Codiak BioSciences Reports First Quarter 2022 Financial Results and Operational Progress
05 Mayo 2022 - 3:01PM
Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage
biopharmaceutical company focused on pioneering the development of
exosome-based therapeutics as a new class of medicines, today
reported first quarter 2022 financial results and operational
progress.
“We are making exciting progress with our clinical and
preclinical programs, which continue to generate further
confirmatory evidence that our engEx™ Platform can harness exosomes
for potent and selective delivery of therapeutics, not only in
immuno-oncology, but in vaccines and gene therapy as well,” said
Douglas E. Williams, Ph.D., President and Chief Executive Officer
of Codiak. “We remain on track to deliver on several key milestones
by the end of this quarter, including results from all five dose
cohorts in our exoSTING trial, initial CTCL patient data from the
exoIL-12 program, and commencement of dosing in the Phase 1 study
of our third candidate to enter the clinic, exoASO-STAT6.”
First Quarter 2022 and Recent Highlights
- Completed enrollment and dose escalation in cohorts 4 and 5 in
the Phase 1/2 clinical trial of exoSTING (CDK-002) for the
treatment of advanced/metastatic, recurrent and injectable solid
tumors; patient follow-up continues in all dose cohorts, as well as
enrollment of enrichment cohorts
- Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1
trial of exoIL-12 (CDK-003); implemented plans for protocol
amendment to include a broader range of CTCL patients, and
developed plans to enroll patients with additional cutaneous
malignancies responsive to rIL-12
- Activated sites for Phase 1 trial of exoASO-STAT6 (CDK-004) for
the intravenous treatment of hepatocellular carcinoma in
preparation for patient dosing
- Presented new preclinical data from the exoVACC™ pan-beta
coronavirus vaccine program, as part of Codiak’s collaboration with
the Ragon Institute, at the World Vaccine Congress 2022
- Presented preclinical data for exoASO™-C/EBPb, a proprietary
engineered exosome loaded with antisense oligonucleotides targeting
C/EBPβ, at the American Association for Cancer Research (AACR)
Annual Meeting
- Published a manuscript describing the full exoASO-STAT6
preclinical program in the American Association for the Advancement
of Science’s journal, Science Advances
- Named industry veteran oncology drug developer David Mauro,
M.D., Ph.D. as Chief Medical Officer
Anticipated Milestones and Events
- First patients dosed in exoASO-STAT6 Phase 1 clinical trial in
hepatocellular carcinomas anticipated during 1H 2022
- Safety, PK, PD, objective response rate (ORR), and efficacy
data in injected and non-injected tumors from dose escalation
cohorts 1-5 in the Phase 1/2 trial of exoSTING and recommended
Phase 2 dose expected in late 1H 2022
- Initial safety, PK/PD and efficacy data from at least the first
cohort of CTCL patients in the Phase 1 clinical trial of exoIL-12
anticipated in late 1H 2022
- Presentation of new data from engEx-AAV discovery program
describing the generation of potent and high-yield
exosome-associated AAV constructs as a strategy for improving gene
therapy delivery at the American Society of Gene and Cell Therapy
Annual Meeting to be held May 16-19, 2022
Dr. Williams added, “As we have noted in prior quarters,
enrollment in the exoIL-12 study at trial sites in the UK has been
challenging, and we have worked to pursue options for expediting
enrollment. We’re looking forward to the positive impact of
protocol enhancements for this trial to include a broader CTCL
population (stage IIIa) and the potential to enroll patients with
cutaneous malignancies responsive to rIL-12 in past studies –
including Kaposi’s sarcoma, Merkel cell carcinoma, and Squamous
cell carcinoma – each orphan cutaneous diseases treated by the same
physicians, where local treatment is common.”
First Quarter 2022 Financial Results
Total revenues for the quarter ended March 31, 2022, were $12.7
million, compared to $13.2 million for the same period in 2021.
These results reflect deferred revenue recognized under the
Company’s collaboration with Jazz Pharmaceuticals.
Net loss for the quarter ended March 31, 2022, was $8.0 million,
compared to a net loss of $10.3 million for the same period in
2021. The decrease in net loss for the quarter was driven primarily
by a reduction in research and development expenses, some of which
were in connection with the Company’s agreement with Lonza.
Research and development expenses were $14.2 million for the
quarter ended March 31, 2022, compared to $16.6 million for the
same period in 2021. The decrease in research and development
expenses was driven primarily by decreases in lab expenses and
personnel-related costs in connection with our agreement with
Lonza.
General and administrative expenses were $6.7 million for the
quarter ended March 31, 2022, compared to $6.6 million for the same
period in 2021. The increase was driven primarily by an increase in
personnel expenses.
As of March 31, 2022, Codiak had cash, cash equivalents, and
marketable securities of approximately $56.5 million.
