1. Veteran life sciences executive brings more than 30 years CMC and product development strategy expertise to rapidly advance programs and oversee manufacturing

    CAMBRIDGE, Mass., June 15, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 appointment of Chulani Karunatilake, Ph.D. as Chief Technology Officer (CTO). Dr. Karunatilake brings more than 30 years of experience in Chemistry and Manufacturing Controls (CMC) process and strategy development and will oversee manufacturing operations in the newly formed role.

    "I am…

    Veteran life sciences executive brings more than 30 years CMC and product development strategy expertise to rapidly advance programs and oversee manufacturing

    CAMBRIDGE, Mass., June 15, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 appointment of Chulani Karunatilake, Ph.D. as Chief Technology Officer (CTO). Dr. Karunatilake brings more than 30 years of experience in Chemistry and Manufacturing Controls (CMC) process and strategy development and will oversee manufacturing operations in the newly formed role.

    "I am excited to welcome Chulani as Chief Technology Officer to the Werewolf team at this critical time of growth for the company," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Chulani's extensive expertise in product characterization, drug development, regulatory and supply chain management, as well as his proven track record to in the manufacturing of biologic immuno-oncology medicines, will be a valuable addition as we advance our lead therapeutic programs WTX-124 and WTX-330 into the clinic."

    Dr. Karunatilake joins Werewolf from Maverick Therapeutics where he served as Senior Vice President of Technical Operations until the company's acquisition by Takeda in March 2021. In this role, he was responsible for CMC, including process development, analytics, formulation, quality, manufacturing, regulatory and supply chain for the company's two conditionally activated bispecific T-cell engager molecules targeting solid tumors. Prior to Maverick, Dr. Karunatilake was Senior Vice President, Pharmaceutical Development at Nektar Therapeutics where he established and led the Biologics CMC division.

    "Werewolf's conditionally activated INDUKINE™ molecules represent a novel class of therapeutics that potentially offer a safer and highly effective alternative to existing cancer treatments," said Dr. Karunatilake. "I am thrilled to join this veteran team of drug developers and contribute my expertise toward bringing these treatments through clinical studies and to patients."

    Throughout his career, Dr. Karunatilake has held numerous leadership positions at Amgen, Novartis, Genentech, and Eli Lilly. Dr. Karunatilake earned his Ph.D. in Chemistry/Biochemistry from the University of Illinois and holds a B.S. in Chemistry from the University of Colombo in Sri Lanka.

    About Werewolf Therapeutics, Inc.

    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 product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules for the treatment of solid tumors. We are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

    To learn more visit www.werewolftx.com.

    Investor Contact:

    Alan Lada

    Solebury Trout

    617.221.8006

      

    Media Contact:

    Amanda Sellers

    VERGE Scientific Communications

    301.332.5574

       

    Company Contact:

    Ellen Lubman

    Chief Business Officer

    Werewolf Therapeutics



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  2. CAMBRIDGE, Mass., June 10, 2021 (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 financial results for the quarter ended March 31, 2021.

    "Our recently completed IPO will help us advance our two lead programs to the clinic and will enable us to continue to build our immuno-oncology R&D organization," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Despite important recent advances in the treatment of cancer, using the body's immune system without eliciting…

    CAMBRIDGE, Mass., June 10, 2021 (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 financial results for the quarter ended March 31, 2021.

    "Our recently completed IPO will help us advance our two lead programs to the clinic and will enable us to continue to build our immuno-oncology R&D organization," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Despite important recent advances in the treatment of cancer, using the body's immune system without eliciting off-target side effects remains a challenge. We are leveraging our novel PREDATOR™ platform to engineer conditionally activated proinflammatory immunomodulators, or INDUKINE™ molecules, which are delivered systemically but activated only in the tumor microenvironment, with the goal of generating potent anti-tumor response while minimizing toxicities."

    Successful Initial Public Offering Completed: On May 4, 2021, Werewolf completed its initial public offering (IPO). In connection with the offering, the Company issued and sold 7,500,000 shares of common stock at a public offering price of $16.00 per share, resulting in net proceeds of approximately $108.9 million.

