On May 05, 2016 Athersys, Inc. (Nasdaq:ATHX) reported its financial results for the three months ended March 31, 2016 (Press release, Athersys, MAY 5, 2016, View Source [SID:1234511972]).

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Highlights of the first quarter of 2016 and recent events include:

Announced positive one-year follow-up results from the Phase 2 study of MultiStem cell therapy to treat ischemic stroke – demonstrating progressive improvements and significantly higher rate of excellent outcomes at one year for MultiStem-treated patients – with greater benefits for patients receiving MultiStem treatment within 36 hours of the stroke;
Established collaboration with HEALIOS K.K. ("Healios") to develop MultiStem cell therapy for stroke in Japan, which included an upfront payment of $15 million, additional potential milestone payments aggregating up to $225 million, double-digit royalties on product sales and an option for Healios to expand the collaboration to include acute respiratory distress syndrome ("ARDS") and another indication with a $10 million expansion payment and additional associated milestone payments and royalties;
Advanced preparations for next stroke trials, including working with Healios to reach agreement with the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA") on study design to potentially clear the way for a Japanese investigational new drug ("J-IND") filing and subsequent trial launch, and engaging with other regulators about requirements for the Company’s planned international stroke study;
Continued enrollment of Phase 2a study evaluating administration of MultiStem therapy to ARDS patients, and Phase 2 acute myocardial infarction ("AMI") study, evaluating and taking measures to accelerate enrollment;
Recorded revenues of $15.5 million for quarter ended March 31, 2016, reflecting the recognition of the $15.0 million license fee payment from Healios, and net income of $4.8 million; and
Ended the quarter with $30.4 million in cash and cash equivalents.
"We remain very excited about our ischemic stroke program," stated Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "As we have presented at several conferences, we have seen that MultiStem treatment has the potential to help ischemic stroke victims, especially those who can be treated within 36 hours following the stroke. We were especially pleased with the one-year follow-up results, which showed continued and significant functional improvement with MultiStem treatment. As a result, we are moving forward diligently with clinical development in Japan with our partner Healios, and with planning for a corresponding study in the United States and Europe, focused on MultiStem treatment within 36 hours of the stroke.

"Our partnership with Healios is off to a strong start," continued Dr. Van Bokkelen. "Building from our previous engagement with the PMDA and with our support, Healios has reached general agreement with the PMDA about trial design and requirements. Healios is preparing its J-IND filing and planning for the subsequent launch of its planned study, and we are engaged in manufacturing to support their clinical product requirements. Based on discussions with the PMDA, we believe that a successful trial in Japan could make contingent, or even full, approval possible, utilizing Japan’s progressive regulations for the development and approval of regenerative medicine products.

"We are also fully engaged in planning and preparing for an international ischemic stroke study focused in the United States and several European countries. Upcoming discussions with the U.S. Food and Drug Administration and other regulators will help us refine and finalize the trial design and complete trial preparations," noted Dr. Van Bokkelen.

"We are also enrolling our two grant-supported Phase 2 trials, in AMI and ARDS, although progress has been slower than we have anticipated," commented Dr. Van Bokkelen. "We have undertaken a number of actions to accelerate enrollment, including adding clinical sites. We believe that MultiStem cell therapy is well-suited to treat these acute conditions based on our preclinical and clinical experience to date, and we are motivated to move these studies forward expeditiously.

"We continue to focus on other important areas, including actively exploring partnering opportunities around multiple programs. Finally, we have a substantial effort underway in manufacturing and process development focused, first, on supplying our planned clinical studies, and second, on advancing our manufacturing platform and related capabilities to support high-volume, low-cost production important to commercialization," concluded Dr. Van Bokkelen.

First Quarter Results

For the three months ended March 31, 2016, total revenues were $15.5 million compared to $0.7 million in the same period in 2015, reflecting the recognition of $15.0 million in contract revenue from our Healios collaboration in the first quarter of 2016. Grant revenue was $0.3 million less in the first quarter of 2016 compared to the same period in 2015, and grant revenues may fluctuate from period to period based on the timing of grant-related activities and the award and expiration of new grants.

