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 first quarter
ended March 31, 2024, and provided a corporate update.
“It was a catalyst-rich first quarter for
Candel, marked by significant advances across both our clinical and
preclinical programs,” said Paul Peter Tak, MD, PhD, FMedSci,
President and Chief Executive Officer of Candel. “Notably, as our
clinical data mature with long-term follow up, we are beginning to
observe highly differentiated results in long-term survival of
patients treated with our viral immunotherapies. An example of
these clinical results was recently shared in an update of the
phase 2 randomized clinical trial of CAN-2409 in patients with
borderline resectable pancreatic cancer, where a notable
improvement in overall survival, in patients treated with CAN-2409
plus standard of care chemoradiation, was demonstrated compared to
chemoradiation alone. The FDA granted CAN-2409 both Fast Track
Designation and Orphan Drug Designation for treatment of patients
with pancreatic ductal adenocarcinoma to improve median overall
survival and treatment of pancreatic cancer, respectively,
providing steady momentum to advance this promising investigational
treatment for patients with significant unmet medical need.”
Dr. Tak continued, “We are also excited to
announce that topline overall survival data from our phase 2
clinical trial of CAN-2409 in patients with stage III/IV non-small
cell lung cancer and an inadequate response to immune checkpoint
inhibitors will be presented at the upcoming ASCO meeting in
Chicago on Monday, June 3, 2024.”
“In addition to our advances in the clinic, we
have made great progress with our enLIGHTENTM Discovery Platform.
In April 2024, we presented our second drug candidate from this
platform, a first-in-class multimodal immunotherapy candidate for
induction of tertiary lymphoid structures, in a late-breaking
presentation at the American Association for Cancer Research (AACR)
Annual Meeting. We believe this preclinical candidate offers
groundbreaking potential in the treatment of cancer,” continued Dr.
Tak. “We expect to release additional preclinical and clinical data
in the coming year, consistent with our commitment to innovation
and patient care.”
First Quarter 2024 & Recent
Highlights
- Program Updates
- CAN-2409 – Pancreatic Cancer
- In early April, announced positive updated survival data, from
the ongoing randomized phase 2 clinical trial of CAN-2409 plus
valacyclovir (prodrug), together with standard of care (SoC)
chemoradiation, followed by resection for borderline resectable
pancreatic ductal adenocarcinoma (PDAC).
- Data showed notable improvements in estimated median overall
survival (mOS) of 28.8 months after experimental treatment with
CAN-2409 versus 12.5 months in control group.
- At 24 months, survival rate was 71.4% in CAN-2409 treated
patients versus 16.7% in the control group after chemoradiation. At
36 months, estimated survival was 47.6% in the CAN-2409 group
versus 16.7% in the control group.
- No new safety signals were observed, providing further support
that multiple injections of CAN-2409 have been generally well
tolerated to date, with no dose-limiting toxicities and no cases of
pancreatitis reported.
- Previous analysis of resected tumors showed dense aggregates of
immune cells, including CD8+, cytotoxic tumor infiltrating
lymphocytes and dendritic cells, in PDAC tissue after CAN-2409
administration, confirming activation of a robust antitumoral
immune response.
- Received Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for CAN-2409 for the treatment of pancreatic
cancer.
- CAN-2409 – Non-small cell lung cancer (NSCLC)
- Announced a poster titled “Overall survival after treatment
with CAN- 2409 plus valacyclovir in combination with continued ICI
in patients with stage III/IV NSCLC with inadequate response to
ICI” was accepted for the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting, and will be presented by Charu
Aggarwal, MD, MPH, Associate Professor for Lung Cancer Excellence,
Perelman School of Medicine, University of Pennsylvania, on June 3,
2024 in Chicago, IL.
- CAN-3110 – Recurrent High-Grade Glioma (rHGG)
- Received Fast Track Designation from the FDA for CAN-3110 for
the treatment of patients with rHGG to improve OS.
- Announced during the 5th Glioblastoma Drug Development Summit
in Boston that six patients have been treated with multiple
injections (up to six injections) of CAN-3110 in cohort C of the
ongoing phase 1b clinical trial, reporting a favorable safety and
tolerability profile.
- Announced a Trial-in-Progress poster, titled “Longitudinal
stereotactic injections of oncolytic immunoactivating
rQNestin34.5v.2 (CAN-3110) with concomitant biopsies for “-omic”
analyses in recurrent glioblastoma (GBM)” was accepted for the 2024
ASCO Annual Meeting, and will be presented by David A. Reardon, MD,
Professor of Medicine at Harvard Medical School and Clinical
Director, Center for Neuro-Oncology at Dana Farber Cancer
Institute, on June 1, 2024, in Chicago, IL.
- enLIGHTEN™ Discovery Platform
- Presented preclinical data at the AACR Annual Meeting unveiling
the second candidate from the enLIGHTEN™ Discovery Platform, a
first-in-class multimodal immunotherapy candidate to induce
tertiary lymphoid structures (TLS), being developed as a novel
therapeutic for solid tumors.
