On May 05, 2016 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the first quarter of 2016 (Press release, Pain Therapeutics, MAY 5, 2016, View Source [SID:1234512056]). Net loss in Q1 2016 was $5.8 million, or $0.13 per share, compared to a net loss in Q1 2015 of $2.6 million, or $0.06 per share.

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Cash and investments were $28.1 million as of March 31, 2016, with no debt. We continue to expect net cash usage for the first half of 2016 will be approximately $8 million.

"Our focus continues to be on REMOXY and its potential to receive regulatory approval in 2016," said Remi Barbier, Chairman, President & CEO. "The REMOXY PDUFA target action date is September 25, 2016. Between now and then, we look forward to working closely with the FDA during the regulatory review process."

Financial Highlights for Q1 2016

At March 31, 2016, cash and investments were $28.1 million, compared to $31.3 million at December 31, 2015. The Company has no debt.
Net cash used in Q1 2016 was $3.2 million.
Research and development expenses increased to $3.6 million in Q1 2016 from $1.1 million in Q1 2015, primarily due to increased activities related to the REMOXY NDA resubmission. Research and development expenses included non-cash stock-related compensation costs of $0.8 million in Q1 2016 and $0.3 million in Q1 2015.
General and administrative expenses increased to $2.2 million in Q1 2016 from $1.5 million in Q1 2015 primarily due to increased non-cash stock-related compensation costs of $1.0 million in Q1 2016 compared to $0.6 million in Q1 2015.

About REMOXY (oxycodone capsules CII)
REMOXY is a proprietary, abuse-deterrent, oral, extended-release formulation of oxycodone (CII). The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. REMOXY targets the $2.5 billion marketplace for long-acting oxycodone. We own exclusive, worldwide rights to REMOXY. The FDA has not yet established the safety or efficacy of REMOXY.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, opioid abuse and misuse remains a serious, persistent problem. Nearly 19,000 people died from opioid overdose in 2014, according to the NIH’s National Institute on Drug Abuse. For over a decade, we have pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to tamper with a long-acting opioid formulation, recognizing that no drug or drug formulation can be made abuse-proof.

On May 05, 2016 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the first quarter ended March 31, 2016, and provided updates on its development programs (Filing, Q1, Conatus Pharmaceuticals, 2016, MAY 5, 2016, View Source [SID:1234512021]). After the market close yesterday, the company announced top-line results from the second stage of its Phase 2 Liver Cirrhosis trial. A conference call and webcast are scheduled for 8:00 a.m. ET today, as detailed below, to discuss both the trial results and financial results.

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Financial Results
The net loss was $7.3 million for the first quarter of 2016 compared with $6.0 million for the first quarter of 2015.

Research and development expenses increased to $4.7 million for the first quarter of 2016 from $3.9 million for the first quarter of 2015, primarily due to higher external clinical trial and manufacturing costs. General and administrative expenses increased to $2.6 million for the first quarter of 2016 from $2.1 million for the first quarter of 2015, primarily due to higher legal, consulting and accounting fees.

Cash, cash equivalents and marketable securities were $32.6 million at March 31, 2016, compared with $36.5 million at December 31, 2015. The company believes current financial resources are sufficient to maintain operations and ongoing clinical development activities for at least the next 12 months.

Program Updates
Conatus is developing emricasan, a first-in-class, orally active pan-caspase inhibitor, for the treatment of patients with chronic liver disease. To date in 2016, the company announced:

in January, positive top-line results from the three-month, double-blind, placebo-controlled first stage of the company’s Phase 2 Liver Cirrhosis clinical trial, evaluating potential improvements in Model for End-stage Liver Disease (MELD) score and Child-Pugh-Turcotte status in patients with liver cirrhosis and baseline MELD scores of 11 to 18, and in May, positive top-line results from the three-month, open-label second stage of the Liver Cirrhosis clinical trial;

