On November 3, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported an oral and a poster presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 3-6 in San Diego, California (Press release, Sunesis, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219247 [SID1234516325]).

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The details for the oral presentation are as follows:

Date and Time: Monday, December 5, 2016 at 3:15 p.m. Pacific Time
Abstract Title: Durable Overall Survival Benefit in Patients ≥ 60 Years with Relapsed or Refractory AML Treated with Vosaroxin/Cytarabine Vs Placebo/Cytarabine: Updated Results from the Valor Trial
Session Number: 616
Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Clinical trials of Novel Drugs and Combinations in AML
Publication Number: 903
Location: Marriott Marquis San Diego Marina, San Diego Ballroom AB

The full abstract can be viewed here.

The details for the poster presentations are as follows:

Date and Time: Saturday, December 3, 2016, 5:30 PM-7:30 PM
Abstract Title: First-in-Human Phase 1a Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects
Session Number: 642
Session Name: CLL: Therapy, excluding Transplantation: Poster I
Publication Number: 2032
Location: San Diego Convention Center, Hall GH

On November 3, 2016 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported financial results for the third quarter ended September 30, 2016 including:

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Total revenues of $53.6 million and $177.8 million for the three and nine months ended September 30, 2016, respectively(Press release, PDL BioPharma, NOV 3, 2016, View Source [SID1234516311]).

GAAP diluted EPS of $0.08 and $0.45 for the three and nine months ended September 30, 2016, respectively.

GAAP net income attributable to PDL’s shareholders of $13.9 million and $73.9 million for the three and nine months ended September 30, 2016, respectively.

Non-GAAP net income of $18.9 million and $118.2 million for the three and nine months ended September 30, 2016, respectively.

The largest component of the difference in non-GAAP net income compared to GAAP net income is the exclusion of (i) the mark-to-market reduction in fair value of our investments in royalty rights and (ii) the amortization of intangible assets. A full reconciliation of all components of the GAAP to non-GAAP quarterly financial results can be found in Table 4 at the end of this release.

