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Repare Therapeutics(RPTX) - 2023 Q4 - Annual Report
2024-02-28 12:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39335 Repare Therapeutics Inc. (Exact name of Registrant as specified in its Charter) Québec Not applicable (State or other jurisdict ...
Repare Therapeutics(RPTX) - 2023 Q4 - Annual Results
2024-02-28 12:10
• Lunresertib • Presented initial positive data from its ongoing Phase 1 MYTHIC trial evaluating lunresertib (RP-6306) alone and in combination with camonsertib in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations at the 2023 American Association for Cancer Research (AACR)-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Initial combination data included an overall RECIST response rate of 50% in ten patients with hea ...
Repare Therapeutics(RPTX) - 2023 Q3 - Quarterly Report
2023-11-09 12:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to ___________________ Commission File Number: 001-39335 Repare Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) ( ...
Repare Therapeutics(RPTX) - 2023 Q2 - Quarterly Report
2023-08-09 20:12
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to ___________________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ 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 Commission File Number: 001-39335 Repare Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) (State ...
Repare Therapeutics(RPTX) - 2023 Q1 - Quarterly Report
2023-05-09 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to ___________________ Commission File Number: 001-39335 Repare Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) (Stat ...
Repare Therapeutics(RPTX) - 2022 Q4 - Annual Report
2023-02-28 21:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Commission File Number 001-39335 Repare Therapeutics Inc. OR (Exact name of Registrant as specified in its Charter) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO (State or other jurisdiction of incorporation o ...
Repare Therapeutics(RPTX) - 2022 Q3 - Quarterly Report
2022-11-09 21:29
WASHINGTON, DC 20549 FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to ___________________ Commission File Number: 001-39335 Repare Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) ( ...
Repare Therapeutics (RPTX) Investor Presentation - Slideshow
2022-08-05 18:42
| --- | --- | --- | --- | |-------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | A Leader in Precision Oncology Corporate Presentation August 2022 | | | | 2 Disclaimer Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," ...
Repare Therapeutics(RPTX) - 2022 Q2 - Quarterly Report
2022-08-04 20:44
PART I. FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Repare Therapeutics Inc. as of June 30, 2022, including balance sheets, statements of operations, and cash flows, with accompanying notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and shareholders' equity as of June 30, 2022, and December 31, 2021 Balance Sheet Summary (in thousands of U.S. dollars) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $275,834 | $334,427 | | Total current assets | $289,738 | $351,414 | | **Total Assets** | **$308,044** | **$368,715** | | Total current liabilities | $39,440 | $35,089 | | **Total Liabilities** | **$82,527** | **$80,294** | | **Total Shareholders' Equity** | **$225,517** | **$288,421** | - The company's cash and cash equivalents decreased by approximately **$58.6 million** during the first six months of 2022, primarily due to funding operating activities[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2022 and 2021 Statement of Operations Summary (in thousands of U.S. dollars, except per share data) | Metric | Q2 2022 | Q2 2021 | Six Months 2022 | Six Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $679 | $279 | $1,087 | $445 | | R&D Expenses | $31,475 | $20,205 | $57,933 | $36,714 | | G&A Expenses | $7,938 | $6,741 | $16,717 | $11,978 | | **Net Loss** | **$(38,093)** | **$(26,309)** | **$(72,850)** | **$(47,726)** | | **Net Loss Per Share** | **$(0.91)** | **$(0.71)** | **$(1.74)** | **$(1.29)** | - Net loss increased significantly year-over-year for both the three and six-month periods, driven by a substantial rise in Research and Development expenses as the company advanced its clinical programs[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2022 and 2021 Cash Flow Summary for Six Months Ended June 30 (in thousands of U.S. dollars) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(58,199) | $(32,285) | | Net cash used in investing activities | $(906) | $(889) | | Net cash provided by financing activities | $446 | $632 | | **Net Decrease in Cash** | **$(58,593)** | **$(32,543)** | - Cash used in operating activities increased by **$25.9 million** year-over-year, primarily due to higher net loss adjusted for non-cash items like share-based compensation[20](index=20&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of significant accounting policies, collaboration agreements, and subsequent events impacting the financial statements - The company entered into a significant collaboration and license agreement with Roche on June 1, 2022, for its product candidate camonsertib (RP-3500), including a **$125 million upfront payment** received in July 2022 and potential for up to **$1.172 billion in