−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS
+Added: OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
You should read the following discussion and
1 unchanged sentence
appearing elsewhere in this Annual Report on Form 10-K.
−Removed: In addition to historical information, this discussion and analysis contains
−Removed: forward-looking statements that involve risks, uncertainties and assumptions.
−Removed: Our actual results may differ materially from those discussed
−Removed: Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those
−Removed: discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K.
−Removed: All amounts in this
−Removed: report are in U.S.
+Added: In addition to historical information, this discussion and analysis contains forward-looking
+Added: statements that involve risks, uncertainties and assumptions.
+Added: Our actual results may differ materially from those discussed below.
+Added: that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the
+Added: section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K.
+Added: All amounts in this report are in U.S.
dollars, unless otherwise noted.
−Removed: are a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs.
−Removed: We are focused
−Removed: on developing (i) a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001);
−Removed: (ii) a treatment
−Removed: for mast-cell derived cancers and anaphylaxis (HT-KIT);
−Removed: and (iii) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory
−Removed: diseases (HT-ALZ).
−Removed: We also have assets being developed for (i) atopic dermatitis (also known as eczema) (BioLexa);
−Removed: (ii) a treatment for
−Removed: asthma and allergies using inhalational administration (HT-004);
−Removed: and (iii) a treatment for obesity, and obesity-related diseases and
−Removed: conditions (HT-VA).
−Removed: of Operations
−Removed: of Our Results of Operations for the Years Ended December 31, 2024 and 2023
−Removed: Costs and Expenses
−Removed: and Development Expenses
+Added: We are a clinical-stage biopharmaceutical company
+Added: focused on developing new generation therapies for unmet medical needs.
+Added: We are focused on developing (i) a topical formulation for treating
+Added: side effects from drugs used for the treatment of cancer (HT-001);
+Added: (ii) a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT);
+Added: and (iii) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ).
+Added: We also have assets being
+Added: developed for (i) atopic dermatitis (also known as eczema) (BioLexa);
+Added: (ii) a treatment for asthma and allergies using inhalational administration
+Added: and (iii) a treatment for obesity, and obesity-related diseases and conditions (HT-VA).
+Added: Results of Operations
+Added: Comparison of Our Results of Operations for the Years Ended December
+Added: 31, 2025 and 2024
+Added: Operating Costs and Expenses
+Added: Research and Development Expenses
For the year ended December 31, 2025, research
3 unchanged sentences
(i) HT-001, approximately $3,646,000
−Removed: million related to manufacturing and clinical activities;
−Removed: (ii) HT-KIT, approximately $0.6 million related to manufacturing and preclinical
−Removed: (iii) HT-ALZ, approximately $0.2 million related to preclinical studies;
−Removed: and (iv) HT-004, approximately $0.1 million related
−Removed: to sponsored research.
−Removed: In addition to the foregoing, we also incurred fees of approximately $0.2 million payable to members of our scientific
−Removed: advisory board for services.
+Added: related to manufacturing and clinical activities;
+Added: (ii) HT-KIT, approximately $753,000 related to manufacturing and preclinical activities;
+Added: (iii) HT-VA, approximately $137,000, and (iv) HT-ALZ, approximately $12,000 related to preclinical studies.
+Added: In addition to the foregoing,
+Added: we also incurred fees of approximately $131,000 payable to members of our scientific advisory board for services and recorded approximately
+Added: $1,268,000 of in-process research and development expenses in connection with the acquisition of patent applications.
For the year ended December 31, 2024, research
5 unchanged sentences
(ii) HT-KIT, approximately $0.6 million related to manufacturing and preclinical
−Removed: (iii) HT-ALZ, approximately $65,000 related to preclinical studies;
−Removed: (iv) BioLexa, approximately $56,000 related to manufacturing;
−Removed: and (v) HT-004, approximately $59,000 related to sponsored research.
−Removed: In addition to the foregoing, we also incurred fees of approximately
−Removed: $0.2 million payable to members of our scientific advisory board for services.
