terlipressin for use in its planned Phase 2 and Phase 3 trials, subject to FDA clearance, which could eventually provide up
−Removed: to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent
−Removed: issues from a patent application according to the patent laws of each issuing country.
−Removed: Royalty Agreements
−Removed: Pursuant to the Agreement and Plan of Merger
−Removed: entered into on April 11, 2016 between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated
−Removed: to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members,
+Added: is controlled by our Chairman and Chief Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang,
+Added: Cuong Do and Michael Sherman, who are members of our Board.
+Added: Purchase Agreement contained customary representations and warranties.
+Added: In connection with the disclosure schedule associated with
+Added: the representations and warranties, we also disclosed customary information, including the following:
+Added: (i) the existence of the
+Added: Mallinckrodt petition before the U.S.
+Added: Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low
+Added: single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members,
PharmaIN Corporation and The Barrett Edge, Inc.
−Removed: The Company and PharmaIN Corporation, LAT
−Removed: Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but
−Removed: not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug
−Removed: development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues.
−Removed: On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development
−Removed: program and simultaneously paid the remaining balance due on a related debt.
−Removed: PharmaIN, Corp.
−Removed: rights to our program remain
−Removed: Additionally the Company obligation to pay a low single digit royalty on the net sales of BIV201 (continuous
−Removed: infusion terlipressin) to be shared among LAT Pharma LLC members, and The Barrett Edge, Inc.
−Removed: pursuant to the Agreement and
−Removed: Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC.
−Removed: The Company has an obligation to pay a low single digit
−Removed: royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant
−Removed: to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy).
−Removed: Pursuant to the Technology Transfer Agreement entered into on July
−Removed: 25, 2016 between BioVie and the University of Padova (Italy), BioVie is obligated to pay a low single digit royalty on net sales
−Removed: of all terlipressin products covered by US patent no.
−Removed: 9,655,645 and any future foreign issuances capped at a maximum of $200,000
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Fair Value Measurements
−Removed: At June 30, 2020, the estimated fair value of derivative liabilities
−Removed: measured on a recurring basis are as follows:
+Added: pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between
+Added: LAT Pharma LLC and us, (iv) our obligation to pay a low single digit royalty on net sales of all terlipressin products covered
+Added: by specified patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016,
+Added: by and between us and the University of Padova (Italy), and (v) certain recent issuances of common stock by us.
+Added: share of Preferred Stock automatically converted into 1 share of common stock upon the filing with the Secretary of State of the
+Added: State of Nevada of a Certificate of Amendment to our Articles of Incorporation (the Amendment) on August 13, 2018
+Added: that increased the number of authorized shares of common stock to 800,000,000.
+Added: The Amendment was approved by the written consent
+Added: of the holders of more than a majority of our issued and outstanding common stock on July 3, 2018 and was filed with the Secretary
+Added: of State of the State of Nevada 20 calendar days following the distribution of our Definitive Information Statement on Schedule
+Added: 14 that was filed with the SEC on July 13, 2018.
+Added: to a letter agreement dated June 24, 2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:
+Added: agreed to immediately exchange its existing 1,606,667 Warrants for common stock such that it will have effectively exercised its
+Added: Warrants in full pursuant to a cashless exercise thereof at an assumed current market price of $45.00 per share and, as a result
+Added: received an aggregate of 95% of the shares covered thereby, or 1,526,094 shares of common stock;
+Added: agreed to (i) waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise
+Added: price of the Warrants and the price per share in the Subsequent Sale in the event of certain reductions in the useful life of
+Added: our current intellectual property rights, and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale
+Added: pursuant to a cashless purchase at an assumed current market price of approximately $11.25 per share, conditioned
+Added: in each case on the listing of our common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another
+Added: securities offering, in either case not later than November 30, 2019, which will result Acuitas having irrevocably waived its
+Added: rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants
+Added: and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 1,339,958 shares of common
+Added: stock (the Subsequent Sale Shares) to Acuitas, which is expected to occur concurrently with the closing of our potential
+Added: public offering and listing on Nasdaq;
+Added: shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and
+Added: warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1,
+Added: 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the Funding
+Added: Option), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share
+Added: the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned
+Added: Debenture Transaction with Acuitas
+Added: September 24, 2019, the Company entered into a Securities Purchase Agreement (the 2019 Purchase Agreement) with
+Added: Acuitas pursuant to which (i) Acuitas agreed to purchase a 10% OID Convertible Delayed Draw Debenture due September 24, 2020 for
+Added: an aggregate commitment amount of up to $2.0 million, and (ii) the Company issued 1,125,000 shares (the Commitment Shares)
+Added: of the Companys common stock and warrants (the Commitment Warrants) to purchase an equal number of shares,
+Added: each subject to the terms and conditions set forth in the 2019 Purchase Agreement.
+Added: The Debenture accrues additional principal
+Added: at the rate of 6% per annum and interest at the rate of 10% per annum, is convertible into shares of common stock at $4.00 per
+Added: share prior to the completion of the companys planned public offering of units (the Public Offering) or,
+Added: subsequent to the closing of the Public Offering, the lower of $4.00 or 80% of the offering price per unit to the public in the
+Added: Public Offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to
+Added: the date of redemption.
