Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a
clinical stage biopharmaceutical company focused on developing
multimodal biological immunotherapies to help patients fight
cancer, today reported financial results for the fourth quarter and
year ended December 31, 2023, and provided a corporate update.
“2023 was a significant year for Candel with two additional FDA
Fast Track Designations for CAN-2409 for non-small cell lung cancer
and borderline resectable pancreatic cancer, and most recently
Candel received FDA Fast Track Designation for CAN-3110 for
recurrent high-grade glioma in February of 2024. We are also
excited that initial results in CAN-3110’s ongoing phase 1b
clinical trial were published in the high-impact scientific
journal, Nature,” said Paul Peter Tak, MD PhD FMedSci, President
and CEO of Candel. “Further, initial patient data showed improved
survival after experimental treatment with Candel’s investigational
viral multimodal immunotherapies, as compared to standard of care,
in non-small cell lung cancer (CAN-2409), pancreatic cancer
(CAN-2409), and high-grade glioma (CAN-3110).”
Dr. Tak continued, “In 2024, we are expecting six data readouts
across our three platforms, which include novel clinical and
biomarker data in lung cancer, pancreatic cancer, and brain cancer,
and a potentially registrational phase 3 clinical trial in prostate
cancer. We look forward to sharing additional updates in the year
ahead.”
Fourth Quarter 2023 & Recent Highlights
- CAN-2409 – Pancreatic Cancer
- Announced initial positive interim data from our randomized
phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic
cancer which showed prolonged and sustained survival, robust
activation of immune response after dosing of CAN-2409, and a
favorable tolerability profile.
- U.S. Food and Drug Administration (FDA) granted Fast Track
Designation for CAN-2409 plus prodrug (valacyclovir) for the
treatment of patients with pancreatic ductal adenocarcinoma to
improve overall survival (OS).
- CAN-3110 - Recurrent High-Grade Glioma (HGG)
- The results from
the ongoing first-in-human phase 1b clinical trial of CAN-3110 in
recurrent high-grade glioma, showing extended survival associated
with immune activation, were published online on October 18, 2023,
in Nature.
- FDA granted Fast
Track Designation to CAN-3110 for the treatment of patients with
recurrent high-grade glioma (HGG) to improve OS.
- enLIGHTEN™ Discovery Platform CAN-2409 – Pancreatic Cancer
- Presented encouraging preclinical data from the first
experimental candidate from its discovery pipeline, Alpha
201-macro-1, at both the Society for Immunotherapy of Cancer (SITC)
and the International Oncolytic Virus Conference (IOVC) in November
2023. This investigational, locally delivered, biological oncolytic
therapeutic, which is designed to interfere with the CD47/SIRP1a
pathway, demonstrated better inhibition of tumor growth, when
compared to systemic anti-CD47 antibody therapy, in a mouse model
of breast cancer.
- Announced an upcoming "late-breaking” poster presentation at
the 2024 AACR Annual Meeting unveiling the second drug candidate
from the enLIGHTEN™ Discovery Platform.
Anticipated Milestones
- New preclinical data on the second drug candidate from the
enLIGHTEN™ Discovery Platform to be presented at the 2024 AACR
Annual Meeting taking place April 5-10, 2024
- Phase 2 topline OS data for CAN-2409 in NSCLC expected in Q2
2024
- Phase 2 updated OS data for CAN-2409 in borderline resectable
pancreatic cancer expected in Q2 2024
- Phase 2 topline data for CAN-2409 in low-to-intermediate-risk,
localized, non-metastatic prostate cancer expected in Q4 2024
- Phase 3 topline data for CAN-2409 in localized
intermediate/high-risk prostate cancer expected in Q4 2024
Financial Results for the Year and Fourth Quarter Ended
December 31, 2023
Research
and Development Service Revenue, related
party: Research and development service revenue, related
party, for each of the quarter and full year ended December 31,
2023 was $0, as compared to $31,000 and $125,000 for the quarter
and full year ended December 31, 2022.
