Core Insights - The stock market has performed well in 2024, with significant gains for Viking Therapeutics and Summit Therapeutics, whose shares have more than doubled [1] Group 1: Viking Therapeutics - Viking Therapeutics' stock increased by 157% from the end of 2023 to December 12, 2024, driven by the potential success of its experimental weight loss treatment VK2735 [3] - VK2735 is a dual GLP-1 and GIP receptor agonist, similar to Eli Lilly's tirzepatide, which has seen substantial sales growth, reaching $11 billion in the first nine months of 2024 [4] - Mid-stage clinical trial results indicate that VK2735 could capture a significant market share, with patients in a recent study losing 8.2% of their weight after four weeks [5] - An earlier trial of an oral version of VK2735 showed a 5.3% weight reduction in patients after 28 days [6] Group 2: Summit Therapeutics - Summit Therapeutics has licensed ivonescimab, a bispecific antibody that targets both PD-1 and VEGF, which has shown promising results in lung cancer patients compared to Keytruda [7][8] - The stock of Summit Therapeutics surged by approximately 583% in 2024, reflecting investor optimism about ivonescimab's potential [7] - The company is currently conducting a phase 3 trial for ivonescimab in the U.S., with expectations of success based on prior results from China [10] - Summit Therapeutics' market cap recently reached $13.2 billion, but there are concerns about the sustainability of this valuation if long-term survival data does not meet expectations [13]

Group 1 - Brendan completed a Ph.D. in organic synthesis at Stanford University in 2009 and has a background in both pharmaceutical and biotech industries [1] - He worked for Merck from 2009 to 2013 and was involved in biotech startups such as Theravance and Aspira before joining Caltech [1] - Brendan is a co-founder and the first employee of 1200 Pharma, which received significant investment in the eight-figure range [1] - He remains an active investor with a focus on market trends, particularly in biotechnology stocks [1]

Core Viewpoint - Summit Therapeutics has received a buy recommendation from JMP Securities, indicating strong potential for its stock price to rise significantly due to its focus on oncology drugs, particularly ivonescimab for lung cancer treatment [1][2][3]. Group 1: Analyst Coverage and Stock Performance - JMP Securities analyst Reni Benjamin initiated coverage of Summit Therapeutics with an outperform rating and set a price target of $32 per share, which is 60% above the stock's recent closing price [2]. - Following the analyst's recommendation, Summit Therapeutics' stock price increased by more than 5%, contrasting with a slight decline in the S&P 500 [1]. Group 2: Product Development and Market Potential - The analyst's optimism is based on Summit's successful transition to oncology drugs, highlighted by positive phase 3 trial results for ivonescimab in lung cancer treatment conducted in China [3]. - Despite skepticism regarding clinical data from China, the analyst believes the market has matured enough for these results to gain acceptance among healthcare professionals and investors [4]. - The ongoing development of ivonescimab is seen as a promising strategy, given the significant health impact of lung cancer globally [5].

Company Overview - Summit Therapeutics Inc initially focused on infectious diseases but pivoted to oncology in 2022 [1] - The company in-licensed ivonescimab (PD-1 X VEGF bispecific) from Akeso for $500 million upfront and $5 billion in potential milestones [1] - JMP Securities initiated coverage on Summit Therapeutics with a Market Outperform rating and a price target of $32 [2] Clinical Data and Potential - Ivonescimab demonstrated a statistically significant improvement in progression-free survival with a hazard ratio (HR) of 0.51 compared to pembrolizumab in the Phase 3 HARMONi-2 trial [2] - The overall survival data for ivonescimab is still in progress but has a strong chance of showing an advantage over pembrolizumab in first-line non-small cell lung cancer (NSCLC) [3] - Summit Therapeutics is positioned to potentially commercialize its treatment in the more targeted EGFRm and first-line NSCLC patient groups [3] Market Opportunity - If successful, ivonescimab could lead to an estimated $17.9 billion in peak global revenue upon potential entry into the first-line NSCLC market by 2034 [4] - The company's stock price increased by 5.33% to $20.00 following the news [4] Competitive Landscape - Despite the success of Merck & Co's Keytruda and Bristol Myers Squibb's Opdivo, ivonescimab is seen as a formidable opponent with higher response rates and longer median progression-free survival [1]

Summit Therapeutics (SMMT) reported third-quarter 2024 loss per share of 8 cents, wider than the Zacks Consensus Estimate of a loss of 7 cents. In the year-ago period, the company posted a loss of 3 cents per share.The reported loss included stock-based compensation expenses. Excluding these expenses, the adjusted loss per share was 5 cents, wider than the year-ago adjusted loss of 3 cents.As the company lacks any marketed product in its portfolio, it did not record quarterly revenues.More on SMMT’s Earning ...

Summit Therapeutics Inc. (NASDAQ:SMMT) Q3 2024 Earnings Conference Call October 30, 2024 9:00 AM ET Company Participants Dave Gancarz - Chief Business and Strategy Officer Bob Duggan - Chairman and CEO Maky Zanganeh - CEO and President Manmeet Soni - COO and CFO Allen Yang - Chief Medical Officer Conference Call Participants Mitchell Kapoor - H. C. Wainwright Brad Canino - Stifel Yigal Nochomovitz - Citi Operator Good morning. And welcome to Summit Therapeutics' Q3 2024 Earnings and Update Call. All partici ...

