C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation science, today reported financial results for the year
ended December 31, 2023, as well as recent business updates.
“2023 was an important year for C4T as we executed across three
clinical trials, entered into two new collaborations, generated
positive dose escalation data from our CFT7455 program for patients
with relapsed/refractory multiple myeloma, and meaningfully
extended our cash runway,” said Andrew Hirsch, president and chief
executive officer of C4 Therapeutics. “We began 2024 with positive
momentum across our portfolio and are looking forward to sharing
data from our two lead programs, CFT7455 and CFT1946, in the second
half of the year, as well as supporting our partner, Betta
Pharmaceuticals, with trial start-up activities for the Phase 1
trial of CFT8919 in Greater China this year. As we continue to
advance our portfolio, we are well-positioned with a strong balance
sheet to deliver on our goals and execute through and beyond
meaningful value inflection points in order to bring new
therapeutic options to patients with difficult-to-treat
diseases.”
FOURTH QUARTER 2023 AND RECENT ACHIEVEMENTS
CFT7455: 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).
- Presented Positive Data from the Ongoing Phase 1/2
Trial in R/R MM. In December 2023, presented positive
clinical data from the ongoing CFT7455 Phase 1/2 trial in R/R MM
showing that the 14 days on/14 days off schedule is optimal.
Additionally, the data demonstrated anti-myeloma activity,
including International Myeloma Working Group (IMWG) responses in
patients who have undergone numerous lines of prior therapy for MM,
including BCMA therapies.
- Advanced the Phase 1/2 Clinical Trials. The
dose escalation portion of the Phase 1/2 trials evaluating CFT7455
in combination with dexamethasone for R/R MM and as a monotherapy
for R/R NHL continues to progress. As of February 2024, two dose
levels are open for enrollment in the Phase 1/2 trial for R/R MM
and one dose level open for enrollment in the Phase 1/2 trial for
R/R NHL.
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.
- Shared Encouraging Initial Pharmacokinetic (PK) and
Pharmacodynamic (PD) Data. In January 2024, shared PK and
PD data from the initial escalation cohorts of the CFT1946 Phase
1/2 trial demonstrating dose proportional exposure and oral
bioavailability, which are associated with deep degradation of BRAF
V600E, a clinically validated target.
- New Preclinical Data Accepted as a Poster
at the American Association for Cancer Research (AACR)
Annual Meeting 2024. Accepted to present CFT1946
preclinical data demonstrating differentiated activity in
preclinical models of BRAF V600X melanoma, CRC, NSCLC and brain
metastasis.
- 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
progress. As of February 2024, three escalation cohorts are
complete and dose escalation continues with a fourth dose level
currently enrolling.
Collaborations:
Merck
- In December 2023, C4T and Merck entered into a license and
research collaboration to discover and develop degrader antibody
conjugates. Under the terms of the agreement, C4T and Merck will
collaborate to develop degrader antibody conjugates directed to an
initial undisclosed oncology target exclusive to the collaboration;
in January 2024, C4T received the $10 million upfront payment for
this initial target. C4T is eligible to receive milestone payments
totaling approximately $600 million, as well as tiered royalties on
future sales, for degrader antibody conjugates directed to this
initial target. The agreement also provides Merck with the option
to extend the collaboration to include three additional targets
that would be exclusive to the collaboration, which could yield
option exercise payments as well as potential milestones and
royalties. If Merck exercises all of its options to extend the
collaboration, C4T would be eligible to receive up to approximately
$2.5 billion in potential payments across the entire
collaboration.
Betta Pharmaceuticals
- In January 2024, the previously announced $25 million stock
purchase by a subsidiary of partner Betta Pharmaceuticals was
completed.
- In December 2023, Betta Pharmaceuticals received approval from
the Chinese National Medical Products Administration for the
Clinical Trial Application of CFT8919, which is being evaluated in
patients with EGFR L858R NSCLC.
Corporate Updates:
- In January 2024, C4T announced 2024 strategic priorities
focused on advancing product candidates CFT7455 and CFT1946,
delivering on discovery collaborations, and streamlined internal
research efforts, which resulted in an approximately 30% reduction
in the company’s workforce.
- As announced in January 2024, C4T sold approximately 13.7
million shares under the company’s at the market (ATM) offering
arrangement, at an average price of $5.42 per share, resulting in
approximately $72 million of new equity capital, net of commissions
and fees. As of December 31, 2023, 11.2 million of these shares had
settled for net proceeds of $57.7 million.
- In November 2023, C4T appointed Owen Hughes to its board of
directors. Mr. Hughes is an accomplished life sciences executive
with nearly three decades of experience in investing, operations
and corporate governance.
KEY UPCOMING MILESTONES
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 preclinical data demonstrating differentiated activity
in preclinical models of BRAF V600X NSCLC, CRC, melanoma and brain
metastasis at the AACR Annual Meeting taking place April 5 – 10,
2024 in San Diego, CA.
- Present clinical data from the ongoing Phase 1 dose escalation
trial in NSCLC, CRC, melanoma and other cancers with BRAF V600X
mutations in 2H 2024.