+Added: The Commitment Warrants are five-year warrants, exercisable upon the earlier of the effectiveness of the
+Added: Companys current reverse stock split or December 1, 2019, at an amount equal to the lower of $4.00 or 80% of the offering
+Added: price per unit to the public in the Public Offering.
+Added: Upon entering into the 2019 Purchase Agreement, the Company drew an initial
+Added: $500,000 under the Debenture and in accordance with the 2019 Purchase Agreement, Acuitas received an additional 125,000 warrants
+Added: (the Bridge Warrants) having the same terms as the Commitment Warrants.
+Added: future draws under the Debenture, which may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in
+Added: equal tranches of $500,000 each, will entitle Acuitas to receive additional Bridge Warrants in equal amount upon such funding.
+Added: In addition, the 2019 Purchase Agreement provides that, should the underwriters in the Public Offering exercise their option to
+Added: purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas
+Added: beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas shall be issued a number of
+Added: additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership
+Added: (on a fully diluted basis) of shares of common stock equaling 60%.
+Added: issuance of 1,125,000 shares of the Companys commons stock and warrants to purchase an equal amount number of shares, to
+Added: its controlling stockholder for the Bridge Financing was accounted for as a deemed dividend due to its related party nature and
+Added: $17.1 million representing the excess of the fair value of the consideration given for the financing, net of debt discount;
+Added: recorded in accumulated deficit for the year ended June 30, 2020, accordingly.
+Added: A debt discount of $500,000 against the debenture
+Added: was recorded which will be amortized over the term of the debenture using the effective interest method.
+Added: Company received draws under the Debenture that totaled approximately $1.3 million during the year ended June 30, 2020.
+Added: interest expense related to the draws under the Debenture was approximately $99,000 for the year ended June 30, 2020.
+Added: 1, 2020, the Company entered an amendment to modify the payment of accrued interest amounts under the original terms of the Debenture
+Added: to capitalize all such amounts as would otherwise accrue on the Debenture.
+Added: On January 4, 2020, payment of $13,487 accrued interest
+Added: due was paid through the issuance of 4,422 shares of the Companys common stock.
+Added: Acuitas and the Company continue to discuss
+Added: the need and timing for some or all the remaining draws under the Debenture Agreement.
+Added: Subsequent to the initial $500,000
+Added: draw on September 24, 2019, the Company received draws that totaled $813,000 as July 13, 2020, and accordingly;
+Added: the Company issued
+Added: additional Bridge Warrants to purchase 203,250 shares of common stock to its controlling stockholder under the terms of the Bridge
+Added: Accordingly, on April 16, 2020, the Company recorded the warrants to purchase 125,000 common stock related to the second
+Added: $500,000 draw under the debenture as a derivative warrant liability as of June 30, 2020.
+Added: The Company recorded the warrants related
+Added: to the draws totaling $313,000 to purchase 78,250 common shares as derivative liabilities.
+Added: to the 2019 Purchase Agreement, Acuitas has agreed to further modify its existing rights under the Purchase Agreement dated July
+Added: 3, 2018 with the Company so that Acuitas previous agreement in June 2019 to waive its rights to a 50% adjustment of the
+Added: purchase price of the Preferred Stock in the July 2018 transaction, the exercise price of the warrants in such transaction and
+Added: the price per share in a Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property
+Added: rights, and effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a cashless purchase
+Added: at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of the Companys
+Added: common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either
+Added: case not later than November 30, 2019, such that Acuitas will have irrevocably waived its rights to an adjustment in the purchase
+Added: price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in
+Added: the Subsequent Sale upon the issuance by us of an aggregate of 2,679,916 shares of common stock and 2,679,916 warrants having
+Added: the same terms as the Commitment Warrants to Acuitas, upon the closing of the Public Offering.
+Added: to an amendment to the 2019 Purchase Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019
+Added: Purchase Agreement so that:
+Added: Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar
+Added: terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the
+Added: common stock;
+Added: existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent
+Added: Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019
+Added: Purchase Agreement);
+Added: provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase
+Added: additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas
+Added: beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of
+Added: additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership
+Added: (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option
+Added: by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas fully diluted
+Added: beneficial ownership after the exercise of such option being the same as prior thereto.
+Added: July 14, 2020, the Company, entered into a further extension of its letter agreements dated April 8, 2020, that furthered extended
+Added: its letter agreement dated February 10, 2020 with Acuitas regarding Acuitas previous agreement to modify its existing rights
+Added: under the Purchase Agreement dated July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment
+Added: of the purchase price applicable to its initial investment in the Company and the exercise price of the warrants received in such
+Added: transaction and the price per share should it exercise certain rights to purchase additional securities in the event of certain
+Added: reductions in the useful life of the Companys intellectual property rights and commitment to purchase such securities upon
+Added: the closing of the Companys planned public offering of shares of Class A common stock (the Common Stock)
+Added: as described in its Registration Statement on Form S-1 (File No.
+Added: 333-231136) and commitment to purchase such additional securities
+Added: would remain effective until October 31, 2020, and accordingly Acuitas shall be entitled to receive an aggregate of 5,359,832
+Added: shares of Common Stock at such closing.
+Added: In addition, the parties agreed that certain draws under the Companys current bridge
+Added: financing with Acuitas were to be made based with respect to the Companys ongoing capital requirements and current market
+Added: conditions, notwithstanding certain scheduled availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued
+Added: in connection therewith.
