NEW YORK, April 28, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ Capital Markets:BYSI), a late-stage clinical development company focused on a rich pipeline of innovative immuno-oncology cancer therapies, today provided an operational update to the investment community, including financial results for the year ended December 31, 2016.
"In our first earnings report as a public company, we are pleased to provide the investment community with an update on our operations and insight into our clinical pipeline,” said Dr. Lan Huang, Ph.D., BeyondSpring CEO. “In March 2017, BeyondSpring successfully completed its initial public offering and concurrent private placement with Chinese and U.S. investors, significantly strengthening our balance sheet with an additional $48.17 million in total net proceeds.”
Dr. Huang added, “As a result of the IPO, BeyondSpring is well-positioned to advance our planned combination clinical programs for our lead asset, Plinabulin, a GEF-H1 activator with immune enhancing and neutropenia prevention activities. Our two most advanced clinical studies in registration trial stages for Plinabulin are for the prevention of chemotherapy-induced neutropenia and increasing overall survival in patients with advanced Non-Small Cell Lung Cancer (NSCLC) who have measurable lung lesions. Both neutropenia and NSCLC represent tremendous worldwide opportunities for BeyondSpring. We are extremely encouraged by our clinical results to date and expect to have additional catalysts in 6-12 months.”
2016 and Recent Business Highlights
BeyondSpring successfully completed its Initial Public Offering (IPO) and a concurrent private placement with the pricing on March 9, and closing on March 14, 2017. BeyondSpring raised total net proceeds of approximately $48.17 million; selling 174,286 ordinary shares at $20.00 per share in the IPO and concurrently completed a private placement transaction for 2,541,048 ordinary shares at $20.00 per share.
Plinabulin Mechanism of Action Update
Based on a three year collaborative effort with University of Basel and Massachusetts General Hospital, it is now understood that Plinabulin is a GEF-H1 activator.
- Plinabulin destabilizes microtubule networks in the cell’s cytoskeleton and releases the guanine nucleotide exchange factor, GEF-H1.
- This activates downstream signal transduction pathways, leading to the activation of c-Jun.
- The activated c-Jun enters the nucleus of dendritic cells (DC) to up-regulate immune-related genes, which leads to DC maturation, T cell activation and neutropenia prevention.
Plinabulin is differentiated from other microtubule depolymerizing agents, such as the CA4P class, which cannot induce DC maturation or neutropenia prevention.
This groundbreaking finding was presented at the Keystone Meeting on March 23, 2017.
Clinical Programs Update
Plinabulin, for the Prevention of Chemotherapy-Induced Neutropenia
Plinabulin, in combination with docetaxel, a leading chemotherapy, has delivered encouraging results in the Phase 2 portion of a Phase 1/2 clinical trial conducted in the United States and other western countries, in the reduction of docetaxel-induced severe neutropenia and as an anticancer agent in increasing overall survival in a subset of patients with advanced NSCLC who have measurable lung lesions. The Phase 2 data on neutropenia reduction was presented at the ASH Meeting in December of 2016.
Based on encouraging Phase 2 results in which Plinabulin reduced severe neutropenia of docetaxel from 33% to less than 5% (p=0.0003), and discussions with the FDA, BeyondSpring plans to enroll patients in two Registration Phase 2/3 trials:
- Phase 2/3 Registration Clinical Trials: First Trial (Trial 105)
• Commenced first trial, a combination study of Plinabulin with a standard regimen of docetaxel in patients with solid tumors in approximately 200 patients in the United States, other western countries and China.
• Primary endpoint is duration of severe neutropenia (DSN) in first cycle with non-inferiority compared to the standard of care pegfilgrastim.
• Expect to obtain the initial results for the Phase 2 portion in the second half of 2017 and interim data for the Phase 3 portion in the first half of 2018.
- Phase 2/3 Registration Clinical Trials: Second Trial (Trial 106)
• Expect to initiate the second trial in the first half of 2017, a combination study of Plinabulin with a myelosuppresive chemotherapeutic regimen composed of three agents, TAC, in patients with solid tumors in approximately 200 patients.
• Powered to measure superiority in DSN in first cycle.
• Expect to obtain the final results from the second trial (Trial 106) in the first half of 2019.
Plinabulin, combination with docetaxel, for NSCLC
- Phase 2 Portion of Phase 1/2 Clinical Trial
• Results suggest that the addition of Plinabulin to standard regimen of docetaxel may increase anti-tumor activity compared to docetaxel monotherapy (survival benefit of 4.6 months vs. docetaxel alone; and response rate almost double at 18.4% vs 10.5% of docetaxel alone)
• Results of this randomized trial were presented in an oral presentation at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium in February 2017.
• Received clinical trial approval from China CFDA for the Chinese portion of the Phase 3 trial.
- Phase 3 Clinical Trial
• Active enrollment for this trial in June 2016 in the United States, China and Australia.
