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Grace Therapeutics, Inc.

For the period ended Dec 31, 2025. Filed Feb 12, 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.

Dec 31, 2025 · Filed Feb 12, 2026

GRCE$1.85+3.9%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 2025-09-30; filed 2025-11-13.

0001140361-25-041804

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

Current report: 10-Q

Period ended 2025-12-31; filed 2026-02-12.

0001140361-26-004924

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 164 previous paragraphs and 161 current paragraphs.

125 unchanged; 34 reworded; 2 added; 5 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 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 (2)

Current report

Stock-based compensation of $40 and $167 for the three and nine months ended December 31, 2025, respectively, decreased by $10 and $9 compared to $50 and $176 for the three and nine months ended December 31, 2024, respectively.
Removed paragraphs (5)

Previous report

Stock-based compensation of $58 and $127 for the three and six months ended September 30, 2025, decreased by $2 and increased by $1 compared to $60 and $126 for the three and six months ended September 30, 2024.
Reworded paragraphs (34)

Previous wording

This management’s discussion and analysis (“MD&A”) is presented in order to provide the reader with an overview of the financial results and changes to our financial position as at September 30, 2025 and for the three and six months then ended. This MD&A also explains the material variations in our operations, financial positions and cash flows for the three and six months ended September 30, 2025 and 2024.

Current wording

This management’s discussion and analysis (“MD&A”) is presented in order to provide the reader with an overview of the financial results and changes to our financial position as at December 31, 2025 and for the three and nine months then ended. This MD&A also explains the material variations in our operations, financial positions and cash flows for the three and nine months ended December 31, 2025 and 2024.

Previous wording

This MD&A should be read in conjunction with our unaudited condensed consolidated interim financial statements for the three and six months ended September 30, 2025 and 2024 included elsewhere in this quarterly report. Our unaudited condensed consolidated financial statements were prepared in accordance with U.S. GAAP.

Current wording

This MD&A should be read in conjunction with our unaudited condensed consolidated interim financial statements for the three and nine months ended December 31, 2025 and 2024 included elsewhere in this quarterly report. Our unaudited condensed consolidated financial statements were prepared in accordance with U.S. GAAP.

Previous wording

On June 25, 2025, we announced the submission of a New Drug Application (“NDA”) to the FDA for GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (“aSAH”) patients. On August 22, 2025 the FDA accepted our NDA for review and established April 23, 2026 as the Prescription Drug User Fee Act (PDUFA) target date for completing its review of our submission.

Current wording

On June 25, 2025, we announced the submission of a New Drug Application (“NDA”) to the FDA for GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (“IV”) infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (“aSAH”) patients. On August 22, 2025 the FDA accepted our NDA for review and established April 23, 2026 as the Prescription Drug User Fee Act (PDUFA) target date for completing its review of our submission.

Previous wording

On September 18, 2025 we announced that the U.S. Patent and Trademark Office issued a U.S. Patent No. 12,414,943, titled “Nimodipine Parenteral Administration”. The new method of use patent, published on September 16, 2025, covers the dosing regimen for I.V. administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104.

Current wording

On September 18, 2025 we announced that the U.S. Patent and Trademark Office issued a U.S. Patent No. 12,414,943, titled “Nimodipine Parenteral Administration”. The new method of use patent, published on September 16, 2025, covers the dosing regimen for IV administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104.

Previous wording

This new patent enhances our multi-layered intellectual property estate for GTx-104, which includes five patents on the composition of our formulation of nimodipine, providing patent protection to 2037. The new patent on the I.V. dosing regimen for GTx-104 strengthens our intellectual property position and extends protection to 2043.

Current wording

This new patent enhances our multi-layered intellectual property estate for GTx-104, which includes five patents on the composition of our formulation of nimodipine, providing patent protection to 2037. The new patent on the IV dosing regimen for GTx-104 strengthens our intellectual property position and extends protection to 2043.

