Monte Rosa Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-104550
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-268045
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 100 previous paragraphs and 105 current paragraphs.
68 unchanged; 22 reworded; 14 added; 9 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
In September 2025, our wholly-owned subsidiary Monte Rosa Therapeutics AG entered into a collaboration, option, and license agreement with Novartis, or the 2025 Novartis Agreement. Pursuant to the 2025 Novartis Agreement, we granted to Novartis an exclusive, royalty-bearing, sublicensable and transferable license to degraders for one I&I program, or the First Licensed Program, and the exclusive option to obtain exclusive, royalty-bearing, sublicensable and transferable licenses with respect to two programs from our growing preclinical immunology portfolio, or the Options, and together with the programs, the Optioned I&I Programs. Such Options are individually exercisable at Novartis’ discretion until a program meets criteria for investigational new drug application-filing-readiness. On a program-by-program basis, if Novartis does not exercise an Option, all rights with respect to such program are retained by us; if Novartis does exercise its Option, such program becomes a Licensed Program, and together, with the First Licensed Program, the Licensed Programs. Under the 2025 Novartis Agreement, we will apply our proprietary AI/ML-enabled QuEEN™ product engine for the discovery and development of degraders for the First Licensed Program and the Optioned I&I Programs. The Licensed Programs will be further developed and commercialized by Novartis, unless otherwise agreed to by the parties in accordance with the 2025 Novartis Agreement.
Current report
General and administrative expenses for the three months ended September 30, 2025 and 2024 included non-cash stock-based compensation expense of $1.9 million and $1.7 million, respectively.
Current report
Other income
Current report
Other income was comprised of (in thousands):
Current report
Income tax benefit (provision)
Current report
For the three months ended September 30, 2025, the income tax benefit is primarily related to the enactment of the the “One Big Beautiful Bill Act”, or OBBBA. On July 4, 2025, H.R. 1, the OBBBA, was signed into law. The modification to IRC Sec. 174 included in this act allows the deduction of domestic based research and development expenses in the period in which they are incurred which reduced the taxable income which was being generated from the $150 million upfront payment for the 2024 Novartis Agreement. In accordance with U.S. GAAP, we have accounted for the tax effects of changes in tax law in the period of enactment. As a result of these factors, in the third quarter of 2025, we have reduced our provision for income taxes by $3.2 million.
Current report
Results of operations for the nine months ended September 30, 2025 and 2024
Current report
Other income
Current report
Other income was comprised of (in thousands):
Current report
The increase in other income for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, is principally attributable to higher marketable securities balances during the nine months ended September 30, 2025 and to fluctuations in currency exchange rates, principally between the U.S. Dollar and Swiss Franc.
Current report
Income tax provision (benefit)
Current report
For the nine months ended September 30, 2025 the tax benefit of $1.2 million is primarily related to the requirement of carrying back the Research and Development credit generated in tax year 2025 to the tax liability of 2024.
Current report
In September 2025, we entered into the 2025 Novartis Agreement. Pursuant to the 2025 Novartis Agreement, we granted to Novartis an exclusive, royalty-bearing, sublicensable and transferable license to degraders for the First Licensed Program and the exclusive option to obtain exclusive, royalty-bearing, sublicensable and transferable licenses with respect to the Optioned I&I Programs. Such Options are individually exercisable at Novartis’ discretion until a program meets criteria for investigational new drug application-filing-readiness. On a program-by-program basis, if Novartis does not exercise an Option, all rights with respect to such program are retained by us; if Novartis does exercise its Option, such program becomes a Licensed Program. Under the Agreement, we will apply our proprietary AI/ML-enabled QuEEN™ product engine for the discovery and development of degraders for the First Licensed Program and the Optioned I&I Programs. The Licensed Programs will be further developed and commercialized by Novartis, unless otherwise agreed to by the parties in accordance with the 2025 Novartis Agreement.
