– Company to host call today, April 14, 2022 at 8:00 am ET
– Conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or +1-201-389-0879 (International). The passcode is 13728822. The live webcast can be accessed here or by visiting the “investors” section of the BeyondSpring website
NEW YORK, Apr. 14, 2022 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs, today announced its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update. At the start of 2022, the Company took steps to streamline its operations and is focused on executing on near-term opportunities for value creation.
“We are pleased with the ongoing discussions with China NMPA on the NDA review of the Plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia (CIN). The G-CSF market in China is significant, with $1.2B in sales in 2020 and approximately 30% annual growth since 2017,” said Dr. Lan Huang, co-founder, chairman and chief executive officer of BeyondSpring. “We are also moving forward to target an NDA filing in China by year-end for Plinabulin in the non-small cell lung cancer (NSCLC) indication. In addition, we are continuing our discussions with the FDA regarding the clinical and regulatory pathway for Plinabulin in CIN and NSCLC in the U.S. Above all, we remain committed to bringing Plinabulin to market to help many patients in need.”
Recent Clinical and Corporate Highlights
Business Development Update
- In August 2021, entered into an exclusive commercialization and co-development partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui’) for Plinabulin in Greater China
- Hengrui, a leading oncology R&D and commercial company in China, has exclusive commercialization and co-development rights to all indications for Plinabulin;
- In September 2021, the Company received a 200M RMB (est. US$31M) upfront payment and will be eligible to receive up to 1.1B RMB (est. US$171M) upon achieving certain regulatory and sales milestones;
- The Company will supply Plinabulin, retaining manufacturing rights. The Company will receive all proceeds from sales of Plinabulin and pay Hengrui a pre-determined percentage of such sales.
Clinical Development Update
- In September 2021, presented new data on Plinabulin from the CIN prevention program with three posters at the European Society for Medical Oncology (ESMO) 2021 Congress
- Severe Neutropenia (Grade 4) as a Population-Based Predictor for Adverse Clinical Outcome of CIN;
- Prediction of Febrile Neutropenia, Hospitalization Rates, and Infection Rates in CIN Patients Treated with the Plinabulin and Pegfilgrastim Combination using a Meta-Analysis -based Tool;
- Impact of Adding Plinabulin to Pegfigrastim for the Prevention of CIN, on Patient Quality of Life.
- In September 2021, presented positive top-line final Phase 3 DUBLIN-3 data in 2nd/3rd line NSCLC patients with EGFR Wild Type at the ESMO 2021 Congress
- The combination (Plinabulin + docetaxel) showed superior efficacy benefit in overall survival (OS), progression-free survival (PFS), objective response rate (ORR) with statistical significance and a significant reduction of grade 4 neutropenia vs. docetaxel alone.
- IIT Studies of Plinabulin combined with PD-1/PD-L1 inhibitors in multiple cancers
- In October 2021, initiated Phase 2 study of Plinabulin in combination with nivolumab and ipilimumab in extensive stage small cell lung cancer (SCLC) who failed platinum and checkpoint inhibitors (Big Ten Cancer Research Consortium). In the Phase 1 portion of the study, this combination showed encouraging efficacy of 43% ORR and long duration of treatment in the same patient population;
- In June 2021, initiated Phase 1 study of Plinabulin in combination with PD-1/PD-L1 inhibitor and radiotherapy for patients in seven advanced solid tumors (MD Anderson Cancer Center).
Fourth Quarter 2021 Financial Results `
- General and administrative (G&A) expenses were $5.0 million for the quarter ended December 31, 2021, which included a non-cash credit of $2.0 million related to the reversal of share-based compensation expense. For the same period in the prior year, G&A expenses were $10.4 million, which included $2.1 million in non-recurring personnel costs. The decrease was primarily driven by lower share-based compensation expense.
- Net loss attributable to the Company was $9.5 million for the quarter ended December 31, 2021, compared to $17.6 million for the quarter ended December 31, 2020.
Full Year 2021 Financial Results
- R&D expenses were $36.9 million for the year ended December 31, 2021, compared to $41.8 million for the year ended December 31, 2020. The $4.9 million decrease was primarily due to lower clinical development expense and non-cash share-based compensation expense, partially offset by higher personnel costs, pre-clinical and professional services expenses, as well as the $2.9 million NDA application fee paid to the FDA, which is expected to be refunded during the second quarter of 2022.
