C4 Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights
May 08 2024 - 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, 2024, as well as recent business
highlights.
“We are off to a strong start in 2024 with enrollment
progressing well in our ongoing Phase 1/2 trials of CFT7455, now
known as cemsidomide, and CFT1946. We look forward to maintaining
this momentum and are on track for clinical readouts from both
trials in the second half of the year,” said Andrew Hirsch,
president and chief executive officer of C4 Therapeutics. “During
the first quarter, we continued to leverage our discovery expertise
as we entered into a new license and collaboration agreement with
Merck KGaA, Darmstadt, Germany and delivered our first development
candidate to Biogen. Together, these accomplishments further
validate the excitement around our TORPEDO® platform and our
ability to design innovative molecules for a range of diseases
where degraders have the potential to become new therapeutic
options for patients searching for treatments.”
FIRST QUARTER 2024 AND RECENT ACHIEVEMENTS
Cemsidomide (CFT7455): Cemsidomide (CFT7455) is
an oral degrader of IKZF1/3 for the potential treatment of
relapsed/refractory (R/R) multiple myeloma (MM) and R/R
non-Hodgkin’s lymphomas (NHL).
- Advanced the Phase 1/2 Clinical Trial. The
dose escalation portion of the Phase 1/2 trial evaluating
cemsidomide (CFT7455) in combination with dexamethasone for R/R MM
and as a monotherapy for R/R NHL continues to enroll patients. For
the combination with dexamethasone MM arm, the 62.5 µg dose has
been declared safe and patients are enrolling at a higher dose
level. Simultaneously, additional patients are enrolling in the
62.5 µg expansion cohort. For the monotherapy NHL arm, the 62.5 µg
cohort has been declared safe and patients are enrolling at a
higher dose level.
CFT1946: CFT1946 is an oral degrader targeting
BRAF V600X mutations for the potential treatment of solid tumors
including non-small cell lung cancer (NSCLC), colorectal cancer
(CRC) and melanoma.
- Advanced the Phase 1/2
Clinical Trial. The dose escalation portion of the CFT1946
Phase 1/2 trial for BRAF V600X mutations, including NSCLC, CRC and
melanoma, continues to enroll patients. The 320 mg dose has been
declared safe and patients are enrolling at a higher dose level.
Simultaneously, additional patients are enrolling at the 160 mg and
320 mg dose levels for pharmacokinetic, pharmacodynamic and
anti-tumor activity evaluation.
- Presented New Preclinical
Data at the American Association for Cancer Research (AACR) Annual
Meeting 2024. In April 2024, C4T presented preclinical
data highlighting superior activity of CFT1946 compared to BRAF
inhibitor standard of care combinations in models of BRAF V600X
NSCLC, CRC, melanoma and brain metastasis.
- Trial-in-Progress Poster
Accepted at European Society for Medical Oncology Congress (ESMO)
Gastrointestinal (GI) Cancers Congress 2024. C4T will
present a trial-in-progress poster on the CRC opportunity within
the ongoing CFT1946 Phase 1/2 trial at ESMO GI 2024, taking place
from June 26 to June 29, 2024.
Collaborations:
- Delivered development
candidate to Biogen. In April 2024, C4T earned an $8
million payment after Biogen accepted delivery of a development
candidate in an undisclosed indication. Biogen is responsible for
all future clinical development and commercialization for this
program.
- License and collaboration
agreement with Merck KGaA, Darmstadt, Germany (MKDG). In
March 2024, C4T entered into a license and collaboration agreement
with MKDG to exclusively discover two targeted protein degraders
against critical oncogenic proteins that C4T has progressed within
its internal discovery pipeline. Under the terms of the
agreement, C4T received an upfront payment of $16 million.
MKDG will fund C4T’s discovery research efforts. C4T has the
potential to receive up to approximately $740 million in discovery,
regulatory and commercial milestone payments across the
collaboration. In addition, C4T is eligible for mid-single to
low-double digit tiered royalties on future sales for each
program.
CORPORATE UPDATES
- In April 2024, Dan Powers, DO, was appointed as senior vice
president, clinical development. Dr. Powers brings over 20 years of
leadership experience in clinical development and medical affairs
within the hematology and solid tumor space. Dr. Powers reports to
C4T’s chief medical officer, Len Reyno, M.D., and is responsible
for leading clinical development programs as well as supporting and
executing our ongoing clinical studies.
KEY UPCOMING MILESTONES
Cemsidomide (CFT7455):
- Present updated data from the ongoing Phase 1 dose escalation
trial in R/R MM in 2H 2024.
- Present data from the ongoing Phase 1 dose escalation trial in
R/R NHL in 2H 2024.
- Complete Phase 1 dose exploration in R/R MM and R/R NHL by
year-end 2024.
CFT1946:
- Present data from the ongoing Phase 1 monotherapy dose
escalation trial in NSCLC, CRC, melanoma and other cancers with
BRAF V600X mutations in 2H 2024.
FIRST QUARTER 2024 FINANCIAL RESULTS
Revenue: Total revenue for the first quarter of
2024 was $3.0 million, compared to $3.8 million for the first
quarter of 2023. The decrease in revenue was primarily due to the
Biogen and Calico research terms ending in 2023. In 2024, we
commenced work on our new collaboration agreements with Merck Sharp
& Dohme LLC (Merck) and MKDG, which were signed in December
2023 and March 2024, respectively. Total revenue for the first
quarter of 2024 reflects revenue recognized under our
collaborations with MKDG, Merck, Roche and Biogen, and total
revenue recognized in the first quarter of 2023 reflects revenue
recognized under collaboration agreements with Roche, Biogen and
Calico.