in January, the initiation of active recruitment in its double-blind, placebo-controlled Phase 2b ENCORE-NF (EmricasaN, a Caspase inhibitOR, for Evaluation in patients with nonalcoholic steatohepatitis (NASH), and confirmed resultant Fibrosis) clinical trial;

in February, U.S. Food and Drug Administration (FDA) Fast Track designation for the development of emricasan in patients with liver cirrhosis caused by NASH;

an oral late-breaker presentation (#LBO5) entitled, "Emricasan (IDN-6556) orally for three months in patients with cirrhosis and MELD scores 11-18 improves clinical parameters of cirrhosis in patients with baseline MELD score ≥15," delivered at The International Liver Congress 2016, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, by Catherine Frenette, M.D., Medical Director of Liver Transplantation at Scripps Clinic, La Jolla, CA, and a principal investigator in the company’s multicenter Phase 2 Liver Cirrhosis clinical trial of emricasan; and

a poster (#FRI-078) entitled, "The potent pan-caspase inhibitor IDN-7314 does not affect tumor growth rate nor does it antagonize the efficacy of sorafenib in models of hepatocellular carcinoma," presented at The International Liver Congress 2016, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, by Patricia C. Contreras, Ph.D., Vice President, Preclinical Development at Conatus and lead author on the poster.
Conatus has two ongoing emricasan Phase 2 clinical trials:

POLT-HCV-SVR: A randomized, double blind, placebo-controlled Phase 2b clinical trial initiated in May 2014 evaluating potential improvements in Ishak Fibrosis Score in post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy. Results after two years of twice-daily treatment or placebo are expected in the first half of 2018.

ENCORE-NF: A randomized, double blind, placebo-controlled Phase 2b clinical trial initiated in January 2016 evaluating potential improvements in fibrosis and steatohepatitis in patients with NASH fibrosis. Results after 18 months of twice-daily treatment or placebo are expected in 2018.
The company plans to initiate the following additional emricasan clinical trials on a staggered basis through early 2017 as resources permit and expects top-line results to be available periodically beginning in 2018, which the company believes could position it to advance directly to filing for accelerated approval in NASH cirrhosis:

ENCORE-PH: A planned randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of emricasan in reducing hepatic venous pressure gradient (HVPG) in patients with clinically significant Portal Hypertension and impaired hepatic function in patients with NASH cirrhosis.

ENCORE-LF: A planned randomized, double-blind, placebo-controlled clinical trial to assess long-term Liver Function endpoints of MELD score and Child-Pugh-Turcotte status, related serum biomarkers and laboratory parameters associated with liver function, and will collect chronic administration safety information in patients with NASH cirrhosis. With the continued engagement of the regulatory authorities, the six-month data from the Liver Cirrhosis trial may allow redesign of the ENCORE-LF clinical trial, originally planned as a Phase 2 trial, to qualify as a Phase 3 clinical trial.

ENCORE-XT: A planned eXTension clinical trial to continue treatment for at least an additional 18 months, for a total of at least two years, in patients who complete the ENCORE-PH or ENCORE-LF trials, with continued monitoring for efficacy, safety, clinical outcomes and health-related quality of life.

On May 05, 2016 pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, reported a Company update and announced financial results for its third fiscal quarter ended March 31, 2016 (Press release, pSivida, MAY 5, 2016, View Source [SID:1234512057]).

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pSivida continued to advance its lead product candidate, Medidur. The European Commission granted Medidur orphan medicinal product designation for the treatment of posterior uveitis. Orphan designation provides up to 10 years of market exclusivity in Europe upon marketing approval as well as other regulatory and financial incentives. In accordance with published EU regulatory guidance, pSivida plans to file for EU marketing approval based upon the strength of the results from Medidur’s first Phase 3 trial. The trial met its primary efficacy endpoint with high statistical significance with positive safety results.
"We are very pleased with the regulatory position of Medidur in the EU and are planning to file for regulatory approval under the centralized marketing authorization procedure around the end of 2016," said Dr. Paul Ashton, Ph.D., president and Chief Executive Officer of pSivida.

pSivida recently met with the U.S. Food and Drug Administration (FDA) to confirm the data required to support the U.S. New Drug Application (NDA) for Medidur. As a result of the meeting, pSivida continues to plan for an NDA submission based on the results of two Phase 3 trials together with data incorporated from the ILUVIEN Phase 3 trials and data from a short inserter utilization study. The second Phase 3 trial is approximately 60% enrolled. With favorable results, pSivida plans to file an NDA for Medidur around mid-2017.

