Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage
biotechnology company developing novel molecular glue degrader
(MGD)-based medicines, today reported business highlights and
financial results for the quarter ended March 31, 2023.
“During the first quarter, we made significant progress with our
Phase 1/2 clinical trial of MRT-2359 in MYC-driven solid tumors.
This trial continues to attract top oncologists and academic
centers, and patient enrollment is on track for us to have initial
data to share in the second half of the year. We remain excited
about the prospect of bringing a potential therapeutic option to a
range of indications driven by MYC, one of the most frequently
altered families of oncogenes,” said Markus Warmuth, M.D., CEO of
Monte Rosa. “Furthermore, we expect to declare a development
candidate in our VAV1 program in the second quarter. This milestone
will mark a significant advancement in our pipeline of MGD-based
medicines in the field of immunology and inflammation. We believe
the underlying biology and our preclinical data support the
potential of our VAV1-directed MGD to provide clinical benefit in
multiple autoimmune diseases. Our continued progress with our
pipeline speaks to the power of our QuEEN discovery engine and our
position as a leading molecular glue degrader company. Backed by a
strong balance sheet and a sharp focus on developing impactful
medicines, we look forward to continuing to further the development
of our molecular glue therapeutics.”
FIRST QUARTER 2023 AND RECENT HIGHLIGHTS
- Presented preclinical data highlighting the preferential
activity of MRT-2359, an orally bioavailable GSPT1-directed MGD, in
MYC-driven tumor cells at the American Association for Cancer
Research (AACR) Annual Meeting 2023 in Orlando, FL
- Appointed Jan Skvarka, Ph.D., MBA, an accomplished
biopharmaceutical executive with extensive operational, strategic,
and financial expertise to the Company’s Board of Directors
UPCOMING MILESTONES
- On track to announce initial clinical data, including
pharmacokinetic (PK), pharmacodynamic (PD), safety, and available
initial efficacy data from the Phase 1 part of the ongoing Phase
1/2 clinical trial evaluating MRT-2359 in MYC-driven tumors,
including non-small cell lung cancer, small cell lung cancer, and
other MYC-driven tumors, in the second half of 2023
- On track to advance multiple preclinical programs to
development candidates in immunology, inflammation, and oncology,
including declaring a VAV1 development candidate in the second
quarter of 2023
FIRST QUARTER 2023 FINANCIAL RESULTS
Research and Development (R&D) Expenses:
R&D expenses for the first quarter of 2023 were $26.8 million,
compared to $17.9 million for the first quarter of 2022. These
increases were driven by the successful achievement of key
milestones in our R&D organization, including the advancement
of MRT-2359 in the clinic, the progression of our preclinical
pipeline in lead optimization, and the continued development of the
Company’s QuEEN platform for discovery efforts. The increase in
R&D expenses was driven by increased headcount and
laboratory-related expenses to achieve these milestones. Non-cash
stock-based compensation constituted $2.1 million of R&D
expenses for Q1 2023, compared to $1.2 million in the same period
in 2022.
General and Administrative (G&A) Expenses:
G&A expenses for the first quarter of 2023 were $7.5 million
compared to $6.4 million for the first quarter of 2022. The
increase in G&A expenses was 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 $1.8 million for the first quarter of 2023,
compared to $1.1 million for the same period in 2022.
Net Loss: Net loss for the first quarter of
2023 was $32 million, compared to $23.9 million for the first
quarter of 2022.
Cash Position and Financial Guidance: Cash,
cash equivalents, restricted cash, and marketable securities as of
March 31, 2023, were $237 million, compared to cash, cash
equivalents, and restricted cash of $268.1 million as of December
31, 2022. The decrease of $31.1 million was primarily related to
cash used to fund operations in the first quarter, including a
seasonal reduction in accrued expenses. The company expects that
its cash and cash equivalents will be sufficient to fund currently
planned operations and capital expenditures into 2025.
About MRT-2359MRT-2359 is a potent, selective
and orally bioavailable molecular glue degrader (MGD) that induces
the interaction between the E3 ubiquitin ligase component cereblon
and the translation termination factor GSPT1, leading to the
targeted degradation of GSPT1 protein. The MYC transcription
factors (c‑MYC, L-MYC and N-MYC) are well-established drivers of
human cancers that maintain high levels of protein translation,
which is critical for uncontrolled cell proliferation and tumor
growth. Preclinical studies have shown that this addiction to
MYC-induced protein translation creates a dependency on GSPT1. By
inducing degradation of GSPT1, MRT-2359 exploits this
vulnerability, disrupting the protein synthesis machinery, leading
to anti-tumor activity in MYC-driven tumors.
About VAV1VAV1, a Rho-family guanine nucleotide
exchange factor, is a key signaling protein downstream of both the
T and B cell receptors, whose expression is restricted to blood and
immune cells, including T and B cells. Preclinical studies have
shown that targeted degradation of VAV1 protein via an MGD
modulates both T- and B-cell receptor-mediated activity in vitro
and in vivo, as displayed by a significant decrease in cytokine
secretion, as well as activity in preclinical models of immune
diseases. VAV1-directed MGDs have the potential to provide
therapeutic benefits in multiple autoimmune indications, such as
multiple sclerosis, rheumatoid arthritis, and dermatological
disorders.