Current report
In September 2025, we received a $120.0 million non-refundable upfront payment from Novartis. Pursuant to the 2025 Novartis Agreement, we are entitled to receive from Novartis payments to maintain the Options totaling up to $60.0 million, and are eligible to receive from Novartis (1) preclinical milestone payments relating to the First Licensed Program and option exercise payments related to the Options of up to $180.0 million, (2) up to $5.4 billion in clinical development, regulatory, and sales milestones relating to the First Licensed Program and the two Optioned I&I Programs, beginning upon initiation of Phase 1 studies, including (a) potential development and regulatory milestone payments up to $2.2 billion if regulatory approval is achieved for multiple indications in multiple territories and (b) potential sales milestones payments up to $3.2 billion, allocated across licensed products, and (3) tiered royalties on global net sales in the high-single to low double-digit range for the First Licensed Program and in the low double-digit range for the two Optioned I&I Programs. We will be responsible for costs related to research activities, while Novartis will be responsible for costs related to development and commercialization activities.
Removed paragraphs (9)
Previous report
Other income (expense)
Previous report
Other income (expense), net was comprised of (in thousands):
Previous report
The increase in interest and other income for the three months ended June 30, 2025, is primarily due to the revaluation of Swiss-franc denominated deposits.
Previous report
Provision for income taxes
Previous report
Results of operations for the six months ended June 30, 2025 and 2024
Previous report
As of June 30, 2025 and 2024 we had 30 and 26 employees engaged in general and administrative activities, respectively. General and administrative expenses for the six months ended June 30, 2025 and 2024 included non-cash stock-based compensation expense of $4.2 million and $4.1 million, respectively.
Previous report
Other income (expense)
Previous report
Other income (expense), net was comprised of (in thousands):
Previous report
Provision for income taxes
Reworded paragraphs (22)
Previous wording
MGDs work by inducing the engagement of defined surfaces identified on target proteins by an E3 ligase, such as cereblon. We have developed a proprietary and industry-leading protein degradation discovery engine, called QuEENTM to enable our unique, target-centric, MGD discovery and development and our rational design of MGD products. We believe our small molecule MGDs may give us significant advantages over existing therapeutic modalities, including other protein degradation approaches. We prioritize our product development on therapeutic targets backed by strong biological and genetic rationale with the goal of discovering and developing novel medicines.
Current wording
We are a biotechnology company developing a portfolio of novel and proprietary MGDs. MGDs are small molecule drugs that employ the body’s natural protein destruction mechanisms to selectively degrade therapeutically-relevant proteins. MGDs work by inducing the engagement of defined surfaces identified on target proteins by an E3 ligase, such as cereblon. We have developed a proprietary and industry-leading protein degradation discovery engine, called QuEENTM to enable our unique, target-centric, MGD discovery and development and our rational design of MGD products. We believe our small molecule MGDs may give us significant advantages over existing therapeutic modalities, including other protein degradation approaches. We prioritize our product development on therapeutic targets backed by strong biological and genetic rationale with the goal of discovering and developing novel medicines.
Previous wording
To date, we have financed our operations primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock or warrants to purchase common stock, registered direct offerings, and through our collaboration agreements. From our inception through the date hereof, there have been aggregate inflows of $836.0 million of gross proceeds from such transactions. Since inception, we have had significant operating losses. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and, to a lesser extent, general and administrative expenditures. For the six months ended June 30, 2025, we reported net income of $34.6 million. For the years ended December 31, 2024 and 2023, we reported net losses of $72.7 million and $135.4 million, respectively. As of June 30, 2025, we had an accumulated deficit of $404.0 million and $295.5 million in cash, cash equivalents, restricted cash and marketable securities.
Current wording
To date, we have financed our operations primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock or warrants to purchase common stock, registered direct offerings, and through our collaboration agreements. From our inception through the date hereof, there have been aggregate inflows of $836.0 million of gross proceeds from such transactions. Since inception, we have had significant operating losses. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and, to a lesser extent, general and administrative expenditures. For the nine months ended September 30, 2025, we reported net income of $7.5 million. For the years ended December 31, 2024 and 2023, we reported net losses of $72.7 million and $135.4 million, respectively. As of September 30, 2025, we had an accumulated deficit of $431.1 million and $396.2 million in cash, cash equivalents, restricted cash and marketable securities, which includes a $120.0 million non-refundable upfront payment we received from Novartis in September 2025 pursuant to the 2025 Novartis Agreement. We also received $9.7 million from Novartis for value added taxes related to the transaction, which is included in our accounts payable balance as of September 30, 2025 and is expected to be remitted to the Swiss government in the fourth quarter of 2025. Subsequent to September 30, 2025, we sold 2,955,082 shares of common stock under the Sales Agreement for aggregate gross proceeds of $25.0 million, respectively, or aggregate net proceeds of $23.9 million, after deducting sales agent discounts, commissions, and other offering costs. We anticipate that our proceeds from sales of our common stock in “at-the-market” offerings, other offerings and collaboration agreements, together with existing cash, cash equivalents, restricted cash and marketable securities, supports our cash runway through 2028.