Revenue Highlights
Total revenues of $53.6 million for the three months ended September 30, 2016 included:
Royalties from PDL’s licensees to the Queen et al. patents of $15.0 million, which consisted of royalties earned on sales of Tysabri under a license agreement;
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $16.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed, Inc., University of Michigan and AcelRx Pharmaceuticals, Inc. royalty rights acquisitions;
Interest revenue from notes receivable financings to late-stage healthcare companies of $8.6 million; and
Product revenues from sales of Tekturna and Tekturna HCT in the United States and Rasilez and Rasilez HCT in the rest of the world of $14.1 million.
Total revenues decreased by 57 percent for the three months ended September 30, 2016, when compared to the same period in 2015.
The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc. PDL continues to receive royalties on sales of Tysabri. The duration of this royalty payment is based on the sales of product manufactured prior to patent expiry, the amount of which is uncertain.
The increase in royalty rights – change in fair value was driven by the $9.6 million increase in the fair value of the Depomed royalty rights assets primarily due to a $5.0 million milestone payment based on FDA approval of Invokamet XR, a Type 2 diabetes drug in our Depomed portfolio, an adjustment to the timing of its estimated cashflows and a reduction in discount rate.
PDL received $15.3 million in net cash royalty and milestone payments from its royalty rights in the third quarter of 2016, compared to $6.9 million for the same period of 2015.
The decrease in interest revenues was primarily due to ceasing to recognize interest from Direct Flow Medical, Inc. notes receivable.
Product revenues were derived from sales of Tekturna and Tekturna HCT in the United States and Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products). Pursuant to the purchase agreement, when Noden Pharma DAC (Noden) acquired the exclusive worldwide rights to manufacture, market, and sell the Noden Products from Novartis. Novartis continued distributing the Noden Products during the third quarter of 2016 and transferred profits with Noden on a net basis (i.e. net of cost of manufacturing and a fee to Novartis). Noden is commercializing the products in the U.S. as of the fourth quarter of 2016.
Total revenues decreased by 57 percent for the nine months ended September 30, 2016, when compared to the same period in 2015.
The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc.
The decrease in royalty rights – change in fair value was driven by the $19.2 million decrease in the fair value of the Depomed royalty rights asset, and a $3.4 million decrease in the fair value of the University of Michigan royalty right asset.
PDL received $47.2 million in net cash royalty payments and milestone payments from its acquired royalty rights in the nine months ended September 30, 2016, compared to $9.0 million for the same period of 2015.
Product revenues and interest revenue variances were the same as the three months ended September 30, 2016.
Operating Expense Highlights
Operating expenses were $21.0 million for the three months ended September 30, 2016, compared to $8.5 million for the same period of 2015. The increase in operating expenses for the three months ended September 30, 2016, as compared to the same period in 2015, was primarily a result of the product sales segment acquisition, contributing an additional $6.0 million of acquisition intangible amortization, $2.1 million in a change in fair value in acquisition-related contingent consideration, $1.9 million in research and development costs for the completion of a pediatric trial for the acquired branded prescription medicines Tekturna by Noden and acquisition related costs of $0.5 million. General and administrative expenses increased by $1.9 million, of which $1.1 million relates to an increased headcount and expenses due to the Noden related product acquisitions and $0.3 million relates to additional stock-based compensation expenses and an increase in legal services mostly related to ongoing legal proceedings.
Operating expenses were $40.7 million for the nine months ended September 30, 2016, compared to $23.5 million for the same period of 2015. The increase in operating expenses for the nine months ended September 30, 2016, as compared to the same period in 2015, was the result of the expenses related to the acquisition of the Noden Products.
Other Financial Highlights
PDL had cash, cash equivalents, and investments of $114.6 million at September 30, 2016, compared to $220.4 million at December 31, 2015.
The decrease was primarily attributable to the acquisition of a business, net of cash of $109.9 million, the purchase of a certificate of deposit for $75.0 million, the purchase of additional royalty rights for $59.5 million, repayment of the March 2015 Term Loan for $25.0 million, payment of dividends of $16.4 million, an additional note receivable purchase of $8.0 million, the purchase of short-term investments of $8.0 million, and the payment of debt issuance costs of $0.3 million, partially offset by the repayment of a note receivable balance of $54.7 million, proceeds from royalty right payments of $47.2 million, proceeds from the sale of available-for-sale securities of $1.7 million, cash received from a noncontrolling investor of $0.3 million and cash generated by operating activities of $86.1 million.
Net cash provided by operating activities in the nine months ended September 30, 2016 was $86.1 million, compared with $231.4 million in the same period in 2015.

On November 3, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the third quarter ended September 30, 2016 (Filing, Q3, Oncolytics Biotech, 2016, NOV 3, 2016, View Source [SID1234516308]).

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"During the quarter we reported additional statistically significant, randomized clinical data that further strengthened the linkage between genetic status and survival outcomes in patients with adenocarcinoma of the lung," said Dr. Matt Coffey, Interim President and CEO of Oncolytics Biotech. "In parallel with reporting data from sponsored Phase 2 randomized studies, we continued to push ahead with preparations for a registration study."

Selected Highlights

Since July 1, 2016, selected highlights announced by the Company include:

