−Removed: MANAGEMENT’S DISCUSSION AND
−Removed: ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
You should read the following discussion and
−Removed: analysis of our financial condition and results of operations together with and our consolidated financial statements and the related
−Removed: notes appearing elsewhere in this Annual Report on Form 10-K.
+Added: analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes
+Added: appearing elsewhere in this Annual Report on Form 10-K.
In addition to historical information, this discussion and analysis contains
6 unchanged sentences
dollars, unless otherwise noted.
−Removed: We are a clinical-stage
−Removed: biopharmaceutical company focused on developing new generation therapies for unmet medical needs.
−Removed: We are focused on developing (i) a
−Removed: topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001);
−Removed: (ii) a treatment for mast-cell derived
−Removed: cancers and anaphylaxis (HT-KIT);
−Removed: (iii) a treatment for traumatic brain injury and ischemic stroke (HT-TBI);
−Removed: and (iv) a treatment and/or
−Removed: prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ).
−Removed: We also have assets being developed for (i) atopic dermatitis
−Removed: (also known as eczema) (BioLexa);
−Removed: (ii) a treatment for asthma and allergies using inhalational administration (HT-004);
−Removed: and (iii) a treatment
−Removed: for acne as well as inflammatory bowel diseases (HT-003).
−Removed: Furthermore, we have interests in certain other assets being developed by third
−Removed: parties including a treatment for patients with lupus that is being developed by Zylö and potential product candidates being developed
−Removed: pursuant to our agreement with Voltron for the prevention of COVID-19.
−Removed: Results of Operations
−Removed: Comparison of Our Results of Operations for the Years Ended December
−Removed: 31, 2023 and 2022
−Removed: Operating Costs and Expenses
−Removed: Research and Development Expenses
+Added: are a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs.
+Added: We are focused
+Added: on developing (i) a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001);
+Added: (ii) a treatment
+Added: for mast-cell derived cancers and anaphylaxis (HT-KIT);
+Added: and (iii) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory
+Added: diseases (HT-ALZ).
+Added: We also have assets being developed for (i) atopic dermatitis (also known as eczema) (BioLexa);
+Added: (ii) a treatment for
+Added: asthma and allergies using inhalational administration (HT-004);
+Added: and (iii) a treatment for obesity, and obesity-related diseases and
+Added: conditions (HT-VA).
+Added: of Operations
+Added: of Our Results of Operations for the Years Ended December 31, 2024 and 2023
+Added: Costs and Expenses
+Added: and Development Expenses
For the year ended December 31, 2024, research
5 unchanged sentences
(ii) HT-KIT, approximately $0.6 million related to manufacturing and preclinical
+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: For the year ended December 31, 2023, research
+Added: and development expenses were approximately $3.9 million.
+Added: Specifically, during the year ended December 31, 2023, our research and development
+Added: costs consisted primarily of the following costs for each of our key research and development projects:
+Added: (i) HT-001, approximately $2.0
+Added: million related to manufacturing and clinical activities;
+Added: (ii) HT-KIT, approximately $1.6 million related to manufacturing and preclinical
(iii) HT-ALZ, approximately $65,000 related to preclinical studies;
3 unchanged sentences
$0.2 million payable to members of our scientific advisory board for services.
−Removed: For the year ended December 31, 2022, research
−Removed: and development expenses were approximately $4.9 million, of which approximately $87,000 was related to licenses acquired and approximately
−Removed: $4.8 million was related to other research and development expenses.
