Monte Rosa Therapeutics(GLUE) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) Presents unaudited condensed consolidated financial statements, detailing financial position, operational performance, and cash flows Condensed Consolidated Balance Sheets Total assets decreased to $393.2 million, liabilities fell to $118.0 million, and equity rose to $275.2 million Condensed Consolidated Balance Sheet Highlights (in millions) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $78.53 | $224.25 | | Marketable securities | $247.54 | $147.90 | | Total Assets | $393.20 | $438.73 | | Current deferred revenue | $32.58 | $117.23 | | Total Liabilities | $118.04 | $215.80 | | Total Stockholders' Equity | $275.16 | $222.94 | Condensed Consolidated Statements of Operations Net income reached $46.9 million in Q1 2025, driven by $84.9 million in collaboration revenue from Novartis and Roche agreements Q1 2025 vs Q1 2024 Performance (in millions, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Collaboration Revenue | $84.93 | $1.06 | | Research and Development | $32.19 | $27.03 | | General and Administrative | $8.70 | $8.99 | | Income (Loss) from Operations | $44.04 | $(34.95) | | Net Income (Loss) | $46.89 | $(31.97) | | Diluted EPS | $0.57 | $(0.53) | Condensed Consolidated Statements of Cash Flows Net cash used in operations was $45.5 million, investing used $100.2 million, resulting in a $145.7 million cash decrease Cash Flow Summary (in millions) | Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(45.49) | $(38.17) | | Net cash (used in) provided by investing activities | $(100.23) | $9.85 | | Net cash provided by financing activities | $0.01 | $0.25 | | Net decrease in cash, cash equivalents and restricted cash | $(145.71) | $(28.07) | Notes to Financial Statements Notes detail liquidity, accounting policies, and major collaboration agreements with Roche and Novartis, primary revenue sources - The company expects its cash, cash equivalents, and marketable securities of $326.1 million as of March 31, 2025, will be sufficient to fund operating expenses and capital requirements for at least 12 months from the financial statement issuance date[24] - In October 2023, the company entered a collaboration with Roche to discover and develop MGDs against cancer and neurological disease targets. The company received a $50.0 million upfront payment and is eligible for over $2 billion in potential milestones plus royalties[48][52] - In October 2024, the company granted Novartis an exclusive license to develop and commercialize its VAV1 MGDs, including MRT-6160. The company received a $150 million upfront payment and is eligible for up to $2.1 billion in milestones, plus a profit/loss sharing arrangement in the U.S[58][59] - For the three months ended March 31, 2025, the company recognized $125.9 million in revenue from the Novartis agreement and a cumulative total of $34.7 million from the Roche agreement through that date[56][64] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial performance, liquidity, and capital resources, emphasizing increased collaboration revenue and R&D expenses Results of Operations Collaboration revenue surged to $84.9 million in Q1 2025, while research and development expenses increased to $32.2 million Comparison of Operating Results (in millions) | Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $84.93 | $1.06 | $83.87 | | Research and Development | $32.19 | $27.03 | $5.16 | | General and Administrative | $8.70 | $8.99 | $(0.28) | - The increase in R&D expenses was primarily driven by the advancement of MRT-6160 into the clinic, progression of the preclinical pipeline including work for the Roche collaboration, and increased personnel costs[107][108] Liquidity and Capital Resources The company held $331.0 million in cash and equivalents, funded by equity offerings and collaborations, sufficient for 12 months - As of March 31, 2025, the company had $331.0 million in cash, cash equivalents, restricted cash and marketable securities[112] - In May 2024, the company raised aggregate net proceeds of $96.4 million from an underwritten public offering of common stock and pre-funded warrants[113][114] - The company has an active At-the-Market (ATM) program, amended in March 2025 to allow for the sale of up to $150.0 million of its common stock[116] - The company believes its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements for at least the next twelve months[125] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Monte Rosa is not required to provide market risk disclosures - As a smaller reporting company, Monte Rosa is not required to provide quantitative and qualitative disclosures about market risk[138] Controls and Procedures Management concluded disclosure controls were effective as of March 31, 2025, with no material changes in internal controls - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[140] - No changes in internal control over financial reporting occurred during the quarter that materially affected, or were reasonably likely to materially affect, internal controls[141] PART II. OTHER INFORMATION Legal Proceedings The company is not party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any claim or litigation that would be reasonably expected to have a material adverse effect on its business[144] Risk Factors No material changes to risk factors from 2024 Annual Report, with continued operating losses and anticipated increased expenses for clinical trials - There have been no material changes to the risk factors set forth in the company's 2024 Annual Report[146] - The company has incurred significant operating losses since inception, with an accumulated deficit of $391.7 million as of March 31, 2025, and expects to incur continued losses for the foreseeable future[147] - Future expenses are expected to increase significantly due to ongoing clinical trials for MRT-2359 and MRT-6160, advancing preclinical programs like NEK7 and CDK2, and expanding the QuEEN™ discovery engine[147] Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities No unregistered sales of equity securities or issuer purchases of equity securities occurred during the period - The company reported no recent sales of unregistered equity securities and no issuer purchases of its equity securities[152] Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[153] Mine Safety Disclosures This item is not applicable to the company - Not Applicable[154] Other Information No directors or officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the quarter[155] Exhibits This section lists the exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL documents