Financial Performance - The company reported a net loss of $15,073,000 for the three months ended September 30, 2023, compared to a net loss of $16,033,000 for the same period in 2022, indicating an improvement of about 6%[19] - The company reported a net loss of $53.495 million for the nine months ended September 30, 2023, compared to a net loss of $46.034 million for the same period in 2022[24] - The comprehensive loss for the three months ended September 30, 2023, was $15,078,000, slightly improved from a comprehensive loss of $16,016,000 in the same period of 2022, indicating a reduction of about 5.9%[19] - Net loss for Q3 2023 was $15.1 million, a decrease of $0.96 million compared to a net loss of $16.0 million in Q3 2022[120] Assets and Cash Position - As of September 30, 2023, total assets decreased to $37,779,000 from $44,036,000 as of December 31, 2022, representing a decline of approximately 14.3%[13] - The company had cash and cash equivalents of $24,379,000 as of September 30, 2023, significantly up from $4,266,000 at the end of 2022, representing an increase of approximately 471.5%[13] - The company had cash, cash equivalents, and restricted cash of $24.429 million at the end of the period, up from $12.780 million at the end of September 2022[24] - As of September 30, 2023, the company had $28.4 million in cash, cash equivalents, and short-term investments, with an accumulated deficit of $431.8 million[120] - The company expects its existing cash and short-term investments will fund operations into 2025[33] Expenses - Research and development expenses for the three months ended September 30, 2023, were $6,093,000, down from $8,105,000 in the same period of 2022, reflecting a decrease of approximately 24.8%[15] - General and administrative expenses for the nine months ended September 30, 2023, were $20,849,000, compared to $15,193,000 for the same period in 2022, reflecting an increase of approximately 37.5%[15] - Research and development expenses for the nine months ended September 30, 2023, totaled $20.9 million, compared to $22.8 million for the same period in 2022[98] - General and administrative expenses increased by $0.1 million from $4.9 million in Q3 2022 to $5.0 million in Q3 2023, mainly due to avasopasem commercial preparations and increased legal expenses[111] Restructuring and Workforce Changes - The company incurred restructuring costs of $2,309,000 during the three months ended September 30, 2023, which were not present in the same period of the previous year[15] - The company incurred total restructuring-related charges of $2.3 million during the three months ended September 30, 2023, due to a workforce reduction of approximately 70%[45] - A reduction in force was implemented in August 2023, affecting 22 employees, or 70% of the workforce, incurring a charge of $2.3 million primarily for severance and related costs[173] Strategic Initiatives - The company is exploring strategic alternatives, including potential mergers or asset divestitures, to maximize shareholder value[31] - The company announced the decision to halt the GRECO-1 and GRECO-2 trials following a futility analysis, aiming to conserve cash[30] - The company has engaged Stifel, Nicolaus & Company, Inc. as its financial advisor to assist in reviewing strategic alternatives[31] - The company is concurrently evaluating strategic alternatives for the continued development of avasopasem and rucosopasem[169] Compliance and Regulatory Issues - As of September 22, 2023, the company was not in compliance with Nasdaq's minimum Market Value of Listed Securities of $50 million and the minimum bid price requirement of $1.00 per share[89] - The company has until March 20, 2024, to regain compliance with Nasdaq's listing requirements[89] - The company received a Complete Response Letter (CRL) from the FDA on August 9, 2023, regarding the NDA for avasopasem, indicating that additional clinical trials are required for resubmission[157] - The FDA requires an additional Phase 3 trial to confirm the efficacy and safety of avasopasem for radiotherapy-induced SOM, which may delay the approval process[165] Funding and Financial Obligations - The company may need substantial additional funding to meet financial obligations and pursue growth strategies, which could be impacted by market conditions[149][152] - Future funding requirements will depend on various factors, including the outcome of strategic alternatives being explored, such as mergers or partnerships[128] - The company entered into a Royalty Agreement with Blackstone Life Sciences, potentially receiving up to $117.5 million based on clinical milestones achieved in the ROMAN trial[133][134] Legal Matters - The company is involved in a lawsuit against Alira Health Clinical, LLC and IQVIA Biotech, LLC related to a breach of contract in the Phase 3 ROMAN trial[146]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) (Exact name of registrant as specified in its charter) Delaware 46-1454898 (State or other jurisdiction of incorporation or organization) 45 Liberty Blvd, Suite 230 Malvern, Pennsylvania 19355 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ ...

