On March 18, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company developing novel cell and gene therapies for serious diseases, reported fourth quarter and full year 2018 financial results, and provided business highlights (Press release, Abeona Therapeutics, MAR 18, 2019, View Source [SID1234534483]). The Company will host a conference call on Tuesday, March 19 at 10:00 a.m. ET to discuss fourth quarter and full year results, and to provide business highlights. Interested parties are invited to participate in the call by dialing 844-369-8770 (toll-free domestic) or 862-298-0840 (International) or via webcast at View Source

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"The diligent work conducted over the past nine months at our GMP manufacturing facility puts us on track to initiate the pivotal VITAL study evaluating EB-101, our gene-corrected cell therapy for the treatment of recessive dystrophic epidermolysis bullosa, in mid-2019. We will produce EB-101 at our Cleveland facility, which is an important milestone for Abeona. We are also advancing our manufacturing capabilities to support our AAV gene therapy programs and expect to be at scale for GMP production in the second half of this year," said João Siffert, M.D., Chief Executive Officer. "On the lysosomal storage disease programs, we have stepped up efforts to accelerate patient enrollment in the MPS III programs and recently implemented the protocols to enroll younger, higher functioning patients."

"We believe that these important steps have positioned Abeona for success in 2019 as we focus on advancing our clinical programs and developing our pipeline utilizing novel AAV capsids," added Dr. Siffert.

Fourth Quarter and Full Year Summary Financial Results:

Cash, cash equivalents and marketable securities as of December 31, 2018 were $85.0 million, compared to $112.2 million as of September 30, 2018. The decrease in cash of $27.2 million was driven primarily by the net cash used for operating activities of $17.0 million and cash used for the acquisition of the REGENXBIO license of $10 million.

Revenues were $0.5 million for the fourth quarter of 2018 compared with $0.2 million for the fourth quarter of 2017. The increased quarterly revenues resulted from the recognition of Foundation grants that were announced during the fourth quarter of 2017.

Net loss was $0.36 per share for the fourth quarter of 2018, compared to $0.19 per share in the comparable period in 2017. For the twelve months ended December 31, 2018, net loss was $1.19 per share compared to $0.66 per share in the same period in 2017.

Fourth Quarter and Recent Highlights:

·December 6, 2018: Provided lead program updates and unveiled data from AIM AAV vector platform in cystic fibrosis and retinal diseases at R&D Day

·January 8, 2019: Appointed Christine Silverstein as Chief Financial Officer and Ed Carr as Chief Accounting Officer

·February 5-6, 2019: Presented new supportive data for novel gene therapies, including new proof-of-concept data for the AIM vector platform at WORLDSymposium

·February 11, 2019: Appointed João Siffert, M.D. as Chief Executive Officer

"As a fully-integrated organization, Abeona is on the forefront of cell and gene therapy thanks to in-house manufacturing facilities, the AIM AAV vector platform, and two programs in the clinic that have exclusive license to the AAV9 vector," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "Under João’s leadership, the Company is focused on maximizing these end-to-end capabilities as it prepares for important near-term milestones and beyond."

On March 18, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing authorization from Australia’s Therapeutic Goods Administration (TGA) to commercialize NERLYNX (neratinib) in Australia for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab based therapy (Press release, Puma Biotechnology, MAR 18, 2019, View Source [SID1234534408]). STA has submitted regulatory applications to gain approval to introduce NERLYNX in Singapore. Further applications are planned by STA in other countries in South East Asia, including Malaysia, Brunei, Vietnam and Thailand.

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TGA approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. Women (n=2,840) with early-stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.

The results of the ExteNET trial demonstrated that after two years of follow-up, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008).

The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.

"TGA approval marks the first time Australian women are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence in patients who would otherwise have had a relapse," said Carlo Montagner, Chief Executive Officer of Specialised Therapeutics. "We are pleased to be at the forefront of this new treatment paradigm and look forward to changing outcomes for these women and their families."

Puma Biotechnology’s CEO and President, Alan H. Auerbach, added, "Reducing the risk of disease recurrence remains a need for patients, despite advances in the treatment of early stage HER2-positive breast cancer. We are pleased that our partner STA will be bringing this new medicine to patients throughout Australia and would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial. We are committed to continuing to expand NERLYNX accessibility to patients around the world."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

On March 18, 2019 Novocure (NASDAQ:NVCR) reported that Wilco Groenhuysen, Novocure’s Chief Financial Officer, will participate in Oppenheimer’s 29th Annual Healthcare Conference on March 20, 2019, in New York City (Press release, NovoCure, MAR 18, 2019, View Source [SID1234534428]). Mr. Groenhuysen’s presentation will begin at 10:55 a.m. EDT. Mr. Groenhuysen will also participate in one-on-one meetings with investors throughout the day.

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A live audio webcast of the presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the events.

Novocure’s corporate presentation is updated periodically, and the current presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations.

On March 18, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, reported that Mr. Adi Frish, senior vice president of business development and licensing, will present a corporate overview at the BIO-Europe Spring 2019 conference on Wednesday, March 27, 2019, at 9:45 a.m. CET at the Messe Wien Exhibition and Congress Center in Vienna, Austria (Press release, RedHill Biopharma, MAR 18, 2019, View Source [SID1234534462]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A copy of the presentation to be delivered by Mr. Frish will be available on the Company’s website and may be viewed at: View Source

On March 18, 2019 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Nell Beattie, Chief Business Officer, will present at the Oppenheimer 29th Annual Healthcare Conference on Wednesday, March 20, 2019 at 9:10 AM ET in New York City (Press release, VBI Vaccines, MAR 18, 2019, View Source [SID1234534486]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the event are as follows:

Oppenheimer 29th Annual Healthcare Conference

Date: Wednesday, March 20, 2019

Presentation Time: 9:10 – 9:40 AM ET

Webcast: https://www.veracast.com/webcasts/opco/healthcare2019/69204395724.cfm

A live webcast of the presentation and a subsequent replay may be accessed by visiting the Investors page of VBI’s website at: www.vbivaccines.com/investors/events-presentations/. A replay of the webcast will be archived on the company’s website for 90 days following the presentation.