Werewolf Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update
11 Mayo 2023 - 6:00AM
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 first quarter ended March 31, 2023.
“In the first quarter, Werewolf has focused on
execution by progressing our INDUKINE pipeline and enrolling
ongoing first-in-human clinical trials for our lead programs,
WTX-124 and WTX-330. In addition, preclinical data presented at
AACR and published in Cancer Immunology Research continues to
demonstrate the robustness of our PREDATOR™ platform showing that
Werewolf’s conditional activation technology results in potent
anti-tumor activity alongside an improved therapeutic index,” said
Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of
Werewolf. “Looking ahead, in the fourth quarter we plan to
share initial safety, tolerability, and preliminary efficacy data
from our Phase 1/1b clinical trial of WTX-124 in solid tumor
types.”
“Finally, we’d like to express our deep
appreciation to Reid Leonard, Ph.D., Werewolf’s Chief Operating
Officer, who is retiring effective June 30, 2023, after a long and
successful career in the biopharmaceutical industry. Reid is a
founding member of the Werewolf Executive Team and has been
instrumental in leading and advancing all aspects of organizational
operations. We have benefited greatly from Reid’s significant
expertise, and the strong team he has built and business process he
has established will ensure continued operational excellence going
forward. We wish Reid the very best in his retirement.”
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.
- 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 checkpoint inhibitor therapy.
- Enrollment is ongoing in
monotherapy dose-escalation cohorts, and the Company anticipates
reporting interim safety, tolerability and preliminary efficacy
data from these monotherapy cohorts in the fourth quarter of
2023.
- During the American Association for
Cancer Research Annual Meeting in April 2023, the Company presented
a poster entitled “Trial in progress: a multicenter phase 1/1b dose
escalation study of WTX-124 as a monotherapy and in combination
with pembrolizumab in patients with selected advanced or metastatic
solid tumors.”
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.
- During the American Association for
Cancer Research Annual Meeting in April 2023, the Company presented
a poster entitled “Trial in progress: a first-in-human, phase 1,
multicenter dose escalation and dose expansion study of WTX-330 in
adult patients with advanced or metastatic solid tumors or
non-Hodgkin lymphoma.”
- Also in April 2023, the Company
announced the publication of preclinical data in Cancer Immunology
Research Online First, demonstrating that mWTX-330 delivers
IL-12 selectively to the tumor environment to inhibit tumor growth
in mouse models. The preclinical data demonstrate that mWTX-330
stimulates a potent anti-tumor response in mice by activating tumor
infiltrating lymphocytes and restoring the metabolic health of
these lymphocytes and has the potential to minimize the toxicity
previously associated with systemic IL-12 administration.
Early-Stage Pipeline:
- During the American Association for
Cancer Research Annual Meeting in April 2023, The Company presented
a poster entitled “Generation of IL-21 INDUKINE molecules for the
treatment of cancer,” which featured preclinical data supporting
the recent nomination of Werewolf’s third wholly owned candidate,
WTX-712, a conditionally activated IL-21 INDUKINE molecule in
development for treatment of cancer. Highlights of the presentation
include:
- IL-21 INDUKINE polypeptides
demonstrated improved tolerability and therapeutic window in mouse
syngeneic tumor models.
- Efficacy in these tumor models was
linked to expansion and activation of tumor infiltrating T cells,
increased polyfunctionality in CD8+ T cells, and signs of increased
activation of B cells.
Financial Results for the First Quarter
of 2023:
- Cash position: As
of March 31, 2023, cash and cash equivalents were $147.9
million, compared to $129.3 million as of December 31, 2022.
The Company also has restricted cash and cash equivalents of $21.2
million, compared to $1.2 million as of December 31, 2022. These
increases are primarily due to proceeds from the Company’s
at-the-market sales facility, the drawdown of remaining capital
available under its term loan agreement with Pacific Western Bank,
and funding received in connection with the Company’s licensing
agreement with Jazz Pharmaceuticals (“Jazz”). 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 $4.5 million for the
first quarter of 2023, compared to zero 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 $11.7
million for the first quarter of 2023, compared to $10.9 million
for the same period in 2022. The increase in research and
development expenses was primarily due to increased personnel
costs.
- General and administrative
expenses: General and administrative expenses were $5.0
million for the first quarter of 2023, compared to $4.4 million for
the same period in 2022. The increase in general and administrative
expenses was primarily due to increased costs to support the
increasing size and complexity of Werewolf’s research, development
and manufacturing activities.
- Net loss: Net loss
was $12.0 million for the first quarter of 2023, compared to $15.3
million for the same period in 2022.
About Werewolf
Therapeutics:Werewolf Therapeutics, Inc. is an innovative
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 clinical stage product
candidates, WTX-124 and WTX-330, are systemically delivered,
conditionally activated Interleukin-2 (IL-2), and Interleukin-12
(IL-12) INDUKINE molecules, respectively, for the treatment of
solid tumors. We expect to advance WTX-124 in multiple tumor types
as a single agent and in combination with an immune checkpoint
inhibitor and WTX-330 in multiple tumor types or Non-Hodgkin
Lymphoma as a single agent. To learn more visit
www.werewolftx.com.
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; the impact of the COVID-19 pandemic on the Company’s
business and operations; as well as the risks and uncertainties
identified in the “Risk Factors” section of the Company’s most
recent Annual Report on Form 10-K for the year ended December 31,
2021, 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 EndedMarch 31, |
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
Collaboration revenue |
$ |
4,464 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
|
11,706 |
|
|
|
10,945 |
|
General and administrative |
|
4,981 |
|
|
|
4,421 |
|
Total operating expenses |
|
16,687 |
|
|
|
15,366 |
|
Operating loss |
|
(12,223 |
) |
|
|
(15,366 |
) |
Other income |
|
241 |
|
|
|
23 |
|
Net loss |
$ |
(11,982 |
) |
|
$ |
(15,343 |
) |
Net loss per share, basic and
diluted |
$ |
(0.34 |
) |
|
$ |
(0.56 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
34,785 |
|
|
|
27,393 |
|
|
|
|
|
|
|
|
|
Werewolf Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
March 31, 2023 |
|
December 31, 2022 |
Cash and cash equivalents |
$ |
147,868 |
|
$ |
129,315 |
Working capital |
$ |
134,840 |
|
$ |
116,211 |
Total assets |
$ |
195,069 |
|
$ |
160,245 |
Total deferred revenue |
$ |
5,317 |
|
$ |
7,660 |
Total notes payable, net of
discount and issuance costs |
$ |
39,063 |
|
$ |
— |
Total stockholders’
equity |
$ |
121,073 |
|
$ |
122,337 |
|
|
|
|
|
|
Investor Contact:Josh RappaportStern
IR212.362.1200Josh.rappaport@sternir.com
Media Contact:Peg RusconiVERGE Scientific
Communications prusconi@vergescientific.com
Company Contact:Ellen LubmanChief Business
OfficerWerewolf Therapeuticselubman@werewolftx.com
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