TUESDAY, NOVEMBER 4, 2025 Third Quarter 2025 Financial Results Nasdaq: EXEL Today's Agenda | Introduction | Susan Hubbard | | --- | --- | | | EVP, Public Affairs and Investor Relations | | Third Quarter 2025 Highlights | Michael M. Morrissey, Ph.D. | | | President and CEO | | Financial Results & Guidance | Chris Senner | | | EVP and CFO | | Research & Development Update | Dana T. Aftab, Ph.D. | | | EVP, Research and Development | | Commercial Update | PJ Haley | | | EVP, Commercial | Q&A All Participants 2 ...

Core Insights - Kura Oncology is advancing the use of farnesyl transferase inhibitors (FTIs) in combination with targeted therapies to overcome resistance mechanisms in cancer treatment [2][11] - Preliminary data from ongoing clinical trials indicate promising efficacy of darlifarnib, showing a 50% objective response rate and an 80% disease control rate in renal cell carcinoma when combined with cabozantinib [1][4] - The company is hosting a virtual investor event to discuss these findings and their implications for future cancer therapies [9][10] Clinical Data Highlights - Darlifarnib demonstrated a 50% objective response rate (ORR) and an 80% disease control rate (DCR) in renal cell carcinoma (RCC) patients in an ongoing dose-escalation trial [1][4] - The combination of tipifarnib and alpelisib showed a 47% ORR in heavily pretreated patients with PIK3CA-altered head and neck squamous cell carcinoma (HNSCC) [6][7] - The ongoing studies are assessing the optimal biologically active dose for combinations across various tumor types [6][4] Mechanism of Action - FTIs like darlifarnib block hyperactivated mTORC1 signaling in tumor endothelial cells, which is crucial for enhancing the efficacy of PI3Kα inhibitors [6][11] - The mechanism of FTIs addresses both innate and adaptive resistance pathways common in targeted oncology therapies [2][6] Future Directions - Kura Oncology plans to further evaluate darlifarnib in combination with PI3Kα inhibitors across different solid tumors [6][11] - A Phase 1b dose-expansion study is planned to determine the optimal dosing strategy for the combination therapies [6][4]

Kura Oncology FY Conference Summary Company Overview - Kura Oncology (NasdaqGS: KURA) is focused on developing targeted therapies for cancer treatment, particularly in acute leukemia and solid tumors [2][3] - The company has a strong cash position with $630.7 million as of the last quarter [2] Pipeline and Product Focus - The primary focus is on the Ziftomenib program for genetically defined acute leukemias, with additional efforts in gastrointestinal stromal tumors (GIST) and other cancers [2] - Kura is also exploring therapies for diabetes, indicating a diverse pipeline [2] Market Opportunity - The initial commercial opportunity for Ziftomenib in acute leukemia is estimated at $350 to $400 million, with a potential peak market opportunity of $7 to $10 billion for the class [3] - Kura anticipates capturing up to $3 billion of that market with Ziftomenib [3] Clinical Development - Ziftomenib has an NDA under review with the FDA, with a PDUFA action date set for November 30 [6] - The company is conducting multiple clinical trials, including a phase 1 study (007) and two phase 3 trials (017) for frontline treatment of acute leukemia [9][22] - The trials are designed to assess the efficacy of Ziftomenib in combination with standard therapies, with a focus on measurable residual disease (MRD) negativity as a key endpoint [23][24] Competitive Landscape - Kura believes Ziftomenib has a best-in-class profile due to its safety, tolerability, and lack of significant drug-drug interactions compared to competitors [12][13] - The company is preparing for a competitive market, with multiple menin inhibitors in development [29] Commercial Strategy - Kura has built a robust commercial team and is ready for a potential launch following FDA approval [15][17] - The partnership with Kyowa Kirin Co., Ltd. enhances Kura's commercial capabilities, with shared responsibilities in U.S. commercialization [18][20] Upcoming Milestones - Key upcoming milestones include the FDA decision on the NDA, data presentations at ASH and ESMO, and the initiation of phase 3 studies [45][46] - The company is also focused on advancing its FTI programs and exploring next-generation menin inhibitors for diabetes [33][39] Financial Outlook - Kura is confident in its cash position and has visibility on milestone payments from its partnership with Kyowa Kirin, which supports its development plans through 2029 [19][46] Conclusion - Kura Oncology is positioned for significant growth with its innovative therapies in oncology and diabetes, backed by a strong financial foundation and strategic partnerships [46]