Previous wording

In September 2025, results from our STRIVE-ON trial were presented at the2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada. The Neurocritical Care Society is the only professional society representing multi-disciplinary teams of neurocritical care providers around the world whose mission is to improve outcomes for patients with life-threatening neurological illnesses. In an oral presentation titledSafety and Tolerability of GTx-104 (Nimodipine Injection for I.V. Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial, Dr. H. Alex Choi (Professor of Neurosurgery and Neurology at UT Health Houston McGovern Medical School, member of the Grace Scientific Advisory Board) highlighted the trial results demonstrating the safety and tolerability of GTx-104 in the treatment of aSAH.

Current wording

In September 2025, results from our STRIVE-ON trial were presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada. The Neurocritical Care Society is the only professional society representing multi-disciplinary teams of neurocritical care providers around the world whose mission is to improve outcomes for patients with life-threatening neurological illnesses. In an oral presentation titled Safety and Tolerability of GTx-104 (Nimodipine Injection for I.V. Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial, Dr. H. Alex Choi (Professor of Neurosurgery and Neurology at UT Health Houston McGovern Medical School, member of the Grace Scientific Advisory Board) highlighted the trial results demonstrating the safety and tolerability of GTx-104 in the treatment of aSAH.

Previous wording

During our second fiscal quarter, we conducted market research analysis to update our assessment of the GTx-104 commercial opportunity and to guide our commercialization planning. We believe the results of this research confirm that GTx-104 is seen as valuable for its improved tolerability, potential cost savings, and simpler route of I.V. administration compared to the oral form of nimodipine.

Current wording

During our second fiscal quarter, we conducted market research analysis to update our assessment of the GTx-104 commercial opportunity and to guide our commercialization planning. We believe the results of this research confirm that GTx-104 is seen as valuable for its improved tolerability, potential cost savings, and simpler route of IV administration compared to the oral form of nimodipine.

Previous wording

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

Current wording

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. IV delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

Previous wording

GTx-102 is targeted as the first potential therapy for the treatment of ataxia-telangiectasia (“A-T”) in a pediatric population. A-T is caused by mutations in the ataxia telangiectasia mutated gene. Children with A-T experience cerebellar ataxia and other motor dysfunctions, oculomotor apraxia, dysarthria, and dysphagia. A Phase-1 pharmacokinetic study was successfully completed and GTx-102 was well tolerated with no serious events reported.

Current wording

GTx-102 is targeted for the treatment of ataxia-telangiectasia (“A-T”) in a pediatric population. A-T is caused by mutations in the ataxia telangiectasia mutated gene. Children with A-T experience cerebellar ataxia and other motor dysfunctions, oculomotor apraxia, dysarthria, and dysphagia. A Phase-1 pharmacokinetic study was successfully completed and GTx-102 was well tolerated with no serious events reported.

Previous wording

Nimodipine was granted FDA approval in 1988 and is the only approved drug that has been clinically shown to improve neurological outcomes in aSAH patients. It is only available in the United States as a generic oral capsule and as a branded oral liquid solution called NYMALIZE™, which is manufactured and sold by Arbor Pharmaceuticals (acquired in September 2021 by Azurity Pharmaceuticals). Nimodipine has poor water solubility and high permeability characteristics because of its high lipophilicity. Additionally, orally administered nimodipine has dose-limiting side-effects such as hypotension, poor absorption and low bioavailability resulting from high first-pass metabolism, and a narrow administration window as food effects lower bioavailability significantly. Due to these issues, blood levels of orally administered nimodipine can be highly variable, making it difficult to manage blood pressure in aSAH patients, often leading to frequent dose interruptions. Nimodipine capsules are also difficult to administer, particularly to unconscious patients or those with impaired ability to swallow, while the oral liquid solution has tolerability challenges due to solubility limitations of nimodipine.