Financial Performance - Net loss for the three months ended March 31, 2023, was $17,710,000, compared to a net loss of $15,443,000 for the same period in 2022, reflecting a 15% increase in losses[16] - The company reported a comprehensive loss of $17,672,000 for the three months ended March 31, 2023, compared to $15,490,000 for the same period in 2022, which is a 14% increase[19] - The company incurred a net loss of $62.2 million for the year ended December 31, 2022, and $17.7 million for the three months ended March 31, 2023, with an accumulated deficit of $396.0 million[93] - For the three months ended March 31, 2023, the net loss was $17.7 million, compared to a net loss of $15.4 million for the same period in 2022, representing an increase of $2.3 million[116] Assets and Liabilities - Total current assets increased to $54,243,000 as of March 31, 2023, compared to $38,535,000 as of December 31, 2022, representing a 41% increase[14] - The company’s total liabilities increased to $157,327,000 as of March 31, 2023, from $153,217,000 as of December 31, 2022, reflecting a 3% increase[14] - The company’s accumulated deficit reached $396,034,000 as of March 31, 2023, compared to $378,324,000 at the end of 2022, indicating an increase of 5%[14] - As of March 31, 2023, the company had $47.8 million in cash, cash equivalents, and short-term investments, expected to fund operations into Q4 2023[96] Research and Development - Research and development expenses decreased to $7,272,000 for Q1 2023, down from $8,107,000 in Q1 2022, indicating a 10% reduction[16] - Research and development expenses for the three months ended March 31, 2023, totaled $7.3 million, a decrease from $8.1 million in the same period of 2022[105] - The company has successfully completed Phase 1 trials of rucosopasem and is currently evaluating it in combination with SBRT in ongoing clinical trials[29] - The company is also developing rucosopasem to enhance the anti-cancer efficacy of stereotactic body radiation therapy, with ongoing clinical trials in patients with non-small cell lung cancer and locally advanced pancreatic cancer[87] Funding and Capital - The company raised $27,598,000 from the sale of common stock in a registered direct offering during Q1 2023[24] - The company completed a registered direct offering on February 17, 2023, resulting in gross proceeds of $30.0 million from the issuance of 14,320,000 shares of common stock and warrants[33] - The company expects to need substantial additional funding to support ongoing operations and product development, with existing cash expected to last into Q4 2023[131] - The Royalty Agreement with Blackstone Life Sciences allows for up to $80.0 million in funding based on clinical milestones, with the first three tranches already received[136] Commercialization and Market Potential - The company’s lead product candidate, avasopasem, targets a market opportunity of over $1.5 billion in the U.S. for the reduction of severe oral mucositis in head and neck cancer patients[79] - The Phase 3 ROMAN trial demonstrated a statistically significant reduction in the incidence of severe oral mucositis, with a median of 8 days in the avasopasem arm compared to 18 days in the placebo arm[80] - The company anticipates significant commercialization expenses if any product candidates receive marketing approval, impacting future financial performance[93] - The company expects to incur significant commercialization expenses related to manufacturing, product sales, marketing, and distribution if marketing approval is obtained for any product candidates[152] Legal and Compliance - The company is not subject to any material legal proceedings, indicating a stable legal environment[150] - The company has opted out of the extended transition period under the JOBS Act, committing to comply with new accounting standards as required for non-emerging growth companies[141] - The report includes certifications from the Principal Executive Officer and Principal Financial Officer under the Sarbanes-Oxley Act[164] Stock and Shareholder Information - The weighted-average shares of common stock outstanding increased to 35,196,134 in Q1 2023 from 26,749,379 in Q1 2022, representing a 31% increase[16] - The company has 7,269,032 stock options and 14,870,661 common stock warrants excluded from the computation of diluted weighted-average shares due to their anti-dilutive effect[46] - The company has 1,007,332 shares available for future issuance under the 2019 Incentive Award Plan as of March 31, 2023[68] - The company reserved 1,500,000 shares of common stock for issuance under the 2023 Employment Inducement Award Plan[70]

Top centers where >80% HNC patients are treated Most Centers Have Ability to Infuse Avasopasem Today Galera 36% 31% Proctitis Dermatitis Esophagitis Patients at risk of experiencing 20% Esophagitis in Lung Cancer Initial Target Population ©2023 Galera Therapeutics, Inc. 28 | --- | --- | --- | --- | |-------|----------------------------------------|------------------------------------|-----------------------------------------------| | | | | | | | 50-60% Get Grade 2+1 | Current Approaches | AESOP Trial Design ...

