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Monte Rosa Therapeutics Q3 revenue reaches $54.4M

A $50 million Novartis milestone was recognized in quarterly revenue, and a second Phase 2 start triggered another $37.5 million in October.

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Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

Monte Rosa Therapeutics reported third-quarter 2026 collaboration revenue of $54.4 million, versus $12.8 million a year earlier, and net income of $3.1 million, versus a $27.1 million loss. Revenue included recognition of a $50.0 million milestone triggered by Novartis’s Phase 2 study initiation in Sjögren’s disease. For the first nine months, revenue was $67.5 million versus $120.9 million, and the company recorded a net loss of $84.8 million versus net income of $7.5 million.

In a Phase 1 study involving 108 subjects, MRT-8102 achieved median NEK7 degradation of approximately 80% to 90% across three dose levels; adverse-event rates were similar to placebo, with no serious adverse events. Monte Rosa expects Phase 2 studies in gout in Q4 2026 and in coronary artery disease and hidradenitis suppurativa in H1 2027. Novartis’s October start of a Phase 2 MRT-6160 psoriatic arthritis study triggered a $37.5 million milestone. Cash, cash equivalents, restricted cash and marketable securities were $582.6 million as of September 30, 2026; the October milestone payment had not been received by that date, and the company expects these resources to support operations into 2029.

2 points · 0 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 2 points

How the balance works

Positive

  • Moderate pointThird-quarter collaboration revenue: $54.4 million, versus $12.8 million in 2025.
  • Minor pointThird-quarter net income: $3.1 million, versus a $27.1 million loss.

Negative

  • Moderate pointNine-month net loss: $84.8 million, versus $7.5 million net income in 2025.
  • Minor pointNine-month collaboration revenue: $67.5 million, versus $120.9 million in 2025.

Filing Explained

At September 30, 2026, Monte Rosa reported 85,431,211 shares issued and outstanding, versus 65,543,723 at December 31, 2025; a holder whose share count did not change therefore held a smaller percentage of the company.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Third-quarter collaboration revenue $54.4 million Three months ended September 30, 2026; compared with $12.8 million in 2025.
Third-quarter net income $3.1 million Three months ended September 30, 2026; compared with a $27.1 million net loss in 2025.
Research and development expenses $45.4 million Third quarter of 2026; compared with $36.7 million in 2025.
General and administrative expenses $10.9 million Third quarter of 2026; compared with $9.1 million in 2025.
Nine-month collaboration revenue $67.5 million Nine months ended September 30, 2026; compared with $120.9 million in 2025.
Nine-month net loss $84.8 million Nine months ended September 30, 2026; compared with $7.5 million net income in 2025.
Cash, cash equivalents, restricted cash, and marketable securities $582.6 million As of September 30, 2026.
molecular glue degrader (MGD) technical
"developing highly selective molecular glue degrader (MGD) medicines"
NEK7 degradation technical
"achieved median NEK7 degradation of approximately 80% to 90%"
fat attenuation index (FAI) medical
"imaging-based coronary artery plaque assessment, such as fat attenuation index (FAI)"
radiographic progression-free survival medical
"Endpoints include PSA response, RECIST response, duration of response, radiographic progression-free survival"
The length of time during which a patient’s cancer does not get worse on medical imaging scans; it is measured from the start of treatment until scans show tumor growth or new lesions. Investors care because it’s a common measure used in clinical trials to signal whether a therapy is working — like a stopwatch showing how long a treatment keeps disease stable — and strong results can influence regulatory approval, sales potential and stock value.
collaboration receivable financial
"Collaboration receivable"
Collaboration revenue $54.4 million Compared with $12.8 million in the third quarter of 2025.
Research and development expenses $45.4 million Compared with $36.7 million in the third quarter of 2025.
General and administrative expenses $10.9 million Compared with $9.1 million in the third quarter of 2025.
Net income (loss) $3.1 million net income Compared with a $27.1 million net loss in the third quarter of 2025.
Cash, cash equivalents, restricted cash, and marketable securities $582.6 million As of September 30, 2026.
Guidance

Cash, cash equivalents, restricted cash, and marketable securities are expected to support operations into 2029.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much revenue and net income did GLUE report for the third quarter of 2026?

