Galera(GRTX) - 2021 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Galera Therapeutics' unaudited interim consolidated financial statements, detailing financial position, performance, and cash flows Consolidated Balance Sheets The company's consolidated balance sheets as of September 30, 2021, and December 31, 2020, are presented Consolidated Balance Sheets (in thousands) | Category | September 30, 2021 (in thousands) | December 31, 2020 (in thousands) | | :---------------------------------- | :-------------------------------- | :--------------------------------- | | Assets: | | | | Cash and cash equivalents | $17,632 | $15,872 | | Short-term investments | $71,073 | $56,904 | | Total current assets | $92,688 | $77,929 | | Total assets | $98,765 | $84,098 | | Liabilities and Stockholders' Equity (Deficit): | | | | Accounts payable | $7,181 | $5,146 | | Accrued expenses | $8,272 | $8,584 | | Royalty purchase liability | $125,751 | $63,369 | | Total liabilities | $141,932 | $77,980 | | Total stockholders' equity (deficit) | $(43,167) | $6,118 | Consolidated Statements of Operations The company's consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020, are detailed Consolidated Statements of Operations (in thousands) | Category | Three months ended Sep 30, 2021 (in thousands) | Three months ended Sep 30, 2020 (in thousands) | Nine months ended Sep 30, 2021 (in thousands) | Nine months ended Sep 30, 2020 (in thousands) | | :-------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $14,813 | $12,133 | $43,203 | $40,225 | | General and administrative | $5,487 | $3,945 | $15,667 | $11,384 | | Loss from operations | $(20,300) | $(16,078) | $(58,870) | $(51,609) | | Interest income | $3 | $235 | $28 | $1,055 | | Interest expense | $(2,327) | $(1,235) | $(4,882) | $(3,625) | | Net loss | $(22,626) | $(17,078) | $(63,727) | $(54,152) | | Net loss per share (basic and diluted) | $(0.86) | $(0.69) | $(2.49) | $(2.18) | Consolidated Statements of Comprehensive Loss The company's consolidated statements of comprehensive loss for the three and nine months ended September 30, 2021 and 2020, are presented Consolidated Statements of Comprehensive Loss (in thousands) | Category | Three months ended Sep 30, 2021 (in thousands) | Three months ended Sep 30, 2020 (in thousands) | Nine months ended Sep 30, 2021 (in thousands) | Nine months ended Sep 30, 2020 (in thousands) | | :---------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net loss | $(22,626) | $(17,078) | $(63,727) | $(54,152) | | Unrealized gain (loss) on short-term investments | $(5) | $(193) | $(14) | $85 | | Comprehensive loss | $(22,631) | $(17,271) | $(63,741) | $(54,067) | Consolidated Statements of Changes in Stockholders' Equity (Deficit) Changes in the company's stockholders' equity (deficit) from January 1, 2021, to September 30, 2021, are outlined Consolidated Statements of Changes in Stockholders' Equity (Deficit) (in thousands) | Category | Balance at Jan 1, 2021 (in thousands) | Balance at Sep 30, 2021 (in thousands) | | :---------------------------------- | :------------------------------------ | :----------------------------------- | | Common stock (shares) | 24,976,142 | 26,438,767 | | Common stock (amount) | $25 | $26 | | Additional paid-in capital | $241,649 | $256,104 | | Accumulated other comprehensive income (loss) | $12 | $(2) | | Accumulated deficit | $(235,568) | $(299,295) | | Total Stockholders' Equity (Deficit) | $6,118 | $(43,167) | - Net loss for the nine months ended September 30, 2021, was $63,727 thousand, contributing to an accumulated deficit of $(299,295) thousand[17][23] - Share-based compensation expense for the nine months ended September 30, 2021, was $5,272 thousand[23] Consolidated Statements of Cash Flows The company's consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020, are presented Consolidated Statements of Cash Flows (in thousands) | Activity | Nine months ended Sep 30, 2021 (in thousands) | Nine months ended Sep 30, 2020 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(50,512) | $(43,087) | | Net cash provided by (used in) investing activities | $(14,413) | $19,689 | | Net cash provided by financing activities | $66,685 | $20,274 | | Net increase (decrease) in cash and cash equivalents | $1,760 | $(3,124) | | Cash and cash equivalents at end of period | $17,632 | $15,232 | - Proceeds from royalty purchase agreement significantly increased financing activities, contributing $57,500 thousand in 2021[25] Notes to Unaudited Interim Consolidated Financial Statements Detailed notes explaining the company's organization, accounting policies, and key financial statement