Research and development expenses increased to $6.7 million in the 2016 first quarter from $5.7 million in the 2015 first quarter, primarily due to increased clinical and preclinical development costs, including process development activities to support manufacturing. General and administrative expenses were relatively consistent at $2.0 million and $1.9 million for the three months ended March 31, 2016 and 2015, respectively.

We recognized net income for the three months ended March 31, 2016 of $4.8 million compared to net loss of $12.5 million for the same period in 2015. The $17.2 million net variance includes the impact of the $15.0 million Healios license revenue, the $0.3 million decrease in grant revenues, the $1.1 million increase in combined R&D and G&A expenses, a $3.4 million decrease in non-cash expense from the change in the fair value of our warrant liabilities, and a $0.2 million increase in net other income. Cash provided in operating activities was $7.3 million during the 2016 first quarter (reflecting $14.8 million of cash received from Healios), compared to $1.1 million in the 2015 first quarter (including $8.0 million of cash received from our former collaborator, Chugai Pharmaceutical Co., Ltd). As of March 31, 2016, we had $30.4 million in cash and cash equivalents, compared to $23.0 million at December 31, 2015.

On May 05, 2016 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported financial results for the quarter ended March 31, 2016 (Press release, Insmed, MAY 5, 2016, View Source [SID:1234512005]).

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Business Update

Global Phase 3 CONVERT study advancing. Patient enrollment continues to proceed on track in the company’s global phase 3 study of ARIKAYCE (liposomal amikacin for inhalation or LAI) in nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) (CONVERT or INS-212 study). The CONVERT study is taking place in 16 countries and at more than 130 sites. The company continues to expect to achieve its enrollment objective in the second half of 2016.
EMA regulatory review of ARIKAYCE progressing. The company remains on track with previous guidance, having submitted its responses to the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) 180-day list of outstanding issues related to the company’s Marketing Authorization Application (MAA) for ARIKAYCE. Insmed expects to participate in an oral explanation meeting in the second quarter of 2016 and the CHMP to render an opinion on its MAA around the middle of 2016.

Data accepted for presentation at ATS 2016. Three ARIKAYCE-related abstracts and one treprostinil prodrug abstract have been accepted for presentation at the American Thoracic Society (ATS) 2016 International Conference taking place May 13-18 in San Francisco. The ATS presentations include (i) one-year follow-up data from the phase 2 112 study, (ii) lung distribution and retention data from a scintigraphy study in patients with NTM lung disease, (iii) a preclinical study of ARIKAYCE, and (iv) a preclinical study of a variety of treprostinil prodrugs.

Phase 1 clinical study of INS1009 submitted for presentation. Insmed has completed a phase 1 study of INS1009 and submitted the results for presentation at a future medical meeting. This first-in-human study of INS1009 was designed to determine the maximum-tolerated dose of a single dose of INS1009 and to characterize the pharmacokinetic profile of free treprostinil and INS1009 in healthy volunteers. INS1009 is one of the company’s nebulized treprostinil prodrugs, which may offer a differentiated product profile with therapeutic potential in rare pulmonary disorders such as pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), sarcoidosis, and severe refractory asthma.

Canadian patent strengthens global patent portfolio. The Canadian Intellectual Property Office issued patent no. 2,838,111, which covers pharmaceutical formulations that include mixtures of liposomal quinolone antibiotics, together with free, unencapsulated quinolone antibiotics, such as ciprofloxacin. The patent also covers the use of such formulations for the treatment of various pulmonary disorders, for example, in bronchiectasis patients. The Canadian patent complements ARIKAYCE’s global intellectual property estate. Counterpart patent applications to this Canadian patent are pending in other countries.