Monte Rosa reported $54.4 million in collaboration revenue and $3.1 million in net income for the third quarter of 2026. The comparable 2025 figures were $12.8 million in collaboration revenue and a $27.1 million net loss; the 2026 revenue included recognition of a $50.0 million Novartis milestone.

What Phase 2 milestone payments did Novartis trigger for Monte Rosa?

Novartis’s Phase 2 study initiations in Sjögren’s disease and psoriatic arthritis triggered $50.0 million and $37.5 million in milestone payments, respectively, for $87.5 million in total Phase 2 milestone payments to date. The psoriatic arthritis milestone was triggered in October, after the third quarter.

How many patients can the GLUE MODeFIRe-1 study enroll, and what is the MRT-2359 schedule?

MODeFIRe-1 will enroll up to 25 patients with AR-mutant metastatic castration-resistant prostate cancer who received prior treatment with a second-generation androgen receptor inhibitor. MRT-2359 is administered orally at 0.5 mg on a 21-days-on, 7-days-off schedule.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false000182645700018264572026-11-052026-11-05

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2026

MONTE ROSA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40522

84-3766197

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(I.R.S. Employer
Identification No.)

321 Harrison Avenue, Suite 900

Boston, MA 02118

(Address of principal executive offices, including zip code)

(617) 949-2643

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange
on which registered

Common Stock, $0.0001 par value per share

GLUE

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 


 

Item 2.02. Results of Operations and Financial Condition

On November 5, 2026, Monte Rosa Therapeutics, Inc. (the "Company") announced its financial results for the quarter ended September 30, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information under Item 2.02 in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

99.1

Press Release issued by Monte Rosa Therapeutics, Inc. dated November 5, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 


 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

 

 

 

Monte Rosa Therapeutics, Inc.

 

 

 

 

Date: November 5, 2026

 

By:

/s/ Markus Warmuth

 

 

 

Markus Warmuth

 

 

 

President and Chief Executive Officer

 

 

 


img106802192_0.jpg

Exhibit 99.1

 

Monte Rosa Therapeutics Announces Third Quarter 2026 Financial Results and Business Updates

 

Positive GFORCE-1 Phase 1 results showed MRT-8102 reduced key pathogenic drivers of atherosclerotic cardiovascular disease (ASCVD) to levels comparable to healthy volunteers across all three dose levels, with treatment-emergent adverse event rates comparable to placebo; Phase 2 initiation in coronary artery disease anticipated in H1 2027

 

Initiation of Phase 2 study of MRT-8102 in gout expected in Q4 2026, with data update expected in H2 2027; additional Phase 2 initiation in hidradenitis suppurativa anticipated in H1 2027

 

Initiated MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in heavily pretreated metastatic castration-resistant prostate cancer (mCRPC) patients with androgen receptor (AR) mutations; Phase 2 data update expected in 2027; updated Phase 1/2 study data expected this year

 

Novartis initiated Phase 2a/b studies of VAV1-directed MGD MRT-6160 (DDY391) in Sjögren’s disease and psoriatic arthritis, triggering a total of $87.5 million in Phase 2 milestone payments to date to Monte Rosa

 

Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of $582.6 million (not including MRT-6160 Phase 2 initiation milestones) as of September 30, 2026, expected to support operations into 2029

 

 

BOSTON, Mass., Nov. 5, 2026 – Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced business highlights and financial results for the third quarter ended September 30, 2026.