With the addition of the net proceeds from a $17.8 million underwritten public offering of common stock during the quarter, the Company’s cash position at the end of the quarter was $33.3 million. "With this solid cash position, we should have adequate funding through our planned Medidur NDA filing and into the fourth quarter of calendar 2017," said Dr. Ashton.

Development of our Durasert product candidate for severe knee osteoarthritis (OA) being developed in partnership with Hospital for Special Surgery is proceeding on schedule. "The stability work requested by the FDA for the Investigational New Drug Application for the severe knee OA product candidate has been completed as planned, and we understand the principal investigator will submit it to the FDA shortly," added Dr. Ashton.

pSivida also continued its work on potential new product candidates. Research continued in its evaluation of off-patent or soon-to-be off-patent anti-cancer drugs that inhibit VEGF and PDGF to treat wet and dry age-related macular degeneration and of Tethadur to deliver antibodies.

Results for the Third Quarter and Nine Months Ended March 31, 2016. At March 31, 2016, cash, cash equivalents and marketable securities totaled $33.3 million compared to $21.1 million at the end of the prior quarter. In January 2016, pSivida enhanced its cash position with approximately $16.5 million of net proceeds from the consummation of a $17.8 million underwritten public offering of 4,440,000 shares of common stock. Net operating cash usage in the fiscal 2016 third quarter totaled $4.3 million, a $1.1 million increase over the prior quarter. The increase primarily reflected expected increases in CRO payments for Medidur clinical development. pSivida expects net cash usage to increase in its fiscal fourth quarter and to continue to vary from quarter to quarter, primarily as a result of the amount and timing of payments for Medidur clinical development.

Revenues for the quarter ended March 31, 2016 totaled $324,000 compared to $328,000 for the prior year quarter.

Research and development expense decreased by $265,000, or 8%, to $3.1 million for the three months ended March 31, 2016 compared to $3.3 million for the three months ended March 31, 2015. This was primarily attributable to lower CRO costs, partially offset by higher personnel costs, for the Medidur clinical development program.

General and administrative expense increased by $305,000, or 15%, to $2.3 million for the quarter ended March 31, 2016 compared to $2.0 million for the prior year quarter. The increase was primarily attributable to higher professional fees and personnel costs, including stock-based compensation.

Net loss for the quarter ended March 31, 2016 was $5.0 million, or $0.15 per share, compared to a net loss of $5.0 million, or $0.17 per share, for the prior year quarter.

Revenues for the nine months ended March 31, 2016 totaled $1.3 million compared to $26.2 million for the nine months ended March 31, 2015. The decrease reflected the $25.0 million milestone for FDA approval of ILUVIEN earned in the fiscal 2015 first quarter.

Research and development expense increased by $1.4 million, or 16%, to $10.3 million for the nine months ended March 31, 2016 compared to $8.9 million for the nine months ended March 31, 2015. The increase was primarily attributable to higher costs related to Medidur clinical development.

General and administrative expense increased by $712,000, or 13%, to $6.4 million for the first nine months of fiscal year 2016 compared to $5.6 million for the prior year period. The increase was primarily the result of higher professional fees, stock-based compensation and personnel-related costs.

Income tax benefit was $117,000 for the nine months ended March 31, 2016 compared to income tax expense of $144,000 for the nine months ended March 31, 2015. Both periods included refundable foreign research and development tax credits, which amounts for the nine months ended March 31, 2015 were more than offset by federal alternative minimum tax expense of $263,000 attributable to receipt of the $25.0 million ILUVIEN FDA approval milestone.

