Core Insights - BeyondSpring Inc. presented phase 2 IIT data on plinabulin for non-small cell lung cancer (NSCLC) at the SITC Annual Meeting, indicating promising efficacy and safety results [1][7]. Study Overview - The 303 Study is an ongoing phase 2 trial evaluating a combination of pembrolizumab, plinabulin, and docetaxel in patients with metastatic NSCLC who have progressed after PD-1/PD-L1 inhibitors [3][9]. - The study aims to enroll a total of 47 patients, with 30 patients already treated and reported on [4][9]. Patient Demographics - The median age of treated patients was 68 years, with 73.3% male and 60% being current or former smokers [4]. - Histological breakdown showed 57% with non-squamous cell carcinoma and 43% with squamous cell carcinoma [4]. Efficacy Results - The confirmed overall response rate (ORR) for the combination therapy was 21.1% [5]. - The median progression-free survival (PFS) was reported at 8.6 months, which is significantly higher than historical controls [5][6]. - The disease control rate was 89.3%, indicating a strong clinical benefit [5][6]. Safety Profile - The combination therapy was generally well tolerated, with 46.7% of patients experiencing grade 3 or higher treatment-related adverse effects [5]. - The most common adverse effects included myelosuppression and gastrointestinal issues, each at 13.3% [5]. Mechanism of Action - Plinabulin acts as a potent inducer of dendritic cell maturation, enhancing T cell activation and potentially overcoming resistance to immune checkpoint inhibitors [6][8]. - This unique mechanism contributes to its differentiated activity and tolerability compared to other treatments [8]. Company Background - BeyondSpring is focused on developing innovative therapies for high unmet medical needs, with plinabulin as its lead asset in late-stage clinical development for NSCLC [10].

Company Overview - BeyondSpring Inc. (BYSI) experienced a stock price increase of 5.39%, reaching $2.54 per share [1] - The company reported a revenue of $1,000,000 and a net loss of $7.26 million, resulting in an earnings per share (EPS) of -$0.19 and a price-to-earnings (P/E) ratio of -6.29 [1] - BeyondSpring is engaged in clinical-stage biopharmaceutical activities, focusing on cancer treatments and immuno-oncology drugs [2] Trading Activity - The trading volume for BeyondSpring was 20,920 shares, with a turnover rate of 0.05% and a volatility of 10.37% [1] - No institutional ratings or recommendations (buy, hold, sell) are currently available for BYSI [1] Industry Context - Within the biotechnology sector, the average decline was 1.17% [1] - Specific stocks in the biotechnology industry showed significant variations, with notable gains in Tc Biopharm (Holdings) Plc, Coeptis Therapeutics Holdings Inc., and Bioatla, Inc. [1] - Stocks with substantial volatility included Pasithea Therapeutics Corp, Tevogen Bio Holdings Inc., and Apollomics Inc., with volatility rates of 145.55%, 70.19%, and 60.44%, respectively [2]

Core Insights - BeyondSpring Inc. presented interim phase 2 data on the 303 Study for 2L/3L non-small cell lung cancer (NSCLC) at the ESMO Congress 2024, highlighting the efficacy of a triple combination therapy involving pembrolizumab, plinabulin, and docetaxel [1][3][6] Company Overview - BeyondSpring is a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, with its lead asset, Plinabulin, in late-stage clinical development for NSCLC and other cancer indications [10] Study Details - The 303 Study is a single-arm, open-label phase 2 trial evaluating the efficacy and safety of a combination regimen of pembrolizumab, plinabulin, and docetaxel in patients with metastatic NSCLC who have progressed after prior treatment with immune checkpoint inhibitors [3][9] - The study aims to enroll a total of 47 patients, with a formal interim analysis conducted on 19 evaluable patients [3][9] Efficacy Results - The confirmed overall response rate (ORR) for the combination therapy was reported at 21.1%, with a median progression-free survival (PFS) of 8.63 months [5] - The disease control rate (DCR) was notably high at 89.5%, indicating a significant clinical benefit for patients with severe unmet medical needs [5][6] - The median duration of response (DoR) was reported at 11.40 months, with a 6-month PFS rate of 67.1% and a 12-month PFS rate of 49.2% [5][6] Safety Profile - The combination therapy was well tolerated, with 52.6% of patients experiencing grade 3 or higher treatment-related adverse effects, and no treatment-related deaths reported [5][6] Mechanism of Action - Plinabulin acts as a potent inducer of dendritic cell maturation, enhancing T cell activation and potentially overcoming resistance to immune checkpoint inhibitors [6][8]

