Table of Contents (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________________________________________________________________ FORM 10-Q ______________________________________________________________________________________ D ...

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, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

Financial Performance - The company incurred a net loss of $53.8 million for the year ended December 31, 2022, with an accumulated deficit of $306.7 million [188]. - As of December 31, 2022, the company had cash and cash equivalents of $129.3 million, which will not be sufficient to complete the development of WTX-124 and WTX-330 [193]. - The company has no products approved for commercial sale and does not expect to generate any revenue from product sales for several years [189]. - The company currently generates no revenue from product sales and does not expect to generate product revenue for many years, if ever [205]. - The company is required to raise at least $50.0 million by September 30, 2023, from equity sales or strategic partnerships to comply with its Loan Agreement [198]. - The company expects to incur increasing expenses and operating losses over the next several years as it pursues clinical development of its product candidates [192]. - The company may need to seek additional financing sooner than planned due to changing circumstances that could cause it to consume capital faster than anticipated [194]. - The company’s ability to raise additional capital may be adversely impacted by worsening global economic conditions, which could limit its operational flexibility [196]. Regulatory and Approval Challenges - The success of the company's business is highly dependent on obtaining regulatory approval and successfully launching its initial product candidates, WTX-124 and WTX-330 [206]. - The FDA approval process for a Biologics License Application (BLA) is expensive, uncertain, and may take several years, with no guarantee of approval [210]. - The company has not previously submitted a BLA to the FDA or similar applications to foreign regulatory authorities, which may impede future approval processes [209]. - The company may face challenges in patient recruitment, trial design revisions, and regulatory compliance, which could delay clinical trials [208]. - The company may need to conduct additional clinical trials or testing, which could lead to increased costs and delays in obtaining marketing approval [226]. - Changes in regulatory requirements, such as the new diversity action plan mandated by FDORA, could impact clinical trial development plans [228]. - The company may need to adapt to changes in FDA guidance following the end of the COVID-19 public health emergency [242]. - The regulatory approval process for product candidates is lengthy, expensive, and uncertain, potentially delaying or preventing commercialization [351]. - The FDA requires extensive preclinical and clinical data to establish safety and efficacy for each therapeutic indication, which can lead to significant delays in approval [352]. - Non-compliance with regulatory requirements could lead to severe penalties, including withdrawal of marketing approvals and damage to reputation [363][372]. Clinical Development Risks - Preclinical and clinical trials are expensive and time-consuming, with high risks of failure at any stage of development [221]. - The company may face substantial delays in clinical trials, which could increase costs and limit revenue generation [224]. - Issues may arise in generating sufficient preclinical or clinical data to obtain regulatory authorizations, potentially delaying trial commencement [225]. - The COVID-19 pandemic has adversely affected clinical trials and may continue to disrupt operations and financial results [240]. - The company is facing delays in clinical trials due to COVID-19 disruptions, impacting supply chains and regulatory approvals [244]. - Delays in patient enrollment for clinical trials could significantly impact development timelines and increase costs [235]. - The development of WTX-124 is ongoing, with trials being conducted both as monotherapy and in combination with Merck's KEYTRUDA [246]. Competition and Market Risks - The company faces substantial competition from established pharmaceutical and biotechnology firms, which may hinder its ability to develop and commercialize products [256]. - The lead product candidate, WTX-124, may face competition from other IL-2 based therapies already on the market [260]. - The potential market sizes for the company's product candidates are difficult to estimate, and inaccuracies in assumptions could lead to smaller actual markets [264]. - Market acceptance of approved products is crucial for commercial success, influenced by factors such as efficacy, safety, and competition from established therapies [270]. Intellectual Property Risks - The company faces risks related to intellectual property, including the ability to obtain and maintain patent protection for its PREDATOR platform and product candidates [292]. - Patent protection may not be sufficiently broad, allowing competitors to develop similar technologies, which could harm the company's competitive advantage [294]. - The company may face challenges in enforcing patent rights, which could allow third parties to commercialize similar products without compensation [300]. - The company may face significant royalty obligations on future product sales, which could hinder profitability [308]. - The company relies on a combination of patents and trade secret protection, but any misappropriation could erode its competitive position [310]. - The strength of the company's patents is uncertain, and challenges to their validity could impact commercialization efforts [313]. - The company may face claims challenging the inventorship or ownership of its patents, which could be expensive and time-consuming to resolve [342]. Manufacturing and Supply Chain Risks - Manufacturing INDUKINE molecules presents significant risks due to their novel class and complexity, which may lead to delays or failures in production [217]. - The company relies on third-party manufacturers, exposing it to risks such as inability to meet drug specifications and quality requirements consistently [286]. - The company has engaged multiple contract manufacturers for drug substance and product manufacturing, which may lead to delays if any CMO fails to meet requirements [284]. - Regulatory compliance is critical, and any failure by contract manufacturers could necessitate costly and time-consuming changes to production processes [285]. - The company relies on contract manufacturers that must meet regulatory requirements, and failure to do so could materially harm the business [374]. Collaboration and Partnership Risks - Collaborations with other companies are part of the strategy to maximize the value of product candidates, with a notable agreement with Jazz Pharmaceuticals in April 2022 [289]. - Collaborators have significant discretion in determining the resources they apply, which may affect the development and commercialization of product candidates [290]. - Collaborations may be terminated, making it more difficult for the company to enter future collaborations or requiring additional capital for product development [298]. Insurance and Liability Risks - The company is exposed to potential product liability claims during clinical trials and post-commercialization, which could significantly impact its financial condition [250]. - The company may need to increase product liability insurance coverage, which could become costly and affect its operations [253].