Drug Development and Clinical Trials - Avasopasem has received Breakthrough Therapy Designation from the FDA for the reduction of severe oral mucositis (SOM) induced by radiotherapy, with a market opportunity exceeding $1.5 billion in the U.S. alone[19] - In the Phase 3 ROMAN trial, avasopasem demonstrated a statistically significant reduction in the incidence of SOM, with a median of 8 days in the avasopasem arm compared to 18 days in the placebo arm[20] - After one year of follow-up in the ROMAN trial, the incidence of chronic kidney disease (CKD) was 10% in the avasopasem group versus 20% in the placebo group, indicating a potential renal protective effect[22] - The New Drug Application (NDA) for avasopasem was submitted in December 2022 and accepted for filing by the FDA in February 2023, with a PDUFA target date of August 9, 2023[23] - The company plans to meet with the European Medicines Agency (EMA) in 2023 to discuss the potential registration pathway for avasopasem in Europe[24] - Avasopasem was evaluated in a Phase 2a trial for reducing esophagitis in lung cancer patients, showing substantial reduction in severe esophagitis compared to historical data[25] - Rucosopasem, the second product candidate, is in clinical development to enhance the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) for non-small cell lung cancer (NSCLC) and locally advanced pancreatic cancer (LAPC)[27] - The GRECO-1 trial for rucosopasem in NSCLC has shown promising interim results, with target tumor reductions observed in five patients ranging from 27% to 61%[30] - The GRECO-2 trial for rucosopasem in LAPC is designed to assess overall survival, with enrollment expected to be completed in the second half of 2023[31] - The company has completed Phase 1 trials of rucosopasem and initiated Phase 1/2 and Phase 2b trials in patients with NSCLC and LAPC, respectively, expecting to complete enrollment in both trials in the second half of 2023[4] - The company aims to present clinical data to the National Comprehensive Cancer Network (NCCN) to support the use of avasopasem for reducing esophagitis and other radiotherapy-induced toxicities[35] - The GT-201 trial demonstrated a 92% reduction in the median duration of SOM in the 90 mg treatment arm compared to placebo (p=0.024)[87] - Avasopasem showed a 10% incidence of chronic kidney disease (CKD) in patients treated with IMRT plus cisplatin, compared to 20% in the placebo arm (p=0.0043)[79] - The meta-analysis of the ROMAN and GT-201 trials (n=551) confirmed clinically meaningful improvements in SOM, including reductions in incidence, duration, and severity compared to placebo[100] - Avasopasem maintained anti-cancer efficacy of radiotherapy, with similar rates of tumor control and survival between avasopasem and placebo arms[65] - The incidence of Grade 4 oral mucositis was reduced by 27% in the avasopasem arm compared to placebo (p=0.052)[74] - Avasopasem was generally well tolerated, with no significant differences in the severity of adverse events compared to placebo[81] - Avasopasem demonstrated a 54.5% incidence of SOM with a median duration of 9 days in the EUSOM trial, consistent with a 54% incidence and 8 days median in the ROMAN trial[105] - In a trial with 46 patients, those receiving 6-7 weeks of avasopasem had a 29% incidence of SOM and a median duration of 2.5 days, with no Grade 4 OM cases reported[107] - One-year post-radiotherapy outcomes showed LRC, DMF, PFS, and OS rates of 93%, 93%, 84%, and 93% respectively, indicating that avasopasem does not compromise anti-cancer efficacy[108] - The AESOP trial enrolled 39 patients, with 35 completing treatment; 29 patients receiving at least five weeks of 90 mg avasopasem showed a substantial reduction in severe esophagitis incidence compared to historical data[112] - Rucosopasem is being developed to enhance the anti-cancer efficacy of SBRT, with preclinical studies indicating significant tumor reduction when combined with high daily doses of radiotherapy[119][126] - The Phase 1/2 pilot trial of avasopasem in LAPC patients evaluated three SBRT dose levels, ranging from 10 Gy/dose to 12 Gy/dose, focusing