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]

Financial Performance - Summit Therapeutics reported a third-quarter 2024 loss per share of 8 cents, wider than the Zacks Consensus Estimate of a loss of 7 cents, and compared to a loss of 3 cents per share in the year-ago period [1] - The adjusted loss per share, excluding stock-based compensation expenses, was 5 cents, also wider than the year-ago adjusted loss of 3 cents [1] - The company did not record any quarterly revenues as it lacks marketed products [1] Expenses - Adjusted research and development expenses totaled $31.9 million, up from $15.2 million in the year-ago period, primarily due to increased clinical costs for pipeline development [2] - Adjusted general and administrative expenses amounted to $6.8 million, reflecting a 42% increase year-over-year [2] Cash Position - As of September 30, 2024, Summit had cash, cash equivalents, and short-term investments worth $487 million, an increase from $326 million as of June 30, 2024, following a $235 million private financing round [3] Pipeline Developments - Summit has one pipeline drug, ivonescimab, a bispecific antibody targeting PD-1 and VEGF, currently undergoing two late-stage studies, HARMONi and HARMONi-3, for metastatic non-small cell lung cancer (NSCLC) [4] - The design of the HARMONi-3 study is being amended to include patients with nonsquamous histologies and now has two primary endpoints: overall survival (OS) and progression-free survival (PFS) [5] Study Updates - The HARMONi study has completed enrollment, focusing on patients with EGFR-mutated, locally advanced or metastatic nonsquamous NSCLC who have progressed after third-generation EGFR TKI treatment, with data expected in mid-2025 [8] - Results from the HARMONi-2 study indicated that ivonescimab reduced the risk of disease progression or death by nearly half compared to Merck's Keytruda, supporting the drug's efficacy [10] - A late-stage study, HARMONi-7, is planned to start in early 2025, comparing ivonescimab with Keytruda in patients with metastatic NSCLC and high PD-L1 expression, with data expected in 2027 [11] Stock Performance - Shares of Summit Therapeutics have increased over 600% year to date, contrasting with a 4.4% decline in the industry [6]

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 ...

Shares of Summit Therapeutics (SMMT) have soared 689% year to date, significantly outperforming the industry’s 2.5% decline. The stock has outperformed the sector and the S&P 500 during the same period. SMMT’s shares are also trading above the 50-day and 200-day moving averages.SMMT Stock Outperforms Industry, Sector & S&P 500 Image Source: Zacks Investment ResearchThis uptick in stock price started in May after the company reported that its lead pipeline drug ivonescimab outdid Merck’s (MRK) blockbuster on ...

Millennium Management just initiated a position in a small biotech company developing a new cancer drug.Israel Englander is a billionaire hedge fund manager and serves as the CEO of Millennium Management. During the second quarter, Millennium initiated a new position that I found to be quite curious. Below, I'm going to share one of the fund's new positions and explore the benefits and risks of investing in this particular up-and-coming biotech stock.Millennium Management's curious moveAccording to Millenni ...

The shares have experienced a pullback in the past couple of weeks. No stock has unlimited upside potential. When a company's shares rise significantly during a short period, it makes sense to wonder whether it's still worth investing in, even if it boasts solid fundamentals: Overvalued stocks are much less likely to generate strong returns. That brings us to Summit Therapeutics (SMMT 1.50%), a drugmaker whose shares have skyrocketed by almost 700% since the year started (although that's down from a gain of ...

Viking Therapeutics - Viking is developing VK2735, a therapy for obesity, with phase 3 trials for the injectable formulation and phase 2 trials for the oral formulation soon to begin [3] - The anti-obesity medicine market is projected to reach $105 billion annually by 2030, with Viking aiming to capture a share of this growing market [5] - Viking has $942 million in cash, equivalents, and short-term investments as of Q2, with operating expenses of just over $34 million, ensuring sufficient funding for late-stage trials [6] - If VK2735 is approved, Viking could see significant returns, especially if it captures even 10% of the anti-obesity market [12] Summit Therapeutics - Summit is focused on commercializing ivonescimab, a biologic drug for non-small cell lung cancer (NSCLC), licensed from Akesobio [7] - The NSCLC drug market is expected to grow to $26 billion annually by 2032, up from $11.5 billion currently, with Summit aiming to carve out a niche with ivonescimab [9] - Summit has $326 million in cash, equivalents, and short-term investments as of Q2, and recently raised $235 million, providing ample capital to bring its advanced programs to market [10] - Summit's first two programs could hit the market within the next 3-4 years, with one receiving FDA Fast Track designation [10] Market Comparison - Viking is targeting the larger anti-obesity market ($105 billion by 2030), while Summit is focused on the smaller NSCLC market ($26 billion by 2032) [5][9] - Viking's internal R&D allows for further development of its candidates, while Summit relies on Akesobio's pipeline for future opportunities [12][13] - Viking is seen as a more appealing investment due to the larger market potential, despite being riskier without a collaborator like Akesobio [11][12]