On September 15, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that they addressed shareholders on the development of PharmaCyte’s therapy for advanced pancreatic cancer today (Press release, PharmaCyte Biotech, SEP 15, 2016, View Source [SID:SID1234515154]).

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The Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner, commented, "We understand that shareholders are frustrated with our current share price; however, the share price doesn’t reflect where PharmaCyte is today. In what has been a relatively short time for a biotech company, we have dramatically moved our Cell-in-a-Box technology forward along the path toward the clinic, we have surrounded our technology with some of the best minds in the industry and we have put together a team that is working diligently every single day to get PharmaCyte in front of the U.S. Food and Drug Administration (FDA) so that we can clear the final hurdles that will allow us to begin our clinical trial in advanced pancreatic cancer. There are numerous moving parts on many fronts. Just because our shareholders aren’t seeing news on a weekly basis, this does not mean there isn’t a flurry of work being done every single day.

"It is important for our shareholders to realize that PharmaCyte’s pancreatic cancer therapy is classified by drug regulatory authorities as a ‘biologic’ rather than a single molecule drug or a New Chemical Entity (NCE). This is because our therapy involves the use of living, genetically altered human cells. The overall development process is much more involved and more complex for a biologic than an NCE. Nevertheless, PharmaCyte’s therapy is moving forward at a realistic pace. Our partner Austrianova will be carrying out an engineering manufacturing ‘run’ in the near future of the production of the capsules that will be used with low dose ifosfamide as our pancreatic cancer therapy. If successful, not only will this run define the specifications of the capsules that will be use to encapsulate the living cells, it will also set the stage for cGMP production of the capsules for our planned clinical trial.

"An example of the different environment that we’re working in is that biologic products – particularly encapsulated living cell products like PharmaCyte’s and unlike most pharmaceutical products which can be simply ‘end-sterilized’ and delivered as sterile products – must be kept alive from the moment the cells are thawed from the frozen research cell bank and then encapsulated until they are implanted in a patient. At all times during these operations our product must be kept free of contamination by bacteria, yeast and fungi. Thus our biologic product is more akin to a live vaccine or to a stem cell therapy. The cell culture medium used to maintain the living cells within the capsules is also an excellent growth medium for all of those previously mentioned undesirable contaminants. Contaminant and other testing of our research cell bank is underway at ViruSure, one of PharmaCyte’s contractors, while Austrianova continues to make steady progress in order to manufacture cGMP clinical trial material that we will need to begin the trial.

"It goes without saying that great care has to be taken at every step to ensure the maintenance of aseptic conditions; this is one reason for carrying the production out in an ‘isolator’ that prevents actual contact between production staff and the product being manufactured. A living cell product also brings with it new regulatory challenges. PharmaCyte has been steadily working through these challenges with a number of regulatory advisors both in the United States and in the United Kingdom. These exciting new "Advanced Medicinal Products" are the future of treatment for serious diseases, and in many ways pioneering companies, like PharmaCyte, are working with the regulators to lay the ground work for tomorrow’s regulatory framework."

On September 14, 2016 Aviragen Therapeutics, Inc. (NASDAQ:AVIR) reported its financial results for the fourth quarter and 2016 fiscal year ended June 30, 2016, and also provided an update on recent corporate and clinical developments (Press release, Nabi Biopharmaceuticals, SEP 14, 2016, View Source [SID:SID1234515155]).

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"Over the last twelve months we have made significant advances with our three next generation direct-acting antivirals that address serious infections with limited therapeutic options. Enrollment is 90% complete in the SPIRITUS Phase 2b trial of vapendavir for the treatment of human rhinovirus infections in moderate and severe asthmatic patients, and we look forward to announcing top-line data from the trial around the end of the year. We also announced today comparable bioavailability results for two new formulations of vapendavir that are appropriate for pediatrics, Phase 3 and commercial scale-up," remarked Joseph M. Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics.

