1 unchanged sentence
thousands, except for share amounts and per share data)
−Removed: should read the following discussion and analysis of our financial condition and results of operations (the “MD&A”)
−Removed: together with our unaudited consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report
−Removed: on Form 10-Q (the “Quarterly Report”), and with our audited financial statements and notes thereto for the year ended
−Removed: December 31, 2024, included in our annual report on Form 10-K initially filed with the Securities Exchange Commission (the
−Removed: “SEC”) on April 15, 2025, as amended on April 29, 2025 and July 28, 2025 (the “2024 Annual
+Added: should read the following discussion and analysis of our financial condition and results of operations (the “MD&A”) together
+Added: with our unaudited consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q
+Added: (the “Quarterly Report”), and with our audited financial statements and notes thereto for the year ended December 31, 2024
+Added: included in our annual report on Form 10-K initially filed with the Securities Exchange Commission (the “SEC”) on April 15,
+Added: 2025, as amended on April 29, 2025 and July 28, 2025 (the “2024 Annual Report”) .
Note Regarding Forward-Looking Statements
−Removed: addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly
−Removed: Report, including information with respect to our plans and strategy for our business, constitute forward-looking statements within the
−Removed: meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities
−Removed: Exchange Act of 1934, as amended (the “Exchange Act”).
−Removed: We have based these forward-looking statements on our current expectations
−Removed: and any projections about future events.
−Removed: The following information and any forward-looking statements should be considered in light of
−Removed: factors discussed elsewhere in this Quarterly Report, along with the risks identified under the “Part I – Item 1A”
−Removed: in our 2024 Annual Report and in our other filings with the Securities Exchange Commission (the “SEC”).
+Added: addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this
+Added: Quarterly Report, including information with respect to our plans and strategy for our business, constitute forward-looking
+Added: statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and
+Added: Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
+Added: We have based these forward-looking
+Added: statements on our current expectations and any projections about future events.
+Added: The following information and any forward-looking
+Added: statements should be considered in light of factors discussed elsewhere in this Quarterly Report, along with the risks identified
+Added: under the “Part I – Item 1A” in our 2024 Annual Report and in our other filings made with the Securities Exchange
+Added: Commission (the “SEC”).
caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial
16 unchanged sentences
suppression to develop a new class of novel drugs that are designed to target drug resistance and checkpoints of immune suppression.
−Removed: of the date of this Quarterly Report, our product candidates have not been approved as safe or effective by the FDA or any other comparable
+Added: As of the date of this Quarterly Report, our product candidates have not been approved as safe or effective by the FDA or any other comparable
foreign regulator.
4 unchanged sentences
inception, we have incurred significant operating losses.
−Removed: Our net losses were $2,684 and $2,603, respectively, for the six months ended June 30, 2025
−Removed: and the year ended December 31, 2024.
−Removed: As of June 30, 2025, we had an accumulated deficit of $11,499.
−Removed: We expect to continue
−Removed: to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product
−Removed: candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current
−Removed: and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and
−Removed: business personnel, and operate as a public company.
+Added: Our net losses were $4,082 and $2,603, respectively, for the nine months ended
+Added: September 30, 2025 and the year ended December 31, 2024.
+Added: As of September 30, 2025, we had an accumulated deficit of $12,897.
+Added: to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and
+Added: future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval
+Added: for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and
+Added: development and business personnel, and operate as a public company.
will not generate revenue from product sales unless and until we successfully complete our clinical trials and obtain regulatory approval
19 unchanged sentences
LTD (“Helena”), pursuant to which Helena agreed to purchase from the Company up to $30,000 of common stock (the “ELOC
−Removed: Shares”), which the Company may exercise at any time following effectiveness of a registration statement at a price equal
−Removed: to the 95% of the lowest trading price during the three days following the Company’s notice to Helena to exercise the ELOC Agreement.
−Removed: The Company issued 670,641 shares of restricted common stock (the “Commitment Fee Shares”) to Helena as a
−Removed: “Commitment Fee” for the ELOC Agreement.
