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Werewolf Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

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Werewolf Therapeutics (HOWL) reported Q3 2024 financial results and provided updates on its clinical pipeline. The company reported a net loss of $16.7 million with cash and equivalents of $122.8 million, providing runway through Q2 2026. Key developments include ongoing Phase 1/1b trials of WTX-124 and WTX-330, with initial efficacy data expected in H1 2025. The company introduced WTX-921, a new IL-10 INDUKINE molecule for inflammatory diseases. Clinical trials showed promising results, including confirmed partial responses in melanoma patients and a complete response in an advanced CSCC patient that has remained in remission for over twelve months.

Werewolf Therapeutics (HOWL) ha riportato i risultati finanziari del terzo trimestre 2024 e fornito aggiornamenti sulla sua pipeline clinica. L'azienda ha registrato un perdita netta di 16,7 milioni di dollari con disponibilità liquide e equivalenti pari a 122,8 milioni di dollari, garantendo fondi fino al secondo trimestre del 2026. I principali sviluppi includono l'attività in corso degli studi di Fase 1/1b per WTX-124 e WTX-330, con i dati iniziali di efficacia attesi nel primo semestre del 2025. L'azienda ha presentato WTX-921, una nuova molecola IL-10 INDUKINE per malattie infiammatorie. Le prove cliniche hanno mostrato risultati promettenti, inclusi riscontri parziali confermati nei pazienti affetti da melanoma e una risposta completa in un paziente con CSCC avanzato che è rimasto in remissione per oltre dodici mesi.

Werewolf Therapeutics (HOWL) informó sobre los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre su pipeline clínico. La compañía reportó una pérdida neta de 16,7 millones de dólares con efectivo y equivalentes de 122,8 millones de dólares, lo que proporciona financiaciones hasta el segundo trimestre de 2026. Los desarrollos clave incluyen ensayos en curso de Fase 1/1b de WTX-124 y WTX-330, con datos de eficacia iniciales esperados para el primer semestre de 2025. La compañía presentó WTX-921, una nueva molécula IL-10 INDUKINE para enfermedades inflamatorias. Los ensayos clínicos mostraron resultados prometedores, incluyendo respuestas parciales confirmadas en pacientes con melanoma y una respuesta completa en un paciente con CSCC avanzado que ha permanecido en remisión durante más de doce meses.

Werewolf Therapeutics (HOWL)는 2024년 3분기 재무 결과를 발표하고 임상 파이프라인에 대한 업데이트를 제공했습니다. 회사는 1670만 달러의 순손실을 기록했으며, 현금 및 현금성 자산은 1억 2280만 달러로, 2026년 2분기까지 운영 자금을 제공합니다. 주요 개발 사항으로는 WTX-124 및 WTX-330에 대한 진행 중인 1/1b상 시험이 있으며, 초기 효능 데이터는 2025년 상반기에 기대됩니다. 회사는 염증성 질환을 위한 새로운 IL-10 INDUKINE 분자인 WTX-921을 소개했습니다. 임상 시험은 유망한 결과를 보여주었으며, 친구증식성이 확인된 흑색종 환자에서 부분 반응이 나타났고, CSCC가 진행된 환자에서 12개월 이상 관해가 유지된 완전 반응이 있었습니다.

Werewolf Therapeutics (HOWL) a annoncé ses résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur son pipeline clinique. La société a enregistré une perte nette de 16,7 millions de dollars avec des liquidités et équivalents s'élevant à 122,8 millions de dollars, assurant un financement jusqu'au deuxième trimestre 2026. Les développements clés comprennent des essais en cours de Phase 1/1b pour WTX-124 et WTX-330, avec des données initiales d'efficacité attendues au premier semestre 2025. La société a introduit WTX-921, une nouvelle molécule IL-10 INDUKINE pour les maladies inflammatoires. Les essais cliniques ont montré des résultats prometteurs, y compris des réponses partielles confirmées chez des patients atteints de mélanome et une réponse complète chez un patient atteint de CSCC avancé qui est resté en rémission pendant plus de douze mois.