on maximum tolerated dose and overall response rate[129] - The GRECO-1 trial aims to enroll approximately 66 NSCLC patients, assessing the efficacy and safety of rucosopasem in combination with SBRT[134] - Interim results from the GRECO-1 trial showed in-field partial responses in 3 out of 7 patients and stable disease in another 3 patients[136] - The GRECO-2 trial expects to enroll approximately 160 patients to determine the impact on overall survival of adding rucosopasem to SBRT[138] Market Opportunity and Commercialization - The company plans to build a specialized sales and marketing organization in the U.S. with approximately 40 sales representatives targeting around 5,000 radiation oncologists for the commercialization of avasopasem and rucosopasem, if approved[4] - The company estimates that approximately 70% of head and neck cancer (HNC) patients treated with radiotherapy will develop severe oral mucositis (SOM), representing a target patient population of approximately 43,500 in the U.S.[56] - The total market opportunity for treating SOM in HNC patients in the U.S. is estimated to exceed $1.5 billion[62] - Market research indicates that 48% to 69% of oncologists would use avasopasem for eligible patients, with many planning to adopt it within the first 12 months of availability[64] - Current treatments for radiotherapy-induced esophagitis are largely symptomatic, with no FDA-approved drugs available, highlighting a significant market opportunity for avasopasem[110] - Avasopasem's mechanism targets the root cause of radiotherapy-induced esophagitis, potentially establishing it as the standard of care for lung cancer patients[111] - The company plans to commercialize avasopasem by building a specialized sales and marketing organization focused on radiation and medical oncologists[146] Intellectual Property and Regulatory Considerations - As of December 31, 2022, the company had approximately 18 issued U.S. patents and 112 issued foreign patents[159] - Avasopasem is covered by a composition of matter patent in the U.S. with a natural expiration date in March 2022, and potential extensions could extend to 2031[161] - Avasopasem is projected to expire between 2032 and 2035, while rucosopasem may have an expiration date in 2038 if patent term extensions are granted[162][164] - The company has a trademark portfolio consisting of 3 registered U.S. trademarks, 9 pending U.S. trademark applications, 26 registered foreign trademarks, and 9 pending foreign trademark applications as of December 31, 2022[165] - The FDA's review process for new drug applications (NDAs) typically takes about 10 months from the date of filing for a new molecular entity, but can be longer depending on various factors[185] - The FDA may refer an NDA application for a novel drug to an advisory committee for independent expert review and recommendations[186] - The company must submit progress reports detailing clinical trial results to the FDA at least annually, with more frequent submissions if serious adverse events occur[182] - The company has pending patent applications that may provide protection for the use of its product candidates in connection with oncology products, projected to expire between 2037 and 2041[164] - The company relies on trade secrets and technological innovation to maintain its competitive position, protected through confidentiality and invention assignment agreements[166] - The FDA may impose post-approval requirements, including Phase 4 clinical trials, to monitor a product's safety and effectiveness after commercialization[196] - The FDA offers expedited programs such as fast track designation, which allows for more frequent interactions with the FDA review team during product development[190] - Priority review designation can reduce the FDA review goal to six months for drugs that offer major advances in treatment[191] - Products providing meaningful advantages over existing treatments may be eligible for accelerated approval based on surrogate endpoints[192] - The FDA may withdraw approval if compliance with regulatory requirements is not maintained, leading to potential product recalls