Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a
clinical stage biopharmaceutical company focused on developing
viral immunotherapies to help patients fight cancer, today reported
financial results for the third quarter ended September 30, 2023,
and provided a corporate update.
“Candel has made very significant progress with our viral
immunotherapy platforms and oncology-focused pipeline,” said Paul
Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer
of Candel. “We are encouraged by the recent clinical and biomarker
data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in
recurrent HGG. The quality of the science was recently validated by
a publication in Nature. Our off-the-shelf investigational
medicines are designed to elicit individualized, systemic
anti-tumor immune responses and, to date, have shown promise for
extended survival beyond historical rates, along with a generally
favorable safety and tolerability profile. We observed markedly
increased immune cell infiltration in immunosuppressive tumors and
systemic immune activation after experimental treatment with both
CAN-2409 and CAN-3110.”
“We look forward to multiple anticipated data readouts in 2024,
including topline overall survival data from the phase 2 clinical
trial of CAN-2409 in NSCLC in Q2 2024, topline progression-free
survival data from the randomized phase 2 study of CAN-2409 vs.
active surveillance alone in early localized prostate cancer, and
topline disease-free survival data from the randomized phase 3
clinical trial of CAN-2409 in intermediate to high risk localized
prostate cancer in Q4 2024, in addition to the first data on
multiple injections of CAN-3110 in recurrent HGG in the second half
of 2024,” Dr. Tak concluded.
Third Quarter 2023 & Recent Highlights
- Program Updates:
- CAN-2409 –
Non-Small Cell Lung Cancer (NSCLC)
- Initial data from the phase 2 NSCLC
clinical trial suggested promising extension of overall survival,
consistent with an increased tail on the maturing survival curve in
patients whose disease progressed despite receiving anti-PD(L)1
treatment (Cohort 2).
- Data showed 93% of patients with
long survival (≥12 months) were low or negative for PD-(L)1
expression, which supports the potential of CAN-2409 to convert
patients unresponsive to immune checkpoint inhibitor treatment into
long-term survivors.
- Robust activation of the immune
system and immunological correlations between early changes in key
effector immune populations after CAN-2409 treatment and survival
suggested the potential to use early biological readouts as
predictors of clinical response.
- CAN-3110 -
Recurrent High-Grade Glioma (HGG)
- Nature published results from the
phase 1 investigator-sponsored clinical trial of CAN-3110 in 41
patients with recurrent HGG.
- New findings demonstrated that the
proposed dual mechanism of CAN-3110 to trigger potent oncolysis and
immune activation may be further enhanced in the presence of
pre-existing antibodies to HSV (herpes simplex virus)-1.Median
overall survival (mOS) of 14.2 months was observed in the patients
with antibodies to HSV-1 virus (66%), present either at baseline or
developed after CAN-3110 treatment.
- As of the data cut-off of April 20,
2023, data support the continued tolerability of a single injection
of CAN-3110 in recurrent HGG with no dose-limiting toxicity and
observed nearly doubling of the expected mOS in 50 patients (Arm A
and B).
- The observed increase in diversity
of the T-cell receptor repertoire associated with improved survival
after a single injection, suggests that CAN-3110 can induce a broad
and diverse immune response against HSV-1 and against the newly
released tumor antigens.
- Arm C, supported by the Break
Through Cancer Foundation, is currently evaluating the effects of
repeat dosing of CAN-3110 (up to six injections over four
months).
- CAN-2409 –
Pancreatic Cancer
- Positive overall survival and
immunological biomarker data were presented at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting for 2023, based on an
interim analysis of the ongoing, randomized, phase 2 clinical trial
of CAN-2409 plus prodrug together with SoC chemoradiation followed
by resection for borderline resectable non-metastatic pancreatic
ductal adenocarcinoma (PDAC) as of the August 21, 2023 data cutoff
date.
- An estimated survival rate of 71.4%
at 36 months was observed in patients who received 2 or 3
injections of CAN-2409 regimen together with SoC chemoradiation
prior to surgery, versus only 16.7% estimated survival at 36 months
with SoC chemoradiation prior to surgery.