Current wording

Nimodipine was granted FDA approval in 1988 and is the only approved drug that has been clinically shown to improve neurological outcomes in aSAH patients. It is only available in the United States as a generic oral capsule, as a branded oral liquid solution called NYMALIZE™, which is manufactured and sold by Arbor Pharmaceuticals (acquired in September 2021 by Azurity Pharmaceuticals), and as a generic oral liquid solution. Nimodipine has poor water solubility and high permeability characteristics because of its high lipophilicity. Additionally, orally administered nimodipine has dose-limiting side-effects such as hypotension, poor absorption and low bioavailability resulting from high first-pass metabolism, and a narrow administration window as food effects lower bioavailability significantly. Due to these issues, blood levels of orally administered nimodipine can be highly variable, making it difficult to manage blood pressure in aSAH patients, often leading to frequent dose interruptions. Nimodipine capsules are also difficult to administer, particularly to unconscious patients or those with impaired ability to swallow, while the oral liquid solution has tolerability challenges due to solubility limitations of nimodipine.

Previous wording

In September 2025, results from our STRIVE-ON trial were presented by Dr. H. Alex Choi (Professor of Neurosurgery and Neurology at UT Health Houston McGovern Medical School, member of the Grace Scientific Advisory Board) at the 2025Neurocritical Care annual meeting, held in Montreal, Quebec, Canada.

Current wording

In September 2025, results from our STRIVE-ON trial were presented by Dr. H. Alex Choi (Professor of Neurosurgery and Neurology at UT Health Houston McGovern Medical School, member of the Grace Scientific Advisory Board) at the 2025 Neurocritical Care annual meeting, held in Montreal, Quebec, Canada.

Previous wording

Route of Administration - GTx-104’s immediate usability without nasogastric tube tube placement was seen as an advantage, enabling earlier intervention, especially in unstable or intubated patients where time sensitive dosing is key

Current wording

Route of Administration - GTx-104’s immediate usability without nasogastric tube placement was seen as an advantage, enabling earlier intervention, especially in unstable or intubated patients where time sensitive dosing is key

Previous wording

These results were obtained from a survey of 45 healthcare professionals, including neuro-intensivist, neurosurgeons, P&T committee members, and hospital pharmacists, during the summer of 2025.

Current wording

These results were obtained from a survey of 45 healthcare professionals (“HCPs”), including neuro-intensivist, neurosurgeons, P&T committee members, and hospital pharmacists, during the summer of 2025. During the three months ended December 31, 2025, we provided grant support for the development of a Continuing Medical Education (“CME”) program for healthcare professionals in these and related specialties. Content for the CME program was independently developed by leading providers of CME content, and is intended to educate HCPs on the challenges represented by oral nimodipine administration in the care of aSAH patients. We believe the CME program can play an important role in educating the professional marketplace on the potential benefits of GTx-104 should it be approved by the FDA.

Previous wording

Our assets as of September 30, 2025 include cash and cash equivalents of $16,862 and intangible assets and goodwill of $49,266. Our current liabilities of $1,245 as of September 30, 2025 were comprised primarily of amounts due to or accrued for creditors.

Current wording

Our assets as of December 31, 2025 include cash and cash equivalents of $18,672 and intangible assets and goodwill of $49,266. Our current liabilities of $1,284 as of December 31, 2025 were comprised primarily of amounts due to or accrued for creditors.

Previous wording

In February 2025, we completed a private placement of Company securities with certain institutional and accredited investors. Net proceeds to the Company were $13,705. Refer to Note 5, Stockholders’ Equity - 2025 Private Placement, in the accompanying unaudited condensed consolidated financial statements elsewhere in this document for additional information. In October 2025, the Company received $4,000 in gross proceeds from exercises of common warrants that were previously issued in a private placement in September 2023. We believe our existing cash and cash equivalents will be sufficient to sustain planned operations through at least 12 months from the issuance date of these unaudited condensed consolidated financial statements.