+Added: The letter agreement of July 14, 2020 also confirmed the understanding between the Company and Acuitas
+Added: regarding certain amounts funded to BioVie that were intended as partial draws of credit available under the Debenture
+Added: which, as of the date hereof aggregated $813,000 in aggregate principal amount in additional to amounts initial funded under the
+Added: Accordingly, such partial draws shall accrue additional principal as amounts otherwise funded pursuant
+Added: to the original schedule of draws included in the Debenture (as modified by the letter agreement between BioVie and Acuitas dated
+Added: April 1, 2020 regarding the capitalization of interest otherwise payable) and shall entitle Acuitas to receive a pro rata amount
+Added: of Bridge Warrants.
+Added: Value Measurements
+Added: September 22, 2020, concurrent with the closing of the Offering;
+Added: the warrants related to derivative liabilities were automatically
+Added: exercised in full and the convertible Debenture was paid off in cash expiring the conversion option.
+Added: The fair value of the derivative
+Added: liabilities – warrants and derivative liability – conversion option on convertible Debenture prior to redemption at
+Added: September 22, 2020 was $13.1 million, and the change in the fair value of $8.3 million from June 30, 2020 was recorded in the
+Added: accompanying Statements of Operations.
+Added: At September 22, 2020, the derivative liabilities, both the warrants and expired conversion
+Added: option totaling $ 13.1 million were then recorded as additional paid in capital upon automatic exercise of the warrants and payoff
+Added: of the Debenture.
+Added: June 30, 2021 and 2020, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:
Fair Value Measurements at
3 unchanged sentences
Total derivatives
−Removed: The following table presents the activity for liabilities measured
−Removed: at fair value using unobservable inputs for the year ended June 30, 2020:
−Removed: Derivative liabilities - Warrants
+Added: Fair Value Measurements at
+Added: June 30, 2020
+Added: Derivative liability – Warrants
Derivative liability -Conversion option on convertible debenture
−Removed: Beginning balance at July 1, 2019
+Added: Total derivatives
+Added: following table presents the activity for liabilities measured at fair value using unobservable inputs for the year ended June
+Added: 30, 2021 and 2020:
+Added: liabilities –
+Added: Balance at July 1, 2019
Additions to level 3 liabilities
1 unchanged sentence
Transfer in and/or out of Level 3
+Added: Balance at July 1, 2020
+Added: Additions to level 3 liabilities
+Added: Change in in fair value of level 3 liability
+Added: ( 6,054,121 )
+Added: ( 2,225,798 )
+Added: Transfer in and/or out of Level 3
+Added: ( 10,357,383 )
+Added: ( 2,775,002 )
Balance at June 30, 2021
−Removed: Derivative liability –
−Removed: The Company accounts for stock purchase warrants
−Removed: as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements.
−Removed: Under applicable
−Removed: accounting guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet
−Removed: anti-dilution provisions or the adjustments to the strike price due to an occurrence of a future event;
−Removed: are accounted for as derivative
−Removed: financial instruments.
−Removed: The stock warrants issued September 24, 2019 were not considered indexed to the Company’s own stock because
−Removed: of the adjustment to strike price, an occurrence of a future event such as the Company’s pending capital raise.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Fair Value Measurements (continued)
−Removed: The warrants associated with the level 3 liability
−Removed: were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model with the following assumptions:
−Removed: of $8.95, exercise price of $4.00, term of 5 years expiring September 2024, volatility of 71.44%, dividend yield of 0%, and risk-free
−Removed: interest rate of 1.52%.
+Added: liability – Warrants
+Added: Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific
+Added: terms of the warrant agreements.
+Added: Under applicable accounting guidance, stock warrants that are precluded from being indexed to
+Added: the Companys own stock because of full-rachet anti-dilution provisions or the adjustments to the strike price due to an
+Added: occurrence of a future event;
+Added: are accounted for as derivative financial instruments.
+Added: The stock warrants issued September 24, 2019
+Added: were not considered indexed to the Companys own stock because of the adjustment to strike price, an occurrence
+Added: of a future event such as the Companys pending capital raise.
+Added: warrants associated with the level 3 liability were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model.
The valuation at June 30, 2020 used the following assumptions:
−Removed: stock price of $14, exercise price of $4.00,
−Removed: term of 4.25 year expiring September 2024, volatility of 78.12%, dividend yield of 0%, and risk-free interest rate of 0.24%.
−Removed: note 6 “Related Party Transactions –
−Removed: Convertible debenture transactions ”
−Removed: The warrants associated with the level 3 liability
−Removed: issued on April 16th, 2020 and were valued using the Black-Scholes-Merton model with the following assumptions:
stock price of $ 14 ,
−Removed: $3.95, exercise price of $4.00, term of 5 years expiring April 2025, volatility of 76.19%, dividend yield of 0%, and risk-free
−Removed: interest rate of 0.35%.
−Removed: The valuation at June 30, 2020 used the following assumptions:
−Removed: stock price of $14, exercise price of $4.00,
−Removed: term of 5 year expiring April 2025, volatility of 76.61%, dividend yield of 0%, and risk-free interest rate of 0.29%.
