{"id":382788,"date":"2020-11-17T08:03:27","date_gmt":"2020-11-17T13:03:27","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=382788"},"modified":"2020-11-17T08:03:27","modified_gmt":"2020-11-17T13:03:27","slug":"beyondspring-announces-third-quarter-2020-financial-results-and-provides-business-updates","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/beyondspring-announces-third-quarter-2020-financial-results-and-provides-business-updates\/","title":{"rendered":"BeyondSpring Announces Third Quarter 2020 Financial Results and Provides Business Updates"},"content":{"rendered":"
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\n – Announced SEED Therapeutics Inc.(\u201cSEED\u201d)\u2019s collaboration with Eli Lilly and Company(\u201cLilly\u201d)<\/em>
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NEW YORK, Nov. 17, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. <\/strong>(the \u201cCompany\u201d or \u201cBeyondSpring\u201d) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results and provided an operational update for the three months ended September 30, 2020.<\/p>\n

\u201cWe were thrilled to announce positive top-line data in our pivotal Phase 3 study demonstrating plinabulin in combination with pegfilgrastim (peg) provides superior benefits for patients in preventing chemotherapy-induced neutropenia (CIN) compared with peg alone. Results show combination plinabulin + peg\u2019s ability to reduce infection and hospitalization rates after chemotherapy, allowing for the potential for patients to continue receiving life-saving treatments. This means patients may potentially receive more stable doses, longer sustained cycles and the strongest regimens possible resulting in potential survival benefit,\u201d said Dr. Lan Huang, co-founder, chairperson and chief executive officer of BeyondSpring. \u201cWe expect to file a New Drug Application (NDA) for CIN, plinabulin\u2019s first indication, in the U.S. in early 2021, soon followed by an NDA submission in China and look forward bringing this important therapy to market.<\/em>\u201d<\/p>\n

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\n Select Third Quarter 2020 and Recent Business Highlights<\/u>
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\n Recent Clinical Highlights<\/u>
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\n Breakthrough Therapy Designation<\/em>\n <\/p>\n

Received Breakthrough Therapy Designation for plinabulin in CIN from both the U.S. FDA and China\u2019s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). FDA\u2019s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life- threatening disease or condition in which clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.<\/p>\n

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\n Recent Corporate Highlights<\/u>
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\n SEED\u2019s collaboration with Lilly<\/em>\n <\/p>\n

Announced a research collaboration and license agreement and a share purchase agreement between SEED and Lilly in the area of targeted protein degradation (TPG), or \u201cmolecular glue\u201d, SEED will receive a $10 million upfront payment, up to $10 million investment and up to approximately $780 million in milestones related to preclinical, clinical, regulatory and commercial milestones, plus royalties on net sales of products that result from the collaboration.<\/p>\n

\n BeyondSpring Appoints Elizabeth Czerepak as Chief Financial Officer<\/em>\n <\/p>\n

Announced the appointment of Elizabeth Czerepak to the role of chief financial officer. Ms. Czerepak brings to BeyondSpring more than 30 years of senior finance and leadership experience, including Board and venture capital experience. Ms. Czerepak most recently served as CFO and chief business officer of Genevant Sciences. Simultaneously, the Company announced the appointment of Edward Liu as chief financial officer to SEED focused on a targeted protein degradation platform to attack previously believed undruggable targets.<\/p>\n

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\n Financial Results for the Three Months Ended September 30, 2020<\/u>
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Research and development (\u201cR&D\u201d) expenses were $8.6 million for the quarter ended September 30, 2020, compared to $7.2 million for the quarter ended September 30, 2019. The $1.4 million increase was largely attributable to higher clinical trial costs and NDA preparation costs.<\/p>\n

General and administrative (\u201cG&A\u201d) expenses were $6.7 million for the quarter ended September 30, 2020, compared to $2.5 million for the quarter ended September 30, 2019. The $4.2 million increase was primarily due to an increase of $2.0 million related to pre-launch commercialization costs for plinabulin, and an increase of $1.9 million in G&A employees\u2019 compensation.<\/p>\n

Net loss attributable to the Company was $14.5 million for the quarter ended September 30, 2020, compared to $9.4 million for the quarter ended September 30, 2019.<\/p>\n

As of September 30, 2020, the Company had cash and cash equivalents of $30.9 million on hand. The Company believes with the implementation of a cost reduction plan it has sufficient cash to support its clinical trials and the preparation of NDA submissions in the U.S. and China for plinabulin for the CIN and NSCLC indications, as well as to advance its immuno- oncology pipeline and protein degradation research platform.<\/p>\n

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\n Anticipated Milestones<\/u>
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The following outlines the Company\u2019s anticipated upcoming milestones and projected timelines:<\/p>\n