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 June 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: 001-40522 Monte Rosa Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-3 ...

| --- | --- | --- | --- | --- | |-------------------------------------------------------------|-------|-------|-------|--------------------------| | | | | | | | | | | | | | | | | | | | From Serendipity to Rational Design | | | | | | Taking Molecular Glue Degraders to New Heights \| June 2022 | | | | | | | | | | | | | | | | | | | | | | Monte Rosa l herapeutics | 2 | --- ...

PART I. FINANCIAL INFORMATION Presents the unaudited condensed consolidated financial statements and related notes for the three months ended March 31, 2022 [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents the unaudited condensed consolidated financial statements and accompanying notes for the three months ended March 31, 2022 [Condensed Consolidated Balance Sheets (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28Unaudited%29) Details the company's financial position, including assets, liabilities, and equity, as of March 31, 2022 Condensed Consolidated Balance Sheets (in thousands) | (in thousands) | March 31, 2022 | December 31, 2021 | Change (2022 vs 2021) | | :-------------------------------- | :------------- | :---------------- | :-------------------- | | **Assets** | | | | | Cash and cash equivalents | **$138,305** | **$346,071** | **$(207,766)** | | Marketable securities | **$178,858** | — | **$178,858** | | Total current assets | **$320,366** | **$348,666** | **$(28,300)** | | Total assets | **$346,005** | **$366,329** | **$(20,324)** | | **Liabilities** | | | | | Total current liabilities | **$12,490** | **$16,638** | **$(4,148)** | | Total liabilities | **$20,130** | **$18,814** | **$1,316** | | **Stockholders' Equity** | | | | | Total stockholders' equity | **$325,875** | **$347,515** | **$(21,640)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20%28Unaudited%29) Reports the company's revenues, expenses, and net loss for the three months ended March 31, 2022, and 2021 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share) | (in thousands, except per share) | Three months ended March 31, 2022 | Three months ended March 31, 2021 | Change (2022 vs 2021) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :-------------------- | | Research and development | **$17,915** | **$9,273** | **$8,642** | | General and administrative | **$6,387** | **$2,231** | **$4,156** | | Total operating expenses | **$24,302** | **$11,504** | **$12,798** | | Loss from operations | **$(24,302)** | **$(11,504)** | **$(12,798)** | | Total other income (expense) | **$370** | **$(772)** | **$1,142** | | Net loss | **$(23,932)** | **$(12,276)** | **$(11,656)** | | Comprehensive loss | **$(24,044)** | **$(12,140)** | **$(11,904)** | | Net loss per share—basic and diluted | **$(0.51)** | **$(7.18)** | **$6.67** | [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (deficit) (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20%28deficit%29%20%28Unaudited%29) Outlines changes in convertible preferred stock and stockholders' equity (deficit) for the three months ended March 31, 2022 Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (deficit) (in thousands, except shares) | (in thousands, except shares) | Balance—January 1, 2022 | Restricted common stock vesting | Exercise of common stock options | Stock-based compensation expense | Unrealized loss on available-for-sale securities | Net Loss | Balance—March 31, 2022 | | :-------------------------------- | :---------------------- | :------------------------------ | :----------------------------- | :------------------------------ | :---------------------------------------------- | :--------- | :--------------------- | | Common stock (shares) | **46,535,966** | **34,505** | **60,240** | — | — | — | **46,630,711** | | Common stock (amount) | **$5** | — | — | — | — | — | **$5** | | Additional paid-in capital | **$471,566** | — | **$153** | **$2,251** | **$0** | — | **$473,970** | | Accumulated other comprehensive loss | **$(2,021)** | — | — | — | **$(146)** | — | **$(2,133)** | | Accumulated deficit | **$(122,035)** | — | — | — | — | **$(23,932)** | **$(145,967)** | | Total stockholders' equity | **$347,515** | — | **$153** | **$2,251** | **$(146)** | **$(23,932)** | **$325,875** | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) Presents cash flows from operating, investing, and financing activities for the three months ended March 31, 2022, and 2021 Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | **$(27,404)** | **$(13,815)** | | Net cash used in investing activities | **$(180,520)** | **$(2,217)** | | Net cash provided by financing activities | **$153** | **$142,769** | | Net (decrease) increase in cash, cash equivalents and restricted cash | **$(207,771)** | **$126,737** | | Cash, cash equivalents and restricted cash—end of period | **$143,638** | **$169,600** | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [1. Description of business, contribution and exchange, and liquidity](index=9&type=section&id=1.