Werewolf Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
November 14 2023 - 3:25PM
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 third quarter ended September 30, 2023.
“Werewolf has made tremendous strides since last quarter, most
notably with the presentation of promising first-in-human data from
our lead clinical program, WTX-124. Preliminary data presented at
SITC indicate that WTX-124 is well-tolerated and elicits
monotherapy biomarker and clinical activity, including two patients
with ongoing unconfirmed partial responses in the 12 mg cohort,”
said Daniel J. Hicklin, Ph.D., President and Chief Executive
Officer of Werewolf. “We look forward to sharing additional data to
inform our recommended dose to proceed into monotherapy expansion
arms in the first half of 2024. We are also pleased to announce the
addition of WTX-518, an IL-18 INDUKINE molecule, as our newest
pipeline candidate and expect to present preclinical data on this
molecule in the first half 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
checkpoint inhibitor therapy in multiple solid tumor types.
- In November 2023, at the Society for Immunotherapy of Cancer
(SITC) 38th Annual Meeting, Werewolf presented preliminary clinical
data from the first four monotherapy dose escalation cohorts of
Study WTX-124x2101, its Phase 1/1b, multi-center, open-label
clinical trial evaluating WTX-124 in patients with immunotherapy
sensitive advanced or metastatic solid tumors who have failed
standard of care treatment, including checkpoint inhibitor therapy.
The preliminary data established proof of mechanism for WTX-124 and
proof of concept for Werewolf’s INDUKINE design, with highlights as
follows, as of the data cut-off date of October 18, 2023:
- WTX-124 was generally well-tolerated across 16 patients, with
no Grade 3 or higher treatment-related adverse events, no related
serious adverse events and no evidence of vascular leak syndrome,
at doses up to and including 12 mg.
- Early evidence of antitumor activity was observed in
monotherapy dose escalation cohorts 3 (6 mg) and 4 (12 mg),
including two patients with ongoing unconfirmed partial responses
(PR) dosed at 12 mg. An additional patient dosed at 12 mg showed
evidence of anti-tumor activity.
- These WTX-124 data are consistent with key INDUKINE
pharmaceutical properties, including systemic delivery of the
WTX-124 prodrug with preferential activation in the tumor
microenvironment while preserving a wide therapeutic index
supportive of continued dose escalation.
- Werewolf is progressing Study WTX-124x2101, and dose escalation
is ongoing in both the monotherapy and combination therapy arms of
the study. The Company expects to report additional interim data
from monotherapy dose escalation cohorts, declaration of a
recommended dose for expansion, and opening of the monotherapy
expansion arms in the first half of 2024.
- In September 2023, Werewolf hosted a virtual event reviewing
the IL-2 landscape and opportunity for WTX-124 among
next-generation therapeutic approaches. The event featured key
opinion leader in cytokines and cancer immunotherapy, Michael
Atkins, M.D., William M. Scholl Professor and Vice Chair of the
Department of Oncology at Georgetown University.
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.
Additional Updates:
- Werewolf is announcing the addition
of WTX-518 as a pipeline candidate for preclinical development.
WTX-518 is a conditionally activated IL-18 INDUKINE molecule in
development for the treatment of cancer and is wholly owned by
Werewolf. IL-18 is designed to promote activation of immune cells
in the tumor microenvironment resulting in antitumor immunity.
Werewolf expects to present preclinical data regarding this
molecule in the first half of 2024.
- At SITC, Werewolf also presented five posters with preclinical
and translational data supporting PREDATOR platform capabilities;
pipeline programs, including both clinical candidates as well as
WTX-712 (IL-21); and the potential of INDUKINE molecules as a
complement to other anti-cancer approaches, such as checkpoint
inhibitors and cell therapy. All posters are available at
investors.werewolftx.com/news-and-events/scientific-resources.
Financial Results for the Third Quarter
of 2023:
- Cash position: As
of September 30, 2023, cash and cash equivalents were
$130.1 million, compared to $137.5 million as of June 30,
2023. The Company also had restricted cash and cash equivalents of
$21.2 million as of September 30, 2023, and June 30, 2023,
respectively. The Company expects that its existing cash and cash
equivalents 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 $5.9 million for
the third quarter of 2023, compared to $5.0 million for the
same period in 2022. Collaboration revenue consists of revenue
recognized from the Company’s licensing agreement with Jazz
Pharmaceuticals (Jazz) and includes fixed payments received from
Jazz, plus costs incurred for research services to be reimbursed by
Jazz.
- Research and development
expenses: Research and development expenses were
$10.8 million for the third quarter of 2023, compared to
$13.1 million for the same period in 2022. The decrease in
research and development expenses was primarily due to a decrease
in contract manufacturing costs associated with WTX-124 and
WTX-330. The decline in contract manufacturing costs was partially
offset by an increase in clinical trial costs for WTX-124 and
WTX-330.
- General and administrative
expenses: General and administrative expenses were
$4.3 million for the third quarter of 2023, compared to
$4.4 million for the same period in 2022. The decrease in
general and administrative expenses was primarily due to a
reduction in insurance premiums, which was offset in part by an
increase in costs incurred to protect the Company’s intellectual
property.
- Net loss: Net loss
was $8.3 million for the third quarter of 2023, compared to
$11.9 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 StatementsThis 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, and plans; the
projection of the cash runway; the expected timeline for the
pre-clinical and clinical development of product candidates and
availability of data from such pre-clinical and clinical
development; and the potential activity and efficacy of product
candidates in preclinical studies and clinical trials, and the
anticipated safety profile of product candidates; 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; whether preliminary data
from a clinical trial will be predictive of the results of the
trial and future 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.
Werewolf Therapeutics, Inc.Condensed Consolidated
Statements of Operations (unaudited)(amounts in thousands,
except per share data) |
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
5,897 |
|
|
$ |
4,970 |
|
|
$ |
18,442 |
|
|
$ |
9,118 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
10,838 |
|
|
|
13,070 |
|
|
|
32,127 |
|
|
|
37,902 |
|
General and administrative |
|
4,310 |
|
|
|
4,439 |
|
|
|
13,856 |
|
|
|
14,093 |
|
Total operating expenses |
|
15,148 |
|
|
|
17,509 |
|
|
|
45,983 |
|
|
|
51,995 |
|
Operating loss |
|
(9,251 |
) |
|
|
(12,539 |
) |
|
|
(27,541 |
) |
|
|
(42,877 |
) |
Other income |
|
966 |
|
|
|
596 |
|
|
|
2,176 |
|
|
|
997 |
|
Net loss |
$ |
(8,285 |
) |
|
$ |
(11,943 |
) |
|
$ |
(25,365 |
) |
|
$ |
(41,880 |
) |
Net loss per share, basic and
diluted |
$ |
(0.23 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.48 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
35,654 |
|
|
|
29,764 |
|
|
|
35,335 |
|
|
|
28,233 |
|
Werewolf Therapeutics, Inc.Selected Condensed
Consolidated Balance Sheet Data (unaudited)(amounts in
thousands) |
|
|
September 30, 2023 |
|
December 31, 2022 |
Cash and cash equivalents |
$ |
130,058 |
|
$ |
129,315 |
Working capital |
$ |
124,819 |
|
$ |
116,211 |
Total assets |
$ |
176,386 |
|
$ |
160,245 |
Total deferred revenue |
$ |
2,402 |
|
$ |
7,660 |
Total notes payable, net of
discount and issuance costs |
$ |
39,231 |
|
$ |
— |
Total stockholders’
equity |
$ |
112,443 |
|
$ |
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
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