C4 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights
May 07 2025 - 7:00AM
C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation science, today reported financial results for the first
quarter ended March 31, 2025, as well as business updates.
“2025 has been marked by focused execution across C4T to
generate key data to optimize development plans across our clinical
portfolio. With cemsidomide demonstrating compelling overall
response rates at multiple dose levels, including one multiple
myeloma patient at 100 µg who achieved a minimal residual disease
negative complete response, we are prioritizing progressing
cemsidomide to the next phase of development to realize its
potential to be a best-in-class IKZF1/3 degrader,” said Andrew
Hirsch, president and chief executive officer of C4 Therapeutics.
“With the achievement of two preclinical milestones in our Roche
collaboration, we continue to demonstrate the productivity of our
TORPEDO platform to discover highly catalytic, orally bioavailable,
and brain penetrant degraders. We remain focused on maximizing
our cash runway, which includes advancing cemsidomide and pursuing
our internal discovery pipeline focused on targets with a clear
degrader rationale and compelling biology applicable to a broad
range of therapeutic areas.”
FIRST QUARTER 2025 HIGHLIGHTS AND RECENT
ACHIEVEMENTS
Cemsidomide:
- Phase 1 dose escalation is complete in multiple myeloma (MM)
with the 100 µg once daily (QD) dose level declared safe for
expansion; 10 additional patients will be treated in a 100 µg QD
expansion cohort to further characterize cemsidomide’s safety and
efficacy profile at this dose level.
- Cemsidomide MM topline data demonstrate compelling responses
rates at multiple doses:
- As of the data cutoff date of April 30, 2025, 10 patients have
been treated at the 100 µg QD dose level, achieving an overall
response rate (ORR) of 50 percent. Notably, one patient who
previously progressed on two prior T-cell engager therapies
achieved a minimal residual disease (MRD) negative complete
response (measured by flow cytometry). Eight patients (80 percent)
treated at this dose level received prior CAR-T or T-cell engager
therapy.
- Since October 11, 2024, six additional patients have been
treated for a total of 20 patients treated at the 75 µg QD dose
level. As of the data cutoff date of April 30, 2025, the 75 µg QD
dose level achieved an ORR of 40 percent.
- Cemsidomide remains well-tolerated with manageable
neutropenia.
- For the non-Hodgkin’s lymphoma (NHL) arm, the Phase 1 dose
escalation is ongoing at the 87.5 µg QD dose level and the maximum
tolerated dose has not yet been reached.
- C4T expects to receive regulatory feedback on registrational
development by mid-year 2025.
CFT1946:
- Phase 1 dose escalation is complete with 640 mg BID declared as
the maximum administered dose. Across the trial, which includes the
dose escalation, melanoma and colorectal cancer cohorts, 89
patients were treated.
- The pharmacodynamic and safety data, including the data
presented at the European Society for Medical Oncology (ESMO)
Congress 2024, supports proof of mechanism and the therapeutic
potential of degrading the BRAF V600 mutant protein.
- Given emerging clinical data and the company’s focus on
strategic capital allocation, C4T will not advance CFT1946 beyond
the ongoing Phase 1 trial. C4T has made the decision to seek
partnership opportunities to advance the BRAF program given the
high unmet need and strong degrader rationale for treating BRAF
V600 mutant solid tumors.
- The CFT1946 Phase 1 data will be presented at a future medical
meeting.
CFT8919:
- Partner Betta Pharmaceuticals continues to advance the CFT8919
Phase 1 dose escalation trial in Greater China.
Research and Discovery Collaborations:
- Advanced Roche collaboration to preclinical milestones. In
March 2025, C4T earned a total of $4 million in payments upon
achieving certain preclinical milestones for two programs. C4T and
Roche continue to advance these programs.
- C4T continues to advance its
internal research pipeline focused on targets in therapeutic areas
in and beyond oncology with a strong degrader rationale and genetic
link to disease.
KEY UPCOMING MILESTONES
- Present data from completed cemsidomide Phase 1 dose escalation
in MM in Q3 2025.
- Complete cemsidomide Phase 1 dose escalation in NHL and present
data in Q4 2025.