−Removed: The ELOC Agreement became available for the Company’s use following
−Removed: the filing and effectiveness of a resale registration statement registering the ELOC Shares for resale.
−Removed: Following effectiveness
−Removed: of the resale registration statement (the “Effective Date”), the Commitment Fee Shares were subject to a “true-up”
−Removed: pursuant to which, as the shares are valued at less than $900 on the Effective Date, additional shares were issued to Helena
−Removed: to bring the ELOC Shares to the full $900 value.
+Added: Shares”), which the Company may exercise at any time following effectiveness of a registration statement at a price equal to the
+Added: 95% of the lowest trading price during the three days following the Company’s notice to Helena to exercise the ELOC Agreement.
+Added: The Company issued 670,641 shares of restricted common stock (the “Commitment Fee Shares”) to Helena as a “Commitment
+Added: Fee” for the ELOC Agreement.
+Added: The ELOC Agreement became available for the Company’s use following the filing and effectiveness
+Added: of a resale registration statement registering the ELOC Shares for resale.
+Added: Following effectiveness of the resale registration statement
+Added: (the “Effective Date”), the Commitment Fee Shares were subject to a “true-up” pursuant to which, as the shares
+Added: were valued at less than $900 on the Effective Date, additional shares were issued to Helena to bring the ELOC Shares to the full $900
ELOC Agreement will terminate upon the following events:
−Removed: (i) the first day of the month next following the 36-month anniversary of
−Removed: the date of the ELOC Agreement or (ii) the date on which Helena has purchased the full $30,000 of ELOC Shares.
−Removed: Agreement may also be terminated by the Company after its commencement, at the Company’s discretion, provided that there are
−Removed: no advance notices outstanding for which common stock has yet to be issued, and the Company has paid all amounts owed to Helena
−Removed: under the ELOC Agreement, including the Commitment Fee shares.
−Removed: At the Company’s annual meeting of shareholders on June 10, 2025, a majority of the Company’s shareholders
−Removed: approved the issuance in excess of 19.99% of the Company’s common stock at a price below market value, in accordance with the terms
−Removed: of the ELOC Agreement and in compliance with Rule 713 of the NYSE American LLC Company Guide.
−Removed: the three and six months ended June 30, 2025, in connection with the ELOC Agreement, the Company sold 510,000 shares of
−Removed: our common stock to Helena for net proceeds of $210.
−Removed: The shares were issued to Helena during the three and six months ended June 30,
−Removed: to June 30, 2025, in connection with the ELOC Agreement, the Company sold 3,000,000 shares of our common stock to Helena
−Removed: for net proceeds of $3,693, excluding certain related costs.
−Removed: The shares were issued to Helena in July 2025.
−Removed: of the date of this Quarterly Report on Form 10-Q, we have sold an aggregate of 3,510,000 shares of our common stock for net
−Removed: proceeds of $3,903 under the ELOC Agreement.
−Removed: Boustead Securities LLC (“Boustead”) and D.
−Removed: Boral Capital LLC
−Removed: Boral”) acted as placement agents (the “Placement Agents”) in the ELOC offering and, following each exercise,
−Removed: are entitled to cash compensation of 7%, 1% non-accountable fees and warrants equal to 7%.
−Removed: To date, the Placement Agents have received
−Removed: total cash compensation equal to $313,225 and a total of 245,750 warrants to purchase common stock, exercisable at exercise prices of
−Removed: $0.40, $0.46 and $1,2308 per share, which warrants will expire five years from the date of grant.
+Added: (i) the first day of the month next following the 36-month anniversary of the
+Added: date of the ELOC Agreement or (ii) the date on which Helena has purchased the full $30,000 of ELOC Shares.
+Added: The ELOC Agreement may also
+Added: be terminated by the Company after its commencement, at the Company’s discretion, provided that there are no advance notices outstanding
+Added: for which common stock has yet to be issued, and the Company has paid all amounts owed to Helena under the ELOC Agreement, including
+Added: the Commitment Fee shares.
