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]

It's easier to invest confidently when you know both the pros and the cons in full. Summit Therapeutics (SMMT 7.20%) is an exciting stock for many investors as its shares are up by 158% in the last three months alone. But, as wise investors know, recent price action is in no way a substitute for doing due diligence. And, given that this company doesn't yet have any revenue, the need to do some research and cover your bases is especially important. So with the spirit of delving a bit deeper in mind, let's lo ...

The investment bank analysts who follow these stocks think they can soar even further, with some caveats. Shares of Viking Therapeutics (VKTX 1.33%) and Summit Therapeutics (SMMT 2.58%) are crushing the market this year. Prices for both stocks have more than tripled in 2024 thanks to positive news flow for Viking's oral weight loss candidate and surprising results for Summit's cancer therapy hopeful. What goes up often comes down, but the investment bankers who follow these stocks expect further gains. Oppe ...

This company's promising cancer drug could challenge Merck's $25 billion crown jewel. The pharmaceutical industry is often about hitting home runs. Big pharmaceutical companies start small, and then a blockbuster product catapults them into the spotlight. Summit Therapeutics (SMMT 2.58%) has soared 1,000% over the past year on progress in developing a drug that could rival Merck's Keytruda, a product used to treat various cancers with over $25 billion in sales last year. Those who got in early have gotten r ...