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Dogwood Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 6, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 6, 2026

DWTX$1.28+23.1%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-14.

0001104659-26-096719

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-06.

0001104659-26-123635

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 56 previous paragraphs and 63 current paragraphs.

32 unchanged; 22 reworded; 6 added; 1 removed; 1 previous and 3 current paragraphs rearranged.

Tables are not compared: 18 previous and 18 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (6)

Current report

Following the interim analysis of HAL-CINP-203, a decision was made to add an open-label extension (“OLE”) option for patients who successfully completed the double-blinded study. To simplify the changes in protocol related to the OLE addition, the double-blinded portion of the study is referred to as “Part 1”, and the new OLE protocol elements are referred to as “Part 2”. The formal title of Part 2 is “HAL-CINP-203 Part 2: A 12-Week Open-Label Extension to Evaluate Safety and Efficacy of Halneuron® for the Treatment of Chemotherapy-Induced Neuropathic Pain Symptoms”. Ninety-five patients completing Part 1 of the study were subsequently enrolled into Part 2, where they are eligible to receive an additional 12 weeks of open-label Halneuron® treatment, divided into 3 rounds of injections. Final data from Part 2 of the study will be available in early 2027.

Current report

Subsequent to September 30, 2026, on October 19, 2026, the Company entered into a securities subscription agreement (the “Subscription Agreement”) with its largest shareholder, Sealbond Limited (“Sealbond”). Pursuant to the terms of the Subscription Agreement, the Company issued an aggregate of 4,098,360 shares of Common Stock at a price of $1.22 per share (the “October 2026 Offering”) for gross proceeds to the Company of approximately $5 million. No warrants or other derivative securities were included in the transaction. The transaction closed on October 26, 2026. In addition to the Subscription Agreement, the Company entered into a registration rights agreement with Sealbond, whereby the Company agreed to register the shares issued in the private placement within 15 days following the date of the registration agreement. Proceeds from this investment will enable the advancement of Phase 3 preparatory activities and extend operational runway through March 2027.

Current report

On October 30, 2026, the Company filed a Form S-3 Registration Statement for the resale of 4,098,360 shares of the Company's Common Stock for the Sealbond private placement. At the time of this filing, the registration statement had not been declared effective.

Current report

Subsequent to September 30, 2026, in October 2026, we closed the October 2026 Offering, which consisted of a private placement of 4,098,360 shares of our Common Stock to our largest shareholder at a price of $1.22 per share. Proceeds from the offering were approximately $5 million.
Removed paragraphs (1)
Reworded paragraphs (22)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on March 18, 2026 (the “2025 Annual Report on Form 10-K”), under “Item 1A. Risk Factors”, available on the SEC EDGAR website atwww.sec.gov, Part II, and Item 1A of the report, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those risks noted above.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. For a discussion of the risks, uncertainties and assumptions associated with these statements, see Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2026 (the “2025 Annual Report on Form 10-K”), and Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those discussed in the 2025 Annual Report on Form 10-K and in other filings with the SEC.

Previous wording

This Quarterly Report on Form 10-Q contains “forward-looking statements”, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risks set forth in the 2025 Annual Report on Form 10-K. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

Current wording

This Quarterly Report on Form 10-Q contains “forward-looking statements”, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risks set forth in the 2025 Annual Report on Form 10-K. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

Previous wording

We are a pre-revenue, development-stage biopharmaceutical company focused on developing new medicines to treat pain and peripheral neuropathy associated with cancer treatment, with the ability to expand into other pain states with continued clinical success. Pain and neuropathy affect the majority of patients undergoing chemotherapy treatment with deleterious effects on patient quality of life and function and can result in patients lowering their dose or stopping their chemotherapy resulting from progression to moderate or severe forms of the illness. There are no FDA approved treatments for patients suffering from chemotherapy induced pain or neuropathy (“CINP”), highlighting a significant medical need for advancing new treatments to manage CINP. Chronic pain medications approved by FDA to treat other forms of chronic pain have failed to exhibit consistent clinical benefits in eleven of twelve previous research trials, highlighting limitations of using other pain medications “off-label” to manage CINP symptoms.