+Added: the Company’s annual meeting of shareholders on June 10, 2025, a majority of the Company’s shareholders approved the issuance
+Added: in excess of 19.99% of the Company’s common stock at a price below market value, in accordance with the terms of the ELOC Agreement
+Added: and in compliance with Rule 713 of the NYSE American LLC Company Guide.
+Added: the nine months ended September 30, 2025, in connection with its ELOC agreement with Helena, the Company sold 3,510,000 shares of its
+Added: common stock to Helena for net proceeds of $3,205.
+Added: The shares were issued to Helena during the nine months ended September 30, 2025.
+Added: Securities LLC (“Boustead”) and D.
+Added: Boral Capital LLC (“D.
+Added: Boral”) acted as placement agents (the “Placement
+Added: Agents”) in the ELOC offering and, following each exercise, are entitled to cash compensation of 7%, 1% non-accountable fees and
+Added: warrants equal to 7%.
+Added: To date, the Placement Agents have received total cash compensation equal to $313,225 and a total of 245,750 warrants
+Added: to purchase common stock, exercisable at exercise prices of $0.40, $0.46 and $1.2308 per share, which warrants will expire five years
+Added: from the date of grant.
2025 PIPE Offering
7 unchanged sentences
with an additional $2 payable upon the Investor’s exercise of the Pre-Funded Warrants in full.
−Removed: advance of closing, on January 16, 2025, the Company and the Investor entered into an amended and restated Purchase Agreement
−Removed: (the “A&R Purchase Agreement”), which amended the terms of the Purchase Agreement to include a requirement that the Company
−Removed: obtain shareholder approval prior to issuing in excess of 19.99% of the Company’s common stock and also amended the Common Warrants
−Removed: to make them immediately exercisable and reduce the exercise period from 5.5 years to five years.
−Removed: Other terms of the Purchase Agreement
−Removed: and Common Warrants remained the same.
+Added: advance of closing, on January 16, 2025, the Company and the Investor entered into an amended and restated Purchase Agreement (the “A&R
+Added: Purchase Agreement”), which amended the terms of the Purchase Agreement to include a requirement that the Company obtain shareholder
+Added: approval prior to issuing in excess of 19.99% of the Company’s common stock and also amended the Common Warrants to make them immediately
+Added: exercisable and reduce the exercise period from 5.5 years to five years.
+Added: Other terms of the Purchase Agreement and Common Warrants remained
Boral acted as co-placement agents for the January 2025 PIPE Offering.
1 unchanged sentence
entered into a Placement Agent Agreement with Boustead (the “Placement Agent Agreement”).
−Removed: Under the terms of the
−Removed: Placement Agent Agreement, at closing, the Company paid the Placement Agents (i) a cash commission equal to 8% of the gross proceeds
−Removed: (including a 1% non-accountable expense fee) and (ii) warrants to purchase a total of 175,000 shares of common stock, exercisable at
−Removed: $1.40 per share, with the total cash and warrant compensation split equally between the Placement Agents.
+Added: Under the terms of the Placement
+Added: Agent Agreement, at closing, the Company paid the Placement Agents (i) a cash commission equal to 8% of the gross proceeds (including
+Added: a 1% non-accountable expense fee) and (ii) warrants to purchase a total of 175,000 shares of common stock, exercisable at $1.40 per share,
+Added: with the total cash and warrant compensation split equally between the Placement Agents.
January 20, 2025, the Company obtained the approval of 55.4% of the shareholders (the “Majority Shareholders”) for the issuance
5 unchanged sentences
have not generated any sales to date.
−Removed: No revenue was recorded from any sources during the six months ended June 30, 2025 and 2024.
+Added: No revenue was recorded from any sources during the nine months ended September 30, 2025 and 2024.
operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
58 unchanged sentences
and administrative expenses
−Removed: and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, corporate and
−Removed: business development, as well as administrative functions.
−Removed: General and administrative expenses also include legal fees relating to
−Removed: patent, corporate, IPO-related matters, and SEC reporting matters;
−Removed: professional fees for accounting, auditing, tax and
−Removed: administrative consulting services;
+Added: and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, corporate and business
+Added: development, as well as administrative functions.