Werewolf Therapeutics (HOWL) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und gab Updates zu seiner klinischen Pipeline. Das Unternehmen meldete einen Nettoverlust von 16,7 Millionen Dollar bei liquiden Mitteln und Äquivalenten von 122,8 Millionen Dollar, die eine Finanzierung bis zum zweiten Quartal 2026 sichern. Zu den wichtigsten Entwicklungen gehören die laufenden Phase 1/1b-Studien von WTX-124 und WTX-330, wobei die ersten Wirksamkeitsdaten im ersten Halbjahr 2025 erwartet werden. Das Unternehmen stellte WTX-921 vor, ein neues IL-10 INDUKINE-Molekül für entzündliche Krankheiten. Klinische Studien zeigten vielversprechende Ergebnisse, einschließlich bestätigter partieller Ansprechen bei Melanom-Patienten und einer vollständigen Reaktion bei einem fortgeschrittenen CSCC-Patienten, der seit über zwölf Monaten in Remission ist.

Positive
  • Cash runway extended through Q2 2026 with $122.8M in cash and equivalents
  • Confirmed partial responses in two melanoma patients treated with WTX-124, both progression-free for over 7 months
  • Complete response in CSCC patient treated with WTX-124, maintaining remission for over 12 months
Negative
  • Net loss increased to $16.7M in Q3 2024 from $8.3M in Q3 2023
  • No collaboration revenue in Q3 2024 compared to $5.9M in Q3 2023
  • Research and development expenses increased to $12.5M from $10.8M year-over-year

Insights

The Q3 results reveal significant financial dynamics for Werewolf Therapeutics. The company maintains a healthy cash position of $122.8 million, though this represents a $12.5 million burn from Q2. The extended cash runway through Q2 2026 provides important operational flexibility for their clinical programs.

Key financial metrics show increased R&D expenses at $12.5 million, up 15.7% year-over-year, reflecting investment in clinical trials. The net loss widened to $16.7 million from $8.3 million, primarily due to ceased collaboration revenue from Jazz Pharmaceuticals and higher operational costs. This burn rate appears manageable given the cash reserves, though investors should monitor the acceleration in losses.

The clinical progress shows promising developments across multiple programs. WTX-124's confirmed partial responses in melanoma patients lasting over 7 months and a complete response in CSCC maintaining remission for 12+ months demonstrate meaningful durability. The expansion into multiple indications at the 18mg dose level signals confidence in the safety profile.

The upcoming WTX-330 data presentation at SITC, particularly regarding tumor regression and lymphocyte activation, could validate their IL-12 approach. The expansion into inflammatory diseases with WTX-921 (IL-10 INDUKINE) represents strategic diversification beyond oncology, though early stage.

– Interim data from ongoing Phase 1 clinical trial of WTX-330, further characterizing tolerability and activity profile, to be presented at SITC Annual Meeting –

– Monotherapy and combination expansion arms open and enrolling in ongoing Phase 1/1b clinical trial of WTX-124; initial efficacy data from monotherapy expansion arms anticipated in the first half of 2025 –

– Introduced WTX-921, a promising new development candidate and first-of-its kind IL-10 INDUKINE™ molecule for the treatment of inflammatory diseases –

– Updated cash guidance provides runway through at least the second quarter of 2026

WATERTOWN, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- 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 and other immune-mediated conditions, today provided a business update and reported financial results for the third quarter ended September 30, 2024.

“Werewolf continues to progress our pipeline of INDUKINE therapeutics, led by WTX-124 and WTX-330, which have together provided preliminary clinical validation of our innovative design. To date, initial datasets from both programs have highlighted well-tolerated monotherapy activity in the outpatient setting, establishing WTX-124’s potential best-in-class profile among next-generation approaches to IL-2 and WTX-330’s potential first-in-class design which enables a wider exposure and therapeutic window of IL-12 than previously achieved,” said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. “We continue to progress WTX-124, with both monotherapy and combination expansion arms enrolling in multiple indications. We anticipate sharing monotherapy expansion data in the first half of 2025, which we expect will guide the next steps for the development program. In addition, we look forward to presenting interim data from our Phase 1 WTX-330 clinical trial at SITC this weekend, including the emerging tolerability and clinical activity profile for WTX-330.”

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 pembrolizumab in multiple solid tumor types.