"For our RSV program, we were pleased to resume enrollment in the Phase 2a RSV challenge study of BTA585, a RSV fusion inhibitor, following a short delay. We anticipate that top-line viral load data will be available around the end of the year. Finally, we strengthened our balance sheet with $20 million of non-dilutive cash from the partial monetization of our Inavir royalty stream. This positions us well to aggressively advance our pipeline of clinical-stage antivirals."

Recent Corporate Highlights

Vapendavir Phase 1 Bioavailability Trial. The Company reported today that it has successfully completed a single-center, open-label, bioavailability study in healthy volunteers assessing 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. Forty-six (46) subjects completed three periods of oral dosing and the plasma pharmacokinetic results indicated that the bioavailability of the oral suspension and tablet formulation were comparable to the capsule form of vapendavir which is currently being used in the Phase 2b SPIRITUS trial. 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.

Resumed Enrollment in the Phase 2a Efficacy Study of BTA585 for the Treatment of Respiratory Syncytial Virus (RSV) Infections. In July 2016, the Company reported that, subsequent to receiving approval from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), enrollment has resumed in the double-blind, placebo-controlled, Phase 2a trial that is designed to evaluate the safety, pharmacokinetics, and antiviral activity of orally-dosed BTA585 in healthy volunteers challenged intranasally with RSV. In May, the Company announced that it was voluntarily delaying enrollment in the trial to investigate an aberrant lab result from a subject that was coupled with transient ECG changes. The Company also reported in July that it expects to submit a complete response to the U.S. Food and Drug Administration (FDA) in the first quarter of calendar 2017 regarding the clinical hold of BTA585’s investigational new drug (IND) application. The clinical hold was related to the aberrant lab report.

Entered into a License and Sponsored Research Agreement with Georgia State University Research Foundation (GSURF). In July 2016, the Company announced that it entered into an exclusive, worldwide license and sponsored research agreement with GSURF to jointly develop and commercialize RSV replication inhibitors discovered by Professor Richard Plemper and his team in the Institute for Biomedical Sciences (IBMS) at Georgia State University.

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

The Company reported net loss of $7.0 million for the three month period ended June 30, 2016, as compared to a net loss of $19.9 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.18 for the three month period ended June 30, 2016, as compared to a basic and diluted net loss per share of $0.55 in the same period of 2015. The major components of net loss in both periods are as follows:

Revenue decreased to $0.6 million for the three month period ended June 30, 2016 from $4.1 million in the same period in 2015 due to a $3.7 million reduction in royalty revenues resulting from lower government stockpiling sales of the flu product Relenza.

Research and development expense increased to $6.0 million for the three month period ended June 30, 2016 from $5.2 million in the same period in 2015. The increase reflected higher clinical costs related to the initiation of a Phase 2a challenge trial investigating the use of BTA585 as a treatment for RSV, and higher expenses for producing clinical supplies of BTA074 for its Phase 2 clinical trial for the treatment of condyloma caused by human papillomavirus (HPV) types 6 and 11.

In June 2015, the Company recorded a $17.6 million non-recurring, in-process research and development (IPR&D) expense in connection with the acquisition of Anaconda Pharma. There was no IPR&D expense recorded in 2016.

General and administrative expense was $1.3 million for both the three month period ended June 30, 2016 and the same period in 2015, as higher consulting and professional fees were fully offset by lower employee compensation costs.

Accounting Treatment for the Sale of Royalty Interest to HealthCare Royalty Partners (HCRP):

In April 2016, Aviragen sold a portion of its interest in future royalty payments related to Inavir, a flu product marketed in Japan by Daiichi Sankyo, to HCRP for gross proceeds of $20 million. As a result of a limit on the amount of royalties that HCRP can earn under the arrangement, U.S. accounting rules require Aviragen to account for this transaction under the debt accounting method. Aviragen has no obligation to pay any amounts to HCRP other than to pass through to HCRP its share of royalties as they are received from Daiichi Sankyo. In addition, although the royalty payments were sold to HCRP, the debt accounting rules require the Company to continue to recognize HCRP’s share of the royalties as non-cash revenue in its Statement of Operations and to record the proceeds of $20 million, net of expenses, as a liability on its Balance Sheet. As royalties are passed through Aviragen to HCRP under this arrangement, the liability is reduced. Non-cash implied interest expense will be recognized on the liability. In the fourth quarter of 2016, Aviragen recognized $0.2 million of non-cash royalty revenue and $0.3 million in non-cash interest expense related to this arrangement.