Current wording

We are a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid medicines to treat pain and neuropathic disorders. Dogwood’s research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Pain and neuropathy affect the majority of patients undergoing chemotherapy treatment with deleterious effects on patient quality of life and function and can result in patients lowering their dose or stopping their chemotherapy resulting from progression to moderate or severe forms of the illness. There are no FDA approved treatments for patients suffering from chemotherapy induced pain or neuropathy (“CINP”), highlighting a significant medical need for advancing new treatments to manage CINP. Chronic pain medications approved by FDA to treat other forms of chronic pain have failed to exhibit consistent clinical benefits in eleven of twelve previous research trials, highlighting limitations of using other pain medications “off-label” to manage CINP symptoms.

Previous wording

On April 21, 2026, Dogwood entered into an agreement with PRIDCor Therapeutics, LLC (“PRIDCor”) pursuant to which PRIDCor will be fully responsible for financing and executing future development, commercialization and intellectual property maintenance for both IMC-1 and IMC-2. IMC-1 is a novel, proprietary, fixed dose combination of a nucleoside analog and the anti-inflammatory agent celecoxib for the treatment of fibromyalgia and IMC-2, a combination of valacyclovir and celecoxib that is intended to synergistically suppress herpesvirus activation for the treatment of Long-COVID. In exchange, Dogwood is entitled to a tiered royalty on net sales of up to 15% upon commercialization of IMC-1 or IMC-2. Further, Dogwood is entitled to receive 10% of PRIDCor’s initial Series A financing and 9% of all future capital raised by PRIDCor to advance IMC-1 or IMC-2, as well as future PRIDCor partnership-related development and regulatory payments associated with IMC-1 or IMC-2. Potential payments to Dogwood under the development partnership are capped at $100 million. In July 2026, PRIDCor broke escrow subject to the Series A Payment and Escrow Break Minimum of $1,000,000. As a result, the Company received its first payment under the PRIDCor License Agreement in the amount of $100,000 and submitted $87,750 related to the payment made to the Rights Agent to be distributed to the CVR holders under the CVR Agreement.

Current wording

On April 21, 2026, Dogwood entered into an agreement with PRIDCor Therapeutics, LLC (“PRIDCor”) pursuant to which PRIDCor will be fully responsible for financing and executing future development, commercialization and intellectual property maintenance for both IMC-1 and IMC-2. IMC-1 is a novel, proprietary, fixed dose combination of a nucleoside analog and the anti-inflammatory agent celecoxib for the treatment of fibromyalgia and IMC-2, a combination of valacyclovir and celecoxib that is intended to synergistically suppress herpesvirus activation for the treatment of Long-COVID. In exchange, Dogwood is entitled to a tiered royalty on net sales of up to 15% upon commercialization of IMC-1 or IMC-2. Further, Dogwood is entitled to receive 10% of PRIDCor’s initial Series A financing and 9% of all future capital raised by PRIDCor to advance IMC-1 or IMC-2, as well as future PRIDCor partnership-related development and regulatory payments associated with IMC-1 or IMC-2. Potential payments to Dogwood under the development partnership are capped at $100 million. In July 2026, PRIDCor broke escrow subject to the Series A Payment and Escrow Break Minimum of $1,000,000. As a result, the Company received its first payment under the

