On February 24, 2016 Forty Seven Inc., a clinical-stage immuno-oncology company, reported that it has completed the first half of a committed $75 million Series A financing round and has licensed the rights to multiple immuno-oncology programs from Stanford University (Press release, Forty Seven, FEB 24, 2016, View Source [SID:1234509244]).

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The Series A financing was led by Lightspeed Venture Partners and Sutter Hill Ventures with participation from Clarus Ventures and GV (formerly Google Ventures). The license includes rights to over 100 issued or pending U.S. or foreign patents that cover the antibody Hu5F9-G4 and several other novel immune checkpoint inhibitors and cancer-specific antibodies.
Forty Seven is committed to the advancement of immuno-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity. The financing will allow Forty Seven to continue the clinical development of its lead molecule, Hu5F9-G4, a humanized monoclonal antibody against human CD47 that potentially has broad applications spanning multiple tumor types and treatment modalities.

CD47 is a molecule that is overexpressed on the surface of the majority of tumors and transmits a "don’t eat me" signal, enabling cancer cells to evade phagocytosis by macrophages. The molecule was originally identified as a cancer target by researchers at Stanford. In preclinical models, Hu5F9-G4 facilitated phagocytosis and elimination of cancer cells from multiple human tumor types as a monotherapy. Additionally, when used in combination therapy, it engaged macrophages as effector cells to enhance the efficacy of cancer-specific antibodies via Antibody-Dependent Cellular Phagocytosis (ADCP). Importantly, Hu5F9-G4 also could prime an effective antitumor T-cell response through cross-presentation of cancer cell antigens by macrophages, preventing engraftment of tumors expressing a cross-presented antigen into animals.

Company founder Irv Weissman said, "Targeting CD47 integrates the adaptive and innate immune systems creating synergy with existing cancer-specific antibodies like rituximab, cetuximab and trastuzumab through ADCP, and potentially with T-cell checkpoint inhibitors through cross-presentation. We are grateful to the California Institute for Regenerative Medicine (CIRM) for funding the preclinical studies and the current solid tumor clinical trial at Stanford, and to Ludwig Cancer Research for funding much of the research."

"The founders, Irv Weissman, Ravi Majeti, Mark Chao and Jens Volkmer, have studied the CD47 pathway extensively since they initially identified it as a cancer target in two papers published in 2009," commented Chris Schaepe, Partner at Lightspeed Venture Partners. "The company’s scientific founders have done an outstanding job of advancing Hu5F9-G4 into two Phase 1 clinical trials in patients with relapsed or refractory solid tumors or acute myeloid leukemia (AML)."

"Forty Seven’s accomplishments pre-Series A funding are unusual as is the breadth of its patent portfolio which also has broad potential applications outside of cancer," remarked Jeff Bird, Partner at Sutter Hill Ventures.

Forty Seven will use the proceeds of the Series A financing to complete the two ongoing clinical studies, fund additional clinical trials in 2016 to assess Hu5F9-G4 in combination therapy and advance some preclinical programs towards IND.

"Forty Seven has hired a strong management team with deep industry experience. I feel confident that this combined team along with the support we have from our Series A investors and our scientific founders will enable us to fully explore the clinical utility of our lead molecule and the licensed technology," said Jonathan MacQuitty, CEO of Forty Seven Inc.

Forty Seven Senior Management
Chief Executive Officer, Jonathan MacQuitty, Ph.D., M.B.A. former Partner at Abingworth and former CEO of GenPharm.
Chief Business Officer, Craig Gibbs, Ph.D., M.B.A. former VP and Head of Commercial Strategy, Corporate Development and Biology Research at Gilead.
Chief Medical Officer, Chris Takimoto M.D. Ph.D. former VP Experimental Medicine Early
Development Oncology at Janssen/J&J.
Chief Patent Officer, Norm Kruse Ph.D., J.D. former Head of Intellectual Property at Verinata Health and Maxygen.
VP Clinical Operations, Hassan Movahhed, M.S. former SVP and Head of Clinical Operations at United Therapeutics.

Forty Seven Board of Directors
Jeff Bird, Sutter Hill Ventures.
Dennis Henner, Clarus Ventures.
Jonathan MacQuitty, Forty Seven Inc.
Ravi Majeti, Stanford University School of Medicine.
Chris Schaepe, Lightspeed Venture Partners.
Irv Weissman, Stanford University School of Medicine.