The Company held $69.0 million in cash, cash equivalents, and short-term investments as of June 30, 2016.

Financial Results for the Fiscal Year Ended June 30, 2016

The Company reported a net loss of $25.4 million for its fiscal year ended June 30, 2016, as compared to a net loss of $19.1 million in the prior year. The $6.3 million increase in net loss from the prior year was primarily due to a $15.5 million decrease in revenues reflecting a reduction of $7.0 million in royalty revenue, principally related to Relenza, and $8.5 million in lower service revenue, due to the cancellation of the BARDA contract in 2014. The net loss comparison was also impacted by a $6.5 million increase in research and development expense, largely related to higher costs for the Company’s vapendavir and BTA585 clinical development programs. These items were partially offset by the impact of a non-recurring $17.6 million IPR&D expense recorded in fiscal 2015 related to the acquisition of Anaconda Pharma. Basic and diluted net loss per share was $0.66 for the fiscal year ended June 30, 2016, as compared to a basic and diluted net loss per share of $0.54 in the prior year.

On September 14, 2016 – Third Rock Ventures, LLC reported the formation
of Relay Therapeutics with $57 million in Series A financing, including participation from an affiliate of
D. E. Shaw Research, LLC (Press release, Relay Therapeutics, SEP 14, 2016, View Source [SID1234520734]).

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Relay Therapeutics is building the world’s first dedicated drug discovery
platform centered on protein motion, with the aim of designing and developing new medicines that will
make a transformative difference for patients. Relay’s novel approach will build on recent scientific and
technological advances in structural biology, biophysics, computation, chemistry and biology to create
an integrated drug discovery engine fueled by a detailed understanding of the dynamic structural
changes undergone by protein molecules within the body. The company’s groundbreaking activities are
being spearheaded by a team that includes some of the world’s leaders in these emerging areas.
"Our integration of protein motion into the heart of the drug discovery process represents both a
philosophical and technological once-in-a-generation paradigm shift," said Alexis Borisy, Executive
Chairman and interim CEO of Relay Therapeutics, and Partner at Third Rock Ventures. "At Relay, we
have assembled the team and tools to build the first company with a dedicated drug discovery pipeline
centered around protein motion. This advancement in drug discovery – from static to dynamic – creates
opportunities to develop more effective therapies that we believe will improve and extend the lives of
millions of patients."