Clinical Program

· Additional data from a randomized, sponsored Phase II clinical study of REOLYSIN in non-small cell lung cancer (IND 211), which showed that:
· progression free survival ("PFS") was statistically significantly better for female patients in the test arm (n=20) than for those in the control arm (n=16) in patients with adenocarcinoma. Median PFS was 5.39 months compared with 3.02 months, respectively (p=0.0201);
· evolving overall survival ("OS") demonstrated a strong trend towards survival benefit for female patients in the test arm with adenocarcinoma (n=20, six of whom remained alive at the time of the analysis) over those in the control arm (n=16, three of whom remained alive at the time of the analysis). Median OS was 10.68 months compared with 7.59 months, respectively (p=0.145) (Figure B). By contrast, no PFS or OS benefit was noted for the male patients with adenocarcinoma; and
· patients with adenocarcinoma treated with REOLYSIN with one or more target biomarkers (EGFR, Hras, Kras, Nras, Braf and/or p53 mutations) had a greater PFS (p=0.039) and OS (p=0.031) than patients treated with REOLYSIN without any of these biomarkers. The presence of these biomarkers may account, at least in part, for the difference between the survival outcomes for male and female patients; target biomarkers were present in a higher proportion of the female patients in the study than the male patients (66.7% versus 43.6%). As a result, pre-screening for target biomarkers in patients with adenocarcinoma of the lung is warranted.
Financial
At September 30, 2016, the Company reported $17.7 million in cash, cash equivalents and short-term investments. At November 2, 2016, the Company had approximately $16.7 million in cash, cash equivalents and short-term investments.

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

September 30,
2016
$ December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 15,612,729 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 44,991 340,059
Prepaid expenses 356,741 506,669
Total current assets 18,103,261 26,923,980
Non-current assets
Property and equipment 333,926 459,818
Total non-current assets 333,926 459,818

Total assets 18,437,187 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,809,008 2,709,492
Total current liabilities 2,809,008 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
September 30, 2016 – 120,873,222
December 31, 2015 – 118,151,622 262,218,228 261,324,692
Contributed surplus 26,536,601 26,277,966
Accumulated other comprehensive income 492,637 760,978
Accumulated deficit (273,619,287) (263,689,330)
Total shareholders’ equity 15,628,179 24,674,306
Total liabilities and equity 18,437,187 27,383,798

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

Three
Month
Period
Ending
September
30, 2016
$ Three
Month
Period
Ending
September
30, 2015
$ Nine Month
Period
Ending
September
30, 2016
$ Nine Month
Period
Ending
September 30,
2015
$
Expenses
Research and development 2,141,737 1,704,784 6,358,822 6,601,877
Operating 1,222,447 1,176,023 3,708,317 3,780,812
Operating loss (3,364,184) (2,880,807) (10,067,139) (10,382,689)
Interest 31,691 52,756 136,849 153,313
Loss before income taxes (3,332,493) (2,828,051) (9,930,290) (10,229,376)
Income tax expense 19 4,074 333 3,303
Net loss (3,332,474) (2,823,977) (9,929,957) (10,226,073)
Other comprehensive income items that may be
reclassified to net loss

Translation adjustment 32,545 192,586 (268,341) 377,060

Net comprehensive loss (3,299,929) (2,631,391) (10,198,298) (9,849,013)
Basic and diluted loss per common share (0.03) (0.02) (0.08) (0.09)
Weighted average number of shares (basic and
diluted) 120,552,638 117,963,979 119,455,440 110,757,811

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193
Net loss and other comprehensive income — — 377,060 (10,226,073) (9,849,013)
Issued, pursuant to Share Purchase Agreement 4,305,396 — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,267,267 — — — 19,267,267
Share based compensation — 181,436 — — 181,436
As at September 30, 2015 261,229,719 26,029,865 657,103 (260,192,408) 27,724,279

Share Capital
$ Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$ Total
$
As at December 31, 2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and other comprehensive loss — — (268,341) (9,929,957) (10,198,298)
Issued, pursuant to "At the Market" Agreement 852,536 — — — 852,536
Issued, pursuant to incentive share award plan 41,000 (41,000) — — —
Share based compensation — 299,635 — — 299,635
As at September 30, 2016 262,218,228 26,536,601 492,637 (273,619,287) 15,628,179

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

Three
Month
Period
Ending
September
30, 2016
$ Three
Month
Period
Ending
September
30, 2015
$ Nine Month
Period
Ending
September
30, 2016
$ Nine Month
Period
Ending
September
30, 2015
$

