Galera(GRTX) - 2021 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents Galera Therapeutics' unaudited interim consolidated financial statements and accompanying notes for Q1 2021 and 2020 Consolidated Balance Sheets This section provides a snapshot of the company's assets, liabilities, and equity at specific dates Consolidated Balance Sheet Highlights (Amounts in Thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $13,687 | $15,872 | | Short-term investments | $43,833 | $56,904 | | Total current assets | $64,240 | $77,929 | | Total assets | $70,486 | $84,098 | | Total current liabilities | $15,855 | $13,968 | | Royalty purchase liability | $64,622 | $63,369 | | Total liabilities | $81,059 | $77,980 | | Total stockholders' equity (deficit) | $(10,573) | $6,118 | Consolidated Statements of Operations This section details the company's revenues, expenses, and net loss over specific periods Consolidated Statements of Operations Highlights (Amounts in Thousands) | Metric | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $12,423 | $14,252 | | General and administrative | $5,058 | $3,566 | | Loss from operations | $(17,481) | $(17,818) | | Net loss | $(18,715) | $(18,417) | | Net loss per share, basic and diluted | $(0.75) | $(0.74) | Consolidated Statements of Comprehensive Loss This section presents the net loss and other comprehensive income (loss) components, leading to total comprehensive loss Consolidated Statements of Comprehensive Loss (Amounts in Thousands) | Metric | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(18,715) | $(18,417) | | Unrealized gain (loss) on short-term investments | $(2) | $648 | | Comprehensive loss | $(18,717) | $(17,769) | Consolidated Statements of Changes in Stockholders' Equity (Deficit) This section outlines changes in equity components, including additional paid-in capital, accumulated deficit, and comprehensive income Stockholders' Equity (Deficit) Changes (Amounts in Thousands) | Metric | Balance at Jan 1, 2021 | Balance at Mar 31, 2021 | | :-------------------------------- | :--------------------- | :---------------------- | | Additional paid-in capital | $241,649 | $243,675 | | Accumulated other comprehensive income | $12 | $10 | | Accumulated deficit | $(235,568) | $(254,283) | | Total Stockholders' Equity (Deficit) | $6,118 | $(10,573) | Key Changes (Q1 2021): * Share-based compensation expense: $1,791 * Exercise of stock options: $235 * Unrealized loss on short-term investments: $(2) * Net loss: $(18,715) Consolidated Statements of Cash Flows This section summarizes cash inflows and outflows from operating, investing, and financing activities Consolidated Statements of Cash Flows (Amounts in Thousands) | Activity | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(15,303) | $(12,392) | | Net cash provided by (used in) investing activities | $12,883 | $(4,395) | | Net cash provided by financing activities | $235 | $20,009 | | Net increase (decrease) in cash and cash equivalents | $(2,185) | $3,222 | | Cash and cash equivalents at end of period | $13,687 | $21,578 | Notes to Unaudited Interim Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the interim consolidated financial statements 1. Organization and description of business This note describes Galera Therapeutics' business, product candidates, and financial position, including recurring losses and funding outlook - Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to transform radiotherapy in cancer. Its lead product candidate, avasopasem manganese (GC4419), is being developed for the reduction of severe oral mucositis (SOM) and received Breakthrough Therapy Designation from the FDA in February 2018[28] - Avasopasem is currently in a Phase 3 registrational trial (ROMAN trial) for SOM in head and neck cancer (HNC) and a Phase 2a trial for esophagitis in lung cancer. The company is also developing GC4711 to increase the anti-cancer efficacy of stereotactic body radiation therapy (SBRT), with Phase 1 trials completed and Phase 1/2 and Phase 2b trials planned/ongoing[29][30] - The company has incurred recurring losses and negative cash flows, with an accumulated deficit of $254.3 million as of March 31, 2021. Existing cash, cash equivalents, and short-term investments, along with expected payments from Blackstone Life Sciences ($57.5 million upon clinical enrollment milestones), are projected to fund operations into the second half of 2022[31] 2. Basis of presentation and significant accounting policies This note outlines the basis of financial statement preparation, key accounting policies, and the impact of the COVID-19 pandemic - The interim consolidated financial statements are prepared in conformity with U.S. GAAP and include all normal and recurring adjustments. Management's estimates are crucial, particularly for share-based compensation, royalty purchase liability, and accrued research and development expenses[33][35][36][37] - Research and development costs are expensed as incurred, including third-party services, clinical/preclinical development, manufacturing, and