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 Immune Design Corp. (Nasdaq:IMDZ) reported that it plans to offer and sell shares of its common stock in an underwritten public offering. All of the shares in the proposed offering are to be sold by Immune Design (Press release, Immune Design, SEP 14, 2016, View Source [SID:SID1234515147]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Jefferies LLC, Leerink Partners LLC and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. In connection with the offering, Immune Design intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.

Immune Design plans to use the net proceeds of the offering to fund further clinical development of its Antigen Specific and Antigen Agnostic approaches, including CMB305, G100, ZVexNeo and ZVex2.0, continue developing the manufacturing process and scale up of its product candidates, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Jefferies LLC Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: [email protected]; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6142, email: [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, telephone: (800) 326-5897, email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 13, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), reported that the Company and its collaborators from the University of Texas MD Anderson Cancer Center presented new data in a research poster entitled "Activity of dianhydrogalactitol (VAL-083) in ovarian tumor models, sensitive or resistant to cisplatin" at the 11th Biennial Ovarian Cancer Research Symposium (Press release, DelMar Pharmaceuticals, SEP 13, 2016, View Source [SID:SID1234515118]).

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The data, presented on the evening of Monday, September 12th at the Rivkin Center for Ovarian Cancer in Seattle, Washington, support a distinct mechanism of action for VAL-083 versus platinum-based chemotherapy currently used in the treatment of ovarian cancer.

"We were pleased to present these data, which are highly supportive of VAL-083’s potential as a new therapeutic option for ovarian cancer patients whose treatment is underserved by currently available therapy. We plan to work with our advisors to develop a strategy to advance VAL-083 into clinical trials for the treatment of ovarian cancer, either as a single-agent or in combination with other approved agents," said Jeffrey Bacha, Chairman & CEO of DelMar.

The researchers also reported observations of synergy when VAL-083 was combined with platinum-based chemotherapy or PARP inhibitors and that the potency of VAL-083 is increased when a cell’s homologous recombination ("HR") DNA repair mechanism is impaired, further suggesting that VAL-083-induced DNA lesions are repaired via the HR pathway.

Dr. Dennis Brown, DelMar’s Chief Scientific Officer noted, "These data are important because they provide further support of our previous research suggesting that VAL-083 imparts its anti-cancer activity via double-strand breaks as a result of DNA cross-links at the N7-position of guanine. Homologous recombination is the mechanism generally employed by cells to repair damage resulting from DNA double strand breaks. Deficiencies in HR are a hallmark of many cancers, including ovarian cancers, while normal cells retain HR function. This may explain why VAL-083 has been observed to possess high activity against cancer yet exhibit limited toxicity against normal cells."

In summary,

VAL-083 demonstrated cytotoxic activity against all ovarian cancer cell lines tested and is substantially less dependent on wild-type p53 for cytotoxic activity.
VAL-083 was able to circumvent 70-85% of cisplatin-resistance in an ovarian cancer cell line panel with several known p53 mutations and displays synergy with cisplatin in p53 mutant cell line H1975.
VAL-083 demonstrated synergy with AstraZeneca’s PARP inhibitor Olaparib in ovarian cancer cell line A2780.
The potency of VAL-083 activity was increased when HR was impaired in A2870 cells with BRCA1 knockdown, demonstrating that VAL-083 induced DNA-lesions are repaired via HR.
"Taken together, these results support VAL-083’s potential as a treatment option for ovarian cancer patients failing platinum-based therapy particularly in an HR-impaired setting. They further suggest a potential benefit of therapeutic combination regimens containing VAL-083 plus platinum-based chemotherapy or VAL-083 in combination with a PARP inhibitor such as Olaparib," concluded Mr. Bacha.

VAL-083 is a "first-in-class" small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia in prior clinical trials sponsored by the US National Cancer Institutes both as a single-agent and in combination with other treatments. DelMar recently announced completion of Phase I/II clinical trials with VAL-083 as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The Company plans to advance VAL-083 into a pivotal Phase III clinical trial for refractory GBM and also plans to advance VAL-083 into clinical trials for other solid tumors such as non-small cell lung cancer and ovarian cancer.

