Zevra Therapeutics (ZVRA) FY 2025 Conference May 20, 2025 12:30 PM ET Speaker0 Alright. Good afternoon, everyone. My name is Brandon Folks. I'm one of the biopharma analysts here at H. C. Wainwright. And joining me for a fireside chat from Zebra Therapeutics is CEO, Neil McFarlane. Neil, thank you very much. Speaker1 Yeah. Thank you for having us. Speaker0 So maybe just to start, do you wanna just spend a few minutes giving people a quick overview of Zebra and the products that you currently have? Speaker1 ...

Financial Data and Key Metrics Changes - The company reported a 67% complete response (CR) rate in the pivotal BCG unresponsive cohort as of April, indicating strong performance in this segment [13][21]. - The target for the unresponsive dataset is a CR rate in the sixties, potentially reaching the seventies, which would be competitive with existing therapies [21]. Business Line Data and Key Metrics Changes - The lead asset, Tara 002, is positioned as a broad-spectrum immunopotentiator, with a focus on muscle invasive bladder cancer (MIBC) and non-muscle invasive bladder cancer (NMIBC) [10][12]. - The company is in late-stage development across three programs, including Tara 002 and IV choline chloride phospholipid substrate replacement therapy, indicating a diversified pipeline [9]. Market Data and Key Metrics Changes - The unmet need in NMIBC is characterized by a strong motivation to reduce cystectomies, with the company aiming to address this through innovative treatment options [10][11]. - The competitive landscape includes various mechanisms of action, with the company’s product being the only broad-spectrum immunopotentiator in late-stage development [12]. Company Strategy and Development Direction - The company aims to redefine risk in its portfolio by understanding and containing risks associated with each asset, particularly in the context of evolving regulatory and manufacturing landscapes [5][9]. - The strategy includes engaging with the FDA to demonstrate that standard of care for BCG eligible patients extends beyond just BCG, incorporating other chemotherapeutics [24][26]. Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of real-world evidence in shaping trial designs and regulatory interactions, particularly in the context of BCG shortages [24][26]. - The company anticipates that as the dataset broadens, fewer patients will require reinduction, which could enhance the overall treatment profile [30]. Other Important Information - The company is conducting a single-arm open-label study for Tara 002 in pediatric nonmalignant diseases, which has garnered interest due to its potential and existing standard of care in Japan [9]. - The company emphasizes the importance of tolerability and ease of use in community settings, which could drive adoption among urologists [36][38]. Q&A Session Summary Question: What is the unmet need in NMIBC and how does Tara 002 address it? - The unmet need is categorized into three buckets, with a focus on reducing cystectomies and addressing the heterogeneous nature of the disease through various treatment modalities [10][11]. Question: What benchmarks should be set for the six-month data in the BCG unresponsive cohort? - The company targets a CR rate of around 75% in CIS only patients, with expectations that the overall CR rate will be in the sixties or seventies [21]. Question: How does the company plan to approach the FDA regarding registrational studies? - The company plans to present real-world evidence to the FDA, arguing that the standard of care includes both BCG and other chemotherapeutics due to BCG shortages [24][26]. Question: What are the key differentiating factors for Tara 002 in the NMIBC space? - Key differentiators include the drug's tolerability, safety profile, and the ability to be integrated into existing workflows without causing disruptions [36][38].

