Heron Therapeutics Announces Third Quarter 2015 Financial Results and Recent Corporate Progress
Recent Corporate Progress:
October 2015, Heron appointed Neil J. Clendeninn, M.D., Ph.D. as Senior Vice President and Chief Medical Officer. Dr. Clendeninn brings more than 25 years of drug development and clinical practice experience to his role at Heron. Prior to his appointment, Dr. Clendeninn advised Heron during the recently completed MAGIC study for SUSTOL® (granisetron) Injection, extended release and with the resubmission of Heron’s New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration( FDA). Dr. Clendeninn, in addition to his experience as a practicing physician, has held academic positions, and served as a board member and scientific advisor for numerous institutions and companies within the oncology field.
September 2015, Heron reported positive, top-line results from its recently completed Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. In the study, HTX-011 showed a significant reduction in pain intensity, reduction in the need for opioid rescue medications, and increase in time to first use of rescue medications.
September 2015, the FDAaccepted for review Heron’s NDA resubmission for SUSTOL for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The FDAassigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016.
- Based on the positive Phase 2 results of HTX-011 in patients undergoing bunionectomy, the Company plans to expand target enrollment for its ongoing Phase 2 clinical trial of HTX-011 in patients undergoing inguinal hernia repair. The increased target enrollment to approximately 100 patients now is expected to provide 90% power to detect a statistical improvement (p < 0.05) in the study. The Company expects to report results from this study in the first half of 2016.
- Heron plans to study HTX-011 as part of a broad-based development program designed to target patients undergoing a wide range of surgeries who experience significant post-operative pain, potentially including abdominoplasty, orthopedic procedures, nerve block and further studies in inguinal hernia repair and bunionectomy.
“This has been an exciting quarter for Heron with the FDA’s acceptance
of the SUSTOL NDA and the release of positive, top-line results from our
Phase 2 study of HTX-011 in patients undergoing bunionectomy,” commented
Barry D. Quart, Pharm.D., Chief Executive Officer of
Results of Operations
Heron’s net cash used for operating activities for the three and nine
Heron’s net loss for the three and nine 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, costs associated with the development of HTX-019, as well
as costs incurred in preparation for the commercial launch of SUSTOL, if
approved by the
SUSTOL® (granisetron) Injection, extended release is being
developed for the prevention of both acute and delayed
chemotherapy-induced nausea and vomiting (CINV) associated with
moderately emetogenic chemotherapy (MEC) or highly emetogenic
chemotherapy (HEC). CINV is one of the most debilitating side effects of
chemotherapy and is a leading cause of premature discontinuation of
cancer treatment. Heron recently reported positive, top-line results
from its Phase 3 MAGIC study. In
All of Heron’s product candidates utilize Heron’s innovative science and technology platforms, including its proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks with a single injection.
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 based on management’s
expectations and assumptions as of the date of this news release and 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: whether the
HERON THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
Nine Months Ended
|Research and development||$||14,241||$||14,731||$||44,920||$||40,638|
|General and administrative||8,250||4,222||20,945||14,428|
|Total operating expenses||22,491||18,953||65,865||55,066|
|Loss from operations||(22,491||)||(18,953||)||(65,865||)||(55,066||)|
|Other expense, net||(181||)||(241||)||(484||)||(677||)|
|Basic and diluted net loss per share||$||(0.63||)||$||(0.66||)||$||(2.07||)||$||(2.17||)|
|Shares used in computing basic and diluted net loss per share||
|HERON THERAPEUTICS, INC.|
Condensed Consolidated Balance Sheet Data
|September 30,||December 31,|
|Cash and cash equivalents||$||152,989||$||72,675|
|Total stockholders’ equity||$||141,701||$||63,062|
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations
Barry D. Quart, Pharm D., 650-366-2626
Chief Executive Officer