−Removed: expect our research and development activities to increase as we develop our existing product candidates and potentially acquire new
−Removed: product candidates, reflecting increasing costs associated with the following:
−Removed: employee-related
−Removed: expenses, which include salaries and benefits, and rent expenses;
−Removed: related to in-licensed products and technology;
−Removed: incurred under agreements with CROs, investigative sites and consultants that conduct our clinical trials and a substantial portion
−Removed: of our pre-clinical activities;
−Removed: cost of acquiring and manufacturing clinical trial materials;
−Removed: associated with non-clinical activities and regulatory approvals.
−Removed: and Administrative Expenses
+Added: (iii) HT-ALZ, approximately $0.2 million related to preclinical studies;
+Added: and (iv) HT-004, approximately $0.1 million related
+Added: to sponsored research.
+Added: In addition to the foregoing, we also incurred fees of approximately $0.2 million payable to members of our scientific
+Added: advisory board for services.
+Added: We expect our research and development activities
+Added: to increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs
+Added: associated with the following:
+Added: ● employee-related expenses,
+Added: which include salaries and benefits, and rent expenses;
+Added: ● fees related to in-licensed
+Added: products and technology;
+Added: ● expenses incurred under agreements
+Added: with CROs, investigative sites and consultants that conduct our clinical trials and a substantial portion of our pre-clinical activities;
+Added: ● the cost of acquiring and manufacturing
+Added: clinical trial materials;
+Added: ● costs associated with non-clinical
+Added: activities and regulatory approvals.
+Added: General and Administrative Expenses
For the year ended December 31, 2025, general
7 unchanged sentences
During the year ended December 31, 2025, the increase
−Removed: in general and administrative expenses of approximately $754,000 was primarily attributed to an increase other general and administrative
−Removed: expenses of approximately $246,000, which primarily consisted of an increase in conference fees of approximately $154,000, and an increase
−Removed: in travel expenses of approximately $32,000, an increase in compensation and related expenses of approximately $681,000, comprising of
−Removed: an increase in stock-based compensation of approximately $612,000 related to the issuance of stock options to executives and board of
−Removed: director members and an increase in health insurance, and an increase in rent of approximately $14,000, offset by a decrease in professional
−Removed: and consulting expenses of approximately $187,000.
+Added: in general and administrative expenses of approximately $1,449,000 was primarily attributed to an increase in compensation and related
+Added: expenses of $590,000, primarily attributable to the issuance of 800,000 shares of common stock to our Chief Executive Officer valued at
+Added: $968,000 and an increase in other compensation and related expenses of $196,000, which were offset by a decrease in stock-based compensation
+Added: of approximately $574,000 in connection with the issuance of stock options during the year ended December 31, 2025 as compared to the
+Added: year ended December 31, 2024.
+Added: Additionally, during the year December 31, 2025, professional and consulting expenses increased by approximately
+Added: $892,000 which was primarily attributable to an increase in legal and consulting fees of approximately $538,000, an increase in stock-based
+Added: professional fees of $333,000 an increase in directors’ fees of approximately $21,000, and an increase in rent expense of $1,000.
+Added: These increases were offset by a decrease in other general and administrative expenses of approximately $34,000.
We anticipate that our general and administrative
expenses will increase in future periods, reflecting continued and increasing costs associated with:
−Removed: of our research and development activities;
−Removed: compensation granted to key employees and non-employees;
−Removed: of business development activities;
−Removed: professional fees and other costs associated with regulatory requirements that we are subject to.
−Removed: Income (Expenses), net
−Removed: For the year ended December 31, 2024, net other
−Removed: income was approximately $27,000, which primarily resulted from $27,000 of dividend and interest income.
−Removed: the year ended December 31, 2023, net other expenses were approximately $0.1 million, which primarily resulted from $0.2 million of unrealized
−Removed: losses on marketable securities, partially offset by approximately $0.1 million of dividend income.