UPCOMING INVESTOR EVENTS
- March 4, 2024: Management will present at TD
Cowen’s 44th Annual Health Care Conference taking place March 4 -
6, 2024, at the Marriott Copley Place in Boston, MA.
- March 11, 2024: Management will participate in
a fireside chat at the Leerink Partners Global Biopharma Conference
taking place March 11 - 13, 2024, at the Fontainebleau in Miami,
FL.
FULL YEAR 2023 FINANCIAL RESULTS
Revenue: Total revenue for the year ended
December 31, 2023 was $20.8 million, compared to $31.1 million for
the year ended December 31, 2022. The decrease in revenue was
primarily due to the collaboration agreement with Calico ending in
January 2023 and completion of research activities for a target
under the collaboration agreement with Biogen, partially offset by
the completion of research activities for select targets under the
collaboration agreement with Roche. 2023 revenue reflects amounts
recognized under our collaboration agreements with Biogen, Calico,
and Roche.
Research and Development (R&D)
Expense: R&D expense for the year ended December
31, 2023 was $117.7 million, compared to $117.8 million for the
year ended December 31, 2022. R&D expense was relatively flat
year over year as preclinical costs decreased and clinical costs
increased with the transition of CFT1946 to clinical
development.
General and Administrative (G&A)
Expense: G&A expense for the year ended December
31, 2023 was $42.1 million, compared to $42.8 million for the year
ended December 31, 2022. The decrease in G&A expense was
primarily attributable to a decrease in professional fees.
Net Loss and Net Loss per Share: Net loss
for the year ended December 31, 2023 was $132.5 million, compared
to $128.2 million for the year ended December 31, 2022. Net loss
per share for the year ended December 31, 2023 was $2.67, compared
to $2.62 for the year ended December 31, 2022.
Cash Position and Financial
Guidance: Cash, cash equivalents and marketable
securities as of December 31, 2023 were $281.7 million,
compared to $337.1 million as of December 31, 2022. Cash and cash
equivalents as of December 31, 2023 do not include $25 million in
proceeds from the sale of shares of our common stock to a
subsidiary of Betta Pharmaceuticals, $14.1 million of proceeds in
connection with the settlement of 2,500,601 shares under our ATM
program, and the $10.0 million upfront payment related to our
collaboration agreement with Merck, all of which were received in
January 2024. The company expects that its cash, cash equivalents
and marketable securities as of December 31, 2023, together with
these amounts received in January 2024, which result in a proforma
balance of approximately $330 million, 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 CFT7455CFT7455 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). CFT7455 is
currently in a Phase 1 dose escalation study in MM and NHL. Initial
clinical data show 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
V600 mutant solid tumors including non-small cell lung cancer,
colorectal cancer and melanoma. More information about this trial
may be accessed at www.clinicaltrials.gov (identifier:
NCT05668585).
About CFT8919CFT8919 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 and
collaboration agreement for the development and commercialization
of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and
Taiwan.
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)
|
December 31, |
|
|
2023 |
|
|
2022 |
Cash, cash equivalents and
marketable securities |
$ |
281,689 |
|
$ |
337,115 |
Total assets |
|
376,451 |
|
|
430,840 |
Deferred revenue |
|
37,285 |
|
|
33,513 |
Long-term debt - related
party |
|
- |
|
|
11,482 |
Total stockholders' equity |
|
246,114 |
|
|
289,234 |
|
|
|
|
|
|
Condensed Consolidated Statement of
Operations(in thousands, except share and per
share amounts)
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
Revenue from collaboration
agreements |
$ |
20,756 |
|
|
$ |
31,096 |
|
Operating expenses: |
|
|
|
Research and development |
|
117,706 |
|
|
|
117,841 |
|
General and administrative |
|
42,081 |
|
|
|
42,789 |
|
Total operating expenses |
|
159,787 |
|
|
|
160,630 |
|
Loss from operations |
|
(139,031 |
) |
|
|
(129,534 |
) |
Other income (expense),
net |
|
|
|
Interest expense and amortization of long-term debt—related
party |
|
(1,373 |
) |
|
|
(2,216 |
) |
Loss on early extinguishment of debt |
|
(621 |
) |
|
|
- |
|
Interest and other income, net |
|
9,812 |
|
|
|
3,575 |
|
Total other income (expense),
net |
|
7,818 |
|
|
|
1,359 |
|
Loss before income taxes |
|
(131,213 |
) |
|
|
(128,175 |
) |
Income tax expense |
|
(1,280 |
) |
|
|
- |
|
Net loss |
$ |
(132,493 |
) |
|
$ |
(128,175 |
) |
Net loss per share - basic and
diluted |
$ |
(2.67 |
) |
|
$ |
(2.62 |
) |
Weighted-average number of
shares - basic and diluted |
|
49,640,505 |
|
|
|
48,861,665 |
|
Grafico Azioni C4 Therapeutics (NASDAQ:CCCC)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni C4 Therapeutics (NASDAQ:CCCC)
Storico
Da Set 2023 a Set 2024