Full Press Release Details
Monte Rosa Therapeutics Announces First Development Candidate and Reports Third Quarter 2021 Financial
Results and Business Updates
Initiated Investigational New Drug (IND)-Enabling Activities for
MRT-2359, a Molecular Glue Degrader Selectively Targeting GSPT1
Preclinical Data at AACR-NCI-EORTC Highlighting the Potential of GSPT1-directed Molecular Glue Degraders for the Treatment of Myc-driven Cancers
BOSTON, Nov. 10, 2021 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue-based precision
medicines, today reported business highlights and financial results for the third quarter, ended Sept. 30, 2021.
This year has been marked by
several exciting and significant milestones for Monte Rosa, culminating in the naming of our first development candidate, MRT-2359, selectively targeting GSPT1 for the treatment of cancers driven by one of the
Myc family genes, said Markus Warmuth, M.D., CEO of Monte Rosa. Preclinical data recently presented at AACR-NCI-EORTC underscores the potential of our
molecular glue degraders to differentially induce cell death in Myc-addicted tumors. With the selection of MRT-2359 as our lead candidate, we are now positioned to rapidly advance our clinical development plan
in both solid tumors and hematological malignancies. We have initiated IND-enabling studies and look forward to submitting our first IND to the FDA in mid-2022.
Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa, added, Advancing our first development candidate into
IND-enabling activities is one of the most important milestones for our company to date. On a similar trajectory, our NEK7 degrader program has progressed into lead optimization, and we expect at least one
additional program to move into lead optimization in 2021. In parallel, we continue to make important progress in the development of our unique and proprietary QuEEN platform and compound
library, bringing us closer to our goal of tackling the previously undruggable target protein universe and fostering a new generation of precision medicine therapeutics.
THIRD QUARTER 2021 & RECENT HIGHLIGHTS
UPCOMING MILESTONES + EVENTS
THIRD QUARTER 2021 FINANCIAL RESULTS
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $15.1 million, compared to
$5.5 million for the third quarter of 2020. The increase in R&D expense was primarily due to the expansion of research and development activities, including the advancement of development candidate
MRT-2359, increased headcount and facilities in the United States and Switzerland, as well as corresponding increases in laboratory-related expenses.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2021 were $4.8 million, compared to
$0.9 million for the third quarter of 2020. 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.
Net Loss: Net loss for the third quarter of 2021 was $19.8 million, compared to $6.6 million
for the third quarter of 2020.
Cash Position and Financial Guidance: Cash and cash equivalents as of Sept. 30,
2021, were $367.0 million, compared to $41.7 million as of December 31, 2020. The company expects its cash and cash equivalents, including the aggregate net proceeds from the initial public offering, will be sufficient to
fund planned operations and capital expenditures into late 2024.