−Removed: 6 “Related Party Transactions –
−Removed: Convertible debenture transactions ”
−Removed: The warrants associated with the level 3 liability
−Removed: issued on June 30th, 2020 and were valued using the Black-Scholes-Merton model with the following assumptions:
+Added: exercise price of $ 4.00 ,
+Added: year expiring April 2025, volatility of 76.61 % ,
+Added: dividend yield of 0 % ,
+Added: and risk-free interest rate of 0.29 % .
+Added: The valuation at September 22, 2020 of the
+Added: warrants associated with equity financing prior to their automatic exercise in full used were the following assumptions:
+Added: price of $ 9.55 , exercise price of $ 4.00 , term of 4 year expiring September 2024, volatility of 79.69 % , dividend yield of 0 % , and
+Added: risk-free interest rate of 0.21 % .
+Added: (See note 5 Related Party Transactions)
+Added: liability – Conversion option in convertible debenture
+Added: The Company recognized a derivative liability
+Added: for the conversion option of the $2 million 10% OID Convertible Delayed Draw Debenture;
+Added: which may be convertible into shares of
+Added: common stock at $4.00 per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower
+Added: of $4.00 or 80% of the offering price per unit to the public in such offering and are mandatorily redeemable upon such closing
+Added: at 100% of the accrued principal amount and unpaid interest to the date of redemption.
+Added: The valuation at June 30, 2020 used the
+Added: following assumptions:
+Added: stock price of $ 14 , conversion price of $ 4.00 , term of 0.25 year expiring September 2020, volatility of
+Added: 62.47 % , dividend yield of 0 % , and risk-free interest rate of 0.16 % .
+Added: valuation at September 22, 2020 used the following assumptions:
stock price of $ 9.55 ,
−Removed: exercise price of $4.00, term of 5 years expiring June 2025, volatility of 76.61%, dividend yield of 0%, and risk-free interest
−Removed: rate of 0.29%.
−Removed: (See note 6 “Related Party Transactions –
−Removed: Convertible debenture transactions ”
−Removed: Derivative liability –
−Removed: option in convertible debenture
−Removed: The Company valued the conversion option of
−Removed: the $2 million 10% OID Convertible Delayed Draw Debenture which may be convertible into shares of common stock at $4.00 per share
−Removed: prior to the completion of an offering or, subsequent to the closing of the offering, the lower of $4.00 or 80% of the offering
−Removed: price per unit to the public in such offering and are mandatorily redeemable upon such closing at 100% of the accrued principal
−Removed: amount and unpaid interest to the date of redemption.
−Removed: (See note 6 “Related Party Transactions –
−Removed: Convertible debenture
−Removed: transactions with Acuitas ”
−Removed: as of September 24, 2019).
−Removed: The conversion option was valued on September 24, 2019 using the
−Removed: Black Scholes-Mertons model with the following assumptions:
−Removed: stock price of $8.95, conversion price of $4.00, term of 1 year expiring
−Removed: September 2020, volatility of 75.48%, dividend yield of 0%, and risk-free interest rate of 1.78%.
−Removed: The valuation at June 30, 2020
−Removed: used the following assumptions:
−Removed: stock price of $14, conversion price of $4.00, term of 0.25 year expiring September 2020, volatility
−Removed: of 62.47%, dividend yield of 0%, and risk-free interest rate of 0.16%.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Equity Transactions
−Removed: Stock Options
−Removed: The following table summarizes the activity
−Removed: relating to the Company’s stock options for the years ended June 30, 2020 and 2019:
−Removed: Weighted-Average Exercise Price
−Removed: Weighted Remaining Average Contractual Term
−Removed: Aggregate Intrinsic Value
+Added: conversion price of $ 4.00 ,
+Added: term of 0.008 year expiring September 2020, volatility of 45.49 % ,
+Added: dividend yield of 0 % ,
+Added: and risk-free interest rate of 0.01 % .
+Added: related Debenture was paid off in cash on September 22, 2020, expiring the conversion option.
+Added: (See note 5 Related Party Transactions)
+Added: following table summarizes the activity relating to the Companys stock options for the years ended June 30, 2021 and 2020:
Outstanding at June 30, 2019
4 unchanged sentences
Exercisable at June 30, 2021
−Removed: The fair value of each option grant
−Removed: on the date of grant is estimated using the Black-Scholes Option –
−Removed: Pricing model reflecting the following weighted-average
+Added: fair value of each option grant on the date of grant is estimated using the Black-Scholes Option – Pricing model reflecting
+Added: the following weighted-average assumptions :
+Added: June 30, 2021
+Added: June 30, 2020
Expected life of options (In years)
2 unchanged sentences
Dividend Yield
−Removed: Expected volatility is based on the
−Removed: historical volatilities of three comparable companies of the daily closing price of their respective common stock and the expected
−Removed: life of options is based on historical data with respect to employee exercise periods.
−Removed: The Company accounts for forfeitures as
−Removed: they are incurred.
−Removed: The Company recorded stock-based compensation
−Removed: expense of $24,846 and $64,860 for the years ended June 30, 2020 and 2019, respectively.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Equity Transactions (continued)
−Removed: The following is a summary of stock
−Removed: options outstanding and exercisable by exercise price as of June 30, 2020:
+Added: volatility is based on the historical volatilities of three comparable companies of the daily closing price of their respective
+Added: common stock and the expected life of options is based on historical data with respect to employee exercise periods.
+Added: accounts for forfeitures as they are incurred.
