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 For the transition period from ____________ to ____________ Commission File Number: 001-40522 Monte Rosa Therapeutics, Inc. (Exact name of registrant as specified in its charter) | | | (State or other jurisdiction of incorporation or organization) 321 Harrison Avenue, Suite 900 Bo ...

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 ☐ 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: 001-40522 Monte Rosa Therapeutics, Inc. (Exact name of registrant as specified in its charter) | | | (State ...

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: 001-40522 Monte Rosa Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84- ...

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 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 001-40522 Monte Rosa Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 84-3766197 (State or other jurisd ...

p-valuep-value Target A Target A Protein fold-change; (log2) Protein fold-change; (log2) 10 Proprietary AI/ML Engines Allow for Discovery of Glueable Targets and Highly Selective MGDs PPI propensity & pocket identification for reprogrammability E3 ligase surface evaluation Proteome-wide glueability assessment Surface complementarity connecting E3 ligases to neosubstrates Ternary complex modelling and in-silico screening Fast algorithms leveraging ensembles, dynamics and quantum mechanics Candidate neosubstr ...

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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | Common stock, ...

From Serendipity to Rational Design Taking Molecular Glue Degraders to New Heights | April 2022 Monte Rosa l herapeutics Forward-Looking Statements | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

From Serendipity to Rational Design Taking Molecular Glue Degraders to New Heights | April 2022 Monte Rosa l herapeutics Forward-Looking Statements | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a net loss of **$50.5 million** for the nine months ended September 30, 2021, significantly higher than **$16.2 million** in 2020, with its financial position strengthened by the IPO to **$367.0 million** in cash and cash equivalents [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2021, the company's balance sheet reflects a strong liquidity position with **$367.0 million** in cash and cash equivalents, a significant increase from **$41.7 million** at year-end 2020, primarily due to IPO proceeds and preferred stock financings Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $367,034 | $41,699 | | Total current assets | $370,519 | $43,591 | | Total assets | $384,049 | $49,378 | | **Liabilities & Equity** | | | | Total liabilities | $14,744 | $30,342 | | Total stockholders' equity (deficit) | $369,305 | $(48,728) | [Condensed Combined and Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Combined%20and%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company, a pre-revenue entity, experienced a significant widening of its net loss to **$50.5 million** for the nine months ended September 30, 2021, from **$16.2 million** in 2020, driven by increased research and development and general and administrative expenses Statement of Operations Highlights (in thousands) | Metric | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Research and development | $39,025 | $14,142 | | General and administrative | $10,470 | $1,932 | | Loss from operations | $(49,495) | $(16,074) | | Net loss | $(50,518) | $(16,223) | | Net loss per share | $(2.85) | $(11.01) | [Condensed Combined and Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Combined%20and%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2021, net cash used in operating activities was **$45.2 million**, while financing activities provided a significant inflow of **$377.7 million**, primarily from the IPO and preferred stock issuances, leading to a net increase in cash of **$325.9 million** Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(45,191) | $(14,479) | | Net cash used in investing activities | $(6,606) | $(2,203) | | Net cash provided by financing activities | $377,697 | $60,070 | [Notes to the Condensed Combined and Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Combined%20and%20Consolidated%20Financial%20Statements) Key notes detail the company's pre-revenue biotech business, the **$203.9 million** net proceeds from its June 2021 IPO, the conversion of all preferred stock to common stock, and the termination of a significant related-party service agreement - The company completed its IPO in June 2021, receiving net proceeds of **$203.9 million**, and an additional **$31.0 million** in July 2021 from the full exercise of the underwriters' option[26](index=26&type=chunk) - The company expects its cash and cash equivalents of **$367.0 million** as of September 30, 2021, will be sufficient to fund operating expenses and capital requirements for at least 12 months from the report's issuance date[30](index=30&type=chunk) - Immediately prior to the IPO, all outstanding Series A, A-2, B, and C convertible preferred stock was converted into **31,068,102 shares** of common stock[27](index=27&type=chunk)[51](index=51&type=chunk) - The company terminated its service agreement with related party Ridgeline Therapeutics GmbH on August 9, 2021, with payments to Ridgeline for R&D services totaling **$7.8 million** in the first nine months of 2021[68](index=68&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's pre-revenue status, the significant increase in net loss to **$50.5 million** for the first nine months of 2021 due to expanded R&D and G&A, and enhanced liquidity of **$367.0 million** from the IPO [Results of Operations](index=22&type=section&id=Results%20of%20operations) For the nine months ended September 30, 2021, R&D expenses increased by **$24.9 million** to **$39.0 million**, and G&A expenses rose by **$8.5 million** to **$10.5 million**, primarily due to increased headcount and external service costs Comparison of