Scientific Approach
While much of biology is controlled by the three-dimensional motion of proteins, this reality is not
reflected in today’s drug discovery process. Relay Therapeutics is using emerging technologies and
insights to move from a static perspective to a moving one, allowing for the rational discovery and
design of medicines for diseases where effective therapies do not currently exist. The company’s drug
discovery engine illuminates the full mobility of a protein and the ways in which protein motion
regulates function. By applying these technologies as an integrated team focused on disease-causing
targets, Relay Therapeutics aims to develop breakthrough medicines for patients in need. The
company’s initial programs are focused on oncology.
"Relay’s novel approach enables us to observe large-scale and subtle protein motions, identifying new
opportunities for the drug design process," said Mark Murcko, Ph.D., Chief Scientific Officer of Relay
Therapeutics. "This innovative and integrated approach allows us to pursue novel medicines against a
wide array of compelling drug targets that, until now, have been challenging or even inaccessible."
History of Protein Motion in Drug Discovery
Sixty years ago, scientists acquired the ability to generate detailed static images of the molecular
machines that operate within our bodies, yielding an improved understanding of the molecular
underpinnings of certain diseases. By the late 1980s, after a generation of technological improvements,
the adoption of these stationary molecular snapshots into the drug discovery process marked a turning
point in the history of the pharmaceutical industry, accelerating the design of more effective drugs. In
recent years, however, it has become clear that such static images tell only part of the story, and that the
emerging ability to observe how these machines move, function, and interact has the potential to once
again transform the process of drug design. Today – two generations after the first static pictures of
molecular structures, and one generation after they were first incorporated into drug discovery – Relay
Therapeutics is drawing on new computational and experimental advances to move beyond the era of
static snapshots into one in which movies of the body’s molecular machines become central to drug
discovery.
Founders
Relay Therapeutics was founded by a group of experts in structural biology, biophysics and
biomolecular simulation who have played a pioneering role in the development of technologies that are
central to the company’s approach. The founding team is applying this expertise to Relay’s drug
discovery efforts, focusing on achieving a deeper understanding of the relationship between protein
motion and drug action. The company founders are:
• Matthew Jacobson, Ph.D., Professor and Pharmaceutical Chemistry Department Chair,
University of California, San Francisco (UCSF)
• Dorothee Kern, Ph.D., Professor, Brandeis University; Investigator, Howard Hughes Medical
Institute
• Mark Murcko, Ph.D., Chief Scientific Officer and Co-Founder, Relay Therapeutics; Senior
Lecturer, Massachusetts Institute of Technology (MIT)
• D. E. Shaw Research (David E. Shaw, Ph.D., Chief Scientist)
About Relay Therapeutics
Relay Therapeutics is committed to discovering and developing medicines that will make a
transformative difference for patients by building the first dedicated drug discovery pipeline centered on
protein motion. Bringing together the latest scientific advances in structural biology, biophysics,
computation, chemistry and biology, Relay’s drug discovery engine illuminates the full mobility of a
protein and the ways in which protein motion regulates function. By applying this approach as an
integrated team focused on disease-causing targets, Relay aims to develop breakthrough medicines for
patients in need. The company’s initial programs are focused on developing therapeutics in oncology.
Headquartered in Cambridge, Massachusetts, Relay Therapeutics is a private company launched in 2016
with $57 million in Series A financing from Third Rock Ventures and an affiliate of D. E. Shaw
Research.

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On September 14, 2016 Varian Medical Systems (NYSE: VAR), reported it has been selected by Proton Therapy Pte., Ltd. (View Source) to install and service a Varian ProBeam Compact single-room proton therapy system for a new oncology center in Singapore. Construction of the new center is expected to begin by the end of 2016 (Press release, InfiMed, SEP 14, 2016, View Source [SID:SID1234515137]). In addition to a 10 year service agreement, Varian will also provide its Eclipse treatment planning system training environment for use by Proton Therapy Pte., Ltd. at its new Advanced Medicine Training Centre. Varian booked the order for the equipment in the fourth quarter of its fiscal year 2016.

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The Varian ProBeam Compact system is the only single room system capable of fully rotational intensity modulated proton therapy (IMPT). Treatments can be delivered with an unmatched combination of speed, flexibility and cost efficiency. The full-featured ProBeam Compact includes a cyclotron, Varian’s unique Dynamic Peak scanning technology for IMPT, a fully rotational gantry, robotic patient positioning tools, and a comprehensive suite of motion management tools. It incorporates cone beam CT imaging for positioning the patient based on high quality anatomical images with excellent soft tissue resolution, and Varian’s world-class Eclipse and ARIA software systems for the planning and managing of treatments.

"We selected the Varian ProBeam Compact system because it is the only system suitable to fit within the existing building constraints and for its many technical advantages, the full system integration with ARIA and Eclipse, and Varian’s history of innovation and providing its customers access to new technology for the life of the platform," said Dr. Djeng Shih Kien, chairman, Proton Therapy Pte., Ltd. "We look forward to working closely with the Varian team on this important cancer-fighting technology in Singapore."

"We have given our Compact system all the technical capabilities of our multi-room ProBeam systems so that clinics can offer the best possible treatment without having to make any sacrifices in performance," said Dr. Moataz Karmalawy, general manager of Varian’s Particle Therapy division. "By working closely with Proton Therapy Pte., Ltd. on the adoption of precision proton treatments, we are providing the opportunity for increased access to this technology for cancer patients across Southeast Asia and Australasia."