C4 Therapeutics Inc.

08/07/2025 | Press release | Distributed by Public on 08/07/2025 05:12

Quarterly Report for Quarter Ending June 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited interim condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited condensed consolidated financial statements and notes and 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 SEC on February 27, 2025. As discussed in the section titled "Special Note Regarding Forward-Looking Statements," the following discussion and analysis contains forward-looking statements that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include, but are not limited to, those identified below and those discussed in the section titled "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024.
Business overview
We are a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation, or TPD, science to create a new generation of small-molecule medicines that transform patients' lives. By leveraging our proprietary TORPEDO platform, we have the capability to efficiently design and optimize small molecule protein degraders that are highly active against their desired targets by harnessing the body's natural process for destroying unwanted proteins.
Our most advanced product candidate, cemsidomide, is an orally bioavailable MonoDAC degrader of protein targets called IKZF1 and IKZF3. Cemsidomide is currently in clinical development for multiple myeloma, or MM, and non-Hodgkin lymphoma, or NHL. The United States Food and Drug Administration, or FDA, has granted orphan drug designation to cemsidomide for the treatment of MM. In December 2024, we shared data from the ongoing Phase 1/2 clinical trial of cemsidomide in MM and NHL as of an October 11, 2024 cutoff date. The dose escalation portion of the trial evaluating cemsidomide in combination with dexamethasone in MM demonstrated a well-tolerated safety profile and compelling anti-myeloma activity, as measured by overall response rate and clinical benefit rate. Additionally, we previously shared MM monotherapy data that showed cemsidomide activates immune cells at clinically relevant doses. In December 2024, we also shared data evaluating cemsidomide as a monotherapy in NHL that demonstrated a well-tolerated profile and compelling anti-lymphoma activity in NHL and in peripheral t-cell lymphoma, or PTCL, as measured by overall response rate and complete metabolic response rate. Going forward, we will prioritize MM development for cemsidomide.
CFT1946 is an orally bioavailable BiDAC degrader designed to be potent and selective against BRAF V600 mutant proteins to treat melanoma, colorectal cancer, or CRC, and other malignancies that harbor V600 mutations. In preclinical studies, CFT1946 has demonstrated the ability to cross the blood-brain barrier with Kp,uu, values ranging from 0.34 to 0.88, an important feature as a portion of patients with BRAF V600 mutant solid tumors develop brain metastases. In September 2024, we presented initial monotherapy data from the ongoing Phase 1/2 trial, which demonstrated that CFT1946 was well tolerated with initial signs of anti-tumor activity across all dose levels. While we will complete the ongoing Phase 1 trial, we have made the decision not to advance CFT1946 beyond the current Phase 1 trial.
CFT8919 is an orally bioavailable, allosteric, mutant-selective BiDAC degrader of epidermal growth factor receptor, or EGFR, with an L858R mutation in non-small lung cancer, or NSCLC. In May 2023, we entered into a license and collaboration agreement with Betta Pharma to collaborate on the development and commercialization of CFT8919 in mainland China, Hong Kong SAR, Macau SAR and Taiwan, with us retaining rights to develop and commercialize CFT8919 in the rest of the world. In November 2024, Betta Pharma initiated a Phase 1 clinical trial in NSCLC patients with the EGFR L858R mutation in Greater China. The Phase 1 clinical trial is ongoing, and data generated from this trial will inform our ex-China clinical development strategy.
Beyond these product candidates, we are further diversifying our pipeline by developing new degraders in therapeutic areas in and beyond oncology for our own proprietary pipeline and in collaboration with MKDG, Merck and Roche.
Financial operations overview
Revenues
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for the foreseeable future. Our revenues to date have been generated through research collaboration and license agreements. We recognize revenue over the expected performance period under each agreement. We expect that our revenue for the next several years will be derived primarily from our current collaboration agreements and any additional collaborations that we may enter into in the future. To date, we have not received any royalties under any of our existing collaboration agreements.