"2016 is off to a solid start with all of our clinical, regulatory, and commercial-readiness activities remaining on track with our previously stated timelines," said Will Lewis, president and chief executive officer of Insmed. "Our top corporate priority is our global phase 3 CONVERT study and we look forward to achieving our patient enrollment objective later this year. In parallel with our clinical activities, our team is advancing the regulatory process for ARIKAYCE in Europe. For INS1009, we completed the phase 1 study and submitted the results for presentation at an international respiratory congress in the third quarter. Lastly, our talented team of scientists remain focused on advancing a number of preclinical programs and identifying our next candidates for clinical development."

First Quarter Financial Results

For the first quarter of 2016, Insmed posted a net loss of $33.5 million, or $0.54 per share, compared with a net loss of $27.4 million, or $0.55 per share, for the first quarter of 2015.

Research and development expenses were $20.5 million for the first quarter of 2016, compared with $17.2 million for the first quarter of 2015. The increase was primarily due to the advancement of the company’s global phase 3 CONVERT study of ARIKAYCE in NTM lung disease.

General and administrative expenses for the first quarter of 2016 were $12.5 million, compared with $9.5 million for the first quarter of 2015. The increase was primarily related to pre-commercial activities in Europe, namely the buildout of the company’s infrastructure and NTM disease awareness activities, as well as an increase in headcount and related expenses.

Balance Sheet Highlights and Cash Guidance

As of March 31, 2016, Insmed had cash and cash equivalents of $253 million. Excluding depreciation and stock-based compensation expense, the company’s cash operating expenses for the quarter ended March 31, 2016 were $28 million. Insmed ended the first quarter of 2016 with $25 million in debt and working capital of $233 million.

The company is investing in the following activities in 2016: (i) clinical development of ARIKAYCE, (ii) regulatory and pre-commercial initiatives for ARIKAYCE, and (iii) preclinical and clinical activities for its earlier-stage pipeline. Insmed continues to expect its cash-based operating expenses for the first half of 2016 to be in the range of $58 to $68 million.

On May 5, 2016 PharmaCyte Biotech (OTCQB: PMCB) reported that it has now reached a point in its life cycle where it is ready to start working with the U.S. FDA to get the company’s Phase 2b clinical trial in advanced pancreatic cancer underway (Press release, PharmaCyte Biotech, MAY 5, 2016, View Source [SID:1234512035]). Let that sink in for a moment. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, has taken up the mantle to move the company’s signature technology, Cell-in-a-Box, to the clinic. And now, three short years later, he has the small biotech on the doorstep of what could be an eye-opening clinical trial to treat pancreatic cancer patients.

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According to the American Cancer Society’s cancer statistics for 2016, pancreatic cancer is the third leading cause of cancer-related deaths in the United States, and it’s one of the few cancers for which survival has not improved substantially over nearly 40 years. But help could be on the way. After PharmaCyte announced last week that the live-cell encapsulation facility where its Cell-in-a-Box capsules are produced is now current Good Manufacturing Practices or cGMP-compliant, the company cleared what was a major milestone on the way to a clinical trial and is now closer than ever to taking on the challenge of improving the lives of pancreatic cancer patients.

These are truly exciting times at PharmaCyte, and with the cell encapsulation facility now cGMP-compliant, the company can set its sights on first requesting a pre-IND (Investigational New Drug application) meeting with the FDA to discuss the design of its upcoming clinical trial.

This pre-IND meeting will be crucial to developing a relationship with the FDA and getting the necessary answers and guidance moving forward that will allow PharmaCyte to submit its formal IND to the FDA. The pre-IND meeting and the IND submission to the FDA are the next two major milestones for PharmaCyte and its investors.