−Removed: Specifically, during the year ended December 31, 2022, our research
−Removed: and development costs consisted primarily of the following costs for each of our key research and development projects:
−Removed: approximately $1.0 million related to clinical trial costs;
−Removed: (ii) HT-001, approximately $2.9 million related to manufacturing, preclinical
−Removed: and clinical activities;
−Removed: (iii) HT-TBI, approximately $0.4 million related to manufacturing and preclinical activities;
−Removed: (iv) HT-003, approximately
−Removed: $41,000 related to preclinical studies;
−Removed: (v) HT-004, approximately $0.1 million related to sponsored research;
−Removed: (vi) HT-006, approximately
−Removed: $51,000 related to sponsored research (on July 12, 2022, our non-exclusive commercial evaluation license agreement with the United States
−Removed: Army Medical Research and Development Command terminated and we are no longer pursuing HT-006);
−Removed: (vii) GW breath based diagnostic device,
−Removed: approximately $76,000 related to research and development with respect to the design of device;
−Removed: (viii) HT-KIT, approximately $0.2 million
−Removed: related to manufacturing and preclinical activities;
−Removed: and (ix) HT-ALZ, approximately $0.2 million in sponsored research.
−Removed: In addition to
−Removed: the foregoing, we also incurred fees of approximately $0.3 million payable to members of our scientific advisory board for services.
−Removed: We expect our research and development activities
−Removed: to increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs
−Removed: associated with the following:
+Added: expect our research and development activities to increase as we develop our existing product candidates and potentially acquire new
+Added: product candidates, reflecting increasing costs associated with the following:
employee-related
1 unchanged sentence
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 of
−Removed: our pre-clinical activities;
+Added: incurred under agreements with CROs, investigative sites and consultants that conduct our clinical trials and a substantial portion
+Added: of our pre-clinical activities;
cost of acquiring and manufacturing clinical trial materials;
associated with non-clinical activities and regulatory approvals.
−Removed: General and Administrative Expenses
−Removed: For the year ended December 31, 2023, General
−Removed: and Administrative Expenses were approximately $4.2 million, which primarily consisted of approximately $1.6 million related to payroll
−Removed: expenses and stock-based compensation, approximately $2.1 million for professional fees and approximately $0.5 million for other expenses.
+Added: and Administrative Expenses
For the year ended December 31, 2024, general
−Removed: and Administrative Expenses were approximately $6.1 million, which primarily consisted of approximately $2.6 million related to payroll
−Removed: expenses and stock-based compensation, approximately $2.5 million for professional fees and approximately $1.0 million for other expenses.
+Added: and administrative expenses amounted to approximately $5.0 million as compared to $4.2 million for the year ended December 31, 2023, an
+Added: increase of $0.8 million, or 17.9%.
+Added: For the years ended December 31, 2024 and 2023, general and administrative expenses consisted of the
+Added: following (rounded to the nearest $1,000):
+Added: Compensation and related expenses
+Added: Professional and consulting expenses
+Added: Other general and administrative expenses
+Added: During the year ended December 31, 2024, the increase
+Added: in general and administrative expenses of approximately $754,000 was primarily attributed to an increase other general and administrative
+Added: expenses of approximately $246,000, which primarily consisted of an increase in conference fees of approximately $154,000, and an increase
+Added: in travel expenses of approximately $32,000, an increase in compensation and related expenses of approximately $681,000, comprising of
+Added: an increase in stock-based compensation of approximately $612,000 related to the issuance of stock options to executives and board of
+Added: director members and an increase in health insurance, and an increase in rent of approximately $14,000, offset by a decrease in professional
+Added: and consulting expenses of approximately $187,000.
We anticipate that our general and administrative
expenses will increase in future periods, reflecting continued and increasing costs associated with:
−Removed: ● support of our research and development activities;
−Removed: ● stock compensation granted to key employees and non-employees;
−Removed: ● support of business development activities;
−Removed: ● increased professional fees and other costs associated with
−Removed: regulatory requirements that we are subject to.
−Removed: Other Income (Expenses), net
−Removed: For the year ended December 31, 2023, net other
−Removed: expenses were approximately $0.1 million, which primarily resulted from $0.2 million of unrealized losses on marketable securities, partially
−Removed: offset by approximately $0.1 million of dividend income.
+Added: of our research and development activities;
+Added: compensation granted to key employees and non-employees;
+Added: of business development activities;
+Added: professional fees and other costs associated with regulatory requirements that we are subject to.