- Patients whose cancer progressed
showed an altered disease course after salvage chemotherapy with
improved CA19-9 levels (biomarker of tumor burden) and ongoing
survival. Similar responses were not observed in the control
arm.
- Biomarker analysis demonstrated
dense aggregates of immune cells that included CD8 positive
granzyme B positive cytotoxic T cells, dendritic cells, and B cells
in PDAC tissue resections obtained after CAN-2409 treatment, which
confirmed activation of a robust antitumoral immune response.
- enLIGHTEN™ Discovery Platform
- Presented the first experimental
agent from the enLIGHTEN™ Discovery Platform, Alpha-201-macro1,
during SITC. This new agent is an investigational viral
immunotherapy that is designed to interfere with the CD47/ SIRPα
pathway and activate innate immune surveillance. Results
demonstrated monotherapy activity following local administration in
a preclinical model of breast cancer.
- Additional preclinical data
presented at SITC confirmed the capability of the enLIGHTEN™
Advanced Analytics suite to predict optimal gene payload
combinations to arm viral vectors, that enable the design of
potential combination therapeutics to overcome tumor resistance
especially in cancers resistant to immune checkpoint inhibitor
treatment.
Anticipated Milestones
- Expect to report topline overall
survival data on the phase 2 clinical trial of CAN-2409 plus
valacyclovir combined with continued PD-(L)1 targeting agents in
patients whose disease progresses despite receiving anti-PD-(L)1
treatment with late-stage NSCLC (Cohort 2) in Q2 2024.
- Expect to report topline
disease-free survival data on the fully enrolled, pivotal,
placebo-controlled, randomized phase 3 clinical trial of CAN-2409
in combination with valacyclovir in localized
intermediate/high-risk prostate cancer in Q4 2024.
- Expect to report topline
progression-free survival data on the fully enrolled,
placebo-controlled, randomized phase 2 clinical trial of CAN-2409
in patients with low-to-intermediate-risk, localized,
non-metastatic prostate cancer in Q4 2024.
- Expect to report clinical and
immunological biomarker data in patients with recurrent HGG
enrolled into Arm C, evaluating repeat dosing regimen of CAN-3110
in 2H 2024.
Financial Results for the Quarter Ended September 30,
2023
Research
and Development Service Revenue, related
party: Research and development service revenue, related
party, was $0 for the third quarter of 2023 compared to $31,000 for
the third quarter of 2022, as the amortizable $1.0 million up-front
license fee that Candel received in 2014 and 2015 from Ventagen LLC
was fully recognized as of December 2022.
Research
and Development Expenses:
Research and development expenses were $5.8 million for the third
quarter of 2023 compared to $5.4 million for the third quarter of
2022. The increase was primarily due to manufacturing and
regulatory activities in support of the Company’s CAN-2409
programs. Research and development expenses included non-cash stock
compensation expense of $0.3 million for both the third quarter of
2023 and the third quarter of 2022.
General and
Administrative Expenses: General
and administrative expenses were $3.0 million for the third quarter
of 2023 compared to $3.5 million for the third quarter of 2022. The
decrease was primarily due to lower professional service and
consulting expenses, recruiting and insurance costs. General and
administrative expenses included non-cash stock compensation
expense of $0.4 million for both the third quarter of 2023 and the
third quarter of 2022.
Net Loss: Net loss for the
third quarter of 2023 was $8.4 million compared to a net loss of
$8.7 million for the third quarter of 2022, and included net other
income of $0.4 million and $0.2 million, respectively, primarily
related to the change in the fair value of the Company’s warrant
liability.
Cash Position: Cash and cash
equivalents as of September 30, 2023 were $43.0 million. The
Company expects that its existing cash and cash equivalents will be
sufficient to fund its current operating plan into the second
quarter of 2024.
