11/06/2025 | Press release | Distributed by Public on 11/06/2025 06:05
Item 2. Management's discussion and analysis of financial condition and results of operations
The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report. This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth in "Part I, Item 1A, Risk Factors" in our 2024 Annual Report and under Part II, Item 1A, "Risk Factors" and elsewhere in this Quarterly Report. You should carefully read the "Risk Factors" section of this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section entitled "Special note regarding forward-looking statements."
Overview
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 QuEENTMto 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.
Monte Rosa Therapeutics AG, a Swiss operating company, was incorporated under the laws of Switzerland in April 2018. Monte Rosa Therapeutics, Inc. was incorporated in Delaware in November 2019. In 2020, through a common control reorganization, Monte Rosa Therapeutics, Inc. acquired the net assets and shareholding of Monte Rosa Therapeutics AG. Monte Rosa Therapeutics, Inc. includes wholly owned subsidiaries Monte Rosa Therapeutics AG and Monte Rosa Securities Corporation. We are headquartered in Boston, Massachusetts with research operations in both Boston and Basel, Switzerland.
Recent Developments
In June 2025, the United States Food and Drug Administration cleared the investigational new drug application for MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory diseases driven by the NLRP3 inflammasome and IL-1β. In July 2025, we initiated a Phase 1 study evaluating MRT-8102, with the first patients being dosed. The MRT-8102 Phase 1 study is a randomized, double-blind, placebo-controlled trial in healthy volunteers that includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The study is designed to evaluate safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), including NEK7 degradation and ex vivoresponses to inflammasome stimulation. Part 3 of the Phase 1 study is a randomized, placebo-controlled trial that will enroll subjects with increased CVD risk due to obesity and elevated CRP, designed to evaluate safety and tolerability, change in CRP levels, pharmacokinetics, and changes in other inflammatory markers. Initial results from the Phase 1 study are anticipated in the first half of 2026.
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.
Liquidity
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.
Impact of global economic and political developments
The development of our product candidates could be disrupted and materially adversely affected in the future by global economic or political developments. In addition, economic uncertainty in global markets caused by political instability and conflict, and economic challenges caused by global pandemics or other public health events, may lead to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions. Our business, financial condition and results of operations could be materially and adversely affected by negative impacts on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen.
Components of operating results
Collaboration revenue
Collaboration revenue represents amounts earned from our collaboration and license agreements with Roche and Novartis. We expect that our revenue for the next several years will be derived primarily through our current collaboration and license agreements and any additional collaborations that we may enter into in the future.
Research and development expenses
Our research and development expenses include:
Most of our research and development expenses have been related to the development of our QuEENTMdiscovery engine and advancement of our GSPT1 and VAV1 programs, advancement of our disclosed and undisclosed programs including for NEK7, CDK2, and CCNE1.
We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers.
The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects, the costs of related clinical development costs or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in manufacturing, as we advance our programs and conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects, the costs of related clinical development costs or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
General and administrative expenses
Our general and administrative expenses consist primarily of personnel costs and other expenses for outside professional services, including legal fees relating to patent and corporate matters, professional fees for accounting, auditing, tax and administrative consulting services, insurance costs and other operating costs. We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, and the potential commercialization of our product candidates and development of commercial infrastructure. We also anticipate our general and administrative costs will increase with respect to the hiring of additional personnel, fees to outside consultants, lawyers and accountants, and increased costs associated with being a public company, such as expenses related to services associated with maintaining compliance with Nasdaq listing rules and SEC reporting requirements, insurance and investor relations costs.
Non-operating income and (expense)
Our non-operating income and (expense) includes (i) interest earned on our investments, including principally U.S. government-backed money-market funds and marketable securities; (ii) gains and losses on transactions of our Swiss subsidiary denominated in currencies other than the U.S. Dollar; and (iii) proceeds from the sale of fixed assets.
Results of operations for the three months ended September 30, 2025 and 2024
The following sets forth our results of operations (in thousands):
|
Three months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
Collaboration revenue |
$ |
12,768 |
$ |
9,216 |
$ |
3,552 |
||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
36,678 |
$ |
27,616 |
$ |
9,062 |
||||||
|
General and administrative |
9,065 |
8,127 |
938 |
|||||||||
|
Total operating expenses |
45,743 |
35,743 |
10,000 |
|||||||||
|
Loss from operations |
(32,975 |
) |
(26,527 |
) |
(6,448 |
) |
||||||
|
Other income |
2,717 |
2,739 |
(22 |
) |
||||||||
|
Net loss before income taxes |
(30,258 |
) |
(23,788 |
) |
(6,470 |
) |
||||||
|
Income tax benefit (provision) |
3,177 |
(71 |
) |
3,248 |
||||||||
|
Net loss |
$ |
(27,081 |
) |
$ |
(23,859 |
) |
$ |
(3,222 |
) |
|||
Collaboration revenue
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.
