On April 18, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve clinical outcomes for patients with high unmet medical needs, reported a business update and provided results for the year ended December 31, 2022 (Press release, BeyondSpring Pharmaceuticals, APR 18, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-provides-business-update-and-reports-year-end-2022-financial-results [SID1234630230]).
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"I am pleased to report that BeyondSpring’s subsidiary, SEED Therapeutics, has made significant headway in advancing internal and external collaboration assets with Eli Lilly, achieving on-time delivery of R&D objectives, which triggered milestones and investment payments," said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. "SEED Therapeutics, which specializes in ‘molecular glue’ development with its proprietary targeted protein degradation (TPD) platform for novel drug discovery, continues to attract increased partnering interest."
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, as a ‘pipeline in a drug’ on the regulatory front in the U.S. and in China, and in a number of Plinabulin IIT studies at MD Anderson, Memorial Sloan Kettering and other institutions in the U.S. and China."
Recent Business and Clinical Updates
Business Updates
SEED Milestone Achievements
SEED Therapeutics received investment payment in June 2022 and milestone payment in February 2023 for pre-clinical development from Eli Lilly, totaling $7 million.
Plinabulin
In March 2023, BeyondSpring withdrew its NDA submission for the CIN indication from China’s National Medical Products Administration (NMPA) review. The Company will continue to communicate with the NMPA regarding its re-filing of the NDA for the CIN indication and plan to re-file the NDA by mid-2023. In addition, the Company plans to submit the NDA for the NSCLC indication with the NMPA by mid-2023.
Clinical Updates
Conference Presentations at ASH (Free ASH Whitepaper), SABCS, and ESMO (Free ESMO Whitepaper) Asia for Plinabulin
In December 2022, the Company exhibited two posters and gave one oral presentation on positive data with Plinabulin for the prevention of docetaxel-induced neutropenia (DIN) in patients with NSCLC and breast cancer at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress and San Antonio Breast Cancer Symposium (SABCS).
Enrollment Completion for Three IIT Studies in the U.S. for Plinabulin
In February 2023, the Phase 2 IIT study enrollment was completed for Plinabulin combined with Bristol Myers Squibb’s Opdivo and Yervoy in 2nd/3rd line extensive-stage small cell lung cancer (ES-SCLC) patients who had failed prior immunotherapy. In the Phase 1 IIT study, the preliminary data showed over 40% of tumor response in this population.
In March 2023, the Phase 1 IIT study enrollment was completed for Plinabulin, combined with PD-1 / PD-L1 inhibitors and radiation, in a variety of cancer patients who had failed prior immunotherapies at the MD Anderson Cancer Center.
In March 2023, the Phase 1 IIT study enrollment was completed for Plinabulin in combination with Pegfilgrastim in multiple myeloma (MM) patients who had undergone autologous hematopoietic cell transplantation (AHCT) at the Memorial Sloan Kettering Cancer Center (MSKCC). The topline data will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting in June 2023.
First Patient Enrollment in Phase 2 IIT Study for Plinabulin Combined with Keytruda and Docetaxel in 2nd/3rd line NSCLC
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 metastatic NSCLC who had failed immunotherapy alone or in combination with platinum-doublet chemotherapy.
Expected Milestones in 2023
Advance a lead SEED-owned new chemical entity (NCE) to the IND-candidate milestone
Advance a second SEED-owned NCE to the Hit milestone with efficacy in animal model
Complete three IIT studies in the U.S. with Topline Data Readout
Plan to Submit NSCLC NDA in China by mid-2023
Plan to Re-submit CIN NDA in China by mid-2023
Full Year 2022 Financial Results
Research and development ("R&D") expenses were $25.6 million for the year ended December 31, 2022, compared to $36.9 million for the year ended December 30, 2021. The $11.3 million decrease was primarily due to lower clinical development expense, lower regulatory fees and professional service expense to support NDA submission and lower personnel costs as a result of the organizational streamlining announced in January 2022.
General and administrative ("G&A") expenses were $13.0 million for the year ended December 31, 2022, compared to $30.7 million for the year ended December 31, 2021. The $17.7 million decrease was primarily due to lower pre-commercialization expenses for Plinabulin and lower personnel costs, as results of the organizational streamlining announced in January 2022. There were also decreases in professional service expenses.
Net loss attributable to the Company was $33.3 million for the year ended December 31, 2022, compared to $64.2 million for the year ended December 31, 2021.
As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of $37.3 million.