About Monte RosaMonte 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. The Company’s lead
program, MRT-2359, is being developed in a Phase 1/2 study in
MYC-driven tumors, including non-small cell lung cancer and
small-cell lung cancer. MGDs are small molecule protein degraders
designed to employ the body’s natural mechanisms to eliminate
therapeutically relevant proteins selectively. 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, A.I./machine
learning, and computational chemistry capabilities. For more
information, visit www.monterosatx.com
Forward-Looking StatementsThis 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 herein
include, but are not limited to, statements about our product
development activities, our ongoing clinical development of our
GSPT1 degrader referred to as MRT-2359, including our expectations
for the nature, significance, and timing for our disclosure of any
initial data from our Phase 1/2 clinical trial of MRT-2359 in
MYC-driven solid tumors, statements about the advancement of our
preclinical programs, pipeline and the various products therein,
including the ongoing development of our VAV1 directed molecular
glue degrader program in the second quarter, our expectations
regarding the potential clinical benefit for this program and our
expectations of timings for the program, statements around the
advancement and application of our pipeline and platform, and
statements concerning our expectations regarding our ability to
nominate and the timing of our nominations of additional targets,
product candidates, and 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 those
risks and uncertainties set forth in our most recent Annual Report
on Form 10-K for the year ended December 31, 2023, filed with the
U.S. Securities and Exchange Commission on March 16, 2023, 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) |
|
|
March 31, |
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
51,847 |
|
|
$ |
54,912 |
|
Marketable securities |
|
|
179,887 |
|
|
|
207,914 |
|
Other receivables |
|
|
2,170 |
|
|
|
7,656 |
|
Prepaid expenses and other current assets |
|
|
5,692 |
|
|
|
4,444 |
|
Current restricted cash |
|
|
960 |
|
|
|
960 |
|
Total current assets |
|
|
240,556 |
|
|
|
275,886 |
|
Property and equipment, net |
|
|
33,266 |
|
|
|
27,075 |
|
Operating lease right-of-use
assets |
|
|
30,534 |
|
|
|
34,832 |
|
Restricted cash, net of
current |
|
|
4,321 |
|
|
|
4,318 |
|
Other long-term assets |
|
|
351 |
|
|
|
278 |
|
Total assets |
|
$ |
309,028 |
|
|
$ |
342,389 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
7,382 |
|
|
$ |
7,862 |
|
Accrued expenses and other current liabilities |
|
|
10,243 |
|
|
|
14,580 |
|
Current portion of operating lease liability |
|
|
2,890 |
|
|
|
3,127 |
|
Total current liabilities |
|
|
20,515 |
|
|
|
25,569 |
|
Defined benefit plan
liability |
|
|
1,512 |
|
|
|
1,533 |
|
Operating lease liability |
|
|
43,275 |
|
|
|
43,874 |
|
Total liabilities |
|
|
65,302 |
|
|
|
70,976 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Common stock, $0.0001 par value;
500,000,000 shares authorized, 49,450,063 shares issued and
49,360,984 shares outstanding as of March 31, 2023; and 500,000,000
shares authorized, 49,445,802 shares issued and 49,323,531 shares
outstanding as of December 31, 2022 |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
507,688 |
|
|
|
503,696 |
|
Accumulated other comprehensive loss |
|
|
(1,393 |
) |
|
|
(1,752 |
) |
Accumulated deficit |
|
|
(262,574 |
) |
|
|
(230,536 |
) |
Total stockholders’ equity |
|
|
243,726 |
|
|
|
271,413 |
|
Total liabilities and stockholders’ equity |
|
$ |
309,028 |
|
|
$ |
342,389 |
|
Consolidated Statement of Operations and Comprehensive
Loss |
(in thousands, except share and per share
amounts) |
(unaudited) |
|
|
Three months endedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
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 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest income, net |
|
|
2,437 |
|
|
|
149 |
|
Foreign currency exchange (loss) gain, net |
|
|
(85 |
) |
|
|
96 |
|
Gain on disposal of fixed assets |
|
|
— |
|
|
|
125 |
|
Loss on sale of marketable securities |
|
|
(131 |
) |
|
|
— |
|
Total other income |
|
|
2,221 |
|
|
|
370 |
|
Net loss |
|
$ |
(32,038 |
) |
|
$ |
(23,932 |
) |
Net loss per share attributable
to common stockholders—basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.51 |
) |
Weighted-average number of shares
outstanding used in computing net loss per common share—basic and
diluted |
|
|
49,347,473 |
|
|
|
46,595,782 |
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(32,038 |
) |
|
$ |
(23,932 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
Provision for pension benefit obligation |
|
|
14 |
|
|
|
34 |
|
Unrealized gain (loss) on available-for-sale securities |
|
|
345 |
|
|
|
(146 |
) |
Comprehensive loss |
|
$ |
(31,679 |
) |
|
$ |
(24,044 |
) |
Investors
Shai Biran, Monte Rosa Therapeutics
ir@monterosatx.com
Media
Courtney Heath, Scient PR
media@monterosatx.com
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