Research and development expenses
Research and development expenses were comprised of (in thousands):
|
Three months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
External research and development expense: |
||||||||||||
|
MRT-2359 |
$ |
2,176 |
$ |
2,434 |
$ |
(258 |
) |
|||||
|
MRT-6160 |
1,444 |
1,914 |
(470 |
) |
||||||||
|
MRT-8102 |
7,307 |
2,053 |
5,254 |
|||||||||
|
Other development and discovery programs |
6,288 |
3,898 |
2,390 |
|||||||||
|
Personnel expense |
10,889 |
9,862 |
1,027 |
|||||||||
|
Overhead and administrative expense |
8,574 |
7,455 |
1,119 |
|||||||||
|
Total research and development expense |
$ |
36,678 |
$ |
27,616 |
$ |
9,062 |
||||||
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.
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.
General and administrative expenses
General and administrative expenses to support our business activities were comprised of (in thousands):
|
Three months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
Personnel costs |
$ |
5,696 |
$ |
5,702 |
$ |
(6 |
) |
|||||
|
Professional services |
1,619 |
572 |
1,047 |
|||||||||
|
Facility costs and other expense |
1,750 |
1,853 |
(103 |
) |
||||||||
|
Total general and administrative expense |
$ |
9,065 |
$ |
8,127 |
$ |
938 |
||||||
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 three months ended September 30, 2025 and 2024 included non-cash stock-based compensation expense of $1.9 million and $1.7 million, respectively.
Other income
Other income was comprised of (in thousands):
|
Three months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
Interest income |
$ |
2,746 |
$ |
2,892 |
$ |
(146 |
) |
|||||
|
Foreign currency exchange loss |
(29 |
) |
(153 |
) |
124 |
|||||||
|
Other income |
$ |
2,717 |
$ |
2,739 |
$ |
(22 |
) |
|||||
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.
Income tax benefit (provision)
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.
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.
Results of operations for the nine months ended September 30, 2025 and 2024
The following sets forth our results of operations (in thousands):
|
Nine months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
Collaboration revenue |
$ |
120,891 |
$ |
14,975 |
$ |
105,916 |
||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
99,521 |
82,697 |
16,824 |
|||||||||
|
General and administrative |
25,863 |
26,394 |
(531 |
) |
||||||||
|
Total operating expenses |
125,384 |
109,091 |
16,293 |
|||||||||
|
Loss from operations |
(4,493 |
) |
(94,116 |
) |
89,623 |
|||||||
|
Other income |
10,846 |
8,385 |
2,461 |
|||||||||
|
Net income (loss) before income taxes |
$ |
6,353 |
$ |
(85,731 |
) |
$ |
92,084 |
|||||
|
Income tax benefit (provision) |
1,156 |
(406 |
) |
1,562 |
||||||||
|
Net income (loss) |
$ |
7,509 |
$ |
(86,137 |
) |
$ |
93,646 |
|||||
Collaboration revenue
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.
Research and development expenses
Research and development expenses were comprised of (in thousands):
|
Nine months ended |
||||||
|
2025 |
2024 |
Dollar change |
||||
|
External research and development expense: |
||||||
|
MRT-2359 |
$6,363 |
$9,357 |
$(2,994) |
|||
|
MRT-6160 |
6,902 |
6,468 |
434 |
|||
|
MRT-8102 |
10,388 |
4,849 |
5,539 |
|||
|
Other development and discovery programs |
17,216 |
10,553 |
6,663 |
|||
|
Personnel expense |
33,999 |
29,585 |
4,414 |
|||
|
Overhead and administrative expense |
24,653 |
21,885 |
2,768 |
|||
|
Total research and development expense |
$99,521 |
$82,697 |
$16,824 |
|||
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.
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.
General and administrative expenses
General and administrative expenses to support our business activities were comprised of (in thousands):
|
Nine months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
Personnel costs |
$ |
16,854 |
$ |
16,443 |
$ |
411 |
||||||
|
Professional services |
4,147 |
3,850 |
297 |
|||||||||
|
Facility costs and other expenses |
4,862 |
6,101 |
(1,239 |
) |
||||||||
|
Total general and administrative expenses |
$ |
25,863 |
$ |
26,394 |
$ |
(531 |
) |
|||||
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.
