Tillkännagivande • Jun 25

Werewolf Therapeutics Highlights Initial Safety and Efficacy Data from its Ongoing Phase 1 Clinical Trial Evaluating WTX-330 in Patients with Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

Werewolf Therapeutics, Inc. announced initial results from the Phase 1 clinical trial evaluating WTX-330, its conditionally activated interleukin-12 (IL-12) INDUKINE™ molecule, as monotherapy in patients with immunotherapy insensitive or resistant locally advanced or metastatic solid tumors or non-Hodgkin lymphoma. IL-12 therapy holds tremendous promise for immune-resistant cancer patients but has been historically limited by severe toxicity, like many cytokines. Werewolf is developing a novel, conditionally activated IL-12, WTX-330, in order to overcome this key limitation with its systemically administered, tissue-targeted technology, optimizing its therapeutic index so that efficacious doses can be delivered for clinical impact. As of the cutoff date of June 12, 2024, the study had dosed eleven patients in dose escalation with solid tumors relapsed or refractory to all standard of care therapies with at least one dose of WTX-330 across three dose escalation cohorts, 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), or 0.032 mg/kg (n=5) and two patients in dose expansion at 0.024 mg/kg. Preliminary results as of the cutoff date showed: Greatly increased therapeutic window: Compared to previous IL-12 therapeutic strategies (recombinant human IL-12 (rhIL-12) at 500 ng/kg (maximum tolerated dose)), at the 0.024 mg/kg dose, WTX-330 demonstrated an approximately 23-fold higher systemic drug concentration of IL-12 prodrug delivered to patients in the outpatient setting, with low free IL-12 levels across all dose levels (<1.6% of prodrug exposure). Encouraging signals of clinical activity: One patient with metastatic melanoma who had previously progressed on adjuvant pembrolizumab was treated with 0.024 mg/kg WTX-330 administered intravenously once every two weeks (IV Q2W) and achieved an unconfirmed partial response by Response Evaluation Criteria in Solid Tumors (RECIST) after eight weeks with no evidence of disease on biopsy and marked decreased uptake on positron emission tomography (PET) imaging. A confirmatory scan for this patient is pending. Two additional patients with microsatellite stable (MSS) colorectal cancer (CRC) were treated with 0.032 mg/kg WTX-330 IV Q2W and achieved RECIST stable disease, one for 24 weeks with evidence of tumor biomarker activity. Robust activation of immune biomarkers: Evidence of increased antitumor CD8+ T and natural killer (NK) cell expansion and activation in on-treatment tumor biopsies and/or upregulation of tumor immune gene signatures were observed in the two MSS CRC patients with stable disease. Emerging tolerability profile: All patients exhibited mild to moderate treatment-related toxicities (fever, chills, cytopenias) primarily associated with the first dose, with no Grade 4 or Grade 5 related adverse events. These were correlated with dose-dependent increases in peripheral IFN? and IP-10. Two patients experienced reversible dose-limiting toxicities (Grade 3 mucositis, Grade 3 aspartate aminotransferase (AST) increase) at the 0.032 mg/kg dose level, including the MSS CRC patient with prolonged stable disease who remained on therapy for over 6 months after resolution of the mucositis. A maximum tolerated dose has not been established. Expanded Phase 1 program: The Company has opened two expansion arms evaluating 0.024 mg/kg of WTX-330. Eligible patients include those with immune checkpoint inhibitor (ICI)-sensitive solid tumors who demonstrate primary or secondary resistance to immunotherapy (Arm A) and patients with solid tumors or lymphoma for whom ICI blockade is not approved or indicated (Arm B). Two patients have been enrolled into the expansion arms to date and have received at least one dose of WTX-330. Interleukin-12 (IL-12) is a cytokine well recognized as a promising antitumoral therapeutic agent due to its range of functions that include activation of natural killer (NK) cells, NK T and CD8+ T cells, promotion of dendritic cell (DC) antigen presentation, and production of IFN-?. Native IL-12 is highly toxic, and all previous methods of administration of the molecule at potentially efficacious doses have resulted in unmanageable systemic toxicities or lack of efficacy. To leverage the potent therapeutic properties of IL-12, there is a need to develop locally active but systemically blocked IL-12-based treatment approaches. WTX-330 was designed to be a systemically dosed prodrug with the ability to deliver fully active IL-12 selectively into the tumor microenvironment via targeted intratumoral activation of the INDUKINE molecule, potentially broadening the therapeutic window and promoting local activation and immune response against the tumor.