Previous wording
Collaboration revenue of $23.2 million and $4.7 million for the three months ended June 30, 2025 and 2024, respectively, represents revenue recorded under our collaboration and license agreements with Roche and Novartis. As of June 30, 2025, $18.4 million was classified as current deferred revenue on the condensed consolidated balance sheet.
Current wording
Collaboration revenue of $12.8 million and $9.2 million for the three months ended September 30, 2025 and 2024, respectively, represents revenue recorded under our collaboration and license agreements with Roche and Novartis. As of September 30, 2025, $24.8 million was classified as current deferred revenue on the condensed consolidated balance sheet.
Previous wording
As of June 30, 2025, we had 112 employees engaged in research and development activities in our facilities in the U.S. and Switzerland. As of June 30, 2024, we had 103 research and development employees in our facilities in the U.S. and Switzerland.
Current wording
As of September 30, 2025, we had 116 employees engaged in research and development activities in our facilities in the U.S. and Switzerland. As of September 30, 2024, we had 105 research and development employees in our facilities in the U.S. and Switzerland.
Previous wording
Most of our research and development expenses were driven by the successful achievement of key research milestones in our research and development organization, including the continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the advancement of MRT-8102 into the clinic, the progression of our preclinical pipeline including research performed for our collaboration with Roche, and the continued development of our QuEEN™ discovery engine, and reflect increased personnel expense and external R&D costs to achieve these milestones. Research and development expenses for the three months ended June 30, 2025 and 2024 included non-cash stock-based compensation expense of $2.9 million and $2.6 million, respectively.
Current wording
Most of our research and development expenses were driven by the successful achievement of key research milestones in our research and development organization, including the the advancement of MRT-8102 into the clinic, continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the progression of our preclinical pipeline including research performed for our collaboration with Roche, and the continued development of our QuEEN™ discovery engine, and reflect increased personnel expense and external R&D costs to achieve these milestones. Research and development expenses for the three months ended September 30, 2025 and 2024 included non-cash stock-based compensation expense of $2.5 million and $2.6 million, respectively.
Previous wording
The increase in interest and other income for the six months ended June 30, 2025, is principally attributable to higher interest rates on marketable securities.
Current wording
Other income for the three months ended September 30, 2025,was primarily attributable to interest earned on marketable securities and remained consistent with the three months ended September 30, 2024.
Previous wording
For the six months ended June 30, 2025, we recorded a provision for income taxes of $2.0 million, primarily driven by the current federal and state taxes related to the $150 million upfront payment for the Novartis License Agreement, which will be recognized as taxable NCTI. For the six months ended June 30, 2024, the income tax provision was primarily related to interest income on marketable securities in Massachusetts and the U.S. taxable income generated from the capitalization of research and development expenses.
Current wording
For the three months ended September 30, 2024, the income tax provision was primarily related to interest income on marketable securities in Massachusetts and the U.S. taxable income generated from the capitalization of research and development expenses.
Previous wording
Collaboration revenue of $108.1 million and $5.8 million for the six months ended June 30, 2025 and 2024, respectively, represents revenue recorded under our collaboration and license agreements with Roche and Novartis. As of June 30, 2025, $18.4 million was classified as current deferred revenue on the condensed consolidated balance sheet.
Current wording
Collaboration revenue of $120.9 million and $15.0 million for the nine months ended September 30, 2025 and 2024, respectively, represents revenue recorded under our collaboration and license agreements with Roche and Novartis. As of September 30, 2025, $24.8 million was classified as current deferred revenue on the condensed consolidated balance sheet.
