11/13/2025 | Press release | Distributed by Public on 11/13/2025 06:16
Management's Discussion and Analysis ofFinancial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many important factors, including those set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025 (the 2024 Form 10-K), and this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by these forward-looking statements.
Overview
We are a biopharmaceutical company that historically was focused on developing a portfolio of small molecule superoxide dismutase (SOD) mimetics to improve radiotherapy in cancer, primarily by reducing one of the most common side effects of radiotherapy, severe oral mucositis (SOM). In October 2025 we sold our assets related to avasopasem and rucosopasem and all other dismutase mimetics assets to Biossil, Inc. (Biossil), a privately-held company based in Toronto, Canada. In connection with selling these assets, we assigned and Biossil assumed all rights and obligations under the Royalty Agreement with Blackstone Life Sciences (Blackstone), as described below. We received consideration from Biossil in the form of an upfront payment of $3.5 million and are eligible to receive further payments upon the achievement of future regulatory and commercial milestones and received contingent value rights of up to $105.0 million in the aggregate.
On December 30, 2024, we completed the acquisition of Nova Pharmaceuticals, Inc. (Nova), a privately-held biotechnology company advancing a pan-inhibitor of nitric oxide synthase (NOS). With that acquisition, we have shifted our strategic focus to developing product candidates to treat certain types of advanced breast cancer, including metaplastic breast cancer (MpBC) and other refractory subsets of triple-negative breast cancer (TNBC). In support of the acquisition, a syndicate of investors led by Ikarian Capital invested $2.9 million to purchase Galera common stock and pre-funded warrants. The Company continues as Galera Therapeutics, Inc., and our common stock is listed on the Over-The-Counter Quote Bulletin Board - Venture Market (OTCQB:GRTX).
Following the sale to Biossil, our portfolio is now comprised of a pan-NOS inhibitor. Our lead program is a Phase 1/2 trial of the pan-NOS inhibitor in combination with nab-paclitaxel and alpelisib for MpBC. This is an investigator-sponsored trial that is funded by a National Institutes of Health (NIH) grant to investigators at the Methodist Hospital in Houston, Texas (Houston Methodist), including the drug supply for the trial. A second trial for this agent is being planned in TNBC in collaboration with the I-SPY 2 consortium.
Since our inception, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, acquiring and developing product and technology rights, and conducting research and development. We have incurred recurring losses and negative cash flows from operations and have funded our operations primarily through the sale and issuance of equity and $117.5 million of proceeds received under the Royalty Agreement with Blackstone, receiving aggregate gross proceeds of $379.9 million.
Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful resumption of development and eventual commercialization of one or more of our current or future product candidates. We may never succeed in these activities, and we expect to continue to incur losses for the foreseeable future. Our net loss was $19.0 million and $59.1 million for the years ended December 31, 2024 and 2023, respectively. As of September 30, 2025, we had $4.5 million in cash and cash equivalents and an accumulated deficit of $460.4 million.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect our existing cash and cash equivalents as of September 30, 2025 and the $3.5 million received in October 2025 from the sale to Biossil will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report on Form 10-Q. Future capital requirements will depend on our strategic alternatives, which may include pursuit of a strategic transaction, a voluntary dissolution, or the continued operation of product development. Our anticipated operating expenses involve significant risks and uncertainties and are dependent on our current assessment of the extent and costs of activities required to advance our product candidates. In the future, we anticipate that we will need to raise substantial additional financing to fund our operations through equity or debt financings, or through strategic transactions. To meet these requirements, we may seek to sell equity or convertible securities in public or private transactions that may result in significant dilution to our stockholders. We may
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
offer and sell shares of our common stock under an existing registration statement or any registration statement we may file in the future. If we raise additional funds through the issuance of convertible securities, these securities could have rights senior to those of our common stock and could contain covenants that restrict our operations. We may also defer certain operating expenses unless and until additional capital is received. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us, or that we will be successful in deferring certain operating expenses. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of our operations and planned capital expenditures and may decide to delay or discontinue certain activities, including planned research and development activities, hiring plans, manufacturing activities and commercial preparation efforts.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those described below. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Our critical accounting policies are described under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies" in the 2024 Form 10-K and the notes to the unaudited interim consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2025 there were no material changes to our critical accounting policies from those discussed in the 2024 Form 10-K.
