Core Viewpoint - Werewolf Therapeutics, Inc. (HOWL) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based on the Zacks Consensus Estimate, which aggregates EPS estimates from sell-side analysts for the current and following years [2]. - Changes in earnings estimates are crucial for near-term stock price movements, making the Zacks rating system valuable for investors [3][5]. Impact of Institutional Investors - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, leading to buying or selling actions that affect stock prices [5]. Business Improvement Indicators - The upgrade in rating for Werewolf Therapeutics reflects an improvement in the company's underlying business, which is expected to drive the stock price higher [6]. Importance of Earnings Estimate Revisions - Research indicates a strong correlation between earnings estimate revisions and stock movements, highlighting the importance of tracking these revisions for investment decisions [7]. Zacks Rank System Performance - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. Current Earnings Estimates for Werewolf Therapeutics - For the fiscal year ending December 2025, Werewolf Therapeutics is expected to earn -$1.61 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 10.6% over the past three months [9]. Overall Rating System Characteristics - The Zacks rating system maintains a balanced distribution of "buy" and "sell" ratings across its universe of over 4,000 stocks, with only the top 5% receiving a "Strong Buy" rating [10][11].

Core Insights - Werewolf Therapeutics has received Fast Track Designation from the FDA for WTX-124, aimed at treating locally advanced or metastatic cutaneous melanoma after standard immunotherapy [1][3] - WTX-124 is a conditionally activated interleukin 2 (IL-2) therapy designed to enhance anti-tumor immune responses while minimizing systemic toxicities [2][4] - The Fast Track Designation allows for expedited development and frequent interactions with the FDA, potentially leading to priority review and accelerated approval [3] Company Overview - Werewolf Therapeutics is focused on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions, leveraging its proprietary PREDATOR® platform [4] - The company is advancing WTX-124 and WTX-330, both conditionally activated IL-2 and IL-12 INDUKINE molecules, for the treatment of solid tumors [4] - WTX-124 is currently being evaluated in a Phase 1/1b clinical trial, including both single-agent and combination arms with pembrolizumab [2][3]

Core Insights - Werewolf Therapeutics, Inc. is set to present three posters at the Society for Immunotherapy of Cancer's 40th Annual Meeting, highlighting its innovative biopharmaceutical developments aimed at stimulating the immune system for cancer treatment [1][2]. Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics designed to enhance the body's immune response against cancer and other immune-mediated conditions [3]. - The company utilizes its proprietary PREDATOR platform to create INDUKINE™ and INDUCER™ molecules that selectively activate in the tumor microenvironment while remaining inactive in peripheral tissues [3]. - The lead clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3]. Upcoming Presentations - The first poster will discuss the sequential administration of WTX-124 and mWTX-330, demonstrating enhanced antitumor activity in mice with poorly immunogenic EMT6 tumors without systemic toxicity [2]. - The second poster will focus on the development of conditional T cell engagers (INDUCER™ molecules) that utilize a masking approach to minimize dose-limiting cytokine release and off-target toxicity [2]. - The third poster will provide pharmacokinetic insights into the IL-2 INDUKINE prodrug WTX-124, assessing tumor-specific activation and immune modulation in real-time [2].

