Core Insights - Werewolf Therapeutics, Inc. reported a quarterly loss of $0.43 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and a significant increase from a loss of $0.14 per share a year ago [1] - The company posted revenues of $1.14 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 42.85% and down from $8.08 million in the same quarter last year [2] - The stock has underperformed significantly, losing about 55.7% since the beginning of the year compared to the S&P 500's gain of 9% [3] Financial Performance - The earnings surprise for the recent quarter was -13.16%, and the company has not been able to beat consensus revenue estimates over the last four quarters [1][2] - The current consensus EPS estimate for the upcoming quarter is -$0.37 on revenues of $2 million, and for the current fiscal year, it is -$1.52 on revenues of $6.85 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Werewolf Therapeutics belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a relatively strong position [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Werewolf Therapeutics' stock performance [5]

Revenue and Collaboration Agreements - For the six months ended June 30, 2024, the company recognized $1.9 million in revenue from the Collaboration Agreement with Jazz Pharmaceuticals[77] - Collaboration revenue for the six months ended June 30, 2024, was $1.9 million, down $10.7 million from $12.5 million in 2023[99] - The company anticipates fluctuations in future revenue based on the achievement of development and regulatory milestones[77] Research and Development Expenses - Research and development expenses are expected to increase substantially as the company progresses its clinical trials for WTX-124 and WTX-330[80] - Research and development expenses increased to $15.3 million for the three months ended June 30, 2024, compared to $9.6 million in 2023, reflecting a rise of $5.7 million[90] - Research and development expenses increased by $5.7 million, driven by ongoing development efforts of product candidates[118] Operating Loss and Financial Performance - The operating loss for the three months ended June 30, 2024, was $(18.96) million, compared to $(6.07) million in the same period of 2023, an increase of $12.89 million[87] - The net loss for the three months ended June 30, 2024, was $(17.25) million, compared to $(5.10) million in 2023, an increase of $12.15 million[87] - The company reported a net loss of $17.2 million for the three months ended June 30, 2024, compared to a net loss of $5.1 million for the same period in 2023, with an accumulated deficit of $377.5 million as of June 30, 2024[106] External Development Costs - External development costs for WTX-330 amounted to $7.9 million for the six months ended June 30, 2024, compared to $1.2 million for the same period in 2023[80] - The company reported total external development costs of $15.9 million for the six months ended June 30, 2024, up from $9.4 million in the same period of 2023[80] Cash Flow and Financing Activities - Net cash used in operating activities for the six months ended June 30, 2024, was $29.5 million, an increase of $8.7 million compared to $20.8 million for the same period in 2023, primarily due to a decrease in revenue from collaboration agreements[118] - Net cash provided by financing activities for the six months ended June 30, 2024, was $10.5 million, significantly lower than $49.3 million for the same period in 2023[119] - The company expects to require additional funding to complete the development of WTX-124, WTX-330, and other product candidates[116] Interest Income and Expense - Interest income for the three months ended June 30, 2024, was $1.8 million, a decrease of $0.1 million from $1.9 million in 2023[93] - Interest income rose to $3.8 million for the six months ended June 30, 2024, compared to $3.5 million for the same period in 2023, driven by higher yields on cash equivalents[103] - Interest expense increased to $1.1 million for the three months ended June 30, 2024, compared to $1.0 million in 2023, reflecting a rise of $0.1 million[94] - Interest expense increased significantly to $2.1 million for the six months ended June 30, 2024, from $1.1 million in the same period of 2023, primarily due to the timing of term loan drawdowns[103] Share Issuance and Cash Position - The company sold 4,342,320 shares of common stock at an average price of $5.11 per share during the six months ended June 30, 2024, generating net proceeds of $21.1 million[112] - As of June 30, 2024, the company had cash and cash equivalents of $135.3 million and restricted cash of $1.2 million, expected to fund operations through at least Q1 2026[114] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $19.1 million for the six months ended June 30, 2024[117] Loan Agreements and Obligations - The K2HV Loan Agreement provides up to $60.0 million in term loans, with $30.0 million received at closing and additional tranches available based on certain milestones[109] - The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the three months ended June 30, 2024[96] - The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the six months ended June 30, 2024[105] Clinical Trials and Product Development - The company is currently evaluating WTX-124 in a Phase 1/1b clinical trial, with preliminary data from 16 patients indicating proof of mechanism and proof of concept for the INDUKINE design[74] - The company executed a Transfer Agreement in June 2024, completing all material performance obligations under the Collaboration Agreement with Jazz[77] - The company reported initial data from the Phase 1 clinical trial of WTX-330 in June 2024, with patient dosing initiated in February 2023[74] - The company has no remaining material performance obligations under the Collaboration Agreement as of June 2024[77] Future Financial Considerations - The company may need to raise additional funds through equity or debt financing, which could lead to dilution for existing shareholders[116] - The company is actively considering collaboration arrangements for clinical development and commercialization to support its financial needs[116] - The company anticipates that the costs of obtaining marketing approval for WTX-124 and WTX-330 will significantly impact future cash flows[116] General and Administrative Expenses - General and administrative expenses increased to $9.8 million for the six months ended June 30, 2024, from $9.5 million in the same period of 2023, primarily due to a $0.3 million increase in personnel costs and a $0.4 million increase in professional services costs[102]

