BeyondSpring Reports First-Quarter 2020 Financial Results and Operational Update
June 11, 2020
PROTECTIVE-2 (Study 106) Phase 3 Interim Analysis This Month to Evaluate Superiority in CIN
PROTECTIVE-2 Phase 2 Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes
DUBLIN-3 (Study 103 Phase 3) Second Interim Analysis for NSCLC Received DSMB’s Recommendation to Continue Without Modification
NEW YORK, June 11, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today its financial results and provided an operational update for the three months ended March 31, 2020. “During the first quarter, we continued to make progress in the two lead indications for Plinabulin for both the prevention of chemotherapy-induced neutropenia (CIN) and treatment of non-small cell lung cancer (NSCLC),” said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer. “Our recent data from PROTECTIVE-2 Phase 2 showed Plinabulin combined with G-CSF improves chemotherapy compliance compared to G-CSF alone, which potentially leads to better clinical outcomes. The Plinabulin-G-CSF combination’s potential to prevent infection and hospitalization becomes even more important to the physicians, patients and the healthcare system in the COVID-19 pandemic. We expect to reach the pre-specified interim analysis for PROTECTIVE-2 Phase 3 this month to evaluate superiority in CIN, which has the potential to mark the first significant enhancement in preventing neutropenia in 30 years.” “With over 1,200 patients enrolled to date for Plinabulin clinical programs, we believe we are well-positioned to capitalize on our upcoming regulatory milestones with multiple New Drug Application (NDA) filings followed by near term commercial opportunities. Looking ahead, we continue to advance our clinical studies to support our view of Plinabulin as a ‘pipeline in a drug’ and believe its potential in improving standard of care in CIN prevention and cancer treatments will help many patients in need globally.”
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin 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 two 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. 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.
Select First-Quarter 2020 and Recent Operational Highlights
Chemotherapy-Induced Neutropenia (CIN)
PROTECTIVE-2 Phase 2 for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes In June 2020, BeyondSpring announced that PROTECTIVE-2 Phase 2 superiority trial for CIN shows that Plinabulin in combination with Neulasta (pegfilgrastim), a long-lasting G-CSF, which is a predominant therapy to treat CIN, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes. In breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (n=16) compared with 6mg of Neulasta alone (n=22), Plinabulin + G-CSF improved compliance with targeted chemotherapy Dose reduction (over 15 percent): only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement Downgraded regimen (from TAC to TC): No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm – p < 0.05 Plinabulin’s Mechanism of Action Complements Neulasta in Cancer Treatment In May 2020, two Company abstracts were presented at this year’s American Society of Clinical Oncology (ASCO) Virtual Scientific Program, evaluating Plinabulin alongside Neulasta. BeyondSpring’s e-publication, titled, “Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin),” demonstrates the efficacy of Plinabulin-Neulasta combination in increasing CD34+ counts for patients, with fewer adverse events Additionally, BeyondSpring’s poster presentation, titled, “Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial,” compares Plinabulin versus Neulasta as an effective monotherapy for CIN prevention.
Non-Small Cell Lung Cancer (NSCLC)
DSMB Recommends DUBLIN-3 Phase 3 NSCLC to Continue Without Modification In June 2020, BeyondSpring reported it had reached the pre-specified second interim analysis for DUBLIN-3 for NSCLC treatment with Plinabulin. Upon reviewing the efficacy and safety data of over 500 patients at an approximately 300-patient death event, DSMB advised BeyondSpring to continue the study without any modifications DUBLIN-3 is a global Phase 3 trial for Plinabulin, in combination with docetaxel versus docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC Thus far, over 600 cancer patients have been dosed with Plinabulin, which has demonstrated good tolerability and satisfies the safety database standard of both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA)
BeyondSpring Granted U.S. Patent for Plinabulin to Treat Severe CIN from Taxane in Cancer Patients In May 2020, the U.S. Patent and Trademark Office (USPTO) granted BeyondSpring a new patent for methods of treating severe CIN in cancer patients treated with taxane with protection through 2033. This patent establishes Plinabulin’s beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies The Company currently owns 76 patents, including 17 issued U.S. patents, for Plinabulin and its analogs with protection through 2036
Financial Results for the Three Months Ended March 31, 2020
Research and development (“R&D”) expenses were $13.7 million for the quarter ended March 31, 2020, compared to $6.3 million for the quarter ended March 31, 2019. The $7.4 million increase was largely attributable to an increase of $4.4 million in clinical trial expenses and an increase of $3.0 million in non-cash share-based compensation. Selling, general and administrative (“SG&A”) expenses were $2.9 million for the quarter ended March 31, 2020, compared to $1.6 million for the quarter ended March 31, 2019. The $1.3 million increase was mainly due to a $0.6 million increase in commercial and marketing expense, a $0.3 million increase in salary, wages and benefits expense, and a $0.4 million increase in other expenses. Net loss attributable to the Company was $16.1 million for the quarter ended March 31, 2020, compared to $7.3 million for the quarter ended March 31, 2019. As of March 31, 2020, the Company had a cash balance of $24.9 million. The Company believes currently available financial resources will be sufficient to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the CIN and NSCLC indications, as well as to advance its immuno-oncology pipeline and ubiquitination protein degradation research platform.