On May 05, 2016 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported its financial results for the first quarter ended March 31, 2016, and provided recent corporate highlights (Press release, Radius, MAY 5, 2016, View Source [SID:1234511959]). As of March 31, 2016, Radius had $439.8 million in cash, cash equivalents and marketable securities.

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"We are extremely pleased to have submitted our first New Drug Application to the U.S. FDA for abaloparatide-SC for the treatment of postmenopausal osteoporosis and our MAA is currently under review in Europe. In anticipation of our first potential launch, we are developing our commercial plans and building our marketing organization in the U.S.," said Robert Ward, President and Chief Executive Officer of Radius. "To maximize the potential of this new investigational drug outside the U.S., we are continuing our productive partnering discussions and anticipate entering into a marketing collaboration prior to a potential first commercial launch."

Pipeline Updates

Abaloparatide-SC

In March 2016, Radius submitted a new drug application ("NDA") in the United States for the treatment of postmenopausal women with osteoporosis. In November 2015, Radius submitted a marketing authorisation application ("MAA") to the European Medicines Agency ("EMA"), which subsequently was validated and is currently undergoing regulatory review. We anticipate a CHMP scientific opinion in 2016.

Abaloparatide-TD

Radius also is developing abaloparatide-transdermal, which it refers to as abaloparatide-TD, based on 3M’s patented Microstructured Transdermal System technology for potential use as a short wear-time transdermal patch. Radius commenced a human replicative clinical evaluation of the optimized abaloparatide-TD patch in December 2015 with the goal of achieving comparability to abaloparatide-SC.

RAD1901

In December 2014, Radius commenced a Phase 1 multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer in the United States. The Phase 1 study is designed to evaluate escalating doses of RAD1901 in Part A. The Part B expansion cohorts allow for an evaluation of additional safety, tolerability and preliminary efficacy. In addition, in December 2015, Radius commenced a Phase 1 FES-PET study in patients with metastatic breast cancer in the European Union, which includes the use of FES-PET imaging to assess estrogen receptor occupancy in tumor lesions following RAD1901 treatment. Upon completion of these studies, we plan to submit to present the data at an appropriate scientific meeting.

Radius Expects the Following Upcoming Milestones

Abaloparatide-SC
Receive opinion from the Committee for Medicinal Products for Human Use regarding the EMA’s review of the abaloparatide-SC MAA
FDA determination on acceptance of NDA for abaloparatide-SC for filing in the second quarter of 2016
Enter into a collaboration for the potential commercialization of abaloparatide-SC prior to a commercial launch
Abaloparatide-TD
Planned mid-year update on human replicative study of optimized abaloparatide-TD patch
RAD1901
Initiate expansion cohorts for Phase 1 dose escalation study in metastatic breast cancer patients
Report results at upcoming scientific meeting
Radius Expects To Make Presentations at the Following Upcoming Conferences

Bank of America Merrill Lynch 2016 Healthcare Conference, May 10-12, 2016, in Las Vegas, NV.
Abstract presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, June 3-7, 2016 in Chicago
"A Phase I study of RAD1901, an oral selective estrogen receptor degrader, in ER positive, HER2 negative, advanced breast cancer patients".
Recent Corporate Highlights

On April 1, 2016, at the 2016 Endocrine Society Annual Meeting, Dr. Felicia Cosman, an osteoporosis specialist and Professor of Medicine at Columbia University, presented "Abaloparatide-SC Significantly Reduces Vertebral and Nonvertebral Fractures and Increases BMD Regardless of Baseline Risk"

On April 15, 2016, three oral presentations were made from the abaloparatide-SC development program at the 2016 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases meeting in Malaga, Spain:

Dr. Lorie Fitzpatrick, Chief Medical Officer of Radius Health presented "Effects of Abaloparatide on Vertebral, Non-Vertebral, Major Osteoporotic and Clinical Fracture Incidence in Postmenopausal Women with Osteoporosis: Results of the Phase 3 Active Trial"