Operating Activities
Net loss for the period (3,332,474) (2,823,977) (9,929,957) (10,226,073)
Amortization – property and equipment 44,014 44,761 134,631 134,743
Share based compensation 98,369 10,791 299,635 181,436
Unrealized foreign exchange gain (49,400) (182,131) (152,019) (485,653)
Net change in non-cash working capital 216,611 92,792 978,847 (327,690)
Cash used in operating activities (3,022,880) (2,857,764) (8,668,863) (10,723,237)
Investing Activities
Acquisition of property and equipment (4,851) (17,695) (10,553) (47,292)
Purchase of short-term investments — — (27,823) (29,292)
Cash used in investing activities (4,851) (17,695) (38,376) (76,584)
Financing Activities
Proceeds from Share Purchase Agreement — — — 4,305,396
Proceeds from "At the Market" equity distribution agreement 242,706 213,742 852,536 19,267,267
Cash provided by financing activities 242,706 213,742 852,536 23,572,663
(Decrease) increase in cash (2,785,025) (2,661,717) (7,854,703) 12,772,842
Cash and cash equivalents, beginning of period 18,320,981 30,018,217 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents 76,773 605,962 (548,843) 1,036,795
Cash and cash equivalents, end of period 15,612,729 27,962,462 15,612,729 27,962,462

On November 3, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2016 (Press release, Nektar Therapeutics, NOV 3, 2016, View Source [SID1234516305]).

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Cash and investments in marketable securities at September 30, 2016 were $253.5 million as compared to $308.9 million at December 31, 2015. Our cash and investments in marketable securities at September 30, 2016 do not include net proceeds of approximately $189.1 million from the recent sale and issuance of our common stock on October 24, 2016.

"Our pipeline is rapidly advancing with several important data catalysts and potential approvals expected over the next several quarters," said Howard W. Robin, President and Chief Executive Officer of Nektar. "With the positive clinical results from our ongoing Phase 1 study of NKTR-214, we have now demonstrated that NKTR-214 is the first investigational medicine in immuno-oncology that selectively stimulates the in vivo proliferation of endogenous tumor-killing lymphocytes within the tumor micro-environment. In Q3, these data led to a broad clinical collaboration with Bristol-Myers Squibb to evaluate combination regimens with their anti-PD-1 agent in five different tumor types and at least seven indications. Within the next two quarters, we will have Phase 3 data for four programs: two Bayer anti-infective programs, Ophthotech’s Fovista in wet AMD, and our own proprietary pain program, NKTR-181, in chronic low back pain. We are also expecting a decision from the European CHMP on conditional approval of ONZEALD by the end of Q1 2017."

Year-to-date revenue for 2016 was $128.0 million as compared to $191.4 million in the first nine months of 2015. Revenue in 2016 included recognition of $31.0 million from AstraZeneca as a result of its sublicense of MOVENTIG (naloxegol) to ProStrakan (Kyowa Kirin) in Europe. In addition, product sales, royalty revenue, and non-cash royalty revenue increased in the first nine months of 2016 compared to the first nine months of 2015. Revenue in 2015 included recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. in Q1 2015 and the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVENTIG in the EU in Q3 2015. Revenue in the third quarter of 2016 was $36.3 million as compared to $60.0 million in the third quarter of 2015.

Revenue included non-cash royalty revenue, related to our 2012 royalty monetization, of $7.7 million and $22.3 million in the third quarter and first nine months of 2016, respectively, and $6.1 million and $14.8 million in the third quarter and first nine months of 2015, respectively. This non-cash royalty revenue is offset by non-cash interest expense also incurred in connection with the 2012 royalty monetization of $4.9 million and $14.9 million in the third quarter and first nine months of 2016, respectively and $5.2 million and $15.4 million in the third quarter and first nine months of 2015, respectively.

Total operating costs and expenses in the third quarter of 2016 were $69.2 million as compared to $59.5 million in the third quarter of 2015. Year-to-date total operating costs and expenses in 2016 were $208.7 million as compared to $191.4 million for the same period in 2015. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2016 was $52.0 million as compared to $43.2 million in the third quarter of 2015. Year-to-date R&D expense for 2016 was $153.6 million as compared to $135.7 million for the same period in 2015. R&D expense was higher in the third quarter and first nine months of 2016 as compared to the same periods in 2015 primarily due to expenses for the NKTR-181 Phase 3 studies and the initiation of the Phase 1/2 study of NKTR-214.

