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Note 1 - Business
3 Months Ended
Mar. 31, 2017
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]
1.
     Business
 
Overview
 
We are a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments that address some of the biggest unmet patient needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already approved pharmacological agents for patients suffering from cancer or pain.
 
 
On
August
9,
2016,
our
first
commercial product, SUSTOL
®
(granisetron) extended-release injection (“SUSTOL”), was approved by the U.S. Food and Drug Administration (“FDA”). We developed SUSTOL for the prevention of chemotherapy-induced nausea and vomiting (“CINV”). SUSTOL is indicated, in combination with other antiemetics, in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens. We commenced commercial sales of SUSTOL in
October
2016.
 
We have
two
investigational pharmaceutical products for patients suffering from cancer or post-operative pain. CINVANTI™ (HTX-
019),
an intravenous formulation of the neurokinin-
1
receptor antagonist aprepitant, has been developed for the prevention of CINV as an adjunct to other antiemetic agents. We submitted a New Drug Application (“NDA”) with the FDA for CINVANTI. Our NDA is pending review with the FDA, and has been assigned a Prescription Drug User Fee Act goal date of
November
12,
2017.
 
HTX-
011
is a long-acting formulation of the local anesthetic bupivacaine in a fixed-ratio combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-
011
was designed to provide superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-
011
is the subject of a broad-based Phase
2
development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain. Following a planned End of Phase
2
meeting with the FDA, we anticipate initiating Phase
3
studies in
2017
and filing an NDA in
2018.
 
 
We have incurred significant operating losses and negative cash flows from operations. As of
March
31,
2017,
our accumulated deficit was
$636.3
million, and we had
$165.2
million in cash, cash equivalents and short-term investments. Based on our current operating plan and projections, management believes that available cash, cash equivalents and short-term investments are sufficient to fund operations for at least
one
year from the date this Quarterly Report on Form
10
-Q is filed with the U.S. Securities and Exchange Commission (the “SEC”).