Components of Results of Operations
Research and Development Expense
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred. These expenses include:
We track our external research and development expenses on a program-by-program basis, such as fees paid to CROs, CMOs and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities. However, we do not track our internal research and development expenses on a program-by-program basis as they primarily relate to personnel-related and share-based compensation expense, early-stage research expenses and other costs that are deployed across multiple projects under development.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
The following table summarizes our research and development expenses by program for the three and nine months ended September 30, 2025 and 2024 (in thousands):
|
Three months ended |
Nine months ended |
|||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||||||
|
Avasopasem manganese |
$ |
25 |
$ |
(10 |
) |
$ |
59 |
$ |
(159 |
) |
||||||
|
Rucosopasem manganese |
8 |
27 |
25 |
687 |
||||||||||||
|
Other research and development expense |
97 |
120 |
204 |
567 |
||||||||||||
|
Personnel related and share-based compensation |
- |
168 |
19 |
2,128 |
||||||||||||
|
$ |
130 |
$ |
305 |
$ |
307 |
$ |
3,223 |
|||||||||
We have ceased all clinical trial activity and have suspended the clinical development of certain of our product candidates.
The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the development of our product candidates. We are unable to predict when, if ever, material net cash inflows will commence from sales of any future product candidates that we may develop due to the numerous risks and uncertainties associated with clinical development, including:
We may never succeed in achieving regulatory approval for any future product candidates we may develop.
General and Administrative Expense
General and administrative expense consists primarily of personnel expenses, including salaries, benefits and share-based compensation expense for employees in executive, finance, accounting, legal, information technology, commercial, business development and human resource functions. General and administrative expense also includes corporate facility costs, including rent, utilities, depreciation and maintenance, not otherwise included in research and development expense, as well as legal fees related to intellectual property and corporate matters and fees for accounting and consulting services.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Assuming we are successful in securing additional capital, we expect that our expenses will increase in the future to support our continued research and development activities and to expand our operations.
Interest Income
Interest income consists of amounts earned on our cash and cash equivalents held with large institutional banks and a money market mutual fund invested in U.S. Treasury obligations.
Net Operating Loss and Research and Development Tax Credit Carryforwards
As of December 31, 2024, we had federal and state tax net operating loss carryforwards (NOLs) of $209.5 million and $231.9 million, respectively, which will begin to expire in 2032 unless previously utilized. As of December 31, 2024, we also had federal research and development tax credit carryforwards of $9.0 million. The federal research and development tax credit carryforwards will begin to expire in 2032 unless previously utilized.
Utilization of the federal and state net operating losses and credits may be subject to a substantial annual limitation. The annual limitation may result in the expiration of our net operating losses and credits before we can use them. In addition, future changes in our stock ownership, some of which might be beyond our control, could result in an ownership change under Section 382 of the Internal Revenue Code, further limiting our ability to utilize a material portion of the NOLs and credits. We have recorded a valuation allowance on substantially all of our deferred tax assets, including our deferred tax assets related to our NOLs and research and development tax credit carryforwards, given the current uncertainty over our ability to utilize such amounts.
Under Internal Revenue Code section 382, if a corporation undergoes a specified change in ownership, the corporation's ability to use its pre-change net operating loss (NOL) carryforwards and other pre-change tax attributes to offset its post-change income may be limited. Such limitation may result in the expiration of the NOL carryforwards generated before 2018 and other pre-change tax attributes prior to their utilization. During the quarter ended September 30, 2025 we performed a section 382 study and determined that an ownership change occurred on December 30, 2024 upon the completion of the acquisition of Nova. We calculated the section 382 annual limitation and evaluated the corporation's ability to use its NOL carryforwards and other pre-change tax attributes in future periods, and determined that a portion of them would likely expire before being utilized. Consequently, $62.6 million of pre-2018 federal NOLs, $230.2 million of state NOLs and $9 million of federal research and development tax credits were written off during the quarter. However, as we had previously recorded a full valuation allowance on all deferred tax assets, this write-off resulted in no impact to the net deferred tax position or net income during the quarter.