 

“The last quarter marks a tremendously important step forward for our clinical portfolio, with a positive readout from the GFORCE-1 study of MRT-8102, the initiation of Phase 2 development for MRT-2359, and the advancement of our partnered VAV1 program into two Phase 2 studies,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “The GFORCE-1 results reinforce our view that targeting NEK7 at the top of the NLRP3 signaling cascade could address a broader set of disease drivers than targeting individual downstream cytokines. Our planned Phase 2 studies in coronary artery disease (CAD), gout, and hidradenitis suppurativa, conditions with major unmet needs, are intended to deepen our understanding of the therapeutic potential of NEK7 degradation. In CAD, our innovative study design integrates molecular and imaging-based readouts to explore how MRT-8102’s broad biological activity translates into changes in coronary plaque biology, to inform patient selection and design for an efficient future Phase 3 study.”

 

Dr. Warmuth continued: “We are particularly excited about the opportunity in gout, where there is a substantial unmet need for effective flare prevention that is well tolerated with prolonged use. With the emergence of next-generation urate-lowering drugs and their propensity to induce flares in the first 6 to 12 months of use, we believe the need for a well-tolerated, non-immunosuppressive flare prevention treatment will only increase. We expect initial data from our Phase 2 gout study in H2 2027. Across the broader pipeline, we are pursuing a focused development strategy for MRT-2359 through MODeFIRe-1, evaluating its potential in combination with apalutamide in mCRPC patients with AR mutations. We have shown previously that degradation of GSPT1 dampens MYC signaling in CRPC, a pathway we believe is

 

 


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moving to center stage for new treatment options in CRPC. We look forward to a data update from this Phase 2 study in 2027, as well as a final data update from our completed Phase 1/2 study of MRT-2359 in combination with enzalutamide by year-end. Novartis’s advancement of MRT-6160 (DDY391) into Phase 2 studies in Sjögren’s disease and psoriatic arthritis expands the evaluation of VAV1 degradation across immune-mediated diseases and brings additional non-dilutive funding to Monte Rosa. With our balance sheet expected to support operations into 2029, we are well positioned to pursue these opportunities while maintaining a disciplined focus on generating clinical evidence and advancing our pipeline.”

 

RECENT HIGHLIGHTS

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by NEK7/NLRP3 and IL-1

•
In October, Monte Rosa reported positive results from GFORCE-1 (NCT07119125), a Phase 1 study of MRT-8102 in 108 obese subjects with elevated cardiovascular disease risk. Across all three dose levels, MRT-8102 achieved median NEK7 degradation of approximately 80% to 90%. MRT-8102 also resulted in substantial reductions of IL-1β as well as HMGB1, calprotectin, S100A12, and SAA, damage-associated molecular patterns (DAMPs) linked to pathogenic biology within atherosclerotic plaques and vessel walls. MRT-8102 was well tolerated, with no serious adverse events, adverse event rates similar to placebo, and no evidence of increased infection risk.
•
With dose selection informed by the GFORCE-1 data, Monte Rosa plans to initiate three Phase 2 studies of MRT-8102:
o
GEMINI-1, a Phase 2 study in patients with gout, is expected to initiate in Q4 2026. The study will evaluate prevention of flare recurrence following management of acute flares, with initial data expected in H2 2027.
o
GFORCE-2, a focused Phase 2b study in patients with stable coronary artery disease and residual inflammation, is expected to initiate in H1 2027. The study is expected to evaluate imaging-based coronary artery plaque assessment, such as fat attenuation index (FAI), along with NLRP3 genetics and molecular drivers of local disease pathogenesis and systemic inflammation, to inform the design of an innovative and efficient Phase 3 study focused on the most disease-modifiable patient population.
o
GALAXY-1, a Phase 2 study in patients with moderate to severe hidradenitis suppurativa, is expected to initiate in H1 2027.
•
Due to prioritization of the MRT-8102 Phase 2 study initiations, Investigational New Drug (IND) submission for the next-generation NEK7 MGD is now anticipated in 2027.

