On September 18, 2019 BeyondSpring Inc. ("BeyondSpring" or the "Company") (NASDAQ:BYSI), a global biopharmaceutical company focused on developing transforming immuno-oncology cancer therapies, reported its financial results for the three months ended June 30, 2019, and provided an update on its operations (Press release, BeyondSpring Pharmaceuticals, SEP 18, 2019, View Source [SID1234539609]).
"During the second quarter, we continued to demonstrate Plinabulin’s favorable drug profile for the treatment of NSCLC and CIN," said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. "In addition to results from our CIN studies, which provided strong rationale for the use of Plinabulin alone and in combination with G-CSF for the prevention of intermediate-risk and high-risk CIN, the Data Safety Monitoring Board advised Study 103 to continue after the first interim analysis."
"In the near term, we expect to continue to generate additional data for Plinabulin in both NSCLC and CIN indications to support NDA filings in China followed by the U.S. Our recent financing activities position us well to achieve these key milestones," added Dr. Huang.
Select Second-Quarter 2019 and Recent Highlights
NSCLC
Study 103
In September 2019, BeyondSpring announced that a poster describing the Company’s novel design for Study 103, titled "DUBLIN-3, a Phase (Ph) III Trial Comparing the Plinabulin (P) / Docetaxel (D) Combination with D Alone in Stage IIIB / IV NSCLC," was presented at the International Association for the Study of Lung Cancer World Conference on Lung Cancer in Barcelona, Spain.
CIN
Study 105 (Intermediate-Risk Chemotherapy)
In August 2019, BeyondSpring announced that an abstract, titled "Quality of Life (QoL) in Advanced NSCLC Patients Treated with Docetaxel and with Either Plinabulin or Pegfilgrastim for the Prevention of Neutropenia," was accepted for presentation at the September 8, 2019 IASLC World Conference on Lung Cancer. The abstract demonstrates that, compared to Neulasta, Plinabulin at 20mg/m2 significantly improves QoL over four treatment cycles. Plinabulin also significantly improved fatigue, pain and insomnia.
At the International Society for Pharmacoeconomics and Outcomes Research 2019 Conference in May 2019, Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University Medical Center, presented data derived from the Phase 2 portion of Study 105 demonstrating that Plinabulin at 20mg/m2 has a similar efficacy profile in reducing docetaxel-induced neutropenia as Neulasta 6mg, while avoiding the patient-reported bone pain typically observed with Neulasta.
Study 106 (High-Risk Chemotherapy)
In June 2019, BeyondSpring announced that two abstracts were accepted for publication in the Proceedings of the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. The data, derived from the Phase 2 portion of Study 106, provided a strong rationale for the Plinabulin-G-CSF combination for the prevention of CIN for improved CIN control. Additionally, the Plinabulin-G-CSF combination nearly eliminated patients’ treatment-related bone pain.
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BeyondSpring is currently initiating the Phase 3 portion of Study 106.
Mechanism of Action
In April 2019, BeyondSpring presented novel data relevant to predictive biomarkers for patient selection for Plinabulin at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. At the same conference, BeyondSpring presented preclinical data demonstrating Plinabulin’s ability to reduce tumor associated M2 macrophages, which are thought to support tumor cell survival and metastasis, as well as shift the phenotypic balance to one favoring M1 macrophages, which are thought to have anti-cancer properties.
Equity Financings
On July 19, 2019, BeyondSpring closed a public offering, led by Decheng Capital, of 2,058,825 ordinary shares at a public offering price of $17.00 per share. Gross proceeds from the public offering were $35.0 million, before deducting underwriting discounts and commissions and other offering expenses. The Company intends to use the net proceeds of this offering to support continued clinical and pre-clinical development and for general corporate purposes.
In June and July 2019, BeyondSpring’s partially owned Chinese subsidiary, Dalian Wanchunbulin Pharmaceuticals Ltd. ("Wanchunbulin") entered into definitive agreements for the sale of its equity interests ("Equity Purchase Agreements") to certain investors led by Efung Capital. Under the Equity Purchase Agreements, Wanchunbulin expects to sell 4.76% of the equity of Wanchunbulin for aggregate cash consideration of RMB 100 million, or approximately $14.5 million, before deducting offering expenses, to finance clinical and pre-clinical development and for general corporate purposes. To date, the Company has received RMB 70 million, or approximately $10.1 million, from this equity financing.
In May 2019, BeyondSpring entered into an Open Market Sale AgreementSM with Jefferies LLC to sell ordinary shares of the Company, with aggregate gross proceeds of up to $30.0 million, from time to time, through an at-the-market ("ATM") facility. In July 2019, this facility was suspended in anticipation of the public offering completed on July 19, 2019. As at the ATM’s suspension date, the Company had received aggregate gross proceeds of $13.0 million on 620,753 ordinary shares already sold through this facility.
Financial Results for the Three Months Ended June 30, 2019
Research and development ("R&D") expenses were $5.2 million for the quarter ended June 30, 2019, compared to $11.0 million for the quarter ended June 30, 2018. The $5.8 million decrease in R&D expenses was largely attributable to a $3.9 million decrease in expense incurred by clinical research organizations and other service fee related to clinical trials, a $1.1 million decrease in manufacturing expenses and a $0.8 million decrease in non-cash share-based compensation.
General and administrative ("G&A") expenses were $2.1 million for the quarter ended June 30, 2019, compared to $1.4 million for the quarter ended June 30, 2018. The $0.7 million increase in G&A expenses was mainly due to non-cash share-based compensation.
Net loss attributable to the Company was $7.4 million for the quarter ended June 30, 2019, compared to $12.2 million for the quarter ended June 30, 2018.
As of June 30, 2019, the Company had a cash balance of $0.7 million. With the net proceeds received from the recent equity financing activities described above, the Company believes it has sufficient cash to support its clinical trials and submit NDAs in China for Plinabulin for the treatment of CIN and NSCLC, and to advance its immuno-oncology pipeline and its ubiquitination protein degradation research platform.
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Anticipated Milestones
The following outlines the Company’s key anticipated upcoming milestones and projected timelines.
Second interim analysis for Study 103 Phase 3 for NSCLC – Q4 2019 / Q1 2020
Final data readout for Study 105 Phase 3 for CIN – Q1 2020
Top line data readout for Study 106 Phase 3 for CIN – Q1 2020
Submit NDAs to China’s National Medical Products Administration for Plinabulin for NSCLC and CIN – Q1 2020
Submit NDAs to the FDA for Plinabulin for NSCLC and CIN – 2020
Conference Call and Webcast Information
BeyondSpring’s management will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the financial results and provide a corporate update. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID 13694411. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under "Events & Presentations" in the Investors section. An archived replay of the webcast will be available for 30 days.