08/13/2025 | Press release | Distributed by Public on 08/13/2025 05:01
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 since its inception has been 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). The U.S. Food and Drug Administration (FDA) has granted Fast Track and Breakthrough Therapy designations to our product candidate, avasopasem, for the reduction of SOM induced by radiotherapy. Galera advanced avasopasem through Phase 1, then conducted a 223-patient randomized Phase 2 (GT-201) clinical trial and a 455-patient Phase 3 (ROMAN) clinical trial. Both trials achieved statistical significance in their respective primary endpoints.
In February 2023, we announced that the FDA had accepted for filing our New Drug Application (NDA) for avasopasem for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment, and had granted priority review. In August 2023, we received a Complete Response Letter (CRL) from the FDA that required a second Phase 3 trial to support resubmission of the NDA. During the Type A meeting held in September 2023, and in the subsequently received meeting minutes, the FDA reiterated the need for a second Phase 3 trial to support resubmission of the NDA. Since we lacked sufficient resources to consider conducting this additional trial, we wound down our commercial readiness efforts for avasopasem, reduced headcount across several departments and began to pursue strategic alternatives. In October 2023, we announced that we had engaged Stifel, Nicolaus & Company, Inc., as a financial advisor to assist in reviewing strategic alternatives, with the goal of maximizing value for our stockholders. We also halted our clinical trials of our other product candidate, rucosopasem, following a futility analysis.
Following the conclusion of our review of strategic alternatives, on August 8, 2024 our board of directors approved our liquidation and dissolution pursuant to a plan of complete liquidation and dissolution (Plan of Dissolution), subject to stockholder approval. The Plan of Dissolution contemplated an orderly wind down of the Company's business and operations in accordance with the provisions of Delaware law. However, at the special meeting of stockholders held on October 17, 2024 the Plan of Dissolution was not approved by the Company's stockholders. As our stockholders did not approve the Plan of Dissolution, the board of directors and management continued to explore what, if any, other alternatives were available for the future of the Company in light of its discontinued business activities and limited resources.
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. 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).
Galera's clinical portfolio now includes three clinical-stage product candidates: a pan-NOS inhibitor and two SOD mimetics. Galera's lead program is now 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. The Company's cash balance at closing is anticipated to fund operations into 2026 and through data readout from its lead program. A second trial for this agent is planned in TNBC in collaboration with the I-SPY 2 consortium. We also intend to support an investigator-sponsored trial of avasopasem, one of its small molecule dismutase mimetics, in hormone-receptor positive (HR+) breast cancer in patients who have developed resistance to conventional therapies. This trial is funded by an NIH grant, and is expected to commence enrollment in the second half of 2025. Our obligation is to provide the drug supply for this trial, which we can do from existing supplies of avasopasem.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
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 Life Sciences, 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 June 30, 2025, we had $5.2 million in cash and cash equivalents and an accumulated deficit of $459.0 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 June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements through the first quarter of 2026, but not for more than one year after the date of the filing of this Quarterly Report on Form 10-Q. As a result there is substantial doubt about our ability to continue as a going concern after such time. 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.
Our Common Stock is now quoted under its existing symbol "GRTX" on the Over-The-Counter Quote Bulletin Board - Venture Market (OTCQB).
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 six months ended June 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:
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
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.
The following table summarizes our research and development expenses by program for the three and six months ended June 30, 2025 and 2024 (in thousands):
|
Three months ended |
Six months ended |
|||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||||||
|
Avasopasem manganese |
$ |
16 |
$ |
(2 |
) |
$ |
34 |
$ |
(149 |
) |
||||||
|
Rucosopasem manganese |
9 |
17 |
17 |
660 |
||||||||||||
|
Other research and development expense |
59 |
126 |
107 |
447 |
||||||||||||
|
Personnel related and share-based compensation |
- |
1,289 |
19 |
1,960 |
||||||||||||
|
$ |
84 |
$ |
1,430 |
$ |
177 |
$ |
2,918 |
|||||||||
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:
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
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.
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.
We are not yet able to estimate 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.
Results of Operations
Comparison of the Three and Six months ended June 30, 2025 and 2024
The following table sets forth our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
|
Three Months Ended |
Six months ended |
|||||||||||||||||||||||
|
2025 |
2024 |
Change |
2025 |
2024 |
Change |
|||||||||||||||||||
|
Operating expenses: |
||||||||||||||||||||||||
|
Research and development |
$ |
84 |
$ |
1,430 |
$ |
(1,346 |
) |
$ |
177 |
$ |
2,918 |
$ |
(2,741 |
) |
||||||||||
|
General and administrative |
1,051 |
2,779 |
(1,728 |
) |
2,921 |
5,868 |
(2,947 |
) |
||||||||||||||||
|
Loss from operations |
(1,135 |
) |
(4,209 |
) |
3,074 |
(3,098 |
) |
(8,786 |
) |
5,688 |
||||||||||||||
|
Other income: |
||||||||||||||||||||||||
|
Interest income |
60 |
149 |
(89 |
) |
137 |
345 |
(208 |
) |
||||||||||||||||
|
Change in fair value of warrant liability |
- |
- |
- |
294 |
- |
294 |
||||||||||||||||||
|
Foreign currency loss |
- |
(4 |
) |
4 |
- |
(4 |
) |
4 |
||||||||||||||||
|
Net loss |
$ |
(1,075 |
) |
$ |
(4,064 |
) |
$ |
2,989 |
$ |
(2,667 |
) |
$ |
(8,445 |
) |
$ |
5,778 |
||||||||
Research and Development Expense
Research and development expense decreased by $1.3 million from $1.4 million for the three months ended June 30, 2024 to $0.1 million for the three months ended June 30, 2025. Personnel related and share-based compensation expense decreased $1.3 million, as the employment of the remaining research and development employees ended in 2024; we accrued $0.8 million in severance costs during the three months ended June 30, 2024.