Core Insights - Werewolf Therapeutics, Inc. is set to present three posters at the Society for Immunotherapy of Cancer's 40th Annual Meeting, highlighting its innovative biopharmaceutical developments aimed at stimulating the immune system for cancer treatment [1][2]. Group 1: Poster Presentations - The first poster will discuss the sequential administration of WTX-124 and mWTX-330, showcasing enhanced antitumor activity in mice with poorly immunogenic EMT6 tumors without systemic toxicity [2]. - The second poster will focus on the development of conditional T cell engagers (INDUCER™ molecules) that utilize a masking approach to minimize dose-limiting cytokine release and off-target toxicity [2]. - The third poster will provide pharmacokinetic insights into the IL-2 INDUKINE prodrug WTX-124, emphasizing real-time assessment of tumor-specific activation and immune modulation [2]. Group 2: Company Overview - Werewolf Therapeutics is pioneering the development of therapeutics designed to stimulate the immune system for treating cancer and other immune-mediated conditions, leveraging its proprietary PREDATOR® platform [3]. - The company is advancing its most clinical-stage product candidates, WTX-124 and WTX-330, which are conditionally activated Interleukin-2 and Interleukin-12 INDUKINE molecules, respectively, for solid tumor treatment [3]. - Werewolf is also developing INDUCER molecules, with the first candidate, WTX-1011, targeting STEAP1 for prostate cancer, building on positive data from its INDUKINE molecules [3].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Xcel Brands, Inc. (XELB) increased by 48% to $2.57 [3] - Astrotech Corporation (ASTC) rose by 21% to $5.85 [3] - Rumble Inc. (RUM) saw a 13% increase to $8.36 [3] - ClearPoint Neuro, Inc. (CLPT) gained 9% reaching $27.38 [3] - USA Rare Earth, Inc. (USAR) also increased by 9% to $24.92 [3] - Q/C Technologies, Inc. (QCLS) rose by 8% to $5.51 [3] - Lazydays Holdings, Inc. (GORV) increased by 8% to $2.61 [3] - K Wave Media Ltd. (KWM) saw a 7% rise to $2.78 [3] - Galectin Therapeutics Inc. (GALT) increased by 6% to $4.53 [3] - Wrap Technologies, Inc. (WRAP) rose by 6% to $2.86 [3] Premarket Losers - Black Titan Corporation Ordinary Shares (BTTC) decreased by 29% to $16.80 [4] - Masonglory Limited (MSGY) fell by 14% to $2.54 [4] - Aspire Biopharma Holdings, Inc. (ASBP) declined by 12% to $0.37 [4] - Urban One, Inc. (UONE) saw an 11% drop to $1.15 [4] - Reitar Logtech Holdings Limited (RITR) decreased by 7% to $2.74 [4] - Iveda Solutions, Inc. (IVDA) fell by 7% to $1.88 [4] - Erayak Power Solution Group Inc. (RAYA) decreased by 6% to $4.93 [4] - Megan Holdings Limited (MGN) saw a 6% drop to $3.32 [4] - Werewolf Therapeutics, Inc. (HOWL) declined by 5% to $1.81 [4] - SOS Limited (SOS) decreased by 4% to $2.04 [4]

Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]

Technical Analysis - Werewolf Therapeutics, Inc. (HOWL) has reached a key level of support, with its 50-day simple moving average crossing above its 200-day simple moving average, indicating a "golden cross" [1] - A golden cross is a bullish chart pattern that suggests a potential breakout, formed when a stock's short-term moving average surpasses a longer-term moving average [2] Stock Performance - Over the past four weeks, HOWL has gained 15.4%, indicating positive momentum [3] - The stock currently holds a 3 (Hold) rating on the Zacks Rank, suggesting it may be poised for further breakout [3] Earnings Expectations - Recent earnings expectations for HOWL show two upward revisions compared to none lower over the past 60 days, with the Zacks Consensus Estimate also moving up [3] - Positive earnings estimate revisions further support the bullish outlook for the stock [4]

Summary of Werewolf Therapeutics FY Conference Call Company Overview - **Company**: Werewolf Therapeutics (NasdaqGS:HOWL) - **Focus**: Leader in conditional activation immunotherapies, specifically through the INDUKINE and INDUCER platforms [3][1] Core Insights and Arguments - **Differentiation in Technology**: - Utilizes native cytokines without mutations, specifically native IL-2, to reduce systemic toxicity [3][4] - Employs protease-cleavable linkers that do not rebind after cleavage, enhancing specificity in tumor microenvironments [4][5] - Achieved a high therapeutic index and a safety profile distinct from traditional high-dose IL-2 therapies, which often require intensive monitoring due to toxicity [9][10] - **Clinical Data and Efficacy**: - WTX-124 shows promising clinical data with a recommended dose of 18 mg for both monotherapy and combination therapy with pembrolizumab [11][12] - Demonstrated anti-tumor activity in melanoma and cutaneous squamous cell carcinoma, with a notable complete response in a patient resistant to previous therapies [12][13] - Plans to expand trials into renal cell carcinoma and non-small cell lung cancer [12][14] - **Regulatory Pathway**: - Anticipates discussions with the FDA regarding a monotherapy trial for advanced metastatic melanoma, emphasizing the need for effective treatments in this area [16][17] - **Future Developments**: - Development of WTX-330, an IL-12 INDUKINE, which has shown outpatient delivery potential and activity in melanoma and colorectal cancer [18][19] - Ongoing business development activities for T-cell engager programs, with expectations for a second nomination by the end of the year [21][23] Important but Overlooked Content - **Cytokine Misconceptions**: - There is a persistent misconception that cytokines can be delivered systemically without modulating efficacy. Werewolf Therapeutics believes their approach allows for effective local action while minimizing systemic toxicity [24][25] - **Upcoming Catalysts**: - Key upcoming events include FDA meetings, data releases for WTX-124, and the nomination of a second INDUKINE development candidate by year-end [26][26] This summary encapsulates the key points discussed during the conference call, highlighting Werewolf Therapeutics' innovative approaches, clinical advancements, and future plans in the immunotherapy landscape.