+Added: General and administrative expenses also include legal fees relating to patent, corporate,
+Added: IPO-related matters, and SEC reporting matters;
+Added: professional fees for accounting, auditing, tax and administrative consulting services;
insurance costs;
administrative travel expenses;
−Removed: marketing expenses and other operating
+Added: marketing expenses and other operating costs.
anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business
2 unchanged sentences
of Operations
−Removed: of the Three Months Ended June 30, 2025 and 2024
−Removed: following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:
+Added: of the Three Months Ended September 30, 2025 and 2024
+Added: following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:
+Added: and development
+Added: and administrative
operating expenses
−Removed: Research and development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Other expenses:
−Removed: Interest expense
−Removed: Debt discount amortization
−Removed: Interest income
−Removed: Total other income (expenses)
+Added: from operations
+Added: discount amortization
+Added: other income (expenses)
and Development Expenses
−Removed: table below summarizes our research and development expenses for the three months ended June 30, 2025 and 2024:
+Added: table below summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:
+Added: and Development Expenses:
+Added: trial and related expenses
research and development expenses
−Removed: Clinical and related expenses
−Removed: Total research and development expenses
−Removed: and development expenses were $496 and $63 for the three months ended June 30, 2025 and 2024, respectively.
−Removed: The increase in R&D expenses
−Removed: in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
+Added: and development expenses were $608 and $14 for the three months ended September 30, 2025 and 2024, respectively.
+Added: The increase in R&D
+Added: expenses in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
and Administrative Expenses
−Removed: table below summarizes our general and administrative expenses for the three months ended June 30, 2025 and 2024:
+Added: table below summarizes our general and administrative expenses for the three months ended September 30, 2025 and 2024:
+Added: and Administrative Expenses:
+Added: Stock-related
+Added: compensation and wages
+Added: related expenses
+Added: professional service expenses and fees
+Added: relating to license agreements
+Added: advances amortization expense
+Added: amortization expense
general and administrative expenses
−Removed: Stock-related expenses
−Removed: Officer compensation and wages
−Removed: Patent related expenses
−Removed: Legal expenses
−Removed: Accounting expenses
−Removed: Other professional service expenses and fees
−Removed: Fees relating to license agreements
−Removed: Insurance expenses
−Removed: Vendor advances amortization expense
−Removed: Intangible amortization expense
−Removed: Other expenses
−Removed: Total general and administrative expenses
−Removed: and administrative expenses were $960 and $159 for the three months ended June 30, 2025 and 2024, respectively.
−Removed: Significant changes between
−Removed: periods consisted of the increase in vendor advance amortization expense in 2025, relating to our vendor advances in 2025.
+Added: and administrative expenses were $827 and $369 for the three months ended September 30, 2025 and 2024, respectively.
+Added: Significant changes
+Added: between periods consisted of the increase in vendor advance amortization expense in 2025 relating to our vendor advances in 2025.
Income (Expenses)
−Removed: income (expenses) was $34 and $(31) for the three months ended June 30, 2025 and 2024, respectively.
−Removed: In 2025, other income consisted
−Removed: of interest income earned from our money market account.
−Removed: In 2024, other expenses consisted of interest expense of $12 and debt
−Removed: discount amortization of $19.
−Removed: of the Six Months Ended June 30, 2025 and 2024
−Removed: following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
+Added: income (expenses) was $37 and $(664) for the three months ended September 30, 2025 and 2024, respectively.
+Added: In 2025, other income was
+Added: interest income earned from our money market account.
+Added: In 2024, other expenses were interest expense of $12, financing costs of $537 and
+Added: debt discount amortization of $115.
+Added: of the Nine months Ended September 30, 2025 and 2024
+Added: following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
+Added: and development
+Added: and administrative
operating expenses
−Removed: Research and development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Other expenses:
−Removed: Interest expense
−Removed: Debt discount amortization
−Removed: Interest income
−Removed: Total other expenses, net
+Added: from operations
+Added: discount amortization
+Added: other expenses, net
and Development Expenses
−Removed: table below summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
+Added: table below summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:
and Development Expenses:
1 unchanged sentence
research and development expenses
−Removed: and development (“R&D”) expenses were $989 and $228 for the six months ended June 30, 2025 and 2024, respectively.
