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 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 5, 2016 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) reported a poster presentation by researchers, covering preclinical work in squamous cell carcinoma of the head and neck ("SCCHN"), is being made at the 2016 American Society of Gene and Cell Therapy ("ASGCT") annual meeting being held from May 4th to 7th, 2016 in Washington, DC (Filing, 6-K, Oncolytics Biotech, MAY 5, 2016, View Source [SID:1234512053]).

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"Preclinical work continues to play an important role in REOLYSIN’s further development," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are evaluating REOLYSIN in combination with both established and emerging treatment options in a range of indications in order to determine which pairings merit clinical testing."

The abstract/poster is titled "The Potency of a Histone Deacetylase Inhibitor and REOLYSIN in Head and Neck Squamous Cell Carcinoma," and was authored by Old, et al. The authors used the first FDA approved histone deacetylase inhibitor ("HDACi"), vorinostat (suberoylanilide hydroxamic acid) ("SAHA"), in combination with REOLYSIN in vitro and in vivo. They had previously found a synergistic combination of SAHA and REOLYSIN in a nude mouse model. Preclinical models using oncolytics are often conducted in immunocompromised mice, negating the significant impact of the immune system. The data demonstrates that combination of reovirus plus SAHA therapy has significant activity in the treatment of SCCHN, even in an immunocompetent model and that immune system rebound likely plays a significant role in the long-term anti-tumor response.

On May 4, 2016 Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, reported its financial results for the first quarter ended March 31, 2016 (Filing, Q1, Novavax, 2016, MAY 5, 2016, View Source [SID:1234512052]).

Novavax First Quarter Achievements:

· Continued execution of Resolve, a pivotal Phase 3 trial of our RSV F Vaccine in older adults (60 years of age and older). Resolve is a randomized, observer-blinded, placebo-controlled trial in 11,850 older adults at 60 sites in the United States. The primary efficacy objective is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. Enrollment was completed in the fourth quarter of 2015.

· Ongoing execution of a Phase 2 rollover clinical trial of our RSV F Vaccine in 1,330 older adults. The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed to enroll from the population of older adults who participated in the prior Phase 2 trial. The primary endpoints of the trial will evaluate safety and serum anti-F IgG antibody concentrations in response to immunization with our RSV F Vaccine. Enrollment was completed in the fourth quarter of 2015.

· Expanded enrollment of Prepare, a pivotal Phase 3 trial of our RSV F Vaccine in healthy pregnant women, to multiple international sites to take advantage of the RSV season in the southern hemisphere. Prepare is a randomized, observer-blinded, placebo-controlled trial. The primary objective is to determine the efficacy of maternal immunization with our RSV F Vaccine against symptomatic RSV lower respiratory tract infection with hypoxemia in infants through the first 90 days of life. Prepare is supported by a grant of up to $89 million from the Bill & Melinda Gates Foundation (BMGF).

· Issued a total of $325 million Convertible Senior Notes, resulting in net proceeds of $276.5 million. The Notes’ initial conversion price of approximately $6.81 per common share represents a 22.5% premium to Novavax’ common stock on January 25, 2016, the day the Notes were issued. In conjunction with the issuance of the Notes, the Company entered into capped call transactions with an initial cap price of $9.73 per share. The capped call will serve to reduce dilution from issuance of shares upon conversion at prices greater than the Notes’ conversion price of $6.81.

· Appointed Bob Darius to Senior Vice President, Quality Operations and promoted Gregory M. Glenn, M.D., to President, Research & Development, Amy B. Fix to Senior Vice President, Regulatory Affairs, Louis F. Fries III, M.D., to Senior Vice President and Chief Medical Officer, and Iksung Cho to Vice President, Biostatistics.

2016 Anticipated Events:

· Announce top-line data from Resolve, the Phase 3 pivotal RSV F Vaccine trial in older adults in the third quarter of 2016; and

·
Announce top-line data from the Phase 2 RSV F Vaccine rollover trial in older adults in the second half of 2016.

Summary

"During the first quarter, we continued to successfully execute on our two ongoing pivotal Phase 3 trials of our RSV F Vaccine. We also raised $325 million in a successful Convertible Senior Notes offering, which strengthens Novavax’ balance sheet ahead of data from the pivotal Phase 3 Resolve clinical trial," said Stanley C. Erck, President and CEO. "We are pleased to see significant interest from a number of multinational, world-class vaccine companies seeking potential partnership and commercialization rights to our RSV F Vaccine franchise outside of North America. We remain well positioned to announce value creating data from the Resolve trial and the Phase 2 rollover trial in older adults in 2016."

Financial Results for the Three Months Ended March 31, 2016

Novavax reported a net loss of $77.3 million, or $0.29 per share, for the first quarter of 2016, compared to a net loss of $24.4 million, or $0.10 per share, for the first quarter of 2015.