Previous wording

In the first quarter of 2025, we commenced dosing of patients in the HAL-CINP-203 clinical trial in the United States. HAL-CINP-203 is a Phase 2b, double-blind, placebo controlled clinical trial intended to assess the efficacy and safety of Halneuron® in approximately 230 patients with moderate to severe neuropathic pain caused by previous platinum and/or taxane based cancer chemotherapy. The primary efficacy endpoint is the reduction in pain from baseline to week 4 in the weekly average of daily 24-hour recall pain intensity scores captured on an electronic diary and analyzed as a responder analysis. The responder analysis will compare Halneuron® to placebo in terms of the proportion of patients who achieve 50% or more reduction in their pain from baseline to the primary endpoint. The secondary endpoints include patient global impression of change, PROMIS fatigue, PROMIS sleep, PROMIS-29, pain interference, hospital anxiety and depression scale and the neuropathic pain symptom inventory. In December 2025, we announced interim results from a planned interim assessment of the ongoing Halneuron® Phase 2b trial, the goal of which was to finalize the statistical methodology and the endpoint analysis to be used to determine Halneuron® safety and effectiveness as a treatment for CINP. Key highlights from the first 97 patients completing the trial included Halneuron demonstrating treatment effect versus placebo, with responders exhibiting durable treatment effects over the course of the four-week trial. Halneuron®’s treatment effect was observed when used alone or in combination with other pain medications as compared with placebo. Notably, the overall drop out rate was 4.5% for this cohort and is far below the drop out rate observed with other FDA approved chronic pain medications, including duloxetine (20+%) and pregabalin (30-40%). Based on the recommendation of the independent statisticians conducting the assessment, we plan to enroll between 210-240 patients by the end of summer to ensure a sample size that provides 80+% power to achieve a statistically significant outcome via responder analysis. Currently, we have enrolled 217 patients and expect top-line data from the trial in the fall of 2026.

Current wording

In the first quarter of 2025, we commenced dosing of patients in the HAL-CINP-203 clinical trial in the United States. HAL-CINP-203 is a Phase 2b, double-blind, placebo controlled clinical trial intended to assess the efficacy and safety of Halneuron® in patients with moderate to severe neuropathic pain caused by previous platinum and/or taxane based cancer chemotherapy. The primary efficacy endpoint is the reduction in pain from baseline to week 4 in the weekly average of daily 24-hour recall pain intensity scores captured on an electronic diary and analyzed as a responder analysis. The responder analysis will compare Halneuron® to placebo in terms of the proportion of patients who achieve 50% or more reduction in their pain from baseline to the primary endpoint. The secondary endpoints include patient global impression of change, PROMIS fatigue, PROMIS sleep, PROMIS-29, pain interference, hospital anxiety and depression scale and the neuropathic pain symptom inventory. In December 2025, we announced interim results from a planned interim assessment of the ongoing Halneuron® Phase 2b trial, the goal of which was to finalize the statistical methodology and the endpoint analysis to be used to determine Halneuron® safety and effectiveness as a treatment for CINP. Key highlights from the first 97 patients completing the trial included Halneuron® demonstrating treatment effect versus placebo, with responders exhibiting durable treatment effects over the course of the four-week trial. Notably, the overall drop out rate was 4.5% for this cohort and is far below the drop out rate observed with other FDA approved chronic pain medications, including duloxetine (20+%) and pregabalin (30-40%). Based on the recommendation of the independent statisticians conducting the assessment to slightly increase sample size from the planned 200, we chose to enroll 239 patients to maintain 80+% power, and will have top-line data from the trial available in November of 2026.

Previous wording

We licensed the rights to the IV formulation of SP16 for the treatment of CIPN in September 2025. SP16 is a 17 amino acid peptide drug that has been designed to mimic the anti-inflammatory and immunomodulatory properties of Alpha-1 Antitrypsin, without the limitations seen with the much larger Alpha-1 Antitrypsin protein. The initial Phase 1 evaluation of SP16’s safety when used to treat CIPN will be conducted by the University of Virginia Cancer Center under a National Cancer Institute (“NCI”) grant. Patient recruitment for this initial evaluation is expected to start in the second half of 2026. We will be providing our clinical development expertise, but with the NCI funding the trial, we will incur no further expenses in connection with this initial evaluation of the safety of SP16 in cancer patients. Dogwood announced FDA acceptance of the Investigational New Drug (“IND”) application for SP16, administered intravenously (“IV”), for the treatment of CINP. Patient dosing in the planned Phase 1b trial should commence in the second half of this year.

