C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation science to develop a new generation of small-molecule
medicines and transform how disease is treated, today reported
financial results for the second quarter ended June 30, 2023, as
well as recent business highlights.
“In the first half of 2023, we achieved important objectives to
support the continued advancement of our degrader medicine
portfolio. We completed an exclusive licensing agreement with
Betta Pharmaceuticals to develop CFT8919, our EGFR-L858R degrader,
in Greater China, strengthened our leadership team, and progressed
three clinical studies across multiple cancer indications,” said
Andrew Hirsch, president and chief executive officer of C4
Therapeutics. “In the second half of the year, we expect to share
clinical updates from the dose escalation portion of the ongoing
Phase 1/2 trials for our two lead programs, CFT7455 in multiple
myeloma and CFT8634 in synovial sarcoma and SMARCB1-null
cancers.”
SECOND QUARTER 2023 AND RECENT ACHIEVEMENTS
CFT7455: CFT7455 is an oral degrader of IKZF1/3
for the treatment of multiple myeloma (MM) and non-Hodgkin’s
lymphomas (NHL).
- Progressed the Phase 1/2
Clinical Trial: The dose escalation portion of the CFT7455
Phase 1/2 clinical trial continues in MM and NHL. The three arms of
the trial are evaluating CFT7455 as a monotherapy for MM, in
combination with dexamethasone for MM and as a monotherapy for
NHL.
- Presented New Preclinical
Data at the International Conference on Malignant
Lymphoma (ICML): In June 2023, C4T
presented preclinical CFT7455 data in NHL demonstrating potent
anti-tumor activity in peripheral and CNS models of NHL as a single
agent or in combination with clinically approved agents.
CFT8634: CFT8634 is an oral degrader of
BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid
tumors.
- Progressed the Phase 1/2
Clinical Trial: The dose escalation portion of the CFT8634
Phase 1/2 clinical trial continues in synovial sarcoma and
SMARCB1-null solid tumors.
- Initiated the first
enrichment cohort: In August, C4T
initiated the first enrichment cohort to further assess
pharmacodynamic and safety data. This planned additional cohort
further helps support enrollment demand for the ongoing dose
escalation portion of the CFT8634 Phase 1/2 clinical trial.
CFT1946: CFT1946 is an oral degrader targeting
BRAF V600 mutations for the treatment of solid tumors including
non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and
melanoma.
- Progressed the Phase 1/2
Clinical Trial: The dose escalation portion of the CFT1946
Phase 1/2 clinical trial continues in V600 solid tumors, including
NSCLC, CRC and melanoma. Trial sites are now open and enrolling
patients in the U.S. and Europe.
- Presented Trial in Progress
Poster at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting: In June 2023, C4T presented a trial in
progress poster titled “A Phase 1/2 Study of CFT1946, A Novel
Bifunctional Degradation Activating Compound, or BiDAC Degrader, of
Mutant BRAF V600 as Monotherapy and in Combination with Trametinib,
in Mutant BRAF V600 Solid Tumors.”
CFT8919: CFT8919 is an oral degrader designed
to be potent and selective against EGFR L858R for non-small cell
lung cancer (NSCLC).
- Exclusive Licensing
Agreement with Betta Pharmaceuticals in Greater China: In
May 2023, C4T entered into an exclusive license and collaboration
agreement for the development and commercialization of CFT8919 in
Greater China, including Hong Kong SAR, Macau SAR and Taiwan. C4T
expects to receive a total of $35.0 million, which includes $10.0
million in upfront cash paid in June 2023 under the collaboration
agreement and a $25.0 million one-time equity investment under the
stock purchase agreement. Additionally, C4T is eligible for up to
$357.0 million in potential milestones and low to mid-double-digit
percent royalties on net sales in the licensed territories.
- Investigational New Drug
(IND) Application Clearance Achieved: In June 2023, the
U.S. Food and Drug Administration (FDA) cleared C4T’s IND
application for CFT8919. C4T expects to initiate clinical trial
activities outside Greater China following the completion of Betta
Pharmaceuticals’ Phase 1 dose escalation study in Greater
China.