With the encapsulation facility now ready for the production of clinical trial material, let’s look at the trial design that PharmaCyte has announced for its Phase 2b clinical trial:

PharmaCyte’s pancreatic cancer therapy consists of placing microcapsules containing genetically engineered live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. When the blood carries the chemotherapy drug to where the capsules have been placed, activation of the drug takes place right at the source of the cancer instead of in the patient’s liver, which eliminates any side effects in these patients.
The trial will be a multi-site trial held in both the United States and Europe. It will also be an open-label trial in which the patients will be randomized between two study groups. The trial has been designed to meet a clear unmet medical need that exists for a particular group of pancreatic cancer patients.
The randomization ratio of patients between the two study groups will be 1:1 (an equal number of patients will be randomly assigned to the capecitabine + radiation group and the PharmaCyte pancreatic cancer therapy group).
Only patients who have locally advanced, non-metastatic, inoperable cancer and whose tumors no longer respond after 4-6 months of treatment with either the widely used Abraxane + gemcitabine combination therapy or FOLFIRINOX, will be eligible for the trial. These patients are usually treated with the combination of the chemotherapy drug capecitabine + radiation, but this treatment is only marginally effective and is quite toxic for the patients.
Study sites under consideration in the U.S. include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute also in Boston, the Baylor Cancer Center in Dallas, Texas, Cedars-Sinai Medical Center in Los Angeles, as well as sites in Germany and Spain.
It is believed that 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
Unlike in earlier clinical trials using PharmaCyte’s pancreatic cancer therapy where patients received only two cycles of therapy with ifosfamide, multiple cycles of ifosfamide will be given to those being treated with PharmaCyte’s pancreatic cancer therapy. This will continue until the patients’ tumors no longer respond to PharmaCyte’s therapy or until treatment-related toxicity accumulates to unacceptable levels.
And the best news of all for investors heading into these exciting times is that PharmaCyte has been awarded the Orphan Drug designation by both the U.S. FDA and the European Medicines Agency (EMA). This designation means that the company’s pancreatic cancer therapy will have complete protection and market exclusivity for years to come. After PharmaCyte’s therapy is approved for marketing by these two regulatory agencies, they will enjoy 7 years of market exclusivity in the United States and 10 years of protection in the European Union.

PharmaCyte’s CEO also recently stated that the company’s pancreatic cancer therapy qualifies for 12 years of data exclusivity because it is considered a "biologic" as outlined by the Biologics Price Competition and Innovation Act (BPCIA).

So, as the company marches headlong into a Phase 2b clinical trial in the U.S. and Europe with a built in "hard stop" about half way through the trial to review the data, there is no better time than the present to get excited about this small biotechnology company and what could very well be a significant contribution to the treatment of pancreatic cancer.

On May 05, 2016 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the first quarter ended March 31, 2016 (Press release, BioCryst Pharmaceuticalsa, MAY 5, 2016, View Source [SID:1234511974]).

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"We are currently working through the start-up activities for the APeX-1 trial of BCX7353 for prevention of angioedema attacks in HAE patients and are targeting the end of the year to report results," said Jon P. Stonehouse, President & Chief Executive Officer. "In addition, we are conducting a Phase 1 clinical pharmacology study in healthy volunteers to determine if we are able to meaningfully increase exposure and get to a twice-daily oral dosage form of avoralstat. We expect to report results from this study this summer."

First Quarter Financial Results
For the three months ended March 31, 2016, revenues decreased to $4.8 million from $6.8 million in the first quarter of 2015. The decrease was primarily due to lower collaborative revenue associated with BCX4430 development under the advanced development contract with the Biomedical Advanced Research and Development Authority (BARDA/HHS) awarded in March 2015. In the first quarter of 2015, the Company recorded $537,000 in RAPIVAB revenue, representing drug sold under the sell-through revenue recognition methodology. No RAPIVAB revenue was received in the first quarter 2016 as RAPIVAB commercialization is now being handled by Seqirus UK Limited (Seqirus).

Research and Development (R&D) expenses for the first quarter of 2016 increased to $20.6 million from $17.1 million in the first quarter of 2015. The R&D expense increase in 2016 resulted primarily from higher development costs associated with the Company’s hereditary angioedema (HAE) programs, as well as ongoing post approval clinical trials of RAPIVAB in both pediatric and elderly/high risk influenza patient populations.