−Removed: The increase in R&D expenses in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
+Added: and development expenses were $1,597 and $242 for the nine months ended September 30, 2025 and 2024, respectively.
+Added: The increase in R&D
+Added: expenses in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
and Administrative Expenses
−Removed: table below summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024:
+Added: table below summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024:
+Added: and Administrative Expenses:
+Added: Stock-related
+Added: compensation and wages
+Added: related expenses
+Added: professional service expenses and fees
+Added: relating to license agreements
+Added: advances amortization expense
+Added: amortization expense
general and administrative expenses
−Removed: Stock-related expenses
−Removed: Officer compensation and wages
−Removed: Patent related expenses
−Removed: Legal expenses
−Removed: Accounting expenses
−Removed: Other professional service expenses and fees
−Removed: Fees relating to license agreements
−Removed: Insurance expenses
−Removed: Vendor advances amortization expense
−Removed: Intangible amortization expense
−Removed: Other expenses
−Removed: Total general and administrative expenses
−Removed: and administrative expenses were $1,733 and $286 for the six months ended June 30, 2025 and 2024, respectively.
−Removed: Significant changes between
−Removed: periods consisted of the increase in vendor advance amortization expense in 2025, relating to our vendor advances in 2025.
+Added: and administrative expenses were $2,560 and $655 for the nine months ended September 30, 2025 and 2024, respectively.
+Added: changes between periods consisted of the increase in vendor advance amortization expense in 2025, relating to our vendor advances in
+Added: and the increase in insurance costs in 2025, relating to our increased costs of directors and officers liability insurance as
+Added: a public company.
Income (Expenses)
−Removed: income (expenses) was $38 and $(62) for the six months ended June 30, 2025 and 2024, respectively.
−Removed: In 2025, other income consisted
−Removed: of interest income earned from our money market account.
−Removed: In 2024, other expenses consisted of interest expense of $23 and debt
−Removed: discount amortization of $39.
+Added: income (expenses) was $75 and $(726) for the nine months ended September 30, 2025 and 2024, respectively.
+Added: In 2025, other income was interest
+Added: income earned from our money market account.
+Added: In 2024, other expenses were interest expense of $35, financing costs of $537 and debt discount
+Added: amortization of $154.
and Capital Resources
−Removed: the six months ended June 30, 2025, the Company incurred a net loss of $2,684 and used cash in operations of $1,519.
−Removed: period, the Company closed a private financing in which the Company received net proceeds of $3,058 and closed two financings from
−Removed: the Equity Line of Credit (“ELOC”) for net proceeds of $223.
−Removed: At June 30, 2025, the Company had cash and cash equivalents
+Added: the nine months ended September 30, 2025, the Company incurred a net loss of $4,082 and used cash in operations of $2,357.
+Added: period, the Company closed a private financing in which the Company received net proceeds of $3,058 and closed three financings from
+Added: our ELOC for net proceeds of $3,602.
+Added: At September 30, 2025, the Company had cash and cash equivalents
totaling $5,575 and shareholders’ equity of $7,664.
−Removed: Subsequent to June 30, 2025, the Company closed an additional financing
−Removed: from the ELOC totaling net proceeds of $3,693.
−Removed: The Company expects our current cash reserves to fund the Company’s operations
+Added: The Company expects its current cash reserves to fund the Company’s operations
for at least 12 months from the date of this filing.
−Removed: Company’s ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations
−Removed: in the future, which will primarily be accomplished by raising additional capital to meet our operating needs and repay our
−Removed: liabilities arising from normal business operations when they come due.
−Removed: Since inception, the Company has funded our operations
−Removed: primarily through equity and debt financings and we expect to continue to rely on these sources of capital in the future until it
−Removed: is able to generate revenues.
+Added: Company’s ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations in
+Added: the future, which will primarily be accomplished by raising additional capital to meet its operating needs and repay its liabilities
+Added: arising from normal business operations when they come due.