CORPORATE UPDATES
- In July 2023, C4T appointed two new
senior leaders. Leonard (Len) Reyno, M.D., joined C4T as chief
medical officer with nearly 30 years of clinical development
experience, spanning first-in-human studies to Phase IV clinical
trials. Mary Christian, Pharm.D. joined C4T as senior vice
president, regulatory with more than two decades of experience in
regulatory and drug development.
UPCOMING KEY MILESTONES
- CFT7455: Present
Phase 1 dose escalation data from the Phase 1/2 clinical trial of
Arm B1, evaluating CFT7455 as a monotherapy in MM, in the second
half of 2023.
- CFT8634: Present
Phase 1 dose escalation data from the Phase 1/2 clinical trial for
synovial sarcoma and SMARCB1-null solid tumors in the second half
of 2023.
SECOND QUARTER 2023 FINANCIAL RESULTS
Revenue: Total revenue for the second
quarter of 2023 was $2.7 million, compared to $13.8 million for the
second quarter of 2022. The decrease in revenue was due to a
reduction of revenue recognized for research activities under the
Biogen and Calico collaborations. Total revenue for the second
quarter of 2023 reflects revenue recognized under collaboration
agreements with Roche and Biogen, and total revenue recognized in
the second quarter of 2022 reflects revenue recognized under
collaborations agreements with Roche, Biogen, and Calico.
Research and Development (R&D)
Expense: R&D expense for the second quarter of
2023 was $29.9 million, compared to $31.3 million for the second
quarter of 2022. The reduction in R&D expense was primarily
attributable to a decrease in IND-enabling activities as programs
transition to the clinic.
General and Administrative (G&A)
Expense: G&A expense for the second quarter of
2023 was $10.3 million, compared to $9.9 million for the second
quarter of 2022. The higher G&A expense was attributable to a
slight increase in professional fees.
Net Loss and Net Loss per
Share: Net loss for the second quarter of 2023 was
$35.9 million, compared to $27.4 million for the second quarter of
2022. Net loss per share for the second quarter of 2023 was $0.73
compared to $0.56 for the second quarter of 2022.
Cash Position and Financial
Guidance: Cash, cash equivalents and marketable
securities as of June 30, 2023, were $286.7 million, compared to
$337.1 million as of December 31, 2022. The decrease in cash was
primarily driven by expenditures to fund operations, partially
offset by the $10.0 million upfront payment received from Betta
Pharmaceuticals. C4T expects that its cash, cash equivalents and
marketable securities as of June 30, 2023, along with the
anticipated equity investment from an affiliate of Betta
Pharmaceuticals, will be sufficient to fund planned operating
expenses and capital expenditures into the second half of 2025.
About C4 Therapeutics
C4 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 leveraging its
TORPEDO® platform to efficiently design and optimize
small-molecule medicines that 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. C4T is advancing
multiple targeted oncology programs to the clinic and expanding its
research platform to deliver the next wave of medicines for
difficult-to-treat diseases. For more information, please
visit www.c4therapeutics.com.
About CFT7455
CFT7455 is an orally bioavailable MonoDAC™ degrader designed to
be highly potent and selective against its intended targets of
Ikaros (IKZF1) and Aiolos (IKZF3). CFT7455 binds with high affinity
to the E3 ligase adapter protein, cereblon, to target and degrade
IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin's
lymphomas, including peripheral T cell lymphoma and mantle cell
lymphoma. In early clinical data, CFT7455 demonstrated deep and
durable degradation of IKZF1/3. C4T is enrolling patients in its
ongoing Phase 1/2 clinical trial of CFT7455. More information about
this trial may be accessed at www.clinicaltrials.gov (identifier:
NCT04756726).