Novavax revenue in the first quarter of 2016 decreased 57% to $4.2 million, compared to $9.9 million for the same period in 2015. Lower revenue under the HHS BARDA contract of $7.3 million is the primary driver of this decrease. The lower HHS BARDA revenue is the result of a lower level of activity in the three months ended March 31, 2016, as compared to the same period in 2015, along with a one-time revenue recognition of $3.1 million in the first quarter of 2015. This decrease in HHS BARDA revenue was partially offset by $1.6 million in revenue recorded under the BMGF grant relating to our ongoing Prepare clinical trial.

Research and development expenses increased 143% to $69.0 million in the first quarter of 2016, compared to $28.3 million for the same period in 2015. The increase in research and development expenses was primarily due to increased costs associated with the clinical trials and development activities of our RSV F Vaccine and higher employee-related costs, including non-cash stock-based compensation.

General and administrative expenses increased 80% to $10.5 million in the first quarter of 2016, compared to $5.8 million for the same period in 2015. The increase was primarily due to higher employee-related costs, including non-cash stock-based compensation expense, and professional fees for pre-commercialization activities, as compared to the same period in 2015.

Interest income (expense), net for the first quarter of 2016 includes $2.1 million of interest expense relating the Company’s Convertible Senior Notes offering.

As of March 31, 2016, the company had $433.9 million in cash and cash equivalents and marketable securities compared to $230.7 million as of December 31, 2015. Net cash used in operating activities for the first quarter of 2016 was $69.8 million, compared to $30.5 million for same period in 2015. The increase in cash usage was primarily due to increased costs relating to our RSV F Vaccine, higher employee-related costs and timing of vendor payments. As previously mentioned, Novavax completed a $325 million Convertible Senior Notes offering in the first quarter of 2016.

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On May 05, 2016 (QLT Inc. (NASDAQ:QLTI) (TSX:QLT) ("QLT" or the "Company") reported financial results today for the first quarter ended March 31, 2016 (Press release, QLT, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165383 [SID:1234512045]). Unless otherwise specified, all amounts are reported in U.S. dollars and in accordance with U.S. GAAP.

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Synthetic Retinoid Program Update

On April 22, 2016, QLT announced that it had completed enrollment and collection of data from its retrospective, uncontrolled, multicenter Natural History Study in subjects with Inherited Retinal Disease (IRD) in Retinitis Pigmentosa and Leber Congenital Amaurosis patients due to underlying RPE65 or LRAT gene mutations. As QLT expected, the preliminary analysis of the study data suggests that IRD subjects, without therapeutic intervention, demonstrate a continuing decline in visual field and eventually visual acuity over time. Given these results, the Company is in the process of finalizing its data analysis and plans to hold discussions with select national European agencies in the second quarter of 2016. The results of this study are expected to provide important data to support the ongoing development of QLT091001 and planned future submissions for regulatory approval in Europe and the U.S., including the potential filing of a marketing authorization application (MAA) with the European Medicines Agency (EMA) for conditional approval in the second half of 2016.

QLT continues to advance toward initiating a pivotal Phase III, multi-center, placebo-controlled, double-masked clinical study for QLT091001 in this indication in the third quarter of 2016. The pivotal trial is expected to enroll 48 patients at approximately 12 sites in the EU, U.S. and Canada.

2016 FIRST QUARTER FINANCIAL RESULTS

Operating Expenses/Income

During the first quarter of 2016, research and development ("R&D") expenditures were $3.0 million compared to $2.2 million for the same quarter in 2015. The net $0.8 million (36%) increase was primarily due to higher costs incurred in 2016 related to our ongoing preparatory activities for our QLT091001 pivotal trial and our natural history study. These cost increases were partially offset by lower salary and overhead costs resulting from (i) the 2015 transfer and outsourcing of our bio-analytical functions and laboratories to an external contract research organization and (ii) the foreign exchange impact of the weakened Canadian dollar. In addition, no stock compensation expense was recorded during the period due to the accelerated vesting of all outstanding stock options in June 2015.

During the first quarter of 2016, selling, general and administrative ("SG&A"), expenditures were $6.0 million compared to $3.6 million for the same quarter in 2015. The $2.4 million (66%) increase in SG&A expense was primarily due to a $4.0 million advisory fee paid to our advisors, Greenhill & Co, LLC. ("Greenhill"), on February 5, 2016, which was partially offset by a $0.9 million decrease in general strategic consulting and advisory fees.

Excluding the impact of these consulting and advisory fees, SG&A expenses decreased by $0.7 million. The $0.7 million (41%) decrease in SG&A expense was primarily due to a decrease in directors’ fees, general operating costs that were affected by the foreign exchange impact of the weakened Canadian dollar, downsizing of our lease space, and the absence of stock compensation expense for the same reasons described above.

Other Expenses/Income

On February 5, 2016, QLT completed a $45.0 million investment in Aralez Pharmaceuticals, Inc. ("Aralez"). In exchange, QLT received 7,200,000 Aralez common shares at US $6.25 per common share.

