NEW YORK, April 03, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company”) (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, today announced its fourth-quarter and full-year financial results for the period ended Dec. 31, 2017, and provided an update on the Company’s operations.
“BeyondSpring successfully achieved multiple significant milestones in 2017, including our initial public offering earlier in the year, followed by several clinical development advances for our novel lead clinical candidate, Plinabulin, as well as advancement of our emerging, early-stage pipeline of immuno-oncology therapies, and ubiquitination protein degradation research platform,” said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. “Our proprietary pipeline, combined with our unique China-U.S. development, regulatory and commercialization strategy, set the stage for us to continue the momentum begun in 2017, with a milestone-rich year ahead for the Company.
“In China, BeyondSpring’s leadership and lead-asset, Plinabulin, have received numerous grants and honorary recognition from the Chinese government, including an unprecedented one-month approval of our clinical trial application, or CTA, in China for chemotherapy-induced neutropenia last year, that enable us to pursue early NDA submissions for Plinabulin and expedited regulatory review for both indications,” Dr. Huang continued. “We eagerly await the next data readouts from global registrational studies, Study 103 in non-small cell lung cancer, and Studies 105 and 106 in chemotherapy-induced neutropenia. If positive, these could position us for our first two NDA submissions to the China Food and Drug Administration late this year or early next year, with potential first commercialization in China in 2019, followed by NDA submissions to the U.S. Food and Drug Administration in 2019 for the CIN indication, and 2020 for the non-small cell lung cancer indication.”
Key Upcoming Milestones
The following outlines the Company's key anticipated upcoming milestones for the next 12 to 18 months.
- Announce Phase 3 interim analysis data for Study 105 evaluating Plinabulin + docetaxel for chemotherapy-induced neutropenia (CIN) – 4Q 2018
- Announce topline Phase 2 data for Study 106 evaluating Plinabulin + TAC (Taxotere®/Adriamycin™/cyclophosphamide) for CIN – late 2018
- Announce Phase 3 interim data for Study 103 evaluating Plinabulin + docetaxel for non-small cell lung cancer (NSCLC) – 4Q 2018/early 2019
- Submit NDA to China Food and Drug Administration (CFDA) for Plinabulin for CIN – late 2018/early 2019
- Submit NDA to CFDA for Plinabulin for NSCLC – 1H 2019
- Advance two Plinabulin triple combination immuno-oncology programs into Phase 1 – 2018
- Advance new pipeline asset, BPI-002, an oral CTLA-4 inhibitor, into Phase 1 in 2019
- Advance ubiquitination protein degradation research platform, first target of mutant KRAS, lead asset - 2019
Fourth-Quarter 2017 and Recent Highlights
Initiation of Phase 3 clinical development for Plinabulin for prevention of CIN
In March 2018, BeyondSpring announced that the Company had initiated the Phase 3 portion of Study 105 evaluating Plinabulin for the prevention of CIN associated with docetaxel, a cytotoxic chemotherapeutic. The Phase 3 portion of Study 105 is expected to enroll approximately 150 cancer patients at 55 sites in the U.S., China, Ukraine, Russia and Hungary. Patients will be randomized to receive either Neulasta® (pegfligrastim) or Plinabulin. The protocol provides for an interim analysis after 100 patients have been dosed after first-cycle chemotherapy, and the primary endpoint of the study is reduction of neutropenia measured by duration to severe neutropenia (DSN) in the first cycle.
Reported topline data from Phase 2 portion of global Phase 2/3 study of Plinabulin in CIN (Study 105)
At the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium in January, BeyondSpring presented data from the Phase 2 portion of its global Phase 2/3 Study 105 clinical trial of Plinabulin in the prevention of docetaxel CIN, showing comparable DSN for patients administered one dose of Plinabulin 30 minutes after docetaxel on the first day and one dose of G-CSF, Neulasta, 24 hours after docetaxel use. The data also showed a comparable incidence of grade 4 neutropenia for Neulasta and Plinabulin 20 mg/m2, the dose selected for the Phase 3 portion of the trial now initiated.