milestones**[61](index=61&type=chunk)[64](index=64&type=chunk) - Revenue recognized during the period is from the collaboration agreement with Bristol-Myers Squibb (BMS), with **$1.1 million** recognized for the six months ended June 30, 2022, and **$41.4 million** in deferred revenue remaining on the balance sheet[44](index=44&type=chunk)[46](index=46&type=chunk) - On August 4, 2022, the company entered into an "at-the-market" (ATM) sales agreement with Cowen and Company, allowing it to offer and sell up to **$125.0 million** of its common shares from time to time[66](index=66&type=chunk) - Share-based compensation expense for the six months ended June 30, 2022, was **$9.5 million**, a significant increase from **$5.2 million** in the prior-year period, reflecting increased headcount and equity awards[58](index=58&type=chunk)[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, recent developments, financial results, and liquidity, highlighting the new Roche collaboration and funding outlook [Overview and Recent Developments](index=18&type=section&id=Overview%20and%20Recent%20Developments) This section provides an overview of the company's precision oncology platform and recent progress in its clinical programs, including the Roche collaboration - The company is a clinical-stage precision oncology company using its proprietary SNIPRx platform to develop novel therapeutics based on synthetic lethality[68](index=68&type=chunk) - A worldwide license and collaboration agreement was closed with Roche for camonsertib (RP-3500), with Repare receiving a **$125 million upfront payment** and eligibility for up to **$1.172 billion in milestones** plus royalties[78](index=78&type=chunk)[79](index=79&type=chunk) - The company is advancing RP-6306, a first-in-class oral PKMYT1 inhibitor, in multiple Phase 1 trials, with initial monotherapy data readout now expected in the first half of 2023 due to COVID-19 disruptions[80](index=80&type=chunk)[85](index=85&type=chunk) - The pipeline is progressing with IND-enabling studies initiated for Polθ inhibitor RP-2119, with clinical trials planned for summer 2023[85](index=85&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section analyzes the drivers behind changes in collaboration revenue and operating expenses for the periods presented Comparison of Operating Expenses (in millions of U.S. dollars) | Expense Category | Six Months 2022 | Six Months 2021 | Change | Primary Driver | | :--- | :--- | :--- | :--- | :--- | | R&D, net of tax credits | $57.9 | $36.7 | +$21.2 | Increased development activities for RP-3500 and RP-6306 programs and higher personnel costs | | General & Administrative | $16.7 | $12.0 | +$4.7 | Increased personnel costs and professional fees related to public company status | - The increase in R&D expenses for the first six months of 2022 was driven by a **$12.1 million** increase in direct external costs for clinical programs (RP-6306: **+$6.8M**, RP-3500: **+$4.0M**, RP-2119: **+$1.0M**) and a **$7.5 million** increase in personnel-related costs[119](index=119&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's cash position, funding strategy, and outlook on its ability to finance future operations - As of June 30, 2022, the company had **$282.1 million** in cash, cash equivalents, and marketable securities[125](index=125&type=chunk) - Management believes that existing cash combined with the **$125 million upfront payment** from the Roche agreement (received in July 2022) will be sufficient to fund operations and capital expenditures into 2026[125](index=125&type=chunk) - The company anticipates increased cash tax payments in 2022 due to a change in U.S. tax law (IRC Section 174) requiring capitalization and amortization of R&D expenditures over five years, rather than immediate deduction[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposures are related to interest rate fluctuations on its cash and investments and foreign currency exchange rate volatility - The company is exposed to foreign currency risk from its Canadian operations, where a **10% depreciation** of the U.S. dollar relative to the Canadian dollar would result in an approximate **$0.1 million increase** to the company's net loss[145](index=145&type=chunk) - Interest rate risk is considered minimal as investments are primarily in short-term U.S. Treasury bills and interest-bearing bank accounts[142](index=142&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2022 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[148](index=148&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[149](index=149&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other material information relevant to the company [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal actions - As of the filing date, the company is not involved in any material legal proceedings[152](index=152&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section outlines the numerous risks associated with investing in the company, including limited operating history, funding needs, and clinical development uncertainties - The company has a limited operating history, has incurred significant losses since inception (**$283.1 million accumulated deficit** as of June 30, 2022), and will require substantial additional funding to finance