regulatory compliance. A Small Business Innovation Research grant from the National Cancer Institute reduced R&D expenses by $0.3 million for the three months ended March 31, 2021[38][40] - The COVID-19 pandemic has impacted clinical trial timelines, leading to a delay in the EUSOM trial and an increase in ROMAN trial enrollment. A pilot Phase 2 trial for avasopasem in critically ill COVID-19 patients was initiated in September 2020, with topline data expected in the first half of 2021[43][45] 3. Fair value measurements This note details the fair value hierarchy and classification of the company's short-term investment instruments Fair Value Measurements (Amounts in Thousands) | Asset Category | March 31, 2021 (Level 1) | March 31, 2021 (Level 2) | December 31, 2020 (Level 1) | December 31, 2020 (Level 2) | | :-------------------------------- | :----------------------- | :----------------------- | :-------------------------- | :-------------------------- | | Money market funds and U.S. Treasury obligations (cash equivalents) | $10,070 | — | $14,943 | — | | U.S. government agency securities | — | $5,030 | — | $5,062 | | U.S. Treasury obligations | $38,803 | — | $51,842 | — | | Total short-term investments | $38,803 | $5,030 | $51,842 | $5,062 | - The company classifies its short-term investment instruments using Level 1 inputs (quoted market prices) and Level 2 inputs (observable inputs other than quoted prices in active markets) within the fair value hierarchy. There were no changes in valuation techniques during the three months ended March 31, 2021[47][48] 4. Property and equipment This note provides a breakdown of property and equipment, net, and associated depreciation expense Property and Equipment, Net (Amounts in Thousands) | Category | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Laboratory equipment | $1,321 | $1,135 | | Computer hardware and software | $260 | $260 | | Leasehold improvements | $264 | $264 | | Furniture and fixtures | $173 | $173 | | Property and equipment, gross | $2,018 | $1,832 | | Less: Accumulated depreciation | $(914) | $(809) | | Property and equipment, net | $1,104 | $1,023 | - Depreciation expense for the three months ended March 31, 2021 and 2020 was $0.1 million for both periods[49] 5. Accrued expenses This note presents a detailed breakdown of the company's accrued expenses by category Accrued Expenses (Amounts in Thousands) | Category | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Compensation and related benefits | $831 | $2,632 | | Research and development expenses | $5,240 | $5,525 | | Professional fees and other expenses | $271 | $427 | | Total accrued expenses | $6,342 | $8,584 | 6. Royalty purchase liability This note describes the Royalty Agreement with Blackstone Life Sciences, including proceeds, terms, and related interest expense - The company entered into a Royalty Agreement with Blackstone Life Sciences, receiving $60.0 million in proceeds across three tranches by February 2020, recorded as a debt instrument. An Amendment in May 2020 increased the total Royalty Purchase Price to $117.5 million by adding a new tranche and increasing an existing one[51][52][53] - Under the amended agreement, Galera sells a high single-digit percentage of worldwide net sales of avasopasem and GC4711 (Products) to Blackstone during the Royalty Period. The agreement remains in effect until aggregate Product Payments exceed a fixed single-digit multiple of the Royalty Purchase Price[54][55][56] - In connection with the Amendment, Galera issued common stock warrants to Blackstone Purchaser to purchase 550,661 shares at $13.62 per share, valued at $4.7 million using the Black-Scholes model and recorded as a discount to the royalty purchase liability[57] - Noncash interest expense related to the royalty purchase liability was $1.3 million for the three months ended March 31, 2021, compared to $1.1 million for the same period in 2020, with an effective interest rate of 8.0% as of March 31, 2021[52] 7. Leases This note details the company's operating lease arrangements, related assets, liabilities, and future payment obligations - The company has non-cancelable operating leases for office and laboratory space in Malvern, PA, and Creve Coeur, MO, with remaining terms of approximately 2.0 and 0.8 years, respectively. The discount rate used for operating leases under ASC 842 is 5.3%[58] Operating Lease Information (Amounts in Thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Right-of-use lease assets | $526 | $530 | | Lease liabilities, current | $296 | $238 | | Lease liabilities, net of current portion | $235 | $296 | | Total operating lease liabilities | $531 | $534 | Lease Expense (Three months ended March 31): * Operating lease rental expense: $73 (2021), $74 (2020) * Interest on lease liabilities: $7 (2021), $10 (2020) * Total operating lease expense: $80 (2021), $84 (2020) Future Minimum Rental Payments (Amounts in Thousands) | Period | Amount | | :---------------- | :----- | | Remainder of 2021 | $245 | | 2022 | $266 | | 2023 | $44 | | Total | $555 | | Less: imputed interest | $(24) | | Total Lease Liabilities | $531 | 8. Share-based compensation This note outlines the company's share-based compensation plans, expense, and stock option grant assumptions - The company operates under the 2019 Incentive Award Plan and the 2019 Employee Stock Purchase Plan (ESPP), with shares available for issuance increasing annually. The Prior Plan ceased new grants but continues to govern outstanding awards[61][62][63][64] Share-based Compensation Expense (Amounts in Thousands) | Category | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $784 | $594 | | General and administrative | $1,007 | $616 | | Total share-based compensation expense | $1,791 | $1,210 | - As of March 31, 2021, unrecognized compensation cost was $21.7 million, to be amortized over an estimated weighted-average period of 3.1 years. The aggregate intrinsic value of outstanding options was $12.0 million, and exercisable options was $11.3 million[66] Stock Option Grant Assumptions (Weighted-Average) | Assumption | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Expected term (in years) | 6.2 | 6.2 | | Expected stock price volatility | 91.6% | 89.0% | | Risk-free interest rate | 0.59% | 1.32% | | Expected dividend yield | 0% | 0% | 9. Related party transactions This note discloses transactions with related parties, including services provided by IntellectMap - IntellectMap, whose CEO is the brother of Galera's CEO, provided IT advisory services. Fees incurred were $49 thousand for the three months ended March 31, 2021, a decrease from $0.1 million for the same period in 2020[70] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Galera Therapeutics' financial condition and results of operations, highlighting key business developments, financial performance, liquidity, and capital resources Overview This section provides an overview of Galera Therapeutics' business, product candidates, and financial performance - Galera Therapeutics is a clinical-stage biopharmaceutical company developing novel therapeutics to transform radiotherapy in cancer, leveraging superoxide dismutase mimetics to reduce normal tissue toxicity and increase anti-cancer efficacy[72] - The lead product candidate, avasopasem manganese (GC4419), is in a Phase 3 ROMAN trial for severe oral mucositis (SOM) in head and neck cancer (HNC), with topline data expected in H2 2021. It also has Breakthrough Therapy Designation for SOM[72] - The company's second product candidate, GC4711, is being developed to increase the anti-cancer efficacy of SBRT, with a Phase 1/2 trial in NSCLC initiated in October 2020 and a Phase 2b trial in pancreatic cancer planned for H1 2021. Updated data from a pilot Phase 1/2 trial of avasopasem in pancreatic cancer showed median overall survival nearly doubled in the treatment arm (20.1 months vs. 10.9 months placebo)[73][74] - Galera initiated a pilot Phase 2 clinical trial of avasopasem in September 2020 to evaluate its ability to improve 28-day mortality in critically ill COVID-19 patients, with topline data expected in H1 2021[75] - The company has incurred significant losses since inception, with a net loss of $18.7 million for Q1 2021 and an accumulated deficit of $254.3 million as of March 31, 2021. It expects to continue incurring losses and will require substantial additional capital[76][77] Business Update Regarding COVID-19 This section discusses the impact of the COVID-19 pandemic on the company's clinical trial timelines and operations - The COVID-19 pandemic has directly or indirectly impacted the timeline for some clinical trials. The EUSOM trial initiation was delayed, leading to a decreased target enrollment of approximately 35 patients. The ROMAN trial's target enrollment was increased to approximately 450 patients to maintain the safety database size[81] - Enrollment for the EUSOM trial is complete, with data readout expected in H2 2021. ROMAN trial enrollment completion is expected in H1 2021, with topline data in H2 2021, both subject to ongoing COVID-19 impacts[81] - The company's third-party contract manufacturing partners continue to operate near normal levels, and no material interruptions in clinical trial supply or manufacturing scale-up activities are currently anticipated. Work-from-home policies are in place for eligible employees, while essential R&D activities continue with precautionary measures[83][84] Critical Accounting Policies This section highlights the company's critical accounting policies and management's estimates and judgments - The company's 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. No material changes to critical accounting policies occurred during the three months ended March 31, 2021[85][86] Components of Results of Operations This section details the various components contributing to the company's results of operations Research and Development Expense This section details the nature of research and development expenses and their expected future trends - Research and development expenses are expensed as incurred and include