- G&A expenses were $30.7 million for the year ended December 31, 2021, compared to $22.6 million for the year ended December 31, 2020. The majority of the $8.1 million increase was due to higher pre-commercialization expenses for Plinabulin. We do not expect to continue to incur pre-commercialization expenses during the next year. There were also increases in personnel costs, administrative expenses and other costs, which were partially offset by lower non-cash share-based compensation expense.
- Net loss attributable to the Company was $64.2 million for the year ended December 31, 2021, compared to $61.0 million for the year ended December 31, 2020.
- As of December 31, 2021, the Company had cash, cash equivalents, and short-term investments of $72.4 million. The Company believes it has sufficient cash to support its ongoing operations and clinical programs over the next year.
Fourth Quarter and Full Year 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, April 14, 2022, at 8:00 am ET. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or +1-201-389-0879 (International). The passcode for the conference call is 13728822. To access the live webcast or subsequent archived recording, click here or visit the “investors” section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the Company’s website for 90 days.
Headquartered in New York City, BeyondSpring is a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset, Plinabulin, is being developed as a “pipeline in a drug” in various cancer indications as a direct anti-cancer agent and to prevent chemotherapy-induced neutropenia (CIN). The Plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data. In the DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, the Plinabulin and docetaxel combination met the primary endpoint of extending overall survival compared to docetaxel alone, in 2nd/3rd line non-small cell lung cancer (NSCLC) (EGFR wild type). Additionally, Plinabulin is being broadly studied in combination with various immuno-oncology regimens that could boost the efficacy of PD-1/PD-L1 antibodies in seven different cancers. Lastly, BeyondSpring’s pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.
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 the Company’s 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.
Ashley R. Robinson
LifeSci Advisors, LLC
Darren Opland, Ph.D.
Financial Tables to Follow
|CONSOLIDATED BALANCE SHEETS|
|(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)|
|As of December 31,|
|Cash and cash equivalents||109,537||41,625|
|Advances to suppliers||3,505||1,735|
|Prepaid expenses and other current assets||358||1,020|
|Total current assets||113,400||75,123|
|Property and equipment, net||184||1,422|
|Operating lease right-of-use assets||2,174||1,984|
|Other noncurrent assets||1,280||3,119|
|Total noncurrent assets||3,638||6,525|
|Liabilities and equity|
|Current portion of operating lease liabilities||787||538|
|Long-term loans, current portion||–||1,569|
|Other current liabilities||3,806||6,165|
|Total current liabilities||13,766||15,155|
|Operating lease liabilities||1,359||1,468|
|Other noncurrent liabilities||–||709|
|Total noncurrent liabilities||11,451||40,116|
|Commitments and contingencies|
|Contingently redeemable noncontrolling interests||5,196||5,454|
|Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,141,913 and 38,927,563 shares issued and outstanding as of December 31, 2020 and 2021, respectively)||4||4|
|Additional paid-in capital||366,451||369,200|
|Accumulated other comprehensive loss||-297||-523|
|Total BeyondSpring Inc.’s shareholders’ equity||88,340||26,684|
|Total liabilities, mezzanine equity and equity||117,038||81,648|
|CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)|
|Year ended December 31,|
|Research and development||-31,342||-41,793||-36,888|
|General and administrative||-8,965||-22,598||-30,703|
|Loss from operations||-40,307||-64,211||-66,240|
|Foreign exchange (loss) gain, net||-4||355||231|
|Other income, net||–||4||1,360|
|Loss before income tax||-40,333||-63,821||-64,638|
|Income tax expenses||–||–||-3,570|
|Less: Net loss attributable to noncontrolling interests||-2,248||-2,848||-4,029|
|Net loss attributable to BeyondSpring Inc.|
|Net loss per share|
|Basic and diluted||-1.55||-2.03||-1.64|
|Weighted average shares outstanding|
|Basic and diluted||24,645,714||29,984,284||39,023,643|
|Other comprehensive loss, net of tax of nil:|
|Foreign currency translation adjustment gain (loss)||96||-530||-296|
|Unrealized holding gain||–||–||5|
|Less: Comprehensive loss attributable to noncontrolling interests||-2,250||-2,941||-4,094|
|Comprehensive loss attributable to BeyondSpring Inc.||-37,987||-61,410||-64,405|