−Removed: the year ended December 31, 2024 and 2023, we incurred a net loss of approximately $8.2 million, or $1.28 per common share (basic and
−Removed: diluted), and $8.1 million, or $2.38 per common share (basic and diluted), respectively.
−Removed: and Capital Resources
−Removed: To date we have funded our operations primarily
−Removed: through the sale of equity and debt securities.
−Removed: As of December 31, 2024, we had approximately $7.0 million in cash and cash equivalents,
−Removed: working capital of approximately $6.8 million and an accumulated deficit of approximately $60.4 million.
−Removed: Net cash used in operating activities
−Removed: was $7.0 million and $8.4 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: We incurred net losses of approximately
−Removed: $8.2 million and $8.1 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: We have incurred substantial operating losses
−Removed: since inception and expect to continue to incur significant operating losses for the foreseeable future as we continue our pre-clinical
−Removed: and clinical development of our product candidates.
−Removed: We have not yet commercialized any products and have never generated any revenue from
−Removed: product sales.
−Removed: We believe that our existing cash as of December 31, 2024 plus cash proceeds we received of $5,625,000 from exercise
−Removed: of warrants in January 2025 and cash proceeds we received of $1,470,435 from the sale of our common shares under the ATM Agreement during
−Removed: the period from January 7, 2025 to March 28, 2025 will enable us to fund our operating expenses and capital expenditure requirements for
−Removed: at least 12 months from the date that our audited financial statements are available to be issued.
−Removed: the year ended December 31, 2024, we issued 2,500,000 shares (the “Warrant Shares”) of our common stock upon the exercise
−Removed: of the 2,500,000 January 2023 Existing Warrants (as defined herein) for net proceeds of approximately $3.7 million, after deducting placement
−Removed: agent fees and other offering expenses of approximately $0.4 million.
−Removed: The Warrant Shares were issued as a result of a March 27, 2024
−Removed: inducement offer agreement, which closed on April 1, 2024, with a holder (the “Holder”) of certain of our existing warrants
−Removed: (“January 2023 Existing Warrants”) to immediately exercise, for cash, an aggregate of 2,500,000 January 2023 Existing Warrants
−Removed: to purchase shares of our common stock at a reduced exercise price of $1.6775 per share.
−Removed: On November 8, 2024, we entered into an At The
−Removed: Market Offering Agreement (the “ATM Agreement”) with H.C.
−Removed: Wainwright & Co., LLC (“Wainwright”) under
−Removed: which we may offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales
−Removed: manager pursuant to our effective shelf registration statement on Form S-3, including an accompanying prospectus (File No.
−Removed: and a prospectus supplement dated November 8, 2024.
−Removed: Sales of shares of the Company’s common stock through Wainwright, if any, will
−Removed: be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities
−Removed: Act of 1933, as amended.
−Removed: Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time
−Removed: to time, based on instructions from us (including any price, time or size limits or other parameters or conditions we may impose).
−Removed: will pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common
−Removed: stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection
−Removed: with the ATM Agreement.
−Removed: The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant
−Removed: to the ATM Agreement, of shares having an aggregate offering price of $2,700,000 and (2) the termination of the ATM Agreement by
−Removed: either us or Wainwright, as set forth therein.
−Removed: From November 8, 2024 to December 31, 2024 we issued 1,137,250 shares of our common stock
−Removed: for net proceeds of approximately $1.0 million pursuant to the ATM Agreement.
−Removed: have entered into certain license, sublicense, sponsored research and option agreements with third parties.
−Removed: Pursuant to such agreements,
−Removed: we may be required to make certain:
−Removed: (i) license maintenance fee payments;
−Removed: (ii) out-of-pocket expense payments, including, but not limited
−Removed: to, payments related to intellectual property and research related expenses;
+Added: ● support of our research and
+Added: development activities;
+Added: ● stock compensation granted
+Added: to key employees and non-employees;
+Added: ● support of business development
+Added: ● increased professional fees
+Added: and other costs associated with regulatory requirements that we are subject to.
