BeyondSpring Provides Business Update and Reports Year End 2023 Financial Results

- BeyondSpring Dosed First Patient of Two Phase 2 Investigator-Initiated Trials (IIT) in Plinabulin and Keytruda Combination Studies

- SITC 2023 Presentation of the Phase 1 Topline Clinical and Mechanism Data of BeyondSpring’s Lead Asset Plinabulin in Combination with PD-1 Inhibitor and Radiation in a Number of Immune Checkpoint Inhibitor Failed Cancers (Disease Control Rate >50%), Collaboration with MD Anderson

- SEED Therapeutics (“SEED”), a BeyondSpring Subsidiary, Achieves Second and Third Molecular Glue Discovery Milestones in the Eli Lilly R&D Collaboration; Selected Investigational New Drug (IND) Candidate for Lead Oncology Internal Program

- SEED was Featured in “Nature Biotechnology” March 2024 Review Article “The Glue Degraders”

FLORHAM PARK, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today provided a business update and reported results for the year ended December 31, 2023.

“2023 has been a year of building fundamental values for BeyondSpring. It is such an honor for our majority-owned subsidiary SEED Therapeutics to be featured among leading companies using target protein degradation molecular glue for innovative drug discovery. With our proprietary RITE3 platform, SEED continues to attract increased partnering interest. I am also pleased to report that SEED has made significant headway in advancing internal programs, with one oncology asset (expected to enter clinics in 1H 2025), Tau degrader(s), and external collaboration projects with Eli Lilly,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring.

Dr. Huang continued, “BeyondSpring remains strategically positioned to advance our programs to near-term important inflection points. The Company continues to make progress in advancing our lead drug candidate, Plinabulin, a potent dendritic cell maturation agent, on the regulatory front in the U.S. and in China, and through a number of Plinabulin’s IIT studies at MD Anderson, Memorial Sloan Kettering and other institutions in the U.S. and China.”

“PD-1/PD-L1 inhibitors had changed the treatment landscape in cancer, with annual sales well over $40 billion. However, around 60% of patients fail these therapies, and currently very limited therapies have been able to halt or reverse cancer progression in PD-1 failure patients across numerous patient settings, which presents a severe unmet medical need. Using a cost-efficient IIT study model and by working with leading institutions globally, we aim to demonstrate the important role that plinabulin can play in combination with radiation or chemotherapy and immune checkpoint inhibitors (ICI) for these cancer patients who failed ICI. These IIT studies are advancing well, and we aim to report results later in 2024.” Dr. Huang concluded.

Recent Business and Clinical Updates

Plinabulin Clinical Updates

• Conference Presentation at ASCO and SITC for Plinabulin
  • In May 2023, the Company and Memorial Sloan Kettering Cancer Center (MSKCC) presented a poster on new data from a Phase 1 IIT study, highlighting Plinabulin’s ability to reduce infectious neutropenic fever for multiple myeloma patients undergoing Autologous Hematopoietic Stem Cell Transplantation (AHCT), at the American Society of Clinical Oncology (ASCO) Annual Meeting.
  • In November 2023, the Company and The University of Texas MD Anderson Cancer Center presented new clinical data from a Phase 1 IIT study, highlighting preclinical and clinical POC immunomodulating activity of Plinabulin inducing dendritic cell maturation and re-sensitization in immunotherapy refractory tumors when combined with radiation and PD-1 inhibitors, at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting.
• First Patient Enrollment in Two Phase 2 IIT Studies for Plinabulin Combined with Keytruda
  • In March 2023, the first patient was enrolled in a Phase 2 IIT study for Plinabulin in combination with Merck’s anti-PD-1 therapy, Keytruda, and docetaxel for patients with second and third line (2/3L) advanced and metastatic NSCLC who had failed immunotherapy alone or in combination with platinum-doublet chemotherapy.
  • In March 2024, the first patient was enrolled in a Phase 2 IIT study with Keytruda, Plinabulin, plus Etoposide/Platinum (EP) for first-line (1L) Extensive-Stage Small-Cell Lung Cancer (ES-SCLC).

Business Updates

• SEED Therapeutics
  • Milestone Achievements
    • In February 2023 and March 2024, SEED achieved two milestones for pre-clinical developments with Eli Lilly.

• Appointments of Directors
  • In June 2023, SEED appointed Mr. Jackson Tai, a former director at Eli Lilly, HSBC and Mastercard, to the board of directors. Mr. Tai brings almost five decades of experience in finance, strategy, and risk governance.
  • In October 2023, SEED appointed Mr. Ko-Yung Tung, a former board member at Eisai, former general counsel at World Bank, and a lecturer at Harvard Law School and Yale Law School to the board of directors. Mr. Tung brings five decades of experience in global health, law, governance, and international business.
• Announcement of IND Candidate for Oncology at “Targeted Protein Degradation (TPD) Think Tank” Symposium
  • In October 2023, SEED held its first “TPD Think Tank” Symposium, in which SEED co-founders invited TPD thought leaders to present. Domestic and foreign attendees engaged in a collaborative and interactive session to advance the TPD field research.
  • During the “TPD Think Tank” Symposium, it was announced that SEED had successfully discovered a new chemical entity (NCE) molecular glue. SEED has declared an IND Candidate status, targeting first human dose in 1H 2025.
• Advancement in Tau Degrader Molecular Glue Discovery
  • SEED is targeting the protein Tau for degradation with a molecular glue, for the treatment of neurodegeneration. Within 6 months of starting the project, SEED has discovered multiple compound scaffolds with predicted brain permeability that glue tau to a novel E3 ligase selected by SEED’s RITE3 platform. Compounds are now being optimized for relevant activities and properties, including reduced Tau levels in cultured human neurons. SEED is targeting IND Candidate status for the Tau Project in 2H 2025.
    
    

Expected Milestones in 2024

• Plinabulin: Generate preliminary data in 2H 2024 for the Phase 2 IIT Study in combination with Keytruda and docetaxel in 2/3L NSCLC patients who failed PD-1/PD-L1 inhibitors.
• SEED: Significantly advance lead oncology asset in IND-enabling studies to enable its IND filing.

Full Year 2023 Financial Results

Research and development (“R&D”) expenses were $14.6 million for the year ended December 31, 2023, compared to $25.6 million for the year ended December 31, 2022. The $11.0 million decrease was primarily due to lower clinical development expense, lower professional service expense to support NDA submission and lower personnel costs.

General and administrative (“G&A”) expenses were $10.2 million for the year ended December 31, 2023, compared to $13.0 million for the year ended December 31, 2022. The $2.8 million decrease was primarily due to lower personnel costs, and lower professional service expenses.

Net loss attributable to the Company was $21.0 million for the year ended December 31, 2023, compared to $33.3 million for the year ended December 31, 2022.

As of December 31, 2023, the Company had cash, cash equivalents, restricted cash, and short-term investments of $17.9 million.

About BeyondSpring

is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia. BeyondSpring’s also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary TPD drug discovery platform and has an initial R&D collaboration with Eli Lilly. Learn more by visiting.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, our ability to continue as a going concern, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq's continued listing requirements, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

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