Financial Performance - As of June 30, 2024, cash and cash equivalents were $135.3 million, down from $139.2 million as of March 31, 2024, with sufficient funds projected to cover operational expenses through at least Q1 2026[6] - Collaboration revenue for Q2 2024 was $1.1 million, a significant decrease from $8.1 million in the same period of 2023, as the company completed its performance obligations under the collaboration agreement with Jazz Pharmaceuticals[6] - The net loss for Q2 2024 was $17.2 million, compared to a net loss of $5.1 million in Q2 2023[7] - General and administrative expenses were $4.8 million for Q2 2024, slightly up from $4.6 million in Q2 2023[7] - Total operating expenses for Q2 2024 were $20.1 million, compared to $14.1 million in Q2 2023[7] - The weighted-average common shares outstanding for Q2 2024 were 43,521,406, compared to 35,557,701 in Q2 2023[10] Research and Development - Research and development expenses increased to $15.3 million in Q2 2024, compared to $9.6 million in Q2 2023, primarily due to ongoing clinical trials for WTX-124 and WTX-330[7] - WTX-124 achieved three objective clinical responses, including one durable confirmed complete response and two partial responses in patients who were relapsed/refractory to immune checkpoint inhibitor therapy[2] - WTX-330 demonstrated an approximately 23-fold higher systemic drug concentration of IL-12 prodrug compared to previous IL-12 therapeutic strategies at a dose of 0.024 mg/kg[4] - The company anticipates updated data on WTX-124 and WTX-330 in the second half and fourth quarter of 2024, respectively, as part of ongoing clinical trials[1] Contacts - Investor contact is John Norton from Precision AQ, reachable at 212.362.1200[12] - Media contact is Amanda Sellers from Deerfield Group, reachable at 301.332.5574[12] - Company contact is Ellen Lubman, Chief Business Officer of Werewolf Therapeutics[12]

Core Insights - The administration of WTX-330 has shown therapeutically relevant exposure levels of IL-12 prodrug with improved tolerability compared to historical data for rhIL-12 [1][2] - The company is focused on advancing a pipeline of next-generation immunostimulatory medicines, with preliminary clinical data indicating promising tolerability and efficacy signals in heavily pretreated patients with late-stage solid tumors [1][3] Clinical Trial Results - As of June 12, 2024, eleven patients with relapsed or refractory solid tumors have been dosed in dose escalation cohorts, with doses of 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), and 0.032 mg/kg (n=5) [1] - At the 0.024 mg/kg dose, WTX-330 demonstrated a 23-fold higher systemic drug concentration of IL-12 prodrug compared to previous IL-12 strategies, with low free IL-12 levels across all dose levels [2] - One patient with metastatic melanoma achieved an unconfirmed partial response after treatment with 0.024 mg/kg WTX-330, with no evidence of disease on biopsy [2] - Two patients with microsatellite stable colorectal cancer achieved stable disease, with one showing evidence of tumor biomarker activity [2] Immune Response and Tolerability - Evidence of robust activation of immune biomarkers, including increased antitumor CD8+ T and NK cell expansion, was observed in patients with stable disease [2] - All patients experienced mild to moderate treatment-related toxicities, primarily associated with the first dose, with no Grade 4 or Grade 5 adverse events reported [2] - Two patients experienced reversible dose-limiting toxicities at the 0.032 mg/kg dose level, including Grade 3 mucositis and Grade 3 AST increase [2] Future Developments - The company has opened two expansion arms for further evaluation of WTX-330 in patients with immune checkpoint inhibitor-sensitive solid tumors [2][3] - Additional results are anticipated in the fourth quarter of 2024, with a focus on safety, biomarker, and antitumor activity [3] Company Overview - Werewolf Therapeutics is pioneering the development of therapeutics designed to stimulate the immune system for cancer treatment, leveraging its proprietary PREDATOR® platform [5] - The company's INDUKINE™ molecules are engineered to remain inactive in peripheral tissues and activate selectively in the tumor microenvironment [5][10]