+Added: Company recorded stock-based compensation expense of approximately $3.0 million and $24,800 for the years ended June 30, 2021
+Added: and 2020, respectively.
+Added: As of June 30, 2021, unrecognized stock-based compensation cost was $ 3.0 million which is expected to
+Added: be recognized over a weighted-average period of approximately 2.5 years.
+Added: following is a summary of stock options outstanding and exercisable by exercise price as of June 30, 2021:
Exercise Price
Weighted Average Contract Life
−Removed: Issuance of Shares for Cash
−Removed: On July 3, 2018, we entered into a Securities
−Removed: Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holdings, LLC (“Acuitas”)and certain other
−Removed: purchasers identified in the Purchase Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the
−Removed: Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred
−Removed: Stock”) at a price per share of $1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to
−Removed: issue warrants (the “Warrants”) to purchase 1,706,666 shares of common stock, each subject to the terms and conditions
−Removed: set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million.
−Removed: We received $160,000 of the $3.2 million in
−Removed: April and May 2018 as prepaid equity.
−Removed: Acuitas also received an additional 6,667 Warrants in connection with the payoff of a note
−Removed: issued by us in favor of Acuitas.
−Removed: The Initial Sale and issuance of the Warrants occurred on July 3, 2018.
−Removed: In addition, Acuitas
−Removed: had the option to purchase up to an additional 1,600,000 shares of common stock at a price per share of $1.88, and warrants on
−Removed: the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the “Subsequent
−Removed: Sale”) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year
−Removed: anniversary of the closing of the Initial Sale, less any federal or FDA grant funding received by the Company.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Equity Transactions (continued)
−Removed: Acuitas is controlled by our Chairman and Chief
−Removed: Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuang Do and Michael Sherman, who are
−Removed: members of our Board of Directors.
−Removed: The Purchase Agreement contained customary
−Removed: representations and warranties.
−Removed: In connection with the disclosure schedule associated with the representations and warranties,
−Removed: we also disclosed customary information, including the following:
−Removed: (i) the existence of the Mallinckrodt petition before the U.S.
−Removed: Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales
−Removed: of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge,
−Removed: pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation
−Removed: to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000
−Removed: per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy),
−Removed: and (v) certain recent issuances of common stock by us.
−Removed: Each share of Preferred Stock automatically
−Removed: converted into 1 shares of common stock upon the filing with the Secretary of State of the State of Nevada of a Certificate of
−Removed: Amendment to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized
−Removed: shares of common stock to 800,000,000.
−Removed: The Amendment was approved by the written consent of the holders of more than a majority
−Removed: of our issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20
−Removed: calendar days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on
−Removed: July 13, 2018.
−Removed: Pursuant to the Purchase Agreement, Terren
−Removed: Peizer, the Chairman of Acuitas, was appointed as a member of the Company’s Board of Directors (the “Board”)
−Removed: and as the Chief Executive Officer of the Company, effective July 3, 2018.
−Removed: The issuance of the Preferred Stock, the Warrants and
−Removed: the underlying common stock under the Purchase Agreement is exempt from registration under the Securities Act of 1933, as amended
−Removed: (the “Securities Act”), pursuant to the exemption for transactions by an issuer not involving any public offering under
−Removed: Section 4(a)(2) of the Securities Act.
−Removed: Pursuant to a letter agreement dated June 24,
−Removed: 2019, Acuitas has agreed to modify its existing rights under the Purchase Agreement so that:
−Removed: Acuitas agreed to immediately exchange its existing 1,606,667 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless exercise thereof at an assumed current market price of $45.00 per share and, as a result received an aggregate of 95% of the shares covered thereby, or 1,526,094 shares of common stock;
−Removed: Acuitas agreed to (i) waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase”
−Removed: at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of our common stock on NASDAQ or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 1,339,958 shares of common stock (the “Subsequent Sale Shares”) to Acuitas.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Equity Transactions (continued)
−Removed: Issuance of Warrants for Cash and Cashless
−Removed: Exercise of Warrants
−Removed: On August 4, 2018, the Company issued 17,936
−Removed: shares of common stock pursuant to a cashless exercise of warrants to purchase 20,000 shares at an exercise price of $1.88 per
−Removed: On May 13, 2019, the Company issued 479 shares
−Removed: of common stock pursuant to a cashless exercise of warrants to purchase 479 shares at an exercise price of $13.75 per share.
−Removed: On June 24, 2019, the Company issued 1,526,094
−Removed: shares of common stock pursuant to a cashless exercise of warrants to purchase 1,606,667 shares at an exercise price of $45.00
−Removed: Issuance of Shares for Services
−Removed: On January 2, 2019, the Company issued 11,200
−Removed: shares of common stock as part of the annual board of director compensation.
−Removed: The share price on date of issuance was $4.38 per
−Removed: On January 2, 2020, the Company issued 11,200
−Removed: shares of common stock as part of the annual board of director compensation.
−Removed: The share price on date of issuance was $3.50.
−Removed: On January 2, 2020, the Company paid accrued
−Removed: interest on the Debenture of $13,487 to Acuitas through the issuance of 4,422 shares of common stock.
−Removed: Issuance of Shares in Settlement of Debt
−Removed: During the year ended June 30, 2019, the Company
−Removed: settled $1,475,765 of debt and accrued compensation including $1,313,765 owed to related parties, by issuing 7,803 shares of common
−Removed: stock with a fair value of $1,150,135.