Current wording

We licensed the rights to the IV formulation of SP16 for the treatment of CIPN in September 2025. SP16 is a 17 amino acid peptide drug that has been designed to mimic the anti-inflammatory and immunomodulatory properties of Alpha-1 Antitrypsin, without the limitations seen with the much larger Alpha-1 Antitrypsin protein. The initial Phase 1 evaluation of SP16’s safety when used to treat CIPN will be conducted by the University of Virginia Cancer Center under a National Cancer Institute (“NCI”) grant. We will be providing our clinical development expertise, but with the NCI funding the trial, we will incur no further expenses in connection with this initial evaluation of the safety of SP16 in cancer patients. Dogwood announced FDA acceptance of the Investigational New Drug (“IND”) application for SP16, administered intravenously (“IV”), for the treatment of CIPN. Patient dosing in the planned Phase 1b trial is projected to commence in the coming months.

Previous wording

Warrants and Pre-funded Warrants are classified as equity on the Company’s condensed consolidated balance sheet. The Common Stock Warrants include certain rights upon "fundamental transactions," as described in the warrant agreement, including the right of the holder thereof to receive from the Company or a successor entity the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such fundamental transaction if it had been the holder of the number of warrant shares immediately prior to such fundamental transaction. At the holder's option, exercisable within thirty (30) days after the consummation of a fundamental transaction (if within the Company's control), the Company or any successor entity shall purchase the Common Stock Warrant from the holder by paying to the holder an amount of cash equal to the Black Scholes Value of the remaining unexercised portion of the Warrants on the date of the consummation of such fundamental transaction. Each share of Common Stock (or Pre-funded Warrant in lieu thereof) was sold together with one Common Stock Warrant at a combined purchase price of $2.85 per share and accompanying warrant (or $2.8499 per Pre-funded Warrant and accompanying warrant), priced at-the-market under Nasdaq rules. The aggregate gross proceeds to the Company from the January 2026 Offerings were approximately $12.5 million, before deducting placement agent fees and offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Stock Warrants. Net proceeds were approximately $11.4 million.

Current wording

On January 11, 2026, we entered into a securities purchase agreement (the “Purchase Agreement”) with a single healthcare-focused institutional investor (the “Purchaser”) pursuant to which we agreed to issue and sell, in a registered direct offering (the “Registered Offering”), 2,338,948 shares of our Common Stock. In a concurrent private placement (the “Private Offering” and, together with the Registered Offering, the “January 2026 Offerings”), and pursuant to the Purchase Agreement, the Company agreed to sell to the Purchaser (i) unregistered pre-funded warrants to purchase 2,047,089 shares of Common Stock (the “Pre-funded Warrants”) and (ii) unregistered common warrants to purchase up to an aggregate of 4,386,037 shares of Common Stock (the “Common Stock Warrants”, together with the Pre-funded Warrants, the “Warrants”). The Common Stock Warrants and Pre-funded Warrants are classified as equity on the Company’s condensed consolidated balance sheet. The Common Stock Warrants include certain rights upon "fundamental transactions," as described in the warrant agreement, including the right of the holder thereof to receive from the Company or a successor entity the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such fundamental transaction if it had been the holder of the number of warrant shares immediately prior to such fundamental transaction. At the holder's option, exercisable within thirty (30) days after the consummation of a fundamental transaction (if within the Company's control), the Company or any successor entity shall purchase the Common Stock Warrant from the holder by paying to the holder an amount of cash equal to the Black Scholes Value of the remaining unexercised portion of the Warrants on the date of the consummation of such fundamental transaction. Each share of Common Stock (or Pre-funded Warrant in lieu thereof) was sold together with one Common Stock Warrant at a combined purchase price of $2.85 per share and accompanying warrant (or $2.8499 per Pre-funded Warrant and accompanying warrant), priced at-the-market under Nasdaq rules. The aggregate gross proceeds to the Company from the January 2026 Offerings were approximately $12.5 million, before deducting placement agent fees and offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Stock Warrants. Net proceeds were approximately $11.4 million.