Current wording

In February 2025, we completed a private placement of Company securities with certain institutional and accredited investors. Net proceeds to the Company were $13,705. Refer to Note 5, Stockholders’ Equity - 2025 Private Placement, in the accompanying unaudited condensed consolidated financial statements elsewhere in this document for additional information. In October 2025, the Company received $4,040 in gross proceeds from exercises of common warrants that were previously issued in a private placement in September 2023. We believe our existing cash and cash equivalents will be sufficient to sustain planned operations through at least 12 months from the issuance date of these unaudited condensed consolidated financial statements.

Previous wording

Comparison of the three and six months ended September 30, 2025 and 2024

Current wording

Comparison of the three and nine months ended December 31, 2025 and 2024

Previous wording

The following table summarizes our results of operations for the three and six months ended September 30, 2025 and 2024:

Current wording

The following table summarizes our results of operations for the three and nine months ended December 31, 2025 and 2024:

Previous wording

The net loss of $938, or $0.06 per share, for the three months ended September 30, 2025, decreased by $2,494 from the net loss of $3,432, or $0.30 per share, for the three months ended September 30, 2024. The decrease in net loss was primarily due to a $2,408 decrease in research and development expenses, partially offset by increases in general administrative expenses of $106 and an increase in the change of fair value of derivative warrant liabilities of $1,065. The net loss of $4,301, or $0.27 per share, for the six months ended September 30, 2025, decreased by $1,748 from the net loss of $6,049, or $0.53 per share, for the six months ended September 30, 2024. The decrease in net loss was primarily due to a $4,161 decrease in research and development expenses, a $13 decrease in general and administrative expenses, partially offset by $1,576 decrease in income tax benefit and a $816 difference in the change in fair value of derivative warrant liabilities.

Current wording

The net loss of $2,315, or $0.14 per share, for the three months ended December 31, 2025, decreased by $1,840 from the net loss of $4,155, or $0.36 per share, for the three months ended December 31, 2024. The decrease in net loss was primarily due to a $1,732 decrease in research and development expenses and a $1,138 decrease in the change of fair value of derivative warrant liabilities, partially offset by increases in general administrative expenses of $477 and a decrease in income tax benefit of $605. The net loss of $6,615, or $0.41 per share, for the nine months ended December 31, 2025, decreased by $3,589 from the net loss of $10,204, or $0.89 per share, for the nine months ended December 31, 2024. The decrease in net loss was primarily due to a $5,892 decrease in research and development expenses, partially offset by a $463 increase in general and administrative expenses and a $2,181 decrease in income tax benefit and a $322 difference in the change in fair value of derivative warrant liabilities.

Previous wording

Our research and development activities during the three and six months ended September 30, 2025 were focused primarily on completing the clinical development program for our GTx-104 drug candidate and preparation and submission of our GTx-104 NDA to the FDA. Our research and development activities during the three and six months ended September 30, 2024 were focused primarily on our clinical development program for our GTx-104 drug candidate.

Current wording

Our research and development activities during the three and nine months ended December 31, 2025 were focused primarily on completing the clinical development program for our GTx-104 drug candidate and preparation and submission of our GTx-104 NDA to the FDA. Our research and development activities during the three and nine months ended December 31, 2024 were focused primarily on our clinical development program for our GTx-104 drug candidate.

Previous wording

Total research and development expenses for the three months ended September 30, 2025 were $568, compared to $2,976 for the three months ended September 30, 2024. The decrease of $2,408 was primarily due to a $2,515 decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, partially offset by a $109 increase in salaries and benefits due to merit increases.

Current wording

Total research and development expenses for the three months ended December 31, 2025 were $462, compared to $2,194 for the three months ended December 31, 2024. The decrease of $1,732 was primarily due to a $1,846 decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial in February 2025, partially offset by a $124 increase in salaries and benefits due to merit increases.