−Removed: See notes 5 and 6.
−Removed: Issuance of Stock Options
−Removed: On October 1, 2018, the Company issued stock
−Removed: options to purchase 800 shares of common stock to the Chief Financial Officer as part of her compensation.
−Removed: The stock options were
−Removed: issued and are exercisable at an exercise price of $8.75 at any time from date of issuance and expire in 5 years from the date
−Removed: On October 13, 2018, the Company issued stock
−Removed: options to purchase 800 shares of common stock as part of their annual board of director compensation.
−Removed: The stock options were issued
−Removed: and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: On October 27, 2018, the Company issued stock
−Removed: options to purchase 800 shares of common stock as part of their annual board of director compensation.
−Removed: The stock options were issued
−Removed: and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Equity Transactions (continued)
−Removed: On November 10, 2018, the Company issued stock
−Removed: options to purchase 800 shares of common stock as part of their annual board of director compensation.
−Removed: The stock options are exercisable
−Removed: at an exercise price of $6.25 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: On January 19, 2019, the Company issued stock
−Removed: options to purchase 800 shares of common stock to each of five key employees or consultants and two company directors as part of
−Removed: his or her annual compensation, for an aggregate total of 5,600 stock options.
−Removed: The stock options are exercisable at an exercise
−Removed: price of $3.13 at any time from date of issuance until 5 years from the date of issuance.
−Removed: On March 11, 2019, the Company issued stock
−Removed: options to purchase 8,000 shares of common stock to an investor relations (IR) consultant.
−Removed: The stock options were issued and are
−Removed: exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: On October 1, 2019, the Company issued stock
−Removed: options to purchase 800 shares of common stock to the Chief Financial Officer as part of her compensation.
−Removed: The stock options were
−Removed: issued and are exercisable at an exercise price of $8.75 at any time from date of issuance and expire in 5 years from the date
−Removed: On October 13, 2019, the Company issued stock
−Removed: options to purchase 800 shares of common stock as part of their annual board of director compensation.
−Removed: The stock options were issued
−Removed: and are exercisable at $7.50 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: On November 10, 2019, the Company issued stock
−Removed: options to purchase 800 shares of common stock as part of their annual board of director compensation.
−Removed: The stock options were issued
−Removed: and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: On January 19, 2020, the Company issued stock
−Removed: options to purchase 8,000 shares of common stock as part of their annual board of director compensation.
−Removed: The stock options were
−Removed: issued and are exercisable at $2.80 at any time from date of issuance and expire in 5 years from the date of issuance.
−Removed: On June 26, 2020, the Company issued 5,046
−Removed: shares of common stock pursuant to a cashless exercise of stock options to purchase 8,000 shares at an exercise price of $6.25
−Removed: Warrant Price Adjustment
−Removed: In December 2017, the Company issued warrants
−Removed: to purchase 20,000 shares of common stock in a private placement transaction for aggregate gross proceeds of $100,000.
−Removed: were exercisable at an exercise price of $25.00 at any time from date of issuance until 7 years from the date of issuance.
−Removed: warrants have a down round feature that reduces the exercise price if the Company sells stock for a lower price.
−Removed: In January 2018, the Company sold shares at
−Removed: $18.75, which therefore triggered the reduction in the strike price.
−Removed: The Company calculated the difference in fair value of the
−Removed: warrants between the stated exercise price and the reduced exercise price and recorded $20,995 as a deemed dividend.
−Removed: In July 2018, the Company sold shares at $1.88,
−Removed: which therefore triggered the reduction in the strike price.
−Removed: The Company calculated the difference in fair value of the warrants
−Removed: between the stated exercise price and the reduced exercise price and recorded $44,889 as a deemed dividend.
−Removed: The fair value of the
−Removed: warrants granted was estimated using the Black Scholes Method.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Equity Transactions (continued)
−Removed: In January and February 2018, the Company issued
−Removed: warrants to purchase 1,680 shares of common stock in exchange for banking services which was recognized at fair value.
−Removed: were exercisable at an exercise price of $18.75 at any time from date of issuance until 7 years from the date of issuance.
−Removed: warrants have a down round feature that reduces the exercise price if the Company sells stock for a lower price.
−Removed: In July 2018,
−Removed: the Company sold shares at $1.88, which therefore triggered the reduction in the strike price.
−Removed: The Company calculated the difference
−Removed: in fair value of the warrants between the stated exercise price and the reduced exercise price and recorded $3,770 as a deemed
−Removed: The fair value of the warrants granted was estimated using the Black Scholes Method.
−Removed: The following table summarizes
−Removed: the warrants that have been issued:
−Removed: Number of Shares
−Removed: Weighted Average Exercise Price
−Removed: Weighted Average Remaining Life (Years)
−Removed: Aggregate Intrinsic Value
+Added: following table summarizes the warrants activity during the years ended June 30, 2021 and 2020:
Outstanding and exercisable at June 30, 2019
Outstanding and exercisable at June 30, 2020
+Added: Exercised - Acuitas
+Added: ( 1,453,250 )
Outstanding and exercisable at June 30, 2021
−Removed: Of the above warrants, 9,391
−Removed: expire in fiscal year ending June 30, 2022, 4,455 expire in fiscal year ending June 30, 2023, and 1,360,821 expire in fiscal year
−Removed: ending June 30, 2025.