 

MRT-2359, GSPT1-directed MGD for mCRPC

•
In August, Monte Rosa dosed the first patient in MODeFIRe-1 (NCT07745361), a Phase 2 study of MRT-2359 in combination with apalutamide in AR-mutant mCRPC patients who received prior treatment with a second-generation AR inhibitor. The study will enroll up to 25 patients, with MRT-2359 administered orally at 0.5 mg on a 21 days on, 7 days off schedule. Endpoints include PSA response, RECIST response, duration of response, radiographic progression-free survival, PSA progression-free survival, and safety. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the study.
•
Enrollment in the initial Phase 1/2 study expansion arm, in patients with mCRPC, has been completed. A total of 6 patients with AR mutations were enrolled and treated with MRT-2359 in combination with enzalutamide. Monte Rosa plans to provide an update on this patient subset by the end of the year. Interim data were presented at the ASCO Genitourinary Cancers Symposium (ASCO GU) in February.

 

 


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MRT-6160 (DDY391), VAV1-directed MGD for immune-mediated conditions

•
In September, Monte Rosa announced achievement of a milestone associated with its collaborator Novartis initiating a global Phase 2a/b randomized, double-blind, placebo-controlled study (NCT07737743), evaluating the efficacy, safety, and tolerability of up to 52 weeks of treatment with MRT-6160 (DDY391) in participants with Sjögren’s disease. The first patient visit triggered a $50 million milestone payment to Monte Rosa.
•
In October, Monte Rosa announced achievement of an additional milestone associated with Novartis initiating a second Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis (PsA). The Phase 2a/b randomized, double-blind, placebo-controlled, multicenter study (NCT07801495) will evaluate the efficacy, safety, tolerability, and dose-response relationship of MRT-6160 (DDY391). The first patient visit triggered a $37.5 million milestone payment to Monte Rosa.
•
The Sjögren’s and PsA studies are the first two of several studies expected for MRT-6160 (DDY391). Under its global exclusive development and commercialization license agreement with Novartis, Monte Rosa is eligible for additional Phase 2 study initiation milestone payments.

 

CDK2 and Cyclin E1-directed MGD programs for solid tumors

•
Monte Rosa expects to submit IND applications for its CDK2 and cyclin E1 (CCNE1)-directed MGD programs in 2027.

 

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and inflammation programs

•
Initiate GEMINI-1 Phase 2 study of MRT-8102 in gout in Q4 2026, with initial data expected in H2 2027.
•
Initiate GFORCE-2 Phase 2b study of MRT-8102 in stable coronary artery disease in H1 2027.
•
Initiate GALAXY-1 Phase 2 study of MRT-8102 in moderate to severe hidradenitis suppurativa in H1 2027.
•
Monte Rosa expects its collaborator, Novartis, to initiate additional Phase 2 studies of MRT-6160 (DDY391) in immune-mediated diseases.

 

Oncology programs

•
Provide a clinical data update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in mCRPC by the end of 2026.
•
Provide a clinical data update on the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations in 2027.
•
Submit an IND application for a CDK2-directed MGD in 2027.
•
Submit an IND application for a CCNE1-directed MGD in 2027.

 

THIRD QUARTER 2026 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the third quarter of 2026 was $54.4 million, compared to $12.8 million for the third quarter of 2025. The increase was primarily driven by recognition of collaboration revenue from the $50.0 million milestone triggered by the initiation of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with Sjögren's disease. The $37.5 million milestone triggered by the initiation of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with psoriatic arthritis in October is not reflected in third quarter collaboration revenue as it was triggered after the end of the quarter. Collaboration revenue represents amounts earned from Monte Rosa’s collaboration and license agreements with Roche and Novartis.

 

 


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Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $45.4 million, compared to $36.7 million for the third quarter of 2025. The increase was primarily driven by increased spending on development and discovery programs. R&D expenses included non-cash stock-based compensation of $3.3 million for the third quarter of 2026, compared to $2.5 million in the same period in 2025.

 

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were $10.9 million, compared to $9.1 million for the third quarter of 2025. G&A expenses included non-cash stock-based compensation of $3.0 million for the third quarter of 2026, compared to $1.9 million in the same period in 2025.

 

Net Income (Loss): Net income for the third quarter of 2026 was $3.1 million, compared to a net loss of $27.1 million for the third quarter of 2025.

