– NDA Filed by U.S. Food and Drug Administration (FDA) and given Priority Review for plinabulin plus G-CSF for the prevention of CIN. A PDUFA date of November 30, 2021 has been assigned by the FDA
– Highlighted PROTECTIVE-2 Phase 3 data at two scientific conferences – ASCO and FOCIS – showing plinabulin in combination with G-CSF to have superior benefit in reducing the incidence and severity of febrile neutropenia and hospitalization rates and better QoL compared to pegfilgrastim alone
– Advanced clinical development of combination plinabulin + checkpoint inhibitors in PD-1/PD-L1-resistant tumors: presented promising Phase 1 anti-cancer data in PD-1/PD-L1-resistant SCLC at ASCO 2021; dosed first patient in a triple IO combination Phase 1 study in seven advanced solid tumors
NEW YORK, June 16, 2021 (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 for the first quarter ended March 31, 2021 and provided an update on recent corporate events.
“This quarter was marked by meaningful progress on the road toward building our lead first-in-class asset, plinabulin, as a pipeline in a drug, from treating chemotherapy side effects to treating cancer directly,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring. “We are grateful that our NDA for chemotherapy-induced neutropenia (CIN) prevention was filed by the U.S. FDA with priority review. Our plinabulin and G-CSF combination has the potential to elevate the standard of care in CIN for the first time in 30 years. In addition, in the coming months, we plan to announce topline anti-cancer overall survival data from the Phase 3 DUBLIN-3 trial in NSCLC. We are building clinical evidence to demonstrate that plinabulin is a potent antigen presenting cell (APC) inducer with potential to be a ‘game changer’ in cancer treatment for severely unmet medical needs.”
Recent Corporate Highlights
Lead Asset Plinabulin, a “Pipeline in a Drug”
Clinical Update
- June 2021: Announced Food and Drug Administration (FDA) filing of New Drug Application with Priority Review for plinabulin and G-CSF combination for the prevention of CIN. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021.
- June 2021: Presented three poster presentations at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) highlighting the Company’s PROTECTIVE-2 Phase 3 data demonstrating combination plinabulin + pegfilgrastim offers superior benefit in reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone.
- June 2021: Announced late-breaking poster presentation at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting highlighting data from Phase 3 PROTECTIVE-2 CIN Study showing plinabulin in combination with pegfilgrastim improves CIN prevention and reverses key aspects of the immune suppressive profile of monotherapy pegfilgrastim.
- June 2021: Presented data at ASCO 2021 of plinabulin in combination with nivolumab and ipilimumab, showing a 46% objective response rate (ORR) in 13 evaluable patients with PD-1/PD-L1 naïve or resistant tumors in 2nd line and beyond in small cell lung cancer (SCLC). Additionally, data demonstrated the plinabulin combination was able to re-sensitize tumors to I/O therapy, that had progressed on prior PD-1/PD-L1 inhibitors, with a 43% ORR.
- June 2021: Dosed first patient in a triple combination study with plinabulin, PD-1/PD-L1 inhibitor and radiotherapy at MD Anderson for the reversal of resistance to PD-1/PD-L1 inhibitors in patients with seven advanced solid tumors.
Upcoming Clinical Milestones
- Mid-2021 (DUBLIN-3): Topline overall survival (OS) data expected in pivotal Phase 3 non-small cell lung cancer (NSCLC) study.
- 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 PD-1/PD-L1-failed patients in seven cancers, including bladder cancer, melanoma, Merkel cell cancer, MSI-H Cancers (of any histology), NSCLC, renal cell cancer, and SCLC.
First Quarter 2021 Financial Results
Research and development (“R&D”) expenses were $11.3 million for the quarter ended March 31, 2021, compared to $13.7 million for the quarter ended March 31, 2020. The decrease of $2.4 million was primarily due to a decrease in clinical trial expenses and non-cash stock-based compensation expense, partially offset by an increase in manufacturing costs and the cost of the plinabulin regulatory filings.
General and administrative (“G&A”) expenses were $6.4 million for the quarter ended March 31, 2021, compared to $2.9 million for the quarter ended March 31, 2020. The $3.5 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 $17.0 million for the quarter ended March 31, 2021, compared to $16.1 million for the quarter ended March 31, 2020.
As of March 31, 2021, the Company had cash and cash equivalents of $90.6 million on hand. 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.
First Quarter 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, June 16, 2021, at 8:30 am ET. The conference call can be accessed by dialing 855-327-6837 (U.S. and Canada) or +1-631-891-4304 (International). The passcode for the conference call is 10014535. 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.
