PresentationOperator Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Summit Therapeutics Update Call. [Operator Instructions] It is now my pleasure to turn today's call over to Dave Gancarz, Chief Business and Strategy Officer. Dave, please go ahead. ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Summit Therapeutics (NasdaqGM:SMMT) Update / Briefing September 08, 2025 08:00 AM ET Company ParticipantsDave Gancarz - Chief Business & Strategy OfficerH. Jack West - VP - Clinical DevelopmentYigal Nochomovitz - DirectorSalveen Richter - Biotechnology Equity ResearchGreg Wiessner - Biotech Equity Research AssociateCory Kasimov - Senior Managing DirectorManmeet Soni - COO & CFOMohit Bansal - MD & Co-Head - Therapeutics ResearchNone - ExecutiveDaina Graybosch - Senior MD - Immuno-OncologyClara Dong - VP - Eq ...

Summit Therapeutics WCLC Update Call September 8, 2025 8:00am ET Forward Looking Statement Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidates, the p ...

Core Insights - The Phase III HARMONi trial data for ivonescimab plus chemotherapy shows an improving overall survival (OS) trend with a nominal p-value of 0.0332 compared to chemotherapy alone, particularly in North American patients with an OS hazard ratio (HR) of 0.70 [1][4][6] Group 1: Trial Overview - HARMONi trial evaluated ivonescimab plus platinum-doublet chemotherapy against placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed after third-generation EGFR TKI treatment [2][18] - The trial's primary endpoints were progression-free survival (PFS) and overall survival (OS), with previous PD-1 monoclonal antibodies failing to show benefits in similar settings [2] Group 2: Efficacy Results - In the primary analysis, ivonescimab plus chemotherapy showed a median OS of 16.8 months versus 14.0 months for placebo plus chemotherapy, with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057) [4][6] - Longer-term follow-up analysis indicated a median OS of 17.0 months for ivonescimab compared to 14.0 months for placebo in Western patients, with an improved hazard ratio of 0.84 [6][7] - The overall response rate was higher in the ivonescimab arm at 45% compared to 34% in the placebo arm, with a median duration of response of 7.6 months versus 4.2 months [10] Group 3: Safety Profile - Ivonescimab plus chemotherapy demonstrated a manageable safety profile, with 7.3% of patients discontinuing due to treatment-related adverse events (TRAEs) compared to 5.0% in the placebo group [12][13] - The most common TRAEs included anemia and decreases in white blood cell counts, with less than 1% experiencing Grade 3 or higher hemorrhage events [12][13] Group 4: Future Developments - Summit Therapeutics plans to host a conference call on September 8, 2025, to discuss the ivonescimab data presented at the WCLC 2025 [14][30] - The company is engaged in multiple Phase III clinical trials for ivonescimab, including HARMONi-2 and HARMONi-6, which are expected to further evaluate its efficacy [19][20]

Core Viewpoint - H.C. Wainwright has raised the target price for Summit Therapeutics Inc. (SMMT.US) from $44 to $50 while maintaining a "Buy" rating, indicating a positive outlook for the company [1] Company Overview - Summit Therapeutics is a biopharmaceutical company focused on the research and commercialization of innovative therapies aimed at addressing significant unmet medical needs [1] - The company's current clinical development projects primarily target Clostridium difficile infection (CDI) [1] Market Position - The report highlights that now is an opportune time to invest in Summit, as it serves as a partner for CanSino Biologics (09926) in the U.S. market, providing a unique advantage [1] Clinical Data - The report mentions that CanSino's ivonescimab Phase III study HARMONi-A data validates clinical results in China, demonstrating its efficacy superior to Keytruda [1]

Group 1 - H.C. Wainwright raised the target price for Summit Therapeutics Inc. from $44 to $50 while maintaining a "Buy" rating [1] - The report highlights that the phase III study HARMONi-A data from Kangfang Biotech validates clinical results in China, demonstrating efficacy superior to Keytruda [1] - Summit Therapeutics is positioned as a unique partner for Kangfang Biotech in the U.S. market, presenting a favorable opportunity for investment [1] Group 2 - Summit Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative therapies for serious unmet medical needs [1] - The company's current clinical development projects primarily target Clostridium difficile infection (CDI) [1] - Summit's products emphasize benefits for patients, families, healthcare providers, and society, aiming to extend life and improve quality of life [1]