On April 5, 2016, QLT completed a special distribution of these Aralez shares, which was payable, at the election of each shareholder, in either Aralez shares or cash, subject to proration (the "Aralez Distribution"). The cash portion of the Aralez Distribution was subject a maximum limit of $15.0 million, which was funded through the March 17, 2016 sale of 2,400,000 Aralez shares to certain third parties for US $6.25 per share under the terms of a share purchase agreement (the "Backstop Agreement"). On April 5, 2016, QLT distributed $15.0 million of cash and the remaining 4,799,619 Aralez shares to its shareholders, which had a fair market value of $19.3 million based on the NASDAQ quoted closing price of Aralez’s shares on April 5, 2016.

On March 31, 2016, QLT recognized a $13.0 million loss related to the 4,800,000 Aralez shares that were held by the Company at period end for the April 5, 2016 Aralez Distribution. The $13.0 million loss represents the change in value from the acquisition date to March 31, 2016.

Operating Loss and Net Loss per Share

The operating loss for the first quarter of 2016 was $8.9 million, compared to $6.0 million for the same period in 2015. The net $2.9 million increase in our operating loss was primarily due to the strategic consulting and advisory fees described above. Excluding the impact of these fees, the adjusted operating loss for the first quarter of 2016 was $4.1 million, which is consistent with the adjusted operating loss for the same quarter in 2015.

Net loss per common share was $0.41 in the first quarter of 2016, compared to $0.12 for the same quarter in 2015. The decrease in loss per share was primarily due to a $13.0 million fair value loss related to the 4,800,000 Aralez shares held at period end and the strategic consulting and advisory fees described above.

Cash and Cash Equivalents

As at March 31, 2016, the Company’s consolidated cash and cash equivalents were $102.9 million compared to $141.8 million at December 31, 2015. The $38.9 million decrease was primarily due to the $45.0 million Aralez Investment, $4.5 million of strategic consulting and advisory fees and cash used in operating activities during the period. These cash decreases were partially offset by the $15.0 million of cash received on March 17, 2016 pursuant to the terms of the Backstop Agreement to fund the Aralez Distribution on April 5, 2016.

Passive Foreign Investment Company

The Company believes that it was classified as a Passive Foreign Investment Company ("PFIC") for 2008 through 2015, and that it may be classified as a PFIC in 2016, which could have adverse tax consequences for U.S. shareholders. Please refer to our 2015 Annual Report on Form 10-K for additional information.

QLT Inc. – Financial Highlights
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands of U.S. dollars except share and per share information)
Three months ended
March 31,
2016 2015

Expenses
Research and development $ 2,990 $ 2,208
Selling, general and administrative 5,898 3,619
Depreciation 38 188
8,926 6,015

Operating loss (8,926 ) (6,015 )
Other (expense) income
Net foreign exchange (losses) gains (77 ) 98
Interest income 75 32
Fair value loss on investment (12,960 ) -
Other - (2 )
(12,962 ) 128

Loss before income taxes (21,888 ) (5,887 )
Provision for income taxes (6 ) (9 )
Net loss and comprehensive loss $ (21,894 ) $ (5,896 )

Basic and diluted net loss per common share
Net loss per common share $ (0.41 ) $ (0.12 )

Weighted average number of common shares outstanding (thousands)
Basic and diluted 52,829 51,237

CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands of U.S. dollars) March 31, 2016 December 31, 2015
ASSETS
Current assets
Cash and cash equivalents (1) $ 102,856 $ 141,824
Investment (2) 17,040 -
Accounts receivable, net of allowances for doubtful accounts 321 287
Income taxes receivable 14 14
Prepaid and other 725 611
Total current assets 120,956 142,736

Accounts receivable 2,000 2,000
Property, plant and equipment 461 430
Total assets $ 123,417 $ 145,166

LIABILITIES
Current liabilities
Accounts payable $ 2,969 $ 1,656
Accrued liabilities 632 1,827
Total current liabilities 3,601 3,483
Uncertain tax position liabilities 369 342
Total liabilities 3,970 3,825

SHAREHOLDERS’ EQUITY
Share capital
Authorized
500,000,000 common shares without par value
5,000,000 first preference shares without par value, issuable in series
Issued and outstanding common shares $ 475,333 $ 475,333
March 31, 2016 – 52,829,398 shares
December 31, 2015 – 52,829,398 shares
Additional paid-in capital 97,377 97,377
Accumulated deficit (556,232 ) (534,338 )
Accumulated other comprehensive income 102,969 102,969
Total shareholders’ equity 119,447 141,341
Total shareholders’ equity and liabilities $ 123,417 $ 145,166

Footnotes:

1) Cash and cash equivalents as at March 31, 2016 includes $15.0 million of cash which was subsequently distributed to
QLT’s shareholders on April 5, 2016 as part of the Aralez Distribution.

2) Reflects the value of 4,800,000 Aralez shares based on the March 31, 2016 US $3.55 closing price of Aralez’s common
shares. These shares were held by QLT on March 31, 2016 and subsequently distributed to QLT’s shareholders on
April 5, 2016 as part of the Aralez Distribution.