+Added: Other Income (Expenses), net
+Added: For the year ended December 31, 2025, other expense,
+Added: net was approximately $108,000, which resulted from the recording of an unrealized loss of crypto assets of $109,000.
+Added: For the year ended December 31, 2024, other income, net was approximately
+Added: $27,000, which primarily resulted from $27,000 of dividend and interest income.
+Added: For the years ended December 31, 2025 and 2024,
+Added: we incurred a net loss of approximately $12.5 million, or $0.90 per common share (basic and diluted), and $8.2 million, or $1.28 per common
+Added: share (basic and diluted), respectively.
+Added: Liquidity and Capital Resources
+Added: date we have funded our operations primarily through the sale of equity and debt securities.
+Added: As of December 31, 2025, we had
+Added: approximately $6.2 million in cash and cash equivalents, working capital of approximately $5.2 million and an accumulated deficit of
+Added: approximately $72.9 million.
+Added: Net cash used in operating activities was $9.8 million and $7.0 million for the years ended December
+Added: 31, 2025 and 2024, respectively.
+Added: We incurred net losses of approximately $12.5 million and $8.2 million for the years ended December
+Added: 31, 2025 and 2024, respectively.
+Added: We have incurred substantial operating losses since inception and expect to continue to incur
+Added: significant operating losses for the foreseeable future as we continue our pre-clinical and clinical development of our product
+Added: We have not yet commercialized any products and have never generated any revenue from product sales.
+Added: We do not believe
+Added: that our existing cash as of December 31, 2025 will enable us to fund our operating expenses and capital expenditure
+Added: requirements for at least 12 months from the date that our consolidated financial statements are available to be issued.
+Added: On November 8, 2024, we entered into an At The Market Offering Agreement
+Added: (the “ATM Agreement”) with H.C.
+Added: Wainwright & Co., LLC (“Wainwright”) under which we could offer and sell
+Added: shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager pursuant to our
+Added: effective shelf registration statement on Form S-3 (File No.
+Added: 333-272620), including an accompanying base prospectus and
+Added: a prospectus supplement dated November 8, 2024.
+Added: Sales of shares of the Company’s common stock through Wainwright, if any, will be
+Added: made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities
+Added: Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time to time, based on
+Added: instructions from us (including any price, time or size limits or other parameters or conditions we may impose).
+Added: We will pay Wainwright
+Added: a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common stock sold through Wainwright
+Added: under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection with the ATM Agreement.
+Added: 7, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $5,000,000 pursuant to a prospectus
+Added: supplement dated February 7, 2025.
+Added: On November 13, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement
+Added: was increased by $2,439,256 pursuant to a prospectus supplement dated November 13, 2025 for a current offering up to $4,821,200.
+Added: of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant to the ATM Agreement, of shares having
+Added: an aggregate offering price of $10,139,256 and (2) the termination of the ATM Agreement by either us or Wainwright, as set forth
+Added: During the year ended December 31, 2025 we issued an aggregate of 2,782,309 shares of our common stock for net proceeds of approximately
+Added: $4.1 million, after deducting approximately $142,000 in sales agent commissions and other offering expenses payable by us pursuant to
+Added: the ATM Agreement.
+Added: We have entered into certain license, sublicense, sponsored research
+Added: and option agreements with third parties.
+Added: Pursuant to such agreements, we may be required to make certain:
+Added: (i) license maintenance fee
+Added: (ii) out-of-pocket expense payments, including, but not limited to, payments related to intellectual property and research related
(iii) development and commercialization expense payments;
(iv) annual and quarterly minimum payments;
−Removed: (v) diligence expense payments;
+Added: (v) diligence expense
and (vi) revenue interest payments.