We have evaluated the effect, if any, that the tax legislation signed into law on July 4, 2025 will have on our NOLs or research and development tax credit carryforwards. Due to the presence of the valuation allowance, we do not expect it will have a material impact on our consolidated financial statements.
Results of Operations
Comparison of the Three and Nine months ended September 30, 2025 and 2024
The following table sets forth our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
|
Three Months Ended |
Nine months ended |
|||||||||||||||||||||||
|
2025 |
2024 |
Change |
2025 |
2024 |
Change |
|||||||||||||||||||
|
Operating expenses: |
||||||||||||||||||||||||
|
Research and development |
$ |
130 |
$ |
305 |
$ |
(175 |
) |
$ |
307 |
$ |
3,223 |
$ |
(2,916 |
) |
||||||||||
|
General and administrative |
1,306 |
3,439 |
(2,133 |
) |
4,227 |
9,307 |
(5,080 |
) |
||||||||||||||||
|
Write-off of acquired intangible asset |
- |
2,258 |
(2,258 |
) |
- |
2,258 |
(2,258 |
) |
||||||||||||||||
|
Write-off of goodwill |
- |
881 |
(881 |
) |
- |
881 |
(881 |
) |
||||||||||||||||
|
Gain on litigation settlement |
- |
(975 |
) |
975 |
- |
(975 |
) |
975 |
||||||||||||||||
|
Loss from operations |
(1,436 |
) |
(5,908 |
) |
4,472 |
(4,534 |
) |
(14,694 |
) |
10,160 |
||||||||||||||
|
Other income: |
||||||||||||||||||||||||
|
Interest income |
48 |
126 |
(78 |
) |
185 |
471 |
(286 |
) |
||||||||||||||||
|
Change in fair value of warrant liability |
- |
- |
- |
294 |
- |
294 |
||||||||||||||||||
|
Foreign currency loss |
- |
(2 |
) |
2 |
- |
(6 |
) |
6 |
||||||||||||||||
|
Loss before income tax benefit |
(1,388 |
) |
(5,784 |
) |
4,396 |
(4,055 |
) |
(14,229 |
) |
10,174 |
||||||||||||||
|
Income tax benefit |
- |
203 |
(203 |
) |
- |
203 |
(203 |
) |
||||||||||||||||
|
Net loss |
$ |
(1,388 |
) |
$ |
(5,581 |
) |
$ |
4,193 |
$ |
(4,055 |
) |
$ |
(14,026 |
) |
$ |
9,971 |
||||||||
Research and Development Expense
Research and development expense decreased by $0.2 million from $0.3 million for the three months ended September 30, 2024 to $0.1 million for the three months ended September 30, 2025. Share-based compensation expense decreased $0.2 million due primarily to stock options forfeited by terminated employees.
Research and development expense decreased by $2.9 million from $3.2 million for the nine months ended September 30, 2024 to $0.3 million for the nine months ended September 30, 2025. Rucosopasem development costs decreased $0.7 million as we halted the GRECO-1 and GRECO-2 clinical trials. Personnel related and share-based compensation expense decreased $2.1 million, as the employment of the remaining research and development employees ended in 2024, and other research and development expenses decreased $0.4 million. Partially offsetting these expense reductions, avasopasem development costs increased $0.2 million, driven by a credit recorded in the nine months ended September 30, 2024 for the release of an accrual for the ROMAN trial.
General and Administrative Expense
General and administrative expense decreased by $2.1 million from $3.4 million for the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025. Personnel related and share-based compensation expenses decreased $1.2 million due to reduced headcount, severance expense during the three months ended September 30, 2024 for two officers terminated in August 2024, stock options forfeited by terminated employees, and stock options that became fully vested during 2024. In addition, legal and professional fees decreased $0.3 million and insurance expense decreased $0.1 million, while the three months ended September 30, 2024 included a $0.5 million charge for expenses incurred to terminate the Company's office lease.