About Codiak BioSciencesCodiak is a
clinical-stage biopharmaceutical company pioneering the development
of exosome-based therapeutics, a new class of medicines with the
potential to transform the treatment of a wide spectrum of diseases
with high unmet medical need. By leveraging the biology of exosomes
as natural intercellular transfer mechanisms, Codiak has developed
its proprietary engEx Platform to expand upon the innate properties
of exosomes to design, engineer and manufacture novel exosome
therapeutic candidates. Codiak has utilized its engEx Platform to
generate a deep pipeline of engineered exosomes aimed at treating a
broad range of disease areas, spanning oncology, infectious disease
and rare disease.
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including, among
other things, statements concerning the development and therapeutic
potential of exoSTING and exoIL-12, including timing of release of
data, statements concerning the development of exoASO-STAT6,
including the initiation timing of its clinical program, and
statements regarding the capabilities and potential of Codiak’s
engEx Platform and engineered exosomes generally. Any
forward-looking statements in this press release are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. For a discussion of
these risks and uncertainties, and other important factors, any of
which could cause our actual results to differ from those contained
in the forward-looking statements, see the section entitled “Risk
Factors” in Codiak’s Annual Report on Form 10-K for the
year ended December 31, 2021, and in subsequent filings with
the Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties and other important factors in
Codiak’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is current as of
the date of this report, and Codiak undertakes no duty to update
this information unless required by law.
- financial tables follow –
|
CODIAK BIOSCIENCES, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands, except share and
per share data)(unaudited) |
|
|
|
|
|
|
|
|
|
MARCH 31,2022 |
|
|
DECEMBER 31,2021 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
56,494 |
|
|
$ |
76,938 |
|
Prepaid manufacturing expenses |
|
|
7,308 |
|
|
|
7,315 |
|
Prepaid expenses and other current assets |
|
|
6,111 |
|
|
|
5,918 |
|
Total current assets |
|
|
69,913 |
|
|
|
90,171 |
|
Property and equipment, net |
|
|
22,456 |
|
|
|
23,479 |
|
Restricted cash |
|
|
4,170 |
|
|
|
4,170 |
|
Operating right-of-use
assets |
|
|
21,638 |
|
|
|
21,957 |
|
Prepaid manufacturing expenses,
net of current portion |
|
|
31,893 |
|
|
|
31,893 |
|
Total assets |
|
$ |
150,070 |
|
|
$ |
171,670 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,516 |
|
|
$ |
1,838 |
|
Accrued expenses |
|
|
6,808 |
|
|
|
9,703 |
|
Deferred revenue |
|
|
442 |
|
|
|
12,963 |
|
Operating lease liabilities |
|
|
2,775 |
|
|
|
2,661 |
|
Total current liabilities |
|
|
11,541 |
|
|
|
27,165 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion |
|
|
30,503 |
|
|
|
30,686 |
|
Note payable, net of discount |
|
|
25,514 |
|
|
|
25,430 |
|
Operating lease liabilities, net of current portion |
|
|
34,133 |
|
|
|
34,884 |
|
Other long-term liabilities |
|
|
- |
|
|
- |
|
Total liabilities |
|
|
101,691 |
|
|
|
118,165 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized as
of March 31, 2022 and December 31, 2021; 22,493,867 and 22,383,830
shares issued and outstanding as of March 31, 2022 and December 31,
2021, respectively |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
381,652 |
|
|
|
378,750 |
|
Accumulated deficit |
|
|
(333,275 |
) |
|
|
(325,247 |
) |
Total stockholders’ equity |
|
|
48,379 |
|
|
|
53,505 |
|
Total liabilities and stockholders’ equity |
|
$ |
150,070 |
|
|
$ |
171,670 |
|
|
|
|
|
|
|
|
|
|
|
CODIAK BIOSCIENCES, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(In thousands, except share and per share
data)(unaudited) |
|
|
|
|
|
|
THREE MONTHS
ENDEDMARCH 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
12,704 |
|
|
$ |
13,191 |
|
Total revenue |
|
|
12,704 |
|
|
|
13,191 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
14,248 |
|
|
|
16,550 |
|
General and administrative |
|
|
6,707 |
|
|
|
6,588 |
|
Total operating expenses |
|
|
20,955 |
|
|
|
23,138 |
|
Loss from operations |
|
|
(8,251 |
) |
|
|
(9,947 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
819 |
|
|
|
(698 |
) |
Interest income |
|
|
4 |
|
|
|
5 |
|
Other income |
|
|
(600 |
) |
|
|
332 |
|
Total other expense, net |
|
|
223 |
|
|
|
(361 |
) |
Net loss |
|
$ |
(8,028 |
) |
|
$ |
(10,308 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.51 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
22,436,938 |
|
|
|
20,333,398 |
|
|
|
|
|
|
|
|
|
|
Investor Contact:
Christopher Taylor
VP, Investor Relations and Corporate Communications
T: 617-949-4220
E: investor@codiakbio.com
Media Contact:
Lindy Devereux
Scient PR
T: 646-515-5730
E: media@codiakbio.com
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