Previous wording

Under the Warrants, the Company may not effect the exercise of any of Warrant, and a holder will not be entitled to exercise any portion of any Warrant to the extent that immediately following the exercise, holder (together with its affiliates) would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of Common Stock outstanding immediately after giving effect to the issuance of such shares of Common Stock.

Current wording

Under the Warrants, the Company may not effect the exercise of any Warrant, and a holder will not be entitled to exercise any portion of any Warrant to the extent that immediately following the exercise, holder (together with its affiliates) would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of Common Stock outstanding immediately after giving effect to the issuance of such shares of Common Stock.

Previous wording

Research and development expenses increased by $0.6 million and $0.9 million for the three and six months ended June 30, 2026, respectively, compared to prior periods. The increase of $0.6 million for the three months ended June 30, 2026 was primarily related to an increase in HAL-CINP-203 clinical trial costs of $0.7 million offset by a decrease in drug development and manufacturing costs of $0.1 million. The increase of $0.9 million for the six months ended June 30, 2026 was primarily related to an increase in HAL-CINP-203 clinical trial costs of $0.7 and an increase in salaries and related personnel costs of $0.2 million.

Current wording

Research and development expenses decreased by $11.2 million and $10.3 million for the three and nine months ended September 30, 2026, respectively, compared to prior periods. The decrease of $11.2 million for the three months ended September 30, 2026 was primarily related to a decrease of acquired In-Process Research and Development (“IPR&D”) of $12.0 million related to the Serpin Licensing Agreement that took place in the third quarter of 2025 offset by an increase in HAL-CINP-203 clinical trial costs of $0.5 million, an increase in drug development and manufacturing costs of $0.2 million and an increase in salaries and related personnel costs of $0.1 million. The decrease of $10.3 million for the nine months ended September 30, 2026 was primarily related to a decrease in acquired IPR&D of $12.0 million related to the Serpin Licensing Agreement offset by an increase in HAL-CINP-203 clinical trial costs of $1.1 million, an increase in drug development and manufacturing costs of $0.3 million and an increase in salaries and related personnel costs of $0.3 million.

Previous wording

General and administrative expenses increased by $0.3 million and $0.7 million for the three and six months ended June 30, 2026, respectively, compared to prior periods. The increase of $0.3 million for the three months ended June 30, 2026 was primarily related to an increase in salaries and related personnel costs of $0.3 million and an increase in franchise fees of $0.1 million offset by a decrease in public company costs of $0.1 million. The increase of $0.7 million for the six months ended June 30, 2026 was primarily due to an increase in salaries and related personnel costs of $0.8 million offset by a decrease in franchise fees of $0.1 million.

Current wording

months ended September 30, 2026 was primarily related to an increase in salaries and related personnel costs of $0.4 million offset by a decrease in legal and accounting fees of $0.1 million. The increase of $1.0 million for the nine months ended September 30, 2026 was primarily due to an increase in salaries and related personnel costs of $1.2 million offset by a decrease in legal and accounting fees of $0.1 million and a decrease in public company costs of $0.1 million.

Previous wording

In connection with our acquisition of Pharmagesic (Holdings) Inc., we allocated a portion of the purchase price to goodwill and in-process research and development (“IPR&D”) intangible assets. During the first and second quarter of 2026, we experienced a decline in our stock price resulting in market capitalization being less than our stockholders’ equity, which we concluded was an impairment indicator. As a result, we performed a quantitative assessment for goodwill and IPR&D impairment and recognized a non-cash impairment charge of $9.2 million for the three and six months ended June 30, 2026 which was partially offset by a reduction in the Company’s deferred tax liability of $2.5 million. The net impairment charge of $6.7 million had no bearing on the Company’s cash runway.