- Open expansion cohort(s) in PTCL as part of the current
cemsidomide Phase 1/2 trial in the second half of 2025.
- Enable initiation of the next phase of clinical development for
cemsidomide with new studies expected to initiate in early
2026.
UPCOMING INVESTOR EVENTS
- June 4, 2025: Management will participate in
the Jefferies Global Healthcare Conference taking place from June 3
– June 5, 2025 in New York, New York.
FIRST QUARTER 2025 FINANCIAL RESULTS
Revenue: Total revenue for the first
quarter of 2025 was $7.2 million, compared to $3.0 million for the
first quarter of 2024. The increase in revenue was primarily due to
our collaborations with Merck KGaA, Darmstadt, Germany (MKDG),
which commenced in March 2024, as well as our achievement of two
preclinical milestones under our Roche collaboration.
Research and Development (R&D)
Expense: R&D expense for the first quarter of
2025 was $27.1 million compared to $22.5 million for the first
quarter of 2024. The increase in R&D expense was primarily
related to clinical trial expenses for cemsidomide and CFT1946, in
addition to increased preclinical spend as our research
collaborations continue to advance.
General and Administrative (G&A)
Expense: G&A expense for the first quarter of
2025 was $9.3 million compared to $10.3 million for the first
quarter of 2024. The decrease was primarily a result of reduced
personnel costs related to our 2024 restructuring activities.
Net Loss and Net Loss per Share: Net loss
for the first quarter of 2025 was $26.3 million, compared to $28.4
million for the first quarter of 2024. Net loss per share for the
first quarter of 2025 was $0.37 compared to $0.41 for the first
quarter of 2024.
Cash Position and Financial
Guidance: Cash, cash equivalents and marketable
securities as of March 31, 2025 were $234.7 million, compared to
$267.3 million as of December 31, 2024. The decrease was primarily
the result of cash used in operating activities. The balance as of
March 31, 2025 is exclusive of the $4.0 million in milestones
earned under our Roche collaboration, which the company expects to
receive in the second quarter of 2025. The company expects that its
cash, cash equivalents and marketable securities as of March 31,
2025 will enable the company to fund its operating plan into
2027.
About C4 TherapeuticsC4 Therapeutics (C4T)
(Nasdaq: CCCC) is a clinical-stage biopharmaceutical company
dedicated to delivering on the promise of targeted protein
degradation science to create a new generation of medicines that
transforms patients’ lives. C4T is progressing targeted oncology
programs through clinical studies and leveraging its
TORPEDO® platform to efficiently design and optimize
small-molecule medicines to address difficult-to-treat diseases.
C4T’s degrader medicines are designed to harness the body’s natural
protein recycling system to rapidly degrade disease-causing
proteins, offering the potential to overcome drug resistance, drug
undruggable targets and improve patient outcomes. For more
information, please visit www.c4therapeutics.com.
About CemsidomideCemsidomide is an
investigational, orally bioavailable small-molecule degrader
designed to be a more potent and selective degrader of IKZF1/3,
transcription factors that drive multiple myeloma (MM) and
non-Hodgkin’s lymphomas (NHL), with unique pharmacokinetic
properties. Clinical data has shown that cemsidomide is
well-tolerated. In MM, cemsidomide displays evidence of
anti-myeloma activity and immunomodulatory effects. In NHL,
cemsidomide displays evidence of anti-lymphoma activity. More
information may be accessed
at www.clinicaltrials.gov (identifier: NCT04756726).
About CFT1946C4T has advanced preclinical and
clinical research to explore how targeted protein degradation may
offer improvement over approved therapies that inhibit mutant BRAF
V600. C4T advanced CFT1946, an investigational, orally bioavailable
brain penetrant small molecule degrader of BRAF V600 mutations in
solid tumors into a Phase 1/2 global clinical trial in patients
refractory to BRAF inhibitors. CFT1946 is designed to be potent and
selective against the BRAF V600 mutant form. In May 2025, C4T
announced the decision to not advance its BRAF program beyond the
current Phase 1 trial of CFT1946 and seek partnership opportunities
to maximize its potential given the high unmet need and strong
degrader rationale for treating BRAF V600 mutant solid tumors.