General and administrative expense was $10.3 million in the third quarter of 2016 as compared to $9.5 million in the third quarter of 2015. G&A expense in the first nine months of 2016 was $31.5 million as compared to $30.0 million for the same period in 2015.

Net loss in the third quarter of 2016 was $43.2 million or $0.32 loss per share as compared to $8.2 million or $0.06 loss per share in the third quarter of 2015. Net loss in the first nine months of 2016 was $111.3 million or $0.82 loss per share as compared to $27.0 million or $0.21 loss per share in the first nine months of 2015.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2016:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 31st Anniversary Annual Meeting, National Harbor, MD:

Oral Presentation: "A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214"
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: New Cancer Immunotherapy Agents in Development
Date: Wednesday, November 9, 2016, 11:10 a.m. – 12:20 p.m. Eastern Time
Poster 387: "A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214"
Session: Tumor Microenvironment
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time
Poster 343: "Anti-tumor activity of NKTR-214; a CD122-biased agonist that promotes immune cell activation in the tumor microenvironment and lymphoid tissues"
Session: Promoting and Measuring Anti-Tumor Activity
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time
Poster 359: "NKTR-214, an engineered cytokine, synergizes and improves efficacy of anti-cancer vaccination in the treatment of established murine melanoma tumors"
Session: Therapeutic Cancer Vaccines
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time
Poster 342: "NKTR-255: an IL-15-based therapeutic with optimized biological activity and anti-tumor efficacy"
Session: Promoting and Measuring Anti-Tumor Activity
Date: Saturday, November 12, 2016, 11:45 a.m. – 1:00 p.m. and 6:45 – 8:00 p.m. Eastern Time
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, Munich, Germany:

Poster: "Intra-tumoral immune cell mobilization and anti-tumor activity after treatment with the engineered cytokine NKTR-214 in multiple preclinical mouse tumor models", Charych, D., et al.
Poster Session: Immunotherapy
Date: November 30, 2016, 8:30 a.m. Central European Time
2016 San Antonio Breast Cancer Symposium, San Antonio, TX:

Poster OT1-04-08: "Phase 3 study of etirinotecan pegol versus treatment of physician’s choice in patients with metastatic breast cancer who have stable brain metastases previously treated with an anthracycline, a taxane, and capecitabine", Tripathy, D. et al.
Poster Session: Ongoing Trials – Metastases
Date: December 7, 2016, 5:00 p.m. – 7:00 p.m. Central Time

On November 3, 2016 Aviragen Therapeutics, Inc. (NASDAQ:AVIR) reported its financial results for the three month period ended September 30, 2016, which is the first quarter of the Company’s 2017 fiscal year, and also provided an update on recent corporate developments (Press release, Nabi Biopharmaceuticals, NOV 3, 2016, View Source [SID1234516303]).

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"Throughout the last quarter and in recent weeks, we have made significant progress advancing each of our Phase 2 antiviral clinical programs. Most notably, I am pleased to announce the completion of enrollment in the SPIRITUS Phase 2b trial of vapendavir for the treatment of HRV infections in moderate and severe asthmatic patients as well as the Phase 2a RSV challenge study of BTA585. We look forward to announcing top-line data from both of these trials in the coming months," commented Joseph M. Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics.

Recent Corporate Highlights

Announced Completion of Enrollment in the SPIRITUS Phase 2b Trial of Vapendavir for the Treatment of Human Rhinovirus (HRV) Infections. Today, the Company announced completion of patient enrollment in the Phase 2b trial of vapendavir for the treatment of HRV infections in moderate and severe asthmatics. Given the 35 day follow up for each patient, the last patient is expected to complete the study in early December. Top-line data are expected approximately eight weeks after the last patient completes the study. The primary endpoint of SPIRITUS is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score. The secondary endpoints are focused on safety and tolerability, and lung function assessments.