+Added: Income (Expenses), net
For the year ended December 31, 2024, net other
−Removed: expenses were approximately $0.3 million, which primarily resulted from $0.6 million of losses on marketable securities and $0.4 million
−Removed: change in fair value of investments in joint ventures, partially offset by $0.1 million of unrealized gains on marketable securities,
−Removed: $0.5 million of other income related to a research and development tax credit pursuant to Australian regulations and $0.1 million in dividend
−Removed: Liquidity and Capital Resources
+Added: income was approximately $27,000, which primarily resulted from $27,000 of dividend and interest income.
+Added: the year ended December 31, 2023, net other expenses were approximately $0.1 million, which primarily resulted from $0.2 million of unrealized
+Added: losses on marketable securities, partially offset by approximately $0.1 million of dividend income.
+Added: 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
+Added: diluted), and $8.1 million, or $2.38 per common share (basic and diluted), respectively.
+Added: and Capital Resources
To date we have funded our operations primarily
through the sale of equity and debt securities.
−Removed: As of December 31, 2023, we had approximately $9.3 million in cash and marketable securities,
+Added: As of December 31, 2024, we had approximately $7.0 million in cash and cash equivalents,
working capital of approximately $6.8 million and an accumulated deficit of approximately $60.4 million.
1 unchanged sentence
was $7.0 million and $8.4 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: We incurred losses of approximately $7.8
+Added: We incurred net losses of approximately
$8.2 million and $8.1 million for the years ended December 31, 2024 and 2023, respectively.
4 unchanged sentences
product sales.
−Removed: We believe that our existing cash as of December 31, 2023 will enable us to fund our operating expenses and capital expenditure
−Removed: requirements for at least 12 months from the date that our audited financial statements are available to be issued.
−Removed: We have entered into certain license, sublicense,
−Removed: sponsored research and option agreements with third parties.
−Removed: Pursuant to such agreements, we may be required to make certain:
−Removed: maintenance fee payments;
−Removed: (ii) out-of-pocket expense payments, including, but not limited to, payments related to intellectual property
−Removed: and research related expenses;
+Added: We believe that our existing cash as of December 31, 2024 plus cash proceeds we received of $5,625,000 from exercise
+Added: 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
+Added: the period from January 7, 2025 to March 28, 2025 will enable us to fund our operating expenses and capital expenditure requirements for
+Added: at least 12 months from the date that our audited financial statements are available to be issued.
+Added: the year ended December 31, 2024, we issued 2,500,000 shares (the “Warrant Shares”) of our common stock upon the exercise
+Added: of the 2,500,000 January 2023 Existing Warrants (as defined herein) for net proceeds of approximately $3.7 million, after deducting placement
+Added: agent fees and other offering expenses of approximately $0.4 million.
+Added: The Warrant Shares were issued as a result of a March 27, 2024
+Added: inducement offer agreement, which closed on April 1, 2024, with a holder (the “Holder”) of certain of our existing warrants
+Added: (“January 2023 Existing Warrants”) to immediately exercise, for cash, an aggregate of 2,500,000 January 2023 Existing Warrants
+Added: to purchase shares of our common stock at a reduced exercise price of $1.6775 per share.
+Added: On November 8, 2024, we entered into an At The
+Added: Market Offering Agreement (the “ATM Agreement”) with H.C.
+Added: Wainwright & Co., LLC (“Wainwright”) under
+Added: 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
+Added: manager pursuant to our effective shelf registration statement on Form S-3, including an accompanying prospectus (File No.
+Added: and a prospectus supplement dated November 8, 2024.
+Added: Sales of shares of the Company’s common stock through Wainwright, if any, will
+Added: 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
+Added: Act of 1933, as amended.
+Added: Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time
+Added: to time, based on instructions from us (including any price, time or size limits or other parameters or conditions we may impose).
+Added: will pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common
+Added: stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection
+Added: with the ATM Agreement.
+Added: The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant
+Added: to the ATM Agreement, of shares having an aggregate offering price of $2,700,000 and (2) the termination of the ATM Agreement by
+Added: either us or Wainwright, as set forth therein.