Unveiled combination immunotherapy program at 2018 ASCO-SITC Clinical Immuno-Oncology Symposium
Based on Phase 1 data demonstrating potential immune-enhancing effects of Plinabulin that were also presented at the conference, BeyondSpring announced its plans to initiate a broad development program with triple-combination immuno-oncology therapies that include a PD1-inhibitor/CTLA4-inhibitor/Plinabulin combination and PD1-inhibitor/chemotherapy/Plinabulin combination. Additional Phase 1 data from an investigator-sponsored study of Plinabulin in combination with nivolumab were also presented at the meeting, demonstrating that Plinabulin was well tolerated in the ten patients evaluated in the trial to-date, with no immune-related serious adverse events, and only two patients with grade 1 or 2 immune-related adverse events.
Announced interim analysis from Phase 3 Study of Plinabulin in NSCLC (Study 103), demonstrating statistically significant differences in CIN for patients treated with Plinabulin
In December 2017, the Company announced data related to a secondary endpoint of its Study 103 in patients with NSCLC. In this interim analysis of data from 138 patients from this Phase 3 study, Plinabulin was shown to reduce the percentage of patients with grade 4 neutropenia resulting from docetaxel therapy from 27.4 percent to 3.1 percent (p<0.0001).
Initiated second global Phase 2/3 clinical trial of Plinabulin (Study 106) for the prevention of CIN with a superiority endpoint
The Company initiated its second global Phase 2/3 clinical trial of Plinabulin for the prevention of CIN in November 2017. Study 106, first initiated in China, is enrolling patients who receive TAC chemotherapy, which often results in severe neutropenia, with a primary endpoint of DSN in patients administered Plinabulin and Neulasta.
Plinabulin included in China’s National Drug Priority List with Innovation Grant from government
China recognized Plinabulin as a National Science and Technology Major Project in 2017 (13th five-year plan grant awarded) for “essential new drug research and development,” resulting in Plinabulin’s inclusion in the National Drug Priority List, which facilitates a more rapid regulatory process with the CFDA. Subject to NDA approval and successful pricing negotiations with the government, Plinabulin would have the potential to be included in the National Insurance System in China.
Multiple non-dilutive grants support pipeline initiatives
In 2017, BeyondSpring received two China non-equity-diluting grants totaling approximately $920,000 (RMB $6.1 million). BeyondSpring received one grant in August 2017 from the Financial Service Development Council of Dalian for $450,000 (RMB $3.0 million) and received a second grant in September 2017 from the Financial and Monetary Bureau of Jinpu New Area of Dalian for $470,000 (RMB $3.1 million).
Financial Results for the Twelve Months Ended Dec. 31, 2017
Research and development (R&D) expenses were $88.9 million for the twelve months ended Dec. 31, 2017, compared to $10.4 million for the twelve months ended Dec. 31, 2016. R&D expenses for 2017 included $42.3 million in the purchase of the remaining interest in Plinabulin and $17.8 million in share-based compensation expense, both of which are non-cash expenses. Remaining R&D expensewas $28.8 million for 2017. In addition, the increase in R&D expenses in 2017 included increased costs related to the ongoing Phase 3 trial in advanced non-small cell lung cancer (Study 103), including a significant number of patients enrolled, additional investigator sites and additional drug cost, as well as costs related to Study 105.
General and administrative (G&A) expenses were $9.1 million for the twelve months ended Dec. 31, 2017, compared to $1.9 million for the twelve months ended Dec. 31, 2016. The increase in G&A expenses was primarily due to share-based compensation newly incurred in 2017 and the increase in advisory expenses, personnel and legal fees associated with operating as a public company.
U.S. GAAP net loss attributable to BeyondSpring Inc. was $91.8 million for the twelve months ended Dec. 31, 2017, compared to $12.0 million for the twelve months ended Dec. 31, 2016.