General and administrative (G&A) expenses for the first quarter of 2016 decreased to $3.2 million compared to $4 .1 million for the first quarter of 2015. G&A expenses decreased in 2016 due to a significant reduction in unrestricted grants, as well as the elimination of marketing and commercial consulting expense in 2016, as RAPIVAB is now being commercialized by Seqirus.

Interest expense, which is primarily related to non-recourse notes, was $1.5 million in the first quarter of 2016 and $1.3 million in the first quarter of 2015. Also, a $2.8 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the first quarter of 2016, as compared to a $464,000 mark-to-market gain in the first quarter of 2015. The change in the dollar/yen exchange rate between the quarters resulted in a $3.2 million increase to the Company’s net loss for the first quarter of 2016 as compared to 2015. These gains and losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement.

The net loss for the first quarter of 2016 was $22.8 million, or $0.31 per share, compared to a net loss of $15.2 million, or $0.21 per share, for the first quarter 2015.

Cash, cash equivalents and investments totaled $78.9 million at March 31, 2016. Net operating cash use for the first quarter of 2016 was $22.4 million, as compared to $3.8 million for the first quarter of 2015. The first quarter of 2016 is expected to be the largest cash consumption quarter of the four quarters in 2016, and BioCryst expects to remain within previously issued cash use guidance.

Clinical Development Update & Outlook
BioCryst expects to report results of the APeX-1 clinical trial of the once-daily, second generation HAE compound, BCX7353, for prevention of angioedema attacks in HAE patients by year end.

A Phase 1 clinical pharmacology trial testing multiple avoralstat formulations is ongoing in healthy subjects with the aim to develop a twice-daily dosage for HAE patients. Pharmacokinetic results are expected this summer.

BioCryst has completed the Phase 1 clinical trial of single and multiple ascending doses of its broad spectrum antiviral BCX4430 administered by intramuscular (i.m.) injection in healthy volunteers. BCX4430 by i.m. injection was generally safe and well tolerated through doses up to 10mg/kg daily for seven days, the maximum dose planned in the trial.

Nonclinical experiments are continuing with BCX4430 in a model of Zika virus infection in interferon-receptor-deficient mice. Studies conducted to date have shown improved survival with dosing delayed up to 7 days after virus challenge, reduction in viral titer in the blood, and development of protective immunity in surviving animals. This research has been conducted in collaboration with Utah State University and NIAID.

In January, BioCryst submitted a New Drug Submission (NDS) for RAPIVAB in Canada, seeking approval for the treatment of acute uncomplicated influenza in adult patients.

Financial Outlook for 2016
Based upon development plans and our awarded government contracts, BioCryst expects its 2016 net operating cash use to be in the range of $55 to $75 million, and its 2016 operating expenses to be in the range of $78 to $98 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.

On May 05, 2016 Portola Pharmaceuticals Inc. (NASDAQ:PTLA), today provided a corporate update and reported its financial results for the first quarter ended March 31, 2016 (Press release, Portola Pharmaceuticals, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165766 [SID:1234512036]).

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"During the first quarter of 2016, we continued to advance the development of our three product candidates. We reported acceptance of our ANDEXXA (andexanet alfa) BLA and Phase 3 topline data from the APEX trial of betrixaban, completed a successful FDA pre-approval inspection of our Generation 1 commercial manufacturing process for ANDEXXA and completed the Phase 1 cerdulatinib study," said Bill Lis, chief executive officer of Portola. "We remain focused on successfully launching ANDEXXA, an FDA-designated Breakthrough Therapy and filing an NDA for betrixaban, an FDA-designated Fast Track Therapy, this year."