Previous wording

Total research and development expenses for the six months ended September 30, 2025 were $1,523, compared to $5,684 for the six months ended September 30, 2024. The decrease of $4,161 was primarily due to a $4,386 decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, partially offset by a $224 increase in salaries and benefits due to merit increases.

Current wording

Total research and development expenses for the nine months ended December 31, 2025 were $1,985, compared to $7,877 for the nine months ended December 31, 2024. The decrease of $5,892 was primarily due to a $6,231 decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial in February 2025, partially offset by a $348 increase in salaries and benefits due to merit increases.

Previous wording

General and administrative expenses were $1,961 for the three months ended September 30, 2025, an increase of $106 from $1,855 for the three months ended September 30, 2024. The increase was primarily a result of an increase in other general and administrative expenses due to costs for the GTx-104 pre-commercial planning.

Current wording

General and administrative expenses were $1,987 for the three months ended December 31, 2025, an increase of $477 from $1,510 for the three months ended December 31, 2024. The increase was primarily a result of an increase in professional fees and other general and administrative expenses due to costs for the GTx-104 pre-commercial planning.

Previous wording

General and administrative expenses were $4,096 for the six months ended September 30, 2025, a decrease of $13 from $4,109 for the six months ended September 30, 2024. The decrease was primarily a result of decreased legal, accounting, tax, audit and other professional fees related to Continuance and Domestication, partially offset by an increase in other general and administrative expenses primarily due to costs for the GTx-104 commercial assessment, and pre-commercial planning, and an increase in stock-based compensation due to the issuance of new stock option awards.

Current wording

General and administrative expenses were $6,082 for the nine months ended December 31, 2025, an increase of $463 from $5,619 for the nine months ended December 31, 2024. The increase was primarily a result of an increase in other general and administrative expenses due to costs for the GTx-104 pre-commercial planning.

Previous wording

The change in the fair value of derivative warrant liabilities was mainly attributable to a decrease in the expected term as the 2023 Common Warrants expired on the 60th day after the date of the acceptance by the FDA of the NDA for the Company’s product candidate GTx-104 or October 21, 2025.

Current wording

The change in the fair value of derivative warrant liabilities was attributable to expiration of the 2023 Common Warrants which expired on October 21, 2025, the 60th day after the date of the acceptance by the FDA of the NDA for the Company’s product candidate GTx-104. There is no remaining derivative warrant liability as there are no liability classified warrants outstanding as of December 31, 2025.

Previous wording

Interest and other income, net was $172 and $375 for the three and six months ended September 30, 2025, compared to $172 and $407 for the three and six months ended September 30, 2024. The $32 decrease in our interest and other income was due to decreased interest rates.

Current wording

Interest and other income, net was $170 and $547 for the three and nine months ended December 31, 2025, respectively, compared to $138 and $544 for the three and nine months ended December 31, 2024, respectively. The $32 and $3 increases in our interest and other income was due to increased cash and cash equivalents balances compared to the prior year periods.

Previous wording

For the three and six months ended September 30, 2025, the Company did not record an income tax benefit. For the three and six months ended September 30, 2024, the Company recorded an income tax benefit of $852 and $1,576. The period-over-period change is primarily attributable to the establishment of a partial valuation allowance against the Company’s net domestic deferred tax assets. This allowance reflects management’s determination that realization of these assets is not more likely than not at this time. No such valuation allowance was recorded in the prior period.

Current wording

For the three and nine months ended December 31, 2025, the Company did not record an income tax benefit. For the three and nine months ended December 31, 2024, the Company recorded an income tax benefit of $605 and $2,181, respectively. The period-over-period change is primarily attributable to the establishment of a partial valuation allowance against the Company’s net domestic deferred tax assets. This allowance reflects management’s determination that realization of these assets is not more likely than not at this time. No such valuation allowance was recorded in the prior period.