−Removed: In addition, subject
−Removed: to the achievement of certain development and/or commercialization events, we may also be required to make certain:
−Removed: (i) minimum royalty
−Removed: payments, ranging from middle to high five figures, (ii) sales-based royalties and running royalties, ranging from low single digits
−Removed: to low double digits;
−Removed: and (iii) milestone payments, of up to approximately $30 million (if all milestones in all of our current agreements
−Removed: are achieved).
−Removed: funding will be necessary to fund our future clinical and pre-clinical activities.
−Removed: We may obtain additional financing through sales of
−Removed: our equity and debt securities or entering into strategic partnership arrangements, or a combination of the foregoing.
−Removed: There are no assurances
−Removed: that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable
−Removed: to us or at all, particularly in light of the economic downturn.
−Removed: If we are unable to secure adequate additional funding as and when needed,
−Removed: we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.
−Removed: Flows from Operating Activities
−Removed: the year ended December 31, 2024, net cash used in operating activities was approximately $7.0 million, which primarily resulted from
−Removed: a net loss of approximately $8.2 million, offset by $0.8 million in stock-based compensation, a decrease in prepaid expense of $0.2 million
−Removed: and an increase in accounts payable and accrued expenses of $0.2 million.
−Removed: the year ended December 31, 2023, net cash used in operating activities was approximately $8.4 million, which primarily resulted from
−Removed: a net loss of approximately $8.1 million, a $0.3 million gain on termination of license agreement, offset by $0.2 million unrealized
−Removed: loss on marketable securities, $0.2 million stock-based compensation and changes in operating assets and liabilities of approximately
−Removed: $0.5 million.
−Removed: Flows from Investing Activities
−Removed: Company did not have any cash flows from investing activities for the years ended December 31, 2024 or December 31, 2023.
−Removed: Flows from Financing Activities
−Removed: the year ended December 31, 2024, net cash provided by financing activities was approximately $4.7 million, which primarily resulted
−Removed: from net proceeds from the issuance of common stock, common stock warrants, and prefunded warrants of $1.0 million and proceeds from
−Removed: the exercise of warrants of approximately $3.7 million.
−Removed: the year ended December 31, 2023, net cash provided by financing activities was approximately $11.3 million, which primarily resulted
−Removed: from net proceeds from the issuance of common stock, common stock warrants, and prefunded warrants.
−Removed: ultimate success is dependent on our ability to obtain additional financing and generate sufficient cash flow to meet our obligations
−Removed: on a timely basis.
−Removed: We will require significant amounts of capital to sustain operations, and we will need to make the investments we
−Removed: need to execute our longer-term business plan to support new technologies and help advance innovation.
−Removed: Absent generation of sufficient
−Removed: revenue from the execution of our long-term business plan, we will need to obtain debt or equity financing, especially if we experience
−Removed: downturns in our business that are more severe or longer than anticipated, or if we experience significant increases in expense levels
−Removed: resulting from being a publicly traded company or from operations.
−Removed: Such additional debt or equity financing may not be available to us
−Removed: on favorable terms, if at all.
−Removed: plan to pursue our plans with respect to the research and development of our pre-clinical products which will require resources beyond
−Removed: those that we currently have, ultimately requiring additional capital from third-party sources.
−Removed: We currently do not expect to generate
−Removed: Accounting Estimates
−Removed: preparation of consolidated financial statements in accordance with accounting principles generally accepted in the United States of
−Removed: America requires management to make estimates and assumptions that affect the reported amounts and related disclosures in the financial
−Removed: Management considers an accounting estimate to be critical if:
−Removed: requires assumptions to be made that were uncertain at the time the estimate was made;
−Removed: in the estimate or different estimates that could have been selected could have a material impact in our results of operations or
−Removed: financial condition.
−Removed: we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances,
−Removed: actual results could differ from those estimates and the differences could be material.
−Removed: Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for an additional discussion of
−Removed: our significant accounting policies.
−Removed: Company accounts for stock-based payment awards exchanged for services at the estimated grant date fair value of the award.