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 September 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1 ...

Transforming Powerful Proinflammatory Mechanisms into novel therapies for cancer patients Corporate Overview August 2022 Cautionary Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding Werewolf Therapeutics, Inc.'s (the "Company") strategy, future operations, prospects, plans, objectives of management, the expected timeline fo ...

Revenue and Collaboration Agreements - The company has not generated any revenue from product sales to date, but recognized $4.1 million in revenue related to a Collaboration Agreement for the six months ended June 30, 2022[102]. - The company received an upfront payment of $15.0 million in April 2022 under a collaboration agreement with Jazz Pharmaceuticals, with potential milestone payments of up to $520.0 million[94]. - The company received an upfront payment of $15.0 million in April 2022 under a Collaboration Agreement with Jazz, with potential additional milestone payments totaling up to $1.26 billion[124]. - Collaboration revenue for the three months ended June 30, 2022, was $4.1 million, unchanged from 2021[112]. Financial Performance and Expenses - As of June 30, 2022, the company had an accumulated deficit of $282.8 million, with expectations of continued substantial and increasing expenses and net losses in the foreseeable future[96]. - Total operating expenses for the three months ended June 30, 2022, increased to $19.1 million from $11.0 million in 2021, representing an increase of $8.2 million[112]. - Research and development expenses for the three months ended June 30, 2022, were $13.9 million, up from $7.3 million in 2021, an increase of $6.6 million[113]. - General and administrative expenses for the three months ended June 30, 2022, were $5.2 million, compared to $3.7 million in 2021, an increase of $1.5 million[116]. - Net loss for the three months ended June 30, 2022, was $14.6 million, compared to a net loss of $10.9 million in 2021, an increase of $3.7 million[112]. - For the six months ended June 30, 2022, total operating expenses were $34.5 million, up from $18.4 million in 2021, an increase of $16.1 million[118]. - Research and development expenses for the six months ended June 30, 2022, were $24.8 million, compared to $12.1 million in 2021, an increase of $12.8 million[119]. - General and administrative expenses for the six months ended June 30, 2022, were $9.7 million, compared to $6.3 million in 2021, an increase of $3.3 million[121]. - The company has incurred an accumulated deficit of $282.8 million through June 30, 2022, and expects to continue incurring substantial and increasing expenses and net losses for the foreseeable future[133]. Cash Flow and Funding - Existing cash and cash equivalents of $145.7 million are expected to fund operations through at least the fourth quarter of 2023, but this estimate is based on assumptions that may prove incorrect[134]. - Net cash used in operating activities for the six months ended June 30, 2022, was $14.3 million, a decrease of approximately $3.5 million compared to $17.8 million for the same period in 2021[139]. - Net cash provided by financing activities for the six months ended June 30, 2022, was $3.6 million, a significant decrease of $106.1 million compared to $109.7 million for the same period in 2021[141]. - The company has financed operations primarily through proceeds from convertible promissory notes and equity securities, raising a total of $109.2 million from its IPO[95]. - The company will require further funding to complete the development of WTX-124, WTX-330, or any other product candidate[136]. Research and Development Plans - The company expects research and development expenses to continue to increase substantially as it initiates and progresses clinical trials for WTX-124 and WTX-330[106]. - External development costs for the six months ended June 30, 2022, totaled $14.3 million, compared to $7.0 million for the same period in 2021, indicating a significant increase in R&D spending[106]. - The company plans to initiate a Phase 1/1b clinical trial for WTX-124 and submit an IND for WTX-330 in the second half of 2022[93]. - The company plans to increase research and development expenses as it continues preclinical and clinical development of product candidates[132]. - The company may consider entering into collaboration arrangements or selectively partnering for clinical development and commercialization[137]. Operational Challenges - The company has not experienced material financial statement impacts from the COVID-19 pandemic to date, but the future impact remains uncertain[100]. - The company expects general and administrative expenses to increase in the future due to an increase in personnel headcount to support research and development activities[109]. - The company expects to face inflationary pressures that could adversely affect its operations in the future[132]. Deferred Revenue and Lease Obligations - As of June 30, 2022, the company had $13.1 million in deferred revenue, classified as current or net of current portion[102]. - Total estimated base rent payments over the remaining term of the lease for office and laboratory space are approximately $18.9 million[145]. - The net cash used in investing activities for the six months ended June 30, 2022, was $1.1 million, compared to nearly zero for the same period in 2021, primarily due to cash paid for leasehold improvements[140].

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, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________________________________________________________________ FORM 10-K ______________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For t ...

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 September 30, 2021 Delaware 82-3523180 (State or other jurisdiction of incorporation or organization) 1030 ...

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 June 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 F ...