components are provided 1. Organization and description of business Galera Therapeutics is a clinical-stage biopharmaceutical company developing dismutase mimetics for radiotherapy, facing recurring losses - Galera Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to transform radiotherapy in cancer, utilizing selective small molecule dismutase mimetics[27] - Avasopasem manganese (GC4419) is in development for radiotherapy-induced toxicities, including severe oral mucositis (SOM) in HNC and esophagitis in lung cancer, having received Breakthrough Therapy Designation for SOM in February 2018[27] - Rucosopasem manganese (GC4711) is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in NSCLC and LAPC[27][29] - The company has an accumulated deficit of $299.3 million as of September 30, 2021, and expects existing cash, cash equivalents, and short-term investments to fund operations into 2023, assuming limited future development and commercial activities for avasopasem[30] 2. Basis of presentation and significant accounting policies Interim consolidated financial statements adhere to U.S. GAAP, involving management estimates and reflecting COVID-19's impact on clinical trials - The unaudited interim consolidated financial statements are prepared in conformity with U.S. GAAP, and management's estimates and assumptions are periodically reviewed[32][34][35] - Significant areas requiring management's estimates include share-based compensation assumptions, royalty purchase liability assumptions, and accrued research and development expenses[35] - Research and development costs are expensed as incurred, with reimbursements from grants (e.g., $0.3 million from NCI for rucosopasem in NSCLC) accounted for as a reduction to R&D expenses[36][39] - The COVID-19 pandemic impacted clinical trial timelines, leading to a delay in the EUSOM trial and an increase in ROMAN trial enrollment; a pilot Phase 2 COVID-19 trial was ceased due to declining hospitalizations[42][43] - The company adopted ASU 2019-12, Income Taxes, on January 1, 2021, with no impact on its consolidated financial statements[44] 3. Fair value measurements Assets and liabilities are measured at fair value using a hierarchy of observable inputs, primarily Level 1 or Level 2 - The company utilizes valuation techniques that maximize observable inputs, categorizing fair value measurements into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than quoted prices), and Level 3 (unobservable inputs)[45][46] Fair Value Assets (in thousands) | Asset Category | September 30, 2021 (Level 1) | September 30, 2021 (Level 2) | December 31, 2020 (Level 1) | December 31, 2020 (Level 2) | | :--------------------------------------------------- | :--------------------------- | :--------------------------- | :-------------------------- | :-------------------------- | | Money market funds and U.S. Treasury obligations (cash equivalents) | $13,519 | $— | $14,943 | $— | | U.S. government agency securities (short-term investments) | $— | $5,447 | $— | $5,062 | | U.S. Treasury obligations (short-term investments) | $65,626 | $— | $51,842 | $— | - There were no changes in valuation techniques during the nine months ended September 30, 2021[46] 4. Property and equipment Property and equipment, net, decreased from $1,023 thousand to $938 thousand with consistent depreciation Property and Equipment, Net (in thousands) | Category | September 30, 2021 | December 31, 2020 | | :-------------------------- | :----------------- | :---------------- | | Laboratory equipment | $1,332 | $1,135 | | Computer hardware and software | $292 | $260 | | Leasehold improvements | $264 | $264 | | Furniture and fixtures | $173 | $173 | | Property and equipment, gross | $2,061 | $1,832 | | Less: Accumulated depreciation | $(1,123) | $(809) | | Property and equipment, net | $938 | $1,023 | - Depreciation expense was $0.3 million for both the nine months ended September 30, 2021, and 2020[47] 5. Accrued expenses Total accrued expenses slightly decreased from $8,584 thousand to $8,272 thousand, primarily due to compensation changes Accrued Expenses (in thousands) | Category | September 30, 2021 | December 31, 2020 | | :-------------------------------- | :----------------- | :---------------- | | Compensation and related benefits | $1,984 | $2,632 | | Research and development expenses | $5,986 | $5,525 | | Professional fees and other expenses | $302 | $427 | | Total Accrued Expenses | $8,272 | $8,584 | 6. Royalty purchase liability Royalty purchase liability significantly increased to $125.8 million by September 30, 2021, from $57.5 million in additional tranches - The royalty