+Added: From November 8, 2024 to December 31, 2024 we issued 1,137,250 shares of our common stock
+Added: for net proceeds of approximately $1.0 million pursuant to the ATM Agreement.
+Added: have entered into certain license, sublicense, sponsored research and option agreements with third parties.
+Added: Pursuant to such agreements,
+Added: we may be required to make certain:
+Added: (i) license maintenance fee payments;
+Added: (ii) out-of-pocket expense payments, including, but not limited
+Added: to, payments related to intellectual property and research related expenses;
(iii) development and commercialization expense payments;
(iv) annual and quarterly minimum payments;
−Removed: diligence expense payments;
+Added: (v) diligence expense payments;
and (vi) revenue interest payments.
−Removed: In addition, subject to the achievement of certain development and/or
−Removed: commercialization events, we may also be required to make certain:
−Removed: (i) minimum royalty payments, ranging from middle to high five figures,
−Removed: (ii) sales-based royalties and running royalties, ranging from low single digits to low double digits;
−Removed: and (iii) milestone payments, of
−Removed: up to approximately $12 million (if all milestones in all of our current agreements are achieved).
−Removed: Additional funding will be necessary to fund our
−Removed: future clinical and pre-clinical activities.
−Removed: We may obtain additional financing through sales of our equity and debt securities or entering
−Removed: into strategic partnership arrangements, or a combination of the foregoing.
−Removed: There are no assurances that we will be successful in obtaining
−Removed: an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light
−Removed: of the economic downturn.
−Removed: If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay,
−Removed: scale back or discontinue the development and commercialization of one or more of our product candidates.
−Removed: Cash Flows from Operating Activities
−Removed: For the year ended December 31, 2023, net cash used in operating activities
−Removed: was approximately $8.4 million, which primarily resulted from a net loss of approximately $7.8 million, a $0.3 million gain on termination
−Removed: of license agreement, offset by $0.2 million unrealized loss on marketable securities, $0.2 million stock-based compensation and changes
−Removed: in operating assets and liabilities of approximately $0.7 million.
−Removed: For the year ended December 31, 2022, net cash
−Removed: used in operating activities was approximately $9.3 million, which primarily resulted from a net loss of approximately $11.4 million and
−Removed: $0.1 million unrealized gain on marketable securities, partially offset by approximately $0.6 million in stock-based compensation, $0.6
−Removed: million realized loss on marketable securities, $0.4 million change in fair value of investments in joint ventures and changes in operating
−Removed: assets and liabilities of approximately $0.6 million.
−Removed: Cash Flows from Investing Activities
−Removed: The Company did not have any cash flows from investing activities for
−Removed: the year ended December 31, 2023.
−Removed: For the year ended December 31, 2022, net cash
−Removed: provided by investing activities was approximately $1.2 million which was primarily related to the sale of marketable securities.
−Removed: Cash Flows from Financing Activities
−Removed: For the year ended December 31, 2023, net cash provided by financing
−Removed: activities was approximately $11.3 million, which primarily resulted from net proceeds from the issuance of common stock, common stock
−Removed: warrants, and prefunded warrants.
−Removed: For the year ended December 31, 2022, net cash
−Removed: provided by financing activities was approximately $6.0 million, which primarily resulted from net proceeds from the issuance of common
−Removed: Our ultimate success is dependent on our ability
−Removed: to obtain additional financing and generate sufficient cash flow to meet our obligations on a timely basis.
−Removed: We will require significant
−Removed: amounts of capital to sustain operations, and we will need to make the investments we need to execute our longer-term business plan to
−Removed: support new technologies and help advance innovation.
−Removed: Absent generation of sufficient revenue from the execution of our long-term business
−Removed: plan, we will need to obtain debt or equity financing, especially if we experience downturns in our business that are more severe or longer
−Removed: than anticipated, or if we experience significant increases in expense levels resulting from being a publicly traded company or from operations.
−Removed: Such additional debt or equity financing may not be available to us on favorable terms, if at all.