For a description of our collaboration agreements with Roche, Biogen, Betta Pharma, Merck and MKDG, please see Note 8, Collaboration and license agreements, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Research and development expenses
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our product candidates, and include:
•salaries, benefits, and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;
•expenses incurred under agreements with third parties, including contract research organizations and other third parties that conduct research, preclinical, and clinical activities on our behalf as well as third parties that manufacture our product candidates for use in our preclinical and clinical trials;
•cost of outside consultants, including their fees and related travel expenses;
•costs of laboratory supplies and acquiring materials for preclinical studies and clinical trials;
•facility-related expenses, which include direct depreciation costs of equipment and allocated expenses for rent and maintenance of facilities and other operating costs; and
•third-party licensing fees.
We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed consolidated financial statements as prepaid or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses and expensed as the related goods are delivered or the services are performed.
We expect that our research and development expenses will continue to increase substantially in connection with our planned preclinical and clinical development activities.
General and administrative expenses
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, legal, business development, and administrative functions. General and administrative expenses also include legal fees relating to corporate matters; professional fees for accounting, auditing, tax, and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
We expect that our general and administrative expenses will potentially increase in the future to support increased research and development activities. These increases will likely include higher costs related to the hiring of additional personnel; fees to outside consultants, lawyers and accountants; and investor and public relations costs.
Other income, net
Other income, net primarily consists of the following:
•interest income earned on our cash, cash equivalents, and marketable securities and accretion of discount on marketable securities.
Results of operations
Comparison of the three and six months ended June 30, 2025 and 2024
Revenue
Revenue from our collaboration and license agreements consisted of the following for the three and six months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Revenue from collaboration agreements:
MKDG Agreement
$ 3,428 $ 1,894 $ 6,581 $ 1,949
Merck Agreement
1,049 1,102 2,178 1,747
Betta Pharma Agreement
54 - 514 -
Roche Agreement 1,932 963 4,428 2,451
Biogen Agreement - 8,047 - 8,898
Total revenue from collaboration agreements $ 6,463 $ 12,006 $ 13,701 $ 15,045
The $5.5 million decrease in revenue in the three months ended June 30, 2025, as compared to the three months ended June 30, 2024 is primarily driven by an $8.0 million decrease in revenue related to the Biogen collaboration, as a milestone was achieved and recognized in full during the second quarter of 2024.
This was offset by:
•a $1.5 million increase in revenue under the MKDG Agreement, which commenced in March 2024; and
•a $1.0 million increase in revenue under the Roche Agreement as the two targets have progressed to the lead series identification achievement phase in 2025.
The $1.3 million decrease in revenue in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024 is primarily driven by a $8.9 million decrease in revenue related to the Biogen collaboration, as a milestone was achieved and recognized in full during 2024.
This was offset by:
•a $4.6 million increase in revenue under the MKDG Agreement which commenced in March 2024; and
•a $2.0 million increase revenue under the Roche Agreement as the two targets have progressed to the lead series identification achievement phase 2025, and a milestone was earned for each target.
Research and development expenses
The following table summarizes our research and development expenses for the three and six months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Research and development expenses:
Personnel expenses $ 8,851 $ 8,211 $ 18,494 $ 16,757
Preclinical development and discovery expenses 6,466 6,271 13,743 10,879
Clinical expenses 4,728 3,506 9,437 7,368
Facilities and supplies 3,709 3,033 6,839 6,386
Professional fees 1,275 1,832 2,586 3,521
Intellectual property and other expenses 1,168 900 2,170 1,375
Total research and development expenses $ 26,197 $ 23,753 $ 53,269 $ 46,286
The $2.4 million increase in research and development expenses in the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 is primarily driven by:
•a $1.2 million increase in clinical expenses as a result of our ongoing Phase 1/2 clinical trial of cemsidomide;
•a $0.7 million increase in facilities and supplies; and
•a $0.6 million increase in personnel expenses.