purchase liability increased to $125,751 thousand as of September 30, 2021, from $63,369 thousand at December 31, 2020[15] - The company received $57.5 million in additional tranches under the amended Royalty Agreement in June and July 2021, tied to clinical enrollment milestones for the GRECO-2 and ROMAN trials[50][25] - The Royalty Agreement is accounted for as a debt instrument, with interest imputed based on estimated royalty repayment, resulting in noncash interest expense of $4.9 million for the nine months ended September 30, 2021 (up from $3.6 million in 2020) and an effective interest rate of 8.3%[51][53] - The company issued common stock warrants to the Blackstone Purchaser, valued at $4.7 million, as partial consideration for the Amendment, which are recorded as a discount to the royalty purchase liability[56] 7. Leases The company holds non-cancelable operating leases, with total liabilities decreasing to $381 thousand and consistent rental expense - The company has non-cancelable operating leases for office and laboratory space with remaining terms of approximately 1.4 and 0.3 years, respectively, as of September 30, 2021[57] Operating Lease Liabilities (in thousands) | Category | September 30, 2021 | December 31, 2020 | | :-------------------------------- | :----------------- | :---------------- | | Right-of-use lease assets | $374 | $530 | | Lease liabilities, current | $271 | $238 | | Lease liabilities, net of current portion | $110 | $296 | | Total operating lease liabilities | $381 | $534 | Operating Lease Expense (in thousands) | Category | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------- | :----------------------------- | :----------------------------- | | Operating lease rental expense | $225 | $225 | | Interest on lease liabilities | $18 | $27 | | Total operating lease expense | $243 | $252 | 8. Equity The company raised $7.9 million from common stock sales and incurred $5.3 million in share-based compensation expense - During the nine months ended September 30, 2021, the company sold 891,368 shares of common stock under its Open Market Sale Agreement, generating approximately $7.9 million in net proceeds, with $41.7 million of available capacity remaining[60][112] Share-based Compensation Expense (in thousands) | Category | Three months ended Sep 30, 2021 | Three months ended Sep 30, 2020 | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $790 | $662 | $2,141 | $1,923 | | General and administrative | $1,080 | $843 | $3,131 | $2,245 | | Total | $1,870 | $1,505 | $5,272 | $4,168 | - As of September 30, 2021, 4,782,729 stock options were outstanding with a weighted-average exercise price of $8.59, and unrecognized compensation cost was $17.6 million, to be recognized over an estimated 2.7 years[65][67] 9. Related party transactions The company incurred $0.2 million in fees for IT advisory services from IntellectMap, a related party - Fees incurred by the Company with respect to IntellectMap, whose chief executive officer is the brother of the Company's chief executive officer, were $0.2 million for both the nine months ended September 30, 2021, and 2020[70] 10. Subsequent events Topline results from the Phase 3 ROMAN trial for avasopasem did not achieve statistical significance, impacting financial statements - On October 19, 2021, topline results from the Phase 3 ROMAN trial for avasopasem showed relative reductions in the incidence, duration, and severity of SOM but did not achieve statistical significance in the primary endpoint[71] - The company is continuing to analyze the ROMAN trial results and evaluate next steps, which may have a material impact on its consolidated financial statements, including amounts recorded for the royalty purchase liability[71] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section discusses Galera Therapeutics' financial condition and results of operations, covering business, clinical trials, and liquidity Overview Galera Therapeutics develops dismutase mimetics for radiotherapy, with the ROMAN trial missing its primary endpoint, requiring additional funding - Galera Therapeutics is a clinical-stage biopharmaceutical company developing dismutase mimetics to reduce normal tissue toxicity from radiotherapy (avasopasem) and increase the anti-cancer efficacy of radiotherapy (rucosopasem)[73] - The Phase 3 ROMAN trial for avasopasem in radiotherapy-induced SOM did not achieve statistical significance in its primary endpoint, though it showed relative reductions in incidence, duration, and severity of SOM[74] - A pilot Phase 1/2 trial of avasopasem with SBRT in LAPC showed relative improvements in overall