Research
and Development Expenses:
Research and development expenses were $7.3 million for the fourth
quarter of 2023 compared to $5.0 million for the fourth quarter of
2022, and $24.5 million for the full year 2023 compared to $20.8
million for the full year 2022. The increase was primarily due to
manufacturing and regulatory activities in support of the Company’s
CAN-2409 programs, stock compensation costs, and impairment of
fixed assets. Research and development expenses included non-cash
stock compensation expense of $0.5 million and $1.3 million for the
fourth quarter and full year of 2023, respectively, as compared to
a non-cash stock compensation expense of $0.2 million and $0.8
million for the fourth quarter and full year of 2022.
General and
Administrative Expenses: General
and administrative expenses were $3.1 million for the fourth
quarter of 2023 compared to $3.2 million for the fourth quarter of
2022, and $13.9 million for the full year 2023 compared to $14.1
million for the full year 2022. The decrease was primarily due to
lower insurance and recruiting costs, which were partially offset
by increased employee-related expenses. General and administrative
expenses included non-cash stock compensation expense of $0.5
million and $1.7 million for the fourth quarter and full year of
2023, respectively, as compared to a non-cash stock compensation
expense of $0.4 million and $1.5 million for the fourth quarter and
full year of 2022.
Net Loss: Net loss for the
fourth quarter of 2023 was $11.1 million compared to a net loss of
$5.1 million for the fourth quarter of 2022, and included net other
expense of $0.8 million and net other income $3.0 million,
respectively. The change from net other income in the fourth
quarter of 2022 to net other expense in the fourth quarter of 2023
was primarily related to the change in the fair value of the
Company’s warrant liability. Net loss for the full year 2023 was
$37.9 million compared to a net loss of $18.8 million for the full
year 2022, and included net other income of $0.5 million and $15.9
million, respectively, related primarily to the change in the fair
value of the Company’s warrant liability.
Cash Position: Cash and cash
equivalents as of December 31, 2023 were $35.4 million, as compared
to $70.1 million as of December 31, 2022. Based on current plans
and assumptions, the Company expects that its existing cash and
cash equivalents will be sufficient to fund its current operating
plan into the fourth quarter of 2024.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on
developing off-the-shelf multimodal biological immunotherapies that
elicit an individualized, systemic anti-tumor immune response to
help patients fight cancer. Candel has established two clinical
stage multimodal biological immunotherapy platforms based on novel,
genetically modified adenovirus and herpes simplex virus (HSV) gene
constructs, respectively. CAN-2409 is the lead product candidate
from the adenovirus platform and is currently in ongoing clinical
trials in non-small cell lung cancer (NSCLC) (phase 2), borderline
resectable pancreatic cancer (phase 2), and localized,
non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is
the lead product candidate from the HSV platform and is currently
in an ongoing investigator-sponsored phase 1 clinical trial in
recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™
Discovery Platform is a systematic, iterative HSV-based discovery
platform leveraging human biology and advanced analytics to create
new viral immunotherapies for solid tumors.