• Anticipated enrollment of 550 patients, 80% in China, 20% in the United States and Australia.
• Expect to obtain interim data in the first quarter of 2018 and final data one year later during the first quarter of 2019.
Expected Milestone Timeline
- Next 6 Months
• Phase 2 data from neutropenia studies (initial data)
- Next 12-18 Months
• Interim Phase 3 data from both our neutropenia and NSCLC studies
• Data read out from PD-1 Combo study
• Submit an IND for BPI-002 for T cell activation for Phase 1
- Next 24-30 Months
• Final Phase 3 data from both neutropenia and NSCLC studies
• IND submissions
• Phase 3 Plinabulin and PD-1 Combo
• Phase 1 BPI-004 for neoantigen activation
• "molecular glue" agent using ubiquitination degradation pathways in collaboration with University of Washington
Full Year 2016 Financial Highlights
Research and Development Expenses were $10.4 million for the full year 2016, compared to $6.3 million in 2015. The increase in R&D expenses in 2016 was primarily due to increased costs related to the ongoing Phase 3 trial in advanced NSCLC, including a higher number of patients, additional investigator sites and additional drug cost; as well as our planning for the Phase 2/3 trial for Docetaxel-induced Severe Neutropenia.
General and Administrative Expenses were $1.9 million for the full year 2016, compared to $1.2 million in 2015. The increase in G&A expenses was primarily due to an increase in personnel cost and outside professional service expenses incurred preparing for the IPO.
Net loss attributable to BeyondSpring Inc. was $12.0 million for the full year 2016, compared to $8.0 million in 2015.
Cash and cash equivalents were $11.7 million as of December 31, 2016, which does not take into account the capital raised from the IPO and private placement. Net proceeds from the IPO and concurrent private placement were $48.17 million after deducting underwriting fees and other expenses.
Conference Call and Webcast Information
The Company will host an operational update conference call with the investment community on Friday, April 28th at 8:30 a.m. Eastern Time featuring remarks by Dr. Lan Huang, Ph.D., Chairman and CEO, and Richard Brand, CFO. The dial-in numbers for the conference call are +1-877-451-6152 (U.S. Toll Free) or +1-201-389-0879 (International). Please ask the operator to join you into the BeyondSpring Call.
A live webcast of the conference call will be available online which can be accessed through the Investor Relations section of BeyondSpring’s website, 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.
For interested individuals unable to join the conference call, a replay of the call will be available through May 12, 2017, at +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 13659965. Also, a replay of the webcast will remain available on http://ir.beyondspringpharma.com for 30 days following the call.
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 Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.
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.
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, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. 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.
|CONSOLIDATED BALANCE SHEETS|
|(In thousands of U.S. Dollars (“$”), except share and per share amounts)|
|Advances to suppliers||89||799|
|Deferred initial public offering cost||-||1,861|
|Prepaid expenses and other current assets||26||360|
|Total current assets||10,936||14,707|
|Property and equipment, net||34||80|
|Other noncurrent assets||-||121|
|Total noncurrent assets||34||201|
|Liabilities and equity|
|Due to related parties||432||210|
|Other current liabilities||61||235|
|Total current liabilities||1,312||2,609|
|Commitments and contingencies|
|Ordinary shares ($0.0001 par value; 500,000,000 shares|
|Authorized; 15,750,000 shares and 16,879,628 shares|
issued and outstanding as of December 31, 2015 and
|Additional paid-in capital||29,119||44,369|
|Accumulated other comprehensive loss||(53)||(91)|
|Total BeyondSpring Inc.’s equity||8,950||12,152|
|Total liabilities and equity||10,970||14,908|
|CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(In thousands of U.S. Dollars (“$”), except share and per share amounts)|
|Year ended December 31,|
|Research and development (including|
|consulting services provided by a related|
party of $300, $300 and $75 for the years
ended December 31, 2014, 2015 and 2016,
|General and administrative||(1,193)||(1,931)|
|Loss from operations||(7,475)||(12,368)|
|Foreign exchange gain (loss), net||13||(195)|
|Loss on disposal of property and equipment||(27)||-|
|Net loss on equity method investment||(44)||-|
|Net loss before income tax||(8,052)||(12,545)|
|Income tax benefit||-||-|
|Less: Net loss attributable to noncontrolling interests||(82)||(535)|
|Net loss attributable to BeyondSpring Inc.||(7,970)||(12,010)|
|Net loss per share|
|Basic and diluted||(0.53)||(0.75)|
|Weighted average shares outstanding|
|Basic and diluted||15,171,370||16,086,419|
|Other comprehensive loss|
|Foreign currency translation adjustment gain (loss)||(21)||(64)|
|Total comprehensive loss||(8,073)||(12,609)|
|Less: Comprehensive loss|
|attributable to noncontrolling interests||(92)||(561)|
|Comprehensive loss attributable to BeyondSpring Inc.||(7,981)||(12,048)|
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