Research and development expense decreased by $2.7 million from $2.9 million for the six months ended June 30, 2024 to $0.2 million for the six months ended June 30, 2025. Rucosopasem development costs decreased $0.6 million as we halted the GRECO-1 and GRECO-2 clinical trials. Personnel related and share-based compensation expense decreased $1.9 million, as the employment of the remaining research and development employees ended in 2024, and other research and development expenses decreased $0.3 million. Partially offsetting these expense reductions, avasopasem development costs increased $0.2 million, driven by a credit recorded in the six months ended June 30, 2024 for the release of an accrual for the ROMAN trial.
General and Administrative Expense
General and administrative expense decreased by $1.7 million from $2.8 million for the three months ended June 30, 2024 to $1.1 million for the three months ended June 30, 2025, principally due to reduced personnel related and share-based compensation expenses due to reduced headcount and stock options that became fully vested during 2024, reduced legal and professional fees, and reduced insurance expense.
General and administrative expense decreased by $3.0 million from $5.9 million for the six months ended June 30, 2024 to $2.9 million for the six months ended June 30, 2025, principally due to reduced personnel related and share-based compensation expenses due to reduced headcount and stock options that became fully vested during 2024, reduced legal and professional fees, and reduced insurance expense.
Interest Income
Interest income decreased from $0.1 million for the three months ended June 30, 2024 to $60,000 for the three months ended June 30, 2025 and decreased from $0.3 million for the six months ended June 30, 2024 to $0.1 million for the six months ended June 30, 2025, due to the reduction in investable cash and securities.
Change in Fair Value of Warrant Liability
During the six months ended June 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 June 30, 2025, we have funded our operations primarily through the sale and issuance of
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
equity and $117.5 million of proceeds received under the Royalty Agreement with Blackstone Life Sciences, receiving aggregate gross proceeds of $379.9 million.
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 June 30, 2025, we had $5.2 million in cash and cash equivalents and an accumulated deficit of $459.0 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 June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements through the first quarter of 2026, but not for more than one year from the date of the filing of this Quarterly Report on Form 10-Q. As a result, there is substantial doubt about our ability to continue as a going concern through the 12 months from the date of the filing of this Quarterly Report on Form 10-Q. For more information, see the discussion under the heading "Liquidity" in Note 1 to our unaudited interim consolidated financial statements.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated (in thousands):
|
Six months ended |
||||||||
|
2025 |
2024 |
|||||||
|
Net cash used in operating activities |
$ |
(3,694 |
) |
$ |
(7,508 |
) |
||
|
Net cash provided by financing activities |
635 |
- |
||||||
|
Net decrease in cash and cash equivalents |
$ |
(3,059 |
) |
$ |
(7,508 |
) |
||
Operating Activities
During the six months ended June 30, 2025, we used $3.7 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $2.7 million, $0.9 million from other changes in operating assets and liabilities, and net non-cash charges of $0.1 million related to share-based compensation expense and the change in the fair value of the warrant liability. The primary use of cash was to fund our operations.
During the six months ended June 30, 2024, we used $7.5 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $8.4 million and $0.7 million from other changes in operating assets and liabilities, partially offset by non-cash charges of $1.6 million related to share-based compensation and depreciation expense. The primary use of cash was to fund our operations as we reviewed strategic alternatives.
Financing Activities
During the six months ended June 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 June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements through the first quarter of 2026, but not for more than one year after the date of the filing of this Quarterly Report on Form 10-Q. As a result there is substantial doubt about our ability to continue as a going concern through the 12
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
months from the date of the filing of this Quarterly Report on Form 10-Q. 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:
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,
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
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 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.
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 a high single-digit percentage 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 Royalty Agreement and the Amendment, the Royalty Agreement and the Amendment remains in effect and any future purchaser or licensor of the Products will be bound by the terms of the Royalty Agreement and the 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.
Patheon Manufacturing Agreements
In August 2021, we entered into a Master Manufacturing Services Agreement with Patheon (the Master Agreement). The Master Agreement governs the general terms under which Patheon, or one of its affiliates, will provide non-exclusive manufacturing services to us for the drug products specified by us from time to time. Pursuant to the Master Agreement, we have agreed to order from Patheon at least a certain percentage of our commercial requirements for a product under a related product agreement. Each product agreement that we may enter into from time to time will be governed by the terms of the Master Agreement, unless expressly modified in such product agreement.
GALERA THERAPEUTICS, INC.
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
In August 2021, we and Patheon entered into a product agreement for avasopasem (the Product Agreement), under the Master Agreement to govern the terms and conditions of Patheon's manufacture and commercial supply to us of avasopasem manganese from Patheon's Greenville, North Carolina manufacturing site.
The Master Agreement, and any related product agreement, has an initial term that expires on December 31, 2027 and includes renewal terms, as applicable. In addition, each party has the ability to terminate the Product Agreement upon the occurrence of certain customary conditions. The Master Agreement contains representations, warranties and indemnity obligations customary for agreements of this type, and the Product Agreement establishes certain pricing for avasopasem that may be adjusted as set forth in the Master Agreement.
Our obligation to purchase avasopasem under the Product Agreement is subject to certain binding forecast periods at certain established prices, which will be reviewed each year on January 1 by us and Patheon. We currently do not have any contractual commitment to purchase avasopasem under the Product 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 3 and 11 to our unaudited interim consolidated financial statements included in this Quarterly Report on Form 10-Q.
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.