Previous wording
As of June 30, 2025, we had 112 employees engaged in research and development activities in our facilities in the U.S. and Switzerland. As of June 30, 2024, we had 103 research and development employees in our facilities in the U.S. and Switzerland.
Current wording
As of September 30, 2025, we had 116 employees engaged in research and development activities in our facilities in the U.S. and Switzerland. As of September 30, 2024, we had 105 research and development employees in our facilities in the U.S. and Switzerland.
Previous wording
Most of our research and development expenses were driven by the successful achievement of key research milestones in our research and development organization, including the continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the advancement of MRT-8102 into the clinic, the progression of our preclinical pipeline including research performed for our collaboration with Roche, and the continued development of our QuEEN™ discovery engine, and reflect increased personnel expense and external R&D costs to achieve these milestones. Research and development expenses for the six months ended June 30, 2025 and 2024 included non-cash stock-based compensation expense of $6.0 million and $5.3 million, respectively.
Current wording
Most of our research and development expenses were driven by the successful achievement of key research milestones in our research and development organization, including the advancement of MRT-8102 into the clinic, the continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the progression of our preclinical pipeline including research performed for our collaboration with Roche, and the continued development of our QuEEN™ discovery engine, and reflect increased personnel expense and external R&D costs to achieve these milestones. Research and development expenses for the nine months ended September 30, 2025 and 2024 included non-cash stock-based compensation expense of $8.5 million and $7.9 million, respectively.
Previous wording
As of June 30, 2025 and 2024 we had 30 and 26 employees engaged in general and administrative activities, respectively. General and administrative expenses for the three months ended June 30, 2025 and 2024 included non-cash stock-based compensation expense of $2.0 million and $1.9 million, respectively.
Current wording
As of September 30, 2025 and 2024, we had 31 and 28 employees engaged in general and administrative activities, respectively. General and administrative expenses for the nine months ended September 30, 2025 and 2024 included non-cash stock-based compensation expense of $6.1 million and $5.7 million, respectively.
Previous wording
For the three months ended June 30, 2025, we recorded a provision for income taxes of $1.2 million, primarily driven by the current federal and state taxes related to the $150 million upfront payment for the Novartis License Agreement, which will be recognized as taxable net controlled foreign corporation tested income, or NCTI. For the three months ended June 30, 2024, the income tax provision was primarily related to interest income on marketable securities in Massachusetts and the U.S. taxable income generated from the capitalization of research and development expenses.
Current wording
For the nine months ended September 30, 2024, the income tax provision was primarily related to interest income on marketable securities in Massachusetts and the U.S. taxable income generated from the capitalization of research and development expenses.
Previous wording
Due to our significant research and development expenditures, we have generated operating losses since our inception. We have funded our operations primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock or warrants to purchase common stock, registered direct offerings, and through our collaboration agreements. As of June 30, 2025, we had $295.5 million in cash, cash equivalents, restricted cash and marketable securities. We have incurred losses since our inception and, as of June 30, 2025, we had an accumulated deficit of $404.0 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Current wording
Due to our significant research and development expenditures, we have generated operating losses since our inception. We have funded our operations primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock or warrants to purchase common stock, registered direct offerings, and through our collaboration agreements. As of September 30, 2025, we had $396.2 million in cash, cash equivalents, restricted cash and marketable securities, which includes a $120.0 million non-refundable upfront payment we received from Novartis in September 2025. We also received from Novartis $9.7 million for value added taxes related to the transaction, which is included in our accounts payable balance as of September 30, 2025 and is expected to be remitted to the Swiss government in the fourth quarter of 2025. We have incurred losses since our inception and, as of September 30, 2025, we had an accumulated deficit of $431.1 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Previous wording
We will pay to the Jefferies cash commissions of up to 3.0% of the aggregate gross proceeds of sales of common stock under the Sales Agreement. To date through June 30, 2025, 2,612,514 shares have been sold pursuant to the ATM Program.
