– Management to host a call today at 8:00 am ET
NEW YORK, Sept. 10, 2021 – 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 for the second quarter ended June 30, 2021 and provided an update on recent corporate events.
“We had a very productive first half of 2021. Importantly, we were thrilled to announce positive data from our registrational trial of plinabulin in 2nd/3rd line NSCLC, which showed significant improvement in overall survival, especially the doubling of 2-year and 3-year survival in the plinabulin and docetaxel arm vs. docetaxel alone. This underscores plinabulin’s immune durable anti-cancer benefit, which could be the gateway for its development in multiple cancer indication in triple IO combos. With the significant survival benefit and significant reduction in severe neutropenia of chemotherapy, we expect that plinabulin’s optimum profile for patient’s need is just beginning to be revealed. These data set the stage for multiple near-term catalysts over the next 6-12 months,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.
“Our commercial teams are very busy preparing for the potential near-term commercial launch of plinabulin in our first indication in the U.S. At the same time, we have strategically positioned plinabulin for commercial success in Greater China by partnering with Hengrui, the leading oncology R&D and commercial company in China with great synergy in its pipeline with plinabulin. We believe we are truly on the cusp of unlocking the tremendous potential of plinabulin to help many patients in need,” Dr. Huang continued.
Recent Clinical and Corporate Highlights
- DUBLIN-3 Study (2nd/3rd line NSCLC – EGFR wild type, a global, single-blinded randomized active controlled registrational study, Plinabulin + Docetaxel vs. Docetaxel alone, primary endpoint: Overall Survival):
Announced positive topline results of plinabulin in combination with docetaxel for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) with EGFR wild type.
- The data showed that, compared to docetaxel alone, the combination met the primary endpoint of increasing overall survival (mean OS, p=0.03; OS log-rank, p<0.04).
- It also met key secondary endpoints, including significantly improving ORR, PFS, and 24- and 36-month OS (double OS rate vs. docetaxel) rates, and significant reduction in the incidence of Grade 4 neutropenia.
- OS rate for 48 months is at 10.6% for plinabulin + docetaxel vs. 0% for docetaxel alone.
- Greater China Partnership on Plinabulin with Hengrui, leading R&D and commercialization company in oncology products in China:
Announced an exclusive commercialization and co-development agreement between Jiangsu Hengrui Pharmaceuticals Co., Ltd. (or “Hengrui”) and Wanchunbulin, BeyondSpring’s China subsidiary, for plinabulin in Greater China, the key terms of which are outlined below:
- The NDA filing for plinabulin in China has been accepted with Priority Review for prevention of CIN.
- Hengrui receives exclusive commercialization and co-development rights to plinabulin in all indications in Greater China.
- BeyondSpring retains global rights outside of Greater China.
- Wanchunbulin retains manufacturing rights and is entitled to receive the full amount of sales proceeds, and will pay Hengrui a pre-determined percentage of the net sales of plinabulin in Greater China.
- Wanchunbulin to receive up to 1.3B RMB (est. US$200M), including an upfront payment of 200M RMB (est. US$30M) and regulatory and sales milestones of up to 1.1B RMB (est. US$170M).
- Hengrui to pay all commercialization costs, and will pay 50% of clinical development costs for future indications after CIN and NSCLC.
- Hengrui will make an equity investment of 100M RMB (est. US$15M) into Wanchunbulin at a pre-money valuation of 3.6B RMB (est. US$560M).
- Plinabulin Triple IO combo in severe cancer indications (Phase 1 and phase 2 IIT Studies):
- SCLC phase 1 data (plinabulin + Nivolumab + Ipilimumab) presented at ASCO (patients from US sites): 46% ORR for all 2nd/3rd line patients, and 43% for PD-L1 inhibitor failed patients (with long duration of treatment as long as 18 months).
- Patients with 7 solid tumor types that failed PD-1/PD-L1 inhibitor at MD Anderson: first patient enrolled in June 2021. These 7 cancers include bladder cancer, melanoma, Merkel cell cancer, MSI-H Cancers (of any histology), NSCLC, renal cell cancer, and SCLC.
- Added Board Member to strengthen commercial readiness for plinabulin
Strengthened its Board of Directors with the addition of Mr. Brendan Delaney, bringing significant expertise in commercial oncology drug launches.
- Delaney currently serves as the Chief Commercial Officer of Constellation Pharma. Prior to this, he was the Chief Commercial Officer of Immunomedics, where he led the buildout of the marketing, sales, market access, and commercial operations teams.
- September 20, 2021: ESMO Late-breaking oral presentation on DUBLIN-3
- November 30, 2021: PDUFA date for plinabulin in CIN prevention
- 1H 2022: NDA Submission for plinabulin in NSCLC
- 2022: (Big Ten Cancer Research Consortium, Investigator Initiated study): Phase 2 Data expected in plinabulin + nivolumab + ipilimumab in checkpoint inhibitor-resistant SCLC.
- 2022: (MD Anderson investigator led study): Phase 1 Data expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in patients with seven cancer types that failed PD-1/PD-L1.
Second Quarter Financial Results
- Research and development (“R&D”) expenses were $11.3 million for the quarter ended June 30, 2021, compared to $11.0 million for the quarter ended June 30, 2020. The increase was primarily due to higher personnel and non-cash stock-based compensation expenses, which were partially offset by lower clinical development expenses.
- General and administrative (“G&A”) expenses were $9.0 million for the quarter ended June 30, 2021, compared to $2.6 million for the quarter ended June 30, 2020. The $6.4 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense, and costs associated with plinabulin pre-commercialization activities.
- Net loss attributable to the Company was $19.3 million for the quarter ended June 30, 2021, compared to $12.8 million for the quarter ended June 30, 2020.
- As of June 30, 2021, the Company had cash, cash equivalents, and short-term investments of $76.3 million. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline, and to prepare for a potential launch of plinabulin in CIN in early 2022.
Year-to-Date Financial Results
- R&D expenses were $22.6 million for the six-month period ended June 30, 2021, compared to $24.7 million for the six-month period ended June 30, 2020. The $2.1 million decrease was primarily due to lower clinical development, regulatory and non-cash stock-based compensation expenses that were partially offset by higher personnel costs.
- G&A expenses were $15.4 million for the six-month period ended June 30, 2021, compared to $5.5 million for the six-month period ended June 30, 2020. The $9.9 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense, as well as costs associated with plinabulin pre-commercialization activities.
- Net loss attributable to the Company was $36.3 million for the six-month period ended June 30, 2021, compared to $28.8 million for the six-month period ended June 30, 2020.
Second Quarter 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, September 10, 2021, 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 13722968 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 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 direct anti-cancer agent and to prevent chemotherapy induced neutropenia (CIN). Plinabulin and G-CSF combination has filed for approval and has received breakthrough designation and Priority Review in the U.S. and China for the prevention of CIN with a PDUFA date of November 30, 2021, in the U.S. In DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, plinabulin and docetaxel combination has met the primary endpoint of extending overall survival compared to docetaxel alone, in 2nd/3rd line NSCLC (EGFR wild type). Additionally, it 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. In addition to plinabulin, BeyondSpring’s extensive 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 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.
Ashley R. Robinson
LifeSci Advisors, LLC
Darren Opland, Ph.D.