operations[154](index=154&type=chunk)[158](index=158&type=chunk)[162](index=162&type=chunk) - The business is substantially dependent on the successful development of product candidates from its SNIPRx platform, particularly RP-3500 and RP-6306, where failure or significant delays would materially harm the business[167](index=167&type=chunk)[172](index=172&type=chunk) - The company faces risks from health epidemics like the COVID-19 pandemic, which could adversely impact clinical trial enrollment, site activation, and supply chains, potentially delaying program timelines[175](index=175&type=chunk)[181](index=181&type=chunk) - The company relies on third parties for manufacturing (CMOs) and conducting clinical trials (CROs), where failure to perform or comply could stop or delay product development and commercialization[285](index=285&type=chunk)[293](index=293&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period and confirms consistent use of IPO proceeds - There has been no material change in the use of proceeds from the company's June 2020 IPO[412](index=412&type=chunk) [Item 5. Other Information](index=80&type=section&id=Item%205.%20Other%20Information) On August 4, 2022, the company entered into a Common Shares Sales Agreement with Cowen and Company, LLC, for an "at-the-market" offering - The company established an "at-the-market" (ATM) offering facility on August 4, 2022, allowing for the sale of up to **$125.0 million** in common shares[416](index=416&type=chunk)
Repare Therapeutics(RPTX) - 2022 Q1 - Quarterly Report
2022-05-05 20:43
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the company's unaudited financial information for the reporting period [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents the company's unaudited condensed consolidated financial statements, detailing financial position, operations, and cash flows [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Provides a snapshot of the company's assets, liabilities, and equity at specific reporting dates Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $305,136 | $334,427 | | Total current assets | $319,228 | $351,414 | | **Total Assets** | **$337,149** | **$368,715** | | Total current liabilities | $34,083 | $35,089 | | **Total Liabilities** | **$78,489** | **$80,294** | | **Total Shareholders' Equity** | **$258,660** | **$288,421** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's revenues, expenses, and net loss over the reporting period Condensed Consolidated Statement of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Revenue | $408 | $166 | | Research and development, net | $26,458 | $16,509 | | General and administrative | $8,779 | $5,237 | | Loss from operations | $(34,829) | $(21,580) | | **Net loss and comprehensive loss** | **$(34,757)** | **$(21,417)** | | **Net loss per share — basic and diluted** | **$(0.83)** | **$(0.58)** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,006) | $(14,227) | | Net cash provided by (used in) investing activities | $403 | $(772) | | Net cash provided by financing activities | $241 | $183 | | **Net Decrease In Cash And Cash Equivalents** | **$(29,291)** | **$(14,782)** | | **Cash and cash equivalents at end of period** | **$305,136** | **$311,614** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Offers detailed explanations of accounting policies and specific line items within the financial statements - The company recognized **$0.4 million in revenue** for the three months ended March 31, 2022, related to research activities performed under the Bristol Myers Squibb (BMS) Agreement[41](index=41&type=chunk) - As of March 31, 2022, deferred revenue related to the BMS Agreement was **$42.2 million**[43](index=43&type=chunk) Share-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $2,311 | $987 | | General and administrative | $2,444 | $1,070 | | **Total** | **$4,755** | **$2,057** | - As of March 31, 2022, there was **$53.1 million of unrecognized share-based compensation expense** related to unvested stock options, to be recognized over a weighted average period of 2.4 years[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's perspective on the company's financial performance, liquidity, and capital resources for the quarter - The company is a clinical-stage precision oncology company using its proprietary SNIPRx platform to develop novel therapeutics, with lead candidates RP-3500 and RP-6306 in Phase 1/2 clinical trials[58](index=58&type=chunk) - As of March 31, 2022, the company had **$311.7 million in cash, cash equivalents, and marketable securities**[59](index=59&type=chunk) - Updated clinical data from the Phase 1/2 TRESR trial of camonsertib (RP-3500) showed a **43% overall clinical benefit rate (CBR)**, with a **75% CBR in patients with advanced ovarian cancer**[66](index=66&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Analyzes the company's revenues and expenses, explaining the drivers behind changes in operating results Comparison of Results for the Three Months Ended March 31 (in thousands) | Account | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Revenue | $408 | $166 | $242 | | Research and development, net | $26,458 | $16,509 | $9,949 | | General and administrative | $8,779 | $5,237 | $3,542 | | **Net loss** | **$(34,757)** | **$(21,417)** | **$(13,340)** | - R&D expenses