survival, progression-free survival, local tumor control, and time to distant metastases[75] - The company reported a net loss of $22.6 million for the three months and $63.7 million for the nine months ended September 30, 2021, with an accumulated deficit of $299.3 million[80] - Existing cash, cash equivalents, and short-term investments of $88.7 million as of September 30, 2021, are expected to fund operations into 2023, assuming limited future development and commercial activities for avasopasem[80][83] Business Update Regarding COVID-19 The COVID-19 pandemic impacted clinical trial timelines, causing delays and enrollment adjustments, and led to a trial cessation - The COVID-19 pandemic directly or indirectly impacted clinical trial timelines, causing a delay in the EUSOM trial (leading to decreased target enrollment) and an increase in ROMAN trial enrollment[85] - A pilot Phase 2 clinical trial of avasopasem for critically ill COVID-19 patients was ceased on June 16, 2021, due to limited enrollment and an overall decline in COVID-related hospitalizations in the U.S[78] - Third-party contract manufacturing partners continue to operate at or near normal levels, and the company has implemented measures to protect the health and safety of its workforce[87][88] Critical Accounting Policies Financial statements adhere to U.S. GAAP, requiring estimates for accrued expenses and stock-based compensation, with no material changes - The consolidated financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and judgments, particularly for accrued expenses and stock-based compensation[89] - There were no material changes to the company's critical accounting policies during the nine months ended September 30, 2021, from those discussed in the 2020 Form 10-K[90] Components of Results of Operations This section details operating expenses, interest income/expense, and tax carryforwards, noting a valuation allowance on deferred tax assets - Research and development expenses are expensed as incurred and include costs for preclinical studies, clinical trials, personnel, third-party services (CROs, CMOs), manufacturing, and regulatory activities[92][94] - General and administrative expenses primarily consist of personnel costs (salaries, benefits, share-based compensation), corporate facility costs, legal fees, and accounting/consulting services[96] - Interest expense is primarily non-cash, arising from the Royalty Agreement with Blackstone and the amortization of debt discount related to Blackstone warrants[99] Net Operating Loss and Research and Development Tax Credit Carryforwards (as of December 31, 2020) | Category | Amount (in millions) | Expiration | | :-------------------------------- | :------------------- | :----------------------------------- | | Federal Net Operating Loss (NOL) | $135.6 | Begin 2032 (approx. $73.0M indefinite) | | State Net Operating Loss (NOL) | $157.5 | Begin 2032 | | Foreign Net Operating Loss (NOL) | $1.6 | No expiration | | Federal R&D Tax Credit | $7.5 | Begin 2032 | | Foreign R&D Tax Credit | Included in $7.5 | No expiration | - A valuation allowance has been recorded on substantially all deferred tax assets, including NOL and R&D tax credit carryforwards, due to uncertainty regarding their utilization[102] Results of Operations The company experienced an increased net loss for both the three and nine months ended September 30, 2021, driven by higher expenses Net Loss and Operating Expenses (in thousands) | Category | Three months ended Sep 30, 2021 | Three months ended Sep 30, 2020 | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $14,813 | $12,133 | $43,203 | $40,225 | | General and administrative | $5,487 | $3,945 | $15,667 | $11,384 | | Loss from operations | $(20,300) | $(16,078) | $(58,870) | $(51,609) | | Interest income | $3 | $235 | $28 | $1,055 | | Interest expense | $(2,327) | $(1,235) | $(4,882) | $(3,625) | | Net loss | $(22,626) | $(17,078) | $(63,727) | $(54,152) | - Research and development expense increased by $3.0 million for the nine months ended September 30, 2021, primarily due to increased other R&D expenses ($3.0 million) and rucosopasem development costs ($0.3 million), partially offset by a decrease in avasopasem development costs ($0.7 million)[105] - General and administrative expense increased by $4.3 million for the nine months ended September 30, 2021, driven by increased employee headcount, share-based compensation, potential avasopasem commercialization expenses, and higher insurance, legal, and recruiting costs[107] - Interest income decreased significantly by $1.0 million for the nine months ended September 30, 2021, due to lower