The following outlines the Company’s anticipated upcoming milestones and projected timelines: Interim topline data readout for PROTECTIVE-2 Phase 3 for CIN – June 2020 Final data readout for PROTECTIVE-2 Phase 3 for CIN – H2 2020 Final data readout for PROTECTIVE-1 Phase 3 for CIN – H2 2020 NDA submission for Plinabulin for CIN in the U.S. – H2 2020 Final data readout for DUBLIN-3 for NSCLC – H2 2020 NDA submission for Plinabulin for NSCLC in China – H2 2020 NDA submission for Plinabulin for NSCLC in the U.S. – H1 2021
BeyondSpring is a global clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (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 ubiquitination degradation pathway. 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.
BEYONDSPRING INC. AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2020 (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) December 31, March 31, 2019 2020 $ $ (Unaudited) Assets Current assets: Cash and cash equivalents 35,933 24,917 Advances to suppliers 4,519 4,384 Prepaid expenses and other current assets 410 452 Total current assets 40,862 29,753 Noncurrent assets: Property and equipment, net 209 203 Operating lease right-of-use assets 2,538 2,607 Other noncurrent assets 946 941 Total noncurrent assets 3,693 3,751 Total assets 44,555 33,504 Liabilities and equity Current liabilities: Accounts payable 2,537 5,140 Accrued expenses 5,861 4,697 Due to related parties 29 42 Current portion of operating lease liabilities 537 643 Other current liabilities 1,089 1,685 Total current liabilities 10,053 12,207 Noncurrent liabilities: Long-term loans 1,436 1,413 Operating lease liabilities 1,935 1,892 Total noncurrent liabilities 3,371 3,305 Total liabilities 13,424 15,512 Equity: Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 27,885,613 shares and 27,888,906 shares issued and outstanding as of December 31, 2019 and March 31, 2020, respectively) 3 3 Additional paid-in capital 246,979 250,417 Accumulated deficit (216,845) (232,929) Accumulated other comprehensive income 140 197 Total BeyondSpring Inc.’s shareholder’s equity 30,277 17,688 Noncontrolling interests 854 304 Total equity 31,131 17,992 Total liabilities and equity 44,555 33,504 BEYONDSPRING INC. UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2019 AND 2020 (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) (Unaudited) Three months ended March 31, 2019 2020 $ $ Revenue – – Operating expenses: Research and development (6,330) (13,704) Selling, general and administrative (1,639) (2,928) Loss from operations (7,969) (16,632) Foreign exchange gain (loss), net 173 (74) Interest income 6 64 Interest expense (37)) (21) Other income – 1 Loss before income tax (7,827) (16,662) Income tax benefit – – Net loss (7,827) (16,662) Less: Net loss attributable to noncontrolling interests (534) (578) Net loss attributable to BeyondSpring Inc. (7,293) (16,084) Net loss per share Basic and diluted (0.32)) (0.58) Weighted-average shares outstanding Basic and diluted 23,029,362 27,732,449 Other comprehensive loss Foreign currency translation adjustment (loss) gain (194) 53 Comprehensive loss (8,021) (16,609) Less: Comprehensive loss attributable to noncontrolling interests (575) (582) Comprehensive loss attributable to BeyondSpring Inc. (7,446) (16,027)
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