Core Viewpoint - The article identifies Pfizer, Summit Therapeutics, and Vertex Pharmaceuticals as strong investment opportunities in the pharmaceutical sector, highlighting their growth potential and current market conditions. Group 1: Pfizer - Pfizer is considered a top stock in healthcare due to its low valuation, high yield, and growth prospects, appealing to both dividend and growth investors [3][7] - Despite facing challenges this year related to tariffs and healthcare reform, Pfizer's underlying financials remain solid, with an adjusted EPS guidance increase to between $2.90 and $3.10 from a previous forecast of $2.80 to $3.00 [4] - The company has seen strong growth across major segments, including primary care (12%), specialty care (7%), and oncology (11%), and currently offers a dividend yield of around 6.7% [5] Group 2: Summit Therapeutics - Summit Therapeutics has experienced a significant stock increase of nearly 2,000% over three years, now holding a market cap of $18 billion [8] - The leading candidate, ivonescimab, has shown promising results in clinical trials for non-small cell lung cancer, potentially challenging the market leader, Keytruda [9][10] - Analysts project ivonescimab could generate approximately $4.4 billion in sales by 2030, indicating substantial future growth potential [11] Group 3: Vertex Pharmaceuticals - Vertex Pharmaceuticals' stock has declined over 20% due to recent pipeline setbacks, but it is viewed as a buying opportunity [13] - The company has three new products expected to drive significant sales growth, including Alyftrek for cystic fibrosis and Casgevy for rare blood disorders [14] - Vertex's new pain medication, Journavx, is gaining traction, and the company is investing in its sales and marketing efforts [15] - Vertex's PEG ratio is notably low at 0.58, suggesting it is undervalued relative to its growth prospects [17]

Core Insights - Ivonescimab, a PD-1xVEGF bispecific antibody developed by Summit Therapeutics and Akeso, has shown potential to extend overall survival (OS) in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after EGFR-TKI treatment [1][2] Group 1: Clinical Trial Results - The final analysis of the phase 3 HARMONi study indicated a "statistically significant and clinically meaningful" OS benefit for ivonescimab [2] - Ivonescimab, in combination with chemotherapy, demonstrated a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.52 [4] - In a separate analysis, ivonescimab reduced the risk of disease progression or death by 49% compared to Merck's Keytruda [4] Group 2: Market Implications - Analysts believe the market is underestimating the significance of Akeso's OS win in EGFR-mutant NSCLC, with a focus on the credibility of trial results from China aligning with previous findings [5] - The strong PFS advantage of ivonescimab over Keytruda positions it to challenge Keytruda's substantial market presence, valued at over $30 billion [6] - HC Wainwright has raised the price forecast for Summit Therapeutics from $44 to $50, reflecting an increased probability of approval in NSCLC to 85% [6] Group 3: Acquisition Potential - There is speculation that Summit Therapeutics could become an attractive acquisition target as global pharmaceutical companies seek to secure PD-1xVEGF bispecific antibodies to remain competitive in the evolving market [7]

Core Insights - Summit Therapeutics (SMMT) reported a second-quarter 2025 loss per share of $0.76, significantly wider than the Zacks Consensus Estimate of a loss of $0.10, and compared to a loss of $0.09 in the same period last year [1][7] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Year-to-date, SMMT shares have increased by 58.3%, outperforming the industry average increase of 5.3% [2] Financial Performance - Adjusted research and development expenses reached $79.4 million, a 190.8% increase year-over-year, primarily due to higher costs for expanding clinical studies for ivonescimab [4] - Adjusted general and administrative expenses rose by 64.5% year-over-year to $10.2 million, driven by costs associated with developing infrastructure for ivonescimab [4] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $297.9 million, down from $361.3 million as of March 31, 2025 [5] Pipeline Developments - Summit's only pipeline drug, ivonescimab, is a first-in-class bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [8] - The phase III HARMONi study showed that ivonescimab plus chemotherapy reduced the risk of disease progression by 48% compared to chemotherapy alone, but did not achieve statistically significant overall survival benefits [9][10] - The company plans to file for approval of the ivonescimab-chemo combination for previously treated EGFR-mutated NSCLC, pending further discussions with the FDA regarding the need for statistically significant overall survival benefits [10] Recent Study Results - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, where ivonescimab plus chemotherapy showed significant improvement in progression-free survival compared to BeiGene's PD-1 inhibitor [11] - The HARMONi-3 study is evaluating ivonescimab against Merck's Keytruda in first-line metastatic NSCLC patients [12] - The HARMONi-2 study previously demonstrated that ivonescimab outperformed Keytruda in patients with positive PD-L1 expression [13] Collaborations and Approvals - Akeso has secured approval for ivonescimab in a second indication for front-line PD-L1 positive advanced NSCLC based on HARMONi-2 results [14] - Summit has entered clinical trial collaborations with Pfizer and Revolution Medicines to evaluate ivonescimab in combination with their drugs across various solid tumor settings [15]