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 second quarter ended June 30, 2023, and
provided a corporate update.
“We continue to be encouraged by the therapeutic potential of
our pipeline of oncology drug candidates that have shown clinical
activity across multiple hard-to-treat solid tumor cancers,” said
Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive
Officer of Candel. “With multiple clinical trials underway, we are
well-positioned for a number of upcoming data catalysts. We expect
to announce additional clinical and immunological biomarker data
from our phase 2 clinical trial in late stage PD-(L)1 inhibitor
therapy-resistant non-small cell lung cancer in the third quarter
of this year and topline overall survival data in the second
quarter of 2024. In addition, we plan to announce initial overall
survival and immunological biomarker data from the phase 2 clinical
trial of CAN-2409 in patients with borderline resectable pancreatic
adenocarcimoma in the fourth quarter of 2023.”
Dr. Tak further commented, “For our CAN-3110 drug candidate,
recent data presented from our phase 1 clinical trial in 50
patients with recurrent high-grade glioma demonstrated that a
single injection of CAN-3110 was associated with encouraging median
overall survival without dose-limiting toxicities. We have also
begun evaluating whether multiple injections of CAN-3110 in this
patient population could further boost the anti-tumor immune
response with added drug exposure. This clinical trial program may
also enable future expansion into other indications that are
characterized by Nestin expression. We remain determined in our
efforts to bring the next generation of viral immunotherapies to
patients with cancer.”
Second Quarter 2023 & Recent Highlights
- Program Updates:
- CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)
- Fast Track Designation granted by the U.S. Food and Drug
Administration for CAN-2409 plus valacyclovir in combination with
continued pembrolizumab in order to improve survival or delay
progression in patients with stage III/IV NSCLC who are resistant
to first line PD-(L)1 inhibitor therapy and who do not have
activating molecular driver mutations or have progressed on
directed molecular therapy.
- Presented an overview of the phase 2 NSCLC clinical trial
design, study protocol, and dosing regimen in a trials-in-progress
poster session at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting.
- Based on the estimated completion of patient enrollment in
Cohort 2, expect to report topline overall survival data from the
phase 2 NSCLC clinical trial in Q2 2024.
- CAN-3110 - Recurrent High-Grade Glioma (HGG)
- Presented new data at the 2023 American Society of Gene and
Cell Therapy (ASGCT) Annual Meeting. The data from the phase 1
investigator-sponsored clinical trial demonstrated that a single
injection of CAN-3110 resulted in a median overall survival (mOS)
of 11.8 months in patients with recurrent HGG who had failed
standard of care (SoC) treatment. Further results demonstrated
CAN-3110 to be well tolerated with no dose-limiting
toxicities.
- Advanced patient enrollment in Arm C, supported by the Break
Through Cancer Foundation, to evaluate the repeat dosing regimen of
CAN-3110 (up to six injections over four months) and whether
additional doses can increase mOS.
- Corporate Updates:
- Appointed experienced manufacturing leader Nicoletta Loggia,
PhD, RPh, to the Candel Board of Directors.
Anticipated 2023 Milestones
- Expect to announce additional clinical and immunological
biomarker activity data from newly enrolled patients and additional
follow-up on the 26 patients who received two injections of
CAN-2409 in Cohort 2 of the phase 2 clinical trial of CAN-2409 plus
valacyclovir combined with continued PD-(L)1 targeting agents in
patients with late-stage NSCLC in Q3.
- Expect to announce
initial overall survival and immunological biomarker data from the
open-label, randomized phase 2 clinical trial of CAN-2409 plus
valacyclovir combined with SoC for patients with borderline
resectable pancreatic adenocarcimoma in Q4.