Cash and cash equivalents were $30.6 million at Dec. 31, 2017, compared to $40.7 million at Sept. 30, 2017, and $11.7 million at Dec. 31, 2016. The Company believes it has sufficient cash resources necessary to advance its ongoing clinical trials and submit the NDAs in China for Plinabulin for both the CIN and non-small cell lung cancer indications in late 2018 or early 2019 and the first half of 2019, respectively.
Conference Call and Webcast Information
The Company will host an operational update conference call on Tuesday, April 3, 2018, at 8:00 a.m. Eastern Time. The dial-in numbers for the conference call are (866) 362-6591 (U.S. Toll Free) or (706) 758-3199 (international). Please reference conference ID 3765248.
A live webcast of the conference call will be available through the Investors section of BeyondSpring’s website at http://ir.beyondspringpharma.com. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. A replay of the webcast will remain available on http://ir.beyondspringpharma.com for 30 days following the call.
Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia.
BeyondSpring is a global, clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with University of Washington in de novo drug discovery using ubiquitination platform. BeyondSpring’s lead asset, 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 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.
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," “project,” "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, the anticipated amount needed to finance the company's future operations; unexpected results of clinical trials; our expectations regarding the potential safety, efficacy or clinical utility of our product candidates; delays in our NDA submissions to the CFDA and U.S. Food and Drug Administration; delays or denial in regulatory approval processes; introduction of new clinical candidates that may be competitive with our drug candidates in development and increased competition in the marketplace; and other risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission (SEC). The 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.
Neulasta is a registered trademark of Amgen, Inc. Taxotere is a registered trademark of Aventis Pharma S.A. Corporation. Adriamycin is a trademark of Pharmacia & Upjohn Company LLC.
|CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)|
|Three months ended December 31,||Year ended December 31,|
|Research and development||(3,023||)||(14,704||)||(10,437||)||(88,928||)|
|General and administrative||(457||)||(1,835||)||(1,931||)||(9,053||)|
|Loss from operations||(3,480||)||(16,539||)||(12,368||)||(97,981||)|
|Foreign exchange gain (loss), net||(216||)||192||(195||)||555|
|Less: Net loss attributable to noncontrolling interests||(156||)||(797||)||(535||)||(4,625||)|
|Net loss attributable to BeyondSpring Inc.||(3,535||)||(15,492||)||(12,010||)||(91,763||)|
|Net loss per share|
|Basic and diluted||(0.21||)||(0.68||)||(0.75||)||(4.4||)|
|Weighted average shares outstanding|
|Basic and diluted||16,879,628||22,901,691||16,086,419||20,866,084|
|Other comprehensive loss|
|Foreign currency translation adjustment loss||(35||)||13||(64||)||(1||)|
|Total comprehensive loss||(3,726||)||(16,276||)||(12,609||)||(96,389||)|
|Less: Comprehensive loss||(167||)||(765||)||(561||)||(4,535||)|
|attributable to noncontrolling interests|
|Comprehensive loss attributable to BeyondSpring Inc.||(3,559||)||(15,511||)||(12,048||)||(91,854||)|
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|As of December 31,|
|Short term investment||-||3,074|
|Advances to suppliers||799||1,525|
|Deferred initial public offering cost||1,861||-|
|Prepaid expenses and other current assets||360||264|
|Total current assets||14,707||32,344|
|Property and equipment, net||80||123|
|Other noncurrent assets||121||361|
|Total noncurrent assets||201||484|
|Liabilities and equity|
|Due to related parties||210||-|
|Other current liabilities||235||299|
|Total current liabilities||2,609||4,792|
|Commitments and contingencies|
|Ordinary shares ($0.0001 par value; 500,000,000 shares|
|Authorized; 16,879,628 shares and 22,530,702 shares issued and outstanding as of December 31, 2016 and 2017, respectively)||2||2|
|Additional paid-in capital||44,369||151,147|
|Accumulated other comprehensive loss||(91||)||(182||)|
|Total BeyondSpring Inc. shareholders' equity||12,152||27,076|
|Total liabilities and equity||14,908||32,828|
Laura Perry or Joe Rayne