−Removed: Stock options
−Removed: issued under the Company’s long-term incentive plans are granted with an exercise price equal to no less than the market price
−Removed: of the Company’s stock at the date of grant and expire up to ten years from the date of grant.
−Removed: Options are generally issued fully
−Removed: The Company accounts for forfeited awards as they occur.
−Removed: Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating
−Removed: the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application
−Removed: of management’s judgment.
−Removed: Term - The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding
−Removed: based on the simplified method, which is the half-life from vesting to the end of its contractual term.
−Removed: Volatility - The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
−Removed: Interest Rate - The Company bases the risk-free interest rate on the implied yield available on U.S.
−Removed: Treasury zero-coupon issues
−Removed: with an equivalent remaining term.
−Removed: Dividend - The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends
−Removed: in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
−Removed: Company grants restricted stock awards under its equity incentive plan.
+Added: In addition, subject to the achievement of certain development and/or commercialization
+Added: events, we may also be required to make certain:
+Added: (i) minimum royalty payments, ranging from middle to high five figures, (ii) sales-based
+Added: royalties and running royalties, ranging from low single digits to low double digits;
+Added: and (iii) milestone payments, of up to approximately
+Added: $25 million (if all milestones in all of our current agreements are achieved).
+Added: Additional funding will be necessary to fund our
+Added: future clinical and pre-clinical activities.
+Added: We may obtain additional financing through sales of our equity and debt securities or entering
+Added: into strategic partnership arrangements, or a combination of the foregoing.
+Added: There are no assurances that we will be successful in obtaining
+Added: an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light
+Added: of the economic downturn.
+Added: If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay,
+Added: scale back or discontinue the development and commercialization of one or more of our product candidates.
+Added: Cash Flows from Operating Activities
+Added: For the year ended December 31, 2025, net cash used in operating activities
+Added: was approximately $9.8 million, which primarily resulted from a net loss of approximately $12.5 million and an increase in prepaid expenses
+Added: and other current assets of approximately $460,000 and an increase in accounts payable and accrued expenses of approximately $644,000,
+Added: offset by approximately $850,000 of non-cash research and development-acquired patent, $1.5 million in stock-based compensation and professional
+Added: fees, and unrealized loss on crypto assets of $109,000.
+Added: For the year ended December 31, 2024, net cash
+Added: used in operating activities was approximately $7.0 million, which primarily resulted from a net loss of approximately $8.2 million, offset
+Added: by $0.8 million in stock-based compensation, a decrease in prepaid expense of $0.2 million and an increase in accounts payable and accrued
+Added: expenses of $0.2 million.
+Added: Cash Flows from Investing Activities
+Added: During the year ended December 31, 2025, the Company purchased $300,000
+Added: in crypto assets.
+Added: The Company did not have any cash flows from investing activities for
+Added: the year ended December 31, 2024.
+Added: Cash Flows from Financing Activities
+Added: For the year ended December 31, 2025, net cash provided by financing
+Added: activities was approximately $9.3 million, which primarily resulted from net proceeds from the issuance of common stock of approximately
+Added: $4.1 million and proceeds from the exercise of warrants of approximately $5.6 million, offset by the payment of taxes related to the net
+Added: share settlement of an equity award of $376,000.
+Added: For the year ended December 31, 2024, net cash
+Added: provided by financing activities was approximately $4.7 million, which primarily resulted from net proceeds from the issuance of common
+Added: stock, common stock warrants, and prefunded warrants of $1.0 million and proceeds from the exercise of warrants of approximately $3.7
+Added: Our ultimate success is dependent on our ability
+Added: to obtain additional financing and generate sufficient cash flow to meet our obligations on a timely basis.
+Added: We will require significant
+Added: amounts of capital to sustain operations, and we will need to make the investments we need to execute our longer-term business plan to
+Added: support new technologies and help advance innovation.