Current wording
We will pay to the Jefferies cash commissions of up to 3.0% of the aggregate gross proceeds of sales of common stock under the Sales Agreement. To date through September 30, 2025, 2,612,514 shares have been sold pursuant to the ATM Program. During October 2025, we sold 2,955,082 shares of common stock under the Sales Agreement for aggregate gross proceeds of $25.0 million, or aggregate net proceeds of $23.9 million, after deducting sales agent discounts, commissions, and other offering costs.
Previous wording
Net cash used in operating activities of $80.2 million during the six months ended June 30, 2025, was attributable to decreases in our working capital of $20.4 million and a decrease in deferred revenue of $106.9 million, partially offset by our net income of $34.6 million. The decreases in working capital accounts and deferred revenue were partially off-set by non-cash charges of $12.5 million, principally with respect to depreciation expense and stock-based compensation.
Current wording
Net cash provided by operating activities of $20.2 million during the nine months ended September 30, 2025, was attributable to our net income of $7.5 million; non-cash charges of $18.5 million, principally with respect to depreciation expense and stock-based compensation; and an increase in deferred revenue of $3.3 million. This was partially offset by decreases in our working capital of $9.1 million.
Previous wording
Net cash used in operating activities of $65.9 million during the six months ended June 30, 2024 was attributable to our net loss of $62.3 million and decreases in our working capital of $6.8 million, partially off-set by non-cash charges of $12.2 million, principally with respect to depreciation expense and stock-based compensation.
Current wording
Net cash used in operating activities of $86.9 million during the nine months ended September 30, 2024 was attributable to our net loss of $86.1 million and decreases in our working capital of $18.3 million, partially off-set by non-cash charges of $17.5 million, principally with respect to depreciation expense and stock-based compensation.
Previous wording
Cash used in investing activities of $74.9 million during the six months ended June 30, 2025 was primarily attributable to purchases of marketable securities of $157.0 million and purchases of property and equipment of $3.3 million, partially offset by proceeds from the maturity of marketable securities of $85.4 million.
Current wording
Cash used in investing activities of $36.8 million during the nine months ended September 30, 2025 was primarily attributable to purchases of marketable securities of $223.0 million and purchases of property and equipment of $3.9 million, partially offset by proceeds from the maturity of marketable securities of $190.2 million.
Previous wording
Cash used in investing activities of $51.3 million during the six months ended June 30, 2024 was primarily attributable to proceeds from the maturity of marketable securities of $82.1 million, offset by purchases of marketable securities of $130.0 million and purchases of property and equipment of $3.4 million.
Current wording
Cash used in investing activities of $13.6 million during the nine months ended September 30, 2024 was primarily attributable to proceeds from the maturity of marketable securities of $152.6 million, offset by purchases of marketable securities of $162.4 million and purchases of property and equipment of $3.8 million.
Previous wording
Cash provided by financing activities of $0.4 million for the six months ended June 30, 2025 was primarily due to the proceeds of purchases from the 2021 ESPP.
Current wording
Cash provided by financing activities of $0.7 million for the nine months ended September 30, 2025 was primarily due to the proceeds from purchases from the 2021 ESPP and to the exercise of employee stock options.
Previous wording
Net cash provided by financing activities of $98.3 million for the six months ended June 30, 2024 was primarily due to the net proceeds from our Offering of $96.4 million.
Current wording
Net cash provided by financing activities of $98.3 million for the nine months ended September 30, 2024 was primarily due to the net proceeds from our Offering of $96.4 million.
Previous wording
There have been no significant changes to our critical accounting policies from those described in “Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2024 Annual Report.
Current wording
There have been no significant changes to our critical accounting policies from those described in “Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2024 Annual Report, and our revenues related to the 2025 Novartis Agreement are accounted for consistent with the revenue recognition policy described therein.
Previous wording
During the three months ended June 30, 2025, there have been no material changes to our contractual obligations and commitments from those described under “Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 20, 2025.
Current wording
During the three months ended September 30, 2025, there have been no other material changes to our contractual obligations and commitments from those described under “Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 20, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
As of September 30, 2025 and 2024, we had 31 and 28 employees engaged in general and administrative activities, respectively.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We are a biotechnology company developing a portfolio of novel and proprietary MGDs. MGDs are small molecule drugs that employ the body’s natural protein destruction mechanisms to selectively degrade therapeutically-relevant proteins.