Dr. Serge Ferrari, Professor of Medicine, Geneva University presented "Eighteen Months of Treatment with Abaloparatide Followed by Six Months of Treatment with Alendronate in Postmenopausal Women with Osteoporosis- Results of the ACTIVExtend Trial"

Dr. Eugene McCloskey, Professor in Adult Bone Diseases, University of Sheffield presented "Effect of Investigational Treatment Abaloparatide for Prevention of Major Osteoporotic Fracture or Any Fracture is Not Altered by Baseline Fracture Probability"
Abaloparatide-SC as a treatment for postmenopausal women with osteoporosis is an investigational product and its safety and efficacy have not been established.

First Quarter 2016 Financial Results

For the three months ended March 31, 2016, Radius reported a net loss of $40.5 million, or $0.94 per share, as compared to a net loss of $17.1 million, or $0.47 per share for the three months ended March 31, 2015. The increase in net loss for the three months ended March 31, 2016 as compared to the three months ended March 31, 2015 was primarily due to an increase in research and development and general and administrative expenses, partially offset by a decrease in interest expense and an increase in interest income.

Research and development expenses for the three months ended March 31, 2016 were $27.5 million, compared to $11.6 million for the same period in 2015. The increase for the 2016 period as compared to the 2015 period was primarily attributable to an increase in professional contract services costs associated with the development of RAD1901 to support a Phase 1 study in metastatic breast cancer that commenced in late 2014 and a Phase 2b study in postmenopausal vasomotor symptoms that commenced in December 2015. This increase was also a result of an increase in compensation expense, including stock-based compensation, due to an increase in headcount from March 31, 2015 to March 31, 2016.

General and administrative expenses for the three months ended March 31, 2016 were $13.6 million, compared to $4.8 million for the same period in 2015. The increase for the 2016 period as compared to the 2015 period was primarily attributable to an increase in professional support costs and legal fees, including the costs associated with increasing headcount and preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review.

As of March 31, 2016, Radius had $439.8 million in cash, cash equivalents and marketable securities. Based upon Radius’ cash, cash equivalents and marketable securities balance, Radius believes that, prior to the consideration of revenue from the potential future sales of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities into 2018.

About Abaloparatide

Abaloparatide is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity.

Abaloparatide has completed Phase 3 development for potential use as a daily self-administered injection (abaloparatide-SC). In the fourth quarter of 2015, Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of patients with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius submitted a New Drug Application (NDA) for abaloparatide-SC to the US Food and Drug Administration (FDA) at the end of the first quarter of 2016.

Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M’s patented Microstructured Transdermal System technology for potential use as a treatment for osteoporosis.

About RAD1901

RAD1901 is a selective estrogen receptor down-regulator/degrader (SERD), which at high doses is being evaluated for potential use as an oral non-steroidal treatment for hormone-driven, or hormone-resistant, breast cancer. RAD1901 is currently being investigated for potential use in postmenopausal women with advanced estrogen receptor positive (ER+), HER2-negative breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

RAD1901 also is being evaluated in a Phase 2b study at low doses for potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. Additional information on the clinical trial program of RAD1901 is available on www.clinicaltrials.gov.

RAD140

RAD140 is a non-steroidal selective androgen receptor modulator (SARM) that is currently in preclinical development for potential use in multiple indications including cancer. RAD140 resulted from an internal drug discovery program focused on the androgen receptor pathway, which is highly expressed in many breast cancers. Due to its receptor and tissue selectivity, potent oral activity and long half-life, RAD140 could have clinical potential in the treatment of conditions where androgen modulation may play a role.

On May 5, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the first quarter of 2016 (Filing, Q1, DURECT, 2016, MAY 5, 2016, View Source [SID:1234512022]). Total revenues were $3.6 million and net loss was $7.9 million for the three months ended March 31, 2016 as compared to total revenues of $4.8 million and net loss of $4.9 million for the three months ended March 31, 2015.