Financial Performance - For the six months ended June 30, 2024, BeyondSpring Inc. reported revenue of $1,000,000, an increase from $875,000 in the same period of 2023, representing a growth of approximately 14.3%[7] - The net loss for the six months ended June 30, 2024, was $7,377,000, a significant reduction from the net loss of $13,261,000 in the prior year, indicating an improvement of about 44.1%[7] - The basic and diluted net loss per share improved to $(0.19) for the six months ended June 30, 2024, compared to $(0.33) for the same period in 2023[7] - The company reported a comprehensive loss of $6,801,000 for the six months ended June 30, 2024, down from $12,017,000 in the prior year, reflecting a decrease of approximately 43.5%[7] Research and Development - Research and development expenses decreased to $4,149,000 for the six months ended June 30, 2024, down from $9,214,000 in the same period of 2023, reflecting a reduction of approximately 55.0%[7] Assets and Liabilities - Total current assets decreased to $14,919,000 as of June 30, 2024, compared to $18,419,000 as of December 31, 2023, a decline of about 19.0%[5] - Total assets decreased to $20,897,000 as of June 30, 2024, down from $24,808,000 as of December 31, 2023, representing a decrease of approximately 15.9%[5] - Total liabilities decreased to $47,172,000 as of June 30, 2024, compared to $48,269,000 as of December 31, 2023, indicating a reduction of about 2.3%[5] Cash and Revenue - Cash and cash equivalents increased to $8,397,000 as of June 30, 2024, from $7,809,000 as of December 31, 2023, an increase of about 7.5%[5] - Deferred revenue decreased slightly to $34,344,000 as of June 30, 2024, from $35,993,000 as of December 31, 2023, a decline of approximately 4.6%[5]

Core Insights - SEED Therapeutics has entered a strategic research collaboration with Eisai to develop novel molecular glue degraders targeting neurodegeneration and oncology [1][2] - The collaboration includes financial terms that allow SEED to receive up to $1.5 billion in payments and tiered royalties [2] - SEED has initiated Series A-3 financing, raising $24 million in the first close, with a second close planned for Q4 2024 [3] Collaboration Details - SEED will lead preclinical discovery activities, while Eisai will have exclusive rights to develop and commercialize the resulting compounds [2] - This collaboration follows an ongoing partnership between SEED and Eli Lilly for the development of molecular glue degraders [2] Series A-3 Financing - The Series A-3 financing aims to accelerate SEED's clinical development in cancer and neurodegeneration, expanding its TPD platform and pipeline [3] - SEED plans to advance its oral RBM39 Degrader into Phase 1 testing in 2025 and its Tau degrader program for Alzheimer's into in vivo efficacy testing in 2025, with an IND submission in 2026 [3] Company Background - SEED Therapeutics focuses on developing molecular glues and targeted protein degradation therapies for previously undruggable targets [6] - The company has a growing pipeline of drug candidates in neurodegeneration and oncology, supported by collaborations with Eli Lilly and Eisai [6][5] Eisai's Role - Eisai is recognized for its commitment to human health care and aims to address unmet medical needs in neurology and oncology [7] - The collaboration with SEED is seen as a unique opportunity to leverage molecular glue technology in both oncology and neurology [4]

FLORHAM PARK, N.J., May 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it hosted a virtual Research and Development (R&D) Day to discuss its lead asset Plinabulin, a dendritic cell (DC) maturation agent, in drug combinations to potentially address the current unmet medical needs in cancer indications where patients failed prior PD-1/PD-L1 ...

FLORHAM PARK, N.J., May 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it hosted a virtual Research and Development (R&D) Day to discuss its lead asset Plinabulin, a dendritic cell (DC) maturation agent, in drug combinations to potentially address the current unmet medical needs in cancer indications where patients failed prior PD-1/PD-L1 ...

FLORHAM PARK, N.J., May 03, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced it will host a Research and Development (R&D) Day to discuss the current unmet medical needs and the potential of Plinabulin as a novel immunochemotherapeutic in drug combinations and updates for SEED Therapeutics on Wednesday, May 15th, 2024 at 10:00 a.m. ET. The conference ...

FLORHAM PARK, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2023 with the U.S. Securities and Exchange Commission ("SEC") on April 29, 2024. The annual report on Form 20-F, which contains the Company's audited consolidated financial statements, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...