Summary of Arcus Biosciences FY Conference Call (September 10, 2025) Company Overview - **Company**: Arcus Biosciences (NYSE: RCUS) - **Industry**: Biotechnology, specifically focused on oncology Strategic Priorities - **Execution of Phase III Programs**: The primary focus is on the global Phase III program for casdatifan, a HIF2 inhibitor, with two studies targeting earlier line settings in renal cell carcinoma (RCC) [2][3] - **Funding and Partnerships**: The company has received significant funding from partners like Gilead Sciences, AstraZeneca, and Taiho Pharmaceutical, allowing them to operationalize only two of five Phase III studies [2] - **Capital Preservation**: The company has over $900 million in cash and is focused on conserving capital by pausing less strategic initiatives [8] Pipeline Highlights - **Casdatifan**: - Targeting RCC with a market opportunity of approximately $5 billion in G7 countries [4] - Data from 90 patients showed clear differentiation from Merck's belzutifan on efficacy measures [3] - Upcoming data presentation on 120 patients expected to provide more follow-up information [4][12] - **Domvanalimab**: - An Fc-silent anti-TIGIT antibody being evaluated in combination with anti-PD-1 and chemotherapy in first-line gastric cancer [5] - Expected readout in 2026 from a 1,000-patient study [5] - **Quemliclustat**: - A small molecule CD73 inhibitor in combination with chemotherapy for first-line pancreatic cancer, with a 600-patient study expected to provide data soon [5] Competitive Landscape - **FDA Interactions**: The company reports steady communication with the FDA, with no significant impact from recent changes in agency policies [10] - **Benchmarking Against Belzutifan**: - Casdatifan has shown a confirmed overall response rate (ORR) of 33%, significantly higher than belzutifan's 18%-22% [14] - Progression-free survival (PFS) for casdatifan was reported at 9.7 months, compared to belzutifan's 5.6 months [15][16] Market Opportunities - **Gastric Cancer**: The market opportunity for TAP greater than 5 is estimated at $3 billion in G7 countries [70] - **Lung Cancer**: The lung cancer market is projected to exceed $10 billion, with potential for multiple players [77] Collaboration and Partnerships - **Collaboration with AstraZeneca**: AstraZeneca is operationalizing the Evolve study, which is capital-efficient for Arcus, allowing them to retain all economic rights [48] Intellectual Property - **IP Duration**: Casdatifan has a patent life extending to 2041, providing a long-term competitive advantage [51] Conclusion - Arcus Biosciences is strategically positioned with a robust pipeline and significant market opportunities in oncology, particularly with casdatifan and its combination therapies. The company is focused on execution, capital preservation, and leveraging partnerships to enhance its operational efficiency and market presence.

Core Viewpoint - The Schall Law Firm is investigating Exelixis, Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Exelixis issued false or misleading statements and failed to disclose critical information to investors [2]. - Exelixis reported Q2 2025 financial results on July 28, 2025, indicating product revenue for cabozantinib was below expectations [2]. - The company decided not to proceed to the phase 3 portion of the STELLAR-305 study due to emerging competition and assessment of other commercial opportunities [2]. Group 2: Market Reaction - Following the announcement regarding the phase 3 trial decision, Exelixis shares fell by almost 16.8% the next day [2].