Current wording

In connection with our acquisition of Pharmagesic (Holdings) Inc., we allocated a portion of the purchase price to goodwill and IPR&D intangible assets. During the first half of 2026, we identified impairment indicators related to our goodwill and IPR&D assets, primarily due to a sustained decline in market capitalization. Following quantitative impairment assessments, we recorded a non-cash IPR&D impairment charge of $9.2 million during the nine months ended September 30, 2026. No impairment charge was recorded during the three months ended September 30, 2026. After considering the related deferred tax benefit of $2.5 million, the net year-to-date impairment charge was approximately $6.7 million. The impairment charge had no impact on the Company's cash balances, liquidity, or cash runway. There was no impairment charge for the three and nine months ended September 30, 2025.

Previous wording

Since our inception, we have financed our operations through public offerings of common stock and proceeds from private placements of membership interests and convertible promissory notes. To date, we have not generated any revenue from the sale of products and we do not anticipate generating any revenue from the sales of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of June 30, 2026, our principal source of liquidity was our cash, which totaled $9.6 million.

Current wording

Since our inception, we have financed our operations through public offerings of common stock and proceeds from private placements of membership interests and convertible promissory notes. To date, we have not generated any revenue from the sale of products and we do not anticipate generating any revenue from the sales of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of September 30, 2026, our principal source of liquidity was our cash, which totaled $4.9 million. Cash on hand of $4.9 million along with the proceeds of approximately $5.0 million received from the October 2026 Offering is expected to fund operations through March of 2027.

Previous wording

There were no debt financings during the six months ended June 30, 2026. On February 18, 2025, we received $3,000,000 in loan proceeds pursuant to the Loan Agreement dated October 7, 2024 with the Lender. In March 2025, the Company entered into a Debt Exchange and Cancellation Agreement (the “Exchange and Cancellation Agreement”) with the Lender. Pursuant to the Exchange and Cancellation Agreement, the principal amount of all loans made to the Company under the Loan Agreement, along with accrued interest through March 12, 2025, was deemed repaid and all of the Company’s obligations satisfied in full and cancelled in exchange for 284.2638 shares of the Company’s Series A-1 Non-Voting Convertible Preferred Stock, par value $0.0001 per share. There was no debt outstanding at June 30, 2026 and December 31, 2025.

Current wording

There were no debt financings during the nine months ended September 30, 2026. On February 18, 2025, we received $3,000,000 in loan proceeds pursuant to the Loan Agreement dated October 7, 2024 with the Lender. In March 2025, the Company entered into a Debt Exchange and Cancellation Agreement (the “Exchange and Cancellation Agreement”) with the Lender. Pursuant to the Exchange and Cancellation Agreement, the principal amount of all loans made to the Company under the Loan Agreement, along with accrued interest through March 12, 2025, was deemed repaid and all of the Company’s obligations satisfied in full and cancelled in exchange for 284.2638 shares of the Company’s Series A-1 Non-Voting Convertible Preferred Stock, par value $0.0001 per share. There was no debt outstanding at September 30, 2026 and December 31, 2025.

Previous wording

We anticipate our cash on hand at June 30, 2026 of approximately $9.6 million will fund operations into the fourth quarter of 2026. The Company will need to secure additional financing to fund its ongoing clinical trials and operations beyond the fourth quarter of 2026 to continue to execute its strategy. We will need to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. To the extent that we raise additional funds by issuing equity or equity-linked securities, our shareholders will experience dilution. We can give no assurances that we will be able to secure such additional sources of funds to support our operations, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs. As a result, substantial doubt exists regarding our ability to continue as a going concern 12 months from the issuance of this Quarterly Report on Form 10-Q. Failure to secure the necessary financing in a timely manner and on favorable terms could have a material adverse effect on the Company’s strategy and value and could require the delay of product development and clinical trial plans.

