Werewolf Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
10 8월 2023 - 8:10PM
Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq:
HOWL), an innovative biopharmaceutical company pioneering the
development of conditionally activated therapeutics engineered to
stimulate the body’s immune system for the treatment of cancer,
today provided a business update and reported financial results for
the second quarter ended June 30, 2023.
“Throughout the second quarter, we have
continued advancing our INDUKINE pipeline with ongoing enrollment
of our first-in-human clinical trials for WTX-124 and WTX-330, our
two lead programs,” said Daniel J. Hicklin, Ph.D., President and
Chief Executive Officer of Werewolf. “We look towards the fourth
quarter, when we anticipate sharing initial safety, tolerability,
pharmacokinetics and biomarker data from our Phase 1/1b trial of
WTX-124 in multiple solid tumors. Additionally, we are pleased that
Jazz Pharmaceuticals has announced the Investigational New Drug
(IND) application clearance of JZP898 (formerly WTX-613), an
engineered IFNα INDUKINE molecule. Werewolf continues to operate
from a position of financial strength with a cash runway projected
to carry us through at least the fourth quarter of 2024.”
Recent Highlights and Upcoming
Milestones
WTX-124: a systemically
delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE
molecule being developed as monotherapy and in combination with
KEYTRUDA® (pembrolizumab) in multiple solid tumors.
- Werewolf is progressing Study
WTX-124x2101, its Phase 1/1b, multi-center, open-label clinical
trial evaluating WTX-124 as a monotherapy and in combination with
KEYTRUDA® (pembrolizumab) in patients with immunotherapy sensitive
advanced or metastatic solid tumors who have failed standard of
care, including prior checkpoint inhibitor therapy.
- Enrollment is ongoing in
monotherapy dose-escalation and combination therapy cohorts, and
the Company anticipates reporting initial safety, tolerability,
pharmacokinetics and biomarker data from monotherapy dose
escalation in the fourth quarter of 2023.
WTX-330: a systemically
delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE
molecule being developed in refractory and/or immunologically
unresponsive tumors.
- Werewolf is progressing Study
WTX-330x2101, its Phase 1, multi-center, open-label trial
evaluating WTX-330 as a monotherapy in patients with immunotherapy
insensitive or resistant advanced or metastatic solid tumors or
non-Hodgkin lymphoma. Enrollment is ongoing in
dose-escalation.
JZP898 (Formerly WTX-613): an
engineered IFNα INDUKINE pro-drug that is activated specifically
within the tumor microenvironment where it can stimulate IFNα
receptors on cancer-fighting immune effector cells.
- In April 2022, Werewolf entered
into an exclusive global collaboration and license agreement with
Jazz Pharmaceuticals under which Werewolf is responsible for
certain pre-clinical development and other development activities
with respect to JZP898.
- Jazz Pharmaceuticals recently
disclosed that in July 2023, JZP898 received Investigational New
Drug (IND) application clearance.
Financial Results for the Second Quarter
of 2023:
- Cash position: As
of June 30, 2023, cash and cash equivalents were $137.5 million,
compared to $147.9 million as of March 31, 2023. The Company also
had restricted cash and cash equivalents of $21.2 million as of
June 30, 2023, and March 31, 2023, respectively. The Company
expects that its existing cash and cash equivalents, together with
anticipated collaboration revenue, will be sufficient to fund its
operational expenses and capital expenditure requirements through
at least the fourth quarter of 2024.
- Collaboration
revenue: Collaboration revenue was $8.1 million for the
second quarter of 2023, compared to $4.1 million for the same
period in 2022. Collaboration revenue is related to partial
recognition of the $15.0 million upfront payment received in April
2022 upon the execution of Werewolf’s licensing agreement with Jazz
and costs incurred for research services to be reimbursed by
Jazz.
- Research and development
expenses: Research and development expenses were $9.6
million for the second quarter of 2023, compared to $13.9 million
for the same period in 2022. The decrease in research and
development expenses was primarily due to a decrease in the costs
incurred with contract manufacturing associated with WTX-124 and
WTX-330 and favorable adjustments recognized during the quarter
upon the closeout of completed purchase orders.
- General and administrative
expenses: General and administrative expenses were $4.6
million for the second quarter of 2023, compared to $5.2 million
for the same period in 2022. The decrease in general and
administrative expenses was primarily due to reduced insurance
premiums and decreased utilization of outside advisors.
- Net loss: Net loss
was $5.1 million for the second quarter of 2023, compared to $14.6
million for the same period in 2022.