Kura Oncology Conference Call Summary Company Overview - **Company**: Kura Oncology - **Key Product**: Ziftomenib (also referred to as ZYPTOMENIB) - **Upcoming Milestones**: PDUFA for Ziftomenib, data updates at medical conferences, initiation of COMMOD-17 studies Core Industry Insights Ziftomenib Development and Market Position - **PDUFA Status**: Kura is optimistic about the NDA review process for Ziftomenib, receiving positive feedback from Key Opinion Leaders (KOLs) regarding its profile in relapsed/refractory settings [2][3] - **Efficacy and Safety**: The company emphasizes four pillars for Ziftomenib: efficacy, convenience, simplicity of administration, and safety [3] - **Commercial Readiness**: Kura's team is fully trained and prepared for market access and pre-approval information exchange [3] - **Combination Studies**: Data sharing is anticipated at the end of the year for the combination of Ziftomenib with venetoclax and azacitidine [3] Competitive Landscape - **Market Dynamics**: Kura expects to compete effectively against other menin inhibitors in the market, with a focus on strong efficacy and safety profiles [11][12] - **Physician Feedback**: Physicians have shown enthusiasm for Ziftomenib's once-daily oral administration and its potential for combination therapies [11][12] - **Patient Segmentation**: Initial patient starts are expected to be new patients rather than switches from existing therapies [14] Clinical Trials and Data Expectations - **Phase 3 Studies**: Kura is on track to initiate two parallel Phase 3 studies in Q4 [4] - **Combination Therapy Data**: The company aims to improve upon existing combination therapies' outcomes without increasing toxicity [28] - **Enrollment Strategy**: Kura's trial design allows for easier patient enrollment, which is expected to enhance participation rates [30][31] Financial Position - **Cash Reserves**: Kura reported $630.7 million in cash, with expectations of substantial milestone payments to maintain a strong financial position [6] Additional Opportunities Menin Inhibitors in Other Indications - **GIST and Diabetes**: Kura is exploring the use of menin inhibitors in GIST and has nominated a next-gen menin inhibitor for diabetes [45] - **Long-term Vision**: The company aims to lead the discovery and development of menin inhibitors across various oncology applications [45] Future Priorities - **Strategic Goals**: Key priorities include the approval and launch of Ziftomenib, additional combination data, and the start of the COMMOD-17 study [46] Important but Overlooked Aspects - **Collaboration with Kyowa Kirin**: Kura has a strong partnership with Kyowa Kirin for co-development and co-promotion, with Kura leading commercialization efforts in the US [25][26] - **Focus on Safety and Efficacy**: The emphasis on maintaining a favorable safety profile while improving efficacy in combination therapies is crucial for Kura's strategy [28][40] This summary encapsulates the key points discussed during the conference call, highlighting Kura Oncology's strategic direction, product development, and market positioning.

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Exelixis, Inc. and its officers or directors [1] Financial Performance - On July 28, 2025, Exelixis reported second-quarter financial results, revealing net product revenues for cabozantinib were approximately 2% below the consensus estimate of $531.3 million [3] - Following the announcement, Exelixis's stock price dropped by $7.45 per share, or 16.78%, closing at $36.94 per share on July 29, 2025 [3] Clinical Development Update - Exelixis decided not to proceed to the phase 3 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck due to emerging competition and assessment of other commercial opportunities [3]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Exelixis, Inc. and its officers or directors [1] Financial Performance - Exelixis reported net product revenues for cabozantinib at approximately $520.9 million, which is about 2% below the consensus estimate of $531.3 million [3] - Following the announcement of financial results, Exelixis's stock price dropped by $7.45 per share, or 16.78%, closing at $36.94 per share on July 29, 2025 [3] Clinical Development - Exelixis decided not to proceed to the phase 3 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck due to emerging competition and assessment of other commercial opportunities [3]