In April 2016, the FDA Office of Orphan Products Development (OOPD) granted orphan drug designation for VAL-083 in the treatment of ovarian cancer. VAL-083 had earlier received an orphan designation for glioma and medulloblastoma in the United States and for glioma in Europe.

DelMar CEO to Present Today at 18th Annual Rodman & Renshaw Global Investment Conference in New York

Jeffrey Bacha, DelMar’s president and CEO, will deliver a corporate address today at the 18th Annual Rodman & Renshaw Global Investment Conference. Mr. Bacha’s presentation is scheduled for 10:50-11:15 AM Eastern Time in the Kennedy II Ballroom at the Lotte New York Palace Hotel. A live webcast of the presentation will be available by accessing a link that will be posted on the Company’s website (www.DelMarPharma.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.

About Ovarian Cancer

According to Evaluate Pharma, the annual market for ovarian cancer therapies is expected to reach approximately $570 million in 2016, and is projected to grow to more than $3.5 billion in 2022. The American Cancer Society estimates that approximately 22,000 women will receive a new diagnosis of ovarian cancer and approximately 14,000 women will die from ovarian cancer in the United States each year. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Ovarian cancers are commonly treated with a platinum-based chemotherapy regimen. Initial tumor response rates are relatively high; however, as up to 75% of ovarian cancer patients who respond to initial treatment will relapse within approximately 18 months after completing first-line therapy. In published studies, median survival in platinum-resistant recurrent ovarian cancer patients ranged from six to nine months.

On September 13, 2016 Cellceutix Corporation (OTCQB: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, reported a fiscal year-end business update including a timeline of key upcoming milestones (Filing, Annual, CellCeutix, 2015, SEP 13, 2016, View Source [SID:SID1234515120]).

Leo Ehrlich, Chief Executive Officer, commented, "We are extremely pleased with the tremendous progress that we have made, especially within the last 12 months. We have assembled an attractive portfolio of three unique compounds, each of which addresses very large markets and is supported by strong IP protection. To date, we have met all of the primary endpoints in each of our clinical trials, and we have a number of very important milestones upcoming during the course of the next 12 to 18 months. Many of these milestones have the potential to create a substantial inflection (turning) point in our market cap."

Upcoming Milestones

Drug Candidate
Event
Description
Period
Year
Brilacidin
Kevetrin
Prurisol

Clinical Update
Ulcerative Proctitis- Interim analysis Ph2a trial
4Q
2016

Trial Progress
Ovarian Cancer- Initiation Ph2a trial
4Q
2016

Trial Progress
Psoriasis- Initiation Ph2b trial
4Q
2016

Clinical Update
Oral Mucositis- Interim analysis Ph2
1H
2017

Clinical Update
Psoriasis- Interim Analysis Ph2b
1H
2017

Clinical Update
Ulcerative Proctitis- Complete Ph2a trial
1H
2017

Clinical Update
Oral Mucositis- Complete analysis Ph2 trial
2H
2017

Clinical Update
Ovarian Cancer- PoC p53 modulation (Ph2a)
2H
2017

Trial Progress
ABSSSI- Start Ph3 trial
*
2017
____________
*Timetable dependent on reaching SPA agreement with FDA

Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix, commented, "We are making progress advancing Prurisol through the clinical pathway. We completed a Phase 2a trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis in May 2016. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis. On the heels of these data, we are now planning our Phase 2b trial of Prurisol for patients with moderate-to-severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses and we expect to have our interim analysis top-line results in the second quarter of 2017. We believe that the potential safety profile of Prurisol may make this an attractive alternative to Celgene’s OTEZLA, which is on its way to achieving $1 billion in sales within just three years of its launch."