About Forty Seven Inc.
Forty Seven Inc. is a clinical-stage immuno-oncology company that is developing therapies licensed from Stanford University targeting cancer immune evasion pathways. The lead program Hu5F9-G4 is a monoclonal antibody against the CD47 receptor, a "don’t eat me" signal that cancer cells commandeer to avoid being ingested by the immune system. This antibody is currently being evaluated in two Phase 1 clinical studies in patients with solid tumors and in patients with acute myeloid leukemia. Forty Seven is located at 1661 Page Mill Road, Suite C, Palo Alto, CA 94304, U.S.A. For more information please visit www.fortyseveninc.com or contact Chief Business Officer Craig Gibbs at (650)-352-4136.

On February 24, 2016 Genoscience Pharma, a biopharmaceutical company dedicated to discovering and developing cancer treatment drugs, reported the arrival of four new members to its board of directors (Press release, GenoScience, FEB 24, 2016, View Source [SID:1234509200]). Dr Mahkam Zanganeh, Robert Duggan and Manmeet Soni, respectively the former chief operating officer, chief executive officer and chief financial officer of Pharmacyclics, are joining the board along with Chaim Hurvitz, who has worked in many management roles for Teva International Group. The new members will support the strategic and financial development of Genoscience, alongside existing board members – Antoine Béret, Jean-Marc Feryn, Vincent Fert and Chalom Sayada. Their arrival is accompanied by an increase in capital, the terms of which have not been disclosed.

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The four new members are all recognized biotechnology entrepreneurs. While at Pharmacyclics Pharmaceuticals, in less than seven years, Mahkam Zanganeh and Robert Duggan developed and brought to the market Imbruvica, a first-in-class compound treating patients with Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL) and Waldenstrom’s macroglobulinemia (WM). In May 2015, Abbvie acquired Pharmacyclics for $21Bn (€18.9Bn), one of the biggest buyouts for a biotechnology company to date.

Genoscience Pharma’s most advanced compound, GNS561, is in preclinical development for the treatment of liver cancer. It is a small active molecule that works against a new target. It is unique as it targets not only hepatic cancerous cells, but also the progenitors of the cancerous hepatocyte stem cells. GNS561 begins its regulatory process with the aim of starting the first-in-man phase 1b/2a trials in 2017. Preclinical studies have demonstrated GN561’s potential to become a major therapeutic breakthrough in the treatment of hepatocellular carcinoma.

"I am delighted to welcome this high caliber team to our board of directors. Robert Duggan and Mahkam Zanganeh’s experience in the development of anti-tumor molecules will be a credit to our company," said Prof. Philippe Halfon, president and founder of Genoscience Pharma. "It is an honor and a true mark of recognition to be joined by such a team, who participate very selectively in high potential projects. Their scientific expertise in pharmaceutical development will undoubtedly help us achieve our objectives and get to phase 2 quickly."

"The next challenge in oncology is to cure cancer patients by targeting the seed of the disease; cancer stem cells which cause cancer to recur," said Dr. Mahkam Zanganeh. "The strategy proposed by Genoscience Pharma is unique and will allow us to make a decisive step forward in curing cancer."

About cancer stem cells

Since 2012, Genoscience has been involved in an ambitious program to discover and develop compounds that target cancer stem cells. These stem cells, which are ultra-resistant to traditional chemotherapy and radiotherapy, form a minority subpopulation of the cells in a tumor and are responsible for tumor growth and metastases. They renew themselves indefinitely, differentiating themselves to form and maintain the tumor tissue. These cells do not respond to conventional chemotherapy that targets the majority of differentiated tumor cells. This explains the indefinite development of tumors as well as metastases and relapses. Consequently, eradicating cancer stem cells is essential in order to achieve lasting clinical remission and to improve the prognosis of cancer patients.

Genoscience is one of the pioneers in this emerging domain of cancer biology, which aims to revolutionize the traditional approach to treating cancer. Genoscience’s main candidate, GNS561, is also under evaluation for treating other cancers (kidney and colorectal), which could respond to its first-in-class action mechanism.

About liver cancer

Liver cancer (or HCC – hepatocellular carcinoma) is the third most common cause of death by cancer in the world[1]. The medical needs for treating it are considerable and not yet resolved. The only existing chemotherapy treatment for HCC is sorafenib, which slightly increases survival rates, but has many adverse effects[2].

On February 23, 2016 Shire plc (LSE: SHP, NASDAQ: SHPG) (the "Company") reported on February 11, 2016, an interim dividend of 22.16 US cents per Ordinary Share payable on April 12, 2016, to shareholders on the register of members at the close of business on March 11, 2016 (Filing, 8-K, Shire, FEB 23, 2016, View Source [SID:1234509169]).