About BeyondSpring
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, a Selective Immunomodulating Microtubule-Binding Agent (SIMBA), is being developed a “pipeline in a drug.” It is filed for approval and has received Priority Review in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021, and has a fully enrolled pivotal study (Dublin-3) to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. 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.
Investor Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
arr@lifesciadvisors.com
Media Contact:
Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
darren@lifescicomms.com
| BEYONDSPRING INC. | ||||||
| AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2020 AND | ||||||
| UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2021 | ||||||
| (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) | ||||||
| December 31, | March 31, | |||||
| 2020 | 2021 | |||||
| $ | $ | |||||
| (Unaudited) | ||||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | 109,537 | 90,574 | ||||
| Advances to suppliers | 3,505 | 3,436 | ||||
| Prepaid expenses and other current assets | 358 | 362 | ||||
| Total current assets | 113,400 | 94,372 | ||||
| Noncurrent assets: | ||||||
| Property and equipment, net | 184 | 175 | ||||
| Operating lease right-of-use assets | 2,174 | 1,250 | ||||
| Other noncurrent assets | 1,280 | 1,296 | ||||
| Total noncurrent assets | 3,638 | 2,721 | ||||
| Total assets | 117,038 | 97,093 | ||||
| Liabilities, mezzanine equity and equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | 2,216 | 1,569 | ||||
| Accrued expenses | 5,607 | 5,756 | ||||
| Current portion of operating lease liabilities | 787 | 505 | ||||
| Deferred revenue | 1,350 | 1,350 | ||||
| Long-term loans, current portion | – | 1,526 | ||||
| Other current liabilities | 3,806 | 1,924 | ||||
| Total current liabilities | 13,766 | 12,630 | ||||
| Noncurrent liabilities: | ||||||
| Long-term loans | 2,167 | 635 | ||||
| Operating lease liabilities | 1,359 | 673 | ||||
| Deferred revenue | 7,925 | 7,587 | ||||
| Total noncurrent liabilities | 11,451 | 8,895 | ||||
| Total liabilities | 25,217 | 21,525 | ||||
| Commitments and contingencies | ||||||
| Mezzanine Equity | ||||||
| Contingently redeemable noncontrolling interests | 5,196 | 5,196 | ||||
| Equity | ||||||
| Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,141,913 and 39,106,476 shares issued and outstanding as of December 31, 2020 and March 31, 2021, respectively) | 4 | 4 | ||||
| Additional paid-in capital | 366,451 | 367,555 | ||||
| Accumulated deficit | (277,818 | ) | (294,806 | ) | ||
| Accumulated other comprehensive loss | (297 | ) | (247 | ) | ||
| Total BeyondSpring Inc.’s shareholders’ equity | 88,340 | 72,506 | ||||
| Noncontrolling interests | (1,715 | ) | (2,134 | ) | ||
| Total equity | 86,625 | 70,372 | ||||
| Total liabilities, mezzanine equity and equity | 117,038 | 97,093 | ||||
| The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. | ||||||
| BEYONDSPRING INC. | ||||||
| UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF | ||||||
| COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2020 AND 2021 | ||||||
| (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) | ||||||
| (Unaudited) | ||||||
| Three months ended March 31, | ||||||
| 2020 | 2021 | |||||
| Revenue | – | 338 | ||||
| Operating expenses | ||||||
| Research and development | (13,704 | ) | (11,311 | ) | ||
| General and administrative | (2,928 | ) | (6,447 | ) | ||
| Loss from operations | (16,632 | ) | (17,420 | ) | ||
| Foreign exchange loss, net | (74 | ) | (31 | ) | ||
| Interest income | 64 | 32 | ||||
| Interest expense | (21 | ) | (24 | ) | ||
| Other income | 1 | – | ||||
| Loss before income tax | (16,662 | ) | (17,443 | ) | ||
| Income tax benefit | – | – | ||||
| Net loss | (16,662 | ) | (17,443 | ) | ||
| Less: Net loss attributable to noncontrolling interests | (578 | ) | (455 | ) | ||
| Net loss attributable to BeyondSpring Inc. | (16,084 | ) | (16,988 | ) | ||
| Net loss per share | ||||||
| Basic and diluted | (0.58 | ) | (0.44 | ) | ||
| Weighted average shares outstanding | ||||||
| Basic and diluted | 27,732,449 | 39,004,609 | ||||
| Other comprehensive loss, net of tax of nil: | ||||||
| Foreign currency translation adjustment gain | 53 | 73 | ||||
| Comprehensive loss | (16,609 | ) | (17,370 | ) | ||
| Less: Comprehensive loss attributable to noncontrolling interests | (582 | ) | (432 | ) | ||
| Comprehensive loss attributable to BeyondSpring Inc. | (16,027 | ) | (16,938 | ) | ||
| The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. | ||||||