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 second quarter
ended June 30, 2024, and provided a corporate update.
“The second quarter of 2024 represented a pivotal period for
Candel, characterized by robust clinical advancements and key
regulatory successes, that further validate our innovative approach
to cancer immunotherapy,” said Paul Peter Tak, MD, PhD, FMedSci,
President and Chief Executive Officer of Candel. “Our encouraging
overall survival phase 2 data for CAN-2409 highlights the potential
of our lead candidate to address a significant unmet need for
non-small cell lung cancer patients, who are non-responsive to
immune checkpoint inhibitor treatment, and for patients with
borderline resectable pancreatic cancer. In addition, the FDA
granting orphan drug designation for CAN-3110 in recurrent
high-grade glioma underscores the promise of this first-in-class,
novel asset developed for difficult-to-treat cancers.”
Dr. Tak continued, “Our inclusion in the Russell 3000 Index also
marks a significant milestone in Candel’s growth and offers an
opportunity to increase our recognition within the investment
community. These achievements, coupled with a successful R&D
event at ASCO, have set a strong foundation as we approach several
key readouts in the latter half of 2024.”
Second Quarter 2024 & Recent Highlights
- Program
Updates
- CAN-2409 – Pancreatic Cancer
- In early April, announced positive
updated survival data from the phase 2 randomized controlled
clinical trial of CAN-2409 plus valacyclovir (prodrug), together
with standard of care (SoC) chemoradiation, in 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 after chemoradiation and prior
to surgery versus 16.7% in the control group. At 36 months,
estimated survival was 47.6% in the CAN-2409 group after
chemoradiation and prior to surgery 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.
- Analysis of resected tumors showed
the formation of dense aggregates of immune cells, including CD8+,
cytotoxic tumor infiltrating lymphocytes and dendritic cells,
within the tumor microenvironment after CAN-2409 administration,
confirming the activation of a robust antitumoral immune
response.
- Received orphan drug designation
from the FDA for CAN-2409 for the treatment of pancreatic
cancer.
- CAN-2409 – Non-Small Cell Lung
Cancer
- Presented topline overall survival
data from the phase 2 clinical trial of CAN-2409 plus valacyclovir
in combination with continued immune checkpoint inhibitor (ICI)
therapy in patients with stage III/IV NSCLC inadequately responding
to ICI therapy at the 2024 ASCO Annual Meeting.
- Data showed mOS of 20.6 months in
patients with progressive disease despite ICI treatment compared to
published results of less than 12 months with SoC docetaxel-based
chemotherapy in similar patient populations.1
- CAN-2409 treatment resulted in
activation of the systemic immune response after two
administrations of CAN-2409, including increased numbers of
circulating cytotoxic and memory T cells associated with subsequent
prolonged survival.
- As of the
April 1, 2024 data cut-off date, CAN-2409 treatment in NSCLC
continued to exhibit a favorable safety and tolerability
profile.
- CAN-3110
– Recurrent High-Grade Glioma
- Received
orphan drug designation from the FDA for CAN-3110 for the treatment
of rHGG.
- Presented
a Trial-in-Progress poster at the 2024 ASCO Annual Meeting on the
ongoing phase 1b clinical trial exploring multiple doses of
CAN-3110 in patients with rHGG.
-
enLIGHTEN™ Discovery Platform
- Presented
preclinical data at the American Association for Cancer Research
(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.
- Corporate Updates
- Hosted successful NSCLC Research and Development panel during
the 2024 ASCO Annual Meeting, featuring prominent scientific and
medical thought leaders discussing the topline overall survival
data from the phase 2 clinical trial of CAN-2409 in NSCLC.
- Announced inclusion in the Russell 3000 Index, effective July
1, 2024, as part of FTSE Russell’s annual reconstitution of its
U.S. equity indexes.
Anticipated Milestones
-
Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2
2024.
-
Phase 2b 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 Second Quarter Ended June 30,
2024
Research and
Development Expenses: Research and development
expenses were $5.0 million for the second quarter of 2024 compared
to $5.9 million for the second quarter of 2023. The decrease was
primarily due to lower clinical development costs driven by a
reduction in regulatory, manufacturing and clinical trial costs for
CAN-2409 programs and lower payroll-related expenses following the
corporate restructuring in the fourth quarter of 2023. These
decreases were partially offset by increased stock-based
compensation expense. Research and development expenses included
non-cash stock compensation expense of $1.3 million for the second
quarter of 2024 compared to $0.3 million for the second quarter of
2023.