%20Description%20of%20business%2C%20contribution%20and%20exchange%2C%20and%20liquidity) Describes the company's biotechnology focus, IPO proceeds, and current liquidity position - Monte Rosa Therapeutics, Inc. is a biotechnology company focused on developing novel small molecule precision medicines that utilize the body's natural mechanisms to selectively degrade therapeutically-relevant proteins[21](index=21&type=chunk) - The Company completed its Initial Public Offering (**IPO**) in June 2021, issuing **11,700,000** shares of common stock at **$19.00** per share, generating aggregate net proceeds of **$203.6 million**. An additional **1,755,000** shares were issued in July 2021 for **$31.0 million** net proceeds[23](index=23&type=chunk) - As of March 31, 2022, the Company had an **accumulated deficit of $146.0 million** and incurred **net losses of $23.9 million** for the three months ended March 31, 2022. **Cash, cash equivalents, and marketable securities of $317.2 million** are **expected to fund operations for at least 12 months** from the financial statement issuance date[27](index=27&type=chunk) [2. Summary of significant accounting policies](index=10&type=section&id=2.%20Summary%20of%20significant%20accounting%20policies) Outlines key accounting principles and policies adopted by the company, including recent pronouncements - The Company adopted ASU No. 2016-02, Leases (Topic 842), on January 1, 2022, recognizing **operating lease right-of-use assets of $7.3 million** and **corresponding operating lease liabilities of $7.4 million**[33](index=33&type=chunk) - The Company elected the extended transition period for complying with new or revised accounting standards as available under the JOBS Act[30](index=30&type=chunk) [3. Fair value measurements](index=11&type=section&id=3.%20Fair%20value%20measurements) Details the fair value hierarchy and measurements for the company's financial assets Fair Value Measurements (in thousands) | (in thousands) | Level 1 | Level 2 | Level 3 | Total | | :----------------------- | :------ | :------ | :------ | :------ | | Money market funds | **$123,634** | — | — | **$123,634** | | Pension plan assets | — | **$3,818** | — | **$3,818** | | Corporate debt securities | — | **$111,076** | — | **$111,076** | | U.S Treasury securities | — | **$67,782** | — | **$67,782** | | Total assets measured at fair value | **$123,634** | **$182,676** | — | **$306,310** | - Money market funds are classified as **Level 1**, while marketable securities (corporate debt and U.S. Treasury securities) are classified as **Level 2** due to observable pricing inputs other than quoted prices in active markets[37](index=37&type=chunk)[38](index=38&type=chunk) [4. Marketable Securities](index=11&type=section&id=4.%20Marketable%20Securities) Provides information on marketable securities, including cost, unrealized gains/losses, and fair value Marketable Securities (in thousands) | Description | Amortized Cost (in thousands) | Unrealized Gains (in thousands) | Unrealized Losses (in thousands) | Fair Value (in thousands) | | :------------------------ | :------------- | :--------------- | :---------------- | :--------- | | Corporate debt securities | **$111,182** | — | **$(106)** | **$111,076** | | U.S Treasury securities | **$67,822** | **$5** | **$(45)** | **$67,782** | | Total | **$179,004** | **$5** | **$(151)** | **$178,858** | - As of March 31, 2022, the Company held **13 marketable securities** with an **aggregate fair value of $80.3 million** in an **unrealized loss position**, primarily due to economic and market conditions, but does not intend to sell them before recovery of carrying values[40](index=40&type=chunk) [5. Property and Equipment, net](index=12&type=section&id=5.%20Property%20and%20Equipment%2C%20net) Presents the breakdown of property and equipment, net of depreciation, and related expenses Property and Equipment, net (in thousands) | (in thousands) | March 31, 2022 | December 31, 2021 | | :-------------------------- | :------------- | :---------------- | | Laboratory equipment | **$14,664** | **$12,315** | | Construction in process | **$150** | **$852** | | Total property and equipment, at cost | **$16,675** | **$15,028** | | Less: accumulated depreciation | **$(3,279)** | **$(2,703)** | | Property and equipment, net | **$13,396** | **$12,325** | - **Depreciation expense** for the three months ended March 31, 2022, was **$0.8 million**, an **increase from $0.3 million** in the prior year[41](index=41&type=chunk) [6. Leases](index=12&type=section&id=6.%20Leases) Details lease expenses, weighted average lease terms, and significant new lease agreements Lease Expense (in thousands) | Lease Expense (in thousands) | Three Months Ended March 31, 2022 | | :------------------------- | :-------------------------------- | | Operating lease expense | **$502** | | Variable lease expense | **$118** | | Total lease expense | **$620** | - The **weighted average remaining lease term is 3.9 years** with a **weighted average discount rate of 7%**[45](index=45&type=chunk) - On **December 14, 2021**, the Company entered into a new non-cancelable lease for **63,327 square feet** of office and laboratory space, with an initial term of **128 months** commencing **April 1, 2022**. Estimated future minimum lease payments for this new lease are substantial, **totaling $44.4 million** thereafter[47](index=47&type=chunk) [7. Common stock](index=13&type=section&id=7.