On August 2, 2018 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, reported its second quarter 2018 financial results (Press release, AcelRx Pharmaceuticals, AUG 2, 2018, View Source [SID1234528314]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The first half of the year has been productive on all fronts as we have accomplished all the milestones we established for the period. We’re very focused on reaching our remaining milestones for the year and, if DSUVIA is approved in November, eager to start commercializing our first U.S. product in Q1 2019," said Vince Angotti, Chief Executive Officer of AcelRx. "We continue to believe we have a unique product for the management of moderate to severe acute pain that can fulfill an unmet need within appropriate healthcare settings. We look forward to continued dialogue with the FDA during the coming months to achieve these objectives," continued Angotti.
Recent Highlights
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for DSUVIA in May.
Received approval from the European Commission for DZUVEO for the management of acute moderate-to-severe pain in medically monitored settings.
Completed an underwritten public offering of 7,272,727 shares of common stock, at a price of $2.75 per share to the public with estimated net proceeds to the company of $18.7 million.
Financial Information
June 30, 2018 cash and short-term investment balance of $50.1 million;
R&D and G&A expenses for the quarter ended June 30, 2018 totaled $7.2 million compared to $9.1 million for the prior year period. Excluding stock-based compensation expense, these figures were $6.2 million for the second quarter of 2018 compared to $8.1 million for the prior year period. R&D and G&A expenses for the first half of 2018 totaled $14.7 million compared to $20.1 million in the first half of 2017. Excluding stock-based compensation expense, these figures were $12.8 million for the first half of 2018 compared to $18.1 million for the prior year period. The decrease in R&D and G&A expenses in both periods is primarily due to lower Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
Net cash use during the second quarter 2018 was $8.5 million excluding proceeds from ATM facility, included $2.3 million of debt service; and
For the second quarter of 2018 net loss was $10.5 million, or $0.20 per basic and diluted share, compared to $13.1 million, or $0.29 per basic and diluted share, for the second quarter of 2017. Net loss for the first half of 2018 was $22.1 million, or $0.43 basic and diluted net loss per share, compared to $28.6 million, or $0.63 basic and diluted net loss per share, for the prior year period.
2018 Remaining Milestones
Expected FDA advisory committee meeting for DSUVIA in late Q3/early Q4 2018;
Prescription Drug User Fee Act, PDUFA, date for DSUVIA on November 3, 2018; and
Anticipated resubmission of NDA for Zalviso in Q4 2018.
Conference Call and Webcast Information
As previously announced, AcelRx will conduct an investment-community conference call today, August 2, 2018 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.