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this Annual Report on Form 10-K, entitled “Risk Factors.” References in this discussion and analysis to “us,”
−Removed: “we,” “our,” or “the Company” refer collectively to MyMD Pharmaceuticals, Inc.
+Added: “we,” “our,” or “the Company” refer collectively to TNF Pharmaceuticals, Inc.
financial statements are prepared in accordance with GAAP.
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market conditions;
−Removed: impact of dilution on our shareholders;
−Removed: ability to realize the intended benefits of the Merger (as defined below) and the Contribution Transaction (as defined below);
−Removed: impact of our ability to realize the anticipated tax impact of the Merger;
+Added: impact of dilution on our stockholders;
outcome of litigation or other proceedings we may become subject to in the future;
−Removed: of our Common Stock from the Nasdaq;
+Added: the impact of our ability to meet the continued listing requirements of
+Added: the Nasdaq Capital Market;
availability and ability to continue to obtain sufficient funding to conduct planned research and development efforts and realize
potential profits;
−Removed: ability to develop and commercialize our product candidates, including MYMD-1, Supera-CBD and other future product candidates;
+Added: ability to develop and commercialize our product candidates, including Isomyosamine, Supera-CBD and other future product candidates;
impact of the complexity of the regulatory landscape on our ability to seek and obtain regulatory approval for our product candidates,
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potential impact of changes in the legal and regulatory landscape, both within and outside of the U.S.;
−Removed: the impact of pandemics, such as COVID-19, on the administration, funding
−Removed: and policies of regulatory authorities, both within and outside of the U.S.;
+Added: potential future impact of pandemics on the administration, funding and policies of regulatory authorities, both within and outside
dependence on third parties to conduct pre-clinical and clinical trials and manufacture its product candidates;
−Removed: the impact of the pandemics, such as COVID-19, on our results of operations,
−Removed: business plan and the global economy;
+Added: impact of the future pandemics on our results of operations, business plan and the global economy;
we may face with respect to our product candidates achieving market acceptance by providers, patients, patient advocacy groups, third
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compliance with all laws, rules, and regulations applicable to our business.
−Removed: the closing of the Merger and the Contribution Transaction described below that occurred on April 16, 2021, we have been focused on developing
−Removed: and commercializing two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and Supera-CBD:
−Removed: is a clinical stage small molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited
−Removed: to) multiple sclerosis, diabetes, rheumatoid arthritis, and inflammatory bowel disease.
−Removed: MYMD-1 is being developed to treat age-related
−Removed: illnesses such as frailty and sarcopenia.
−Removed: MYMD-1 works by regulating the release of numerous pro-inflammatory cytokines, such as
−Removed: TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”).
−Removed: MYMD-1 currently is being evaluated in
−Removed: patients with sarcopenia (age-related muscle loss).
−Removed: The company has significant intellectual property coverage to protect these autoimmune
−Removed: indications, as well as therapy as an anti-aging product;
−Removed: in collaboration with its CRO is in the final stages of preparing the end of Phase II, “A double-blind, randomized, Phase 2
−Removed: study to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in the treatment of participants aged 65 years or older
−Removed: with chronic inflammation associated with sarcopenia/frailty” for submission to the FDA.
−Removed: The submission is planned for the
−Removed: beginning of the second quarter of 2024.
−Removed: Exploratory analysis indicates the biomarker sTNFR1 is the most sensitive biomarker for
−Removed: Sarcopenia patients aged 65-75 years old.
−Removed: phase II study for rheumatoid arthritis, “A double-blind, randomized, placebo-controlled multicenter Phase II proof-of-concept
−Removed: study to evaluate the efficacy, safety, biological activity, and pharmacokinetics of MYMD-1™ added to methotrexate in patients
−Removed: with moderate-to-severe active rheumatoid arthritis” IND application was reviewed and approved by the FDA to begin clinical
−Removed: trials on August 9, 2023.
−Removed: November 17, 2023 an Annual Report was submitted to the FDA.
−Removed: We completed enrollment in the fourth and final cohort of patients in the Phase 2 Aging and Sarcopenia Study (“A Double-Blind,
−Removed: Placebo-controlled, Randomized Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD-1 in The Treatment of
−Removed: Participants Aged 65 Years or Older with Chronic Inflammation Associated with Sarcopenia/Frailty”).
−Removed: As mentioned above, MyMD
−Removed: is preparing the submission to the FDA in the beginning of the second quarter of 2024.
−Removed: Exploratory analysis indicates the biomarker
−Removed: sTNFR1 is the most sensitive biomarker for Sarcopenia patients aged 65-75 years old.
−Removed: PK analysis indicates that PK/PD strategy is
−Removed: consistent at measurements of biomarkers 2-4 hours post-dose.
−Removed: There were no serious adverse events reported, no subject dropout’s
−Removed: secondary to an adverse event.
−Removed: Additionally, there were no clinically significant cardiovascular, ECG issues, or neurotoxicity issues
−Removed: with any patients during the study.
+Added: is a clinical stage pharmaceutical company committed to extending healthy lifespan.
+Added: TNF is focused on developing and commercializing
+Added: two therapeutic platforms based on well-defined therapeutic targets, Isomyosamine and Supera-CBD:
+Added: Isomyosamine is a clinical
+Added: stage small molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited to) sarcopenia,
+Added: frailty, adverse effects of drugs used to treat diabetes and obesity, rheumatoid arthritis, and inflammatory bowel disease.
+Added: indication for which Isomyosamine is being developed is to treat age-related frailty and sarcopenia.
+Added: Isomyosamine works by regulating
+Added: the release of numerous pro-inflammatory cytokines, such as TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”)
Supera-CBD is a synthetic
−Removed: analog of cannabidiol (“CBD”) being developed to treat various conditions, including, but not limited to, epilepsy, pain,
−Removed: and anxiety/depression, through its effects on the CB2 receptor, and a monoamine oxidase enzyme (“MAO”) type B.
−Removed: has shown tremendous promise in treating neuroinflammatory and neurodegenerative diseases, and will be a major focus as the Company
−Removed: moves forward.
−Removed: rights to Supera-CBD were previously owned by Supera and were acquired by MyMD Florida (as defined below) immediately prior to the closing
−Removed: of the Merger.
−Removed: Merger and Milestone Payments
−Removed: April 16, 2021, pursuant to the previously announced Agreement and Plan of Merger and Reorganization, dated November 11, 2020 (as subsequently
−Removed: amended, the “Merger Agreement”), by and among the Company, previously known as Akers Biosciences, Inc., XYZ Merger Sub,
−Removed: Inc., a wholly-owned subsidiary of the Company (“Merger Sub”), and MyMD Pharmaceuticals (Florida), Inc., a Florida corporation
−Removed: previously known as MyMD Pharmaceuticals, Inc.
−Removed: (“MyMD Florida”), Merger Sub was merged with and into MyMD Florida, with MyMD
−Removed: Florida continuing after the merger as the surviving entity and a wholly owned subsidiary of the Company (the “Merger”).
−Removed: The Merger consideration included potential milestone payments to the pre-Merger MyMD Florida stockholders (the “Milestone Payments”)
−Removed: payable in shares of the Company’s Common Stock upon the achievement of certain market capitalization milestone events (the “Milestone
−Removed: Events”) during the 36-month period immediately following the closing of the Merger (the “Milestone Period”).
−Removed: The Milestone
−Removed: Events and corresponding Milestone Payments are set forth in the table below.
−Removed: capitalization of the combined company for at least ten (10) trading days during any 20 consecutive trading day period during the
−Removed: Milestone Period is equal to or greater than $500,000,000 (the “First Milestone Event”).
−Removed: every $250,000,000 incremental increase in market capitalization of the combined company after the First Milestone Event to the extent
−Removed: such incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone Period,
−Removed: up to a $1,000,000,000 market capitalization of the combined company.
−Removed: per each incremental increase (it being understood, however, that, if such incremental increase results in market capitalization
−Removed: equal to $1,000,000,000, such $10,000,000 payment in respect of such incremental increase shall be payable without duplication of
−Removed: any amount payable in respect of a Second Milestone Event, as defined below).
−Removed: capitalization of the combined company for at least 10 trading days during any 20 consecutive trading day period during the Milestone
−Removed: Period is equal to or greater than $1,000,000,000 (the “Second Milestone Event”)
−Removed: every $1,000,000,000 incremental increase in market capitalization of the combined company after the Second Milestone Event to the
−Removed: extent such incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone
−Removed: per each incremental increase
−Removed: purposes of the table above, “market capitalization” means, with respect to any trading day, the product of (i) the total
−Removed: outstanding shares of the combined company Common Stock and (ii) the volume weighted average trading price for the combined company Common
−Removed: Stock for such trading day.
−Removed: Company previously owned, through its subsidiary Cystron Biotech, LLC (“Cystron”), an exclusive license from Premas Biotech
−Removed: (“Premas”) with respect to Premas’ vaccine platform for the development of a vaccine against COVID-19 and
−Removed: other coronavirus infections.
−Removed: On April 16, 2021, pursuant to the Contribution and Assignment Agreement, dated March 18, 2021 (the “Contribution
−Removed: Agreement”) by and among the Company, Cystron, Oravax Medical, Inc.
−Removed: (“Oravax”) and, for the limited purpose set forth
−Removed: therein, Premas, the Company caused Cystron to contribute substantially all of the assets associated with its business of developing
−Removed: and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax.
−Removed: Oravax is pursuing the development of the COVID-19 vaccine candidate.
−Removed: MyMD’s interest in Oravax consists of 13% of Oravax’s outstanding shares of capital stock and the rights to a 2.5% royalty
−Removed: on all future net sales.
−Removed: MyMD has evaluated several options with respect to its interest in Oravax, including a potential distribution
−Removed: of Oravax shares to the MyMD shareholders.
−Removed: This would make Oravax a publicly held company.
−Removed: In addition, MyMD currently has the right
−Removed: to designate a member of the board of directors of Oravax, pursuant to which Mr.
−Removed: Joshua Silverman, our Chairman of the Board, has been
−Removed: designated to serve as a director of Oravax.
+Added: analog of CBD being developed to treat various conditions, including, but not limited to, epilepsy, pain and anxiety/depression,
+Added: through its effects on the CB2 receptor, opioid receptors and monoamine oxidase enzyme (“MAO”) type B.
+Added: to Supera-CBDTM were previously owned by Supera Pharmaceuticals, Inc.
+Added: (“Supera”) and were acquired by MyMD Florida (as defined
+Added: below) immediately prior to the closing of the Merger (as defined below) that occurred in 2021.
October 2023, the Company implemented a reduction in workforce, eliminating three of the Company’s ten employees.
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from the date of separation.
−Removed: Going Concern
of December 31, 2024, the Company’s cash on hand was $173,154 and marketable securities were $8,345,082.
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a net loss attributable to shareholders of $27,161,219 for the year ended December 31, 2024.
−Removed: As of December 31, 2023, the Company had
−Removed: working capital of $828,253 and stockholders’ equity of $12,369,572 including an accumulated deficit of $101,977,067.