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At March 31, 2016, we had cash and investments of $24.3 million, compared to cash and investments of $29.3 million at December 31, 2015. Subsequent to the end of the first quarter, we raised net proceeds of approximately $17.0 million from the sale of additional shares of common stock. Including these proceeds, our pro forma cash and investments at March 31, 2016 would have been approximately $41.3 million. At March 31, 2016, we had $19.7 million in short and long term debt.
"The highlight of the quarter was undoubtedly the resubmission of the REMOXY NDA, followed by its acceptance for review by the FDA and the establishment of a September 25, 2016 PDUFA date," stated James E. Brown, D.V.M., President and CEO of DURECT. "With respect to DUR-928, we have progressed into our first two patient studies with results anticipated during the course of this year. For POSIMIR, we continued the PERSIST Phase 3 trial which we are in the process of amending in response to an FDA recommendation."
Update of Selected Programs:

• Epigenomic Regulator Program. DUR-928, our Epigenomic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.
During the first quarter, we began our first patient trial utilizing DUR-928. This study is an open-label single-ascending-dose safety and pharmacokinetic Phase 1b trial of DUR-928 in NASH patients and matched control subjects. This study will be conducted in successive cohorts evaluating single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to the next higher dose. The study is being conducted in Australia, and we anticipate that we will start obtaining results from this trial in the second quarter of 2016. This study is designed to enable and inform a subsequent multi-dose study in NASH or other patients with other liver function impairment.
In addition, our protocol has been approved by the institutional review board for a second study in patients with DUR-928, also being conducted in Australia. This Phase 1b trial of DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function and matched control subjects. This study will be

1
conducted in successive cohorts evaluating single-dose levels of DUR-928 administered by injection. After a PK/safety review at each dose, the study can proceed to the next higher dose. We anticipate that this study will be completed in 2016, and that this study will enable and inform subsequent trials for patients with either acute kidney injury or other kidney function impairment.

• REMOXY (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. Pain Therapeutics (our licensee) resubmitted the NDA on schedule in March 2016. In April 2016, Pain Therapeutics announced that the FDA had determined that the NDA was sufficiently complete to permit a substantive review and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA). The extended release oxycodone market is greater than $2 billion in the U.S. alone, and we are eligible for a potential royalty on REMOXY between 6.0% to 11.5% of net sales depending on sales volumes.

• POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. In November 2015, we began enrolling patients for PERSIST, a new POSIMIR Phase 3 clinical trial, consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. In a previous clinical trial of 50 patients undergoing laparoscopic cholecystectomy, POSIMIR was compared with the active control bupivacaine hydrochloride, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024), using the same statistical methodology specified for the current trial. We began recruiting patients for this trial with an intent to compare POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial including by incorporating standard bupivacaine HCl as an active control. This change will add to the time and cost to complete the PERSIST trial, but we believe that a positive outcome from this trial design would result in a stronger NDA filing and potentially commercial advantages. This clinical trial is designed to generate data necessary to support an NDA resubmission.
POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.

• Relday (Risperidone Program). Relday is a proprietary, long-acting, once-monthly subcutaneous injectable formulation of risperidone for the treatment of schizophrenia. In September 2015, Zogenix (our licensee) announced that they had completed a multi-dose Phase 1b trial with results consistent with the profile of risperidone and a previous Phase 1 single-dose clinical trial. Zogenix has stated that it is seeking a development and commercialization partner for Relday and that Relday is well-positioned to begin a Phase 3 program once a partner is secured.

•
ORADUR-ADHD Program. In 2013, we selected a formulation for the lead program in our ORADUR-ADHD (Attention Deficit Hyperactivity Disorder) program, ORADUR-Methylphenidate. This formulation was chosen based on its potential for rapid onset of
action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a Phase 1 trial. In addition, this product candidate utilizes a small capsule size relative to the leading existing long acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing it in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.

• Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2016 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 5 and is available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.