- Phase 1/1b clinical trial for IL-2 INDUKINE™ WTX-124 progressing in patients with advanced or metastatic solid tumors; initial first-in-human clinical data from monotherapy dose-escalation arm expected in 4Q 2023 -
- Phase 1 clinical trial for IL-12 INDUKINE WTX-330 progressing in patients with advanced or metastatic solid tumors or lymphoma -
“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
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 ofMarch 31, 2023 . The Company also had restricted cash and cash equivalents of$21.2 million as ofJune 30, 2023 , andMarch 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 inApril 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
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
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Condensed Consolidated Statements of Operations (unaudited) | |||||||||||||||
(amounts in thousands, except per share data) | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
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 | |||||||||||
Selected Condensed Consolidated Balance Sheet Data (unaudited) | |||||
(amounts in thousands) | |||||
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:
Stern IR
212.362.1200
Josh.rappaport@sternir.com
Media Contact:
prusconi@vergescientific.com
Company Contact:
Chief Business Officer
elubman@werewolftx.com
Source:
2023 GlobeNewswire, Inc., source