General and administrative expense decreased by $5.1 million from $9.3 million for the nine months ended September 30, 2024 to $4.2 million for the nine months ended September 30, 2025. Personnel related and share-based compensation expenses decreased $2.6 million due to reduced headcount, severance expense during the nine months ended September 30, 2024 for two officers terminated in August 2024, stock options forfeited by terminated employees, and stock options that became fully vested during 2024. In addition, legal and professional fees decreased $1.2 million and insurance expense decreased $0.4 million, while the nine months ended September 30, 2024 included a $0.5 million charge for expenses incurred to terminate the Company's office lease.
Write-off of Acquired Intangible Asset and Goodwill
In August 2024, the Company's board of directors approved the Plan of Dissolution, under which future development of the Company's product candidates would no longer continue. In connection with this decision, the board of directors concluded that the related IPR&D asset and related goodwill were each impaired in their entirety, and as such the Company recognized non-cash impairment charges of $2.3 million for the IPR&D and $0.9 million for the goodwill during the three and nine months ended September 30, 2024. There were no comparable charges during the three and nine months ended September 30, 2025.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Gain on Litigation Settlement
We recognized a $1.0 million gain during the three and nine months ended September 30, 2024 in connection with the settlement of litigation, which was recorded in operating expenses. There was no comparable gain during the three and nine months ended September 30, 2025.
Interest Income
Interest income decreased from $0.1 million for the three months ended September 30, 2024 to $48,000 for the three months ended September 30, 2025, and decreased from $0.5 million for the nine months ended September 30, 2024 to $0.2 million for the nine months ended September 30, 2025, due to the reduction in investable cash and securities.
Change in Fair Value of Warrant Liability
During the nine months ended September 30, 2025, we recognized a $0.3 million change in the fair value of the warrant liability. This adjustment was recorded prior to the reclassification of the liability-classified warrants to equity.
Liquidity and Capital Resources
We do not have any products approved for sale, and we do not expect to generate any revenue from product sales unless and until we successfully complete development and obtain regulatory approval for one or more product candidates, which we do not expect to be for many years, if ever. Through September 30, 2025, we have funded our operations primarily through the sale and issuance of equity and $117.5 million of proceeds received under the Royalty Agreement with Blackstone, receiving aggregate gross proceeds of $379.9 million. On October 15, 2025, we entered into, and subsequently amended, an Asset Purchase and Sale Agreement with Biossil, pursuant to which Biossil agreed to acquire all of our right, title and interest in and to our assets related to avasopasem and rucosopasem and all other dismutase mimetic assets. In connection with acquiring these assets, we assigned and Biossil assumed all rights and obligations under the Royalty Agreement with Blackstone. We received consideration from Biossil in the form of an upfront payment of $3.5 million and are eligible to receive further payments upon the achievement of future regulatory and commercial milestones and received contingent value rights of up to $105.0 million in the aggregate.
In February 2023, we completed a registered direct offering, which resulted in the issuance and sale of 14,320,000 shares of our common stock and warrants to purchase up to 14,320,000 shares of common stock at a combined offering price of $2.095 per share and accompanying warrant, and received net proceeds of $27.6 million, after deducting placement agent fees and offering expenses. The warrants are equity-classified, have an exercise price of $1.97 per share of common stock, are exercisable immediately following their issuance and will expire five years from the date of issuance. We received net proceeds of approximately $27.6 million from this offering, after deducting placement agent fees and offering expenses.
In December 2024, we completed a private placement with a group of investors led by Ikarian Capital. We issued approximately 21.1 million shares of common stock plus pre-funded warrants exercisable for approximately 23.0 million shares of common stock at an offering price of $0.065 per share or pre-funded warrant. As a result of the private placement, we received net proceeds of approximately $2.9 million.
As of September 30, 2025, we had $4.5 million in cash and cash equivalents and an accumulated deficit of $460.4 million. We have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years. We expect our existing cash and cash equivalents as of September 30, 2025 and $3.5 million from the sale of our dismutase mimetics assets in October 2025 (see Note 13 in the unaudited consolidated interim financial statements) will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report on Form 10-Q. Future capital requirements will depend on our strategic alternatives, which may include pursuit of a strategic transaction, a voluntary dissolution, or the continued operation of product development.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Cash Flows
The following table shows a summary of our cash flows for the periods indicated (in thousands):
|
Nine months ended |
||||||||
|
2025 |
2024 |
|||||||
|
Net cash used in operating activities |
$ |
(4,451 |
) |
$ |
(9,806 |
) |
||
|
Net cash provided by investing activities |
- |
4 |
||||||
|
Net cash provided by financing activities |
635 |
- |
||||||
|
Net decrease in cash and cash equivalents |
$ |
(3,816 |
) |
$ |
(9,802 |
) |
||
Operating Activities
During the nine months ended September 30, 2025, we used $4.5 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $4.1 million and $0.4 million from other changes in operating assets and liabilities. The primary use of cash was to fund our operations.