The $7.0 million increase in research and development expenses in the six months ended June 30, 2025 as compared to the three months ended June 30, 2024 is primarily driven by:
•a $2.9 million increase in preclinical development and discovery expenses as a result of the progress made on our collaboration programs and internal programs;
•a $2.1 million increase in clinical expenses a result of our ongoing Phase 1/2 clinical trial of cemsidomide and our Phase 1 trial of CFT1946; and
•a $1.7 million increase in personnel expenses.
General and administrative expenses
The following table summarizes our general and administrative expenses for the three and six months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
General and administrative expenses:
Personnel expenses $ 6,260 $ 7,343 $ 13,084 $ 14,983
Professional fees 1,475 1,401 2,943 3,058
Facilities and other expenses 1,032 951 2,070 1,942
Total general and administrative expenses $ 8,767 $ 9,695 $ 18,097 $ 19,983
The $0.9 million decrease in general and administrative expenses in the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 is primarily driven by a $1.1 million decrease in personnel expenses related to lower stock-based compensation expense.
The $1.9 million decrease in general and administrative expenses in the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 is primarily driven by a $1.9 million decrease in personnel expenses related to lower stock-based compensation expense.
Restructuring expenses
The $2.4 million decrease of restructuring expenses in the six months ended June 30, 2025 compared to the six months ended June 30, 2024 is driven by the restructuring activities that occurred and were completed in 2024.
Other income, net
The $1.2 million decrease in other income, net in the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 is primarily driven by a $1.2 million decrease in interest and other income resulting from reduced invested balances as cash was used to fund operations, as well as lower interest rates for the three months ended June 30, 2025.
The $2.3 million decrease in other income, net in the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 is primarily driven by a $2.3 million decrease in interest and other income resulting from reduced invested balances as cash was used to fund operations, as well as lower interest rates for the six months ended June 30, 2025 compared to the prior year period.
Liquidity and capital resources
Sources of liquidity
Since inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical programs and our product candidates through clinical development. We do not currently have any approved products and have never generated any revenue from product sales. To date, we have financed our operations primarily through the sale of preferred stock, public offerings of our common stock, private placements of our common stock, and through payments from collaboration partners. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $223.0 million.
Cash flows
The following table summarizes our sources and uses of cash for the periods presented (in thousands):
Six Months Ended June 30,
2025 2024
Net change in cash, cash equivalents and restricted cash:
Net cash used in operating activities $ (45,342) $ (23,092)
Net cash provided by (used in) investing activities 68,046 (65,102)
Net cash (used in) provided by financing activities (46) 34,718
Total net change in cash, cash equivalents and restricted cash $ 22,658 $ (53,476)
Operating activities
Net cash used in operating activities for the six months ended June 30, 2025 was $45.3 million, and was driven primarily by the following uses of cash:
•net loss of $52.3 million;
•$6.1 million decrease in accrued expenses and other current liabilities;
•$3.4 million decrease in deferred revenue, primarily a result of our advancement of our collaboration programs; and
•$2.8 million decrease in our operating lease liability.
These were offset by:
•$4.0 million decrease in prepaid expenses and other assets; and
•non-cash expenses of $13.6 million, which primarily consisted of stock-based compensation expense of $10.5 million.
Investing activities
Net cash provided by investing activities for the six months ended June 30, 2025 was $68.0 million, and was driven primarily by $68.2 million of sales and maturities of marketable securities, net of purchases.
Financing activities
Net cash used in financing activities for the six months ended June 30, 2025 was driven primarily by payments for repurchase of common stock for tax withholding.
Funding requirements
Since our inception, we have incurred significant operating losses, and we expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we advance the preclinical programs and our product candidates through clinical development. In addition, we expect to continue to incur costs associated with operating as a public company.
Specifically, we anticipate that our expenses will increase substantially in the future, if and as we:
•continue our ongoing first-in-human Phase 1/2 trials;
•initiate later-stage development and potential registrational trials for our product candidates;
•advance additional product candidates into preclinical and clinical development;
•continue to invest in our proprietary TORPEDO platform;
•advance, expand, maintain, and protect our intellectual property portfolio;
•hire additional clinical, regulatory, quality, and scientific personnel;
•add operational, financial and management information systems, and personnel to support our ongoing research, product development, potential future commercialization efforts, operations as a public company and general and administrative roles;
•seek marketing approvals for any product candidates that successfully complete clinical trials; and
•ultimately establish a sales, marketing, and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we may obtain marketing approval.