    First Quarter 2021 Financial Highlights

    • Cash position: As of March 31, 2021, cash and cash equivalents decreased to $84.6 million, compared to $92.6 million as of December 31, 2020. The Company expects that its existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operations for at least the next twenty-four months.
    • Research and development expenses: Research and development expenses were $4.8 million for the first quarter of 2021, compared to $2.8 million for the same period in 2020. The increase in research and development expenses was primarily due to manufacturing expenses incurred to support the production of preclinical and future clinical trial materials associated with the Company's product candidates WTX-124, WTX-330 and WTX-613 and increased employee compensation costs related to increased headcount.
    • General and administrative expenses: General and administrative expenses were $2.6 million for the first quarter of 2021, compared to $1.1 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increased personnel, consulting and recruiting costs in preparation for increased requirements of operating as a public company.
    • Net loss: Net loss was $7.4 million for the first quarter of 2021, compared to $3.8 million for the same period in 2020.

    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 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 are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

    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 strategy, future operations, prospects, plans, objectives of management, the expected timeline for submitting investigational new drug applications and its sufficiency of its cash resources constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "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; the timing of and our 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 final prospectus dated April 29, 2021 for its initial public offering filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, 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 presentation. 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 Ended

    March 31,
     
     2021   2020  
    Operating expenses:      
    Research and development$4,817  $2,763  
    General and administrative 2,635   1,131  
    Total operating expenses 7,452   3,894  
    Operating loss(7,452)  (3,894) 
    Other income 17   67  
    Net loss(7,435) (3,827) 
    Accretion of redeemable convertible preferred stock to redemption value(95,016)    
    Net loss attributable to common stockholders$(102,451) $(3,827) 
    Net loss per share attributable to common stockholders, basic and diluted$(83.36) $(4.58) 
    Weighted-average common shares outstanding, basic and diluted 1,229   836  

    Werewolf Therapeutics, Inc.

    Selected Condensed Consolidated Balance Sheet Data (unaudited)

    (amounts in thousands)

     March 31, 2021

    December 31, 2020
    Cash and cash equivalents$84,602 $92,570 
    Working capital$79,456 $87,630 
    Total assets$89,436 $96,398 
    Total stockholders' deficit$(153,754)$(51,863)

    Investor Contact:

    Alan Lada

    Solebury Trout

    617.221.8006

    Media Contact:

    Amanda Sellers

    VERGE Scientific Communications

    301.332.5574

    Company Contact:

    Ellen Lubman

    Chief Business Officer

    Werewolf Therapeutics



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  3. CAMBRIDGE, Mass., May 28, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 appointment of Mike Sherman, chief executive officer of Chimerix, Inc., as a member of its board of directors.

    "The promise of immunotherapy has long been appreciated, but never fully realized. Werewolf has pioneered an elegant approach that may finally unleash that potential. This platform may translate to multiple drugs to address numerous challenges to treating cancers," Mr. Sherman said. "I am excited about the prospect of bringing this platform…

    CAMBRIDGE, Mass., May 28, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 appointment of Mike Sherman, chief executive officer of Chimerix, Inc., as a member of its board of directors.

    "The promise of immunotherapy has long been appreciated, but never fully realized. Werewolf has pioneered an elegant approach that may finally unleash that potential. This platform may translate to multiple drugs to address numerous challenges to treating cancers," Mr. Sherman said. "I am excited about the prospect of bringing this platform to patients and believe that the experienced Werewolf team can drive quickly to that milestone."

    "I am very pleased to welcome Mike to our board of directors during this exciting phase of growth for our company," added Luke Evnin, Chairman of the Board of Directors and co-founder of Werewolf Therapeutics. "Mike's experience in leading companies through various stages of development, shaping corporate strategy and leading companies to successful strategic transactions compliment those of the current board members. I am confident Mike's unique product-focused background and operational excellence will provide important guidance to Werewolf as we seek to advance our lead candidates, WTX-124 and WTX-330, into clinical development."