Tillkännagivande • Nov 04

Werewolf Therapeutics Presents Preliminary Monotherapy Data from Phase 1/1b Clinical Trial Establishing Proof of Mechanism for WTX-124 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting

Werewolf Therapeutics, Inc. announced preliminary first-in-human clinical data from initial monotherapy dose-escalation cohorts in the Company’s lead clinical program, WTX-124x2101. This clinical program is an ongoing, multi-center Phase 1/1b clinical trial of WTX-124, Werewolf’s interleukin 2 (IL-2) INDUKINE molecule, in patients with advanced or metastatic solid tumors. The preliminary data will be presented now at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting in San Diego, California. Study WTX-124x2101 is evaluating WTX-124 as a monotherapy and in combination with pembrolizumab in patients with immunotherapy sensitive advanced or metastatic solid tumors who have failed standard of care treatment, including checkpoint inhibitor therapy. The preliminary data include data collected as of October 18, 2023, from 16 heavily pretreated patients from the first four monotherapy dose escalation cohorts (1, 3, 6, 12 mg). The preliminary data established proof of mechanism for WTX-124 and proof of concept for Werewolf’s INDUKINE design. The preliminary data include assessments of safety and tolerability, pharmacokinetics, relevant biomarkers and preliminary antitumor activity. Data as of the October 18, 2023, cutoff date are summarized as follows: WTX-124 was generally well-tolerated at all doses tested up to and including 12 mg in the outpatient setting. All treatment-emergent adverse events (TEAEs) were Grade 1 or Grade 2, and arthralgias and fatigue were the most common TEAEs. Vascular leak syndrome was not observed, and there were no dose limiting toxicities, treatment-related serious adverse events (SAEs) or treatment-related study discontinuations. WTX-124 was delivered intravenously once every two weeks (Q2W). WTX-124 showed expected pharmacokinetics with evidence of wide therapeutic index allowing for continued dose escalation. WTX-124 demonstrated both translational biomarker activity and early evidence of monotherapy antitumor activity at 6 mg and 12 mg doses. CD8+ T and NK cell proliferation and activation in the tumor microenvironment and immune cell gene expression changes were seen at 6 mg and 12 mg dose levels. Among five patients treated at 12 mg, one patient achieved an unconfirmed partial response (uPR), one patient had a restaging scan that was consistent with a partial response as of November 1, 2023, and one other showed evidence of anti-tumor activity. Dose escalation is ongoing in the monotherapy and combination therapy arms of the trial with additional data from monotherapy dose-escalation cohorts informing declaration of recommended dose for expansion (RDE) and opening of the monotherapy expansion arms expected in the first half of 2024. In addition, five preclinical posters further supporting the INDUKINE hypothesis, WTX-124 properties, and other INDUKINE molecules are being presented at the meeting, including: Title: PK/RO Modeling of WTX-124, a Tumor-Activated IL-2 Prodrug, Highlights the Potential for a Substantially Improved Therapeutic Index Compared to Other IL-2 Molecules (Abstract #1074) Plasma and tumor data from mice were used to perform pharmacodynamic and receptor occupancy modeling to predict IL-2 receptor occupancy on peripheral lymphocytes and tumor infiltrating lymphocytes (TILs) suggesting WTX-124 has a substantially improved, best-in-class therapeutic index as compared to other IL-2 molecules investigated, including a half-life extended non-alpha IL-2 and a non-alpha IL-2 tumor-activated prodrug. Title: Optimal Antitumor Immunity Triggered by WTX-124, a Clinical Stage Conditionally Activated INDUKINETM Molecule that Releases Fully Potent IL-2 in the Tumor Microenvironment (Abstract #1058) WTX-124 generated robust anti-tumor activity in a MC38 tumor bearing mouse model and promoted the expansion and activation of tumor specific CD8+ T cells as compared to a variant Non-Alpha IL-2 containing INDUKINE molecule which failed to generate anti-tumor activity, to drive tumor specific CD8+ T cell expansion, or to activate tumor infiltrating immune cells even when dosed up to 28 times higher than the active dose of WTX-124. In addition, while both molecules protected tumor infiltrating CD8+ T cells from exhaustion, only treatment with WTX-124 was able to induce an effector phenotype in tumor specific CD8+ T cells and drive clustering of CD8+ T cells with CD103+ cross presenting dendritic cells within the tumor. Title: Spatial Analysis of Tumor Infiltrating Lymphocyte Populations in Syngeneic Mouse Tumor Models After Treatment with IL-12 (mWTX-330) and IL-2 (WTX-124) INDUKINETM Molecules (Abstract #1059) Combination treatment with WTX-124 and alpha PD-1 generated robust anti-tumor activity in a CT26 model resulting in widespread tumor infiltration by CD8+ T cells driving immune activation in the tumor microenvironment. In addition, detection of structured and unstructured lymphoid aggregates, including the clustering of various adaptive and innate immune cells within the tumor microenvironment suggests a zone of cytotoxic cell education within the tumor microenvironment. Title: The Combination of ACT and INDUKINETM Therapy Leads to Improved Antitumor Immunity in Solid Tumors (Abstract # 252) Systemic WTX-124 was shown to preferentially expand CD4 CAR T cells while WTX-330 expanded CD8 CAR T cells, demonstrating that the administration of INDUKINE proteins with adoptive cell therapy could reinvigorate donor cell function leading to improved immunity, engraftment and long-term responses in solid tumors. Title: Development of WTX-712, a Conditionally Activated IL-21 INDUKINETM Molecule for the Treatment of Cancer (Abstract # 1075) WTX-712 was shown to be peripherally inactive in preclinical studies, releasing IL-21 selectively within the tumor microenvironment while driving CD8+ T cell polyfunctionality and promoting immune cell interactions. In addition, WTX-712 demonstrated enhanced activity when combined with immune checkpoint inhibitors, blocking PD-1/PD-L1 or CTLA-4 pathways, indicating further evaluation of WTX-712 is warranted.