About CFT8919CFT8919 is an orally bioavailable
allosteric degrader that is designed to be potent and selective
against EGFR bearing an oncogenic L858R mutation. In preclinical
studies, CFT8919 is active in in vitro and in
vivo models of L858R driven non-small cell lung cancer.
Importantly, CFT8919 retains full activity against additional EGFR
mutations that confer resistance against approved EGFR inhibitors
including L858R-C797S, L858R-T790M and L858R-T790M-C797S. C4T
and Betta Pharmaceuticals have established a strategic partnership
to develop CFT8919 in Greater China, where the Phase 1 clinical
trial is underway. C4T retains development and commercialization
rights for CFT8919 in the United States, European Union and rest of
the world.
Forward-Looking StatementsThis press release
contains “forward-looking statements” of C4 Therapeutics, Inc.
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, but may not
be limited to, express or implied statements regarding our ability
to develop potential therapies for patients; the design and
potential efficacy of our therapeutic approaches; the predictive
capability of our TORPEDO® platform in the development of
novel, selective, orally bioavailable BiDAC™ and MonoDAC®
degraders; the potential timing, design and advancement of our
preclinical studies and clinical trials, including the potential
timing for and receipt of regulatory advice or authorization
related to clinical trials and other clinical development
activities including clinical trial commencement or cohort
initiation; our ability and the potential to successfully
manufacture and supply our product candidates for clinical trials;
our ability to replicate results achieved in our preclinical
studies or clinical trials in any future studies or trials; our
ability to replicate interim or early-stage results from our
clinical trials in the results obtained when those clinical trials
are completed or when those therapies complete later-stage clinical
trials; regulatory developments in the United States and foreign
countries; the anticipated timing and content of presentations
of data from our clinical trials; and our ability to fund our
future operations. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: uncertainties related to the initiation,
timing, advancement and conduct of preclinical and clinical studies
and other development requirements for our product candidates; the
risk that any one or more of our product candidates will cost more
to develop or may not be successfully developed and commercialized;
and the risk that sufficient capital to fund our future operations
will be available to us on acceptable terms or at the times
required. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could
cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk Factors”
in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or
Quarterly Report on Form 10-Q, as filed with the Securities and
Exchange Commission. All information in this press release is as of
the date of the release, and C4 Therapeutics undertakes no duty to
update this information unless required by law.
Contacts:Investors:Courtney SolbergAssociate
Director, Investor RelationsCSolberg@c4therapeutics.com
Media:Loraine SpreenSenior Director, Corporate Communications
& Patient AdvocacyLSpreen@c4therapeutics.com
|
Condensed Consolidated Balance Sheet
Data (in thousands) |
|
|
March 31, 2025 |
|
December 31, 2024 |
Cash, cash equivalents and marketable securities |
$ |
234,706 |
|
$ |
267,263 |
Total
assets |
|
319,524 |
|
|
349,602 |
Deferred
revenue |
|
46,702 |
|
|
47,169 |
Total
stockholders' equity |
|
195,140 |
|
|
215,986 |
|
|
Condensed Consolidated Statements of
Operations (in thousands, except share and
per share amounts) |
|
|
Three Months Ended March 31, |
|
|
2025 |
|
|
|
2024 |
|
Revenue from collaboration
agreements |
$ |
7,238 |
|
|
$ |
3,039 |
|
Operating expenses: |
|
|
|
Research and development |
|
27,072 |
|
|
|
22,533 |
|
General and administrative |
|
9,330 |
|
|
|
10,288 |
|
Restructuring |
|
— |
|
|
|
2,437 |
|
Total operating expenses |
|
36,402 |
|
|
|
35,258 |
|
Loss from operations |
|
(29,164 |
) |
|
|
(32,219 |
) |
Other income, net |
|
|
|
Interest and other income, net |
|
2,842 |
|
|
|
3,858 |
|
Total other income, net |
|
2,842 |
|
|
|
3,858 |
|
Net loss |
$ |
(26,322 |
) |
|
$ |
(28,361 |
) |
Net loss per share - basic and
diluted |
$ |
(0.37 |
) |
|
$ |
(0.41 |
) |
Weighted-average number of
shares - basic and diluted |
|
70,833,044 |
|
|
|
68,432,168 |
|
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