BOSTON, March 16, 2023 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a clinical stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided corporate updates.

“Last year was transformational for Monte Rosa, as we initiated a Phase 1/2 clinical trial with MRT-2359 for the treatment of MYC-driven solid tumors, and advanced our VAV1 program into lead optimization. We have now shown repeatedly that our QuEEN platform has the ability to generate selective molecular glue degraders for therapeutically relevant protein targets, and our pipeline of unique and differentiated MGDs serves as strong validation of QuEEN,” said Markus Warmuth, M.D., CEO of Monte Rosa. “We look forward to presenting the first clinical data for MRT-2359 later this year, as well as nominating multiple development candidates from our pipeline programs. Backed by a strong cash runway, we are well positioned to continue showcasing the unique capabilities of our drug discovery engine and developing new treatment options for patients with serious diseases of high unmet medical need.”

Monte Rosa’s current programs are focused on delivering therapies to targets generally considered undruggable or inadequately drugged in well-characterized biological pathways across clinical indications in oncology, inflammation, immunology, and other diseases with high unmet needs. The Company’s lead program, MRT-2359, is in Phase 1/2 clinical trials. Additional programs focused on the degradation of CDK2 for oncology, VAV1 for autoimmunity and NEK7 for inflammation are at the lead optimization stage, with multiple development candidates expected to be announced in 2023. Further discovery programs are focused on sickle cell disease-related proteins, as well as multiple currently undisclosed targets.

Business Highlights and Recent Developments

2023 Objectives and Upcoming Milestones

Upcoming Data Presentations

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2022 were $24.9 million compared to $18.1 million for the fourth quarter of 2021, and $85.1 million for the year ended December 31, 2022, compared to $57.2 million for the year ended December 31, 2021. The increase in R&D expense was primarily due to the expansion of research and development activities, including the advancement of MRT-2359 into the clinic, pipeline advancement of the VAV1, NEK7 and CDK2 programs, increased headcount and facilities in the United States and Switzerland, and corresponding increases in laboratory-related expenses. R&D expense included non-cash lease expense and non-cash stock compensation expense of $1.6 million and $1.8 million, respectively, for the quarter ended December 31, 2022, and $4.8 million and $6.1 million for the year ended December 31, 2022, respectively. Non-cash stock compensation expense was $1.0 million and $2.6 million for the same periods in 2021.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2022 were $7.6 million compared to $5.3 million for the fourth quarter of 2021, and $27.3 million for the year ended December 31, 2022, compared to $15.7 million for the year ended December 31, 2021. The increase in G&A expenses were a result of increased headcount and expenses in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.6 million for the fourth quarter of 2022 and $5.6 million for the year ended December 31, 2022, compared to $1.0 million and $2.6 million, respectively, for the same periods in 2021.

Net Loss: Net loss for the fourth quarter of 2022 was $30.8 million compared to $23.4 million for the fourth quarter of 2021, and $108.5 million for the year ended December 31, 2022, compared to $74.0 million for the year ended December 31, 2021.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2022, were $268.1 million, compared to $351.4 million as of December 31, 2021. The company expects its cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund planned operations and capital expenditures into 2025.

About Monte Rosa
Monte Rosa Therapeutics is a biotechnology company developing novel molecular glue degrader (MGD) medicines for patients living with serious diseases such as oncology, autoimmune and inflammatory diseases. MGDs are small molecule protein degraders designed to employ the body’s natural mechanisms to selectively eliminate therapeutically relevant proteins. The Company’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) platform enables it to rapidly identify protein targets and design highly selective degraders by combining diverse libraries of proprietary MGDs with in-house proteomics, structural biology, AI/machine learning, and computational chemistry capabilities. 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 potential significance of obtaining Fast Track Designation from the FDA, the ongoing development of our QuEEN™ platform and the advancement of our pipeline and the various products therein, including the timing for initiation of IND-enabling studies for VAV1 and other programs, our expectations regarding and the timing 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, as well as our expectations of success for our programs and the strength of our financial position, among others. By their nature, these statements are subject to numerous risks and uncertainties, including the impact that the COVID-19 pandemic may 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 amounts)
  December 31, 
  2022  2021 
Assets      
Current assets:      
Cash and cash equivalents $54,912  $346,071 
Marketable securities  207,914   — 
Other receivables  7,656   — 
Prepaid expenses and other current assets  4,444   2,595 
Current restricted cash  960   — 
Total current assets  275,886   348,666 
Property and equipment, net  27,075   12,325 
Operating lease right-of-use assets  34,832   — 
Restricted cash, net of current  4,318   5,338 
Other long-term assets  278   — 
Total assets $342,389  $366,329 
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $7,862  $6,558 
Accrued expenses and other current liabilities  14,580   10,080 
Current portion of operating lease liability  3,127   — 
Total current liabilities  25,569   16,638 
Defined benefit plan liability  1,533   2,176 
Operating lease liability  43,874   — 
Total liabilities  70,976   18,814 
Commitments and contingencies      
Stockholders’ equity      
Common stock, $0.0001 par value; 500,000,000 shares authorized, 49,445,802 shares issued and 49,323,531 shares outstanding as of December 31, 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  503,696   471,566 
Accumulated other comprehensive loss  (1,752)  (2,021)
Accumulated deficit  (230,536)  (122,035)
Total stockholders’ equity  271,413   347,515 
Total liabilities and stockholders’ equity $342,389  $366,329 


Consolidated Statements of Operations and Comprehensive Income (Loss)
(In thousands, except share and per share amounts)
  Three months ended
December 31,		  Year ended
December 31,		 
  2022  2021  2022  2021 
Operating expenses:            
Research and development $24,868  $18,130  $85,061  $57,155 
General and administrative  7,621   5,257   27,323   15,727 
Total operating expenses  32,489   23,387   112,384   72,882 
Loss from operations  (32,489)  (23,387)  (112,384)  (72,882)
Other income (expense):            
Interest income, net  1,990   13   3,764   46 
Foreign currency exchange gain (loss), net  (283)  (66)  10   (162)
Gain on disposal of fixed assets  —   —   109   — 
Changes in fair value of preferred stock tranche obligations, net  —   —   —   (960)
Total other income (expense)  1,707   (53)  3,883   (1,076)
Net loss $(30,782) $(23,440) $(108,501) $(73,958)
Net loss per share attributable to common stockholders—basic and diluted $(0.63) $(0.50) $(2.30) $(2.96)
Weighted-average number of shares outstanding used in computing
net loss per common share—basic and diluted		  48,893,160   46,509,897   47,227,370   25,000,124 
Net loss $(30,782) $(23,440) $(108,501) $(73,958)
Other comprehensive income (loss):            
Provision for pension benefit obligation  619   (71)  718   (965)
Unrealized gain (loss) on available-for-sale securities  231   —   (449)  — 
Comprehensive loss $(29,932) $(23,511) $(108,232) $(74,923)


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

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