Other income
Other income was comprised of (in thousands):
|
Nine months ended |
||||||||||||
|
2025 |
2024 |
Dollar change |
||||||||||
|
Interest income |
$ |
9,253 |
$ |
7,971 |
$ |
1,282 |
||||||
|
Foreign currency exchange gain |
1,534 |
414 |
1,120 |
|||||||||
|
Gain on disposal of property and equipment |
59 |
- |
59 |
|||||||||
|
Other income |
$ |
10,846 |
$ |
8,385 |
$ |
2,461 |
||||||
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.
Income tax provision (benefit)
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.
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.
Liquidity and capital resources
Overview
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.
Underwritten public offering
In May 2024, we entered into an underwriting agreement with TD Securities (USA) LLC, as representative of the several underwriters, related to an underwritten public offering, or the Offering, of 10,638,476 shares of common stock at a price of $4.70 per share, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 10,638,524 shares of common stock at a price of $4.6999 per pre-funded warrant, which represents the price per share at which shares of common stock were sold in this Offering, minus $0.0001, which is the exercise price of each pre-funded warrant. The pre-funded warrants are immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised in full. Aggregate gross proceeds from the Offering were $100 million, or aggregate net proceeds of $96.4 million after deducting the underwriter discounts, commissions, and other offering costs.
At-the-market offering
On July 1, 2022, we filed a registration statement on Form S-3 (File No. 333-266003) with the SEC, which was declared effective on July 13, 2022, or the 2022 Shelf Registration Statement, in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings. We also simultaneously entered into the Open Market Sale AgreementSM, or the Sales Agreement, with Jefferies LLC, or Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $100.0 million of our common stock from time to time in "at-the-market" offerings, or the ATM Program, under the 2022 Shelf Registration Statement and subject to the limitations thereof.
On March 20, 2025, we filed a registration statement on Form S-3 (File No. 333-285942) with the SEC, which was declared effective on March 31, 2025, or the 2025 Shelf Registration Statement, in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings. We also simultaneously entered into the Amendment No. 1 to the Sales Agreement, or the Amendment, with Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $150.0 million of our common stock from time to time under the ATM Program, pursuant to the 2025 Shelf Registration Statement and subject to the limitations thereof.
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.
Cash flows
The following table summarizes our cash flows for the periods indicated (in thousands):
|
Nine months ended |
||||||||
|
2025 |
2024 |
|||||||
|
Net cash provided by (used in): |
||||||||
|
Operating activities |
$ |
20,216 |
$ |
(86,926 |
) |
|||
|
Investing activities |
(36,767 |
) |
(13,556 |
) |
||||
|
Financing activities |
727 |
98,284 |
||||||
|
Net decrease in cash, cash equivalents and restricted cash |
$ |
(15,824 |
) |
$ |
(2,198 |
) |
||
Operating activities
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.
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.
Investing activities
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.
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.
Financing activities
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.
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.
Funding requirements
Any product candidates we may develop may never achieve commercialization and we anticipate that we will continue to incur losses for the foreseeable future. We expect that our research and development expenses, general and administrative expenses and capital expenditures will continue to increase. As a result, until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research, manufacturing and development services, costs relating to the build-out of our headquarters, laboratories and manufacturing facility, license payments or milestone obligations that may arise, laboratory and related supplies, clinical costs, manufacturing costs, legal and other regulatory expenses and general overhead costs.
Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. We base this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights. If we raise additional capital through debt
financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
Critical accounting policies and significant judgments and estimates
Our unaudited interim condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the U.S. The preparation of our unaudited interim condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. However, even though we believe we have used reasonable estimates and assumptions in preparing our interim condensed consolidated financial statements, the future effects of global economic and political developments and any future public health events on our results of operations, cash flows, and financial position are unclear. Our actual results may differ from these estimates under different assumptions or conditions.
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.
For a complete discussion of our significant accounting policies and recent accounting pronouncements, see Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report and Note 2 to our 2024 Annual Report.
Recently issued and adopted accounting pronouncements
Refer to Note 2, "Summary of Significant Accounting Policies," in the accompanying notes to our and consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.
Contractual obligations and commitments
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.
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.
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.
Emerging growth and smaller reporting company status
In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an "emerging growth company" may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Therefore, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period and, as a result, we may adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-public companies instead of the dates required for other public companies. However, we may early adopt these standards.
We will cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (ii) the last day of our fiscal year following the fifth anniversary of the date of the closing of our initial public offering, or our IPO, (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (iv) the date on which we are deemed to be a large, accelerated filer under the rules of the SEC.
We are also a "smaller reporting company," meaning that the market value of our stock held by non-affiliates plus the aggregate amount of gross proceeds to us as a result of our IPO is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company after our IPO if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most
recent fiscal years of audited financial statements in our annual reports on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.