Core Insights - Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing conditionally activated therapeutics to stimulate the immune system for cancer and immune-mediated conditions [3] Group 1: Company Overview - Werewolf Therapeutics is leveraging its proprietary PREDATOR platform to design INDUKINE™ and INDUCER™ molecules that enhance both adaptive and innate immunity [3] - The company's advanced clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3] - WTX-124 is being advanced in multiple tumor types both as a single agent and in combination with immune checkpoint inhibitors, while WTX-330 is also being explored in various solid tumor types [3] Group 2: Upcoming Events - Daniel J. Hicklin, Ph.D., President and CEO, and Randi Isaacs, M.D., Chief Medical Officer, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [1] - A live webcast of the presentation will be available, with an archived replay accessible for approximately 90 days post-event [2]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents Werewolf Therapeutics' unaudited condensed consolidated financial statements and management's discussion for Q2 and H1 2025 [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents Werewolf Therapeutics' unaudited condensed consolidated financial statements for Q2 and H1 2025, showing a net loss and decreased cash [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $92.6 million by June 30, 2025, driven by reduced cash, while equity fell due to net losses Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $77,596 | $110,995 | | Total current assets | $80,439 | $113,066 | | Total assets | $92,566 | $126,929 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $15,171 | $15,180 | | Total liabilities | $51,102 | $53,539 | | Accumulated deficit | $(450,659) | $(414,588) | | Total stockholders' equity | $41,464 | $73,390 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q2 2025 was $18.0 million, with H1 2025 net loss at $36.1 million, and collaboration revenue at zero Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,143 | $0 | $1,885 | | Research and development | $13,143 | $15,271 | $26,263 | $28,179 | | General and administrative | $4,399 | $4,832 | $9,270 | $9,828 | | Operating loss | $(17,542) | $(18,960) | $(35,533) | $(36,122) | | Net loss | $(17,982) | $(17,249) | $(36,071) | $(33,442) | | Net loss per share, basic | $(0.40) | $(0.40) | $(0.80) | $(0.79) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $73.4 million to $41.5 million by June 30, 2025, primarily due to the $36.1 million net loss - Total stockholders' equity declined from **$73.4 million** at December 31, 2024 to **$41.5 million** at June 30, 2025, primarily due to a net loss of **$36.1 million** for the six-month period[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $34.1 million in H1 2025, leading to a $33.7 million net decrease in cash Six Months Ended June 30, Cash Flow Summary (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,112) | $(29,474) | | Net cash used in investing activities | $0 | $(128) | | Net cash provided by financing activities | $388 | $10,539 | | **Net decrease in cash** | **$(33,724)** | **$(19,063)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Details accounting policies, the conclusion of the Jazz collaboration, the K2HV loan, and the company's liquidity outlook - The company is an early-stage biopharmaceutical company pioneering therapeutics to stimulate the immune system for cancer treatment[31](index=31&type=chunk) - With **$77.6 million** in cash and cash equivalents as of June 30, 2025, the company expects to fund its operating expenses and capital expenditure requirements for at least the next twelve months, but will require additional funding thereafter[33](index=33&type=chunk) - In June 2024, the company completed its last material performance obligation under the Collaboration Agreement with Jazz Pharmaceuticals, resulting in the recognition of all remaining deferred revenue from that agreement[44](index=44&type=chunk) - In May 2024, the company repaid its loan with Pacific Western Bank and entered into a new loan agreement with K2 HealthVentures (K2HV), drawing down **$30.0 million** in gross proceeds[55](index=55&type=chunk)[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, clinical program updates for WTX-124 and WTX-330, and liquidity, confirming cash sufficiency into Q4 2026 [Overview](index=20&type=section&id=Overview) Werewolf develops conditionally activated immunotherapies, with lead candidates WTX-124 and WTX-330 in Phase 1/1b and Phase 1b/2 trials respectively - The company's most advanced product candidates, WTX-124 (IL-2) and WTX-330 (IL-12), are systemically delivered, conditionally activated INDUKINE molecules for treating various tumor types[91](index=91&type=chunk) - WTX-124 is being evaluated in