Monte Rosa Therapeutics is a biotechnology company developing a portfolio of novel molecular glue degrader precision 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 QuEENTM
(Quantitative and Engineered Elimination of Neosubstrates), that enables it to rapidly identify protein targets and molecular glue degrader, or 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. Monte Rosa was launched from founding investor Versant Ventures Ridgeline Discovery
Engine and is headquartered in Boston, Mass., with research operations in both Boston and Basel, Switzerland.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but
are not limited to, statements regarding MRT-2359 including the timing for filing of an IND with the U.S. FDA, the development of the NEK7 and other programs, including timing for lead optimization and
development candidate selection in each program, and the Company s expected cash runway. Any forward-looking statements in this statement are based on management s current expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the
success, cost, and timing of the Company s program development activities and IND-enabling studies, the Company s ability to execute on its strategy, regulatory developments in the United States, the
Company s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company s clinical trials and pre-clinical studies,
supply chain, and operations, as well as those risks and uncertainties set
forth in its registration statement on form S-1 filed, the quarterly report on Form 10-Q to be filed for the
quarter ended September 30, 2021, and its other filings with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company
undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Consolidated Balance Sheets |
| (in thousands, except share and per share amounts) |
| (unaudited) |
| (in thousands, except share and per share amounts) (unaudited) | September 30, | December 31, | ||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 367,034 | $ | 41,699 | ||||
| Prepaid expenses and other current assets | 3,485 | 1,892 | ||||||
| Total current assets | 370,519 | 43,591 | ||||||
| Property and equipment, net | 11,801 | 4,623 | ||||||
| Restricted cash | 1,729 | 1,164 | ||||||
| Total assets | $ | 384,049 | $ | 49,378 | ||||
| Liabilities, convertible preferred stock and stockholders deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,530 | $ | 7,066 | ||||
| Accrued expenses and other current liabilities | 9,213 | 2,529 | ||||||
| Preferred stock tranche obligations | 19,680 | |||||||
| Total current liabilities | 12,743 | 29,275 | ||||||
| Defined benefit plan liability | 2,001 | 1,067 | ||||||
| Total liabilities | 14,744 | 30,342 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, $0.0001 par value; 10,000,000 shares authorized, an no shares issued and outstanding as of September 30, 2021; and 77,631,514 shares authorized and 53,631,514 shares issued and outstanding as of December 31, 2020 | 67,764 | |||||||
| Stockholders equity (deficit) | ||||||||
| Common stock, $0.0001 par value; 500,000,000 shares authorized, 46,780,847 shares issued and 46,483,918 shares outstanding as of September 30, 2021; and 97,500,000 shares authorized, 2,180,803 shares issued and 1,685,534 shares outstanding as of December 31, 2020 | 5 | 1 | ||||||
| Additional paid-in capital | 469,845 | 404 | ||||||
| Accumulated other comprehensive loss | (1,950 | ) | (1,056 | ) | ||||
| Accumulated deficit | (98,595 | ) | (48,077 | ) | ||||
| Total stockholders equity (deficit) | 369,305 | (48,728 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 384,049 | $ | 49,378 |
| Consolidated Statements of Operations and Comprehensive Loss |
| (in thousands, except share and per share amounts) |
| (unaudited) |
| (in thousands, except share and per share amounts) (unaudited) | Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 15,115 | $ | 5,472 | $ | 39,025 | $ | 14,142 | ||||||||
| General and administrative | 4,753 | 914 | 10,470 | 1,932 | ||||||||||||
| Total operating expenses | 19,868 | 6,386 | 49,495 | 16,074 | ||||||||||||
| Loss from operations | (19,868 | ) | (6,386 | ) | (49,495 | ) | (16,074 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 13 | 2 | 33 | |||||||||||||
| Foreign currency exchange gain (loss), net | 18 | (174 | ) | (96 | ) | (149 | ) | |||||||||
| Changes in fair value of preferred stock tranche obligations, net | (960 | ) | ||||||||||||||
| Total other (expense) income | 31 | (172 | ) | (1,023 | ) | (149 | ) | |||||||||
| Net loss | $ | (19,837 | ) | $ | (6,558 | ) | $ | (50,518 | ) | $ | (16,223 | ) | ||||
| Provision for pension benefit obligation | (535 | ) | (894 | ) | ||||||||||||
| Comprehensive loss | $ | (20,372 | ) | $ | (6,558 | ) | $ | (51,412 | ) | $ | (16,223 | ) | ||||
| Reconciliation of net loss to net loss attributable to common stockholders | ||||||||||||||||
| Net loss | $ | (19,837 | ) | $ | (6,558 | ) | $ | (50,518 | ) | $ | (16,223 | ) | ||||
| Net loss per share attributable to common stockholders basic and diluted | $ | (0.43 | ) | $ | (4.29 | ) | $ | (2.85 | ) | $ | (11.01 | ) | ||||
| Weighted-average number of shares outstanding used in computing net loss per common share basic and diluted | 45,987,866 | 1,529,881 | 17,751,410 | 1,474,045 |
Michael Morabito, Solebury Trout