"We are also making headway with our Kevetrin asset, which has shown potent anti-tumor activity. Following our Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, we are now preparing for a Phase 2a trial of Kevetrin for treating late stage ovarian cancer. We anticipate that this trial will start in the fourth quarter of this year. Our plan is to conduct a small trial that will provide the critical data necessary to forge a partnership with a large pharmaceutical company that could potentially fund development of Kevetrin through FDA approval. We are encouraged by the guidance and feedback that we have received from potential partners which are incorporated in our Phase 2a trial design."

"Lastly, we completed our Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, and are moving forward with our Phase 2 clinical trial with Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin has a novel mechanism of action– robust anti-bacterial as well as anti-inflammatory properties. In fact, a single dose of Brilacidin has been shown to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Moreover, we believe that it will demonstrate a broad spectrum of activity in infectious diseases, gastrointestinal and inflammatory diseases, and a variety of dermatological diseases."

Mr. Ehrlich concluded, "To wrap up, the consistent theme across all of our compounds is strong supporting clinical data and a clear path to delivering a meaningful return on investment. We had previously been largely under the radar of Wall Street and institutional investors, but given our success to-date, we are now engaging in a much more aggressive outreach effort. We have a number of important upcoming milestones, that if successful, we believe will drive meaningful value for shareholders."

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On September 2016 Oxford BioMedica plc (LSE: OXB), ("OXB" or "the Group") a leading gene and cell therapy group, reported interim results for the six months ended 30 June 2016 (Press release, Oxford BioMedica, SEP 13, 2016, View Source [SID:SID1234515125]).

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HIGHLIGHTS (including post-period end):

OPERATIONAL

State-of-the-art bioprocessing facilities
Capacity expansion of bioprocessing and laboratory facilities now complete and approved for GMP vector manufacture

Partnering activities continuing to build

Novartis contract progressing well, contributing to 184% growth in first half Group revenues – multiple confirmed purchase orders through to Q2 2017
Second CAR-T programme for undisclosed indication underway with Novartis
New IP licence and expanded collaboration agreement signed with Immune Design
R&D collaboration signed with Green Cross LabCell to identify and develop gene modified natural killer (NK) cell-based therapeutics

Good progress across product development programmes

OXB to capture value of clinical products via out-licensing or spin out approach
OXB-102 and OXB-202 will be ready to start Phase I/II studies within next 6-9 months, subject to successfully out-licensing or spinning out these products
OXB-302 pre-clinical studies expected to complete by end of 2016
SAR422459 (for Stargardt Disease), licensed to Sanofi, has entered Phase IIa development
Novartis still on course to file CTL019 BLA in early 2017, with approval expected mid-2017 due to Breakthrough Therapy designation

FINANCIAL

Revenue increased by 184% to £12.5 million (H1 2015: £4.4 million) due in large part to Novartis contract
R&D, bioprocessing and administrative costs of £16.1 million (H1 2015: £11.7 million)
Operating loss of £6.9 million (H1 2015: £8.3 million)
Capital expenditure £6.0 million (H1 2015: £4.6 million)
Cash of £11.9 million (31 December 2015: £9.4 million) which includes the $10 million (£7.6 million) ring-fenced under the Oberland loan agreement
Fundraising of £10.0 million net of expenses announced separately today. In February 2016, the Group also raised a net £7.5 million through a 5% placing

Commenting on today’s announcement, John Dawson, Chief Executive Officer at Oxford BioMedica, said: "With world-class facilities, expertise and a broad intellectual property position, Oxford BioMedica is a leading gene and cell therapy company. Our unrivalled expertise in the bioprocessing and production of lentiviral vector makes us an ideal partner for the increasing number of potential companies wishing to use this exciting technology in clinical studies and, in due course, commercial therapeutics.

"Oxford BioMedica’s wholly-owned priority product programmes have progressed well during the period. In order to advance the clinical assets as expeditiously as possible whilst still capturing value for shareholders, the Group has decided to employ an external funding approach, via spin outs or out-licensing partnerships. Based on this approach, the proceeds raised in today’s fundraising will enable us to build upon our strong position by furthering the development and enhancement of our proprietary lentiviral vector delivery platform technology as we look to maximise bioprocessing revenues."