−Removed: We plan to pursue our plans with respect to the
−Removed: research and development of our pre-clinical products which will require resources beyond those that we currently have, ultimately requiring
−Removed: additional capital from third-party sources.
−Removed: We currently do not expect to generate any revenue.
−Removed: Critical Accounting
−Removed: Policies and Significant Judgments and Estimates
−Removed: Our management’s discussion and analysis
−Removed: of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance
−Removed: generally accepted accounting principles (“GAAP”).
−Removed: The preparation of these consolidated financial statements requires
−Removed: us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets
−Removed: and liabilities as of the date of the balance sheet and the reported amounts of expenses during the reporting period.
−Removed: In accordance with
−Removed: GAAP, we evaluate our estimates and judgments on an ongoing basis.
−Removed: The most significant estimates relate to the valuation of stock options
−Removed: and the valuation allowance of deferred tax assets resulting from net operating losses.
−Removed: We base our estimates and assumptions on current
−Removed: facts, our limited historical experience and various other factors that we believe are reasonable under the circumstances, the results
−Removed: of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other
−Removed: Actual results may differ from these estimates under different assumptions or conditions.
−Removed: We define our critical accounting policies as
−Removed: those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely
−Removed: to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those
−Removed: While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing
−Removed: elsewhere in Annual Report on Form 10-K, we believe the following are the critical accounting policies used in the preparation of our
−Removed: consolidated financial statements that require significant estimates and judgments:
−Removed: Stock-based compensation
−Removed: We expense stock-based compensation to employees
−Removed: and non-employees over the requisite service period based on the estimated grant-date fair value of the awards.
−Removed: Stock-based awards with
−Removed: graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion
−Removed: of the award.
−Removed: We record the expense for stock-based compensation awards subject to performance-based milestone vesting over the remaining
−Removed: service period when management determines that achievement of the milestone is probable.
−Removed: Management evaluates when the achievement of
−Removed: a performance-based milestone is probable based on the expected satisfaction of the performance conditions at each reporting date.
−Removed: stock-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations
−Removed: based upon the underlying employees’ or non-employees’ roles.
−Removed: Income taxes are recorded in accordance with Accounting
−Removed: Standards Codification (“ASC”) 740, Income Taxes (“ASC 740”) which provides for deferred taxes using an asset
−Removed: and liability approach.
−Removed: We recognize deferred tax assets and liabilities for the expected future tax consequences of events that have
−Removed: been included in our consolidated financial statements or tax returns.
−Removed: Deferred tax assets and liabilities are determined based on the
−Removed: difference between our financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which
−Removed: the differences are expected to reverse.
−Removed: Valuation allowances are provided, if based upon the weight of available evidence, it is more
−Removed: likely than not that some or all of the deferred tax assets will not be realized.
−Removed: We account for uncertain tax positions in accordance
−Removed: with the provisions of ASC 740.
−Removed: When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the
−Removed: benefit would more likely than not be realized.
−Removed: The determination as to whether the tax benefit will more likely than not be realized
−Removed: is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.
−Removed: Significant Accounting Policies
−Removed: See Note 2 to the consolidated financial statements
−Removed: for a discussion of significant accounting policies and recent accounting pronouncements.
−Removed: On April 5, 2012, the JOBS Act was enacted.
−Removed: 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided
−Removed: in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.
−Removed: In other words, an “emerging
−Removed: growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
−Removed: We have chosen to take advantage of the extended
−Removed: transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards until
−Removed: those standards would otherwise apply to private companies provided under the JOBS Act.
−Removed: As a result, our consolidated financial statements
−Removed: may not be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting
−Removed: Subject to certain conditions set forth in the
−Removed: JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including, without limitation,
−Removed: (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b)
−Removed: of Sarbanes-Oxley and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding
−Removed: mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial
−Removed: statements, known as the auditor discussion and analysis.