Core Insights - Werewolf Therapeutics, Inc. announced initial results from a Phase 1 clinical trial evaluating WTX-330, a conditionally activated interleukin-12 (IL-12) INDUKINE™ molecule, as a monotherapy for patients with immunotherapy-insensitive or resistant locally advanced or metastatic solid tumors or non-Hodgkin lymphoma [18] Group 1: Clinical Trial Results - WTX-330 demonstrated therapeutically relevant exposure levels of systemically delivered IL-12 prodrug with improved tolerability compared to historical data for rhIL-12 [2][20] - Early dose-escalation data showed encouraging clinical activity, including an unconfirmed partial response in a metastatic melanoma patient and stable disease in two patients with microsatellite stable colorectal cancer [14][20] - The study had dosed eleven patients in dose escalation with three cohorts: 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), and 0.032 mg/kg (n=5) [14] Group 2: Mechanism and Technology - WTX-330 is designed to deliver fully active IL-12 selectively into the tumor microenvironment through targeted intratumoral activation, potentially broadening the therapeutic window [4][7] - The INDUKINE™ technology allows for the stimulation of both adaptive and innate immunity while remaining inactive in peripheral tissues [7] Group 3: Safety and Tolerability - Patients exhibited mild to moderate treatment-related toxicities, primarily associated with the first dose, with no Grade 4 or Grade 5 adverse events reported [20] - Two patients experienced reversible dose-limiting toxicities at the 0.032 mg/kg dose level, indicating a manageable safety profile [20] Group 4: Future Developments - The company plans to present further safety, biomarker, and antitumor activity results from patients enrolled in expansion arms at a medical meeting in the fourth quarter of 2024 [3][19] - Expansion arms have been opened to evaluate 0.024 mg/kg of WTX-330 in patients with immune checkpoint inhibitor-sensitive solid tumors [20]

Core Insights - Werewolf Therapeutics announced new clinical data from the Phase 1/1b trial of WTX-124, a conditionally activated IL-2 molecule, at the 2024 ASCO Annual Meeting [1][2] - The trial aims to evaluate WTX-124 in patients with advanced or metastatic solid tumors who have previously failed checkpoint inhibitor therapy [2][3] Clinical Trial Results - WTX-124 demonstrated clinical activity with three objective responses, including one durable confirmed complete response [3][4] - The recommended dose for expansion (RDE) for WTX-124 monotherapy was set at 18 mg administered intravenously every two weeks [6] - The combination of WTX-124 with pembrolizumab was well-tolerated, showing enhanced immune activation in tumors [3][10] Future Development Plans - The company has opened three expansion arms for WTX-124 in advanced or metastatic renal cell carcinoma, cutaneous melanoma, and cutaneous squamous cell carcinoma [6] - Ongoing dose escalation studies for WTX-124 in combination with pembrolizumab are planned, with an RDE expected to be selected in Q3 2024 [6] - The company intends to engage with regulators regarding potential registrational pathways for WTX-124, including accelerated approval strategies [6] Presentation and Webcast - The findings will be presented in a poster session at ASCO and a webcast is scheduled for June 3, 2024, to review the clinical results [1][7]

WATERTOWN, Mass., May 23, 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, today announced the upcoming presentation of clinical data from dose-escalation arms of the Phase 1/1b trial evaluating WTX-124, its conditionally activated Interleukin-2 (IL-2) INDUKINE™ molecule, as m ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________________________________________________________________ FORM 10-Q ______________________________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

Exhibit 99.1 Werewolf Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update – Company announces cash runway extension through at least the first quarter of 2026 — Watertown, Mass., May 3, 2024 – 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 ...

— Company to present an update of its ongoing monotherapy and combination Phase 1/1b trial of WTX-124 in advanced or metastatic solid tumors at ASCO — — Company plans to present interim, first-in-human clinical data from the ongoing Phase 1 trial of WTX-330 in the second quarter of 2024 — — Multiple presentations of preclinical data demonstrate the potential of the PREDATORTM platform, including in immunology-based diseases — — Company announces cash runway extension through at least the first quarter o ...