−Removed: Notes to Financial Statements
−Removed: For the Years Ended June 30, 2020 and 2019
−Removed: Significant components of the Company’s
−Removed: deferred tax assets are as follows:
+Added: the above warrants, 9,391 expire in fiscal year ending June 30, 2022, 4,815 expire in fiscal year ending June 30, 2023, 2,714
+Added: expire in fiscal year ending June 30, 2025 and 141,841 expire in fiscal year ending June 30, 2026.
+Added: of common stock through exercise of Stock Options and Warrants
+Added: On July 28, 2020, the Company issued 2,210
+Added: shares of common stock pursuant to a cashless exercise of stock options to purchase 3,200 shares at an average exercise price of
+Added: $ 4.76 per share.
+Added: On January 27, 2021, the Company issued 304
+Added: shares of common stock pursuant to a cashless exercise of warrants to purchase 320 shares at an average exercise price of $ 1.88
+Added: On March 23, 2021, the Company issued 27,000
+Added: shares of common stock pursuant to a cash exercise of warrants to purchase 27,000 shares at an average exercise price of $ 12.50
+Added: On March 24, 2021, the Company issued 14,324
+Added: shares of common stock pursuant to a cash exercise of warrants to purchase 14,324 shares at an average exercise price of $ 12.50
+Added: April 19, 2021, the Company issued 724 shares of common stock pursuant to a cashless exercise of warrants to purchase 760 shares at an
+Added: average exercise price of $ 1.88 per share.
+Added: April 30, 2021, the Company issued 13,500 shares of common stock pursuant a cash exercise of warrants at $ 12.50 per share.
+Added: of Shares for Services
+Added: January 2, 2020, the Company issued 11,200 shares of common stock to the members of the board of directors as part of the annual
+Added: directors compensation.
+Added: The share price on date of issuance was $3.50.
+Added: January 2, 2020, the Company paid accrued interest on the Debenture of $ 13,487 to Acuitas through the issuance of 4,422 shares
+Added: of common stock.
+Added: of Stock Options
+Added: November 10, 2019, the Company granted stock options to purchase 800 shares of common stock to an executive clinical team member
+Added: as part of her compensation.
+Added: The exercise price of the stock options is $ 6.25 , are exercisable at any time and expire in 5 years
+Added: from the date of issuance.
+Added: January 19, 2020, the Company granted stock options to purchase 8,000 shares of common stock to the members of the board of directors
+Added: as part of their annual director compensation.
+Added: The exercise price of the stock options are $ 2.80 , are exercisable at any time
+Added: and expire in 5 years from the date of issuance.
+Added: June 26, 2020, the Company issued 5,046 shares of common stock pursuant to a cashless exercise of stock options to purchase 8,000 shares
+Added: at an exercise price of $6.25 per share.
+Added: 1, 2020 and 2019, the Company granted stock options to purchase 800
+Added: shares of common stock at each grant date to the Chief Financial Officer as part of her compensation.
+Added: The exercise prices of the
+Added: stock options are $ 9.54
+Added: for the 2020 grant and $ 8.75 for the 2019 grant;
+Added: are exercisable at any time and expire in 5 years from the date of issuance.
+Added: October 13, 2020 and 2019, the Company granted stock options to purchase 800 shares of common stock, at each grant date;
+Added: director as part of his annual directors compensation.
+Added: The exercise price of the stock options is $ 9.90 for the 2020 grant and $ 7.50
+Added: for the 2019 grant;
+Added: are exercisable at any time and expire in 5 years from the date of grant.
+Added: December 18, 2020, the Company granted stock options under the Companys 2019 Omnibus Incentive Compensation Plan to purchase 691,600 shares of common stock to the members of the board as part of their annual compensation.
+Added: The first 25% of the stock options vest on the
+Added: grant date, and the remaining 75% vest over a 3-year period, on the first, second, and third anniversary of the grant date.
+Added: options were issued at an exercise price of $ 13.91 per share and expire 5 years from the date of grant.
+Added: On January 19, 2021, the Company granted stock
+Added: option to purchase a total of 4,800 shares of common stock, granting 800 shares each to then
+Added: Chief Operations Officer, an executive clinical team member and to four of its key consultants as part of their annual compensation.
+Added: The exercise price of the options is $ 42.09 per share, are exercisable at any time and expire 5 years from the date of issuance.
+Added: On July 13, 2020, the Company issued
+Added: Warrants to purchase 203,250 shares of common stock to its controlling stockholder under the terms of the Bridge Financing.
+Added: warrants were exercisable at an exercise price of $ 4 at any time from the date of issuance until 5 years from the date of issuance.
+Added: (See Note 5 Related Party Transactions.)
+Added: On September 22, 2020, the Company issued
+Added: warrants to purchase 89,998 shares of common stock to the underwriters of the Offering in connection with the close of the Offering
+Added: of registered Common Stock The warrants are exercisable at an exercise price of $ 12.50 at any time from date of issuance until
+Added: 5 years from the date of issuance.
+Added: and Contingencies
+Added: July 1, 2019, the Companys office moved with Acuitas new offices to 2120 Colorado Avenue Ste 230, Santa Monica,
+Added: There is no lease agreement for the new premises and the Company continues to accrue monthly lease payments of $1,000
+Added: for the new office under the terms of the previous month-to-month lease for the previous premises which may be cancelled upon
+Added: 30 days written notice.