 

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2026, were $582.6 million, compared to $626.0 million as of June 30, 2026. The decrease of $43.4 million was primarily due to operational use of cash. In September, Monte Rosa announced achievement of a $50 million milestone associated with the first patient visit of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with Sjögren’s disease. In October, Monte Rosa announced achievement of a $37.5 million milestone associated with the first patient visit of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis. Cash receipts from these milestones are not reflected in the September 30th cash balance as the payments had not yet been received as of that date. Monte Rosa expects that its cash, cash equivalents, restricted cash, and marketable securities will support operations into 2029.

 

About Monte Rosa

Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology, and neurology. 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 herein include, but are not limited to, statements about our ability to grow our product pipeline, our ability to successfully complete research and further development and

 


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commercialization of our drug candidates in current or future indications, including the timing and results of our clinical trials and our ability to conduct and complete clinical trials, statements regarding our progress and speed of development of only-in-class and first-in-class molecular glue degrader therapeutics, statements about our QuEEN™ discovery engine and the broad potential applications of the platform and our ability to create long-term value through focused pipeline execution and strategic collaborations, as well as to expand the targetable protein space for MGD drug discovery, statements about our potential to rationally design MGDs with unprecedented selectivity, statements about the advancement and timeline of our preclinical and clinical programs, pipeline and the various products therein, including (i) the ongoing development of our VAV1-directed degrader, referred to as MRT-6160 (DDY391), including the initiation of Phase 2 clinical studies in Sjögren's disease and psoriatic arthritis by our collaborator Novartis, our expectations regarding the milestone payments triggered by the initiation of such Phase 2 studies, additional Phase 2 study activations expected to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases, our eligibility for additional Phase 2 study initiation milestone payments, (ii) the ongoing development of our NEK7-directed MGD, referred to as MRT-8102, including the positive results from the GFORCE-1 Phase 1 study and the clinical significance of the data observed, statements regarding the potential of MRT-8102 to normalize local and systemic pathologic drivers of ASCVD and to provide differentiated clinical impact across NEK7/NLRP3-driven inflammatory diseases, including compared with targeting individual downstream cytokines, our expectations to initiate multiple Phase 2 studies of MRT-8102, including the GEMINI-1 study in gout patients in Q4 2026 with initial data expected in H2 2027, the GFORCE-2 Phase 2b study in patients with stable coronary artery disease and residual inflammation in H1 2027, including use of coronary artery imaging, NLRP3 genetics and biomarkers to identify a disease-modifiable patient population and inform the design of a potential Phase 3 study, and the GALAXY-1 study in moderate to severe hidradenitis suppurativa patients in H1 2027, statements regarding dose selection informed by GFORCE-1 data for further development across various NLRP3-driven diseases, statements regarding the potential of MRT-8102 in gout, (iii) the ongoing development of a next-generation NEK7-directed MGD and expected IND submission in 2027, (iv) our ongoing clinical development of MRT-2359, including the initiation of the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, our plans to provide updated data from the initial Phase 1/2 study expansion arm in patients with metastatic CRPC by the end of the year, statements regarding the clinical significance of the data observed and the potential of MRT-2359 to benefit patients with mCRPC with AR mutations, and our clinical supply agreement with Johnson & Johnson to support such trial, and (v) progress of our CDK2 and cyclin E1-directed MGD programs, including the timing of IND application submissions in 2027 for CDK2-directed and cyclin E1-directed MGDs, as well as statements related to the expected potential clinical benefit of any of our candidates, advancement and application of our platform, our ability to capitalize on and potential benefits resulting from our research and translational insights, including announcements related to preclinical programs, as well as our ability to optimize collaborations with industry partners, statements about obligations under our collaboration agreements, expectations around the receipt of payments under such agreements and the future development and commercialization of various products, statements regarding regulatory filings, including the planned timing of such filings, and potential review by regulatory authorities, our use of capital, expenses and other financial results in the future, ability to fund operations and capital expenditures into 2029, as well as our expectations of success for our programs, strength of collaboration relationships 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, 2025, filed with the U.S. Securities and Exchange Commission on March 17, 2026, and any subsequent

 


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filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements, as well as the risk that outcomes of preclinical studies may not be predictive of clinical trial results and the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials. 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.