Anticipated Milestones
- Phase 2 topline
OS data for CAN-2409 in NSCLC to be presented at ASCO on June 3,
2024
- Updated Phase 1b
data (Arm C) for CAN-3110 in rHGG expected in H2 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
disease-free survival data for CAN-2409 in localized
intermediate/high-risk prostate cancer expected in Q4 2024
Financial Results for First Quarter
Ended March 31, 2024
Research
and Development Expenses:
Research and development expenses were $4.1 million for the first
quarter of 2024 compared to $5.5 million for the first quarter of
2023. The decrease was primarily due to lower employee-related
expenses following the corporate restructuring in the fourth
quarter of 2023 and lower clinical development costs driven by a
reduction in regulatory costs for CAN-2409 programs. Research and
development expenses included non-cash stock compensation expense
of $0.6 million for the first quarter of 2024 compared to $0.3
million for the first quarter of 2023.
General and
Administrative Expenses: General
and administrative expenses were $3.8 million for the first quarter
of 2024 compared to $4.2 million for the first quarter of 2023. The
decrease was primarily due to lower employee-related expenses
following the corporate restructuring in the fourth quarter of 2023
and lower insurance costs. These decreases were partially offset by
increased professional and consulting fees. General and
administrative expenses included non-cash stock compensation
expense of $0.5 million for the first quarter of 2024 compared to
$0.4 million for the first quarter of 2023.
Net Loss: Net
loss for the first quarter of 2024 was $8.2 million, compared to a
net loss of $8.8 million for the first quarter of 2023, and
included other expense, net of $0.3 million and other income, net
$0.8 million, respectively. The change from other income, net in
the first quarter of 2023 to other expense, net in the first
quarter of 2024 was primarily due to the change in the fair value
of the Company’s warrant liability and lower interest income.
Cash Position:
Cash and cash equivalents, as of March 31, 2024, were $25.7
million, as compared to $35.4 million as of December 31, 2023.
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 Ductal
Adenocarcinoma PDAC (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 1b clinical trial in recurrent
high-grade glioma (rHGG). 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 current and future
development programs, including key data readout milestones and
presentations; expectations regarding early biological readouts as
predictor of clinical response; expectations regarding the
therapeutic benefit of the Company’s programs, the ability of
CAN-2409 to improve the median overall survival of patients with
PDAC; the ability of CAN-3110 to improve the median overall
survival of patients with recurrent HGG; expectations regarding the
potential benefits conferred by Orphan Drug Designation and Fast
Track Designation; 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 JenkinsVice President,
Investor Relations, and Business DevelopmentCandel Therapeutics,
Inc.tjenkins@candeltx.com
Media ContactKyle EvansAccount DirectorICR
Westwicke CandelPR@westwicke.com
|
Candel Therapeutics, Inc.Consolidated Statements of Operations(in
thousands, except share and per share amounts)(Unaudited) |
|
|
|
THREE MONTHS ENDED MARCH 31, |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
4,102 |
|
|
$ |
5,469 |
|
General and administrative |
|
|
3,800 |
|
|
|
4,164 |
|
Total operating expenses |
|
|
7,902 |
|
|
|
9,633 |
|
Loss from operations |
|
|
(7,902 |
) |
|
|
(9,633 |
) |
Other income (expense): |
|
|
|
|
Grant income |
|
|
— |
|
|
|
12 |
|
Interest income |
|
|
320 |
|
|
|
711 |
|
Interest expense |
|
|
(646 |
) |
|
|
(609 |
) |
Change in fair value of warrant liability |
|
|
7 |
|
|
|
724 |
|
Total other income (expense), net |
|
|
(319 |
) |
|
|
838 |
|
Net loss and comprehensive loss |
|
$ |
(8,221 |
) |
|
$ |
(8,795 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.30 |
) |
Weighted-average common shares outstanding, basic and
diluted |
|
|
29,197,537 |
|
|
|
28,919,810 |
|
|
|
|
|
|
|
Candel Therapeutics, Inc.Condensed Consolidated Balance Sheet
Data(in thousands) |
|
|
|
MARCH 31,2024(Unaudited) |
|
DECEMBER 31,2023 |
Cash and cash equivalents |
|
$ |
25,713 |
|
|
$ |
35,413 |
|
Working capital (1) |
|
|
13,599 |
|
|
|
22,613 |
|
Total assets |
|
|
31,217 |
|
|
|
41,201 |
|
Warrant liability |
|
|
909 |
|
|
|
916 |
|
Total other liabilities |
|
|
24,329 |
|
|
|
27,540 |
|
Accumulated deficit |
|
|
(145,249 |
) |
|
|
(137,028 |
) |
Total stockholders equity |
|
$ |
5,979 |
|
|
$ |
12,745 |
|
|
|
|
|
|
(1) Working capital is calculated as current assets less current
liabilities |
|
|
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