    Mr. Sherman joins the Werewolf board of directors with more than 30 years' experience in the biotechnology and medical technology industries. He is currently Chief Executive Officer of Chimerix. Before joining Chimerix, he served as Chief Executive Officer of Endocyte, Inc. and led it to its $2.1 billion acquisition by Novartis in 2018. Mr. Sherman joined Endocyte in 2006 and served as its Chief Financial Officer and Chief Operating Officer prior to becoming Chief Executive Officer in 2016. Mr. Sherman repositioned the company by re-prioritizing the pipeline, acquiring an external asset, and aggressively executing a phase 3 regulatory and clinical strategy, and was instrumental in Endocyte's IPO and four subsequent financings. Prior to joining Endocyte, Mr. Sherman served in various executive roles, including as vice president of finance and strategic planning for Guidant Corporation, which was acquired by Boston Scientific Corporation. Mr. Sherman holds a BA in economics from DePauw University and an MBA from the Tuck School of Business at Dartmouth, graduating as a Tuck Scholar. Mr. Sherman currently serves on the Board of Trustees for the Children's Museum of Indianapolis as past chairman. He also served on the Boards of Directors at Biospecifics Technologies, Inc. until its acquisition by Endo Pharmaceuticals and Mead Johnson Nutrition until its acquisition by Reckitt Benckiser.

    About Werewolf Therapeutics, Inc.

    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 product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules for the treatment of solid tumors. We are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

    Investor Contact:

    Alan Lada

    Solebury Trout

    617.221.8006

    Media Contact:

    Amanda Sellers

    VERGE Scientific Communications

    301.332.5574

    Company Contact:

    Ellen Lubman

    Chief Business Officer

    Werewolf Therapeutics

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ccffb6f0-b999-4bb5-a358-92ae825359cb



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  4. CAMBRIDGE, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 that Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics, will present at Jefferies Virtual Healthcare Conference on Thursday, June 3rd, at 11 am ET.

    Access to the live webcast of this event, as well as an archived recording, will be available under the "Events" tab on the investor relations section of the Werewolf Therapeutics website at: https://investors.werewolftx.com/news-and-events/events.

    About Werewolf Therapeutics,

    CAMBRIDGE, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 that Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics, will present at Jefferies Virtual Healthcare Conference on Thursday, June 3rd, at 11 am ET.

    Access to the live webcast of this event, as well as an archived recording, will be available under the "Events" tab on the investor relations section of the Werewolf Therapeutics website at: https://investors.werewolftx.com/news-and-events/events.

    About Werewolf Therapeutics, Inc.

    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 product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2), and Interleukin-12 (IL-12) INDUKINE molecules for the treatment of solid tumors. We are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

    To learn more visit www.werewolftx.com.

    Investor Contact:

    Alan Lada

    Solebury Trout

    617.221.8006

    Media Contact:

    Amanda Sellers

    VERGE Scientific Communications

    301.332.5574

    Company Contact:

    Ellen Lubman

    Chief Business Officer



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  5. CAMBRIDGE, Mass., April 29, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 pricing of its upsized initial public offering of 7,500,000 shares of common stock at a public offering price of $16.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and offering expenses payable by Werewolf, are expected to be approximately $120.0 million. Werewolf has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock at the initial…

    CAMBRIDGE, Mass., April 29, 2021 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (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 pricing of its upsized initial public offering of 7,500,000 shares of common stock at a public offering price of $16.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and offering expenses payable by Werewolf, are expected to be approximately $120.0 million. Werewolf has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Werewolf.

    The shares are expected to begin trading on the Nasdaq Global Select Market on April 30, 2021 under the ticker symbol "HOWL." The offering is expected to close on May 4, 2021, subject to the satisfaction of customary closing conditions.

    Jefferies, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

    A registration statement relating to the offering of these securities was filed with the Securities and Exchange Commission ("SEC") and was declared effective on April 29, 2021. The offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 800-808-7525 ext. 6105 or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

    About Werewolf Therapeutics, Inc.

    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 product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2), and Interleukin-12 (IL-12) INDUKINE molecules for the treatment of solid tumors. We are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

    Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements". These statements include, but are not limited to, statements relating to the expected commencement of trading and the closing date. The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms of the offering or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus that forms a part of the effective registration statement filed with the SEC. Any forward-looking statements contained in this press release are based on the current expectations of Werewolf's management team and speak only as of the date hereof, and Werewolf specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Alan Lada

    Solebury Trout

    617.221.8006

    Media Contact:

    Amanda Sellers

    VERGE Scientific Communications

    301.332.5574

    Company Contact:

    Ellen Lubman

    Chief Business Officer



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