Heron Therapeutics Announces Second Quarter 2015 Financial Results and Recent Corporate Progress
Recent Corporate Progress:
July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL® (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration( FDA).
In June and
July 2015, Heron initiated two Phase 2 clinical trials of HTX-011 for the prevention of post-operative pain, one in patients undergoing bunionectomy and one in patients undergoing inguinal hernia repair.
June 2015, Heron closed an underwritten public offering of 5,520,000 shares of common stock at a public offering price of $24.75per share. Heron received total net proceeds from the offering of approximately $128.2 million.
May 2015, Heron reported positive, top-line results from its recently completed Phase 3 MAGIC study for SUSTOL. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone for the prevention of delayed CINV associated with HEC regimens.
May 2015, the FDAaccepted Heron’s proposal to use the 505(b)(2) regulatory pathway for HTX-019, Heron’s proprietary intravenous formulation of the NK1 receptor antagonist aprepitant for the prevention of CINV. Utilizing the 505(b)(2) regulatory pathway to significantly reduce the costs and time required for development, Heron intends to file an NDA for HTX-019 in the second half of 2016.
“We have achieved several critical milestones since our last quarterly update, including the resubmission of the SUSTOL NDA to the FDA,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “With a pipeline of four exciting product candidates with best-in-class potential and a healthy balance sheet following our successful financing in June, we are looking forward to an eventful and productive second half of 2015.”
Results of Operations
Heron’s net cash used for operating activities for the three and six
Heron’s net loss for the three and six months ended
The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 were primarily due to clinical and manufacturing costs related to our Phase 1 and Phase 2 clinical studies for HTX-011, as well as costs associated with the development of HTX-019.
For more information, visit www.herontx.com.
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include, but are not limited to, those
associated with: the acceptance of the Company’s resubmission of its New
Drug Application (NDA) for SUSTOL, whether the
|HERON THERAPEUTICS, INC.|
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||$||16,175||$||14,279||$||30,679||$||25,907|
|General and administrative||6,839||4,512||12,695||10,206|
|Total operating expenses||23,014||18,791||43,374||36,113|
|Loss from operations||(23,014||)||(18,791||)||(43,374||)||(36,113||)|
|Other expense, net||(93||)||(220||)||(303||)||(436||)|
|Basic and diluted net loss per share||$||(0.74||)||$||(0.78||)||$||(1.45||)||$||(1.52||)|
|Shares used in computing basic and diluted net loss per share||
|HERON THERAPEUTICS, INC.|
Condensed Consolidated Balance Sheet Data
|June 30,||December 31,|
|Cash and cash equivalents||$||171,526||$||72,675|
|Total stockholders’ equity||$||159,866||$||63,062|
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
Barry D. Quart, Pharm D., 650-366-2626
Chief Executive Officer