+Added: July 1, 2021, the Company assumed NeurMedix lease at 6165 Greewich Dr Suite 150, San Diego, CA 92122.
+Added: The lease agreement requires
+Added: monthly payments of $8,782.
+Added: April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S.
+Added: Patent and Trademark Office (USPTO)
+Added: to institute an Inter Partes Review of our U.S.
+Added: 9,655,945 titled Treatment of Ascites (the 945
+Added: Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review
+Added: the patentability of one or more claims of a patent.
+Added: Such review is limited to grounds of novelty and obviousness on the basis
+Added: of prior art consisting of patents and printed publications.
+Added: November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the Board)
+Added: issued a written decision in the inter partes review (IPR) action that was brought by Mallinckrodt Pharmaceuticals
+Added: Ireland Limited (Mallinckrodt) against BioVie Inc.
+Added: (BioVie or Company).
+Added: In that action,
+Added: Mallinckrodt sought to invalidate BioVies patent (U.S.
+Added: 9,655,945, Treatment of Ascites) (the 945
+Added: In its decision, the Board determined that all claims of the 945 Patent were not patentable because they
+Added: were either anticipated or obvious in light of prior art.
+Added: The Board also denied BioVies Motion to Amend the claims on similar
+Added: The result of the Boards decision is that the 945 patent is no longer valid or enforceable.
+Added: Acuitas Group
+Added: Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the Company in July 2018.
+Added: ruling is unrelated to the Companys Orphan drug designations for ascites and hepatorenal syndrome (HRS),
+Added: which remain unchanged.
+Added: An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United
+Added: States for the designated use(s).
+Added: In addition, the ruling does not affect the Companys rights in its pending patent application
+Added: directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2 and Phase 3 trials, subject to FDA
+Added: clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent
+Added: protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing
+Added: to the Agreement and Plan of Merger entered into on April 11, 2016 between our predecessor entities, LAT Pharma LLC and NanoAntibiotics,
+Added: Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared
+Added: among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
+Added: Company and PharmaIN Corporation, LAT Pharmas former partner focused on the development of new modified drug candidates
+Added: in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales
+Added: of each companys ascites drug development programs, or if such program is licensed to a third party, less than 5% of each
+Added: companys net license revenues.
+Added: On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN
+Added: modified terlipressin development program and simultaneously paid the remaining balance due on a related debt.
+Added: PharmaIN, Corp.
+Added: rights to our program remain unchanged.
+Added: Additionally the Company obligation to pay a low single digit royalty on the net sales
+Added: of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, and The Barrett Edge, Inc.
+Added: the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC.
+Added: The Company has an obligation to pay a
+Added: low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per
+Added: year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy).
+Added: to the Technology Transfer Agreement entered into on July 25, 2016 between BioVie and the University of Padova (Italy), BioVie
+Added: is obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no.
+Added: 9,655,645 and
+Added: any future foreign issuances capped at a maximum of $200,000 per year.
+Added: components of the Companys deferred tax assets are as follows:
June 30, 2021
5 unchanged sentences
Valuation Allowance
+Added: ( 2,028,947 )
+Added: ( 1,737,206 )
Net deferred tax assets
−Removed: At June 30, 2020 and 2019, the Company has
−Removed: recorded a full valuation against its net deferred tax assets of $1,737,206 and $992,688, respectively, since in the judgement
−Removed: of management, these assets are not more than likely than not to be realized.
−Removed: The change in the valuation allowance during the
−Removed: year ended June 30, 2020 was $744,518.
−Removed: At June 30, 2020, the Company had a Net Operating
−Removed: Loss (“NOL”) carryforward of approximately $5,100,000.
−Removed: NOL’s generated prior to 2018 will
−Removed: expire during the years ranging from 2032 to 2037.
−Removed: The Company has no current tax expense due
−Removed: to its losses.
−Removed: Reconciliation of the differences between income
−Removed: tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended
−Removed: June 30, 2020 and 2019 is as follows:
+Added: June 30, 2021 and 2020, the Company has recorded a full valuation against its net deferred tax assets of $2,028,947 and $1,737,206,
+Added: respectively, since in the judgement of management, these assets are not more than likely than not to be realized.
+Added: in the valuation allowance during the year ended June 30, 2021 was $291,741.
+Added: June 30, 2021, the Company had a Net Operating Loss (NOL) carryforward of approximately $ 18,190,000 .
+Added: generated prior to 2018 will expire during the years ranging from 2032 to 2037.
+Added: Company has no current tax expense due to its losses.
+Added: Reconciliation
+Added: of the differences between income tax benefit computed at the federal and state statutory tax rates and the provision for income
+Added: tax benefit for the years ended June 30, 2021 and 20120 is as follows:
Income tax expense at federal statutory rate
2 unchanged sentences
Effective tax rate
−Removed: Subsequent Events
−Removed: Subsequent to June 30, 2020, the company received additional draws totaling $170,000 under the Debenture.
−Removed: The total amount of draws outstanding at August 3, 2020 was $1,433,000.
+Added: August 11, 2021, the Company closed a registered public offering issuing 2,500,000 of its Class A common stock at $8.00 per
+Added: share, resulting in net proceeds to the Company of approximately $ 17.8 million, net of issuance cost of approximately $ 2.2 million.
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.