|
Candel Therapeutics,
Inc. |
Condensed
Consolidated Statements of Operations |
(in thousands,
except share and per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED SEPTEMBER 30, |
|
NINE MONTHS ENDED SEPTEMBER 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Research and development service revenue, related
party |
|
$ |
— |
|
|
$ |
31 |
|
|
$ |
— |
|
|
$ |
94 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
5,845 |
|
|
|
5,376 |
|
|
|
17,248 |
|
|
|
15,815 |
|
General and administrative |
|
|
3,016 |
|
|
|
3,536 |
|
|
|
10,825 |
|
|
|
10,900 |
|
Total operating expenses |
|
|
8,861 |
|
|
|
8,912 |
|
|
|
28,073 |
|
|
|
26,715 |
|
Loss from operations |
|
|
(8,861 |
) |
|
|
(8,881 |
) |
|
|
(28,073 |
) |
|
|
(26,621 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Grant income |
|
|
12 |
|
|
|
— |
|
|
|
36 |
|
|
|
— |
|
Interest income |
|
|
502 |
|
|
|
343 |
|
|
|
1,666 |
|
|
|
414 |
|
Interest expense |
|
|
(669 |
) |
|
|
(519 |
) |
|
|
(1,922 |
) |
|
|
(1,130 |
) |
Change in fair value of warrant liability |
|
|
581 |
|
|
|
369 |
|
|
|
1,449 |
|
|
|
13,626 |
|
Total other income (expense),
net |
|
|
426 |
|
|
|
193 |
|
|
|
1,229 |
|
|
|
12,910 |
|
Net
loss |
|
$ |
(8,435 |
) |
|
$ |
(8,688 |
) |
|
$ |
(26,844 |
) |
|
$ |
(13,711 |
) |
Net
loss per share, basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.93 |
) |
|
$ |
(0.48 |
) |
Weighted-average common shares outstanding, basic and
diluted |
|
|
28,919,810 |
|
|
|
28,891,909 |
|
|
|
28,919,810 |
|
|
|
28,798,284 |
|
|
|
|
|
|
|
|
|
|
|
Candel Therapeutics,
Inc. |
Consolidated Balance
Sheet Data |
(in thousands) |
|
|
|
|
|
|
|
SEPTEMBER 30, 2023 (Unaudited) |
|
DECEMBER 31, 2022 |
Cash and cash equivalents |
|
$ |
42,983 |
|
|
$ |
70,058 |
|
Working
capital (1) |
|
|
34,774 |
|
|
|
66,330 |
|
Total
assets |
|
|
50,061 |
|
|
|
77,691 |
|
Warrant
liability |
|
|
433 |
|
|
|
1,882 |
|
Total other
liabilities |
|
|
26,606 |
|
|
|
28,095 |
|
Accumulated
deficit |
|
|
(125,933 |
) |
|
|
(99,089 |
) |
Total
stockholders equity |
|
$ |
23,022 |
|
|
$ |
47,714 |
|
|
|
|
|
|
(1) Working capital is calculated as current assets less current
liabilities |
|
|
|
|
|
|
|
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on
developing off-the-shelf viral immunotherapies that elicit an
individualized, systemic anti-tumor immune response to help
patients fight cancer. Candel’s engineered viruses are designed to
induce immunogenic cell death through direct viral-mediated
cytotoxicity in cancer cells, thus releasing tumor neo-antigens
while creating a pro-inflammatory microenvironment at the site of
injection. This leads to in situ vaccination against the injected
tumor and uninjected distant metastases.
Candel has established two clinical stage viral 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 NSCLC (phase 2), 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. In addition, 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 and presentations, the possibility to use early
biological readouts as predictor of clinical response and,
expectations regarding the therapeutic benefit of its programs,
including the potential for CAN-2409its 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 timing of data readout
milestones and presentations; that final data from our pre-clinical
studies and completed clinical trials may differ materially from
reported interim data from ongoing studies and trials; expectations
regarding the therapeutic benefit of the Company’s programs; 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; the Company’s ability to raise additional capital;
the Company’s ability to continue as a going concern; and strategic
plans for the Company’s business and product candidates, and other
risks identified in the Company’s SEC filings, 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.
Media ContactAljanae ReynoldsDirectorWheelhouse
Life Science Advisorsareynolds@wheelhouselsa.com
Investor ContactSylvia
WheelerPrincipalWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Candel Therapeutics (NASDAQ:CADL)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Candel Therapeutics (NASDAQ:CADL)
Historical Stock Chart
Von Mai 2023 bis Mai 2024