+Added: Absent generation of sufficient revenue from the execution of our long-term business
+Added: plan, we will need to obtain debt or equity financing, especially if we experience downturns in our business that are more severe or longer
+Added: than anticipated, or if we experience significant increases in expense levels resulting from being a publicly traded company or from operations.
+Added: Such additional debt or equity financing may not be available to us on favorable terms, if at all.
+Added: We plan to pursue our plans with respect to the
+Added: research and development of our pre-clinical products which will require resources beyond those that we currently have, ultimately requiring
+Added: additional capital from third-party sources.
+Added: We currently do not expect to generate any revenue.
+Added: Critical Accounting
+Added: The preparation of consolidated financial statements
+Added: in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and
+Added: assumptions that affect the reported amounts and related disclosures in the financial statements.
+Added: Management considers an accounting estimate
+Added: to be critical if:
+Added: ● it requires assumptions to
+Added: be made that were uncertain at the time the estimate was made;
+Added: ● changes in the estimate or
+Added: different estimates that could have been selected could have a material impact in our results of operations or financial condition.
+Added: While we base our estimates and judgments on our
+Added: experience and on various other factors that we believe to be reasonable under the circumstances, actual results could differ from those
+Added: estimates and the differences could be material.
+Added: See Note 2 to our consolidated financial statements
+Added: included elsewhere in this Annual Report on Form 10-K for an additional discussion of our significant accounting policies.
+Added: Stock-based compensation
+Added: The Company accounts for stock-based payment awards
+Added: exchanged for services at the estimated grant date fair value of the award.
+Added: Stock options issued under the Company’s long-term incentive
+Added: plans are granted with an exercise price equal to no less than the market price of the Company’s stock at the date of grant and
+Added: expire up to ten years from the date of grant.
+Added: Options are generally issued fully vested.
+Added: The Company accounts for forfeited awards as
+Added: The Company estimates the fair value of stock
+Added: option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards
+Added: represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
+Added: Expected Term - The
+Added: expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the
+Added: simplified method, which is the half-life from vesting to the end of its contractual term.
+Added: Expected Volatility
+Added: - The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
+Added: Risk-Free Interest Rate
+Added: - The Company bases the risk-free interest rate on the implied yield available on U.S.
+Added: Treasury zero-coupon issues with an equivalent
+Added: remaining term.
+Added: Expected Dividend -
+Added: The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable
+Added: future, and, therefore, uses an expected dividend yield of zero in its valuation models.
+Added: The Company grants restricted stock awards under
+Added: its equity incentive plan.
Restricted stock awards are granted to employees and non-employees.
−Removed: The restricted stock awards are measured based on the grant-date fair value.
−Removed: In general, the restricted stock awards vest over a service
−Removed: period of zero to three years.
−Removed: Stock-based compensation expense is generally recognized based on the straight-line basis over the requisite
−Removed: service period and forfeitures are accounted for as they occur.
−Removed: Company has issued warrants to non-employees.
+Added: The restricted stock awards are measured
+Added: based on the grant-date fair value.
+Added: In general, the restricted stock awards vest over a service period of zero to three years.
+Added: compensation expense is generally recognized based on the straight-line basis over the requisite service period and forfeitures are accounted
+Added: for as they occur.
+Added: The Company has issued warrants to non-employees.
The warrants are measured based on the grant-date fair value.
−Removed: In general, the warrants
−Removed: vest over a term of zero to ten years.
−Removed: Stock-based compensation expense is generally recognized based on the straight-line basis over
−Removed: the vesting term.
−Removed: taxes are recorded in accordance with Accounting Standards Codification (“ASC”) 740, Income Taxes (“ASC 740”)
−Removed: which provides for deferred taxes using an asset and liability approach.
−Removed: We recognize deferred tax assets and liabilities for the expected
−Removed: future tax consequences of events that have been included in our consolidated financial statements or tax returns.