−Removed: year ended December 31, 2023, cash flows used in operating activities were $12,980,625.
−Removed: The Company does not currently have sufficient
−Removed: available liquidity to fund its operations for at least the next 12 months.
−Removed: Such factors raise substantial doubt about our ability to
−Removed: sustain operations for at least one year from the issuance of the audited financial statements included in this Annual Report.
−Removed: The accompanying
−Removed: financial statements do not include any adjustments related to the recoverability and classification of asset amounts or the classification
−Removed: of liabilities that might be necessary should we be unable to continue as a going concern.
+Added: As of December 31, 2024,
+Added: the Company had working capital of $2,710,626 and stockholders’ equity of $9,789,740 including an accumulated deficit of $129,138,286.
+Added: During the year ended December 31, 2024, cash flows used in operating activities were $8,976,347.
+Added: The Company does not currently have
+Added: sufficient available liquidity to fund its operations for at least the next 12 months.
+Added: Such factors raise substantial doubt about our
+Added: ability to sustain operations for at least one year from the issuance of the audited financial statements included in this Annual Report.
+Added: The accompanying financial statements do not include any adjustments related to the carrying amounts of assets or liabilities.
response to these conditions and events, we are evaluating various financing strategies to obtain sufficient additional liquidity to
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ways to raise capital.
−Removed: There is no assurance we will manage to raise additional capital or otherwise increase cash flows, if required.
The sources of financing described above that could be available to us and the timing and probability of obtaining sufficient capital
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the development or commercialization of our product candidates.
−Removed: Nasdaq Deficiency
−Removed: As previously disclosed, on October
−Removed: 11, 2023, we received a written notice (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market
−Removed: indicating that for the last 30 consecutive business days, the bid price for our Common Stock had closed below the minimum $1.00 per share
−Removed: requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
−Removed: The letter also indicated that the Company would be provided with a compliance period until April 8, 2024 (the “Compliance Period”),
−Removed: in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).
−Removed: Effective as of 4:05 p.m.
−Removed: Standard Time on February 14, 2024, we effected the Reverse Stock Split of our common stock at a ratio of one-for-thirty.
−Removed: Simultaneously
−Removed: with the Reverse Stock Split, number of shares of our common stock authorized for issuance was reduced from 500,000,000 shares to 16,666,666
−Removed: shares, and our authorized capital stock was reduced from 550,000,000 shares to 66,666,666 shares.
−Removed: Our common stock continued to be traded
−Removed: on the Nasdaq Capital Market under the symbol MyMD and began trading on a split-adjusted basis at market open on February 15, 2024.
−Removed: March 4, 2024, we were notified by Nasdaq that we had regained compliance with all Nasdaq listing requirements and the matter was closed.
+Added: There is no assurance
+Added: we will manage to raise additional capital or otherwise increase cash flows, if required.
+Added: The financial statements do not include any
+Added: adjustments that might result from the outcome of this uncertainty.
+Added: March 17, 2025, the Company received a letter from the Listing Qualifications Department of Nasdaq indicating that, based upon the closing
+Added: bid price of the Company’s Common Stock for the 30 consecutive business days between January 30, 2025, to March 14, 2025, the Company
+Added: did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq
+Added: Listing Rule 5550(a)(2).
+Added: The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or
+Added: until September 15, 2025 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).
+Added: order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s Common Stock must maintain a minimum
+Added: closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period.
+Added: In the event the Company does not
+Added: regain compliance by the end of the Compliance Period, the Company may be eligible for an additional 180 calendar days to regain compliance.
+Added: There can be no assurance that the Company will be eligible for the additional 180 calendar day compliance period, if applicable, or
+Added: that the Nasdaq staff would grant the Company’s request for continued listing subsequent to any delisting notification.
+Added: event of such a notification, the Company may appeal the Nasdaq staff’s determination to delist its securities.
Operations Overview
will not generate revenue from product sales unless and until we successfully complete clinical development, obtain regulatory approval
−Removed: for, and successfully commercialize our MYMD-1 and Supera-CBD product candidates.
+Added: for, and successfully commercialize our Isomyosamine and Supera-CBD product candidates.
The lengthy process of securing marketing approvals
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In addition, if we obtain regulatory
−Removed: approval for MYMD-1 and/or Supera-CBD, we expect to incur significant expenses related to developing our commercialization capability
+Added: approval for Isomyosamine and/or Supera-CBD, we expect to incur significant expenses related to developing our commercialization capability
to support product sales, marketing, manufacturing and distribution activities.
anticipate that our expenses will increase significantly as we:
−Removed: the development of our MYMD-1 and Supera-CBD;
+Added: the development of our Isomyosamine and Supera-CBD;
and continue research and preclinical and clinical development of potential new product candidates;
−Removed: expand and protect our intellectual property as it pertains to MYMD-1 and Supera-CBD;
+Added: expand and protect our intellectual property as it pertains to Isomyosamine and Supera-CBD;
our infrastructure and facilities to accommodate our growing employee base and ongoing development activities;
agreements with contract research organizations, or CROs, and third-party contract manufacturing organizations, or CMOs, in connection
−Removed: with our Supera-CBD preclinical studies, MYMD-1 ongoing and planned clinical trials, Supera-CBD clinical trials and the development
−Removed: of our manufacturing capabilities for MYMD-1 and Supera-CBD;
−Removed: the large-scale manufacturing processes and capabilities for the commercialization of our MYMD-1 and Supera-CBD drug products;
−Removed: marketing approvals for our MYMD-1 and Supera-CBD product candidates that successfully complete clinical trials and
−Removed: a sales, marketing and distribution infrastructure to commercialize MYMD-1 and Supera-CBD should we obtain marketing approval
+Added: with our Supera-CBD preclinical studies, Isomyosamine ongoing and planned clinical trials, Supera-CBD clinical trials and the development
+Added: of our manufacturing capabilities for Isomyosamine and Supera-CBD;
+Added: the large-scale manufacturing processes and capabilities for the commercialization of our Isomyosamine and Supera-CBD drug products;
+Added: marketing approvals for our Isomyosamine and Supera-CBD product candidates that successfully complete clinical trials and
+Added: a sales, marketing and distribution infrastructure to commercialize Isomyosamine and Supera-CBD should we obtain marketing approval
a result of these anticipated expenditures, we will need substantial additional funding to support our continuing operations and pursue
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have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future.
−Removed: If our research and development efforts with MYMD-1 and Supera-CBD are successful, we may generate revenue from product sales or through
+Added: If our research and development efforts with Isomyosamine and Supera-CBD are successful, we may generate revenue from product sales or through
license agreements with third parties.
operating expenses are broken into several components, including research and development and general and administrative costs.
−Removed: expect operating expenses to increase as we progress through the various clinical trials in the development of MYMD-1 and Supera-CBD.
+Added: expect operating expenses to increase as we progress through the various clinical trials in the development of Isomyosamine and Supera-CBD.
and Development
−Removed: research and development expenses primarily consist of costs associated with the development of MYMD-1 and Supera-CBD.
+Added: research and development expenses primarily consist of costs associated with the development of Isomyosamine and Supera-CBD.
These costs include,
but are not limited to:
−Removed: wages and benefits of the research and development staff;
agreements with third parties including contract research organizations, preclinical activities and clinical trials;
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application and maintenance costs to protect our intellectual property.
−Removed: Four of our six employees are principally involved in research and development activities for either MYMD-1 or Supera-CBD.
+Added: of our two employees are principally involved in research and development activities for either Isomyosamine or Supera-CBD.
Their salaries,
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our staff more efficiently.
−Removed: is difficult to project with absolute accuracy the duration or final cost of the development of MYMD-1 and Super-CBD or if revenue will
+Added: is difficult to project with absolute accuracy the duration or final cost of the development of Isomyosamine and Super-CBD or if revenue will
be generated from the commercialization of these components.
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Based Compensation
−Removed: based compensation includes the fair market value, as determined using the Black-Scholes option pricing model, of stock options issued to
−Removed: key staff and consultants.
+Added: based compensation includes the fair market value, as determined using the Black-Scholes option pricing model, of stock options issued
+Added: to key staff and consultants.
Income (Expense), net
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of Statements of Operations for the Years Ended December 31, 2024 and 2023
−Removed: are focused on developing and commercializing two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and Supera-CBD.
+Added: are focused on developing and commercializing two therapeutic platforms based on well-defined therapeutic targets, Isomyosamine and Supera-CBD.
The following table summarized the results of operations for the years ended December 31, 2024 and 2023.
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Stock Based Compensation
−Removed: Warrant Issuance Expenses
+Added: Series F Warrant Issuance Expenses
+Added: Series F-1 Warrant Issuance Expenses
+Added: Series G Warrant Issuance Expenses
Total Operating Expenses
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$ (23,359,334 )
+Added: $ (3,999,950 )
Preferred Stock Dividends
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Total Administrative Expense
−Removed: costs increased $241,770 during the year ended December 31, 2023.
−Removed: The increase is attributable to changes in the base salary for two
−Removed: executives, bonuses, and the accumulated personal time off and severance paid to separated employees in October and November 2023.
−Removed: services costs decreased $566,266 during the year ended December 31, 2023.
−Removed: These costs included legal, accounting and specialized consulting
−Removed: services related to the initial and quarterly calculation of the fair market value of the Series F Convertible Preferred Stock and its’
−Removed: The decrease is primarily related to a reduction in the usage of general consultants and the allocation of consulting services
−Removed: between the administrative and research and development functions.
+Added: costs decreased $759,850 during the year ended December 31, 2024.
+Added: We reduced administrative staffing during the year ended December
+Added: 31, 2023, from four full-time positions to two and renegotiated one staff members compensation during the year ended December 31,
+Added: In addition, two research and development staff members had 20% of their salaries allocated to general administrative
+Added: expenses to recognize their areas of responsibility.
+Added: One of these staff members separated during the year ended December 31, 2023, and
+Added: the other during the year ended December 31, 2024.
+Added: As of December 31, 2024, we have two full-time administrative staff members.
+Added: services costs increased $206,050 during the year ended December 31, 2024.
+Added: These costs include the consulting fees for our Interim
+Added: Chief Financial Officer and 20% of the consulting fees for our President and Chief Medical Officer.
+Added: Other costs include legal,
+Added: accounting and audit, and specialized consulting services related to the initial and quarterly calculation of the fair market value
+Added: of the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock and their
market and investor relations costs decreased $102,496 during the year ended December 31, 2024.
These costs include the annual Nasdaq
−Removed: listing fees, activities related to keeping the shareholder base informed through press releases, presentations and other communication
−Removed: efforts, transfer agent fees, and the costs of annual shareholder meetings.
−Removed: administrative expenses increased $307,693 during the year ended December 31, 2023.
+Added: listing fees, activities related to keeping the stockholder base informed through press releases, presentations and other communication
+Added: efforts, transfer agent fees, and the costs of annual stockholder meetings.
+Added: The decrease is attributed to a reduction in consulting fees and stockholder meeting expenses.
+Added: administrative expenses decreased $624,683 during the year ended December 31, 2024.