Because of the numerous risks and uncertainties associated with development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital and operating costs associated with our current and anticipated preclinical and clinical development. Our future capital requirements will depend on many factors, including:
•the progress, costs, and results of ongoing and planned first-in-human Phase 1/2 trial for our lead product candidate and any future clinical development of our lead product candidate;
•the scope, progress, costs, and results of preclinical and clinical development for our other product candidates and development programs;
•the number and development requirements of other product candidates that we pursue;
•the progress and success of our existing and any future collaborations with third-party partners, including whether or not we receive additional research support or milestone payments from our existing collaboration partners upon the achievement of milestones;
•the costs, timing, and outcome of regulatory review of our product candidates;
•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
•our willingness and ability to establish additional collaboration arrangements with other biotechnology or pharmaceutical companies on favorable terms, if at all, for the development or commercialization of current or additional future product candidates;
•the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; and
•the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval.
As a result of the anticipated expenditures described above, we will need to obtain substantial additional financing to support our continuing operations and pursue our long-term business plan. Until such time, if ever, that we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, private placements of equity securities, debt offerings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Although we may receive potential future milestone and royalty payments under our collaborations with Roche, Biogen, Betta Pharma, Merck, and MKDG, we do not have any committed external sources of funds as of June 30, 2025.
Adequate additional funds may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
If we raise additional capital through the sale of equity securities, each investor's ownership interest will be diluted, and the terms of any securities we may issue could include liquidation or other preferences that adversely affect the rights of holders of our common stock. Preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as making acquisitions or capital expenditures or declaring dividends.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
At-the-market equity program
In November 2021, we filed an automatically effective registration statement on Form S-3, or the 2021 Registration Statement, with the SEC that registers the offering, issuance and sale of an unspecified amount of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. Simultaneously, we entered into a sales agreement with Cowen and Company, LLC (now known as TD Securities (USA) LLC), as sales agent, to provide for the issuance and sale by us of up to $200.0 million of common stock from time to time in "at-the-market" offerings under the 2021 Registration Statement and related prospectus filed with the 2021 Registration Statement, or the 2021 ATM Program. As of December 31, 2024, a total of 15,318,264 shares of the our common stock at an average purchase price of $5.54 had been
sold through the 2021 ATM Program, resulting in net proceeds of $82.3 million. The 2021 ATM expired in November 2024.
In October 2024, we filed a registration statement on Form S-3, or the Registration Statement, with the SEC that became effective on November 13, 2024 and registered the offering, issuance and sale of an unspecified amount of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. Simultaneously, we entered into a sales agreement with TD Securities (USA) LLC, as sales agent, to provide for the issuance and sale by us of up to $200.0 million of common stock from time to time in "at-the-market" offerings under the Registration Statement and related prospectus filed with the Registration Statement, or the 2024 ATM Program. For the three and six months ended June 30, 2025, no sales were made under the 2024 ATM Program.
Contractual obligations
We enter into contracts in the normal course of business with contract manufacturing organizations, contract research organizations, and other vendors to assist in the performance of our research and development activities and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancellable contracts and not included in the table of contractual obligations and commitments.
During the six months ended June 30, 2025, except for the minimum rental commitments disclosed in Note 6, Leases, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, there were no significant changes to our contractual obligations and commitments described under "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2024.
Critical accounting policies and use of estimates
Our critical accounting policies are those policies that require the most significant judgments and estimates in the preparation of our unaudited condensed consolidated financial statements. We have determined that our most critical accounting policies are those relating to revenue recognition from collaborations, research and development expense recognition, lease liability measurement, and stock-based compensation. There have been no significant changes to our existing critical accounting policies discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 27, 2025.
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