Financial Data and Key Metrics Changes - The company has transitioned from a biosimilars focus to an innovative immuno-oncology (IO) company, indicating a significant strategic shift [1] - The launch of Lactorsi as a preferred therapy in NCCN guidelines is a notable development, with the team reportedly hitting their stride in Q2 after overcoming earlier disruptions [33] Business Line Data and Key Metrics Changes - The company presented encouraging data for its CCRA antibody, CHS 114, showing a partial response in a patient with advanced refractory disease, highlighting the potential of targeted therapies [2][5] - The combination of CHS 114 with toripalumab has shown marked depletion of T regulatory cells, leading to significant immune cell infiltration, which is a positive indicator for its efficacy [10][11] Market Data and Key Metrics Changes - The company is aware of the looming loss of exclusivity (LOE) for Keytruda in 2028 and is strategically positioning Lactorsi to differentiate itself in the market [15][16] - The competitive landscape is evolving, with the company focusing on novel mechanisms and combinations that could provide advantages over existing PD-1 therapies [17][29] Company Strategy and Development Direction - The company aims to develop both CHS 114 and casdosakitug in combination with toripalumab, seeking to maximize the potential of its pipeline [17][24] - The strategy includes forming partnerships that focus on novel mechanisms of action while maintaining a capital-efficient approach [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical data flow and the potential for upcoming collaborations, particularly in liver cancer, head and neck, and lung cancer [22][24] - The company is excited about the differentiated mechanism of action of Lactorsi, which has shown activity in PD-L1 low patients, setting it apart from competitors [28][30] Other Important Information - The company has divested from its biosimilar business to focus on innovative oncology, which is seen as a space with greater potential for value creation [40][41] - The safety profile of castosakitug has been well tolerated, with promising early results in lung and liver cancers, indicating a strong potential for future studies [36][38] Q&A Session Summary Question: What was encouraging about the data for the CCRA antibody? - The data showed a partial response in a patient with advanced refractory disease, which is significant given the patient's history of treatment failures [2] Question: How does the company view the competition with Keytruda? - The company is aware of the LOE for Keytruda and believes that their differentiated therapies will maintain a competitive edge despite the upcoming biosimilars [15][16] Question: What is the strategy for partnerships moving forward? - The company is focusing on collaborations that will yield interesting clinical data and is prioritizing partnerships that involve novel mechanisms of action [24][22]

Financial Data and Key Metrics Changes - The company has $354 million in cash as of the end of Q1 2025, with a runway extended into the second half of 2027, providing a full year beyond previous estimates [38] Business Line Data and Key Metrics Changes - The company is advancing its phase three study for frontotemporal dementia (FTD) with 103 symptomatic patients enrolled, which is a significant increase from the 12 patients in the phase two study [12] - The phase two study for early Alzheimer's disease is fully enrolled, with a treatment period of 76 weeks, focusing on the elevation of progranulin levels [24][25] Market Data and Key Metrics Changes - The company has a partnership with GSK that includes a $700 million upfront payment and $1.5 billion in development and commercial milestones, indicating strong market interest and potential revenue [5] Company Strategy and Development Direction - The company is focused on pioneering disease-modifying treatments for neurodegenerative diseases, particularly through its progranulin programs and proprietary brain penetrant technology [4][32] - The strategy includes leveraging breakthrough designation from the FDA to facilitate regular interactions and potential approval pathways based on biomarker data [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing dialogue with the FDA, noting that there have been no significant changes that would delay the review process for their therapies [20][21] - The company views the upcoming phase three results as a critical opportunity to engage with the FDA for potential approval, given the significant unmet need in the market [14][19] Other Important Information - The company is developing multiple programs targeting different aspects of neurodegenerative diseases, including a beta and GCase enzyme programs, which utilize their proprietary technology for better brain penetration [6][32] Q&A Session Summary Question: Can you discuss the importance of the progranulin program for Alzheimer's disease? - The progranulin program is crucial as it targets patients with a genetic predisposition to Alzheimer's, aiming to elevate progranulin levels to protect against the disease [22][24] Question: How does the company differentiate its technology in the market? - The proprietary brain penetrant technology allows for tunability and versatility, enhancing therapeutic benefits while minimizing safety concerns [32][35] Question: What is the company's financial position and runway? - The company has $354 million in cash, extending its financial runway into the second half of 2027, which supports ongoing development efforts [38]

