BioCryst Reports Second Quarter 2018 Financial Results
“Building on the clear direction from our shareholders and a strong conviction in the medical community that BCX7353 is a highly differentiated asset which can deliver enormous value to patients and shareholders, we have made substantial progress advancing our prophylactic and acute BCX7353 clinical programs, and significantly strengthened our balance sheet,” said
“Enrollment in the ZENITH-1 trial has completed, and we look forward to reporting Part 1 results later this quarter. Enrollment in the APeX-2 and APeX-S trials continues to go extremely well, and we are confident that we will report top-line safety and efficacy in the second quarter of next year. We believe we have the programs, the focused commitment of an experienced team and the financial resources to deliver significant value to patients and shareholders with our existing portfolio and we are excited about the clinical and regulatory milestones ahead of us in the next 12 months,” Stonehouse added.
Second Quarter 2018 Financial Results
For the three months ended
Research and Development (R&D) expenses for the second quarter of 2018 increased to
General and administrative (G&A) expenses for the second quarter of 2018 increased to
Interest expense was
Net loss for the second quarter of 2018 was
Cash, cash equivalents and investments totaled
Year to Date 2018 Financial Results
For the six months ended
R&D expenses increased to
G&A expenses for the first half of 2018 increased to
Interest expense was
Net loss for the first half of 2018 was
Clinical Development Update & Outlook
August 6, 2018, BioCryst announced it had received Fast Track Designation by the U.S. Food and Drug Administration( FDA) for BCX7353 for the prevention of angioedema attacks in patients with HAE.
August 6, 2018, BioCryst announced the full exercise of the underwriters’ option to purchase additional shares and the completion of its public offering resulting in the sale of 10,454,546 shares of its common stock at a price of $5.50per share. The net proceeds from this offering are approximately $53.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
July 11, 2018, BioCryst announced it had completed enrollment in all three cohorts of its ZENITH-1 clinical trial, a proof-of-concept Phase 2 clinical trial liquid formulation of BCX7353 for treatment of acute HAE attacks.
July 25, 2018, BioCryst announced that results from the Phase 2, APeX-1 trial of BCX7353 for the prevention of attacks in patients with HAE were published in the July 26thissue of The New England Journal of Medicine.
July 20, 2018, BioCryst entered into a $30 millionsecured loan facility with MidCap Financial Trustas administrative agent and lender (MidCap), pursuant to the terms and conditions of that certain Amended and Restated Credit and Security Agreement. The Credit Agreement replaces the Credit and Security Agreement dated as of September 23, 2016.
July 10, 2018, BioCryst announced that it had terminated the previously announced merger agreement with Iderafollowing the Company’s stockholders’ failure to approve the adoption of the merger agreement. Pursuant to the merger agreement, the Company reimbursed Idera $6 millionin July.
June 25, 2018, BioCryst announced that the Company had reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for HAE with the Pharmaceuticals and Medical Devices Agencyin Japan.
May 24, 2018, BioCryst announced that the EMA Committee for Orphan Medicinal Products issued a positive opinion on BioCryst’s application for orphan designation of BCX7353 for the treatment of HAE. Inaddition, the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted a Promising Innovative Medicine designation to BCX7353.
Financial Outlook for 2018
Based upon development plans, merger-related incurred costs from the recently terminated merger agreement with
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast
Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 was generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of HAE second generation drug candidates (including ZENITH-1, APeX-2, APeX-S and APeX-J) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the
|BIOCRYST PHARMACEUTICALS, INC.|
|CONSOLIDATED FINANCIAL SUMMARY|
|(in thousands, except per share)|
|Statements of Operations (Unaudited)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaborative and other research and development||12,352||2,610||12,667||5,726|
|Research and development||21,010||15,759||39,451||32,529|
|General and administrative||9,492||2,834||17,101||5,892|
|Total operating expenses||30,745||18,615||56,935||38,737|
|Loss from operations||(18,251||)||(15,516||)||(40,465||)||(26,201||)|
|Interest and other income||493||203||955||312|
|Gain (loss) on foreign currency derivative||1,507||521||(297||)||(1,022||)|
|Basic and diluted net loss per common share||$||(0.19||)||$||(0.21||)||$||(0.45||)||$||(0.40||)|
|Weighted average shares outstanding||98,787||80,418||98,690||77,807|
|Balance Sheet Data (in thousands)|
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents and investments||$||114,484||$||155,692|
|Receivables from collaborations||2,342||6,117|
|Non-recourse notes payable||28,902||28,682|
|Senior credit facility||19,999||23,214|
|Shares of common stock outstanding||98,928||98,411|
|Note 1: Derived from audited financial statements.|
Source: BioCryst Pharmaceuticals, Inc.