Previous wording

Cash flows and financial condition for the six months ended September 30, 2025 and 2024

Current wording

Cash flows and financial condition for the nine months ended December 31, 2025 and 2024

Previous wording

As of September 30, 2025, cash and cash equivalents were $16,862, a net decrease of $5,271 compared to cash and cash equivalents of $22,133 at March 31, 2025.

Current wording

As of December 31, 2025, cash and cash equivalents were $18,672, a net decrease of $3,461 compared to cash and cash equivalents of $22,133 at March 31, 2025.

Previous wording

As described below, in February 2025, we completed a private placement of our securities with certain institutional and accredited investors. Net proceeds to us were $13,705. In October 2025, we received $4,000 in gross proceeds from exercises of common warrants that were previously issued in a private placement in September 2023. We believe our existing cash and cash equivalents will be sufficient to sustain planned operations through at least 12 months from the issuance date of the unaudited condensed consolidated financial statements included with this Form 10-Q.

Current wording

As described below, in February 2025, we completed a private placement of our securities with certain institutional and accredited investors. Net proceeds to us were $13,705. In October 2025, we received $4,040 in gross proceeds from exercises of common warrants that were previously issued in a private placement in September 2023. We believe our existing cash and cash equivalents will be sufficient to sustain planned operations through at least 12 months from the issuance date of the unaudited condensed consolidated financial statements included with this Form 10-Q.

Previous wording

Net cash used in operating activities for the six months ended September 30, 2025 was $4,944, compared to $7,835 for the six months ended September 30, 2024, a decrease of $2,891. The decrease in net cash used in operating activities was primarily due to a $4,248 decrease in research and development activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON trial and changes in prepaid expenses of $231, offset in part by change in trade and other payables of $1,506.

Current wording

Net cash used in operating activities for the nine months ended December 31, 2025 was $7,174, compared to $11,950 for the nine months ended December 31, 2024, a decrease of $4,776. The decrease in net cash used in operating activities was primarily due to a $5,892 decrease in research and development activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON trial, offset in part by an increase in general and administrative expenses of $463, change in trade and other payables of $607, and a change in fair value of derivative warrant liabilities of $322.

Previous wording

There were no investing activities for the six months ended September 30, 2025. Net cash used in investing activities for the six months ended September 30, 2024 was from the purchase of short-term investments of $15.

Current wording

There were no investing activities for the nine months ended December 31, 2025. Investing activities for the nine months ended December 31, 2024 were from the purchase of short-term investments of $15 offset by the maturity of short-term investments of $15.

Previous wording

Net cash used in financing activities for the six months ended September 30, 2025 was from the payment of stock issuance costs of $327 in connection with the 2025 Private Placement. There were no financing activities for the six months ended September 30, 2024.

Current wording

Net cash provided by financing activities for the nine months ended December 31, 2025 was from gross proceeds from common warrant exercises of $4,040, offset from the payment of stock issuance costs of $327 in connection with the 2025 Private Placement. There were no financing activities for the nine months ended December 31, 2024.