These costs include Board expenses, business insurance,
corporate travel, and other general business expenses.
−Removed: The increase is attributable to an increase in corporate travel expenses, offset
−Removed: by small reductions in most other general business expense categories.
+Added: The decrease is attributable to decreases in Board expenses, business insurance expenses, facility leasing expense,
+Added: and corporate travel expenses.
and Development Expenses
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Total Research and Development Expenses
−Removed: and wages increased $677,914 during the year ended December 31, 2023.
−Removed: The increase is attributable to changes in the base salary for
−Removed: an executive, bonuses, and the accumulated personal time off and severance paid to separated employees in October 2023.
+Added: and wages decreased $1,059,574 during the year ended December 31, 2024.
+Added: We reduced administrative staffing during the year ended
+Added: December 31, 2023, from six full-time positions to four and the remaining full-time staff separated during the year ended December
+Added: Two research and development staff members had 20% of their salaries allocated to general administrative expenses to
+Added: recognize their areas of responsibility.
+Added: One of these staff members separated during the year ended December 31, 2023, and the other
+Added: during the year ended December 31, 2024.
+Added: As of December 31, 2024, we have no full-time research and development staff members.
program costs include those associated with pre-clinical development, clinical trials and other material and development programs.
−Removed: increased $1,864,473 during the year ended December 31, 2023, a result of the completion of pre-clinical toxicology studies and the Phase
−Removed: 2 Sarcopenia clinical trial, the analysis of the Phase 2 Sarcopenia study results, and the acquisition of base compounds for use in on-going
−Removed: services costs increased $209,462 during the year ended December 31, 2023.
−Removed: These costs are primarily related to legal and patent related
−Removed: fees associated with the protection of our intellectual property and the allocation of consulting services between the research and development
−Removed: and administrative functions.
−Removed: expenses decreased $4,100,274 during the year ended December 31, 2023.
+Added: Costs decreased $3,205,377 during the year ended December 31, 2024, compared to the year ended December 31, 2023, a result of the
+Added: completion of pre-clinical toxicology studies and the Phase 2 Sarcopenia clinical trial, the analysis of the Phase 2 Sarcopenia
+Added: study results, and the acquisition of base compounds for use in on-going studies.
+Added: During the year ended December 31, 2024, we engaged
+Added: a new Contract Research Organization and began preparing materials for the Phase 2b Sarcopenia clinical trial.
+Added: services costs decreased $12,137 during the year ended December 31, 2024, as compared to the year ended December 31, 2023.
+Added: These costs include the 80% of the consulting fees for our President and
+Added: Chief Medical Officer, other consulting services , and legal and patent related
+Added: fees associated with the protection of our intellectual property.
+Added: expenses decreased $21,184 during the year ended December 31, 2024, as compared to the year ended December 31, 2023.
Regulatory expenses include clinical research organizations (CRO)
and regulatory consulting fees associated with Phase 2 clinical study designs, protocol preparations and the maintenance of the investigator
−Removed: These non-recurring regulatory services were completed in 2022.
−Removed: research and development expenses increased $148,798 during the year ended December 31, 2022.
+Added: research and development expenses decreased $128,513 during the year ended December 31, 2024, as compared to the year ended December 31, 2023.
These expenses include laboratory supplies,
−Removed: training and travel for department personnel while working with third-party trial sites.
−Removed: The increase is attributable to specialized
+Added: training and travel while working with third-party trial sites.
+Added: The decrease is attributable to specialized
freight costs for materials and travel in support of the studies and data analysis of the Phase 2 Sarcopenia trial results.
−Removed: During the year ended December 31, 2023, stock-based compensation totaled
−Removed: These expenses include stock options issued to directors, staff, and service providers.
+Added: the year ended December 31, 2024, stock-based compensation totaled $1,057,271.
+Added: These expenses include stock options issued to directors, staff,
+Added: and service providers.
+Added: During the year ended December 31, 2023, stock-based compensation totaled $3,049,537 for stock options issued
+Added: to staff and service providers, restricted stock units and Common Stock warrants issued for services.
During the year ended December
−Removed: 2022, stock-based compensation totaled $695,191 for stock options issued to staff and service providers, restricted stock units and Common
−Removed: Stock warrants issued for services.
+Added: 31, 2024, we did not issue any new stock options or restricted stock units to staff or service providers.
Income and Expense
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year-over-year:
−Removed: For the Years Ended
−Removed: Interest and Dividend Income
−Removed: Gain/(Loss) on Sale of Marketable Securities
−Removed: Gain on changes in fair value of Marketable Securities
−Removed: Gain on changes in fair value of Derivative Liabilities
−Removed: Gain on changes in fair value of Warrant Liabilities
−Removed: Uninsured Casualty Gain/(Loss)
−Removed: Total Other Income/(Expense)
−Removed: income, net of expenses, totaled $13,123,102 for the year ended December 31, 2023, and other income, net of expenses, totaled $85,427
+Added: the Years Ended
+Added: Dividend Income
+Added: Gain on Sale of
+Added: Marketable Securities
+Added: Gain on changes in fair
+Added: value of Marketable Securities
+Added: Gain/(Loss) on changes in fair
+Added: value of Derivative Liabilities
+Added: Gain/(Loss) on changes in fair
+Added: value of Warrant Liabilities
+Added: Loss on Issuance of Stock
+Added: Casualty Gain/(Loss)
+Added: Other Income/(Expense)
+Added: $ (13,169,544 )
+Added: expenses, net of income, totaled $13.169,544 for the year ended December 31, 2024, and other income, net of expenses, totaled $13,123,102
for the year ended December 31, 2023.
the year ended December 31, 2024 interest and dividend income, the changes in fair value of our investments and realized gains from the
−Removed: sale of investments are primarily the result of rising interest rates.
−Removed: the year ended December 31, 2023, we recorded a gain of $3,088,800 related to the change in fair value of the derivative
−Removed: We estimated the $61,000 fair value of the bifurcated embedded derivative at December 31, 2023 using a Monte Carlo
−Removed: simulation model, with the following inputs:
−Removed: the fair value of our common stock of $0.26 ($7.80 post reverse split) on the valuation
−Removed: date, estimated equity volatility of 140.0%, estimated traded volume volatility of 150.0%, the time to maturity of 0.5 year, a
−Removed: discounted market interest rate of 6.40%, dividend rate of 10.0%, a penalty dividend rate of 15.0%, and probability of default of
+Added: sale of investments are primarily the availability of funds available for investment and the fluctuation of interest rates due to market conditions.
+Added: the year ended December 31, 2024, we recorded a loss of $388,000 related to the change in fair value of the derivative liabilities.
+Added: For the Series F Derivative
+Added: (as defined herein), we recorded a gain of $61,000 , We estimated the $0 fair value of the bifurcated embedded derivative at December
+Added: 31, 2024 using a Monte Carlo simulation model, with the following inputs:
+Added: the fair value of our common stock of $1.15 on the valuation
+Added: date, estimated equity volatility of 105.0%, estimated traded volume volatility of 320.0%, the time to maturity of 0.5 years, a discounted
+Added: market interest rate of 6.0%, dividend rate of 10.0%, a penalty dividend rate of 15.0%, and probability of default of 3.60%.
+Added: For the Series F-1 Derivative
+Added: (as defined herein), we recorded a loss of $449,000.
+Added: We estimated the $1,303,000 fair value of the bifurcated embedded derivative
+Added: at December 31, 2024 using a Monte Carlo simulation model, with the following inputs:
+Added: the fair value of our common stock of $1.15
+Added: on the valuation date, estimated equity volatility of 105.0%, estimated traded volume volatility of 320.0%, the time to maturity
+Added: of 0.5 years, a discounted market interest rate of 7.0%, dividend rate of 10.0%, a penalty dividend rate of 15.0%, and probability
+Added: of default of 3.60%.
+Added: the year ended December 31, 2023, we recorded a gain of $3,088,800 related to the change in fair value of the derivative liabilities.
+Added: We estimated the $61,000 fair value of the bifurcated embedded derivative at December 31, 2023 using a Monte Carlo simulation model,
+Added: with the following inputs:
+Added: the fair value of our common stock of $0.26 ($7.80 post reverse split) on the valuation date, estimated equity
+Added: volatility of 140.0%, estimated traded volume volatility of 150.0%, the time to maturity of 0.5 year, a discounted market interest rate
+Added: of 6.40%, dividend rate of 10.0%, a penalty dividend rate of 15.0%, and probability of default of 3.90%.
+Added: the year ended December 31, 2024, we recorded a loss of $4,410,000 related to the change in fair value of the warrant liabilities as
+Added: For the Series F Warrants
+Added: (as defined herein), we recorded a loss of $7,094,000, The fair value of the Series F warrants of approximately $7,194,000 was estimated
+Added: at March 31, 2024 utilizing the Black Scholes Model using the following weighted average assumptions:
+Added: dividend yield 0%;
+Added: term of 3.90 years;
+Added: equity volatility of 110.0%;
+Added: and a risk-free interest rate of 4.31%.
+Added: For the Series F-1 Short-Term
+Added: Warrants (as defined herein), we recorded a gain of $646,000, The fair value of the Series F-1 Short-Term warrants of approximately
+Added: $2,660,000 was estimated at July 25, 2024 utilizing the Black Scholes Model using the following weighted average assumptions:
+Added: remaining term of 1.33 years;
+Added: equity volatility of 115.0%;
+Added: and a risk-free interest rate of 4.70%.
+Added: For the Series F-1 Long-Term
+Added: Warrants (as defined herein), we recorded a gain of $322,000, The fair value of the Series F-1 Long-Term warrants of approximately
+Added: $34,305,000 was estimated at July 25, 2024 utilizing the Black Scholes Model using the following weighted average assumptions:
+Added: remaining term of 4.83 years;
+Added: equity volatility of 120.0%;
+Added: and a risk-free interest rate of 4.10%.
+Added: For the Series G Short-Term
+Added: Warrants (as defined herein), we recorded a gain of $1,146,000, The fair value of the Series G Short-Term warrants of approximately
+Added: $4,713,000 was estimated at July 25, 2024 utilizing the Black Scholes Model using the following weighted average assumptions:
+Added: remaining term of 1.33 years;
+Added: equity volatility of 115.0%;
+Added: and a risk-free interest rate of 4.70%.
+Added: For the Series G Long-Term
+Added: Warrants (as defined herein), we recorded a gain of $570,000, The fair value of the Series G Long-Term warrants of approximately
+Added: $7,630,000 was estimated at July 25, 2024 utilizing the Black Scholes Model using the following weighted average assumptions:
+Added: remaining term of 4.83 years;
+Added: equity volatility of 120.0%;
+Added: and a risk-free interest rate of 4.10%.
the year ended December 31, 2023, we recorded a gain of $9,756,000 related to the change in fair value of the warrant liabilities.
6 unchanged sentences
rate of 3.91%.
−Removed: For the year ended December
−Removed: 31, 2023, we identified a casualty loss of $178,198 related to wire fraud due to a compromised electronic
−Removed: mail account.