a Phase 1/1b clinical trial as a monotherapy and in combination with KEYTRUDA, with plans to present interim data from expansion arms in the second half of 2025[92](index=92&type=chunk) - WTX-330 initiated a Phase 1b/2 clinical trial in Q1 2025, with the first patient dosed in Q2 2025 for the treatment of advanced or metastatic solid tumors[93](index=93&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q2 2025 saw zero revenue and decreased R&D expenses, while H1 2025 net loss increased to $36.1 million due to lower interest income Comparison of Three Months Ended June 30, (in thousands) | Item | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,143 | $(1,143) | | Research and development | $13,143 | $15,271 | $(2,128) | | General and administrative | $4,399 | $4,832 | $(433) | | **Net loss** | **$(17,982)** | **$(17,249)** | **$(733)** | - The **$2.1 million** decrease in Q2 2025 R&D expenses was primarily due to a **$1.8 million** decrease in manufacturing costs for WTX-330 and a **$0.5 million** decrease in personnel costs[116](index=116&type=chunk)[119](index=119&type=chunk) Comparison of Six Months Ended June 30, (in thousands) | Item | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,885 | $(1,885) | | Research and development | $26,263 | $28,179 | $(1,916) | | General and administrative | $9,270 | $9,828 | $(558) | | **Net loss** | **$(36,071)** | **$(33,442)** | **$(2,629)** | - The **$1.9 million** decrease in H1 2025 R&D expenses was mainly from a **$2.2 million** reduction in manufacturing costs and a **$0.7 million** decrease in personnel costs, partially offset by a **$0.7 million** increase in clinical trial costs for WTX-124 and WTX-330[126](index=126&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $77.6 million in cash, sufficient into Q4 2026, but requires substantial additional funding - As of June 30, 2025, the company had cash and cash equivalents of **$77.6 million**[147](index=147&type=chunk) - Management estimates that existing cash will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026[147](index=147&type=chunk) - The company has an active K2HV Loan Agreement with **$30.0 million** drawn and up to an additional **$20.0 million** available through May 1, 2026, subject to lender consent[139](index=139&type=chunk)[140](index=140&type=chunk) - The company's at-the-market (ATM) offering capacity is limited to an aggregate offering price of up to **$12.5 million** due to the "Baby Shelf Limitation" under Form S-3 rules[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is exempt from providing market risk disclosures - As a smaller reporting company, the registrant is not required to provide the information for this item[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[162](index=162&type=chunk) - There were no changes during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[163](index=163&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents other information including significant risk factors and a list of exhibits filed with the Form 10-Q [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Details risks including limited operating history, dependence on early-stage candidates, funding needs, reliance on third parties, and intense competition [Risks Related to Financial Position and Capital Requirements](index=34&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Capital%20Requirements) The company faces risks from its limited operating history, accumulated deficit of $450.7 million, ongoing losses, and the need for substantial additional funding - The company has a limited operating history, an accumulated deficit of **$450.7 million** as of June 30, 2025, and expects to incur significant losses for the foreseeable future[166](index=166&type=chunk)[167](index=167&type=chunk) - Substantial additional funding is required to complete the development and commercialization of product candidates, and an inability to raise this capital could force the company to delay, reduce, or eliminate its R&D programs[170](index=170&type=chunk) - The K2HV Loan Agreement contains operating covenants that restrict the company's ability to incur future debt, pay dividends, and dispose of assets, among other limitations[177](index=177&type=chunk) [Risks Related to Discovery, Development, and Commercialization](index=38&type=section&id=Risks%20Related%20to%20the%20Discovery,%20Development,%20Regulatory%20Approval%20and%20Commercialization%20of%20Our%20Product%20Candidates) Business success depends on early-stage candidates and an unproven platform, facing risks in development, manufacturing, and intense competition - The company's business is highly dependent on the success of its initial INDUKINE and INDUCER molecules, which are in early stages of development and require significant additional development[187](index=187&type=chunk) - The