Current wording

We anticipate our cash on hand at September 30, 2026 of approximately $4.9 million plus the cash received from the October 2026 Offering of $5 million will fund operations through the first quarter of 2027. The Company will need to secure additional financing to fund its ongoing clinical trials and operations beyond the first quarter of 2027 to continue to execute its strategy. We will need to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. To the extent that we raise additional funds by issuing equity or equity-linked securities, our shareholders will experience dilution. We can give no assurances that we will be able to secure such additional sources of funds to support our operations, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs. As a result, substantial doubt exists regarding our ability to continue as a going concern 12 months from the issuance of this Quarterly Report on Form 10-Q. Failure to secure the necessary financing in a timely manner and on favorable terms could have a material adverse effect on the Company’s strategy and value and could require the delay of product development and clinical trial plans.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025, respectively:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025, respectively:

Previous wording

Cash Flows for the six months ended June 30, 2026 and 2025

Current wording

Cash Flows for the Nine Months Ended September 30, 2026 and 2025

Previous wording

For the six months ended June 30, 2026, net cash used in operations was $8.2 million and consisted of a net loss of $16.5 million offset by a net change in operating assets and liabilities of $0.5 million attributable to a decrease in prepaid expenses and other current assets of $0.6 million and an increase in accrued liabilities of $0.2 million offset by a decrease in accounts payable of $0.3 million further offset by non-cash items of $7.8 million attributable to the IPR&D impairment of $9.2 million, share-based compensation of $1.0 million and reduction in the carrying amount of right-of-use asset and loss on foreign exchange of $0.1 million offset by a deferred tax benefit related to the IPR&D impairment of $2.5 million.

Current wording

For the nine months ended September 30, 2026, net cash used in operations was $12.8 million and consisted of a net loss of $21.4 million offset by a net change in operating assets and liabilities of $0.2 million attributable to a decrease in prepaid expenses and other current assets of $1.0 million offset by a decrease in accrued liabilities of $0.2 million and a decrease in accounts payable of $0.6 million further offset by non-cash

Previous wording

For the six months ended June 30, 2025, net cash used in operations was $8.7 million and consisted of a net loss of $14.7 million and a net change in operating assets and liabilities of $0.5 million attributable to a decrease in accounts payable and accrued liabilities of $0.9 million offset by a decrease in prepaid expenses and other current assets of $0.4 million further offset by non-cash items of $6.5 million attributable to loss on conversion of debt with related party of $6.1 million, deferred tax expense of $0.2 million and share-based compensation, depreciation and amortization of $0.2 million.

Current wording

For the nine months ended September 30, 2025, net cash used in operations was $12.0 million and consisted of a net loss of $30.5 million and a net change in operating assets and liabilities of $0.2 million attributable to a decrease in accounts payable of $0.7 million offset by an increase in accrued liabilities of $0.3 million and a decrease in prepaid expenses and other current assets of $0.2 million further offset by non-cash items of $18.7 million attributable to the acquisition of a license of $12.0 million, loss on conversion of debt with related party of $6.1 million, deferred tax expense of $0.2 million and share-based compensation, depreciation and amortization of $0.4 million.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2026 was $11.3 million and was attributable to gross proceeds from our concurrent registered direct and private placement offering in January 2026 of $12.5 million, net of placement fees and offering costs paid by us during the three months ended June 30, 2026 of $1.1 million and the payment of issuance costs associated with the equity distribution agreement that was terminated in January 2026 of $0.1 million.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2026 was $11.3 million and was attributable to gross proceeds from our concurrent registered direct and private placement offering in January 2026 of $12.5 million, net of placement fees and offering costs paid by us during the nine months ended September 30, 2026 of $1.1 million and the payment of issuance costs associated with the equity distribution agreement that was terminated in January 2026 of $0.1 million.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2025 was $7.3 million and was attributable to cash proceeds from the Loan Agreement of $3.0 million and gross proceeds from our registered direct offering in March 2025 of $4.8 million, net of placement agent fees and offering costs paid by us during the three months ended March 2025 of $0.5 million.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2025 was $7.3 million and was attributable to cash proceeds from the Loan Agreement of $3.0 million and gross proceeds from our registered direct offering in March 2025 of $4.8 million, net of placement agent fees and offering costs paid by us during the nine months ended September 30, 2025 of $0.5 million.