Financial Results for the Quarter Ended June 30,
2023
Research
and Development Service Revenue, related
party: Research and development service revenue, related
party, was $0 for the second quarter of 2023 compared to $31,000
for the second 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 $5.9 million for the second
quarter of 2023 compared to $5.0 million for the second quarter of
2022. The increase was primarily due to personnel-related costs for
additional headcount and manufacturing 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
the second quarter of 2023 compared to $57,000 for the second
quarter of 2022.
General and
Administrative Expenses: General
and administrative expenses were $3.6 million for the second
quarter of 2023 compared to $3.8 million for the second quarter of
2022. The decrease was primarily due to lower recruiting and
insurance costs, partially offset by an increase in professional
service and consulting expenses as well as personnel-related costs
for additional headcount. General and administrative expenses
included non-cash stock compensation expense of $0.4 million for
both the second quarter of 2023 and the second quarter of 2022.
Net Loss: Net loss for the
second quarter of 2023 was $9.6 million compared to a net loss of
$4.1 million for the second quarter of 2022, and included net other
expense of $35,000 and net other income of $4.6 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 June 30, 2023 were $51.9 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 |
|
SIX MONTHS ENDED |
|
|
JUNE 30, |
|
JUNE 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Research and development service revenue, related
party |
|
$ |
— |
|
|
$ |
31 |
|
|
$ |
— |
|
|
$ |
63 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
5,934 |
|
|
|
5,022 |
|
|
|
11,403 |
|
|
|
10,438 |
|
General and administrative |
|
|
3,645 |
|
|
|
3,762 |
|
|
|
7,809 |
|
|
|
7,364 |
|
Total operating expenses |
|
|
9,579 |
|
|
|
8,784 |
|
|
|
19,212 |
|
|
|
17,802 |
|
Loss from operations |
|
|
(9,579 |
) |
|
|
(8,753 |
) |
|
|
(19,212 |
) |
|
|
(17,739 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Grant income |
|
|
12 |
|
|
|
— |
|
|
|
24 |
|
|
|
— |
|
Interest income |
|
|
453 |
|
|
|
70 |
|
|
|
1,164 |
|
|
|
71 |
|
Interest expense |
|
|
(644 |
) |
|
|
(435 |
) |
|
|
(1,253 |
) |
|
|
(611 |
) |
Change in fair value of warrant liability |
|
|
144 |
|
|
|
4,969 |
|
|
|
868 |
|
|
|
13,256 |
|
Total other income (expense), net |
|
|
(35 |
) |
|
|
4,604 |
|
|
|
803 |
|
|
|
12,716 |
|
Net loss |
|
$ |
(9,614 |
) |
|
$ |
(4,149 |
) |
|
$ |
(18,409 |
) |
|
$ |
(5,023 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.17 |
) |
Weighted-average common shares outstanding, basic and
diluted |
|
|
28,919,810 |
|
|
|
28,810,224 |
|
|
|
28,919,810 |
|
|
|
28,750,431 |
|
|
|
|
|
|
|
|
|
|
|
Candel Therapeutics, Inc. |
Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
JUNE 30, |
|
DECEMBER 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
Cash and cash equivalents |
|
$ |
51,894 |
|
|
$ |
70,058 |
|
Working capital (1) |
|
|
45,199 |
|
|
|
66,330 |
|
Total assets |
|
|
58,708 |
|
|
|
77,691 |
|
Warrant liability |
|
|
1,014 |
|
|
|
1,882 |
|
Total other liabilities |
|
|
26,923 |
|
|
|
28,095 |
|
Accumulated deficit |
|
|
(117,498 |
) |
|
|
(99,089 |
) |
Total stockholders equity |
|
$ |
30,771 |
|
|
$ |
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.
The Company 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
non-small cell lung cancer (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 phase 1 clinical trial in recurrent
glioblastoma. 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 key data
readout milestones and presentations; expectations regarding the
therapeutic benefit of its programs; 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;
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; 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
From Apr 2024 to May 2024
Candel Therapeutics (NASDAQ:CADL)
Historical Stock Chart
From May 2023 to May 2024