C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights
01 Noviembre 2023 - 5:00AM
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 third quarter ended September 30, 2023,
as well as recent business highlights.
“Our team has progressed three clinical trials this year and
generated the necessary information to enable data-based portfolio
decisions, which include prioritizing the ongoing Phase 1/2 trials
of CFT7455 and CFT1946,” said Andrew Hirsch, president and chief
executive officer of C4 Therapeutics. “The CFT8634 Phase 1 dose
escalation data demonstrated our ability to safely degrade a
previously undruggable target, further validating our platform to
design BiDAC degraders with desirable drug-like properties.
Unfortunately, high levels of BRD9 degradation did not result in
sufficient efficacy for highly refractory patients with synovial
sarcoma and SMARCB1-null solid tumors treated with CFT8634 as a
single agent; thus, the development strategy to seek registration
of CFT8634 in these rare tumors is not viable for C4T. On behalf of
our entire team, I would like to express my sincere thanks to all
patients and their caregivers as well as clinicians involved in the
CFT8634 trial.”
THIRD QUARTER 2023 AND RECENT ACHIEVEMENTS
CFT7455: CFT7455 is an oral degrader of IKZF1/3
for the potential treatment of relapsed refractory multiple myeloma
(R/R MM) and relapsed refractory non-Hodgkin’s lymphomas (R/R
NHL).
- Progressed the Phase 1/2
Clinical Trial. In October 2023, C4T announced completion
of the Phase 1 dose escalation for CFT7455 as a monotherapy in R/R
MM using a 14 days on/14 days off dosing schedule. Twenty-two
patients were enrolled across five dose escalation cohorts for this
portion of the study. The Phase 1 dose escalation evaluating
CFT7455 in combination with dexamethasone in R/R MM and as a
monotherapy in R/R NHL continues to progress.
CFT8634: CFT8634 is an oral degrader of BRD9
for the potential treatment of synovial sarcoma and SMARCB1-null
solid tumors.
- Presented Phase 1 Dose
Escalation at Connective Tissue Oncology Society (CTOS) Annual
Meeting. In the Phase 1 dose escalation trial, CFT8634 was
dosed orally starting at 2 mg daily and escalating to 50 mg daily.
At the time of the data cutoff on August 29, 2023, 32 patients were
enrolled (23 synovial sarcoma and nine SMARCB1-null tumor) and 84%
of these patients had more than three prior treatments. All
patients were evaluated for safety, the primary endpoint.The median
duration of treatment across all cohorts was 1.8 months (range of
0-11 months). CFT8634 was generally well-tolerated. As of the
cutoff date, the majority of adverse events (AEs) reported were
considered mild to moderate in severity. The most common
treatment-related AEs were (in decreasing frequency) fatigue, dry
mouth, neutropenia, dysgeusia and anemia.Dose proportional
increases in plasma exposure were achieved and maintained after
single and repeat oral administration, respectively. The calculated
half-life is 10 to14 hours after oral administration. Additionally,
high levels of BRD9 degradation in tumor tissue obtained at day 15
were noted across all dose levels studied.At the time of data
cutoff, eight patients had stable disease (RECIST 1.1) as best
responses at eight weeks. One patient (SMARCB1-null tumor) treated
at the 15mg dose had a partial response.
- Portfolio Decision Not to
Advance CFT8634 Beyond Phase 1 Dose Escalation. C4T has
made the portfolio decision not to advance CFT8634 clinical
development beyond the Phase 1 trial. In the dose escalation trial,
high levels of BRD9 degradation did not result in sufficient
efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null
solid tumor patients treated with CFT8634 as a single agent. No
additional patients will be enrolled in the CFT8634 Phase 1 trial
and wind down activities are expected to be complete by the end of
Q1 2024.
CFT1946: CFT1946 is an oral degrader targeting
BRAF V600 mutations for the potential 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 solid tumors with BRAF V600
mutations, including NSCLC, CRC and melanoma.
- Advanced Translational Work
with CFT1946 in Preclinical CRC Models. Ongoing
translational work in preclinical CRC models encoding BRAF V600X
mutations has shown promising single agent CFT1946 anti-tumor
effects.
CFT8919: CFT8919 is an oral degrader designed
to be potent and selective against EGFR L858R mutations for the
potential treatment of non-small cell lung cancer (NSCLC).
- Clinical Trial Application
(CTA) Accepted for Review by China National Medical Products
Administration (NMPA). Betta Pharmaceuticals announced
that their CTA submission for CFT8919 has been accepted for review
by China NMPA.
COLLABORATION AND RESEARCH UPDATES
- Presented at the 6th
Annual Targeted Protein Degradation (TPD) Summit.
In October 2023, C4T delivered a presentation at the TPD Summit
that highlighted the evolution of the TORPEDO® platform to include
chemoproteomic approaches to identify covalent ligands to both
novel targets and E3 ligases.
- Betta Pharmaceuticals Stock Purchase
Agreement. While both C4T and Betta Pharmaceuticals have
met all closing conditions under the Betta Pharmaceuticals Stock
Purchase Agreement, including Overseas Direct Investment (ODI)
approval, Betta Pharmaceuticals has not fulfilled their obligation
to fund the $25 million equity purchase for reasons Betta
Pharmaceuticals has attributed to their own business circumstances.