About Werewolf
Therapeutics:Werewolf Therapeutics, Inc. is an innovative
clinical-stage biopharmaceutical company pioneering the development
of therapeutics engineered to stimulate the body’s immune system
for the treatment of cancer. We are leveraging our proprietary
PREDATOR™ platform to design conditionally activated molecules that
stimulate both adaptive and innate immunity with the goal of
addressing the limitations of conventional proinflammatory immune
therapies. Our INDUKINE™ molecules are intended to remain inactive
in peripheral tissue yet activate selectively in the tumor
microenvironment. Our most advanced product candidates, WTX-124 and
WTX-330, are systemically delivered, conditionally activated
Interleukin-2 (IL-2), and Interleukin-12 (IL-12) INDUKINE molecules
for the treatment of solid tumors. WTX-124 is in development as a
monotherapy and in combination with KEYTRUDA® (pembrolizumab) in
multiple solid tumor types. WTX-330 is in development as a single
agent in refractory and/or immunotherapy unresponsive or resistant
advanced or metastatic solid tumors and non-Hodgkin lymphoma.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements that involve substantial risk and uncertainties. All
statements, other than statements of historical facts, contained in
this press release, including statements regarding Werewolf’s
future operations, prospects, plans, the projection of the cash
runway, the expected timeline for the clinical development of
product candidates and availability of data from such clinical
development, and the potential activity and efficacy of product
candidates in preclinical studies and clinical trials constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. The words “aim,”
“anticipate,” “believe,” “contemplate,” “continue,” “could,”
“design,” “designed to,” “estimate,” “expect,” “goal,” “intend,”
“may,” “might,” “objective,” “ongoing,” “plan,” “potential,”
“predict,” “project,” “promise,” “should,” “target,” “will,” or
“would,” or the negative of these terms, or other comparable
terminology are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. The Company may not actually achieve the plans,
intentions or expectations disclosed in these forward-looking
statements, and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
these forward-looking statements as a result of various important
factors, including: uncertainties inherent in the development of
product candidates, including the conduct of research activities,
the initiation and completion of preclinical studies and clinical
trials; uncertainties as to the availability and timing of results
from preclinical studies and clinical trials; the timing of and the
Company’s ability to submit and obtain regulatory approval for
investigational new drug applications; whether results from
preclinical studies will be predictive of the results of later
preclinical studies and clinical trials; the Company’s ability to
obtain sufficient cash resources to fund the Company’s foreseeable
and unforeseeable operating expenses and capital expenditure
requirements; as well as the risks and uncertainties identified in
the “Risk Factors” section of the Company’s most recent Form 10-Q
filed with the Securities and Exchange Commission (“SEC”), and in
subsequent filings the Company may make with the SEC. In addition,
the forward-looking statements included in this press release
represent the Company’s views as of the date of this press release.
The Company anticipates that subsequent events and developments
will cause its views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this press release.
This press release contains hyperlinks to
information that is not deemed to be incorporated by reference in
this press release.
|
Werewolf Therapeutics, Inc. |
Condensed Consolidated Statements of Operations
(unaudited) |
(amounts in thousands, except per share data) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
8,081 |
|
|
$ |
4,148 |
|
|
$ |
12,545 |
|
|
$ |
4,148 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
9,583 |
|
|
|
13,887 |
|
|
|
21,289 |
|
|
|
24,832 |
|
General and administrative |
|
4,565 |
|
|
|
5,233 |
|
|
|
9,546 |
|
|
|
9,654 |
|
Total operating expenses |
|
14,148 |
|
|
|
19,120 |
|
|
|
30,835 |
|
|
|
34,486 |
|
Operating loss |
|
(6,067 |
) |
|
|
(14,972 |
) |
|
|
(18,290 |
) |
|
|
(30,338 |
) |
Other income |
|
969 |
|
|
|
378 |
|
|
|
1,210 |
|
|
|
401 |
|
Net loss |
$ |
(5,098 |
) |
|
$ |
(14,594 |
) |
|
$ |
(17,080 |
) |
|
$ |
(29,937 |
) |
Net loss per share, basic and
diluted |
$ |
(0.14 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.09 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
35,558 |
|
|
|
27,517 |
|
|
|
35,173 |
|
|
|
27,455 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Werewolf Therapeutics, Inc. |
Selected Condensed Consolidated Balance Sheet Data
(unaudited) |
(amounts in thousands) |
|
|
June 30, 2023 |
|
December 31, 2022 |
Cash and cash equivalents |
$ |
137,452 |
|
$ |
129,315 |
Working capital |
$ |
132,393 |
|
$ |
116,211 |
Total assets |
$ |
185,235 |
|
$ |
160,245 |
Total deferred revenue |
$ |
2,389 |
|
$ |
7,660 |
Total notes payable, net of
discount and issuance costs |
$ |
39,142 |
|
$ |
— |
Total stockholders’
equity |
$ |
118,599 |
|
$ |
122,337 |
|
|
|
|
|
|
Investor Contact:Josh RappaportStern
IR212.362.1200Josh.rappaport@sternir.com
Media Contact:Peg RusconiVERGE Scientific
Communicationsprusconi@vergescientific.com
Company Contact:Ellen LubmanChief Business
OfficerWerewolf Therapeuticselubman@werewolftx.com
Werewolf Therapeutics (NASDAQ:HOWL)
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부터 4월(4) 2024 으로 5월(5) 2024
Werewolf Therapeutics (NASDAQ:HOWL)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024