• Monte Rosa Therapeutics Reports Third Quarter 2022 Financial Results and Business Updates

    Source: Nasdaq GlobeNewswire / 10 Nov 2022 07:30:00   America/New_York

    – Initiated Patient Dosing in Phase 1/2 Clinical Trial Evaluating MRT-2359, a GSPT1-directed Molecular Glue Degrader, for Treatment of MYC-driven Tumors –

    – Progressed VAV1 Molecular Glue Degrader Program into Lead Optimization –

    BOSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today reported business highlights and financial results for the third quarter, ended September 30, 2022.

    “Throughout 2022, we have made important strides in advancing our QuEEN™ platform and our portfolio of MGDs derived from it, including our GSPT1 degrader MRT-2359. The FDA’s clearance of our first investigational new drug application, along with the recent initiation of patient dosing of MRT-2359 in our clinical trial in MYC-driven tumors, serve as strong validation of our platform, the quality of our team and the level of innovation we are bringing to the field,” said Markus Warmuth, M.D., CEO of Monte Rosa. “We are continually progressing toward our goal of discovering and developing MGDs into a new generation of precision medicines for patients who currently have no real alternatives. With a strong cash position and investor support, we are well positioned to continue to execute on our first clinical program, as well as advance additional discovery programs through lead optimization.”

    THIRD QUARTER 2022 & RECENT HIGHLIGHTS

    • Received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2 clinical trial for MRT-2359, a potent, selective and orally bioavailable GSPT1-directed MGD
    • Recently initiated patient dosing with MRT-2359, evaluating the treatment of MYC-driven solid tumors, including lung cancer
    • Advanced VAV1 degrader program into lead optimization; VAV1 plays a key role in T-cell and B-cell development and activation and is a highly validated target for multiple autoimmune diseases, as well as several types of lymphoma
    • Continued progress of CDK2 and NEK7 programs toward development candidate nominations
    • Entered into collaboration with Professor Sereina Riniker, Ph.D., (ETH Zürich) to integrate molecular dynamics into Monte Rosa’s AI/ML engine for target identification and virtual screening
    • Gave multiple presentations at the 5th Annual Targeted Protein Degradation Summit in October in Boston, which included new and updated preclinical data supporting development of MRT-2359 in MYC-driven lung cancer, and novel AI applications for the discovery of MGDs
    • Presented overview of development of MRT-2359 as a GSPT1-directed MGD to target MYC-driven malignancies at the 34th EORTC-NCI-AACR Symposium on Oct. 28 in Barcelona, Spain

    UPCOMING INVESTOR EVENTS

    Monte Rosa will be participating in the following upcoming investor conferences:

    • Jefferies 13th Annual Global Healthcare Conference, Nov. 15-17, London
    • Piper Sandler 34th Annual Healthcare Conference, Nov. 29-Dec. 1, New York
    • 41st Annual J.P. Morgan Health Care Conference, Jan. 9-12, 2023, San Francisco

    THIRD QUARTER 2022 FINANCIAL RESULTS

    Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were $21.3 million, compared to $15.1 million for the third quarter of 2021. These increases were due to the expansion of R&D activities, including the advancement of MRT-2359 toward clinical development and the development of the company’s QuEEN™ platform and its preclinical programs, as well as increased headcount and laboratory-related expenses due to the company’s continued growth as an R&D organization. R&D expenses for the third quarter of 2022 included non-cash stock-based compensation of $1.7 million and non-cash lease expense of $1.5 million due to a rent holiday on the company’s Harrison Avenue facility lease. The same period in 2021 included non-cash stock-based compensation expense of $1.1 million.

    General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were $7.0 million, compared to $4.8 million for the third quarter of 2021. The increase in G&A expenses was a result of additional expenses incurred in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.5 million for the third quarter of 2022, compared to $1.0 million for the same period in 2021.

    Net Loss: Net loss for the third quarter of 2022 was $27.3 million, compared to $19.8 million for the third quarter of 2021.

    Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash and marketable securities as of September 30, 2022, were $277.4 million, compared to cash, cash equivalents and restricted cash of $299.5 million as of June 30, 2022. The decrease is primarily related to cash used to fund operations of $20.6 million and cash used for fixed assets of $1.4 million, partially off-set by proceeds from the exercise of stock options of $0.1 million. The company expects that its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into late 2024.
            