+Added: Since inception, the Company has funded its operations primarily through
+Added: equity and debt financings and the Company expects to continue to rely on these sources of capital until such time as it is able to generate
assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to
Even if the Company is able to obtain additional financing, such financing may contain undue restrictions on our operations,
−Removed: in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.
−Removed: table below summarizes our cash flow activities for the six months ended June 30, 2025 and 2024:
−Removed: Net cash provided by (used in):
−Removed: Operating activities
−Removed: Investing activities
−Removed: Financing activities
−Removed: Net increase (decrease) in cash
−Removed: the six months ended June 30, 2025, we used cash from operating activities of $1,519, as compared to $132 used during the six months
−Removed: ended June 30, 2024.
−Removed: During the six months ended June 30, 2025, we incurred a net loss of $2,684 and had non-cash expenses of
−Removed: $1,531, as compared to a net loss of $576 and non-cash expenses of $119 during the six months ended June 30, 2024.
+Added: in the case of debt financing, or cause substantial dilution to our stockholders, in the case of equity financing.
+Added: table below summarizes our cash flow activities for the nine months ended September 30, 2025 and 2024:
+Added: cash provided by (used in):
+Added: increase (decrease) in cash
+Added: the nine months ended September 30, 2025, we used cash from operating activities of $2,357, compared to $2,152 used during the nine months
+Added: ended September 30, 2024.
+Added: During the nine months ended September 30, 2025, we incurred a net loss of $4,082 and had non-cash expenses
+Added: of $2,301, compared to a net loss of $1,623 and non-cash expenses of $845 during the nine months ended September 30, 2024.
non-cash expense in 2025 was the amortization of vendor advances of $1,958.
−Removed: net change in operating assets and liabilities during the six months ended June 30, 2025 used cash of $366, as compared to $325
−Removed: provided during the six months ended June 30, 2024.
+Added: net change in operating assets and liabilities during the nine months ended September 30, 2025 used cash of $576, compared to $1,374
+Added: used during the nine months ended September 30, 2024.
The primary use of cash relating to operating assets and liabilities during the
−Removed: six months ended June 30, 2025, was the decrease in accounts payable and accrued expenses.
−Removed: The primary source of cash during the six
−Removed: months ended June 30, 2024, was the increase in accounts payable and accrued expenses.
−Removed: the six months ended June 30, 2025, we provided cash from financing activities of $3,281, as compared to $60 provided during the six
−Removed: months ended June 30, 2024.
−Removed: For the six months ended June 30, 2025, cash provided by financing activities consisted of proceeds from
−Removed: our private financing of $3,058 and proceeds of $223 from our ELOC.
−Removed: Net cash provided in 2024 was from proceeds from notes payable
−Removed: – officers of $102.
−Removed: Net cash used in 2024 consisted of the payment of deferred offering costs of $42.
−Removed: expect our expenses to increase substantially in connection with our ongoing research activities, particularly as we pursue the advancement
−Removed: of our product candidates through clinical trials.
−Removed: In addition, we expect to incur additional costs associated with operating as a public
−Removed: The timing and amount of our operating expenditures will depend on numerous variables, including:
−Removed: the initiation, progress,
−Removed: timing, costs and results of the clinical trials for our product candidates or any future product candidates we may develop;
−Removed: the initiation,
−Removed: progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop;
−Removed: our ability to maintain our relationships with key collaborators;
−Removed: the outcome, timing and cost of seeking and obtaining regulatory approvals
−Removed: from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more
−Removed: nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously
−Removed: been agreed to;
−Removed: the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including
−Removed: the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing,
−Removed: prosecuting, defending and enforcing any patents or other intellectual property rights;
−Removed: the effect of competing technological and market
−Removed: developments;
−Removed: the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space;
−Removed: market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement
−Removed: by third-party payors;
−Removed: the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
−Removed: the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing;
−Removed: of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval
−Removed: and that we determine to commercialize;
−Removed: and our need to implement additional internal systems and infrastructure, including financial
−Removed: and reporting systems.
−Removed: believe that our existing cash, including the net proceeds we received from the IPO and the January 2025 PIPE Offering, will enable us
−Removed: to fund our operating expenses and capital expenditure requirements for at least the next 12 months.