Previous wording

In September 2023, we entered into a securities purchase agreement (the “2023 Purchase Agreement”) with certain institutional and accredited investors in connection with a private placement offering of our securities (the “2023 Private Placement”). Pursuant to the 2023 Purchase Agreement, we sold 1,951,371 Common Shares, at a purchase price of $1.848 per Common Share and pre-funded warrants (the “2023 Pre-Funded Warrants”) to purchase up to 2,106,853 Common Shares at a purchase price equal to the purchase price per Common Share less $0.0001. Each 2023 Pre-Funded Warrant is exercisable for one Common Share at an exercise price of $0.0001 per Common Share, is immediately exercisable, and will expire once exercised in full. Pursuant to the 2023 Purchase Agreement, we also issued to such institutional and accredited investors common warrants (the “2023 Common Warrants”, and together with the 2023 Pre-Funded Warrants, the “Warrants”) to purchase Common Shares, exercisable for an aggregate of 2,536,391 Common Shares. Under the terms of the 2023 Purchase Agreement, for each Common Share and each 2023 Pre-Funded Warrant issued in the 2023 Private Placement, an accompanying five-eighths (0.625) of a 2023 Common Warrant was issued to the purchaser thereof. Each whole 2023 Common Warrant is exercisable for one Common Share at an exercise price of $3.003 per Common Share, is immediately exercisable, and will expire on the earlier of (i) the 60th day after the date of the acceptance by the FDA of an NDA for our product candidate GTx-104 or (ii) five years from the date of issuance. The 2023 Private Placement closed on September 25, 2023. The net proceeds to us from the 2023 Private Placement were $7,338, after deducting fees and expenses. In October 2025, the Company received $4,000 in gross proceeds from exercises of 1,345,464 2023 Common Warrants that were issued in the 2023 Private Placement. for 1,345,464 shares of Common Stock. The remaining 1,190,927 2023 Common Warrants issued in the 2023 Private Placement have expired in accordance with the terms of the common warrants as the 60th day after the FDA’s acceptance for review of our NDA for GTx-104 has passed.

Current wording

In September 2023, we entered into a securities purchase agreement (the “2023 Purchase Agreement”) with certain institutional and accredited investors in connection with a private placement offering of our securities (the “2023 Private Placement”). Pursuant to the 2023 Purchase Agreement, we sold 1,951,371 Common Shares, at a purchase price of $1.848 per Common Share and pre-funded warrants (the “2023 Pre-Funded Warrants”) to purchase up to 2,106,853 Common Shares at a purchase price equal to the purchase price per Common Share less $0.0001. Each 2023 Pre-Funded Warrant is exercisable for one Common Share at an exercise price of $0.0001 per Common Share, is immediately exercisable, and will expire once exercised in full. Pursuant to the 2023 Purchase Agreement, we also issued to such institutional and accredited investors common warrants (the “2023 Common Warrants”, and together with the 2023 Pre-Funded Warrants, the “Warrants”) to purchase Common Shares, exercisable for an aggregate of 2,536,391 Common Shares. Under the terms of the 2023 Purchase Agreement, for each Common Share and each 2023 Pre-Funded Warrant issued in the 2023 Private Placement, an accompanying five-eighths (0.625) of a 2023 Common Warrant was issued to the purchaser thereof. Each whole 2023 Common Warrant is exercisable for one Common Share at an exercise price of $3.003 per Common Share, is immediately exercisable, and will expire on the earlier of (i) the 60th day after the date of the acceptance by the FDA of an NDA for our product candidate GTx-104 or (ii) five years from the date of issuance. The 2023 Private Placement closed on September 25, 2023. The net proceeds to us from the 2023 Private Placement were $7,338, after deducting fees and expenses. In October 2025, the Company received $4,040 in gross proceeds from exercises of 1,345,464 2023 Common Warrants that were issued in the 2023 Private Placement. for 1,345,464 shares of Common Stock. The remaining 1,190,927 2023 Common Warrants issued in the 2023 Private Placement have expired on October 21, 2025 in accordance with the terms of the common warrants as the 60th day after the FDA’s acceptance for review of our NDA for GTx-104 has passed.

Previous wording

We utilize CMOs for the development and production of clinical materials, and CROs to perform services related to our clinical trials. Pursuant to the agreements with CMOs and CROs, we have either the right to terminate the agreements without penalties or under certain penalty conditions. As of September 30, 2025, the Company has $185 of commitments to CMOs and $150 of commitments to CROs for the next twelve months.

Current wording

We utilize CMOs for the development and production of clinical materials, and CROs to perform services related to our clinical trials. Pursuant to the agreements with CMOs and CROs, we have either the right to terminate the agreements without penalties or under certain penalty conditions. As of December 31, 2025, the Company has $185 of commitments to CMOs and no commitments to CROs for the next twelve months.