    About Monte Rosa
    Monte Rosa Therapeutics is a biotechnology company developing a portfolio of novel molecular glue degrader (MGD) medicines. These medicines are designed to employ the body’s natural mechanisms to selectively eliminate therapeutically relevant proteins. The company has developed a proprietary protein degradation platform, called QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates), that enables it to rapidly identify protein targets and MGD product candidates that are designed to eliminate therapeutically relevant proteins in a highly selective manner. The company’s drug discovery platform combines diverse and proprietary chemical libraries of small molecule protein degraders with in-house proteomics, structural biology, AI/machine learning-based target selection, and computational chemistry capabilities to predict and obtain protein degradation profiles. For more information, visit www.monterosatx.com

    Forward-Looking Statements
    This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in herein include, but are not limited to, statements about our product development activities, including our expectations around MRT-2359 and the ongoing development of our QuEEN™ platform, and the advancement of our pipeline and the various products therein, , our expectations of timing for of our clinical trial for MRT-2359, our ability to initiate and the timing of initiation of additional lead optimization programs, and our expectations regarding our ability to nominate and the timing of our nominations of additional development candidates. By their nature, these statements are subject to numerous risks and uncertainties, including the impact that the current COVID-19 pandemic will have on our development activities and operations, as well as those risks and uncertainties set forth in our most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K for the year ended December 31, 2021 filed with the US Securities and Exchange Commission, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research.



    Consolidated Balance Sheets
    (in thousands, except share and per share amounts)
    (unaudited)

      September 30,  December 31, 
      2022  2021 
    Assets      
    Current assets:      
    Cash and cash equivalents $112,394  $346,071 
    Marketable securities  159,755    
    Proceeds receivable from common stock sale  13,507    
    Other receivables  4,050    
    Prepaid expenses and other current assets  4,569   2,595 
    Current restricted cash  960    
    Total current assets  295,235   348,666 
    Property and equipment, net  19,384   12,325 
    Operating lease right-of-use assets  38,534    
    Restricted cash, net of current  4,302   5,338 
    Other long-term assets  148    
    Total assets $357,603  $366,329 
    Liabilities and stockholders’ equity      
    Current liabilities:      
    Accounts payable $9,753  $6,558 
    Accrued expenses and other current liabilities  8,972   10,080 
    Current portion of operating lease liability  3,065    
    Total current liabilities  21,790   16,638 
    Defined benefit plan liability  2,128   2,176 
    Operating lease liability  42,593    
    Total liabilities  66,511   18,814 
    Commitments and contingencies      
    Stockholders’ equity      
    Common stock, $0.0001 par value; 500,000,000 shares authorized, 48,528,247 shares issued
       and 48,372,781 shares outstanding as of September 30, 2022; and 500,000,000 shares authorized,
       46,794,295 shares issued and 46,535,966 shares outstanding as of December 31, 2021
      5   5 
    Additional paid-in capital  493,443   471,566 
    Accumulated other comprehensive loss  (2,602)  (2,021)
    Accumulated deficit  (199,754)  (122,035)
    Total stockholders’ equity  291,092   347,515 
    Total liabilities and stockholders’ equity $357,603  $366,329 



    Consolidated Statement of Operations
    (in thousands, except share and per share amounts)
    (unaudited)
      Three months ended
    September 30,
     
       2022   2021  
    Operating expenses:     
    Research and development $21,342  $15,115  
    General and administrative  7,020   4,753  
    Total operating expenses  28,362   19,868  
    Loss from operations  (28,362)  (19,868) 
    Other income:     
    Interest income, net  997   13  
    Foreign currency exchange gain, net  63   18  
    Loss on disposal of fixed assets  (16)    
    Total other income  1,044   31  
    Net loss $(27,318) $(19,837) 
    Net loss per share attributable to common stockholders—basic and diluted $(0.58) $(0.43) 
    Weighted-average number of shares outstanding used in computing
       net loss per common share—basic and diluted
      46,732,353   45,987,866  

    Contacts:

    Investors
    Shai Biran, Monte Rosa Therapeutics
    ir@monterosatx.com

    Media
    Dan Budwick, 1AB
    dan@1abmedia.com


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