−Removed: Deferred tax assets
−Removed: and liabilities are determined based on the difference between our financial statement and tax bases of assets and liabilities using
−Removed: enacted tax rates in effect for the year in which the differences are expected to reverse.
−Removed: Valuation allowances are provided, if based
−Removed: upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
−Removed: account for uncertain tax positions in accordance with the provisions of ASC 740.
−Removed: When uncertain tax positions exist, we recognize the
−Removed: tax benefit of tax positions to the extent that the benefit would more likely than not be realized.
−Removed: The determination as to whether the
−Removed: tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of
−Removed: the available facts and circumstances.
−Removed: Issued Accounting Standards Not Yet Effective or Adopted
−Removed: Taxes (Topic 740)
−Removed: December 2023, the Financial Accounting Standards Board (“FASB”) issued guidance within Accounting Standards Update (“ASU”)
−Removed: 2023-09, Income Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures .
−Removed: The amendments in the ASU are intended to provide more
−Removed: transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation
−Removed: and income taxes paid information.
−Removed: The ASU requires disclosure in the rate reconciliation of specific categories as well as additional
−Removed: information for reconciling items that meet a quantitative threshold.
−Removed: ASU requires disclosure of the following information about income taxes paid on an annual basis:
−Removed: taxes paid (net of refunds received), disaggregated by federal and state taxes and by individual jurisdictions in which income taxes
−Removed: paid (net of refunds received) is equal to or greater than five percent of total income taxes paid (net of refunds received).
−Removed: tax expense (or benefit) from continuing operations disaggregated by federal and state jurisdictions.
−Removed: ASU is effective for annual periods beginning after December 15, 2024.
−Removed: The amendments should be applied on a prospective basis.
−Removed: is evaluating the impact that the adoption of this ASU will have on the Company’s consolidated financial statements, as it may
−Removed: require additional disclosures in the notes to our condensed consolidated financial statements.
+Added: In general, the warrants vest over a term of zero to ten years.
+Added: compensation expense is generally recognized based on the straight-line basis over the vesting term.
+Added: Income taxes are recorded in accordance with Accounting
+Added: Standards Codification (“ASC”) 740, Income Taxes (“ASC 740”) which provides for deferred taxes using an asset
+Added: and liability approach.
+Added: We recognize deferred tax assets and liabilities for the expected future tax consequences of events that have
+Added: been included in our consolidated financial statements or tax returns.
+Added: Deferred tax assets and liabilities are determined based on the
+Added: difference between our financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which
+Added: the differences are expected to reverse.
+Added: Valuation allowances are provided, if based upon the weight of available evidence, it is more
+Added: likely than not that some or all of the deferred tax assets will not be realized.
+Added: We account for uncertain tax positions in accordance
+Added: with the provisions of ASC 740.
+Added: When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the
+Added: benefit would more likely than not be realized.
+Added: The determination as to whether the tax benefit will more likely than not be realized
+Added: is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.
+Added: Recently Issued Accounting Standards Not Yet
+Added: Effective or Adopted
+Added: In November 2024, the Financial Accounting Standards
+Added: Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting Comprehensive
+Added: Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to provide more detailed disaggregation of
+Added: expenses in the income statement, focusing on the nature of the expenses rather than their function.
+Added: The new disclosures will require
+Added: entities to separately present expenses for significant line items, including but not limited to, depreciation, amortization, and employee
+Added: compensation.
+Added: Entities will also be required to provide a qualitative description of the amounts remaining in relevant expense captions
+Added: that are not separately disaggregated quantitatively, disclose the total amount of selling expenses and, in annual reporting periods,
+Added: provide a definition of what constitutes selling expenses.
+Added: This pronouncement is effective for fiscal years beginning after December 15,
+Added: 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted.
+Added: The Company does not expect
+Added: the adoption of this new guidance to have a material impact on its consolidated financial statements.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
−Removed: Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined
−Removed: in Rule 12b-2 of the Exchange Act.
+Added: The Company is not required to provide the information
+Added: required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.
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.