C4T and Betta Pharmaceuticals continue to collaborate on the
development of CFT8919 under the separate License and Collaboration
Agreement.
CORPORATE UPDATES
- In September 2023, C4T appointed Kendra Adams as chief
financial officer. Ms. Adams has more than twenty-five years of
experience in financial, operational and strategic planning.
UPCOMING DATA PRESENTATION
- CFT7455: Present
data from the Phase 1 dose escalation portion of the ongoing Phase
1/2 clinical trial focusing on CFT7455 as a monotherapy in R/R MM
on December 12 at 4:30 PM ET at a virtual company-sponsored
event.
UPCOMING INVESTOR EVENTS
- November 8, 2023:
Management will participate in the virtual BMO Biopharma Spotlight
Series Oncology Day.
- November 14, 2023 at 3:00 PM
ET: Management will participate in a fireside chat at the
Stifel 2023 Conference taking place in New York, NY.
THIRD QUARTER 2023 FINANCIAL RESULTS
Revenue: Total revenue for the third quarter of
2023 was $11.1 million, compared to $6.8 million for the third
quarter of 2022. The increase in revenue was primarily due to the
completion of research activities on a nominated target under the
Roche Agreement. Total revenue for the third quarter of 2023
reflects revenue recognized under collaboration agreements with
Roche and Biogen, and total revenue recognized in the third 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 third quarter of 2023 was $28.3 million,
compared to $29.7 million for the third quarter of 2022. The
reduction in R&D expense was due to a decrease in preclinical
expenses as programs progressed through the clinic.
General and Administrative (G&A) Expense:
G&A expense for the third quarter of 2023 was $10.5 million,
compared to $9.6 million for the third quarter of 2022. The
increase in G&A expense was attributable to stock compensation
expense.
Net Loss and Net Loss per Share: Net loss for
the third quarter of 2023 was $27.0 million, compared to $32.0
million for the third quarter of 2022. Net loss per share for the
third quarter of 2023 was $0.55 compared to $0.65 for the third
quarter of 2022.
Cash Position and Financial Guidance: Cash,
cash equivalents and marketable securities as of September 30,
2023, were $246.4 million, compared to $337.1 million as of
December 31, 2022. The decrease in cash was attributable to ongoing
operating expenses as well as the early payment of the outstanding
principal balance of the term loan held with Perceptive Advisors of
$12.5 million. C4T expects that its cash, cash equivalents and
marketable securities as of September 30, 2023, 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.
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) |
|
|
September 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and marketable securities |
$ |
246,426 |
|
$ |
337,115 |
Total
assets |
|
333,013 |
|
|
430,840 |
Deferred
revenue |
|
28,047 |
|
|
33,513 |
Long-term debt-related party |
|
— |
|
|
11,482 |
Total
stockholders' equity |
|
216,024 |
|
|
289,234 |
Condensed Consolidated Statement of
Operations (in thousands, except share and
per share amounts) |
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue from collaboration
agreements |
$ |
11,072 |
|
|
$ |
6,754 |
|
|
$ |
17,495 |
|
|
$ |
28,242 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
28,347 |
|
|
|
29,663 |
|
|
|
87,315 |
|
|
|
87,189 |
|
General and
administrative |
|
10,533 |
|
|
|
9,579 |
|
|
|
31,784 |
|
|
|
32,294 |
|
Total operating expenses |
|
38,880 |
|
|
|
39,242 |
|
|
|
119,099 |
|
|
|
119,483 |
|
Loss from operations |
|
(27,808 |
) |
|
|
(32,488 |
) |
|
|
(101,604 |
) |
|
|
(91,241 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
Interest expense and
amortization of long-term debt-related party |
|
(167 |
) |
|
|
(554 |
) |
|
|
(1,373 |
) |
|
|
(1,615 |
) |
Loss
on early extinguishment of debt |
|
(621 |
) |
|
|
— |
|
|
|
(621 |
) |
|
|
— |
|
Interest and other income,
net |
|
2,562 |
|
|
|
1,084 |
|
|
|
6,862 |
|
|
|
1,866 |
|
Total other income (expense),
net |
|
1,774 |
|
|
|
530 |
|
|
|
4,868 |
|
|
|
251 |
|
Loss before income taxes |
|
(26,034 |
) |
|
|
(31,958 |
) |
|
|
(96,736 |
) |
|
|
(90,990 |
) |
Income tax expense |
|
(1,003 |
) |
|
|
— |
|
|
|
(1,003 |
) |
|
|
— |
|
Net loss |
$ |
(27,037 |
) |
|
$ |
(31,958 |
) |
|
$ |
(97,739 |
) |
|
$ |
(90,990 |
) |
Net loss per share − basic and
diluted |
$ |
(0.55 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.99 |
) |
|
$ |
(1.86 |
) |
Weighted-average number of
shares used in computed net loss per share − basic and diluted |
|
49,212,126 |
|
|
|
48,921,928 |
|
|
|
49,103,351 |
|
|
|
48,827,503 |
|
|
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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