+Added: During the year ended December 31, 2024, we recorded a loss associated with the issuance of the Series F-1 Preferred
+Added: Stock totaling $3,737,000 and the Series G Preferred Stock totaling $5,109,000.
+Added: The losses resulted from the fair market value of the
+Added: warrants issued exceeding the sum of the gross proceeds, discount and derivative derived from the placement of the preferred shares.
+Added: the year ended December 31, 2023, we identified a casualty loss of $178,198 related to wire fraud due to a compromised electronic mail
This incident occurred on May 17, 2023 and was discovered on July 20, 2023 when the vendor notified us of a delinquent invoice.
1 unchanged sentence
with altered wring instructions from a domain name that varied from the actual vendor’s domain by one character.
−Removed: notified our cyber insurance carrier on November 9, 2023.During the year ended December
−Removed: 31, 2022, we recovered $4,442 from a financial institution involved in an October, 2021 incident.
−Removed: As of December 31, 2023, and 2022, we had U.S.
+Added: We notified our
+Added: cyber insurance carrier on November 9, 2023.
+Added: The Company recovered $100,000 of this loss from the insurance carrier on July 2, 2024.
+Added: of December 31, 2024, and 2023, we had U.S.
federal net operating loss carry forwards of approximately $116.5 million and $113.1 million,
6 unchanged sentences
$69.4 million does not expire, however it is limited to 80% of each subsequent year’s net income.
−Removed: As of December 31, 2023, and 2022, we
−Removed: state net operating loss carry forwards of approximately $45.2 million and $41.0 million, respectively, some of which expire
−Removed: beginning with the year ending December 31, 2024 through 2043.
+Added: As of December 31, 2024, and
+Added: 2023, we had U.S.
+Added: state net operating loss carry forwards of approximately $55.7 million and $45.2 million, respectively, some of which
+Added: expire beginning with the year ending December 31, 2025 through 2044.
Section 382 of the Code, use of our net operating loss carryforwards is limited if we experience a cumulative change in ownership of
6 unchanged sentences
However, the limitation had no impact on our financial
−Removed: statements since we recorded a full valuation allowance for our deferred tax assets as of December 31, 2023 and 2022 (See Note 7 to
−Removed: the Consolidated Financial Statements).
+Added: statements since we recorded a full valuation allowance for our deferred tax assets as of December 31, 2024 and 2023 (See Note 7 to the
+Added: Consolidated Financial Statements).
and Capital Resources
−Removed: As of December 31, 2023, the Company’s cash on hand was $2,681,010
−Removed: and marketable securities were $2,242,106.
−Removed: The Company has incurred a net loss attributable to shareholders of $8,218,163 for the year
−Removed: ended December 31, 2023.
−Removed: As of December 31, 2023, the Company had working capital of $828,253 and stockholders’ equity of $12,369,572
−Removed: including an accumulated deficit of $101,977,067.
+Added: of December 31, 2024, the Company’s cash on hand was $173,154 and
+Added: marketable securities were $8,345,082.
+Added: The Company has incurred a net loss attributable to shareholders of $27,161,219 for the year ended December 31, 2024.
+Added: As of December 31, 2024,
+Added: the Company had working capital of $2,710,626 and stockholders’ equity of $9,789,740 including an accumulated deficit of $129,138,286.
During the year ended December 31, 2024, cash flows used in operating activities were $8,976,347.
−Removed: Since inception, the Company has
−Removed: met its liquidity requirements principally through the sale of its common and preferred stock in public and private placements;
−Removed: there is no assurance that management will be able to obtain additional financing in the future.
−Removed: These factors raise substantial doubt about the Company’s ability to continue as a going concern.
−Removed: information, see the section above titled “Going Concern.”
+Added: Since inception, the Company has met
+Added: its liquidity requirements principally through the sale of its common and preferred stock in public and private placements;
+Added: however, there
+Added: is no assurance that management will be able to obtain additional financing in the future.
+Added: of December 31, 2023, the Company’s cash on hand was $2,681,010 and marketable securities were $2,242,106.
+Added: The Company has incurred
+Added: a net loss attributable to shareholders of $8,218,163 for the year ended December 31, 2023.
+Added: As of December 31, 2023, the Company had
+Added: working capital of $828,253 and stockholders’ equity of $12,369,572 including an accumulated deficit of $101,977,067.
+Added: year ended December 31, 2023, cash flows used in operating activities were $12,980,625.
+Added: net cash used by operating activities during the year ended December 31,
+Added: 2024, were $8,976,347, consisting primarily of a net loss of $23,359,334 a decrease in trade and other payables of $814,114 and a decrease
+Added: in deferred compensation payable of $100,538 offset by fair value adjustments for derivatives of $388,000, fair value adjustments for
+Added: warrants of $4,410,000, non-cash losses on the issuance of preferred stock of $8,846,000, non-cash share-based compensation of $1,057,271,
+Added: and non-cash compensation to a service provider of $600,000.
net cash used by operating activities during the year ended December 31, 2023, were $12,980,625, consisting primarily of a net loss of
−Removed: $3,999,950 and fair value adjustments of $3,088,800 for derivatives and $9,756,000 for warrants related to the Preferred Shares offset
+Added: $3,999,950 and fair value adjustments of $3,088,800 for derivatives and $9,756,000 for warrants related to offering of preferred stock offset
by non-cash share-based compensation of $3,049,537, an increase in trade and other payables of $1,042,997 and a decrease in prepaid expenses
−Removed: net cash used by operating activities totaled $12,270,068 during the year ended December 31, 2022.
−Removed: Net cash used consisted principally
−Removed: of the net loss from operations of $15,197,336 partially offset by an increase in trade and other payables of $1,686,595, a decrease
−Removed: in prepaid expenses of $540,560 and non-cash stock compensation expenses of $695,191.
−Removed: Our net cash provided by investing activities totaled $1,845,726 for the
−Removed: year ended December 31, 2023 as compared to cash provided by investing activities totaling $6,913,163 during the year ended December 31,
−Removed: During the year ended December 31, 2023 we purchased securities totaling $13,454,304 and sold securities totaling $15,300,000.
−Removed: the year ended December 31, 2022 we purchased securities totaling $4,836,837 and sold securities totaling $11,750,000.
−Removed: cash provided by financing activities during the year ended December 31, 2023 was $13,066,819 which consisted of 14,685,689 for the net
−Removed: proceeds from the sale of Preferred Stock offset by $89,635 for the redemption of Preferred Stock, $1,452,145 for dividends and $77,090
−Removed: for premiums related to the Preferred Stock.
+Added: net cash used in investing activities totaled $6,101,329 for the year ended December 31, 2024, as compared to cash provided by investing
+Added: activities totaling $1,845,726 during the year ended December 31, 2023.
+Added: During the year ended December 31, 2024, we purchased securities
+Added: totaling $12,851,809 and sold securities totaling $6,750,480.
+Added: During the year ended December 31, 2023, we purchased securities totaling
+Added: $13,454,304 and sold securities totaling $15,300,000.
+Added: cash provided by financing activities during the year ended December 31,
+Added: 2024, was $12,569,820 which consisted of $14,000,000 for the net proceeds from the sale of preferred stock offset by $73,472 for the redemption
+Added: of preferred stock and dividends on preferred stock of $1,356,708.
Net cash provided by financing activities during the year ended December
−Removed: was $5,550,028 which consisted of the net proceeds from the sale of Common Stock.
−Removed: 2022 Offering
−Removed: August 15, 2022, we entered into a securities purchase agreement (the “August 2022 SPA”) with certain accredited and institutional
−Removed: investors pursuant to which we agreed to issue 47,059 shares of Common Stock (the “August 2022 Shares”) in a registered direct
−Removed: offering and unregistered warrants to purchase up to an aggregate of 47,063 shares of Common Stock in a concurrent private placement
−Removed: (the “August 2022 Warrants”).
−Removed: The August 2022 Warrants have an exercise price of $157.50 per share, became exercisable six
−Removed: months following the date of issuance and have a term of exercise equal to five years from the initial exercise date.
−Removed: We received net
−Removed: proceeds from the sale of the August 2022 Shares and the August 2022 Warrants, after deducting fees and other estimated offering expenses
−Removed: payable by the Company, of approximately $5.5 million.
−Removed: As of December 31, 2023, none of the August 2022 Warrants have been exercised
−Removed: and 47,063 of the August 2022 Warrants remain outstanding.
+Added: 31, 2023, was $13,066,819 which consisted of 14,685,689 for the net proceeds from the sale of preferred stock offset by $89,635 for the
+Added: redemption of Preferred Stock, $1,452,145 for dividends and $77,090 for premiums related to such shares.
2023 Offering
−Removed: February 21, 2023, we entered into a Securities Purchase Agreement (the “February 2023 SPA”) with certain accredited
−Removed: investors, pursuant to which we agreed to sell in a registered direct offering (the “February 2023 Offering”) (i) an
−Removed: aggregate of 15,000 shares (the “Series F Preferred Shares”) of our newly-designated Series F Convertible Preferred
−Removed: Stock, with a stated value of $1,000 per Preferred Share (the “Series F Preferred Stock”), convertible into shares of
−Removed: Common Stock (the “Series F Conversion Shares”) pursuant to the terms of the Certificate of Designations of the Series F
−Removed: Preferred Stock (the “Certificate of Designation”), and (ii) warrants (the “February 2023 Warrants”) to
−Removed: acquire up to an aggregate of 6,651,885 shares of Common Stock (pre-split), subject to adjustment (the “February 2023 Warrant
−Removed: The Conversion Price (as defined below) is subject to customary adjustments for stock dividends, stock splits,
−Removed: reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities
−Removed: convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain
−Removed: Following the Reverse Stock Split, (i) the Conversion Price was adjusted to $3.18 per share pursuant to the terms of
−Removed: the Certificate of Designations, and (ii) the Exercise Price was adjusted to $3.18 per share and the number of February 2023
−Removed: Warrant Shares was adjusted proportionately to 4,716,904 shares pursuant to the terms of the February 2023
+Added: February 21, 2023, the Company entered into a Securities Purchase Agreement (the “Series F Purchase Agreement”) with certain
+Added: accredited investors (the “Series F Investors”), pursuant to which it agreed to sell to the Investors (i) an aggregate of
+Added: 15,000 shares of the Company’s newly-designated Series F convertible preferred stock with a stated value of $1,000 per share, initially
+Added: convertible into up to 6,651,885 shares (pre-split) of the Company’s Common Stock at an initial conversion price (the “Series
+Added: F Conversion Price”) of $2.255 per share (pre-split), subject to adjustment (the “Series F Preferred Shares”), and
+Added: (ii) warrants to acquire up to an aggregate of 6,651,885 shares (pre-split) of the Company’s Common Stock, subject to adjustment
+Added: (the “Series F Warrants”) (collectively, the “February 2023 Offering”).