−Removed: We have based this estimate on assumptions
−Removed: that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
−Removed: We expect that we will continue
−Removed: to require additional funding to complete the clinical development and commercialization of our product candidates, if we receive regulatory
−Removed: approval, and pursue in-licenses or acquisitions of other product candidates.
−Removed: If we receive regulatory approval for our product candidates,
−Removed: we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending
−Removed: on where we choose to commercialize ourselves.
−Removed: such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
−Removed: and debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties.
−Removed: the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially
−Removed: diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our current
−Removed: common stockholder.
−Removed: Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants
−Removed: that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends.
−Removed: If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties,
−Removed: we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant
−Removed: licenses on terms that may not be favorable to us.
−Removed: If we are unable to raise additional funds through equity or debt financings or other
−Removed: arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts,
−Removed: or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
−Removed: Obligations and Commitments
−Removed: Agreement with Prevail Infoworks, Inc.
−Removed: August 2024, the Company entered into a master service and technology agreement with Prevail Infoworks, Inc.
−Removed: pursuant to which Prevail agreed to provide certain clinical research services to the Company.
−Removed: As part of the agreement, the Company
−Removed: was required to make an advance payment of $900 to Prevail before they begin their services.
−Removed: At such time as we notify Prevail to engage
−Removed: their services related to the relevant clinical trial, or six months from the date of the agreement, we will be required to pay approximately
−Removed: $80 per month during the time Prevail performs such clinical research services.
−Removed: The agreement with Prevail is subject to cancellation
−Removed: at any time upon 30 days’ written notice to the other party.
−Removed: The Company made the advance payment to Prevail in October 2024.
−Removed: Agreement with PreCheck Health Services, Inc.
−Removed: September 20, 2024, the Company entered into a bioassay services agreement (the “Bioassay Services Agreement”) with PreCheck
−Removed: Health Services, Inc., a Florida-based corporation (“PreCheck”).
−Removed: Pursuant to the Bioassay Services Agreement, PreCheck will
−Removed: provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV 105) clinical trials in order to assist
−Removed: the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1 clinical trials for lung
−Removed: cancer patients and Phase 2 trials for patients with castrate resistant prostate cancer.
−Removed: In order to identify biomarkers for patient
−Removed: screening and therapy monitoring using carotuximab (ENV 105), PreCheck will utilize its SolidTumorCheck+ platform for the somatic gene
−Removed: expression analysis of biopsy tissue samples derived from patients with lung and prostate cancer, as part of the Company’s ongoing
−Removed: clinical trials.
−Removed: In furtherance of these efforts, PreCheck will develop a companion diagnostic to support its identification of such
−Removed: patients with a three gene PCR analysis or other genetic analysis, which diagnostic test will then be developed and submitted to the
−Removed: FDA for castrate-resistant prostate cancer patients and for lung cancer patients on Tagrisso.
−Removed: In exchange for PreCheck’s services,
−Removed: and according to the terms of the Bioassay Services Agreement, the Company paid $900 to PreCheck as an advance for the future laboratory
−Removed: services to be performed.
−Removed: The term of the agreement is one year from the effective date.
−Removed: Agreement with CEO.CA Technologies Ltd.
−Removed: September 23, 2024, the Company entered into an advisory and consulting services agreement (the “CEO.CA Agreement”) with
−Removed: CEO.CA Technologies Ltd., a Canadian company (“CEO.CA”), pursuant to which CEO.CA will provide certain internet-based financial
−Removed: information and communications services for a period of one year for a services fee of $250.
−Removed: The service fee is an advance on future
−Removed: services to be performed.
−Removed: The CEO.CA Agreement includes such services as strategic news placement, news releases, interviews, monthly
−Removed: analytics and a video launch.
−Removed: The CEO.CA Agreement contains other customary clauses, including representations and warranties, indemnification
−Removed: clauses and governing law clauses.
−Removed: Agreement with Belair Capital Advisors Inc.