increased by **$10.0 million year-over-year**, primarily due to a **$5.5 million increase in direct external costs** for advancing the RP-3500 and RP-6306 programs and a **$4.1 million increase in personnel-related costs** from increased headcount[94](index=94&type=chunk) - General and administrative expenses increased by **$3.6 million year-over-year**, driven by a **$2.0 million increase in personnel costs** and a **$0.9 million increase in professional costs** related to transitioning from emerging growth company status[94](index=94&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's cash position, funding needs, and ability to meet its financial obligations - As of March 31, 2022, the company had **$311.7 million in cash, cash equivalents, and marketable securities**[101](index=101&type=chunk) - Existing cash is expected to be sufficient to fund operating and capital expenditure requirements into **2024**[101](index=101&type=chunk) - Net cash used in operating activities increased to **$30.0 million in Q1 2022** from **$14.2 million in Q1 2021**, primarily due to higher R&D and G&A expenses related to advancing clinical programs[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The Tax Cuts and Jobs Act of 2017, requiring capitalization and amortization of US-based R&D expenditures over five years starting in 2022, is expected to materially reduce cash flows and increase cash tax payments in 2022 compared to 2021[100](index=100&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Assesses the company's exposure to market risks, primarily foreign currency and interest rate fluctuations - The company's main market risk is foreign currency exchange risk, as a portion of its expenses are in Canadian dollars, where a **10% depreciation of the USD against the CAD** would increase net loss by about **$0.1 million**[117](index=117&type=chunk) - Interest rate risk is considered limited due to the short-term nature of the company's cash and marketable securities investments[115](index=115&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the effectiveness of the company's disclosure controls and internal control over financial reporting - As of March 31, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[120](index=120&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[121](index=121&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) Contains additional information not covered in the financial statements, including legal, risk, and equity matters [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[124](index=124&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) Identifies and elaborates on significant risks that could materially affect the company's business or financial results - **Financial Risks:** The company has a limited operating history, has incurred significant losses since inception (**$245.0 million accumulated deficit** as of March 31, 2022), and will require substantial additional funding to continue operations[126](index=126&type=chunk)[130](index=130&type=chunk)[134](index=134&type=chunk) - **Development Risks:** The business heavily depends on the success of its SNIPRx platform and lead candidates, RP-3500 and RP-6306, with development of targeted therapeutics being highly uncertain and early trial success not predicting later results[143](index=143&type=chunk)[154](index=154&type=chunk)[163](index=163&type=chunk) - **Operational Risks:** The COVID-19 pandemic could adversely impact business operations, including preclinical studies and clinical trials, by causing delays in patient enrollment, clinical site initiation, and supply chain interruptions[146](index=146&type=chunk)[152](index=152&type=chunk) - **Competition and Commercialization Risks:** The company faces substantial competition from major pharmaceutical and biotechnology companies, and even if approved, products may not gain market acceptance, with market opportunities potentially smaller than estimated[212](index=212&type=chunk)[205](index=205&type=chunk)[209](index=209&type=chunk) - **Intellectual Property Risks:** Success depends on obtaining and maintaining patent and trade secret protection for proprietary technologies and product candidates, which is a difficult and costly process[276](index=276&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=75&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports on unregistered equity sales and confirms no material change in IPO proceeds usage - There were no unregistered sales of equity securities in the quarter[380](index=380&type=chunk) - There has been no material change in the use of proceeds from the company's IPO[382](index=382&type=chunk) [Item 3. Defaults Upon Senior Securities](index=76&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - None[384](index=384&type=chunk) [Item 4. Mine Safety Disclosures](index=76&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[385](index=385&type=chunk) [Item 5. Other Information](index=76&type=section&id=Item%205.%20Other%20Information) None - None[386](index=386&type=chunk) [Item 6. Exhibits](index=77&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the report, including CEO and CFO certifications and XBRL data files - Lists exhibits filed with the report, including CEO and CFO certifications and XBRL data files[390](index=390&type=chunk)