During the nine months ended September 30, 2024, we used $9.8 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $14.0 million and $0.9 million from other changes in operating assets and liabilities, partially offset by non-cash charges of $5.1 million related to the write-off of the acquired intangible asset and goodwill, deferred tax benefit, share-based compensation, depreciation expense, and loss from disposal of property and equipment. The primary use of cash was to fund our operations.
Investing Activities
During the nine months ended September 30, 2024, investing activities provided $4,000 in cash proceeds from the sale of property and equipment.
Financing Activities
During the nine months ended September 30, 2025, financing activities provided $0.6 million from the sale of our common stock in a private placement in December 2024.
Funding Requirements
We expect our existing cash and cash equivalents as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report on Form 10-Q. Future capital requirements will depend on our strategic alternatives, which may include pursuit of a strategic transaction, a voluntary dissolution, or the continued operation of product development. Our anticipated operating expenses involve significant risks and uncertainties and are dependent on our current assessment of the extent and costs of activities required to advance our product candidates. In the future, we anticipate that we will need to raise substantial additional financing to fund our operations through equity or debt financings, or through strategic transactions. To meet these requirements, we may seek to sell equity or convertible securities in public or private transactions that may result in significant dilution to our stockholders. We may offer and sell shares of our common stock under an existing registration statement or any registration statement we may file in the future. If we raise additional funds through the issuance of convertible securities, these securities could have rights senior to those of our common stock and could contain covenants that restrict our operations. We may also defer certain operating expenses unless and until additional capital is received. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us, or that we will be successful in deferring certain operating expenses. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of our operations and planned capital expenditures and may decide to delay or discontinue certain activities, including planned research and development activities, hiring plans, manufacturing activities and commercial preparation efforts.
Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on, and could increase significantly as a result of, many factors, including:
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, any future product candidates, if approved, may not achieve commercial success.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders' ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders' rights. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate certain activities, including planned research and development activities or hiring plans.
If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Key Agreements
Royalty Agreement with Blackstone Life Sciences (Formerly Known as Clarus Ventures)
In November 2018, we entered into the Royalty Agreement with Blackstone Life Sciences. Pursuant to the Royalty Agreement, Blackstone agreed to pay us, in the aggregate, up to $80.0 million, or the Royalty Purchase Price, in four tranches of $20.0 million each upon the achievement of specified clinical milestones in our ROMAN trial. We agreed to apply the proceeds from such payments primarily to support clinical development and regulatory activities for avasopasem, rucosopasem and any pharmaceutical product comprising or containing avasopasem or rucosopasem, or, collectively, the Products, as well as to satisfy working capital obligations and for general corporate expenses. We received the first tranche of the Royalty Purchase Price in November 2018, the second tranche of the Royalty Purchase Price in April 2019, and the third tranche of the Royalty Purchase Price in February 2020, in each case in connection with the achievement of the first three milestones, respectively, under the Royalty Agreement.
In May 2020, we entered into Amendment No. 1 to the Royalty Agreement, or the Amendment, with Clarus IV Galera Royalty AIV, L.P., or the Blackstone Purchaser. The Blackstone Purchaser is affiliated with Blackstone Life Sciences, successor in
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
interest to Clarus Ventures. The Amendment increased the Royalty Purchase Price by $37.5 million to $117.5 million by increasing the fourth tranche from $20.0 million to $37.5 million and adding a new $20.0 million tranche upon the achievement of an additional clinical enrollment milestone. We received the new $20.0 million tranche of the Amendment in June 2021, in connection with the enrollment of the first patient in the GRECO-2 trial. Also in June 2021, we completed enrollment in the ROMAN trial, thereby achieving the milestone associated with the fourth tranche, and received the associated $37.5 million in July 2021.