costs for preclinical studies, clinical trials, personnel, third-party research (CROs, CMOs), manufacturing, regulatory activities, and facility costs[88][90] Research and Development Expenses by Program (Amounts in Thousands) | Program | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Avasopasem manganese (GC4419) | $7,331 | $9,336 | | GC4711 | $920 | $1,490 | | Other research and development expense | $1,556 | $1,038 | | Personnel related and share-based compensation expense | $2,616 | $2,388 | | Total | $12,423 | $14,252 | - R&D expenses are expected to increase significantly due to advancing later-stage clinical trials for avasopasem and GC4711, conducting other trials, and preparing regulatory filings. The successful development of product candidates is highly uncertain, with costs and timing dependent on numerous factors including trial duration, patient enrollment, and regulatory approvals[89][91][92] General and Administrative Expense This section describes the components of general and administrative expenses and their anticipated future increases - General and administrative expenses primarily consist of personnel expenses (salaries, benefits, share-based compensation) for executive, finance, IT, business development, and HR functions, along with corporate facility costs, legal fees, and accounting/consulting services[93] - These expenses are expected to increase in the future to support continued R&D, potential commercialization efforts, and expansion of operations, including hiring additional personnel, fees for consultants, and costs associated with public company compliance[94] Interest Income This section explains the sources of the company's interest income from cash and investments - Interest income is earned on cash, cash equivalents, and short-term investments, including U.S. Treasury obligations and money market funds[95] Interest Expense This section details the components of interest expense, primarily from the Royalty Agreement - Interest expense consists of non-cash interest on proceeds from the Royalty Agreement with Blackstone and non-cash interest expense from the amortization of the debt discount related to Blackstone warrants[96] Foreign Currency Gains (Losses) This section explains the origin of foreign currency gains and losses from exchange rate fluctuations - Foreign currency gains (losses) arise from exchange rate fluctuations on transactions denominated in currencies other than the U.S. dollar[97] Net Operating Loss and Research and Development Tax Credit Carryforwards This section outlines the company's net operating loss and R&D tax credit carryforwards and valuation allowance - As of December 31, 2020, the company had federal and state net operating loss carryforwards of $135.6 million and $157.5 million, respectively, with approximately $73.0 million of federal NOLs available indefinitely. Foreign NOLs were $1.6 million with no expiration[98] - Federal, state, and foreign research and development tax credit carryforwards totaled $7.5 million as of December 31, 2020. A valuation allowance has been recorded on substantially all deferred tax assets due to the uncertainty of utilization[98][99] Results of Operations (Comparison of the Three Months Ended March 31, 2021 and 2020) This section provides a comparative analysis of the company's financial performance for Q1 2021 and Q1 2020 Results of Operations (Amounts in Thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $12,423 | $14,252 | $(1,829) | | General and administrative | $5,058 | $3,566 | $1,492 | | Loss from operations | $(17,481) | $(17,818) | $337 | | Interest income | $19 | $468 | $(449) | | Interest expense | $(1,253) | $(1,095) | $(158) | | Foreign currency gain | — | $28 | $(28) | | Net loss | $(18,715) | $(18,417) | $(298) | Research and Development Expense This section analyzes the changes in research and development expenses between Q1 2021 and Q1 2020 - Research and development expense decreased by $1.8 million to $12.4 million in Q1 2021 from $14.3 million in Q1 2020. This was primarily due to a $2.0 million decrease in avasopasem development costs (reduced ROMAN trial and preclinical expenses) and a $0.6 million decrease in GC4711 development costs (reduced CMC and preclinical expenses)[101] - These decreases were partially offset by a $0.2 million increase in personnel-related and share-based compensation expense and a $0.5 million increase in other research and development expenses[101] General and Administrative Expense This section analyzes the changes in general and administrative expenses between Q1 2021 and Q1 2020 - General and administrative expense increased by $1.5 million to $5.1 million in Q1 2021 from $3.6 million in Q1 2020. The increase was mainly due to increased employee headcount, higher share-based compensation expense, and increased pre-commercial activities for avasopasem[102] Interest Income This section analyzes the changes in interest income between Q1 2021 and Q1 2020 - Interest income decreased significantly from $0.5 million in Q1 2020 to $19 