average invested cash balances and lower average interest rates[108] - Non-cash interest expense increased by $1.3 million for the nine months ended September 30, 2021, related to the Royalty Agreement with Blackstone Life Sciences[109] Liquidity and Capital Resources The company relies on equity and royalty proceeds, has a $299.3 million deficit, and requires substantial additional funding - The company has funded operations primarily through equity sales (IPO, ATM offerings) and $117.5 million in proceeds from the Royalty Agreement with Blackstone Life Sciences[110] - As of September 30, 2021, the company had $88.7 million in cash, cash equivalents, and short-term investments, and an accumulated deficit of $299.3 million[113] - Existing capital is expected to fund operating expenses and capital expenditure requirements into 2023, assuming limited future development and commercial activities for avasopasem[122] - Substantial additional funding will be required for ongoing R&D, clinical trials, potential commercialization, and public company operations, with future funding dependent on factors like trial outcomes, regulatory approvals, and market conditions[121][123] - Future financing may involve equity offerings (leading to shareholder dilution), debt financings (potentially including restrictive covenants), or collaborations (requiring relinquishment of rights)[124][125][126] Cash Flows Net cash increased by $1.8 million for the nine months ended September 30, 2021, driven by financing activities Summary of Cash Flows (in thousands) | Activity | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(50,512) | $(43,087) | | Net cash provided by (used in) investing activities | $(14,413) | $19,689 | | Net cash provided by financing activities | $66,685 | $20,274 | | Net increase (decrease) in cash and cash equivalents | $1,760 | $(3,124) | - Net cash used in operating activities increased to $50.5 million for the nine months ended September 30, 2021, primarily due to a net loss of $63.7 million, partially offset by non-cash charges and changes in operating assets and liabilities[115] - Net cash used in investing activities was $14.4 million for the nine months ended September 30, 2021, mainly due to net purchases of short-term investments[117] - Net cash provided by financing activities significantly increased to $66.7 million for the nine months ended September 30, 2021, primarily from $57.5 million in royalty agreement proceeds and $7.9 million from ATM stock sales[119] Funding Requirements The company anticipates substantial additional funding needs due to increasing R&D and clinical trial expenses - Operating expenses are expected to continue increasing due to ongoing research and development, clinical trials, and potential commercialization efforts, necessitating substantial additional funding[121] - The company expects its existing cash, cash equivalents, and short-term investments as of September 30, 2021, to fund operating expenses and capital expenditure requirements into 2023, assuming limited future development and commercial activities for avasopasem[122] - Future funding requirements are highly uncertain and depend on factors such as the scope and results of preclinical/clinical trials, regulatory review, ability to establish collaborations, intellectual property costs, and commercialization expenses[123][124] - Financing options include equity offerings (which will dilute shareholder ownership), debt financings (potentially with restrictive covenants), and collaborations (which may require relinquishing rights to technologies or product candidates)[124][125][126] Royalty Agreement with Blackstone Life Sciences (Formerly Known as Clarus Ventures) The Royalty Agreement with Blackstone Life Sciences was amended, increasing the purchase price to $117.5 million, with final tranches received - The Royalty Agreement with Blackstone Life Sciences was amended in May 2020, increasing the total Royalty Purchase Price to $117.5 million[128] - The company received the new $20.0 million tranche in June 2021 (GRECO-2 trial milestone) and the $37.5 million fourth tranche in July 2021 (ROMAN trial enrollment completion)[128] - Blackstone is entitled to a high single-digit percentage of worldwide net sales of avasopasem, rucosopasem, and related products, as well as product-related damages, during a defined Royalty Period[129] - The agreement remains in effect until aggregate Product Payments exceed a fixed single-digit multiple of the Royalty Purchase Price; if no Products are commercialized, the company has no repayment obligation[130] - As partial consideration for the Amendment, the