+Added: the Reverse Stock Split, (i) the Series F Conversion Price was adjusted to $3.18 per share pursuant to the terms of the Series F
+Added: Certificate of Designations, which was subsequently amended and restated by the filing of the Amended and Restated Certificate of
+Added: Designations of Series F Convertible Preferred Stock, effective April 8, 2024 (as amended and restated, the “Series F
+Added: Certificate of Designations”) with the Secretary of State of the State of Delaware, and (ii) the exercise price of the Series
+Added: F Warrants (the “Series F Exercise Price”) was adjusted to $3.18 per share.
+Added: In connection with the Private Placements
+Added: (as defined herein), (i) the Series F Conversion Price was further adjusted to $1.816 per share pursuant to the full ratchet
+Added: anti-dilution provisions contained in the Series F Certificate of Designations and, (ii) the Series F Exercise Price was further
+Added: adjusted to $1.816 per share.
+Added: As of December 31, 2024, in connection with the issuance of shares of Common Stock upon conversion of
+Added: the Series F-1 Preferred Shares (as defined herein), (i) the Series F Conversion Price was equal to $1.30 per share pursuant to
+Added: the full ratchet anti-dilution provisions contained in the Series F Certificate of Designations and, (ii) the Series F Exercise
+Added: Price was equal to $1.30 per share and the number of shares of Common Stock issuable upon exercise of the Series F warrants was
+Added: equal to 11,538,462 shares pursuant to the full ratchet anti-dilution provisions contained in the Series F
closing, we received net proceeds from the February 2023 Offering of approximately $14.1 million, after deducting various fees and expenses.
We intend to use the net proceeds from this offering for general corporate purposes.
+Added: of December 31, 2024, there were 4,211 Series F Preferred Shares outstanding and Series F Warrants outstanding to purchase up to 8,259,911
+Added: shares of Common Stock.
+Added: As of December 31, 2024, Series F Conversion Price was equal to $1.30 and on March 4, 2025, the Series
+Added: F Conversion Price was adjusted to $0.364.
+Added: F Convertible Preferred Stock
+Added: to the Series F Certificate of Amendment (as defined below), the Company was initially required to redeem the Series F Preferred Shares
+Added: in 12 equal monthly installments, commencing on July 1, 2023.
+Added: The amortization payments due upon such redemption are payable, at the
+Added: Company’s election, in cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Series
+Added: F Conversion Price then in effect and (ii) the greater of (A) 80% of the average of the three lowest closing prices of the Company’s
+Added: Series F Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) a “Floor
+Added: Price” of $6.60 on a post-split basis (subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations
+Added: or other similar events) or, in any case, such lower amount as permitted, from time to time, by the Nasdaq Stock Market.
+Added: April 5, 2024, the Company entered into an Omnibus Waiver and Amendment (the “Omnibus Agreement”) with the Required Holders
+Added: (as defined in the Series F Certificate of Designations).
+Added: Pursuant to the Omnibus Agreement, the Required Holders agreed (i) to defer
+Added: payment of the monthly installment amounts due on March 1, 2024, and April 1, 2024 (the “Installments”), under Section 9(a)
+Added: of the Series F Certificate of Designations, until May 1, 2024, and (ii) to waive any breach or violation of the Series F Purchase Agreement,
+Added: the Series F Certificate of Designations, or the Series F Warrants resulting from missing the Installments.
+Added: The Company may require holders
+Added: to convert their Series F Preferred Shares into shares of Common Stock if the closing price of the Common Stock exceeds $6.765 per share
+Added: (as adjusted for the Reverse Stock Split) (subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations
+Added: or other similar events) for 20 consecutive trading days and the daily dollar trading volume of the Common Stock exceeds $3,000,000 per
+Added: day during the same period and certain equity conditions described in the Series F Certificate of Designations are satisfied.
+Added: May 20, 2024, the Company entered into an Omnibus Waiver, Consent, Notice and Amendment (the “May 2024 Series F Agreement”)
+Added: with the Required Holders (as defined in the Series F Certificate of Designations).
+Added: Pursuant to the May 2024 Series F Agreement, the
+Added: Required Holders agreed to (i) amend the Series F Purchase Agreement to amend certain terms relating to purchase rights thereunder, (ii)
+Added: waive certain rights under the Series F Purchase Agreement and Series F Certificate of Designations in respect of the issuance of the
+Added: Company’s Series F-1 Convertible Preferred Stock, with a par value of $0.001 per share and a stated value of $1,000 per share (“Series
+Added: F-1 Preferred Stock”), the Company’s Series G Convertible Preferred Stock, with a par value of $0.001 per share and a stated
+Added: value of $1,000 per share (“Series G Preferred Stock”), and entrance by the Company into the Purchase Agreements (as defined
+Added: herein), (iii) waive the requirement that the Company reserve for issuance a sufficient number of shares of Common Stock as required
+Added: by the Series F Certificate of Designations, the Series F Purchase Agreement and Series F Warrants, until such time as the Company obtains
+Added: the Stockholder Approval (as defined herein), and (iv) consent to the issuance of the Series F-1 Preferred Stock and Series G Preferred
+Added: Stock as required pursuant to certain terms of the Series F Certificate of Designations, the Series F Purchase Agreement and the Series
+Added: F Warrants, as applicable.
+Added: The Company and the Required Holders further agreed pursuant to the May 2024 Series F Agreement, to amend
+Added: the Series F Certificate of Designations by filing a Certificate of Amendment to the Series F Certificate of Designations (the “Series
+Added: F Certificate of Amendment”) with the Secretary of State of the State of Delaware.
+Added: The Series F Certificate of Amendment amends
+Added: the Series F Certificate of Designations to (i) extend the maturity date to December 31, 2024, (ii) permit and modify certain procedures
+Added: related to the payment of installment amounts with respect to the Installment Dates (as defined in the Series F Certificate of Designations)
+Added: falling between (and including) July 1, 2024, and (and including) August 1, 2024, thereunder, and (iii) modify the schedule of Installment
+Added: November 7, 2024, each holder of the Series F Preferred Shares agreed that payment by the Company of any Installment Amounts (as defined
+Added: in the Series F Certificate of Designations) that are accrued and are unredeemed, unconverted and/or otherwise unpaid as of November
+Added: 7, 2024, will be deferred until December 1, 2024.
+Added: April 8, 2025, the Company entered into an Omnibus Amendment Agreement (“April 2025 Amendment Agreement”) with the Required Holders
+Added: (as defined in the Series F Certificate of Designations and Series F-1 Certificate of Designations), pursuant to which, the Required
+Added: Holders agreed to amend (i) the Series F-1 Certificate of Designations, as described below, by filing a Certificate of Amendment to the
+Added: Series F-1 Certificate of Designations with the Secretary of State of the State of Delaware (the “April 2025 Series F-1 Certificate
+Added: of Amendment”), (ii) the Series F Certificate of Designations, as described below, by filing a Certificate of Amendment to the
+Added: Series F Certificate of Designations with the Secretary of State of the State of Delaware (the “April 2025 Series F Certificate
+Added: of Amendment”), (iii) the Series F-1 Purchase Agreement, to amend the definition of “Excluded Securities” such that
+Added: the definition includes the issuance of common stock issued after the date of the Seres F-1 Purchase Agreement pursuant to an Approved
+Added: Stock Plan (as defined in the Series F-1 Purchase Agreement), which in the aggregate does not exceed more than 2% of the shares of common
+Added: stock issued and outstanding as of the date of such issuance (the “Excluded Securities Modification”), and (iv) to amend
+Added: the term of the Series F-1 Short-Term Warrants to be five years from the date of issuance.
+Added: In addition, in consideration of the foregoing,
+Added: the Company agreed to reduce the size of the board of directors of the Company to no more than six directors, no later than the Company’s
+Added: 2025 annual meeting of stockholders.
+Added: April 2025 Series F Certificate of Amendment amends the Series F Certificate of Designations to (A) (i) extend the maturity date to June
+Added: 30, 2025, and (ii) modify the schedule of Installment Dates (as defined in the Series F Certificate of Designations), in each case, effective
+Added: as of December 31, 2024, and (B) subject to obtaining the approval of the Company’s stockholders, effective January 1, 2025, increase
+Added: the aggregate Stated Value of the Series F Preferred Stock outstanding to an amount equal to 110%
+Added: of the aggregate Stated Value of the Series F Preferred Stock outstanding.
+Added: The April 2025 Series
+Added: F Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of April 8, 2025.
+Added: holders of the Series F Preferred Shares are entitled to dividends of 10% per annum, compounded monthly, which is payable in cash or
+Added: shares of Common Stock at the Company’s option, in accordance with the terms of the Series F Certificate of Designations.
+Added: the occurrence and during the continuance of a Triggering Event (as defined in the Series F Certificate of Designations), the Series
+Added: F Preferred Shares accrue dividends at the rate of 15% per annum.
+Added: Upon conversion or redemption, the holders of the Series F Preferred
+Added: Shares are also entitled to receive a dividend make-whole payment.
+Added: Except as required by applicable law, the holders of the Series F
+Added: Preferred Shares are entitled to vote with holders of the Common Stock on as as-converted basis, with the number of votes to which each
+Added: holder of Series F Preferred Shares is entitled to be calculated assuming a conversion price of $60.21 per share, which was the Minimum
+Added: Price (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) applicable immediately before the execution and delivery of the
+Added: Series F Purchase Agreement, subject to certain beneficial ownership limitations as set forth in the Series F Certificate of Designations.
+Added: The Series F Certificate of Designations further provides that the holders of record of the Series F Preferred Shares, exclusively and
+Added: as a separate class, shall be entitled to elect one director of the Company one time on or before June 30, 2024.
+Added: Effective as of April
+Added: 8, 2024, the Company appointed Dr.
+Added: Mitchell Glass to serve as a member of the Company’s board of directors, with Mr.
+Added: been elected to such position by the holders of the Series F Preferred Share.
+Added: Notwithstanding
+Added: the foregoing, the Company’s ability to settle conversions and make amortization and dividend make-whole payments using shares
+Added: of Common Stock is subject to certain limitations set forth in the Series F Certificate of Designations.
+Added: Further, the Series F Certificate
+Added: of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable
+Added: upon conversion of, or as part of any amortization payment or dividend make-whole payment under, the Series F Certificate of Designations
+Added: or Series F Warrants.
+Added: F Common Stock Warrants
+Added: to the February 2023 Offering, the Company issued to investors the Series F Warrants to purchase 4,716,904 shares of Common Stock, with
+Added: an initial exercise price of $3.18 per share (subject to adjustment), for a period of five years from the date of issuance.
+Added: F Exercise Price and the number of shares issuable upon exercise of the Series F Warrants are subject to customary adjustments for stock
+Added: dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis,
+Added: in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below
+Added: the then-applicable Series F Exercise Price (subject to certain exceptions).
+Added: Upon any such price-based adjustment to the exercise price,
+Added: the number of shares issuable upon exercise of the Series F Warrants will be increased proportionately.
+Added: As of December 31, 2024, the
+Added: Series F Exercise Price was equal to $1.30 per share and the number of shares of Common Stock issuable upon exercise of the Series
+Added: F Warrants was equal to 11,538,462 shares pursuant to the full ratchet anti-dilution provisions contained in the Series F
+Added: May 14, 2024, the Company entered into an Amendment (the “Series F Warrant Amendment”) with the Series F Investors in the
+Added: February 2023 Offering, effective as of March 31, 2024.