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Exelixis, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers [1] - Exelixis reported second-quarter financial results on July 28, 2025, revealing net product revenues for cabozantinib were approximately 2% below the consensus estimate of $531.3 million [2] - The company decided not to proceed to the phase 3 portion of the STELLAR-305 study in advanced squamous cell carcinoma due to emerging competition and assessment of other commercial opportunities [2] - Following the announcement, Exelixis's stock price fell by $7.45 per share, or 16.78%, closing at $36.94 per share on July 29, 2025 [2] Company Overview - Exelixis, Inc. is involved in the development and commercialization of innovative therapies for cancer treatment [2] - The company has faced scrutiny regarding its business practices and financial disclosures, leading to an investigation by Pomerantz LLP [1][2] Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3] - The firm has successfully recovered multimillion-dollar damages on behalf of class members in the past [3]

Financial Data and Key Metrics Changes - For Q2 2025, total revenues were approximately $568 million, including net product revenues from the cabozantinib franchise of $520 million, which represents a 19% year-over-year growth from $438 million in Q2 2024 [6][11][14] - GAAP net income was approximately $184.8 million, or $0.68 per share basic and $0.65 per share diluted, while non-GAAP net income was approximately $212.6 million, or $0.78 per share basic and $0.75 per share diluted [14] - Gross to net for the cabozantinib franchise in Q2 2025 was 30.2%, higher than the previous quarter, primarily due to increased 340B volume, which now accounts for over 24% of total volume [12][13][68] Business Line Data and Key Metrics Changes - The cabozantinib U.S. business showed robust performance, with significant growth in demand and revenue, particularly from the recently approved neuroendocrine tumor (NET) indications, contributing approximately 4% to total net product revenue [5][6][21] - CABOMETYX maintained its position as the leading TKI for renal cell carcinoma (RCC), with TRx volume growing 18% year-over-year, outpacing the market growth rate by 10 percentage points [17][18] - The launch of CABOMETYX in NETs has rapidly established a 35% new patient market share for oral therapies, indicating strong early uptake [20][21] Market Data and Key Metrics Changes - The company anticipates further updates to its 2025 financial guidance as it builds momentum on the NET launch and explores additional revenue opportunities for the second half of 2025 [7][15] - The competitive landscape for cabozantinib remains strong, with the drug being viewed as the best-in-class oral therapy in the NET market shortly after its approval [22][23] Company Strategy and Development Direction - The company aims to solidify its leadership in oncology drug discovery, development, and commercialization through innovation and collaboration, focusing on expanding the number of cancer patients served [4][5] - Zanzalutinib is positioned as the next oncology franchise opportunity, with ongoing pivotal trials and a focus on high-potential indications [7][8][29] - The company is committed to rigorous capital allocation decisions based on clinical and competitive data, prioritizing existing and new indications for zanzalutinib [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of CABOMETYX and the NET market, highlighting positive prescriber feedback and the drug's potential to become a new standard of care [19][22] - The management team emphasized the importance of continuous assessment of emerging data and the dynamic regulatory environment in guiding future development strategies [39][60] Other Important Information - The company reported a cash and marketable securities balance of approximately $1.4 billion as of June 30, 2025, and continued share repurchases under its authorized plan [15] - The One Big Beautiful Bill Act, signed into law on July 4, 2025, allows for the accelerated deduction of unamortized domestic R&D expenditures, providing a cash tax benefit estimated at $147 million [14] Q&A Session Summary Question: Insights from head and neck data for future studies - Management acknowledged the need for continuous assessments in drug development and indicated that further data will be shared in the future [39][40] Question: Longevity of market share gains for cabozantinib - Management expressed confidence in sustaining market share gains in both RCC and NET, citing strong franchise growth and positive prescriber feedback [42][45] Question: Importance of NLM subset in STELLAR-303 - Management highlighted the significance of overall survival as a gold standard and indicated that they will continue to follow the NLM patient population for further insights [56][57] Question: Pricing dynamics with cabozantinib and 340B volume - Management noted a shift towards the 340B segment, impacting gross to net, and projected gross to net to be closer to 30% [66][68] Question: Future studies for zanzalutinib in CRC - Management confirmed interest in exploring zanzalutinib in earlier lines of therapy, particularly in the adjuvant setting, and emphasized the potential for significant patient impact [84][90]