Announced Completion of Enrollment in the Phase 2a RSV Challenge Study of BTA585. Today, the Company announced the completion of patient enrollment in the final cohort (600 mg bid) in the Phase 2a trial in healthy volunteers intranasally challenged with RSV. Top-line data from this trial is expected around the end of the year.

Presented BTA585 Phase 1a and 1b Data at ID Week 2016. Pharmacokinetic (PK) and safety data from a Phase 1 single ascending dose and multiple ascending dose study with BTA585 were presented in New Orleans at the annual ID Week in October 2016. The clinical data from 85 healthy volunteers demonstrated that BTA585 was generally well tolerated and there was a low incidence of adverse events with the most common being headache, nausea, and chromaturia. BTA585 plasma Cmax was rapidly achieved at approximately one hour following oral dosing, exposure was dose-proportional, there was no accumulation of BTA585 over the duration of dosing and the half-life (T1/2) was approximately five to six hours. Additionally, dosing of BTA585 with a high fat meal did not adversely affect the PK.

Hosted Key Opinion Leader (KOL) Meeting on HRV Infections. In October 2016, the Company hosted a KOL breakfast focused on the significant burden of HRV infections in at-risk patient populations. The meeting featured keynote presentations from Dr. Frederick G. Hayden, Professor Emeritus of Infectious Diseases and International Health at the University of Virginia School of Medicine, and Dr. Sebastian L. Johnston, Professor of Respiratory Medicine and Allergy at Imperial College London and Director of the Wellcome Trust Centre for Respiratory Infection.

Reported Data from the Vapendavir Phase 1 Bioavailability Trial. In August 2016, the Company completed a single-center, open-label, three-period comparative bioavailability study in healthy volunteers to assess the comparability of the vapendavir phosphate salt capsule, and two new formulations of vapendavir free base in the forms of an oral suspension and tablet. Results showed that the bioavailability of the oral suspension and tablet formulations were comparable to the capsule form of vapendavir. The oral suspension formulation is intended to enable the conduct of future pediatric trials, and the tablet formulation will allow an increase in manufacturing scale appropriate for Phase 3 trials and commercial development.

Financial Results for the Three Month Period Ended September 30, 2016

The Company reported a net loss of $10.0 million for the three month period ended September 30, 2016, as compared to a net loss of $6.6 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.26 for the three month period ended September 30, 2016, as compared to a basic and diluted net loss per share of $0.17 in the same period in 2015. The major components of net loss in both periods are detailed below.

Revenue decreased to $0.1 million for the three month period ended September 30, 2016 from $1.7 million in the same period in 2015 due to a $1.6 million reduction in royalty revenues, reflecting no government stockpiling orders of the flu product Relenza for the three month period ended September 30, 2016. The Company currently receives a 7% royalty on sales of Relenza in the U.S. and in certain other countries. However, in October 2016, the U.S. Court of Appeals for the Federal Circuit Decision Board upheld the Patent Office’s rejection of claims in U.S. Patent Application 08/737,141 relating to the method of prevention and treatment of influenza by inhalation of zanamivir (Relenza). The Company is working with its partner to determine possible next steps in the prosecution of the patent application.

Research and development expense increased to $7.6 million for the three month period ended September 30, 2016 from $5.5 million in the same period in 2015. The $2.1 million increase largely reflected higher clinical and manufacturing costs associated with our ongoing trials.

General and administrative expense was $2.2 million for both the three month period ended September 30, 2016 and the same period in 2015, as higher consulting and professional fees were fully offset by decreased personnel costs.

Non-cash implied interest expense was $0.4 million for the three month period ended September 30, 2016 related to the royalty interest sale in April 2016. There was no non-cash implied interest expense for the same period in 2015.

The Company held $58.3 million in cash, cash equivalents, and short-term investments as of September 30, 2016.