Shareholders are advised that recent developments in global tax law, namely the introduction of the Foreign Account Tax Compliance Act and the Common Reporting Standard, have introduced new reporting obligations relating to the Company’s Income Access Share arrangements ("IAS Arrangements"). These require that certain information relating to shareholders participating in the IAS Arrangements is reported to the appropriate tax authorities. In order to ensure the new reporting obligations are met, the Company is requesting from electing (or deemed electing) shareholders the relevant information via new IAS Arrangements election forms (and continuation forms in respect of joint holders). The relevant IAS Arrangements election forms together with an explanatory covering letter were posted to shareholders on February 16, 2016. In accordance with Listing Rule 9.6.1R, these documents were also uploaded to the National Storage Mechanism and are available for viewing. Internet links to the documents are also available on the Company’s website: www.shire.com

All shareholders who wish to receive, or continue to receive, UK sourced dividends via the IAS Arrangements (and therefore without incurring Irish dividend withholding tax) need to complete the new IAS Arrangements election forms and return to the address stated therein.

In order for submitted IAS Arrangements election forms to be valid in respect of the dividend to be paid on April 12, 2016, they need to be received by the Company’s Registrar, Equiniti, by 5pm (UK time) on March 11, 2016. Election forms received after this date will not be applied to this dividend though will be applied to future dividend payments.

Shareholders who do not elect to receive UK sourced dividends using the new IAS Arrangements election forms are advised that their dividends will be Irish sourced and therefore incur Irish dividend withholding tax, subject to applicable exemptions. If you are in any doubt as to what action to take, please consult your tax advisor immediately.

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On February 23, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported financial results for the fourth quarter and full year ended December 31, 2015 and issued 2016 product revenue guidance (Press release, Ariad, FEB 23, 2016, View Source;p=RssLanding&cat=news&id=2142086 [SID:1234509137]). Additionally, the Company provided an update on corporate developments and key objectives for 2016.

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"We had a strong fourth quarter of sales for Iclusig and 102 percent growth year over year," stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. "This is a very important year for ARIAD as we work to complete our ongoing review of strategic initiatives to deliver patient and shareholder value. In addition to maximizing top-line growth of Iclusig, a key event this year will be the presentation of pivotal, registration data on brigatinib at ASCO (Free ASCO Whitepaper), along with our planned filing for marketing approval of brigatinib in the U.S."

2015 Fourth Quarter and Full-Year Financial Results

Revenues

Net product revenues from sales of Iclusig were $33.3 million for the fourth quarter of 2015, an increase of 56% from the fourth quarter of 2014.

U.S. sales of Iclusig were $25.1 million for the fourth quarter, an increase of 48% from the fourth quarter of 2014.

European sales of Iclusig were $8.2 million for the fourth quarter, an increase of 86% from the fourth quarter of 2014.

Net product revenues from sales of Iclusig for the year ended December 31, 2015 were $112.5 million, an increase of 102% from 2014. In the U.S., net product revenue totaled $85.7 million in 2015, an increase of 114% from 2014, while in the EU, net product revenue totaled $26.8 million in 2015, an increase of 71% from 2014.

Net Loss

Quarter Ended December 31, 2015

Net loss for the fourth quarter ended December 31, 2015 was $59.9 million, or $0.32 per share, compared to a net loss of $5.8 million, or $0.03 per share, for the same period in 2014. The net loss for 2014 included $50 million in non-recurring income resulting from an amendment to our license agreement with Bellicum Pharmaceuticals, Inc.

R&D expenses were $44.8 million for the fourth quarter of 2015, an increase of 37% from the fourth quarter of 2014, reflecting an increase in Iclusig clinical-trial costs, as well as increased manufacturing and other supporting costs related to Iclusig.

Selling, general and administrative expenses were $43.8 million for the fourth quarter of 2015, an increase of 9% from the fourth quarter of 2014, reflecting an increase in personnel and commercial-related expenses.

Year Ended December 31, 2015

Net loss for the full year 2015 was $231.2 million, or $1.23 per share, compared to a net loss of $162.6 million, or $0.87 per share, for the full year 2014. The net loss for 2014 included $50 million in non-recurring income resulting from an amendment to our license agreement with Bellicum, noted above. The net loss for 2015 includes approximately $14.5 million in non-recurring expenses related to the retirement of our chief executive officer and costs associated with our 2015 proxy and legal matters.