+Added: The Series F Warrant Amendment modified certain terms of the Series F Warrants
+Added: relating to the rights of the holders of the Series F Warrants to provide that, in the event of a Fundamental Transaction (as defined
+Added: in the Series F Warrants) that is not within the Company’s control, including the Fundamental Transaction not being approved by
+Added: the Company’s Board of Directors, the holder of the Series F Warrant shall only be entitled to receive from the Company or any
+Added: successor entity the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion
+Added: of such Series F Warrant, that is being offered and paid to the holders of the Company’s common stock in connection with the Fundamental
+Added: Transaction, whether that consideration be in the form of cash, stock or any combination thereof, or whether the holders of Common Stock
+Added: are given the choice to receive from among alternative forms of consideration in connection with the Fundamental Transaction;
+Added: further, that if holders of Common Stock of the Company are not offered or paid any consideration in such Fundamental Transaction, such
+Added: holders of Common Stock will be deemed to have received common stock of the successor entity (which such successor entity may be the
+Added: Company following such Fundamental Transaction) in such Fundamental Transaction.
+Added: The modification resulted in the reclassification of
+Added: the Series F Warrants to be considered equity classified as they were no longer in the scope of ASC 815.
+Added: In accordance with ASC 815-40,
+Added: the Company remeasured the Series F Warrant liabilities at $7,961,000 fair value as of March 31, 2024, the effective date of the modification,
+Added: and recognized the $7,094,000 loss on the change in fair value and reclassified the $7,961,000 fair value of the Series F Warrants to
+Added: additional paid-in capital as of March 31, 2024.
+Added: F-1 Private Placement
+Added: May 20, 2024, the Company entered into a Securities Purchase Agreement (the “Series F-1 Purchase Agreement”) with certain
+Added: accredited investors (the “Series F-1 Investors”) pursuant to which it agreed to sell to the Series F-1 Investors (i) an
+Added: aggregate of 5,050 shares of the Company’s newly-designated Series F-1 Preferred Stock, initially convertible into up to 2,780,839
+Added: shares of Common Stock at a conversion price (the “Series F-1 Conversion Price”) of $1.816 per share, (ii) short-term warrants
+Added: to acquire up to an aggregate of 2,780,839 shares of Common Stock (the “Series F-1 Short-Term Warrants”) at an exercise price
+Added: of $1.816 per share, and (iii) long-term warrants to acquire up to an aggregate of 2,780,839 shares of Common Stock (the “Series
+Added: F-1 Long-Term Warrants,” and collectively with the Series F-1 Short-Term Warrants, the “Series F-1 Warrants”) at an
+Added: exercise price of $1.816 per share (collectively, the “Series F-1 Private Placement”).
+Added: The closing of the Series F-1 Private
+Added: Placement occurred on May 23, 2024 (the “Series F-1 Closing Date”).
+Added: As of December 31, 2024, in
+Added: connection with the issuance of shares of Common Stock upon conversion of the Series F-1 Preferred Stock, (i) the Series F-1 Conversion
+Added: Price was equal to $1.30 per share pursuant to the full ratchet anti-dilution provisions contained in the Series F-1 Certificate of
+Added: Designations and, (ii) the exercise price of the Series F-1 Warrants was equal to $1.30 per share and the number of shares of Common
+Added: Stock issuable upon exercise of the Series F-1 Warrants was equal to 7,769,230 shares pursuant to the full ratchet anti-dilution
+Added: provisions contained in the Series F-1 Warrants.
+Added: received net proceeds from the Series F-1 Private Placement of approximately $5.0 million, after deducting various fees and expenses.
+Added: We intend to use the net proceeds from this offering for general corporate purposes.
+Added: As of December 31, 2024, there were 4,747 shares of Series F-1 Preferred
+Added: Stock outstanding, Series F-1 Short-Term Warrants outstanding to purchase up to 3,884,615 shares of Common Stock and Series F-1 Long-Term
+Added: Warrants outstanding to purchase up to 3,884,615 shares of Common Stock.
+Added: As of December 31, 2024, the Series F-1 Conversion Price was
+Added: equal to $1.30 and as of March 4, 2025, the Series F-1 Conversion Price was adjusted to $0.364.
+Added: F-1 Preferred Stock
+Added: Series F-1 Preferred Stock became convertible upon issuance into Common Stock (the “Series F-1 Conversion Shares”) at the
+Added: election of the holder at any time at the initial conversion price of $1.816.
+Added: The Series F-1 Conversion Price is subject to customary
+Added: adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of
+Added: any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable
+Added: Series F-1 Conversion Price (subject to certain exceptions).
+Added: Company is required to redeem the Series F-1 Preferred Stock in seven (7) equal monthly installments, commencing on December 1, 2024.
+Added: The amortization payments due upon such redemption are payable, at the Company’s election, in cash at 105% of the applicable Installment
+Added: Redemption Amount (as defined in the Series F-1 Certificate of Designations), or subject to certain limitations, in shares of Common
+Added: Stock valued at the lower of (i) the Series F-1 Conversion Price then in effect and (ii) the greater of (A) 80% of the average of the
+Added: three lowest closing prices of the Company’s Common Stock during the thirty consecutive trading day period ending and including
+Added: the trading day immediately prior to the date the amortization payment is due or (B) $0.364, which is 20% of the “Minimum Price”
+Added: (as defined in Nasdaq Stock Market Rule 5635) on the date in which the Series F-1 Stockholder Approval (as defined herein) was obtained
+Added: or, in any case, such lower amount as permitted, from time to time, by the Nasdaq Capital Market, and, in each case, subject to adjustment
+Added: for stock splits, stock dividends, stock combinations, recapitalizations or other similar events, which amortization amounts are subject
+Added: to certain adjustments as set forth in the Series F-1 Certificate of Designations (the “Series F-1 Floor Price”).
+Added: holders of the Series F-1 Preferred Stock are entitled to dividends of 10% per annum, compounded monthly, which are payable in arrears
+Added: monthly in cash or shares of Common Stock at the Company’s option, in accordance with the terms of the Series F-1 Certificate of
+Added: Designations.
+Added: Upon the occurrence and during the continuance of a Triggering Event (as defined in the Series F-1 Certificate of Designations),
+Added: the Series F-1 Preferred Stock will accrue dividends at the rate of 15% per annum.
+Added: Upon conversion or redemption, the holders of the
+Added: Series F-1 Preferred Stock are also entitled to receive a dividend make-whole payment.
+Added: The holders of the Series F-1 Preferred Stock
+Added: are entitled to vote with holders of the Common Stock on as as-converted basis, with the number of votes to which each holder of Series
+Added: F-1 Preferred Stock is entitled to be calculated assuming a conversion price of $2.253 per share, which was the Minimum Price (as defined
+Added: in Rule 5635 of the Rule of the Nasdaq Stock Market) applicable immediately before the execution and delivery of the Series F-1 Purchase
+Added: Agreement, subject to certain beneficial ownership limitations as set forth in the Series F-1 Certificate of Designations.
+Added: Notwithstanding
+Added: the foregoing, the Company’s ability to settle conversions and make amortization and dividend make-whole payments using shares
+Added: of Common Stock is subject to certain limitations set forth in the Series F-1 Certificate of Designations.
+Added: Further, the Series F-1 Certificate
+Added: of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable
+Added: upon conversion of, or as part of any amortization payment or dividend make-whole payment under, the Series F-1 Certificate of Designations
+Added: or Series F-1 Warrants.
+Added: to the Series F-1 Private Placement, the Company issued to investors (i) the Series F-1 Long-Term Warrants to purchase 2,780,839 shares
+Added: of Common Stock, with an initial exercise price of $1.816 per share (subject to adjustment), for a period of five years from the date
+Added: of issuance and (ii) the Series F-1 Short-Term Warrants to purchase 2,780,839 shares of Common Stock, with an initial exercise price
+Added: of $1.816 per share (subject to adjustment), for a period of eighteen months from the date of issuance.
+Added: exercise price of the Series F-1 Warrants and the number of shares issuable upon exercise of the Series F-1 Warrants are subject to customary
+Added: adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full
+Added: ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common
+Added: Stock, at a price below the then-applicable exercise price (subject to certain exceptions).
+Added: Upon any such price-based adjustment to the
+Added: exercise price, the number of shares issuable upon exercise of the Series F-1 Warrants will be increased proportionately.
As of December
−Removed: 31, 2023, there were 6,833 Series F Preferred Shares outstanding and February 2023 Warrants outstanding to purchase
−Removed: up to 4,716,904 shares of Common Stock.
−Removed: F Preferred Shares
−Removed: terms of the Series F Preferred Shares are as set forth in the form of Certificate of Designation.
−Removed: The Series F Preferred Shares
−Removed: became convertible upon issuance into the Conversion Shares at the election of the holder at any time at an initial conversion price
−Removed: of $2.255 (pre-split) (the “Conversion
−Removed: The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the
−Removed: like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or
−Removed: exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions).
−Removed: Following the
−Removed: Reverse Stock Split, the Conversion Price for the Preferred Shares was adjusted to $3.18 per share pursuant to the terms of the
−Removed: Certificate of Designations.
−Removed: The Company is required to redeem the Series F Preferred Shares in 12 equal monthly installments,
−Removed: commencing on July 1, 2023.
−Removed: The amortization payments due upon such redemption are payable, at the company’s election, in
−Removed: cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Conversion Price then in effect
−Removed: and (ii) the greater of (A) 80% of the average of the three lowest closing prices of the Company’s Common Stock during the
−Removed: thirty trading day period immediately prior to the date the amortization payment is due or (B) the Floor Price (as defined below).
−Removed: For purposes of the Certificate of Designation, the “Floor Price” means $6.60 (subject to adjustment for stock splits,
−Removed: stock dividends, stock combinations, recapitalizations or other similar events) or, in any case, such lower amount as permitted,
−Removed: from time to time, by the Nasdaq Stock Market.
−Removed: The Company may require holders to convert their Series F Preferred Shares into
−Removed: Conversion Shares if the closing price of the Common Stock exceeds $202.95 per share (subject to adjustment for stock splits, stock
−Removed: dividends, stock combinations, recapitalizations or other similar events) for 20 consecutive trading days and the daily dollar
−Removed: trading volume of the Common Stock exceeds $3,000,000 per day during the same period and certain equity conditions described in the
−Removed: Certificate of Designation are satisfied.
−Removed: The holders of the Series F Preferred Shares are entitled to dividends
−Removed: of 10% per annum, compounded monthly, which are payable in cash or shares of Common Stock at the Company’s option, in accordance
−Removed: with the terms of the Certificate of Designation.
−Removed: Upon the occurrence and during the continuance of a Triggering Event (as defined in
−Removed: the Certificate of Designation), the Series F Preferred Shares accrue dividends at the rate of 15% per annum.
−Removed: In connection with a Triggering
−Removed: Event, each holder of Series F Preferred Shares is able to require the Company to redeem in cash any or all of the holder’s Series
−Removed: F Preferred Shares at a premium set forth in the Certificate of Designation.