For more information about Candel,
visit: www.candeltx.com
Forward-Looking Statements
This press release includes certain disclosures that contain
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation, express or implied statements regarding the
timing and advancement of development programs, including the
timing and availability of additional data, key data readout
milestones, expectations regarding the therapeutic benefit of the
Company’s programs, including the potential for its programs to
extend patient survival; and expectations regarding cash runway and
expenditures. The words “may,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, those risks and uncertainties related to the timing and
advancement of development programs; the Company’s ability to
continue as a going concern; expectations regarding the therapeutic
benefit of the Company’s programs; that final data from the
Company’s pre-clinical studies and completed clinical trials may
differ materially from reported interim data from ongoing studies
and trials; the Company’s ability to efficiently discover and
develop product candidates; the Company’s ability to obtain and
maintain regulatory approval of product candidates; the Company’s
ability to maintain its intellectual property; the implementation
of the Company’s business model, including strategic plans for the
Company’s business and product candidates, and other risks
identified in the Company’s filings with the U.S. Securities and
Exchange Commission (SEC), including the Company’s most recent
Annual Report on Form 10-K filed with the SEC, and subsequent
filings with the SEC. The Company cautions you not to place undue
reliance on any forward-looking statements, which speak only as of
the date they are made. The Company disclaims any obligation to
publicly update or revise any such statements to reflect any change
in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent the Company’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
Investor ContactTheodore JenkinsVP Investor
Relations and Business DevelopmentCandel Therapeutics,
Inc.tjenkins@candeltx.com
Media ContactAljanae ReynoldsDirectorWheelhouse
Life Science Advisorsareynolds@wheelhouselsa.com
Candel Therapeutics, Inc. Consolidated Statements of Operations (in
thousands, except share and per share amounts) (Unaudited) |
|
|
THREE MONTHS ENDED DECEMBER 31, |
|
TWELVE MONTHS ENDED DECEMBER 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Research and development service revenue, related
party |
$ |
— |
|
|
$ |
31 |
|
|
$ |
— |
|
|
$ |
125 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
7,258 |
|
|
|
4,972 |
|
|
|
24,506 |
|
|
|
20,787 |
|
General and administrative |
|
3,060 |
|
|
|
3,160 |
|
|
|
13,885 |
|
|
|
14,060 |
|
Total operating expenses |
|
10,318 |
|
|
|
8,132 |
|
|
|
38,391 |
|
|
|
34,847 |
|
Loss from operations |
|
(10,318 |
) |
|
|
(8,101 |
) |
|
|
(38,391 |
) |
|
|
(34,722 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Grant income |
|
(36 |
) |
|
|
48 |
|
|
|
— |
|
|
|
48 |
|
Interest income |
|
415 |
|
|
|
804 |
|
|
|
2,081 |
|
|
|
1,218 |
|
Interest expense |
|
(673 |
) |
|
|
(578 |
) |
|
|
(2,595 |
) |
|
|
(1,708 |
) |
Change in fair value of warrant liability |
|
(483 |
) |
|
|
2,744 |
|
|
|
966 |
|
|
|
16,370 |
|
Total other income (expense), net |
|
(777 |
) |
|
|
3,018 |
|
|
|
452 |
|
|
|
15,928 |
|
Net
loss and comprehensive loss |
$ |
(11,095 |
) |
|
$ |
(5,083 |
) |
|
$ |
(37,939 |
) |
|
$ |
(18,794 |
) |
Net
loss per share, basic and diluted |
$ |
(0.38 |
) |
|
$ |
(0.18 |
) |
|
$ |
(1.31 |
) |
|
$ |
(0.65 |
) |
Weighted-average common shares outstanding, basic and
diluted |
|
28,981,222 |
|
|
|
28,899,426 |
|
|
|
28,935,289 |
|
|
|
28,823,480 |
|
Candel Therapeutics,
Inc. Consolidated Balance Sheet Data(in thousands) |
|
|
|
|
|
DECEMBER 31, 2023 |
|
DECEMBER 31, 2022 |
Cash and cash equivalents |
$ |
35,413 |
|
|
$ |
70,058 |
|
Working
capital (1) |
|
22,613 |
|
|
|
66,330 |
|
Total
assets |
|
41,201 |
|
|
|
77,691 |
|
Warrant
liability |
|
916 |
|
|
|
1,882 |
|
Total other
liabilities |
|
27,540 |
|
|
|
28,095 |
|
Accumulated
deficit |
|
(137,028 |
) |
|
|
(99,089 |
) |
Total
stockholders equity |
$ |
12,745 |
|
|
$ |
47,714 |
|
|
|
|
|
(1) Working capital is calculated as current assets less current
liabilities |
|
|
Candel Therapeutics (NASDAQ:CADL)
過去 株価チャート
から 4 2024 まで 5 2024
Candel Therapeutics (NASDAQ:CADL)
過去 株価チャート
から 5 2023 まで 5 2024