Codiak BioSciences Reports Second Quarter 2022 Financial Results and Operational Progress
04 August 2022 - 10:01PM
Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage
biopharmaceutical company pioneering the development of
exosome-based therapeutics as a new class of medicines, today
reported second quarter 2022 financial results and recent
operational progress.
“During the second quarter we made strong progress supporting
our approach and making advancements across our pipeline. We
reported Phase 1 data sets from both our exoSTING™ and exoIL-12™
programs, further validating our engEx® platform, and demonstrating
we were able to deliver repeat doses of exoSTING™ and exoIL-12™ to
the tumor with a high level of specificity. Importantly, we did so
with no observed systemic exposure or associated toxicity, and an
enhanced therapeutic index – while demonstrating tumor shrinkage in
both injected and uninjected lesions,” said Douglas E. Williams,
Ph.D., President and CEO of Codiak. “We also initiated a Phase 1
study of exoASO™-STAT6, our third program to enter the clinic, in
patients with certain liver, gastric and colorectal cancers. These
updates, in combination with preclinical data showing the promise
of our engEx-AAV™ program and a partnership with CEPI to advance
our pan Betacoronavirus program, show that Codiak is broadly
advancing its portfolio programs in 2022, momentum we aim to carry
through this year and into 2023.”
Second Quarter 2022 and Recent Highlights
- Announced platform-validating data from Phase 1 trials of
exoSTING™ and exoIL-12™; both candidates demonstrated potential for
best-in-class profile; Codiak has identified a recommended Phase 2
dose for each program and intends to finalize study plans with the
FDA during the second half of this year to prepare for initiation
of Phase 2 trials for both candidates early next year.
- In a Phase 1 trial, exoIL-12™ demonstrated a differentiating
safety and tolerability profile, with no detectable systemic
exposure of IL-12 and no treatment-related adverse events, which
has not previously been reported by others with recombinant IL-12.
The two patients with cutaneous T cell lymphoma (CTCL) who have
been treated each received multiple (>20) injections of exoIL-12
and experienced tumor regressions in both injected and non-injected
lesions, including a partial response in one patient.
- In the Phase 1/2 clinical trial evaluating exoSTING™ as a
single agent in patients with late-stage refractory solid tumors,
data across all five dose cohorts showed repeat doses of exoSTING™
were well-tolerated, demonstrated tumor retention with no systemic
exposure of the STING agonist, and in a subset of patients, tumor
shrinkage was observed in injected and uninjected lesions.
- Initiated patient dosing in the Phase 1 clinical trial of
exoASO™-STAT6 in patients with advanced hepatocellular carcinoma,
liver metastases from primary gastric cancer and colorectal cancer;
exoASO™-STAT6 is Codiak’s third clinical program and the first to
evaluate a systemically administered exosome-based drug
candidate.
- Partnered with CEPI to continue the advancement of vaccine
candidates from the Company’s pan Betacoronavirus program; as part
of the partnership, CEPI will provide seed funding of up to $2.5
million, which Codiak anticipates will fund the completion of
preclinical development and identification of a clinical
candidate.
- Presented preclinical data on the Company’s engEx-AAV™
discovery program, a novel strategy that aims to leverage exosomes
to improve adeno-associated virus (AAV) vector gene therapy, at the
25th Annual Meeting of the American Society of Gene and Cell
Therapy (ASGCT); data demonstrated that exosome engineering
generates significant increases in AAV yield compared to unmodified
exosomes, while retaining the functionality to transduce cells with
AAV and resist neutralizing antibodies that impair gene therapy
efficacy.
Anticipated Milestones and Events
- Initiate Phase 2 study of exoIL-12™ in an expanded group of
tumor types in 1H 2023; continue to monitor patients enrolled in
Phase 1 study.
- Initiate Phase 2 study of exoSTING™ in bladder cancer in 1H
2023; continue to monitor patients enrolled in ongoing Phase 1/2
study, reporting additional data at an upcoming scientific
conference.
- Continue enrollment for ongoing Phase 1 trial for
exoASO™-STAT6, with initial data expected in 1H 2023.
- Advance exoVACC™ pan Betacoronavirus program toward
identification of a clinical candidate through new partnership with
CEPI.
Second Quarter 2022 Financial ResultsTotal revenues for the
quarter ended June 30, 2022, were $13.1 million, compared to $0.9
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 June 30, 2022, was $6.8 million,
compared to a net loss of $21.8 million for the same period in
2021. The decrease in net loss for the quarter was driven primarily
by an increase in revenues in connection with the Company’s
agreement with Jazz Pharmaceuticals.
Research and development expenses were $12.8 million for the
quarter ended June 30, 2022, compared to $15.4 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 the Company’s agreement
with Lonza.
General and administrative expenses were $7.4 million for the
quarter ended June 30, 2022, compared to $6.9 million for the same
period in 2021. The increase was due primarily to professional
services driven by legal fees for intellectual property rights.