company issued warrants to Blackstone to purchase 550,661 shares of common stock at an exercise price of $13.62 per share[131] Off-Balance Sheet Arrangements The company does not have any material off-balance sheet arrangements or financial partnerships - The company does not have any relationships with unconsolidated entities or financial partnerships for off-balance sheet arrangements[132] - The company does not engage in trading activities involving non-exchange traded contracts[132] Effect of Inflation Inflation did not significantly impact the company's net loss for the three and nine months ended September 30, 2021 and 2020 - Inflation did not have a significant impact on the company's net loss for the three and nine months ended September 30, 2021, and 2020[133] Recent Accounting Pronouncements Refer to Note 2 for a description of recent accounting pronouncements applicable to the company's financial statements - For a description of recent accounting pronouncements applicable to the company's consolidated financial statements, refer to Note 2[134] JOBS Act Transition Period As an emerging growth company, Galera Therapeutics opted out of the extended transition period for new accounting standards - The company, as an emerging growth company, has elected not to use the extended transition period for complying with new or revised financial accounting standards, and will comply on the relevant dates required for non-emerging growth companies[5][135] - The company may still rely on other exemptions and reduced reporting requirements under the JOBS Act until it ceases to be an emerging growth company (e.g., December 31, 2024, or earlier based on revenue, market value, or debt)[136] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Galera Therapeutics is not required to provide market risk disclosures - As a smaller reporting company, Galera Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[137] Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective as of September 30, 2021, with no material internal control changes - Management recognizes that controls and procedures provide only reasonable assurance of achieving desired control objectives[138] - As of September 30, 2021, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[139] - No material changes in internal control over financial reporting were identified during the quarter ended September 30, 2021[140] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently subject to any material legal proceedings - The company is not subject to any material legal proceedings[142] Item 1A. Risk Factors Investing in the company's common stock involves high risk, with no material changes to previously reported factors - Investing in the company's common stock involves a high degree of risk[143] - Investors should carefully consider the risk factors described in Part I, Item 1A. "Risk Factors" of the Annual Report on Form 10-K for the fiscal year ended December 31, 2020[143] - There have been no material changes to the risk factors described in that report[143] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company's IPO generated $58.0 million in net proceeds, fully utilized as of September 30, 2021 - The company completed its IPO in November 2019, issuing 5,000,000 shares and an additional 445,690 shares in December 2019, generating approximately $58.0 million in net proceeds[144] - As of September 30, 2021, the net proceeds from the IPO have been fully utilized[145] - There has been no material change in the expected use of the net proceeds from the IPO[145] Item 3. Defaults Upon Senior Securities There are no defaults upon senior securities to report - There are no defaults upon senior securities[146] Item 4. Mine Safety Disclosures This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[147] Item 5. Other Information No other information is reported under this item - No other information is reported under this item[148] Item 6. Exhibits This section lists all exhibits filed or furnished with the report, including organizational documents and certifications - The exhibits include the Restated Certificate of Incorporation, Amended and Restated Bylaws, Master Manufacturing Services Agreement, Employment Agreements, Certifications (pursuant to Section 302 and 906 of Sarbanes-Oxley Act), and Inline XBRL documents[151] Signatures The report is duly signed by Galera Therapeutics' Chief Executive Officer and Chief Financial Officer on November 10, 2021 - The report was signed by J. Mel Sorensen, M.D., Chief Executive Officer and President, and Christopher Degnan, Chief Financial Officer, on November 10, 2021[156][157]