The 2015 results include an increase in Iclusig product revenue of $56.8 million as well as an increase in operating expenses of $70.5 million in 2015 compared to 2014, reflecting an increase in R&D expenses related to an increase in clinical-trial costs, as well as manufacturing and other support costs related to Iclusig and brigatinib clinical trials, and an increase in personnel and related costs reflecting a larger number of R&D employees in 2015 compared to 2014.

Cash Position

As of December 31, 2015, cash, cash equivalents and marketable securities totaled $242.3 million, compared to $352.7 million in cash and cash equivalents at December 31, 2014.

Cash, cash equivalents and marketable securities include $50 million we received in the third quarter of 2015 from PDL BioPharma, Inc. (PDL) pursuant to a royalty financing agreement. In July 2016, we will receive an additional $50 million from PDL. Under the agreement, we also have an option, in our sole discretion, to receive up to an additional $100 million through July 2016.

2016 Product Revenue Guidance

Net product revenues from sales of Iclusig are expected to be in the range of $190 million to $200 million. This guidance includes sales of Iclusig in the U.S., Europe, and other select countries where ARIAD has distributorships in place.

ARIAD will provide guidance on 2016 operating expenses at the time of completing its ongoing strategic review expected in the second quarter of 2016.

Research and Development Progress and Key Objectives

Iclusig Clinical Development

Late last year we initiated the OPTIC-2L trial, a Phase 3 trial of Iclusig in patients with chronic-phase chronic myeloid leukemia (CP-CML) who have experienced treatment failure after imatinib therapy. This second-line study of Iclusig is aimed at expanding the indication for Iclusig in patients with resistant and intolerant CML.

Patient enrollment is ongoing in the OPTIC (Optimizing Ponatinib Treatment In CML) trial of Iclusig. This randomized, dose-ranging trial is designed to evaluate three different starting doses of ponatinib in patients with refractory CP-CML and is expected to inform the optimal use of Iclusig in these patients.

Otsuka Pharmaceutical Co., Ltd. (Otsuka), our commercial partner for Iclusig in Japan and several other Asian countries, submitted a new drug application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for Iclusig for the treatment of resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL). This marketing application was submitted in early 2016 and is expected to lead to an initial approval of Iclusig in Japan by the end of this year.

Brigatinib Clinical Development

We submitted clinical data from the Phase 2 ALTA trial of brigatinib to this year’s annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, 2016. The ALTA trial enrolled approximately 220 patients at 71 sites in North America, Europe and Asia. In addition to an anticipated data presentation at ASCO (Free ASCO Whitepaper), we are on track to file for approval of brigatinib in the U.S. in the third quarter of this year. Brigatinib has received breakthrough-therapy designation from the U.S. Food and Drug Administration.

The randomized front-line clinical trial of brigatinib is expected to begin in the second quarter of 2016. This Phase 3 trial is designed to compare brigatinib and crizotinib in patients with ALK+ non-small cell lung cancer (NSCLC), who have not received prior ALK inhibitors, and is expected to serve as a confirmatory trial for accelerated approval of brigatinib.

Advancing the Pipeline

We submitted an investigational new drug (IND) application for AP32788 in late 2015 and received clearance from the U.S. Food and Drug Administration at the end of January to begin a Phase 1/2 proof-of-concept clinical trial which we expect to begin in 2016. AP32788 is an orally active tyrosine-kinase inhibitor (TKI), designed to address the unmet medical need in NSCLC patients with specific EGFR and HER2 kinase mutations. ARIAD estimates that there are approximately 6,000 patients in the United States living with EGFR exon 20 or HER2 point mutations.

Upcoming Investor Meetings

ARIAD management will be participating at the following investor conferences:

RBC Capital Markets’ Healthcare Conference, New York City, February 24, 2016

Cowen and Company Healthcare Conference, Boston, March 9, 2016

Barclays Global Healthcare Conference, Miami, March 17, 2016

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.

Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information

On February 23, 2016 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the fourth quarter and full year ended December 31, 2015(Press release, BioCryst Pharmaceuticals, FEB 23, 2016, View Source [SID:1234509139]).

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"In 2015, we gained clarity on both of our HAE drug candidates and brought in additional capital by out-licensing RAPIVAB. Our efforts are now focused on completing the bioavailability study of a solid dosage form of avoralstat and completing the APeX-1 clinical trial of BCX7353," said Jon P. Stonehouse, President & Chief Executive Officer. "We ended 2015 with a balance sheet that enables us to achieve these two near-term data events without the need to raise capital. These two programs give us two shots at achieving our goal of developing a highly effective, conveniently dosed, oral drug candidate for the prophylactic treatment of HAE patients."