−Removed: We will remain an “emerging growth company” until the earliest of
−Removed: (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more;
−Removed: (ii) the last day of our fiscal
−Removed: year following the fifth anniversary of the date of our initial public offering;
−Removed: (iii) the date on which we have issued more than $1 billion
−Removed: in nonconvertible debt during the previous three years;
−Removed: or (iv) the date on which we are deemed to be a large accelerated filer under
−Removed: the rules of the SEC.
−Removed: However, beginning December 31, 2024, we will no longer be an “emerging growth company,” and will no
−Removed: longer have the ability to delay adoption of these new or revised accounting standards, or to take advantage of reduced corporate governance
+Added: In addition, subject
+Added: to the achievement of certain development and/or commercialization events, we may also be required to make certain:
+Added: (i) minimum royalty
+Added: payments, ranging from middle to high five figures, (ii) sales-based royalties and running royalties, ranging from low single digits
+Added: to low double digits;
+Added: and (iii) milestone payments, of up to approximately $30 million (if all milestones in all of our current agreements
+Added: are achieved).
+Added: funding will be necessary to fund our future clinical and pre-clinical activities.
+Added: We may obtain additional financing through sales of
+Added: our equity and debt securities or entering into strategic partnership arrangements, or a combination of the foregoing.
+Added: There are no assurances
+Added: that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable
+Added: to us or at all, particularly in light of the economic downturn.
+Added: If we are unable to secure adequate additional funding as and when needed,
+Added: we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.
+Added: Flows from Operating Activities
+Added: the year ended December 31, 2024, net cash used in operating activities was approximately $7.0 million, which primarily resulted from
+Added: 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
+Added: and an increase in accounts payable and accrued expenses of $0.2 million.
+Added: the year ended December 31, 2023, net cash used in operating activities was approximately $8.4 million, which primarily resulted from
+Added: a net loss of approximately $8.1 million, a $0.3 million gain on termination of license agreement, offset by $0.2 million unrealized
+Added: loss on marketable securities, $0.2 million stock-based compensation and changes in operating assets and liabilities of approximately
+Added: $0.5 million.
+Added: Flows from Investing Activities
+Added: Company did not have any cash flows from investing activities for the years ended December 31, 2024 or December 31, 2023.
+Added: Flows from Financing Activities
+Added: the year ended December 31, 2024, net cash provided by financing activities was approximately $4.7 million, which primarily resulted
+Added: from net proceeds from the issuance of common stock, common stock warrants, and prefunded warrants of $1.0 million and proceeds from
+Added: the exercise of warrants of approximately $3.7 million.
+Added: the year ended December 31, 2023, net cash provided by financing activities was approximately $11.3 million, which primarily resulted
+Added: from net proceeds from the issuance of common stock, common stock warrants, and prefunded warrants.
+Added: ultimate success is dependent on our ability to obtain additional financing and generate sufficient cash flow to meet our obligations
+Added: on a timely basis.
+Added: We will require significant amounts of capital to sustain operations, and we will need to make the investments we
+Added: need to execute our longer-term business plan to support new technologies and help advance innovation.
+Added: Absent generation of sufficient
+Added: revenue from the execution of our long-term business plan, we will need to obtain debt or equity financing, especially if we experience
+Added: downturns in our business that are more severe or longer than anticipated, or if we experience significant increases in expense levels
+Added: resulting from being a publicly traded company or from operations.
+Added: Such additional debt or equity financing may not be available to us
+Added: on favorable terms, if at all.
+Added: plan to pursue our plans with respect to the research and development of our pre-clinical products which will require resources beyond
+Added: those that we currently have, ultimately requiring additional capital from third-party sources.
+Added: We currently do not expect to generate
+Added: Accounting Estimates
+Added: preparation of consolidated financial statements in accordance with accounting principles generally accepted in the United States of
+Added: America requires management to make estimates and assumptions that affect the reported amounts and related disclosures in the financial
+Added: Management considers an accounting estimate to be critical if:
+Added: requires assumptions to be made that were uncertain at the time the estimate was made;
+Added: in the estimate or different estimates that could have been selected could have a material impact in our results of operations or
+Added: financial condition.