Total avkastning till aktieägarna	-29.0%
Framtida utdelningsavkastning	0%
Utdelningstillväxt	n/a
Nästa utbetalningsdag för utdelning	n/a
Ex utdelningsdag	n/a
Utdelning per aktie	n/a
Utdelningsandel	n/a

Segment	Utdelningsavkastning
Företag (HOWL)	n/a
Marknadens lägsta 25% (US)	1.3%
Marknad Topp 25% (US)	4.1%
Genomsnitt för branschen (Biotechs)	2.2%
Prognosanalytiker (HOWL) (upp till 3 år)	0%

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/07/26 07:09
Aktiekurs vid dagens slut	2026/07/24 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Jason Zemansky	BofA Global Research
Maneka Mirchandaney	Evercore ISI
Christopher Howerton	Jefferies LLC

Werewolf Therapeutics Utdelningar och återköp

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Viktig information

Senaste utdelnings- och återköpsuppdateringar

Recent updates

New major risk - Financial position

Here's Why We're A Bit Worried About Werewolf Therapeutics' (NASDAQ:HOWL) Cash Burn Situation

Insufficient new directors

Werewolf Therapeutics, Inc. Announces Executive Changes, Effective February 13, 2026

Werewolf Therapeutics Receives Notice of Nasdaq Bid Price Deficiency and Listing Compliance Period

New major risk - Share price stability

Price target decreased by 18% to US$5.20

New major risk - Share price stability

Price target decreased by 12% to US$6.33

Werewolf Therapeutics, Inc. Presents Data Expanding Its Predator®? Platform At the Society for Immunotherapy of Cancer's (Sitc) 40Th Annual Meeting

Werewolf Therapeutics, Inc. Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer

Werewolf Therapeutics Announces Board Member's Passing Causes Temporary Nasdaq Audit Committee Non-Compliance

Price target decreased by 8.9% to US$6.83

Price target decreased by 12% to US$8.33

Werewolf Therapeutics, Inc. Receives Nasdaq Non-Compliance Notice Regarding Bid Price Deficiency

First quarter 2025 earnings released: US$0.40 loss per share (vs US$0.39 loss in 1Q 2024)

Werewolf Therapeutics Presents New Preclinical Data Further Characterizing Its Il-10 Indukine Molecule, Wtx-921, for the Treatment of Inflammatory Bowel Disease At AAI Annual Meeting

Werewolf Therapeutics, Inc., Annual General Meeting, Jun 12, 2025

Werewolf Therapeutics Appoints Steven Bloom as Chief Business Officer

New minor risk - Share price stability

Full year 2024 earnings: EPS misses analyst expectations

Werewolf Therapeutics, Inc. Announces Board Changes

Price target decreased by 11% to US$10.67

Werewolf Therapeutics (NASDAQ:HOWL) Has Debt But No Earnings; Should You Worry?

