– Announced SEED Therapeutics Inc.(“SEED”)’s collaboration with Eli Lilly and Company(“Lilly”)
NEW YORK, Nov. 17, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (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.
“We 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’s 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,” said Dr. Lan Huang, co-founder, chairperson and chief executive officer of BeyondSpring. “We expect to file a New Drug Application (NDA) for CIN, plinabulin’s 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.”
Select Third Quarter 2020 and Recent Business Highlights
Recent Clinical Highlights
Breakthrough Therapy Designation
Received Breakthrough Therapy Designation for plinabulin in CIN from both the U.S. FDA and China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). FDA’s 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.
Recent Corporate Highlights
SEED’s collaboration with Lilly
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 “molecular glue”, 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.
BeyondSpring Appoints Elizabeth Czerepak as Chief Financial Officer
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.
Financial Results for the Three Months Ended September 30, 2020
Research and development (“R&D”) 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.
General and administrative (“G&A”) 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’ compensation.
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.
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.
The following outlines the Company’s anticipated upcoming milestones and projected timelines:
- NDA submission for plinabulin for CIN in the U.S. – Early 2021
- NSCLC phase 3 data readout – H1 2021
- Rolling NDA submission for plinabulin for NSCLC in China – H1 2021
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring’s lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.
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, 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 our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, 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.
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF SEPTEMBER 30, 2020
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|December 31,||September 30,|
|Cash and cash equivalents||35,933||30,874|
|Advances to suppliers||4,519||4,328|
|Prepaid expenses and other current assets||410||485|
|Total current assets||40,862||35,687|
|Property and equipment, net||209||189|
|Operating lease right-of-use assets||2,538||2,340|
|Other noncurrent assets||946||1,180|
|Total noncurrent assets||3,693||3,709|
|Liabilities and equity|
|Due to related parties||29||–|
|Current portion of operating lease liabilities||537||697|
|Other current liabilities||1,089||1,551|
|Total current liabilities||10,053||12,819|
|Operating lease liabilities||1,935||1,546|
|Total noncurrent liabilities||3,371||3,654|
|Ordinary shares ($0.0001 par value; 500,000,000|
|shares authorized; 27,885,613 and 30,516,401 shares|
|issued and outstanding as of December 31,|
|2019 and September 30, 2020, respectively)||3||3|
|Additional paid-in capital||246,979||284,310|
|Accumulated other comprehensive income (loss)||140||(47||)|
|Total BeyondSpring Inc.’s shareholders’ equity||30,277||24,044|
|Total liabilities and equity||44,555||39,396|
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2019 AND 2020
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Research and development||(7,230||)||(8,637||)||(18,762||)||(33,369||)|
|General and administrative||(2,474||)||(6,710||)||(6,260||)||(12,227||)|
|Loss from operations||(9,704||)||(15,347||)||(25,022||)||(45,596||)|
|Foreign exchange (loss) gain, net||(131||)||174||(127||)||109|
|Loss before income tax||(9,824||)||(15,184||)||(25,271||)||(45,445||)|
|Income tax benefit||–||–||–||–|
|Less: Net loss attributable to|
|Net loss attributable to|
|Net loss per share|
|Basic and diluted||(0.37||)||(0.48||)||(1.01||)||(1.51||)|
|Weighted-average shares outstanding|
|Basic and diluted||25,309,776||30,303,093||23,819,453||28,658,215|
|Other comprehensive loss, net of tax of nil:|
|Foreign currency translation|
|adjustment gain (loss)||113||(277||)||144||(226||)|
|Less: Comprehensive loss attributable to|
|Comprehensive loss attributable to|
Ashley R. Robinson
Darren Opland, PhD