In August 2025, the Company entered into the Second Amendment to the Royalty Agreement (the Second Amendment) with the Blackstone Purchaser. Pursuant to the amended Royalty Agreement, in connection with the payment of each tranche of the Royalty Purchase Price, we have agreed to sell, convey, transfer and assign to Blackstone all of our right, title and interest in four percent (4%) of (i) worldwide net sales of the Products and (ii) all amounts received by us or our affiliates, licensees and sublicensees with respect to Product-related damages (collectively, the Product Payments) during the Royalty Period. The Royalty Period means, on a Product-by-Product and country-by-country basis, the period of time commencing on the commercial launch of such Product in such country and ending on the latest to occur of (i) the 12th anniversary of such commercial launch, (ii) the expiration of all valid claims of our patents covering such Product in such country, and (iii) the expiration of regulatory data protection or market exclusivity or similar regulatory protection afforded by the health authorities in such country, to the extent such protection or exclusivity effectively prevents generic versions of such Product from entering the market in such country.
The amended Royalty Agreement will remain in effect until the date on which the aggregate amount of the Product Payments paid to Blackstone exceeds a fixed single-digit multiple of the actual amount of the Royalty Purchase Price received by us, unless earlier terminated pursuant to the mutual written agreement of us and Blackstone. If no Products are commercialized, we would not have an obligation to make Product Payments to Blackstone, which is the sole mechanism for repaying the liability. Pursuant to the terms of the amended Royalty Agreement, the Royalty Agreement, the Amendment and the Second Amendment remain in effect and any future purchaser or licensor of the Products will be bound by the terms of the Royalty Agreement, the Amendment and the Second Amendment, unless otherwise agreed by Blackstone.
In May 2020, as partial consideration for the Amendment, we issued two warrants to the Blackstone Purchaser to purchase an aggregate of 550,661 shares of our common stock at an exercise price equal to $13.62 per share, each of which became exercisable upon the receipt by us of the applicable specified milestone payment. The issued warrants expire six years after the initial exercise date of each respective warrant.
In connection with the sale of our dismutase mimetics assets to Biossil, we assigned and Biossil assumed all rights and obligations under the amended Royalty Agreement, and Blackstone acknowledged that it would look solely to Biossil to pay and perform the obligations and liabilities under the amended Royalty Agreement.
Methodist Hospital License Agreement
The Company's subsidiary, Nova, has a worldwide license agreement (the License) with Houston Methodist. The License was executed in January 2024 and gives Nova the exclusive rights to certain Houston Methodist patents for use in the field of oncology, and non-exclusive rights to certain Houston Methodist know-how for use in connection with the licensed patents.
As consideration for the License, Nova paid Houston Methodist an initial license fee of $300,000, approximately $147,000 as reimbursement for patent costs incurred prior to the date of the license, and a $100,000 deposit for future patent costs incurred by Houston Methodist to the extent they are not paid by Nova. Under a separate patent prosecution agreement, fees of the law firm maintaining the licensed patents are billed to and payable directly by Nova.
The License includes due diligence requirements for Nova to submit an Investigational New Drug (IND) application by January 31, 2028, and thereafter to initiate Phase 1, 2 and 3 clinical trials and file a Biologics License Application (BLA) by specified dates. If Nova receives FDA approval for a product covered by the License, fees are payable upon attainment of certain commercial milestones, and low-to-mid single digit royalties are payable on net sales. Fees are also payable on any sublicense revenue that Nova receives.
As additional consideration for the License, Nova made an initial issuance of shares of Nova common stock to Houston Methodist, and subsequently issued additional shares such that Houston Methodist maintained an agreed percentage of Nova outstanding shares. On December 30, 2024, the Houston Methodist shares in Nova were exchanged for approximately 7,323 shares of the Company's Series B. Refer to Notes 1 and 3 to our unaudited interim consolidated financial statements included in this Quarterly Report on Form 10-Q.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Unless earlier terminated, the License expires on the later of January 31, 2044, or the end of the patent term for the last licensed patent to expire, after which the license continues on a nonexclusive, royalty-free basis.