Consensus revenue estimates decrease by 45%, EPS upgraded

New minor risk - Revenue size

Third quarter 2024 earnings released: US$0.38 loss per share (vs US$0.23 loss in 3Q 2023)

Werewolf Therapeutics Presents Preclinical and Clinical Data at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting

Werewolf Therapeutics Announces Promising New Development Candidate, WTX-921, a First-Of-Its-Kind IL-10 INDUKINE Molecule for Inflammatory Diseases

Second quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind

Is Werewolf Therapeutics (NASDAQ:HOWL) Using Debt Sensibly?

Werewolf Therapeutics: Continuing To Advance And Show More Promise In Phase 1

Werewolf Therapeutics Highlights Initial Safety and Efficacy Data from its Ongoing Phase 1 Clinical Trial Evaluating WTX-330 in Patients with Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

Some Werewolf Therapeutics, Inc. (NASDAQ:HOWL) Shareholders Look For Exit As Shares Take 34% Pounding

Insufficient new directors

Werewolf Therapeutics to Present Updated Data from Phase 1/1b Clinical Trial of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Solid Tumors at 2024 ASCO Annual Meeting

Consensus revenue estimates fall by 68%

First quarter 2024 earnings: EPS and revenues miss analyst expectations

Werewolf Therapeutics, Inc. Presents First Preclinical Data Highlighting IL-10 INDUKINE Molecules as a Potential Therapy for Inflammatory Bowel Disease at AAI Annual Meeting

Werewolf Therapeutics, Inc., Annual General Meeting, May 24, 2024

Werewolf Therapeutics: In The Hunt For Success In The Cytokine Space

Consensus EPS estimates upgraded to US$1.24 loss

Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

Werewolf Therapeutics, Inc.'s (NASDAQ:HOWL) Share Price Boosted 27% But Its Business Prospects Need A Lift Too

Is Werewolf Therapeutics (NASDAQ:HOWL) A Risky Investment?

There's No Escaping Werewolf Therapeutics, Inc.'s (NASDAQ:HOWL) Muted Revenues Despite A 28% Share Price Rise

Third quarter 2023 earnings: EPS and revenues exceed analyst expectations

Price target increased by 7.9% to US$12.80

Werewolf Therapeutics Presents Preliminary Monotherapy Data from Phase 1/1b Clinical Trial Establishing Proof of Mechanism for WTX-124 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting

Werewolf Therapeutics, Inc. to Present Clinical and Preclinical Data at the Society for Immunotherapy of Cancer's 38th Annual Meeting

New major risk - Share price stability

Analysts Just Shipped A Captivating Upgrade To Their Werewolf Therapeutics, Inc. (NASDAQ:HOWL) Estimates

Consensus revenue estimates increase by 30%

New major risk - Share price stability

Consensus revenue estimates decrease by 23%, EPS upgraded

Werewolf Therapeutics, Inc. (NASDAQ:HOWL) Second-Quarter Results: Here's What Analysts Are Forecasting For This Year

New minor risk - Market cap size

Consensus revenue estimates increase by 71%

Consensus revenue estimates decrease by 57%, EPS upgraded

We're Hopeful That Werewolf Therapeutics (NASDAQ:HOWL) Will Use Its Cash Wisely

Price target decreased by 8.1% to US$13.66

Werewolf Therapeutics (NASDAQ:HOWL) Is In A Good Position To Deliver On Growth Plans

Price target decreased to US$14.86

Consensus revenue estimates increase by 117%

Werewolf Therapeutics Presents Preclinical Data on mWTX-330, A Surrogate IL-12 Indukine™ Molecule, at the Society for Immunotherapy of Cancer Annual Meeting

We're Not Very Worried About Werewolf Therapeutics' (NASDAQ:HOWL) Cash Burn Rate

Werewolf Therapeutics, Inc. Announces Initiation of Patient Dosing in Phase 1/1B Clinical Trial of WTX-124 for the Treatment of Patients with Selected Solid Tumors

We're Hopeful That Werewolf Therapeutics (NASDAQ:HOWL) Will Use Its Cash Wisely

Werewolf Therapeutics, Inc.(NasdaqGS:HOWL) dropped from Russell 2500 Value Index

High number of new directors

Werewolf Therapeutics, Inc., Annual General Meeting, Jun 01, 2022

High number of new directors

Werewolf Therapeutics Presents Promising Preclinical Data on its Two Lead INDUKINE™ Molecules at AACR 2022 Annual Meeting

Werewolf Therapeutics (NASDAQ:HOWL) Is In A Good Position To Deliver On Growth Plans

Chief Scientific Officer exercised options to buy US$354k worth of stock.