Previous wording

The preparation of financial statements in conformity with U.S. GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by management in order to make estimates about the effect of matters that are inherently uncertain. During the six months ended June 30, 2026, there were no significant changes to our critical accounting policies from those described in our annual financial statements for the year ended December 31, 2025, which we included in our 2025 Annual Report on Form 10-K.

Current wording

The preparation of financial statements in conformity with U.S. GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by management in order to make estimates about the effect of matters that are inherently uncertain. During the nine months ended September 30, 2026, there were no significant changes to our critical accounting policies from those described in our annual financial statements for the year ended December 31, 2025, which we included in our 2025 Annual Report on Form 10-K.

Previous wording

The Company’s most recent impairment assessment, performed as of June 30, 2026, concluded that the certain IPR&D assets were impaired but that goodwill was not impaired. If the Company’s market capitalization continues to decline, the Company’s remaining IPR&D asset and goodwill may be at risk of future impairment. Events that could cause management to conclude that fair value has declined below carrying value, and that could result in a material impairment charge in a future period, include but are not limited to, (i) a sustained further decline in the Company’s stock price or market capitalization; (ii) adverse changes in macroeconomic or capital-market conditions; (iii) unfavorable results; (iv) delays in, or failure to obtain, regulatory approval from the U.S. Food and Drug Administration; and (v) the emergence of competitive therapies or changes in the standard of care for chemotherapy-induced neuropathic pain. Should the market value of the Company’s common stock decline further, impairment charges may be recorded in future periods.

Current wording

The Company’s most recent impairment assessment, performed as of September 30, 2026, concluded that the remaining IPR&D asset and goodwill were not impaired. If the Company’s market capitalization continues to decline, the Company’s remaining IPR&D asset and goodwill may be at risk of future impairment. Events that could cause management to conclude that fair value has declined below carrying value, and that could result in a material impairment charge in a future period, include but are not limited to, (i) a sustained decline in the Company's stock price or market capitalization, including declines in average market capitalization measures over extended periods; (ii) increases in discount rates resulting from changes in market conditions, interest rates or company-specific risk factors; (iii) changes in assumptions regarding control premiums or other valuation inputs; (iv) adverse clinical trial results, including the anticipated fourth-quarter 2026 CINP data readout; (v) delays in, or failure to obtain, regulatory approval; (vi) unfavorable changes in projected cash flows, development costs or commercialization assumptions; and (vii) the emergence of competing therapies or changes in the standard of care for chemotherapy-induced neuropathic pain. If one or more of these events occur, the Company could be required to recognize additional material non-cash impairment charges in future periods.
Rearranged current paragraphs (3)

Current report — wording carried from elsewhere

PRIDCor License Agreement in the amount of $100,000 and submitted $87,750 related to the payment made to the Rights Agent to be distributed to the CVR holders under the CVR Agreement.

Current report — wording carried from elsewhere

General and administrative expenses increased by $0.3 million and $1.0 million for three and nine months ended September 30, 2026, respectively, compared to prior periods. The increase of $0.3 million for the three

Current report — wording carried from elsewhere

items of $8.4 million attributable to the IPR&D impairment of $9.2 million, share-based compensation of $1.6 million and reduction in the carrying amount of right-of-use asset and loss on foreign exchange of $0.1 million offset by a deferred tax benefit related to the IPR&D impairment of $2.5 million.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

On January 11, 2026, we entered into a securities purchase agreement (the “Purchase Agreement”) with a single healthcare-focused institutional investor (the “Purchaser”) pursuant to which we agreed to issue and sell, in a registered direct offering (the “Registered Offering”), 2,338,948 shares of our Common Stock. In a concurrent private placement (the “Private Offering” and, together with the Registered Offering, the “January 2026 Offerings”), and pursuant to the Purchase Agreement, the Company agreed to sell to the Purchaser (i) unregistered pre-funded warrants to purchase 2,047,089 shares of Common Stock (the “Pre-funded Warrants”) and (ii) unregistered common warrants to purchase up to an aggregate of 4,386,037 shares of Common Stock (the “Common Stock Warrants”, together with the Pre-funded Warrants, the “Warrants”). The Common Stock