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, 2024 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-36866 _______________________________ Summit Therapeutics Inc. (Exac ...

Clinical Trial Progress and Results - Ivonescimab monotherapy reduced the risk of disease progression or death by 49% compared to pembrolizumab in the Phase III HARMONi-2 trial for first-line PD-L1 positive advanced NSCLC in China[1][11] - Enrollment completed in the global Phase III HARMONi trial for 2L+ EGFRm advanced NSCLC, with topline data expected in mid-2025[1][3] - Summit plans to expand the HARMONi-3 global Phase III trial to include both squamous and non-squamous histologies, with an estimated total sample size of 1,080 patients[3][4] - Summit intends to initiate the global Phase III HARMONi-7 trial in 1L PD-L1 high, metastatic NSCLC in early 2025, with a planned sample size of 780 patients[7] - In the Phase II AK112-201 trial, first-line non-squamous NSCLC patients (n=72) had a median PFS of 13.3 months, while squamous NSCLC patients (n=63) had a median PFS of 11.1 months[6] - In the Phase II AK112-205 trial, 71.8% of patients (n=39) who received ivonescimab plus chemotherapy in the neo-adjuvant setting experienced a major pathological response (MPR), and 43.6% achieved a pathological complete response (pCR)[13] - In the Phase II study for metastatic MSS CRC, the ORR and DCR for 39 patients were 84.6% and 100%, respectively, with median PFS not reached in either group[17] - Over 1,800 patients have been treated with ivonescimab in clinical studies globally[32] - Summit plans to initiate the HARMONi-7 Phase III clinical trial for ivonescimab in early 2025[32] Financial Performance and Expenses - Summit raised $235 million in private financing in September 2024, increasing its cash balance to $487 million at the end of Q3 2024[20][21] - GAAP R&D expenses for Q3 2024 were $37.7 million, up from $15.3 million in the same period of the prior year, primarily due to expansion of clinical study and development costs related to ivonescimab[22][23] - GAAP net loss for Q3 2024 was $56.3 million, compared to $21.2 million in the same period of the prior year[25] - Summit's Q3 2024 net loss was $56.3 million, compared to $21.2 million in Q3 2023, with a net loss per share of $0.08[42] - Research and development expenses increased to $37.7 million in Q3 2024, up from $15.3 million in Q3 2023[42] - Total operating expenses for Q3 2024 were $58.1 million, compared to $20.7 million in Q3 2023[42] - Cash and cash equivalents increased to $487.0 million as of September 30, 2024, up from $186.2 million at the end of 2023[43] - Net cash used in operating activities for the first nine months of 2024 was $93.4 million, compared to $57.3 million in the same period of 2023[44] - Non-GAAP Research and Development Expense for Q3 2024 was $31.9 million, compared to $15.2 million in Q3 2023[45] - Non-GAAP General and Administrative Expenses for Q3 2024 were $6.8 million, down from $4.8 million in Q3 2023[45] - Non-GAAP Net Loss for Q3 2024 was $36.9 million, compared to $20.5 million in Q3 2023[45] - Non-GAAP Net Loss Per Basic and Diluted Common Share for Q3 2024 was $0.05, compared to $0.03 in Q3 2023[45] - GAAP Net Loss for Q3 2024 was $56.3 million, compared to $21.2 million in Q3 2023[45] - Stock-based compensation for Q3 2024 was $19.4 million, compared to $0.7 million in Q3 2023[45] - Acquired In-process Research and Development for the nine months ended September 30, 2024, was $15.0 million, compared to $520.9 million in the same period in 2023[45] - Non-GAAP Operating Expenses for Q3 2024 were $38.7 million, compared to $20.0 million in Q3 2023[75] - GAAP Operating Expenses for Q3 2024 were $58.1 million, compared to $20.7 million in Q3 2023[75] - Basic and Diluted Common Shares outstanding as of September 30, 2024, were 726.7 million, compared to 697.7 million in the same period in 2023[45] Ivonescimab Mechanism and Approval - Ivonescimab demonstrated over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro[31] - Ivonescimab's tetravalent structure enables over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro[31] - Ivonescimab was approved for marketing authorization in China in May 2024[37]

Summit Therapeutics (SMMT) is set to report third-quarter earnings on Oct. 30, before the opening bell. Since the company does not have any marketed drug in its portfolio, we do not expect it to record revenues. The Zacks Consensus Estimate for earnings is pegged at a loss of 7 cents per share.Estimates for 2024 and 2025 loss per share have remained consistent at 27 and 29 cents, respectively, in the past 60 days. The company reported an earnings surprise of 16.67% in the last reported quarter. Image Source ...

This drugmaker's lead candidate could become a top-selling cancer therapy.To say this has been a big year for Summit Therapeutics (SMMT -2.72%) would be a huge understatement. The stock has risen over 600% since the end of 2023, thanks to surprisingly positive trial results for a cancer therapy called ivonescimab.The stock market has been pushing up Summit's stock price because there's a chance that ivonescimab could unseat Merck's Keytruda as the world's top-selling cancer treatment. Keytruda racked up a s ...