Operating Expenses (in thousands) | Expense Category | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Dollar Change | | :--- | :--- | :--- | :--- | | Research and development | $39,025 | $14,142 | $24,883 | | General and administrative | $10,470 | $1,932 | $8,538 | | **Total operating expenses** | **$49,495** | **$16,074** | **$33,421** | - The increase in R&D expenses was primarily due to the expansion of activities in the U.S. and Switzerland, including increased headcount from **18 to 73 R&D employees**, and corresponding increases in laboratory and facility expenses[98](index=98&type=chunk)[99](index=99&type=chunk) - The increase in G&A expenses was driven by increased headcount from **4 to 19 employees** and higher professional service costs to support overall growth[100](index=100&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20capital%20resources) The company's operations are financed by convertible notes, preferred stock, and its IPO, resulting in **$367.0 million** in cash and cash equivalents as of September 30, 2021, which is expected to fund operations for at least the next twelve months - As of September 30, 2021, the company had **$367.0 million** in cash and cash equivalents and an accumulated deficit of **$98.6 million**[104](index=104&type=chunk) - Net cash provided by financing activities for the nine months ended September 30, 2021, was **$377.7 million**, primarily from the IPO and Series B and C convertible preferred stock issuances[110](index=110&type=chunk) - The company believes its existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements for at least the next twelve months[113](index=113&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks, primarily interest rate sensitivities and foreign currency exchange risk, with interest rate risk considered low due to short-term, low-risk cash equivalents, while foreign currency risk arises from Swiss operations - Primary market risks are interest rate sensitivity and foreign currency exchange risk[124](index=124&type=chunk) - Interest rate risk is minimal due to holding **$367.0 million** in cash and cash equivalents in short-term, low-risk U.S. government-backed money market funds[124](index=124&type=chunk) - Foreign currency exchange risk exists due to operations in Switzerland, with exposure primarily to the Swiss franc and the Euro[125](index=125&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of September 30, 2021, due to unremediated material weaknesses in internal control over financial reporting, with a remediation plan underway - Management concluded that disclosure controls and procedures were not effective as of the end of the period covered by the report[126](index=126&type=chunk) - Four material weaknesses were identified: (i) insufficient accounting personnel, (ii) ineffective risk assessment, (iii) lack of segregation of duties, and (iv) inadequate documentation and monitoring of controls[127](index=127&type=chunk) - Remediation efforts include hiring a VP of finance, engaging accounting consultants, implementing a new ERP system, and establishing a disclosure committee[128](index=128&type=chunk)[131](index=131&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) As of September 30, 2021, the company is not a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently party to any claim or litigation expected to have a material adverse effect on the business[133](index=133&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including its limited operating history, lack of revenue, significant losses, dependence on its novel QuEEN platform, preclinical stage programs, absence of issued patents, and identified material weaknesses in internal financial controls - The company is a pre-revenue biotechnology firm with a limited operating history and significant operating losses (**$50.5 million** for the nine months ended Sep 30, 2021), and it anticipates continued losses[135](index=135&type=chunk)[137](index=137&type=chunk) - The company's QuEEN platform is a novel approach, making it difficult to predict the time, cost, and likelihood of successfully developing any products, with all programs still in preclinical stages[147](index=147&type=chunk) - The company currently does not own any issued patents; its portfolio consists of pending patent applications for its QuEEN platform and various programs (GSPT1, CDK2, NEK7)[268](index=268&type=chunk) - Material weaknesses in internal control over financial reporting have been identified and are in the process of remediation[359](index=359&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=97&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the nine months ended September 30, 2021, the company issued unregistered securities primarily through the conversion of **109,686,035** preferred shares into **31,068,102** common shares upon IPO, and the granting of options, generating **$234.8 million** in net proceeds - Upon the IPO closing, all **109,686,035 shares** of redeemable convertible preferred stock automatically converted into **31,068,102 shares** of common stock[387](index=387&type=chunk) - The company granted options to purchase an aggregate of **3,812,300 shares** of common stock to employees, advisors, and directors[388](index=388&type=chunk) - The IPO generated aggregate net proceeds of **$234.8 million** after deducting underwriting discounts and other costs[391](index=391&type=chunk) [Defaults Upon Senior Securities](index=97&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported [Mine Safety Disclosures](index=97&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations [Exhibits](index=98&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, stock agreements, employment agreements, and officer certifications

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 Delaware 81-3766197 (State or other jurisdiction of incorporation or organization) 645 Summer Street, Suite 102 Boston, Massachusetts 02210 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____ ...