%20Common%20stock) Provides information on common stock, including shares issued, outstanding, and historical stock splits - As of March 31, 2022, the Company had **46,854,535 shares of common stock issued** and **46,630,711 shares outstanding**[50](index=50&type=chunk) - A **one-for-3.5305 reverse stock split** was approved and became effective on **June 17, 2021**, retroactively adjusting all share and per share amounts[49](index=49&type=chunk) - The Company has not declared or paid any dividends to common stockholders[50](index=50&type=chunk) [8. Stock-based compensation](index=14&type=section&id=8.%20Stock-based%20compensation) Details stock option and restricted stock activity, along with stock-based compensation expense Stock Option Activity | Stock Option Activity | Outstanding—December 31, 2021 | Granted | Exercised | Forfeited | Outstanding—March 31, 2022 | | :-------------------- | :---------------------------- | :------ | :-------- | :-------- | :--------------------------- | | Number of options | **5,563,513** | **1,671,875** | **(60,240)** | **(70,217)** | **7,104,931** | | Weighted average exercise price ($) | **$7.92** | **$13.41** | **$2.53** | **$5.25** | **$9.28** | | Weighted average remaining contractual term (years) | **8.6** | — | — | — | **9.2** | | Aggregate intrinsic value (in thousands) | **$70,045** | — | — | — | **$40,521** | Restricted Stock Activity | Restricted Stock Activity | Unvested as of December 31, 2021 | Vested | Unvested as of March 31, 2022 | | :------------------------ | :------------------------------- | :----- | :---------------------------- | | Number of shares | **258,329** | **(34,505)** | **223,824** | | Weighted average grant date fair value ($) | **$0.90** | **$0.78** | **$0.92** | Stock-based Compensation Expense (in thousands) | Stock-based Compensation Expense (in thousands) | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | **$1,157** | **$60** | | General and administrative | **$1,094** | **$192** | | Total stock-based compensation expense | **$2,251** | **$252** | [9. Income taxes](index=15&type=section&id=9.%20Income%20taxes) Explains the company's income tax position, including valuation allowance against deferred tax assets - The Company did not record a provision or benefit for income taxes and maintains a **full valuation allowance** against all deferred tax assets due to a history of cumulative **net losses** and lack of commercial products[60](index=60&type=chunk)[61](index=61&type=chunk) [10. Net loss per common share](index=15&type=section&id=10.%20Net%20loss%20per%20common%20share) Presents the calculation of basic and diluted net loss per common share for the reporting periods Net Loss Per Common Share (in thousands, except per share) | (in thousands, except per share) | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | **$(23,932)** | **$(12,276)** | | Net loss per share—basic and diluted | **$(0.51)** | **$(7.18)** | | Weighted-average common shares outstanding | **46,595,782** | **1,709,227** | - Potentially dilutive securities, including stock options and restricted common stock, were excluded from diluted net loss per common share calculation as their effect was **anti-dilutive**[62](index=62&type=chunk) [11. Related parties](index=16&type=section&id=11.%20Related%20parties) Discloses transactions and agreements with related parties, specifically payments to Ridgeline Discovery - The Company **paid $0** to Ridgeline Discovery (a Versant Venture Management, LLC discovery engine) during the three months ended March 31, 2022, **compared to $4.7 million in the prior year**, as the consulting agreement expired **December 31, 2021**[63](index=63&type=chunk) [12. Employee retirement plans](index=16&type=section&id=12.%20Employee%20retirement%20plans) Details expenses related to the Swiss pension plan and U.S. 401(k) matching contributions - The Company **recorded $0.2 million in defined benefit related expense** for its Swiss pension plan and **$0.2 million in 401(k) matching contribution related expense** for its U.S. plan during the three months ended March 31, 2022[64](index=64&type=chunk)[65](index=65&type=chunk) [13. Subsequent Events](index=16&type=section&id=13.