Recent Achievements, Upcoming Events and Milestones

ANDEXXA (andexanet alfa) – an FDA-designated Breakthrough Therapy Factor Xa inhibitor antidote in development for reversal of anticoagulation in patients treated with a Factor Xa inhibitor who are admitted to the hospital with uncontrolled bleeding or who need urgent surgery

The FDA accepted Portola’s BLA submission for ANDEXXA for filing in February 2016
The FDA completed a successful pre-approval inspection of CMC Biologics’ Generation 1 process; the inspection addressed the Generation 1 2,500 liter scale and the 6×2,000 liter scale process and confirmed alignment with the BLA
Completed Generation 2 GMP batches at the 10,000 liter scale at Lonza and achieved target yields
Entered into collaboration agreements with all of the manufacturers of oral Factor Xa inhibitors in Japan to develop and/or commercialize andexanet alfa in that territory
Enrollment remains on track for ANNEXATM-4, a Phase 3b/4 confirmatory study
Plan to present data from the Phase 2 proof-of-concept study with betrixaban in healthy volunteers at a medical conference this year
Preparing for commercial launch shortly after the PDUFA date of August 17, 2016, if approved
Plan to submit an MAA with the EMA in the third quarter of 2016
Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients

Reported topline results from the pivotal Phase 3 APEX Study
Plan to present data from the APEX Study on Friday, May 27, at the International Society on Thrombosis and Haemostasis (ISTH) 62nd Annual SSC (Scientific and Standardization Committee) Meeting in Montpellier, France; will hold an investor webcast directly following the presentation to discuss the APEX Study data
Plan to meet with the FDA in the second quarter and with the European Medicines Agency (EMA) to discuss the APEX Study results and a regulatory path forward
Pending discussions, plan to submit a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the EMA by the end of the year
Cerdulatinib – an oral, dual syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

Achieved the maximum tolerated dose and completed the Phase 1 study; plan to present results in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting in June
Initiated a Phase 2 study and expect to enroll the first patient during the second quarter
First Quarter 2016 Financial Results
Collaboration revenue earned under Portola’s collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Lee’s Pharmaceutical was $8.3 million for the first quarter of 2016 compared with $2.4 million for the first quarter of 2015. The increase in revenue was primarily the result of achieving certain milestones from Portola’s Daiichi Sankyo and Bayer and Janssen clinical agreements with the filing of the ANDEXXA BLA.

Total operating expenses for the first quarter of 2016 were $73.6 million compared with $48.9 million for the same period in 2015. Total operating expenses for the first quarter of 2016 included $7.1 million in stock-based compensation expense compared with $5.2 million for the same period in 2015.

Research and development expenses were $58.8 million for the first quarter of 2016 compared with $39.9 million for the first quarter of 2015 as Portola continued to support its manufacturing scale-up of ANDEXXA in preparation for commercial launch and work on its larger-scale Generation 2 manufacturing process at Lonza, the Phase 3b/4 ANNEXA-4 study of ANDEXXA, and the Phase 1/2a clinical study of cerdulatinib.

Selling, general and administrative expenses for the first quarter of 2016 were $14.8 million compared with $9.0 million for the same period in 2015 as the Company increased headcount to support its growth and increased pre commercial launch activities, including hiring key regional sales directors and national account managers and further developing medical affairs.

For the first quarter of 2016, Portola reported a net loss of $65.0 million, or $1.15 net loss per share, compared with a net loss of $46.9 million, or $0.95 net loss per share, for the same period in 2015.

As of March 31, 2016, cash, cash equivalents and investments totaled $421.0 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.

2016 Annual Financial Guidance
For the fiscal year 2016, Portola expects total pro-forma operating expenses to be between $295 million and $320 million, excluding stock-based compensation. These expenses will be primarily in support of submissions of Generation 1 and Generation 2 manufacturing scale-up of ANDEXXA in preparation for commercial launch, the ongoing ANNEXA-4 study of ANDEXXA, the U.S. launch of ANDEXXA, the submission of NDA and MAA for betrixaban, pending regulatory discussions, and the Phase 2 clinical study of cerdulatinib.

Non-GAAP Financial Projection
This press release and the reconciliation table included herein include a non-GAAP projection of 2016 operating expenses, excluding stock-based compensation. A reconciliation to projected GAAP 2016 operating expenses is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Projected Operating Expenses." Portola management believes this non-GAAP information is useful for investors because it provides information about the Company’s ability to independently advance its assets.