−Removed: Upon conversion or redemption, the holders of the Series
−Removed: F Preferred Shares are also entitled to receive a dividend make-whole payment.
−Removed: The holders of Series F Preferred Shares have no voting
−Removed: rights on account of the Series F Preferred Shares, other than with respect to certain matters affecting the rights of the Series F Preferred
−Removed: Company is subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment
−Removed: transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends
−Removed: pursuant to the Certificate of Designation), distributions or redemptions, and the transfer of assets, among other matters.
−Removed: no established public trading market for the Series F Preferred Shares and the Company does not intend to list the Series F Preferred
−Removed: Shares on any national securities exchange or nationally recognized trading system.
−Removed: 2023 Warrants
−Removed: February 2023 Warrants became exercisable immediately upon issuance, have an exercise price of $2.255 per share (pre-split) (as
−Removed: adjusted, the “Exercise Price”) and expire five years from the date of issuance.
−Removed: The Exercise Price is subject to
−Removed: customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a
−Removed: “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or
−Removed: exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions).
−Removed: Upon any such
−Removed: price-based adjustment to the Exercise Price, the number of Warrant Shares issuable upon exercise of the Warrants will be increased
−Removed: proportionately.
−Removed: The Warrants were issued with an initial Exercise Price of $2.255 per share (pre-split).
−Removed: Following the Reverse
−Removed: Stock Split, the Exercise Price for the Warrants was adjusted to $3.18 per share and the number of February 2023 Warrant
−Removed: Shares was adjusted to 4,716,904 shares pursuant to the terms of the Warrants.
−Removed: There is no established public trading market for the
−Removed: February 2023 Warrants and the Company does not intend to list the February 2023 Warrants on any national securities exchange or
−Removed: nationally recognized trading system.
+Added: 31, 2024, the Series F Exercise Price was adjusted to $1.30 per share and the number of shares of Common Stock issuable upon exercise
+Added: of the Series F Warrants was adjusted proportionally to 7,769,230 shares pursuant to the full ratchet anti-dilution provisions contained in
+Added: the Series F Warrants.
+Added: August 16, 2024, the Company entered into (i) an Amendment (the “Series F-1 Long Term Warrant Amendment”) with the Series
+Added: F-1 Investors, effective as of June 30, 2024 relating to the Series F-1 Long Term Warrants, and (ii) an Amendment (the “Series
+Added: F-1 Short Term Warrant Amendment” and, together with the Series F-1 Long Term Warrant Amendment, the “Series F-1 Warrant
+Added: Amendments”) with the Series F-1 Investors, effective as of June 30, 2024 relating to the Series F-1 Short Term Warrants.
+Added: F-1 Warrant Amendments modified certain terms of the Series F-1 Warrants relating to the rights of the holders of the Series F-1 Warrants
+Added: to provide that, in the event of a Fundamental Transaction (as defined in the Series F-1 Warrants) that is not within the Company’s
+Added: control, including the Fundamental Transaction not being approved by the Company’s Board of Directors, the holder of the Series
+Added: F-1 Warrant shall only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in
+Added: the same proportion), at the Black Scholes Value of the unexercised portion of such Series F-1 Warrant, that is being offered and paid
+Added: to the holders of the Company’s Common Stock in connection with the Fundamental Transaction, whether that consideration be in the
+Added: form of cash, stock or any combination thereof, or whether the holders of Common Stock are given the choice to receive from among alternative
+Added: forms of consideration in connection with the Fundamental Transaction;
+Added: provided, further, that if holders of Common Stock of the Company
+Added: are not offered or paid any consideration in such Fundamental Transaction, such holders of Common Stock will be deemed to have received
+Added: common stock of the successor entity (which such successor entity may be the Company following such Fundamental Transaction).
+Added: Additionally,
+Added: the Series F-1 Warrant Amendments amend the definition of Black Scholes Value related to the volatility input which is now an expected
+Added: volatility equal to the 30 day volatility, obtained from the “HVT” function on Bloomberg (determined utilizing a 365 day
+Added: annualization factor) as of the trading day immediately following the earliest to occur of (1) the public disclosure of the applicable
+Added: Fundamental Transaction and (2) the date of a holder’s request.
+Added: The modification resulted in the reclassification of the Series
+Added: F-1 Warrants to be considered equity classified as they were no longer in the scope of ASC 815.
+Added: G Private Placement
+Added: May 20, 2024, the Company entered into a Securities Purchase Agreement (the “Series G Purchase Agreement” and collectively
+Added: with the Series F-1 Purchase Agreement, each a “Purchase Agreement” and collectively, the “Purchase Agreements”)
+Added: with certain accredited investors (the “Series G Investors” and collectively with the Series F-1 Investors, the “Investors”),
+Added: with certain accredited investors (the “Series G Investors”), pursuant to which it agreed to sell to the Series G Investors
+Added: (i) an aggregate of 8,950 shares of the Company’s newly-designated Series G Preferred Stock, initially convertible into up to 4,928,416
+Added: shares of the Company’s Common Stock, at an initial conversion price (the “Series G Conversion Price”) of $1.816 per
+Added: share (ii) short-term warrants to acquire up to an aggregate of 4,928,416 shares of Common Stock (the “Series G Short-Term Warrants”)
+Added: at an exercise price of $1.816 per share, and (iii) long-term warrants to acquire up to an aggregate of 4,928,416 shares of Common Stock
+Added: (the “Series G Long-Term Warrants,” and collectively with the Series G Short-Term Warrants, the “Series G Warrants”)
+Added: at an initial exercise price (the “Series G Exercise Price”) of $1.816 per share (collectively, the “Series G Private
+Added: Placement” and collectively with the Series F-1 Private Placement, each a “Private Placement” and collectively, the
+Added: “Private Placements”).
+Added: The closing of the Series G Private Placement occurred on May 23, 2024 (the “Series G Closing
+Added: Date” and collectively with the Series F-1 Closing Date, the “Closing Date”).
+Added: As of December 31, 2024, in
+Added: connection with the issuance of shares of Common Stock upon conversion of the Series F-1 Preferred Stock, (i) the Series G Conversion
+Added: Price was equal to $1.30 per share due to the full ratchet anti-dilution provisions contained in the Series G Certificate of Designations
+Added: and, (ii) the exercise price of the Series G Warrants was equal to $1.30 per share and the number of shares of Common Stock issuable
+Added: upon exercise of the Series G Warrants was equal to 13,769,230 shares pursuant to the full ratchet anti-dilution provisions
+Added: contained in the Series G Warrants.
+Added: received net proceeds from the Series G Private Placement of approximately $8.9 million, after deducting various fees and expenses.
+Added: intend to use the net proceeds from this offering for general corporate purposes.
+Added: As of December 31, 2024, there were 8,884 shares of Series G Preferred
+Added: Stock outstanding, Series G Short-Term Warrants outstanding to purchase up to 6,884,615 shares of Common Stock, and Series G Long-Term
+Added: Warrants outstanding to purchase up to 6,884,615 shares of Common Stock.
+Added: As of December 31, 2024, the Series G Conversion Price was equal
+Added: to $1.30 and on March 4, 2025, the Series G Conversion Price was adjusted to $0.364.
+Added: G Preferred Stock
+Added: Series G Preferred Shares became convertible upon issuance into Common Stock (the “Series G Conversion Shares”) at the election
+Added: of the holder at any time at an initial conversion price of $1.816 (the “Series G Conversion Price”).
+Added: The Series G Conversion
+Added: Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based
+Added: adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at
+Added: a price below the then-applicable Series G Conversion Price (subject to certain exceptions).
+Added: any time after the issuance date of the Series G Preferred Shares, the Company has the option to redeem in cash all or any portion of
+Added: the shares of Series G Preferred Shares then outstanding at a premium upon notice by the Company to all holders of the Series G Preferred
+Added: holders of the Series G Preferred Shares will be entitled to dividends of 10% per annum, compounded monthly, which will be payable in
+Added: arrears monthly, at the holder’s options, (i) in cash, (ii) “in kind” in the form of additional shares of Series G
+Added: Preferred Shares (the “PIK Shares”), or (iii) in a combination thereof, in each case, in accordance with the terms of the
+Added: Certificate of Designations of the Series G Preferred Shares (the “Series G Certificate of Designations”).
+Added: Upon the occurrence
+Added: and during the continuance of a Triggering Event (as defined in the Series G Certificate of Designations), the Series G Preferred Stock
+Added: will accrue dividends at the rate of 15% per annum.
+Added: Upon conversion or redemption, the holders of the Series G Preferred Shares are also
+Added: entitled to receive a dividend make-whole payment.
+Added: The holders of the Series G Preferred Shares will be entitled to vote with holders
+Added: of the Common Stock on as as-converted basis, with the number of votes to which each holder of Series G Preferred Share is entitled to
+Added: be calculated assuming a conversion price of $2.253 per share, which was the Minimum Price (as defined in Rule 5635 of the Rule of the
+Added: Nasdaq Stock Market) applicable immediately before the execution and delivery of the Series G Purchase Agreement, subject to certain
+Added: beneficial ownership limitations as set forth in the Series G Certificate of Designations.
+Added: During the years ended December 31, 2024 and 2023, the
+Added: Company recorded dividends totaling $559,032 and $0, respectively, which are reported as Series G Preferred Stock Dividends on the
+Added: Consolidated Statements of Comprehensive Loss.
+Added: Notwithstanding
+Added: the foregoing, the Company’s ability to settle conversions and make dividend make-whole payments using shares of Common Stock is
+Added: subject to certain limitations set forth in the Series G Certificate of Designations.
+Added: Further, the Series G Certificate of Designations
+Added: contains a certain beneficial ownership limitation, which applies to each Series G Investor, other than PharmaCyte Biotech, Inc., after
+Added: giving effect to the issuance of shares of Common Stock issuable upon conversion of the Series G Preferred Shares or as part of any dividend
+Added: make-whole payment under the Series G Certificate of Designations.
+Added: June 17, 2024, the Company entered into an Amendment Agreement (the “Series G Amendment”) with the Required Holders (as defined
+Added: in the Series G Certificate of Designations).
+Added: Pursuant to the Series G Amendment, the Required Holders agreed to amend the Series G Certificate
+Added: of Designations by filing a Certificate of Amendment (“Series G Certificate of Amendment”) to the Series G Certificate of
+Added: Designations with the Secretary of State of the State of Delaware (the “Secretary of State”) to increase the number of authorized
+Added: shares of Series G Preferred Stock from 8,950 to 12,826,273, in order to authorize a sufficient number of shares of Series G Preferred
+Added: Stock for the payment of PIK Shares.
+Added: On June 17, 2024, the Company filed the Series G Certificate of Amendment with the Secretary of
+Added: State, thereby amending the Series G Certificate of Designations.
+Added: The Series G Certificate of Amendment became effective with the Secretary
+Added: of State upon filing.
+Added: August 8, 2024, the Company entered into an Amendment Agreement (the “August Series G Amendment”) with the Required Holders
+Added: (as defined in the Series G Certificate of Designations).