thousand in Q1 2021, driven by lower average invested cash balances and lower average interest rates[103] Interest Expense This section analyzes the changes in interest expense between Q1 2021 and Q1 2020 - Non-cash interest expense related to the Royalty Agreement with Blackstone Life Sciences increased from $1.1 million in Q1 2020 to $1.3 million in Q1 2021[104] Liquidity and Capital Resources This section discusses the company's financial resources, cash flow, funding requirements, and capital raising activities - As of March 31, 2021, the company had $57.5 million in cash, cash equivalents, and short-term investments, and an accumulated deficit of $254.3 million. Operations have been funded primarily through equity sales and $60.0 million from the Royalty Agreement with Blackstone Life Sciences[105] - In December 2020, the company entered into an Open Market Sales Agreement with Jefferies LLC, allowing for the sale of up to $50.0 million in common stock through 'at-the-market' offerings. No securities were issued under this agreement in Q1 2021[106] - Existing cash, cash equivalents, and short-term investments, combined with $57.5 million in expected payments from Blackstone upon clinical enrollment milestones (expected H1 2021), are anticipated to fund operating expenses and capital expenditures into the second half of 2022[114] Cash Flows This section provides a summary and analysis of cash flows from operating, investing, and financing activities Summary of Cash Flows (Amounts in Thousands) | Activity | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(15,303) | $(12,392) | | Net cash provided by (used in) investing activities | $12,883 | $(4,395) | | Net cash provided by financing activities | $235 | $20,009 | | Net (decrease) increase in cash and cash equivalents | $(2,185) | $3,222 | - Net cash used in operating activities increased to $15.3 million in Q1 2021 from $12.4 million in Q1 2020, primarily reflecting the net loss partially offset by non-cash charges[109][110] - Investing activities provided $12.9 million in net cash in Q1 2021, mainly from net sales of short-term investments, a significant shift from using $4.4 million in Q1 2020 for net purchases of short-term investments[111] - Financing activities provided $0.2 million in Q1 2021 from stock option exercises, a decrease from $20.0 million in Q1 2020, which included proceeds from the Royalty Agreement[112] Funding Requirements This section outlines the company's future capital needs and potential financing strategies - Operating expenses are expected to increase substantially due to ongoing R&D, clinical trials, seeking marketing approval, and potential commercialization efforts. Significant additional funding will be required[113] - Future funding requirements are highly uncertain and depend on factors such as the scope and costs of preclinical studies and clinical trials, regulatory review, ability to establish collaborations, intellectual property costs, manufacturing arrangements, and sales/marketing capabilities[115] - If additional capital is not raised when needed or on attractive terms, the company may be forced to delay, reduce, or eliminate R&D programs or commercialization efforts. Financing may involve equity offerings (dilution), debt financings (covenants), or collaborations (relinquishing rights)[113][117][118] Royalty Agreement with Blackstone Life Sciences (Formerly Known as Clarus Ventures) This section details the terms and proceeds of the Royalty Agreement with Blackstone Life Sciences - In November 2018, Galera entered into a Royalty Agreement with Blackstone Life Sciences for up to $80.0 million in four tranches upon clinical milestones. $60.0 million was received by February 2020[119] - An Amendment in May 2020 increased the total Royalty Purchase Price to $117.5 million by increasing the fourth tranche to $37.5 million and adding a new $20.0 million tranche upon an additional clinical enrollment milestone[120] - Galera agreed to sell a high single-digit percentage of worldwide net sales of avasopasem and GC4711 (Products) to Blackstone during the Royalty Period, which extends until aggregate Product Payments exceed a fixed single-digit multiple of the Royalty Purchase Price[121][122] - As partial consideration for the Amendment, Galera issued two warrants to Blackstone Purchaser to buy 550,661 shares of common stock at $13.62 per share, exercisable upon receipt of specified milestone payments[123] Off-Balance Sheet Arrangements This section confirms the absence of off-balance sheet arrangements - The company does not have relationships with unconsolidated entities or financial partnerships (structured finance or special purpose entities) for off-balance sheet arrangements, nor does it engage in trading activities involving non-exchange traded contracts[124] Effect of Inflation This section assesses the impact of inflation on the company's financial performance - Inflation did not have a significant impact on the company's net loss for the three months ended March 31, 2021 or 2020[125] Recent