or marketing restrictions[198] - Non-patent exclusivity for new chemical entities (NCEs) lasts five years, preventing ANDA submissions for generic versions during this period[209] - The Hatch-Waxman Act provides three years of data exclusivity for new clinical investigations deemed essential for approval[210] Financial and Market Dynamics - The Royalty Agreement with Blackstone Life Sciences allows for up to $117.5 million in payments, with the fourth tranche increased to $37.5 million and an additional $20 million tranche for a clinical enrollment milestone[168][170] - The company received $20 million in June 2021 for the enrollment of the first patient in the GRECO-2 trial and $37.5 million in July 2021 for completing enrollment in the ROMAN trial[170] - The Royalty Agreement stipulates that the company will pay Blackstone a high single-digit percentage of worldwide net sales of the products during the Royalty Period[171] - Pharmaceutical product sales are influenced by third-party payor coverage and reimbursement levels, which are determined on a plan-by-plan basis[213] - Third-party payors are increasingly reducing reimbursements for pharmaceutical products, impacting physician usage and patient demand[214] - The U.S. government and state legislatures are implementing cost-containment programs, including price controls and restrictions on coverage, which could limit product sales[214] - International reimbursement and healthcare payment systems vary significantly, with many countries instituting price ceilings on specific products[215] - The European Union allows member states to restrict reimbursement for medicinal products and control their prices, affecting market dynamics[215] - There is no assurance that a product will be deemed medically necessary or cost-effective by third-party payors, impacting profitability[216] - Products may face competition from lower-priced alternatives in countries with price controls and from imported foreign products[215] - Obtaining adequate reimbursement for drugs administered under physician supervision is particularly challenging due to higher associated prices[214] - Decisions regarding coverage and reimbursement for off-label uses are limited and vary by third-party payor[213] - The variability in reimbursement policies across countries can significantly affect the market potential for pharmaceutical products[215]

| --- | --- | --- | |---------------------------------------|-------|-------| | | | | | Transforming | | | | radiotherapy for patients with cancer | | | | August 2022 | | | | | | | | | | | Forward-Looking Statements Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera's own internal estimates and research. While Galera believes these third-par ...

| --- | --- | --- | |---------------------------------------|-------|-------| | | | | | Transforming | | | | radiotherapy for patients with cancer | | | | June 2022 | | | | | | | | | | | Forward-Looking Statements Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera's own internal estimates and research. While Galera believes these third-party ...

| --- | --- | --- | |---------------------------------------|-------|-------| | | | | | Transforming | | | | radiotherapy for patients with cancer | | | | November 2021 | | | | | | | | | | | Forward-Looking Statements Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera's own internal estimates and research. While Galera believes these third-p ...

| --- | --- | --- | --- | --- | --- | |-------|-------|-------|--------------------|---------------------------|-------| | | | | | Transforming Radiotherapy | | | | | with | | | | | | | | Dismutase Mimetics | | | | | | | | | | | | | | | | | Disclaimers and Forward-Looking Statements Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera's own in ...

| --- | --- | --- | --- | --- | --- | |-------|-------|-------|--------------------|---------------------------|-------| | | | | | Transforming Radiotherapy | | | | | with | | | | | | | | Dismutase Mimetics | | | | | | | | | | | | | | | | | Disclaimers and Forward-Looking Statements Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera's own in ...