About CFT8634
CFT8634 is an orally bioavailable BiDAC™ degrader designed to be
potent and selective against BRD9. BRD9 was previously considered
an undruggable target due to the inability of bromodomain
inhibitors to effectively treat cancers dependent on BRD9. Unlike
BRD9 inhibition, BRD9 degradation has been shown to be efficacious
in pre-clinical models of synovial sarcoma. C4T is enrolling
patients in its ongoing Phase 1/2 clinical trial of CFT8634 for the
treatment of synovial sarcoma and SMARCB1-null solid tumors. More
information about this trial may be accessed at
www.clinicaltrials.gov (identifier: NCT05355753).
About CFT1946
CFT1946 is an orally bioavailable BiDAC™ degrader designed to be
potent and selective against BRAF V600 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. C4T is
advancing CFT1946 to the clinic to study treatment for BRAF V600
mutant solid tumors including non-small cell lung cancer,
colorectal cancer, and melanoma. C4T is enrolling patients in its
ongoing Phase 1/2 clinical trial of CFT1946. More information about
this trial may be accessed at www.clinicaltrials.gov (identifier:
NCT05668585).
About CFT8919
CFT8919 is an orally bioavailable allosteric BiDAC™ 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, in preclinical studies,
CFT8919 retains full activity against additional EGFR mutations
that confer resistance against approved EGFR inhibitors including
L858R-C797S, L858R-T790M, and L858R-T790M-C797S. In 2023, C4T
and Betta Pharmaceuticals entered into an exclusive licensing
agreement for the development and commercialization of CFT8919 in
Greater China, including Hong Kong SAR, Macau SAR and Taiwan.
Forward-Looking Statements
This 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 replicate results
achieved in our preclinical studies or clinical trials in any
future studies or trials; regulatory developments in the United
States and foreign countries; 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.
Condensed Consolidated Balance Sheet
Data(in thousands) |
|
|
June 30, |
|
|
December 31, |
|
2023 |
|
|
2022 |
Cash, cash equivalents and marketable securities |
$ |
286,700 |
|
$ |
337,115 |
Total
assets |
|
375,008 |
|
|
430,840 |
Deferred
revenue |
|
38,618 |
|
|
33,513 |
Long-term debt - related party |
|
10,335 |
|
|
11,482 |
Total
stockholders' equity |
|
233,707 |
|
|
289,234 |
Condensed Consolidated Statement of
Operations(in thousands, except share and per
share amounts) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
Revenue from collaboration
agreements |
$ |
2,664 |
|
$ |
13,834 |
|
$ |
6,423 |
|
$ |
21,488 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
29,926 |
|
|
31,323 |
|
|
58,968 |
|
|
57,526 |
|
General and administrative |
|
10,306 |
|
|
9,895 |
|
|
21,251 |
|
|
22,715 |
|
Total operating expenses |
|
40,232 |
|
|
41,218 |
|
|
80,219 |
|
|
80,241 |
|
Loss from operations |
|
(37,568 |
) |
|
(27,384 |
) |
|
(73,796 |
) |
|
(58,753 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
Interest expense and amortization of long-term debt-related
party |
|
(600 |
) |
|
(534 |
) |
|
(1,206 |
) |
|
(1,061 |
) |
Interest and other income, net |
|
2,246 |
|
|
506 |
|
|
4,300 |
|
|
782 |
|
Total
other income (expense), net |
|
1,646 |
|
|
(28 |
) |
|
3,094 |
|
|
(279 |
) |
Net
loss |
$ |
(35,922 |
) |
$ |
(27,412 |
) |
$ |
(70,702 |
) |
$ |
(59,032 |
) |
Net
loss per share − basic and diluted |
$ |
(0.73 |
) |
$ |
(0.56 |
) |
$ |
(1.44 |
) |
$ |
(1.21 |
) |
Weighted-average number of shares used in computed net loss per
share − basic and diluted |
|
49,063,631 |
|
|
48,823,698 |
|
|
49,048,062 |
|
|
48,779,508 |
|
Contacts:Investors: Courtney SolbergSenior
Manager, Investor RelationsCSolberg@c4therapeutics.com
Media: Loraine Spreen Senior Director, Corporate
Communications & Patient
Advocacy LSpreen@c4therapeutics.com
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