Research and Development (R&D) Expense:
R&D expense, net of a one-time $1.9 million restructuring
charge, was $22.5 million for the first quarter of 2024. This is
compared to $29.0 million for the first quarter of 2023. The
reduction in R&D expense was primarily due to the
prioritization of our internal discovery efforts and stopping
clinical development for CFT8634, partially offset by increased
clinical trial expense as cemsidomide (CFT7455) and CFT1946
continue to advance.
General and Administrative (G&A) Expense:
G&A expense, net of a one-time $0.5 million restructuring
charge, was $10.3 million for the first quarter of 2024. This is
compared to $10.9 million for the first quarter of 2023. The
decrease in G&A expense was primarily attributable to a
reduction in external consulting spend.
Net Loss and Net Loss per Share: Net loss for
the first quarter of 2024 was $28.4 million, compared to $34.8
million for the first quarter of 2023. Net loss per share for the
first quarter of 2024 was $0.41 compared to $0.71 for the first
quarter of 2023.
Cash Position and Financial Guidance: Cash,
cash equivalents and marketable securities as of March 31, 2024
were $299.2 million, compared to $281.7 million as of December 31,
2023. The increase was primarily the result of proceeds received in
January 2024 from the sale of shares of our common stock to a
subsidiary of our partner Betta Pharmaceuticals and proceeds from
settlement of shares under our at the market (ATM) offering
arrangement, both of which were previously disclosed. These inflows
were partially offset by cash used in operating activities. C4T
expects that its cash, cash equivalents and marketable securities
as of March 31, 2024 will be sufficient to fund planned operating
expenses and capital expenditures 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 cemsidomide (CFT7455)Cemsidomide
(CFT7455) is an orally bioavailable MonoDAC™ degrader designed to
be highly potent and selective against its intended targets of
Ikaros (IKZF1) and Aiolos (IKZF3) and overcome shortcomings of
currently approved therapies to treat multiple myeloma (MM) and
non-Hodgkin’s lymphoma (NHL). Cemsidomide (CFT7455) is currently in
a Phase 1 dose escalation study in MM and NHL. Initial clinical
data show cemsidomide (CFT7455) is well tolerated, demonstrates
anti-myeloma activity and displays evidence of immunomodulatory
effects. More information about this trial may be accessed at
www.clinicaltrials.gov (identifier: NCT04756726).
About CFT1946CFT1946 is an orally bioavailable
BiDAC™ degrader designed to be potent and selective against BRAF
V600X mutant targets. In preclinical studies, CFT1946 is
active in vivo and in vitro in models with BRAF
V600E driven disease and in models resistant to BRAF inhibitors.
CFT1946 is currently in a Phase 1 dose escalation study in BRAF
V600X mutant solid tumors including colorectal cancer, non-small
cell lung cancer and melanoma. More information about this trial
may be accessed at www.clinicaltrials.gov (identifier:
NCT05668585).
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 authorization related to clinical trials and other
clinical development activities including clinical trial
commencement; our ability and the potential to successfully
manufacture and supply our product candidates for clinical trials;
our ability to successfully perform on our obligations under and
realize downstream economics related to our collaborations; 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 potential timing for updates on our clinical and research
programs; 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; the risk that the
results of preclinical studies and/or clinical trials will or will
not be predictive of results in connection with future studies or
trials. 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 SolbergSenior
Manager, Investor RelationsCSolberg@c4therapeutics.com
Media: Loraine Spreen Senior Director, Corporate Communications
& Patient Advocacy LSpreen@c4therapeutics.com
|
Condensed Consolidated Balance Sheet
Data(in thousands) |
|
|
March 31,2024 |
|
December 31,2023 |
Cash, cash equivalents and marketable securities |
$ |
299,167 |
|
|
$ |
281,689 |
|
Total assets |
|
398,371 |
|
|
|
376,451 |
|
Deferred revenue |
|
55,848 |
|
|
|
37,285 |
|
Total stockholders'
equity |
|
258,282 |
|
|
|
246,114 |
|
|
Condensed Consolidated Statement of
Operations (in thousands, except share and
per share amounts) |
|
|
Three Months EndedMarch 31, |
|
|
2024 |
|
|
|
2023 |
|
Revenue from collaboration
agreements |
$ |
3,039 |
|
|
$ |
3,759 |
|
Operating expenses: |
|
|
|
Research and development |
|
22,533 |
|
|
|
29,042 |
|
General and administrative |
|
10,288 |
|
|
|
10,945 |
|
Restructuring |
|
2,437 |
|
|
|
— |
|
Total operating expenses |
|
35,258 |
|
|
|
39,987 |
|
Loss from operations |
|
(32,219 |
) |
|
|
(36,228 |
) |
Other income (expense),
net |
|
|
|
Interest expense and amortization of long-term debt—related
party |
|
— |
|
|
|
(606 |
) |
Interest and other income, net |
|
3,858 |
|
|
|
2,054 |
|
Total other income (expense), net |
|
3,858 |
|
|
|
1,448 |
|
Loss before income taxes |
|
(28,361 |
) |
|
|
(34,780 |
) |
Income tax expense |
|
— |
|
|
|
— |
|
Net loss |
$ |
(28,361 |
) |
|
$ |
(34,780 |
) |
Net loss per share - basic and
diluted |
$ |
(0.41 |
) |
|
$ |
(0.71 |
) |
Weighted-average number of
shares - basic and diluted |
|
68,432,168 |
|
|
|
49,032,319 |
|
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