%20Subsequent%20Events) Reports significant events occurring after the balance sheet date, such as a lease termination agreement - On **May 5, 2022**, the Company entered into a Lease Termination Agreement, providing an option to terminate its existing lease for office space at **645 Summer Street, Boston, MA**, **between February 1, 2023, and June 1, 2023**, subject to a new tenant[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's analysis of financial condition, operating results, liquidity, and capital resources [Overview](index=17&type=section&id=Overview) Introduces Monte Rosa Therapeutics, a biotechnology company developing precision medicines via its protein degradation platform - Monte Rosa Therapeutics is a biotechnology company developing novel small molecule precision medicines using its proprietary protein degradation platform, QuEENTM, to target therapeutically-relevant proteins[69](index=69&type=chunk) - The company is headquartered in Boston, Massachusetts, with research operations in both Boston and Basel, Switzerland[70](index=70&type=chunk) [Liquidity](index=17&type=section&id=Liquidity) Discusses historical operating losses, accumulated deficit, and current cash and marketable securities position - Since inception, the company has incurred **significant operating losses**, with a **net loss of $23.9 million** for the three months ended March 31, 2022, and an **accumulated deficit of $146.0 million**[71](index=71&type=chunk) - The company has raised an **aggregate of $479.1 million in gross proceeds** from convertible promissory notes, preferred stock, and its **initial public offering**[71](index=71&type=chunk) - As of March 31, 2022, the company **held $322.5 million in cash, cash equivalents, restricted cash, and marketable securities**[71](index=71&type=chunk) [Business effects of COVID-19](index=17&type=section&id=Business%20effects%20of%20COVID-19) Assesses the impact of the COVID-19 pandemic on the company's financial condition and operations - The COVID-19 pandemic has **not significantly impacted** the company's financial conditions and operations to date, and vendors continue to provide services and supplies without anticipated disruption[72](index=72&type=chunk)[73](index=73&type=chunk) - The company has adapted business practices, including routine employee testing, mask use, remote work, and controlled physical participation in meetings, to limit the spread of the virus[74](index=74&type=chunk) [Components of operating results](index=18&type=section&id=Components%20of%20operating%20results) Explains primary drivers and expected trends for R&D, G&A expenses, and non-operating income - Research and development expenses primarily relate to the QuEENTM platform, GSPT1 program, and MRT-2359 advancement, including personnel, laboratory, and third-party service costs, and are **expected to increase substantially**[76](index=76&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - General and administrative expenses consist mainly of personnel costs and professional services, expected to increase due to growth, public company requirements, and potential commercialization efforts[79](index=79&type=chunk) - Non-operating income and expense includes interest income from investments, foreign currency exchange gains/losses, gains on asset disposal, and changes in fair value of preferred stock tranche obligations[80](index=80&type=chunk) [Results of operations for the three months ended March 31, 2022 and 2021](index=19&type=section&id=Results%20of%20operations%20for%20the%20three%20months%20ended%20March%2031%2C%202022%20and%202021) Compares and analyzes operating expenses and net loss for the current and prior year periods Results of Operations (in thousands) | (in thousands) | March 31, 2022 | March 31, 2021 | Dollar change | | :-------------------------- | :------------- | :------------- | :------------ | | Research and development | **$17,915** | **$9,273** | **$8,642** | | General and administrative | **$6,387** | **$2,231** | **$4,156** | | Total operating expenses | **$24,302** | **$11,504** | **$12,798** | | Loss from operations | **$(24,302)** | **$(11,504)** | **$(12,798)** | | Other income (expense) | **$370** | **$(772)** | **$1,142** | | Net loss | **$(23,932)** | **$(12,276)** | **$(11,656)** | - **Research and development expenses increased by $8.6 million**, primarily due to expansion of activities, increased headcount (**77 employees in 2022 vs. 45 in 2021**), and higher laboratory and facility costs[82](index=82&type=chunk)[83](index=83&type=chunk) - **General and administrative expenses increased by $4.2 million**, driven by higher personnel costs (**18 employees in 2022 vs. 12 in 2021**), professional services, and facility costs to support growth[84](index=84&type=chunk) - **Other income (expense) improved by $1.1 million**, mainly due to increased interest income on marketable securities and the absence of preferred stock tranche obligation fair value changes seen in 2021[85](index=85&type=chunk) [Liquidity and capital resources](index=20&type=section&id=Liquidity%20and%20capital%20resources) Details cash flow activities from operations, investing, and financing, and discusses future funding requirements Cash Flow Activities (in thousands) | (in thousands) | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | **$(27,404)** | **$(13,815)** | | Net cash used in investing activities | **$(180,520)** | **$(2,217)** | | Net cash provided by financing activities | **$153** | **$142,769** | | Net increase (decrease) in cash, cash equivalents and restricted cash | **$(207,771)** | **$126,737** | | Cash, cash equivalents and restricted cash—end of period | **$143,638** | **$169,600** | - **Net cash used in operating activities increased to $27.4 million** in Q1 2022 **from $13.8 million