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 001-40522 | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | Common st ...

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 ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited condensed consolidated financial statements for Monte Rosa Therapeutics, Inc. for Q1 2023, including balance sheets, operations, equity, cash flows, and notes [Condensed Consolidated Balance Sheets (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) Total assets decreased to **$309.0 million** from **$342.4 million** as of March 31, 2023, primarily due to reduced cash and marketable securities, with liabilities and equity also declining Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $51,847 | $54,912 | | Marketable securities | $179,887 | $207,914 | | Total current assets | $240,556 | $275,886 | | Total assets | $309,028 | $342,389 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $20,515 | $25,569 | | Total liabilities | $65,302 | $70,976 | | Total stockholders' equity | $243,726 | $271,413 | | Total liabilities and stockholders' equity | $309,028 | $342,389 | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) Net loss for Q1 2023 increased to **$32.0 million** (or **$0.65** per share) from **$23.9 million** in Q1 2022, driven by higher R&D operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $26,755 | $17,915 | | General and administrative | $7,504 | $6,387 | | **Total operating expenses** | **$34,259** | **$24,302** | | Loss from operations | ($34,259) | ($24,302) | | Interest income, net | $2,437 | $149 | | **Net loss** | **($32,038)** | **($23,932)** | | Net loss per share | ($0.65) | ($0.51) | [Condensed Consolidated Statements of Stockholders' Equity (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Unaudited)) Total stockholders' equity decreased from **$271.4 million** to **$243.7 million** as of March 31, 2023, primarily due to the **$32.0 million** net loss, partially offset by stock-based compensation Changes in Stockholders' Equity (in thousands) | Description | Amount | | :--- | :--- | | Balance at January 1, 2023 | $271,413 | | Stock-based compensation expense | $3,974 | | Net Loss | ($32,038) | | Other changes | $367 | | **Balance at March 31, 2023** | **$243,726** | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Net cash used in operating activities was **$23.4 million** for Q1 2023, with investing activities providing **$20.3 million**, leading to a **$3.1 million** decrease in total cash and equivalents Cash Flow Summary (in thousands) | Activity | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($23,406) | ($27,404) | | Net cash provided by (used in) investing activities | $20,326 | ($180,520) | | Net cash provided by financing activities | $18 | $153 | | **Net decrease in cash, cash equivalents and restricted cash** | **($3,062)** | **($207,771)** | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Detailed notes explain accounting policies, the company's biotechnology business, liquidity, lease commitments, collaboration agreements, and equity structure, including stock-based compensation - The company is a biotechnology firm developing small molecule medicines to degrade therapeutically-relevant proteins, with operations in Boston and Basel, Switzerland[25](index=25&type=chunk) - As of March 31, 2023, the company had cash, cash equivalents, and marketable securities of **$231.7 million**, which it expects will be sufficient to fund operations and capital requirements for at least **12 months** from the report's issuance date[28](index=28&type=chunk) - The company has a license and collaboration agreement with CRT and the ICR, which may require future milestone payments up to **$7 million** for a first product and **$3.5 million** for subsequent products, plus low single-digit royalties on net sales[53](index=53&type=chunk)[56](index=56&type=chunk) - Total unrecognized stock-based compensation cost as of March 31, 2023, was **$44.4 million** (**$43.7 million** for options, **$0.1 million** for restricted stock, and **$0.6 million** for RSUs), expected to be recognized over a weighted average period of approximately **2.8 years**[76](index=76&type=chunk) [Item 2. 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 Q1 2023 financial performance, highlighting increased operating losses from R&D expansion, and confirms sufficient liquidity for at least the next twelve months to advance its drug pipeline [Results of Operations](index=20&type=section&id=Results%20of%20operations%20for%20the%20three%20months%20ended%20March%2031%2C%202023%20and%202022) Operating loss for Q1 2023 increased to **$34.3 million** from **$24.3 million** in Q1 2022, driven by higher R&D and G&A expenses due to expanded activities and headcount Comparison of Operating Results (in thousands) | Item | Q1 2023 | Q1 2022 | Dollar Change | | :--- | :--- | :--- | :--- | | Research and development | $26,755 | $17,915 | $8,840 | | General and administrative | $7,504 | $6,387 | $1,117 | | **Total operating expenses** | **$34,259** | **$24,302** | **$9,957** | | **Loss from operations** | **($34,259)** | **($24,302)** | **($9,957)** | - The increase in R&D expenses was primarily due to the expansion of research activities in the U.S. and Switzerland, including increased headcount, facility costs, and laboratory expenses. R&D headcount grew from **77 to 109** year-over-year[96](index=96&type=chunk)[97](index=97&type=chunk) - The increase in G&A expenses was mainly due to higher personnel costs, including a rise in stock compensation from **$1.1 million** to **$1.8 million**, to support the company's growth[98](index=98&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20capital%20resources) As of March 31, 2023, the company had **$237.0 million** in cash and equivalents, deemed sufficient for at least the next twelve months, though additional financing will be required for future clinical development - As of March 31, 2023, the company had **$237.0 million** in cash, cash equivalents, restricted cash, and marketable securities[100](index=100&type=chunk)[130](index=130&type=chunk) - The company expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements for at least the next **twelve months**[108](index=108&type=chunk) - Net cash used in operating activities was **$23.4 million** for Q1 2023, compared to **$27.4 million** in Q1 2022[101](index=101&type=chunk)[102](index=102&type=chunk) - The company will require additional financing to advance its product candidates through clinical development and will seek funds through equity or debt offerings, or collaborations[109](index=109&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Monte Rosa Therapeutics is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Monte Rosa Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[121](index=121&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023[123](index=123&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or were reasonably likely to materially affect, these controls[124](index=124&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) As of March 31, 2023, the company is not party to any legal proceedings expected to have a material adverse effect on its business, though claims may arise in the ordinary course - The company is not currently party to any claim or litigation that is expected to have a material adverse effect on its business[127](index=127&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the 2022 Annual Report, reiterating significant operating losses since inception and expected continuation due to ongoing R&D and clinical trial activities - The company has incurred significant operating losses since inception and anticipates these will continue for the foreseeable future[130](index=130&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of **$262.6 million**[130](index=130&type=chunk) - Future expenses are expected to increase significantly due to activities such as conducting clinical trials for MRT-2359, advancing preclinical programs (NEK7, CDK2, VAV1, SCD), submitting IND applications, and expanding manufacturing capabilities[130](index=130&type=chunk)[131](index=131&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) No unregistered sales of equity securities occurred during the period, and no material change in the planned use of **$234.6 million** net IPO proceeds was reported - There were no unregistered sales of equity securities in the reporting period[135](index=135&type=chunk) - The company received net proceeds of **$234.6 million** from its IPO in June/July 2021, and there has been no material change in the planned use of these funds[138](index=138&type=chunk)[139](index=139&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[140](index=140&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[141](index=141&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents and required certifications

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 ...

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