Accounting Pronouncements This section refers to the notes for details on recent accounting pronouncements - Refer to Note 2 of the interim consolidated financial statements for a description of recent accounting pronouncements applicable to the company's financial statements[126] JOBS Act Transition Period This section explains the company's status as an emerging growth company and its accounting standard compliance election - As an emerging growth company (EGC), Galera has opted out of the extended transition period for complying with new or revised accounting standards, meaning it will comply on the same dates as non-EGCs. This decision is irrevocable[127] - The company can still rely on other EGC exemptions, such as not being required to provide an auditor's attestation report on internal controls (Section 404(b) of Sarbanes-Oxley Act). The EGC status will end by December 31, 2024, or earlier if certain revenue, market value, or debt issuance thresholds are met[129] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Galera Therapeutics, Inc. is not required to provide the information typically mandated under this item regarding quantitative and qualitative disclosures about market risk - Galera Therapeutics, Inc. is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[130] Item 4. Controls and Procedures This section details the company's disclosure controls and procedures, including their inherent limitations, management's evaluation of their effectiveness, and any changes in internal control over financial reporting Limitations on Effectiveness of Controls and Procedures This section acknowledges the inherent limitations of any control system in achieving absolute assurance of control objectives - Management acknowledges that any controls and procedures, regardless of design, can only provide reasonable assurance of achieving control objectives due to inherent limitations and resource constraints[131] Evaluation of Disclosure Controls and Procedures This section presents management's conclusion on the effectiveness of the company's disclosure controls and procedures - As of March 31, 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[132] Changes in Internal Control over Financial Reporting This section reports on any material changes in internal control over financial reporting during the reporting period - There were no changes in internal control over financial reporting during the quarter ended March 31, 2021, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[133] PART II. OTHER INFORMATION Item 1. Legal Proceedings This section confirms that Galera Therapeutics, Inc. is not currently subject to any material legal proceedings - The company is not subject to any material legal proceedings[136] Item 1A. Risk Factors This section directs readers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020, noting no material changes to those risks in the current reporting period - Investing in the company's common stock involves a high degree of risk. Readers should consider 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[137] - There have been no material changes to the risk factors described in the 2020 Form 10-K[137] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section provides an update on the use of net proceeds from the company's initial public offering (IPO) completed in November 2019, confirming the amount used and the investment of remaining funds - The company completed its IPO in November 2019, issuing 5,000,000 shares at $12.00 per share, generating net proceeds of approximately $53.0 million. An additional 445,690 shares were sold in December 2019, generating $5.0 million[138] - As of March 31, 2021, $24.1 million of the IPO net proceeds had been used, with the remaining $33.9 million invested in money market funds and U.S. Treasury/government agency obligations. There has been no material change in the expected use of proceeds[139] Item 3. Defaults Upon Senior Securities This section states that there have been no defaults upon senior securities - There have been no defaults upon senior securities[140] Item 4. Mine Safety Disclosures This item is not applicable to Galera Therapeutics, Inc - This item is not applicable[141] Item 5. Other Information This section indicates that there is no other information to report under this item - There is no other information to report under this item[142] Item 6. Exhibits This section lists all exhibits filed or furnished with the report, or incorporated by reference, including certifications, XBRL documents, and the cover page interactive data file - The exhibits listed on the Exhibit Index are either filed or furnished with this report or incorporated herein by reference[144] Signatures This section contains the required signatures from the registrant's authorized officers, confirming the submission of the report - The report is duly signed on behalf of Galera Therapeutics, Inc. by J. Mel Sorensen, M.D., Chief Executive Officer and President, and Christopher Degnan, Chief Financial Officer, on May 11, 2021[148][150]