in Q1 2021**, primarily due to higher **net loss** and a decrease in working capital[89](index=89&type=chunk)[90](index=90&type=chunk) - **Net cash used in investing activities significantly increased to $180.5 million** in Q1 2022, mainly due to **$179 million in purchases of marketable securities**[91](index=91&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities **will fund operating expenses and capital requirements for at least the next twelve months**, but **additional financing will be required** for future development and operations[95](index=95&type=chunk)[96](index=96&type=chunk) [Critical accounting policies and significant judgments and estimates](index=22&type=section&id=Critical%20accounting%20policies%20and%20significant%20judgments%20and%20estimates) Confirms no significant changes to critical accounting policies from the prior annual report - There have been **no significant changes** to the company's critical accounting policies from those described in its 2021 Annual Report[100](index=100&type=chunk) [Recently issued and adopted accounting pronouncements](index=22&type=section&id=Recently%20issued%20and%20adopted%20accounting%20pronouncements) Refers to Note 2 for a discussion of recent accounting pronouncements - Refer to Note 2, 'Summary of Significant Accounting Policies,' for a discussion of recent accounting pronouncements[101](index=101&type=chunk) [Contractual obligations and commitments](index=22&type=section&id=Contractual%20obligations%20and%20commitments) States no material changes to contractual obligations since the 2021 Annual Report - There have been **no material changes** to the company's contractual obligations and commitments during the three months ended March 31, 2022, from those described in its 2021 Annual Report[102](index=102&type=chunk) [Off-balance sheet arrangements](index=22&type=section&id=Off-balance%20sheet%20arrangements) Confirms the absence of any off-balance sheet arrangements - The company did not have, nor does it currently have, any **off-balance sheet arrangements** as defined under SEC rules[103](index=103&type=chunk) [Emerging growth company status](index=22&type=section&id=Emerging%20growth%20company%20status) Explains the company's status as an emerging growth company and smaller reporting company - The company is an '**emerging growth company**' and has elected to use the extended transition period for complying with new or revised accounting standards[104](index=104&type=chunk) - The company is also a '**smaller reporting company**,' which allows for reduced disclosure obligations regarding executive compensation and financial statements[106](index=106&type=chunk)[107](index=107&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Monte Rosa Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is a **smaller reporting company** and is **not required to provide information** on quantitative and qualitative disclosures about market risk[108](index=108&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures, identifying material weaknesses, outlining the remediation plan, and noting changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=24&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Concludes on the effectiveness of disclosure controls and procedures, noting identified material weaknesses - Management concluded that disclosure controls and procedures were **not effective as of March 31, 2022**, due to **material weaknesses identified** in internal controls[109](index=109&type=chunk) - Identified **material weaknesses** include an **ineffective control environment** (**insufficient accounting resources**), **ineffective risk assessment**, **lack of appropriate control activities for segregation of duties**, and **inadequate documentation of control processes**[110](index=110&type=chunk) [Remediation Plan](index=24&type=section&id=Remediation%20Plan) Outlines the company's plan to address and remediate identified material weaknesses in internal controls - Remediation efforts include **adding finance personnel**, **engaging accounting advisory consultants**, **implementing a new ERP system**, **establishing a disclosure committee**, and **engaging internal control consultants** for risk assessment and control design[111](index=111&type=chunk) - Future remediation activities include **defining user roles in the ERP system for proper segregation of duties**, **documenting remaining controls**, and **performing routine testing of control operating effectiveness**[111](index=111&type=chunk) [Changes in Internal Control over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Reports on any material changes in internal control over financial reporting during the quarter - Except for the remediation efforts of previously identified **material weaknesses**, there were **no material changes in internal control over financial reporting** during the three months ended March 31, 2022[112](index=112&type=chunk) [Inherent Limitations on Effectiveness of Controls](index=25&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls) Acknowledges the inherent limitations of any control system in providing absolute assurance - Management acknowledges that any control system provides **reasonable, not absolute, assurance** of achieving desired control objectives due to inherent judgments and assumptions[113](index=113&type=chunk) PART II. OTHER INFORMATION Contains additional information not included in the financial statements, such as legal proceedings, risk factors, and exhibits [Item 1. Legal proceedings](index=26&type=section&id=Item%201.