 

 


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Condensed Consolidated Balance Sheets

(in thousands, except share amounts)

(unaudited)

 

 

September 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,180

 

 

$

129,883

 

Marketable securities

 

 

532,546

 

 

 

    247,221

 

Collaboration receivable

 

 

50,000

 

 

 

7,000

 

Other receivables

 

 

7,624

 

 

 

4,600

 

Prepaid expenses and other current assets

 

 

4,715

 

 

 

4,481

 

Total current assets

 

 

640,065

 

 

 

393,185

 

Property and equipment, net

 

 

28,632

 

 

 

25,986

 

Operating lease right-of-use assets

 

 

23,343

 

 

 

24,386

 

Restricted cash

 

 

4,918

 

 

 

4,954

 

Other long-term assets

 

 

767

 

 

 

148

 

          Total assets

 

$

697,725

 

 

$

448,659

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

     Accounts payable

 

$ 3,347

 

 

$ 3,550

 

Accrued expenses and other current liabilities

 

 

33,414

 

 

 

26,694

 

Current deferred revenue

 

 

21,098

 

 

 

29,571

 

Current portion of operating lease liability

 

 

4,187

 

 

 

4,397

 

     Total current liabilities

 

 

62,046

 

 

 

64,212

 

Deferred revenue, net of current

 

 

102,261

 

 

 

111,332

 

Defined benefit plan liability

 

 

5,131

 

 

 

5,265

 

Operating lease liability, net of current

 

 

32,079

 

 

 

34,794

 

          Total liabilities

 

 

201,517

 

 

 

215,603

 

Stockholders’ equity

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 shares authorized, 85,431,211 and 65,543,723 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively

 

9

 

 

7

 

     Additional paid-in capital

 

 

1,064,442

 

 

 

 714,090

 

Accumulated other comprehensive loss

 

 

(6,192

)

 

 

(3,827

)

Accumulated deficit

 

 

(562,051

)

 

 

(477,214

)

Total stockholders’ equity

 

 

496,208

 

 

 

233,056

 

Total liabilities and stockholders’ equity

 

$

697,725

 

 

$

448,659

 

 

 


img106802192_1.jpg

 

Consolidated Statements of Income (Loss)

(in thousands)

(unaudited)

 

 

Three months ended
September 30,

 

 

Nine months ended

September 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Collaboration revenue

 

$

54,366

 

 

$

12,768

 

 

$

67,544

 

 

$

120,891

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

45,363

 

 

 

36,678

 

 

 

137,396

 

 

 

99,521

 

General and administrative

 

 

10,942

 

 

 

9,065

 

 

 

31,251

 

 

 

25,863

 

Total operating expenses

 

 

56,305

 

 

 

45,743

 

 

 

168,647

 

 

 

125,384

 

Loss from operations

 

 

(1,939

)

 

 

(32,975

)

 

 

(101,103

)

 

 

(4,493

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

5,625

 

 

 

2,746

 

 

 

17,132

 

 

 

9,253

 

Foreign currency exchange gain (loss)

 

 

93

 

 

 

(29

)

 

 

110

 

 

 

1,534

 

Gain on disposal of property and equipment

 

 

—

 

 

 

—

 

 

 

—

 

 

 

59

 

Total other income

 

 

5,718

 

 

 

2,717

 

 

 

17,242

 

 

 

10,846

 

Net income (loss) before income taxes

 

$

3,779

 

 

$

(30,258

)

 

$

(83,861

)

 

$

6,353

 

Income tax (provision) benefit

 

 

(716

)

 

 

3,177

 

 

 

(976

)

 

 

1,156

 

Net income (loss)

 

$

3,063

 

 

$

(27,081

)

 

$

(84,837

)

 

$

7,509

 

 

 

Investors
Andrew Funderburk

ir@monterosatx.com

 

Media
Cory Tromblee, Scient PR

media@monterosatx.com

 

###

 

 


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