  • Werewolf continues to progress the ongoing Phase 1/1b clinical trial evaluating WTX-124 as a monotherapy and in combination with pembrolizumab.
    • Following the selection of 18 mg WTX-124 administered intravenously every two weeks (IV Q2W) as the monotherapy recommended dose for expansion (RDE), the Company has opened monotherapy expansion arms and is actively enrolling patients with metastatic melanoma, renal cell carcinoma (RCC) and cutaneous squamous cell carcinoma (CSCC) who have failed immune checkpoint inhibitor therapy.
    • The Company has also selected 18 mg WTX-124 administered IV Q2W as its RDE for the combination with pembrolizumab and has opened combination expansion arms in metastatic melanoma, RCC, and non-small cell lung cancer (NSCLC).
    • Previously, the Company disclosed that two patients with metastatic melanoma treated in the 12 mg combination dose escalation cohort had partial and near-partial responses observed in preliminary data. Both patients now have confirmed partial responses, and both patients have remained progression free on study for more than 7 months.
    • The Company also previously disclosed that one patient with advanced CSCC treated in the 12 mg monotherapy dose escalation cohort had a documented complete response and then discontinued study drug at 21 weeks. This patient has remained in complete remission for over twelve months.
    • Cumulative biomarker data from tumor biopsies continue to provide evidence that baseline CD8+ effector T cells are relevant to clinical responses and that there is no evidence of Treg activation with treatment.
  • In the first half of 2025, Werewolf expects to provide an update on the WTX-124 clinical development program, including data from the monotherapy expansion arms that are evaluating WTX-124 in more homogenous, less heavily pre-treated patient populations to inform future development priorities.
  • Pending additional insight into the clinical profile, Werewolf intends to engage with regulators to discuss potential registrational pathways for WTX-124, including strategies for monotherapy accelerated approval.

WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.

  • Werewolf plans to present updated interim safety and efficacy data from its ongoing Phase 1 clinical trial of WTX-330 in patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held November 6-10, 2024, in Houston, Texas. Presentation details are as follows:
    • Title: The tumor-activated IL-12 prodrug WTX-330 expanded/activated tumor infiltrating lymphocytes and caused tumor regression in patients with refractory solid tumors: Interim data from an ongoing Ph1 study
    • Abstract Number: 672
    • Session Date and Time: Saturday, Nov. 9, 2024; 9:00 a.m.–8:30 p.m. CT.
    • Location: George R. Brown Convention Center - Exhibit Halls A B
  • In June 2024, the Company shared a preliminary program update, reflecting the same June 12, 2024, data cut-off as captured in the SITC abstract, showing an improved therapeutic index with systemic administration of WTX-330, producing clinical activity at generally well-tolerated doses, with a 22-fold higher systemic prodrug exposure compared to recombinant IL-12 at its maximum tolerated dose.
  • The data to be presented at SITC will expand on this initial update, further characterizing safety, pharmacokinetics (PK), biomarkers and clinical activity and capturing additional patients treated since this data cut-off.

Preclinical Portfolio: includes development candidates WTX-712 and WTX-518, INDUKINE molecules targeting IL-21 and IL-18, respectively, for treatment of cancer and WTX-921, an INDUKINE molecule delivering IL-10 for treatment of inflammatory diseases.

  • In October 2024, Werewolf announced the addition of WTX-921, a novel IL-10 INDUKINE development candidate for the treatment of inflammatory bowel disease and potentially other inflammatory diseases, to its pipeline, thereby increasing the breadth of the PREDATOR™ platform approach in therapeutic areas outside of oncology.
  • At SITC, the Company plans to present a poster highlighting the distinct mechanisms by which IL-2, IL-12, binding protein resistant IL-18, and IL-21 accomplish antitumor immunity in mice. Presentation details are as follows:
    • Title: INDUKINE™ Molecules Delivering Various Cytokines Utilize Unique Mechanisms of Action to Drive Anti-Tumor Efficacy in Murine Syngeneic Tumor Models
    • Abstract Number: 955
    • Session Date and Time: Friday, Nov. 8, 2024; 9:00 a.m. – 8:30 p.m. CT.
    • Location: George R. Brown Convention Center - Exhibit Halls A B

Financial Results for the Third Quarter of 2024:

  • Cash position: As of September 30, 2024, cash and cash equivalents were $122.8 million, compared to $135.3 million as of June 30, 2024. The Company believes its existing cash and cash equivalents as of September 30, 2024, will be sufficient to fund operational expenses and capital expenditure requirements through at least the second quarter of 2026.
  • Collaboration revenue: No collaboration revenue was recognized during the third quarter of 2024 due to the fact that Werewolf substantially completed its performance obligations under the collaboration agreement with Jazz Pharmaceuticals (Jazz) during the second quarter of 2024. Comparatively, collaboration revenue was $5.9 million for the third quarter of 2023, which 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 $12.5 million for the third quarter of 2024, compared to $10.8 million for the same period in 2023. The increase in research and development expenses was primarily due to the Company’s development efforts for WTX-124 and WTX-330, which continue to progress through their respective clinical trials, resulting in higher clinical trial costs and higher manufacturing costs to support those trials.
  • General and administrative expenses: General and administrative expenses were $4.6 million for the third quarter of 2024, compared to $4.3 million for the same period in 2023.
  • Net loss: Net loss was $16.7 million for the third quarter of 2024, compared to $8.3 million for the same period in 2023.

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 and other immune-mediated conditions. The Company is leveraging its 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. Werewolf’s INDUKINE molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. The Company’s 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. Werewolf is advancing 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 risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Werewolf’s strategy, future operations, prospects, plans, and objectives of management; the projection of the cash runway; the expected timeline for the preclinical and clinical development of product candidates and the availability of data from such preclinical and clinical development; the potential activity and efficacy of product candidates in preclinical studies and clinical trials; the anticipated safety profile of product candidates; and the upcoming presentations at SITC; constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “continue,” “could,” “design,” “designed to,” “engineered,” “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 and 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 or interim data from a clinical trial will be predictive of the results of the trial and future clinical trials; the Company’s ability to manage cash resources and obtain additional 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®, the WEREWOLF logo, PREDATOR®, INDUKINE and other Werewolf trademarks, service marks, graphics and logos are trade names, trademarks or registered trademarks of Werewolf Therapeutics, Inc., in the United States or other countries. All rights reserved.



   
Werewolf Therapeutics, Inc.
Condensed Consolidated Statements of Operations (unaudited)
(amounts in thousands, except share and per share data)
                
 Three Months Ended
September 30,
Nine Months Ended
September 30,
 2024 2023
 2024 2023
Revenue:               
Collaboration revenue$  $5,897  $1,885  $18,442 
Operating expenses:      
Research and development 12,528   10,838   40,707  $32,127 
General and administrative 4,596   4,310   14,424   13,856 
Total operating expenses 17,124   15,148   55,131   45,983 
Operating loss (17,124)  (9,251)  (53,246)  (27,541)
Other income 451   966   3,131   2,176 
Net loss$(16,673) $(8,285) $(50,115) $(25,365)
       
Net loss per common share, basic$(0.38) $(0.23) $(1.17) $(0.72)
Net loss per common share, diluted$(0.38) $(0.23) $(1.19) $(0.72)
Weighted-average common shares outstanding, basic 43,704,836   35,653,924   42,947,282   35,335,286 
Weighted-average common shares outstanding, diluted 43,704,836   35,653,924   43,386,287   35,335,286 
                


Werewolf Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data (unaudited)
(amounts in thousands)
     
 September 30, 2024 December 31, 2023
Cash and cash equivalents$122,827  $134,343 
Working capital$113,371  $118,992 
Total assets$140,036  $174,833 
Total deferred revenue$  $1,340 
Total notes payable, net of discount and issuance costs$25,617  $39,323 
Total stockholders’ equity$89,379  $111,374 
        

Investor Contact:
John Norton
Precision AQ
212.362.1200
John.Norton@precisionaq.com

Media Contact:
Amanda Sellers
Deerfield Group
301.332.5574
amanda.sellers@deerfieldgroup.com

Company Contact:
Ellen Lubman
Chief Business Officer
Werewolf Therapeutics
elubman@werewolftx.com


FAQ

What was Werewolf Therapeutics (HOWL) net loss in Q3 2024?

Werewolf Therapeutics reported a net loss of $16.7 million for the third quarter of 2024, compared to $8.3 million in the same period of 2023.

How much cash does HOWL have as of Q3 2024?

As of September 30, 2024, Werewolf Therapeutics had $122.8 million in cash and cash equivalents, which is expected to fund operations through at least the second quarter of 2026.

When will HOWL release WTX-124 monotherapy expansion data?

Werewolf Therapeutics expects to provide an update on the WTX-124 clinical development program, including monotherapy expansion data, in the first half of 2025.

Werewolf Therapeutics, Inc.

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