%20Legal%20proceedings) This section states that the company is not currently party to any legal proceedings or claims that would individually or in aggregate have a material adverse effect on its business - As of March 31, 2022, the company does not believe it is party to any claim or litigation that would have a **material adverse effect** on its business[116](index=116&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the high degree of risk involved in investing in the company's common stock and refers to the comprehensive risk factors discussed in the 2021 Annual Report, with no material changes noted other than those specified - Investing in the company's common stock involves a **high degree of risk**, and investors should consider risks outlined in this report and the 2021 Annual Report[117](index=117&type=chunk) - There have been **no material changes to the risk factors** set forth in the 2021 Annual Report, other than as specifically detailed in this Quarterly Report[118](index=118&type=chunk) [Risks related to our financial position and capital needs](index=26&type=section&id=Risks%20related%20to%20our%20financial%20position%20and%20capital%20needs) Discusses the company's history of operating losses, expected increase in expenses, and future funding requirements - The company has incurred **significant operating losses** since inception, with an **accumulated deficit of $146.0 million** as of March 31, 2022, and **expects continued losses for the foreseeable future**[119](index=119&type=chunk) - Expenses are **expected to significantly increase** due to planned **IND application submission**, **initiation of clinical trials**, preclinical activities for multiple programs (GSPT1, NEK7, CDK2, VAV1, BCL11A), **platform expansion**, **manufacturing**, and **regulatory approvals**[120](index=120&type=chunk)[122](index=122&type=chunk) - The company is **unable to predict the extent of future losses** or **when it will become profitable, if at all**, due to the numerous risks and uncertainties associated with pharmaceutical drug development[121](index=121&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no recent unregistered sales of equity securities and details the use of proceeds from the initial public offering, noting no material change in the planned use of funds [Recent sales of unregistered equity securities](index=28&type=section&id=Recent%20sales%20of%20unregistered%20equity%20securities) Confirms that there have been no recent unregistered sales of equity securities - There have been **no recent sales of unregistered equity securities**[123](index=123&type=chunk) [Use of proceeds from initial public offering of common stock](index=28&type=section&id=Use%20of%20proceeds%20from%20initial%20public%20offering%20of%20common%20stock) Details the use of proceeds from the initial public offering and confirms no material change in planned use - The company received **aggregate net proceeds of $234.6 million** from its **IPO** in June and July 2021, after deducting underwriting discounts and commissions and other offering costs[125](index=125&type=chunk) - There has been **no material change in the planned use of the net proceeds** from the **IPO** as described in the final prospectus dated June 25, 2021[126](index=126&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there have been no defaults upon senior securities - There have been **no defaults upon senior securities**[127](index=127&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are **not applicable to the company**[128](index=128&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) This section discloses a subsequent event regarding a lease termination agreement entered into on May 5, 2022, for the company's Boston office space - On **May 5, 2022**, the company entered into an **Agreement for Termination of Lease**, providing an option to terminate its existing lease for office space at **645 Summer Street, Boston, MA**, **between February 1, 2023, and June 1, 2023**[129](index=129&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including employment agreements, lease termination agreements, and certifications - Key exhibits include the **Amended and Restated Employment Agreement for Philip Nickson**, the **Agreement for Termination of Lease**, and **certifications from the Principal Executive Officer and Principal Financial Officer**[132](index=132&type=chunk)

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 | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

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, 2021 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 ...

[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 _____ ...