+Added: Pursuant to the August Series G Amendment, the Required Holders agreed to amend
+Added: the Series G Certificate of Designations by filing a Certificate of Amendment (“August Series G Certificate of Amendment”)
+Added: to the Series G Certificate of Designations with the Secretary of State to adjust the calculation of the PIK Shares.
+Added: On August 8, 2024,
+Added: the Company filed the August Series G Certificate of Amendment with the Secretary of State, thereby amending the Series G Certificate
+Added: of Designations.
+Added: The August Series G Certificate of Amendment became effective with the Secretary of State upon filing.
+Added: to the Series G Private Placement, the Company issued to investors (i) the Series G Long-Term Warrants to purchase 4,928,416 shares
+Added: of Common Stock, with an initial exercise price of $1.816 per share (subject to adjustment), for a period of five years from the
+Added: date of issuance and (ii) the Series G Short-Term Warrants to purchase 4,928,416 shares of Common Stock, with an initial exercise
+Added: price of $1.816 per share (subject to adjustment), for a period of eighteen months from the date of issuance.
+Added: As of December 31,
+Added: 2024, the Series G Exercise Price was adjusted to $1.30 per share and the number of shares of Common Stock issuable upon exercise of
+Added: the Series G Warrants was adjusted proportionally to 13,769,230 shares pursuant to the full ratchet anti-dilution provisions
+Added: contained in the Series G Warrants.
+Added: exercise price of the Series G Warrants and the number of shares issuable upon exercise of the Series G Warrants are subject to customary
+Added: adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full
+Added: ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common
+Added: Stock, at a price below the then-applicable exercise price (subject to certain exceptions).
+Added: Upon any such price-based adjustment to the
+Added: exercise price, the number of shares issuable upon exercise of the Series G Warrants will be increased proportionately.
+Added: August 16, 2024, the Company entered into (i) an Amendment (the “Series G Long Term Warrant Amendment”) with the Series G
+Added: Investors, effective as of June 30, 2024, relating to the Series G Long Term Warrants, and (ii) an Amendment (the “Series G Short
+Added: Term Warrant Amendment” and, together with the Series G Long Term Warrant Amendment, the “Series G Warrant Amendments”)
+Added: with the Series G Investors, effective as of June 30, 2024, relating to the Series G Short Term Warrants.
+Added: The Series G Warrant Amendments
+Added: modified certain terms of the Series G Warrants relating to the rights of the holders of the Series G Warrants to provide that, in the
+Added: event of a Fundamental Transaction (as defined in the Series G Warrants) that is not within the Company’s control, including the
+Added: Fundamental Transaction not being approved by the Company’s Board of Directors, the holder of the Series G Warrant shall only be
+Added: entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion), at
+Added: the Black Scholes Value (as defined in the Series G Warrants) of the unexercised portion of such Series G Warrant, that is being offered
+Added: and paid to the holders of the Company’s Common Stock in connection with the Fundamental Transaction, whether that consideration
+Added: be in the form of cash, stock or any combination thereof, or whether the holders of Common Stock are given the choice to receive from
+Added: among alternative forms of consideration in connection with the Fundamental Transaction;
+Added: provided, further, that if holders of Common
+Added: Stock of the Company are not offered or paid any consideration in such Fundamental Transaction, such holders of Common Stock will be
+Added: deemed to have received common stock of the successor entity (which such successor entity may be the Company following such Fundamental
+Added: Transaction).
+Added: Additionally, the Series G Warrant Amendments amend the definition of Black Scholes Value related to the volatility input
+Added: which is now an expected volatility equal to the 60 day volatility, obtained from the “HVT” function on Bloomberg (determined
+Added: utilizing a 365 day annualization factor) as of the trading day immediately following the earliest to occur of (1) the public disclosure
+Added: of the applicable Fundamental Transaction and (2) the date of a holder’s request.
+Added: The modification resulted in the reclassification
+Added: of the Series G Warrants to be considered equity classified as they were no longer in the scope of ASC 815.
+Added: Rights Agreements
+Added: connection with the Series F-1 Private Placement, the Company entered into a Registration Rights Agreement with the Series F-1 Investors
+Added: (the “Series F-1 Registration Rights Agreement,”), pursuant to which the Company agreed to file a resale registration statement
+Added: (the “Series F-1 Registration Statement”) with the SEC to register for resale (A) 200% of the Series F-1 Conversion Shares
+Added: and (B) 200% of the Series F-1 Warrant Shares promptly following the Closing Date, but in no event later than 30 calendar days after
+Added: the Closing Date, and to have such Series F-1 Registration Statement declared effective by the Effectiveness Deadline (as defined in
+Added: the Series F-1 Registration Rights Agreement).
+Added: connection with the Series G Private Placement, the Company entered into a Registration Rights Agreement with the Series G Investors
+Added: (the “Series G Registration Rights Agreement” and, together with the Series F-1 Registration Rights Agreement, the “Registration
+Added: Rights Agreements”) pursuant to which the Company agreed to file a resale registration statement (the “Series G Registration
+Added: Statement”) with the SEC to register for resale (A) 200% of the Series G Conversion Shares, (B) 200% of the shares of Common Stock
+Added: issuable upon conversion of the PIK Shares, and (C) 200% of the Series G Warrant Shares promptly following the Closing Date, but in no
+Added: event later than 30 calendar days after the Closing Date, and to have such Series G Registration Statement declared effective by the
+Added: Effectiveness Deadline (as defined in the Series G Registration Rights Agreement).
+Added: connection with the Registration Rights Agreements, the Company filed a registration statement on Form S-3 covering such securities,
+Added: which registration statement was filed on June 21, 2024, amended on August 8, 2024 and declared effective by the SEC on August 12, 2024.
+Added: Under the Series F-1 Registration Rights Agreement, the Company is obligated to pay certain liquidated damages to the Series F-1 Investors
+Added: if the Company, among other things, failed to file the Series F-1 Registration Statement when required, failed to file or cause the Series
+Added: F-1 Registration Statement to be declared effective by the SEC when required, or fails to maintain the effectiveness of the Series F-1
+Added: Registration Statement.
+Added: Placement Warrants
+Added: connection with the Private Placements, pursuant to (A) an engagement letter (the “GPN Agreement”) with GP Nurmenkari Inc.
+Added: (“GPN”) and (B) an engagement letter (the “Palladium Agreement,” and collectively with the GPN Agreement, the
+Added: “Engagement Letters”) with Palladium Capital Group, LLC (“Palladium,” and collectively with GPN, the “Placement
+Added: Agents”), the Company engaged the Placement Agents to act as non-exclusive placement agents in connection with each Private Placement,
+Added: pursuant to which, the Company agreed to (i) pay the Placement Agents a cash fee equal to 3% of the gross proceeds of each Private Placement
+Added: (including any cash proceeds realized by the Company from the exercise of the Series F Warrants), (ii) reimbursement and payment of certain
+Added: expenses, and (iii) issue to the Placement Agents on the Closing Date, warrants to purchase up to an aggregate of 693,833 of shares of
+Added: Common Stock to each Placement Agent, which is equal to 3% of the aggregate number of shares of Common Stock underlying the securities
+Added: issued in each Private Placement, including upon exercise of any Series F Warrants, with terms identical to the Series G Long-Term Warrants
+Added: and Series F-1 Long-Term Warrants.
+Added: Stockholder Approval
+Added: Company’s ability to issue Series F-1 Conversion Shares and Series G Conversion Shares and Series F-1 Warrant Shares and Series
+Added: G Warrant Shares using shares of Common Stock is subject to certain limitations set forth in the Series F-1 Certificate of Designations
+Added: and Series G Certificate of Designations, as applicable.
+Added: Prior to the Nasdaq Stockholder Approval (as defined below), such limitations
+Added: included a limit on the number of shares that could be issued until the time that the Company’s stockholders have approved the
+Added: issuance of more than 19.99% of the Company’s outstanding shares of Common Stock in accordance with the rules of the Nasdaq Stock
+Added: Each Purchase Agreement requires the Company to hold a meeting of its stockholders no later than August 1, 2024, to seek approval
+Added: (the “Stockholder Approval”) (i) under Nasdaq Stock Market Rule 5635(d) for the issuance of shares of Common Stock in excess
+Added: of 19.99% of the Company’s issued and outstanding shares of Common Stock at prices below the “Minimum Price” (as defined
+Added: in Rule 5635 of the Rules of the Nasdaq Stock Market) on the date of the applicable Purchase Agreement pursuant to the terms of the Series
+Added: F-1 Preferred Shares and Series G Preferred Shares, as applicable, and the Series G Warrants and Series F-1 Warrants, as applicable,
+Added: and (ii) to increase the number of authorized shares of the Company to ensure that the number of authorized shares of Common Stock is
+Added: sufficient to meet the Required Reserve Amount (as defined in the Purchase Agreements) pursuant to the terms of each Purchase Agreement.
+Added: The Company received the Nasdaq Stockholder Approval at a special meeting of stockholders held on July 24, 2024.
Accounting Estimates
59 unchanged sentences
issues under review that could result in significant payments, accruals or material deviations from its position.
−Removed: years from 2019 through 2023 remain subject to examination by federal and state jurisdictions.
+Added: the Company had losses in the past, all prior years that generated net operating loss carryforwards are open and subject to audit examination
+Added: in relation to the net operating loss generated from those years.
account for share-based payments by recognizing compensation expense based upon the estimated fair value of the share-based payments
26 unchanged sentences
as of 4:05 p.m.
−Removed: Eastern Standard Time on February 14, 2024, we effected the Reverse Stock Split of our common stock at a ratio of
−Removed: one-for-thirty.
−Removed: Simultaneously with the Reverse Stock Split, number of shares of our common stock authorized for issuance was
−Removed: reduced from 500,000,000 shares to 16,666,666 shares, and our authorized capital stock was reduced from 550,000,000 shares to
−Removed: 66,666,666 shares.
−Removed: All share and per share information in this report have been retroactively adjusted to reflect the Reverse Stock
+Added: Eastern Standard Time on February 14, 2024, we effected the Reverse Stock Split of our common stock at a ratio of one-for-thirty.
+Added: Simultaneously with the Reverse Stock Split, number of shares of our common stock authorized for issuance was reduced from 500,000,000
+Added: shares to 16,666,666 shares, and our authorized capital stock was reduced from 550,000,000 shares to 66,666,666 shares.
+Added: All share and
+Added: per share information in this report have been retroactively adjusted to reflect the Reverse Stock Split.
+Added: July 25, 2024, the Company increased the number of authorized shares of the Company’s Common Stock from 16,666,666 to 250,000,000
+Added: and made a corresponding change to the number of authorized shares of the Company’s capital stock by filing a Certificate of Amendment
+Added: to its Certificate of Incorporation with the Secretary of State of the State of Delaware (the “Share Increase”).
+Added: Increase was approved by the Company’s stockholders at the Company’s special meeting of stockholders held on July 24, 2024.
Reincorporation
13 unchanged sentences
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.