General and
Administrative Expenses: General
and administrative expenses were $3.6 million for both the second
quarter of 2024 and the second quarter of 2023. There was a small
decrease, primarily due to lower insurance costs and recruiting
costs. These decreases were partially offset by increased
professional and consulting fees. General and administrative
expenses included non-cash stock compensation expense of $0.6
million for the second quarter of 2024 compared to $0.4 million for
the second quarter of 2023.
Net Loss: Net loss for the
second quarter of 2024 was $22.2 million, compared to a net loss of
$9.6 million for the second quarter of 2023, and included other
expense, net of $13.7 million and $35,000, respectively, primarily
due to the change in the fair value of the Company’s warrant
liability.
Cash Position: Cash and cash
equivalents, as of June 30, 2024, were $21.5 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 first quarter of 2025.
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, including the ability of CAN-2409 to
improve overall survival of patients with NSCLC who are
non-responsive to immune checkpoint inhibitor therapy and of
patients with borderline resectable pancreatic cancer; the ability
of CAN-3110 to treat difficult-to-treat cancers; 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 Quarterly Report on Form 10-Q
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 ContactBen ShannonVice PresidentICR
Westwicke CandelPR@westwicke.com
____________________
Reckamp KL, et al. J Clin Oncol. 2022;40(21):2295-2306.
|
Candel Therapeutics, Inc.Consolidated Statements of Operations(in
thousands, except share and per share amounts)(Unaudited) |
|
|
|
THREE MONTHS ENDED JUNE 30, |
|
SIX MONTHS ENDED JUNE 30, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,979 |
|
|
$ |
5,934 |
|
|
$ |
9,081 |
|
|
$ |
11,403 |
|
General and administrative |
|
|
3,592 |
|
|
|
3,645 |
|
|
|
7,392 |
|
|
|
7,809 |
|
Total operating expenses |
|
|
8,571 |
|
|
|
9,579 |
|
|
|
16,473 |
|
|
|
19,212 |
|
Loss from operations |
|
|
(8,571 |
) |
|
|
(9,579 |
) |
|
|
(16,473 |
) |
|
|
(19,212 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Grant income |
|
|
— |
|
|
|
12 |
|
|
|
— |
|
|
|
24 |
|
Interest income |
|
|
240 |
|
|
|
453 |
|
|
|
560 |
|
|
|
1,164 |
|
Interest expense |
|
|
(567 |
) |
|
|
(644 |
) |
|
|
(1,213 |
) |
|
|
(1,253 |
) |
Change in fair value of warrant liability |
|
|
(13,339 |
) |
|
|
144 |
|
|
|
(13,332 |
) |
|
|
868 |
|
Total other income (expense), net |
|
|
(13,666 |
) |
|
|
(35 |
) |
|
|
(13,985 |
) |
|
|
803 |
|
Net loss and
comprehensive loss |
|
$ |
(22,237 |
) |
|
$ |
(9,614 |
) |
|
$ |
(30,458 |
) |
|
$ |
(18,409 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.74 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.03 |
) |
|
$ |
(0.64 |
) |
Weighted-average
common shares outstanding, basic and diluted |
|
|
29,878,210 |
|
|
|
28,919,810 |
|
|
|
29,537,874 |
|
|
|
28,919,810 |
|
|
Candel Therapeutics, Inc.Condensed Consolidated Balance Sheet
Data(in thousands) |
|
|
|
JUNE
30,2024(Unaudited) |
|
DECEMBER 31,2023 |
Cash and cash equivalents |
|
$ |
21,454 |
|
|
$ |
35,413 |
|
Working capital (1) |
|
|
8,739 |
|
|
|
22,613 |
|
Total assets |
|
|
26,485 |
|
|
|
41,201 |
|
Warrant liability |
|
|
14,248 |
|
|
|
916 |
|
Total other liabilities |
|
|
22,209 |
|
|
|
27,540 |
|
Accumulated deficit |
|
|
(167,486 |
) |
|
|
(137,028 |
) |
Total stockholders equity
(deficit) |
|
$ |
(9,972 |
) |
|
$ |
12,745 |
|
1) Working capital is
calculated as current assets less current liabilities |
|
|
|
|
|
|
|
|
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