−Removed: September 23, 2024, the Company entered into a strategic advisory agreement (the “Strategic Advisory Agreement”) with Belair
−Removed: Capital Advisors Inc.
−Removed: BCA, a venture capital and corporate finance advisory firm, has been a long-term investor
−Removed: and advisor to the Company and frequently works with early-stage pharmaceutical companies.
−Removed: The strategic advisory services consist of
−Removed: corporate strategy, market positioning and long-term growth plans within the pharmaceutical sector, digital marketing and engagement,
−Removed: market research analysis and business development assistance, among other things.
−Removed: During the one-year term of the Strategic Advisory
−Removed: Agreement, in exchange for its services, the Company will pay BCA $365 fee and will issue BCA 50,000 RSUs, which will vest at the end
−Removed: of six months.
−Removed: Agreement with Cross Current Capital LLC
−Removed: October 1, 2024, the Company entered into a consulting agreement (the “Consulting Agreement”) with Cross Current Capital
−Removed: LLC, a limited liability company organized under the laws of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”),
−Removed: pursuant to which Cross Current agreed to provide certain financial and business consulting services to the Company including, but not
−Removed: limited, to (a) help drafting a public company competitive overview, (b) help preparing and/or reviewing a valuation analysis, (c) help
−Removed: in drafting marketing materials and presentations, (d) reviewing the Company’s business requirements and discuss financing and
−Removed: businesses opportunities, (e) investor marketing, (f) investor relations introductions, (g) legal counsel introductions, (h) auditor
−Removed: introductions, (i) investment banking and research introductions, (j) M&A canvassing and ways to grow the business organically, and
−Removed: (k) stand by capital markets advisory services.
−Removed: For the services rendered thereunder, the Company agreed to pay Cross Current $200,000
−Removed: in cash and agreed to issue to the Advisor restricted shares of the Company’s common stock, issuable under the Company’s
−Removed: 2023 Equity Inventive Plan, in an amount equal to $500,000 (the “Shares”), which Shares shall vest at the end of six months
−Removed: after issuance.
−Removed: The term of the Consulting Agreement is 24 months and can be extended for another 12 months upon the written consent
−Removed: of both parties.
−Removed: The Company made the $200 payment in October 2024.
−Removed: License Agreements with Cedars
−Removed: have entered into four Exclusive License Agreements with Cedars which grants us licensing rights with respect to certain patent rights
−Removed: owned by Cedars as follows:
−Removed: of use of compounds that bind to RelA of NFkB;
−Removed: and methods for treating fibrosis;
−Removed: and methods for treating cancer and autoimmune diseases;
−Removed: of generating activated T cells for cancer therapy.
−Removed: June 2, 2021, our wholly owned subsidiary, Enviro, entered into two Exclusive License Agreements with Cedars, which granted Enviro exclusive
−Removed: licensing rights (which include the right to sublicense) with respect to certain patent rights owned by Cedars, as follows:
−Removed: Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture,
−Removed: use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating
−Removed: Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented
−Removed: Neil Bhowmick and others;
−Removed: Exclusive License Agreement, (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the
−Removed: Enviro-Cedars License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture,
−Removed: use and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization
−Removed: of Tumors to Therapies Through Endoglin Antagonism” invented by Dr.
−Removed: Neil Bhowmick and others.
+Added: nine months ended September 30, 2025, was the decrease in accounts payable and accrued expenses.
+Added: The primary use of cash during the nine
+Added: months ended September 30, 2024, was the increase in vendor advances.
+Added: the nine months ended September 30, 2025, we provided cash from financing activities of $6,660, compared to $5,276 provided during the
+Added: nine months ended September 30, 2024.
+Added: For the nine months ended September 30, 2025, cash provided by financing activities consisted of
+Added: proceeds from our private financing of $3,058 and proceeds of $3,602 from our ELOC.
+Added: Net cash provided in 2024 was from net proceeds from
+Added: our IPO of $5,524 and proceeds from notes payable – officers of $142.
+Added: Net cash used in 2024 consisted of the payment of deferred
+Added: offering costs of $390.
Quantitative and Qualitative Disclosures about Market Risks.
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