+Added: we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances,
+Added: actual results could differ from those estimates and the differences could be material.
+Added: Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for an additional discussion of
+Added: our significant accounting policies.
+Added: Company accounts for stock-based payment awards exchanged for services at the estimated grant date fair value of the award.
+Added: Stock options
+Added: issued under the Company’s long-term incentive plans are granted with an exercise price equal to no less than the market price
+Added: of the Company’s stock at the date of grant and expire up to ten years from the date of grant.
+Added: Options are generally issued fully
+Added: The Company accounts for forfeited awards as they occur.
+Added: Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating
+Added: the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application
+Added: of management’s judgment.
+Added: Term - The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding
+Added: based on the simplified method, which is the half-life from vesting to the end of its contractual term.
+Added: Volatility - The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
+Added: Interest Rate - The Company bases the risk-free interest rate on the implied yield available on U.S.
+Added: Treasury zero-coupon issues
+Added: with an equivalent remaining term.
+Added: Dividend - The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends
+Added: in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
+Added: Company grants restricted stock awards under its equity incentive plan.
+Added: Restricted stock awards are granted to employees and non-employees.
+Added: The restricted stock awards are measured based on the grant-date fair value.
+Added: In general, the restricted stock awards vest over a service
+Added: period of zero to three years.
+Added: Stock-based compensation expense is generally recognized based on the straight-line basis over the requisite
+Added: service period and forfeitures are accounted for as they occur.
+Added: Company has issued warrants to non-employees.
+Added: The warrants are measured based on the grant-date fair value.
+Added: In general, the warrants
+Added: vest over a term of zero to ten years.
+Added: Stock-based compensation expense is generally recognized based on the straight-line basis over
+Added: the vesting term.
+Added: taxes are recorded in accordance with Accounting Standards Codification (“ASC”) 740, Income Taxes (“ASC 740”)
+Added: which provides for deferred taxes using an asset and liability approach.
+Added: We recognize deferred tax assets and liabilities for the expected
+Added: future tax consequences of events that have been included in our consolidated financial statements or tax returns.
+Added: Deferred tax assets
+Added: and liabilities are determined based on the difference between our financial statement and tax bases of assets and liabilities using
+Added: enacted tax rates in effect for the year in which the differences are expected to reverse.
+Added: Valuation allowances are provided, if based
+Added: 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.
+Added: account for uncertain tax positions in accordance with the provisions of ASC 740.
+Added: When uncertain tax positions exist, we recognize the
+Added: tax benefit of tax positions to the extent that the benefit would more likely than not be realized.
+Added: The determination as to whether the
+Added: tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of
+Added: the available facts and circumstances.
+Added: Issued Accounting Standards Not Yet Effective or Adopted
+Added: Taxes (Topic 740)
+Added: December 2023, the Financial Accounting Standards Board (“FASB”) issued guidance within Accounting Standards Update (“ASU”)
+Added: 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures .
+Added: The amendments in the ASU are intended to provide more
+Added: transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation
+Added: and income taxes paid information.
+Added: The ASU requires disclosure in the rate reconciliation of specific categories as well as additional
+Added: information for reconciling items that meet a quantitative threshold.
+Added: ASU requires disclosure of the following information about income taxes paid on an annual basis:
+Added: taxes paid (net of refunds received), disaggregated by federal and state taxes and by individual jurisdictions in which income taxes
+Added: paid (net of refunds received) is equal to or greater than five percent of total income taxes paid (net of refunds received).
+Added: tax expense (or benefit) from continuing operations disaggregated by federal and state jurisdictions.
+Added: ASU is effective for annual periods beginning after December 15, 2024.
+Added: The amendments should be applied on a prospective basis.
+Added: is evaluating the impact that the adoption of this ASU will have on the Company’s consolidated financial statements, as it may
+Added: require additional disclosures in the notes to our condensed consolidated financial statements.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
−Removed: As a smaller reporting company, we are not required
−Removed: to provide the information required by this item.
+Added: Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined
+Added: 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.