PREDATOR platform approach is unproven, and there is no guarantee it will produce commercially valuable products[196](index=196&type=chunk) - Manufacturing the company's novel multi-domain biologics is complex, has never been done at commercial scale, and is subject to risks of delay or failure[200](index=200&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies developing immunotherapies, including numerous companies developing IL-2 and IL-12 based therapies[238](index=238&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) [Risks Related to Dependence on Third Parties](index=50&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Reliance on third-party CROs and CMOs for clinical trials and manufacturing, and a license agreement with Harpoon Therapeutics, poses significant operational risks - The company depends on third-party CROs to conduct preclinical studies and clinical trials and is responsible for ensuring their compliance with regulations like cGCP[259](index=259&type=chunk)[261](index=261&type=chunk) - Without its own clinical manufacturing capabilities, the company relies on third-party CMOs, exposing it to risks of supply disruption, quality issues, and regulatory non-compliance[265](index=265&type=chunk) - The company relies on a license agreement with Harpoon Therapeutics for patent rights essential to its PREDATOR platform and product candidates[285](index=285&type=chunk) [Risks Related to Intellectual Property](index=54&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success hinges on obtaining and maintaining patent protection, which is uncertain, and managing risks of infringement claims and trade secret protection - The company's success depends on obtaining and maintaining patent protection for its PREDATOR platform and product candidates, but the scope and validity of such protection are uncertain[275](index=275&type=chunk)[276](index=276&type=chunk) - The company may face third-party claims of intellectual property infringement, which could be expensive and time-consuming to defend and could prevent or delay development efforts[309](index=309&type=chunk) - The company relies on trade secret protection for key aspects of its technology, but it cannot guarantee that these secrets will not be disclosed or independently discovered by competitors[305](index=305&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=65&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Marketing%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) Regulatory approval is expensive and uncertain, with ongoing compliance burdens, healthcare fraud laws, data privacy regulations, and potential FDA disruptions posing risks - The regulatory approval process is expensive, time-consuming, and uncertain, and the company has no experience in filing for marketing approvals[338](index=338&type=chunk) - Disruptions at the FDA and other government agencies due to funding cuts, personnel losses, or other factors could hinder the timely approval of product candidates[347](index=347&type=chunk) - The company is subject to healthcare fraud and abuse laws, which could expose it to criminal sanctions, civil penalties, and exclusion from government healthcare programs if found non-compliant[415](index=415&type=chunk) - The company must comply with complex and evolving state, national, and international privacy and data security laws, with non-compliance potentially leading to significant fines and reputational damage[425](index=425&type=chunk) [Risks Related to Business Operations and Public Company Status](index=83&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) Risks include dependence on key personnel, cybersecurity threats, stock price volatility, and increased public company compliance costs - The company is highly dependent on retaining key employees and faces fierce competition for qualified personnel in the Boston area[450](index=450&type=chunk)[451](index=451&type=chunk) - The company is exposed to risks from cyberattacks, which could lead to data loss, operational disruption, and financial loss[453](index=453&type=chunk)[454](index=454&type=chunk) - The company's stock price is volatile, and it may be delisted from Nasdaq if it fails to meet continued listing requirements, such as the minimum bid price[465](index=465&type=chunk)[467](index=467&type=chunk) - In the past, the company has identified material weaknesses in its internal control over financial reporting, which have since been fully remediated[480](index=480&type=chunk) [Item 6. Exhibits](index=91&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications - This section lists the exhibits filed with the report, including corporate governance documents, an employment agreement, and officer certifications required by the Sarbanes-Oxley Act[493](index=493&type=chunk)