Fourth Quarter Financial Results

For the three months ended December 31, 2015, total revenues decreased to $4.6 million from $5.4 million in the fourth quarter of 2014. The decrease resulted primarily from lower 2015 RAPIVAB royalty revenue, as well as lower collaborative revenue associated with BCX4430 development under contracts with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

Research and Development (R&D) expenses for the fourth quarter 2015 of $19.0 million were consistent with the $18.5 million incurred in the fourth quarter 2014. R&D expense in the fourth quarter 2015 was more heavily concentrated in the Company’s hereditary angioedema (HAE) programs, and to a lesser extent, BCX4430 development costs under the NIAID and BARDA contracts, as compared to R&D expenses in the fourth quarter 2014.

Selling, general and administrative (SG&A) expenses for the fourth quarter 2015 increased to $2.7 million compared to $2.0 million in the fourth quarter 2014, largely due to the initiation of activities in preparation for the future commercialization of the Company’s HAE product candidates.

Interest expense, which is related to non-recourse notes, was $1.3 million for the fourth quarter of both 2015 and 2014. Also, a $229,000 mark-to-market gain on the Company’s foreign currency hedge was recognized in the fourth quarter 2015, compared to a $4.8 million mark-to-market gain in the fourth quarter 2014. These gains 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 fourth quarter of 2015 was $18.1 million, or $0.25 per share, compared to a net loss of $11.7 million, or $0.16 per share, for the fourth quarter 2014.

2015 Financial Results

For the year ended December 31, 2015, total revenues increased to $48.3 million from $13.6 million in 2014. The increase in 2015 revenues was primarily due to the recognition of $21.8 million of revenue associated with a $33.7 million upfront payment from the RAPIVAB out-licensing transaction, $6.3 million of RAPIVAB product revenue, and increased collaboration revenue associated with BCX4430 development.

R&D expenses increased to $72.8 million for 2015 from $51.8 million for 2014. This increase was primarily the result of significantly higher HAE development costs and slightly higher RAPIVAB and BCX4430 development costs incurred in 2015, as compared to 2014.

SG&A expenses increased to $13.0 million in 2015 from $7.5 million in 2014, due primarily to increased marketing, medical affairs activities associated with HAE programs, as well as unrestricted grants awarded to the U.S. and international HAE patient advocacy groups.

Interest expense, which is related to non-recourse notes, was $5.2 million in 2015 and $5.0 million in 2014. In addition, a $564,000 mark-to-market loss on the Company’s foreign currency hedge was recognized in 2015, compared to a $5.5 million mark-to-market gain in 2014. These gains 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. We also realized a currency hedge gain of $1.7 million from the exercise of a U.S. Dollar/Japanese yen currency option.

The 2015 net loss decreased to $43.0 million, or $0.59 per share, compared to a net loss of $45.2 million, or $0.68 per share for 2014.

Cash, cash equivalents and investments totaled $100.9 million at December 31, 2015 and represented a $13.1 million decrease from $114.0 million at December 31, 2014. Net operating cash use for 2015 was $42.2 million, as compared to $33.3 million utilized in 2014.

Clinical Development Update & Outlook

On February 8, 2016, we announced results from OPuS-2 (Oral P rophylaxiS-2), a clinical trial of avoralstat administered three times daily in a liquid-filled soft gel formulation for the prophylactic treatment of HAE attacks. The primary efficacy endpoint was angioedema attack frequency. Treatment with 500 mg and 300 mg of avoralstat three times daily failed to demonstrate a statistically significantly lower mean attack rate versus placebo. Statistically significant improvements in duration of attacks and in the Angioedema Quality of Life total score were observed comparing the 500 mg three times a day avoralstat arm to placebo. Following the analysis of OPuS-2 results, the decision was made to discontinue further development of softgel avoralstat formulation in order to focus development efforts on a novel solid dosage form of avoralstat.

BioCryst expects to report results from a relative bioavailability study testing the novel solid dosage form of avoralstat by mid-year 2016. The primary goal of this study is to achieve meaningfully better drug exposure in a twice daily dosing regimen.

BioCryst expects to report results from the BCX7353 APeX-1 dose ranging study in HAE patients by year end. The design of APeX-1 trial will be described once it is initiated.

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.