Financial Data and Key Metrics Changes - The company reported approximately $193 million in cash, bolstered by a recent $75 million capital raise, which is expected to support operations into the second half of 2026 [41][42][44] - The stock price fluctuated, dropping to $4 before recovering to around $8, influencing the decision to raise funds earlier than initially planned [42][43] Business Line Data and Key Metrics Changes - The lead combination therapy ofatumumab plus defecanib received accelerated approval from the FDA for low-grade serous ovarian cancer, indicating a significant milestone for the company [1][5] - The company is actively working on the launch of the approved therapy, with initial orders and positive feedback from the physician community [10][12] Market Data and Key Metrics Changes - Approximately 80% of patients are already being tested for KRAS mutations, which is crucial for the therapy's application, indicating a well-established testing framework in the market [21][22] - The company is planning to pursue approvals in international markets, with Japan being the next target due to a relatively straightforward approval process [23][24] Company Strategy and Development Direction - The company aims to remove barriers to access for its therapies by proactively engaging with payers and large group purchasing organizations [12][14] - Future investments will focus on larger programs contingent on positive results, while the current funding supports the launch of the LGSOC business [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of the therapy, noting that it has gone as well or better than expected, with significant interest from healthcare providers [9][10] - The company is preparing for an upcoming ASCO conference to report data on its frontline pancreatic cancer study, which is anticipated to be a key event for the company [6][28] Other Important Information - The company is developing a companion diagnostic for the therapy, which is a post-marketing commitment but is not required for the initial launch [18][22] - The company is also exploring additional indications beyond ovarian cancer, including lung and pancreatic cancers, with promising preclinical data [26][27] Q&A Session Summary Question: What are the next steps for commercialization? - The company aims to see a good trajectory on uptake by the end of the year and is working to remove barriers with payers and large systems [12][14] Question: How important is the companion diagnostic for the drug? - The companion diagnostic is necessary for regulatory compliance, but a significant proportion of patients are already being tested for KRAS mutations [18][21] Question: What are the plans for international markets? - The company is focusing on Japan for the next approval and is also engaging with European regulators for potential orphan drug designation [23][24] Question: What is the company's cash position and runway? - The company has approximately $193 million in cash, which is expected to support operations and the launch of its therapies into 2026 [41][42][44]

Financial Data and Key Metrics Changes - The company reported a significant increase in the overall response rate for its lead drug, tevesimig, in the second line biliary tract cancer study, with a response rate of 17.1% compared to 5.3% for the control arm, indicating a more than tripling of the response rate [12][13] - The study also showed a statistically significant difference with a p-value of 0.031, highlighting the drug's efficacy [13] Business Line Data and Key Metrics Changes - The lead program, tevesimig, is a bispecific antibody targeting DLL4 and VEGF A, which has shown promising results in clinical trials [4][7] - The company is also advancing CTX-471, a monoclonal antibody agonist targeting CD137, which has shown a 28% response rate in a post-PD-1 patient population [22][23] Market Data and Key Metrics Changes - The company identified a significant unmet medical need in the second line biliary tract cancer market, where there are currently no labeled therapies for the majority of patients [11] - The basket study for tevesimig in DLL4 positive cancers is expected to explore a range of solid tumor indications, indicating a broad market opportunity [19] Company Strategy and Development Direction - The company aims to leverage its unique StitchMaps platform to develop next-generation antibody therapeutics, focusing on dual blockade strategies to enhance efficacy in oncology [3][7] - Future plans include a Phase II basket study for tevesimig and potential label expansion studies following its approval [19] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the upcoming readouts for progression-free survival and overall survival, indicating a positive outlook for tevesimig's clinical development [17] - The company is optimistic about the performance of the control arm in clinical trials, suggesting a potential treatment effect that could lead to fewer deaths than initially expected [17] Other Important Information - The company has fast track status for tevesimig, which could expedite its approval process, with potential approval in the second half of 2026 [19][32] - The company is also developing CTX-8371, a PD-1 PD-L1 bispecific antibody, which is currently in Phase I studies and is expected to present clinical data in the second half of the year [29] Q&A Session Summary Question: Can you provide an overview of tevesimig's clinical data? - The overall response rate for tevesimig plus paclitaxel was 17.1%, significantly higher than the 5.3% for paclitaxel alone, with a statistically significant p-value of 0.031 [12][13] Question: What is the rationale behind the DLL4 positive cancers basket study? - DLL4 notch signaling is involved in various malignancies, and the company aims to explore the efficacy of tevesimig in these cancers due to its demonstrated monotherapy activity [19] Question: What are the upcoming catalysts for the company? - Key upcoming catalysts include readouts from the tevesimig study, the initiation of several important clinical trials, and data from the CTX-471 basket study [34]

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