As of June 30, 2022, Codiak had cash, cash equivalents, and
marketable securities of approximately $41.8 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
initiation of clinical trials, the release of data from clinical
trials and the results of those trials, statements concerning the
clinical development of exoASO™-STAT6, 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. In particular, the statements regarding
the initiation and timing of clinical trials are dependent upon
availability of sufficient cash resources, as to which the Company
can make no assurance. 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 (SEC), as well as discussions of
potential risks, uncertainties and other important factors in
Codiak’s subsequent filings with the SEC. 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)
|
|
JUNE 30,2022 |
|
|
DECEMBER 31,2021 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,785 |
|
|
$ |
76,938 |
|
Prepaid manufacturing expenses |
|
|
9,063 |
|
|
|
7,315 |
|
Prepaid expenses and other current assets |
|
|
5,161 |
|
|
|
5,918 |
|
Total current assets |
|
|
56,009 |
|
|
|
90,171 |
|
Property and equipment,
net |
|
|
21,557 |
|
|
|
23,479 |
|
Restricted cash |
|
|
4,170 |
|
|
|
4,170 |
|
Operating right-of-use
assets |
|
|
21,304 |
|
|
|
21,957 |
|
Prepaid manufacturing
expenses, net of current portion |
|
|
29,670 |
|
|
|
31,893 |
|
Total assets |
|
$ |
132,710 |
|
|
$ |
171,670 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,131 |
|
|
$ |
1,838 |
|
Accrued expenses |
|
|
7,699 |
|
|
|
9,703 |
|
Deferred revenue |
|
|
292 |
|
|
|
12,963 |
|
Operating lease liabilities |
|
|
2,891 |
|
|
|
2,661 |
|
Total current liabilities |
|
|
12,013 |
|
|
|
27,165 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion |
|
|
17,341 |
|
|
|
30,686 |
|
Note payable, net of discount |
|
|
25,596 |
|
|
|
25,430 |
|
Operating lease liabilities, net of current portion |
|
|
33,362 |
|
|
|
34,884 |
|
Other long-term liabilities |
|
|
- |
|
|
- |
|
Total liabilities |
|
|
88,312 |
|
|
|
118,165 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized as
of June 30, 2022 and December 31, 2021; 22,545,531 and 22,383,830
shares issued and outstanding as of June 30, 2022 and December 31,
2021, respectively |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
384,446 |
|
|
|
378,750 |
|
Accumulated deficit |
|
|
(340,050 |
) |
|
|
(325,247 |
) |
Total stockholders’ equity |
|
|
44,398 |
|
|
|
53,505 |
|
Total liabilities and stockholders’ equity |
|
$ |
132,710 |
|
|
$ |
171,670 |
|
CODIAK BIOSCIENCES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except
share and per share data)(unaudited)
|
|
THREE MONTHS
ENDEDJUNE 30, |
|
|
SIX MONTHS
ENDEDJUNE 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
13,145 |
|
|
$ |
890 |
|
|
$ |
25,849 |
|
|
$ |
14,081 |
|
Total revenue |
|
|
13,145 |
|
|
|
890 |
|
|
|
25,849 |
|
|
|
14,081 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,798 |
|
|
|
15,419 |
|
|
|
27,045 |
|
|
|
31,969 |
|
General and administrative |
|
|
7,364 |
|
|
|
6,937 |
|
|
|
14,071 |
|
|
|
13,525 |
|
Total operating expenses |
|
|
20,162 |
|
|
|
22,356 |
|
|
|
41,116 |
|
|
|
45,494 |
|
Loss from operations |
|
|
(7,017 |
) |
|
|
(21,466 |
) |
|
|
(15,267 |
) |
|
|
(31,413 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(649 |
) |
|
|
(704 |
) |
|
|
(1,250 |
) |
|
|
(1,401 |
) |
Interest income |
|
|
34 |
|
|
|
9 |
|
|
|
38 |
|
|
|
14 |
|
Other income |
|
|
848 |
|
|
|
352 |
|
|
|
1,667 |
|
|
|
683 |
|
Realized gain |
|
|
9 |
|
|
|
- |
|
|
|
9 |
|
|
|
- |
|
Total other income (expense), net |
|
|
242 |
|
|
|
(343 |
) |
|
|
464 |
|
|
|
(704 |
) |
Net loss |
|
$ |
(6,775 |
) |
|
$ |
(21,809 |
) |
|
$ |
(14,803 |
) |
|
$ |
(32,117 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.99 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.51 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
22,493,879 |
|
|
|
22,117,593 |
|
|
|
22,444,799 |
|
|
|
21,230,424 |
|
Investor Contact:Christopher TaylorVP, Investor
Relations and Corporate Communications T: 617-949-4220E:
investor@codiakbio.com
Media Contact:Cory TrombleeScient PRE:
media@codiakbio.com
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