On April 2, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported financial results for the fourth quarter and full year ended December 31, 2017 (Press release, BioTime, APR 2, 2018, View Source;p=RssLanding&cat=news&id=2340629 [SID1234525312]).

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"Since our last quarterly update to investors in November, the team at OncoCyte has been busy making substantial progress on several fronts," commented William Annett, President and Chief Executive Officer. "OncoCyte has upgraded its management team, brought additional talent to its Board of Directors, strengthened its balance sheet, expanded its patent estate, and continued to advance the development of DetermaVu to be ready for potential commercialization by the end of 2018. So far in 2018 we have continued to be deeply engaged in a number of activities that we believe should create significant value for our shareholders over time by bringing innovative technologies to market that have the potential to save and improve the lives of cancer patients."
Recent Highlights

Strengthened balance sheet through a $10 million private placement of common shares with two current investors.

Discovered and filed patent applications for 190 novel lung cancer biomarkers that may enhance OncoCyte’s lung cancer test and enable better differentiation of malignant from benign lung nodules for improved lung cancer diagnosis.

Reported positive data from a small study using a preliminary algorithm incorporating a combination of existing and newly discovered biomarkers. The study demonstrated at least equivalent accuracy for DetermaVu in diagnosing lung cancer on three different commercial molecular diagnostic platforms. These results need to be verified in a larger confirmation study to confirm the potential utility of the new biomarker panel. The Company is currently conducting that study and expects that it will be completed during the second quarter of 2018.

Announced the appointment of Cavan Redmond, a director of the Company since 2015, as Chairman of the Board of Directors.

Continued to enhance our abilities to rapidly prototype, evaluate, and develop lung cancer diagnostic products through the continued growth of our well-characterized lung cancer clinical sample bank.

Upcoming Milestones in 2018
First half:
Complete DetermaVu confirmation study.
Second half:
Select final commercial platform for DetermaVu.

Conduct R&D Validation Study of DetermaVu

Conduct and report results of Analytical Validation Study of DetermaVu.

Conduct CLIA Validation Study of DetermaVu.

Conduct and report results of Clinical Validation Study of DetermaVu.

Fourth Quarter 2017 Financial Results

For the quarter ended December 31, 2017, OncoCyte incurred a net loss of $4.0 million, or ($0.13) per share, compared to a net loss of $3.1 million, or ($0.11) per share, in the fourth quarter of 2016.
Operating expenses for the three months ended December 31, 2017, were $3.9 million as reported, and were $3.3 million, on an as adjusted basis.

Research and development expenses for the fourth quarter of 2017, as reported, were $1.5 million compared to $1.4 million for the same period in 2016. The increased costs include outside laboratory and clinical trial expenses, salaries and payroll related expenses, stock-based compensation expenses, and charges to OncoCyte by its former parent company BioTime, Inc. for continued shared facilities and services provided to OncoCyte.

General and administrative expenses for the fourth quarter of 2017, as reported, were $1.8 million compared to $1.1 million for the same period in 2016. The $0.7 million increase was mainly attributable to increased legal and patent related costs, consulting, salaries and payroll related expenses, including stock-based compensation, as we upgraded our management team with additional key hires made in 2017.

Sales and marketing expenses for the fourth quarter of 2017, as reported, were $0.6 million, relatively unchanged from $0.5 million for the same period in 2016.

At December 31, 2017, OncoCyte had cash and cash equivalents of $7.6 million and available-for-sale securities valued at $0.8 million.

Fiscal 2017 Financial Results

For 2017, OncoCyte reported a net loss of $19.4 million, or ($0.64) per share, compared to $11.2 million, or ($0.42) per share, in 2016.

Operating expenses for 2017 were $18.8 million, as reported, and were $12.6 million, on an as adjusted basis.
Research and development expenses for 2017, as reported, were $7.2 million, compared to $5.7 million during 2016. The $1.5 million increase was primarily due to the certification and maintenance costs related to the Company’s CLIA laboratory and the cost of the DetermaVu program. The increased costs include outside laboratory and clinical trial expenses, salaries and payroll related expenses, including stock-based compensation, and charges to OncoCyte by its former parent company, BioTime, Inc., for continued shared facilities and services provided to OncoCyte.

General and administrative expenses for 2017, as reported, were $9.2 million compared to $4.3 million during 2016. The $4.9 million increase was mainly attributable to a $4.1 million noncash charge for the issuance of warrants to certain investors who exercised stock purchase warrants, $0.4 million in legal and patent related expenses, $0.3 million in personnel costs and related benefits, including stock-based compensation expenses, and $0.2 million in insurance expense.

Sales and marketing expenses for 2017, as reported, were $2.4 million compared to $1.2 million during 2016. The $1.2 million increase was mainly attributable to increases of $0.7 million in salaries and payroll related expenses, including stock-based compensation, $0.2 million in consulting expenses, and $0.2 million in amounts charged to OncoCyte by BioTime for continued shared facilities and services provided to OncoCyte.
Conference Call

OncoCyte will host a conference call today, April 2, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.
The dial-in number in the U.S./Canada is 800-281-7973, for international participants the number is 323-794-2093. For all callers, refer to Conference ID 4101947. To access the live webcast, go to the investor relations section on the company’s website, View Source
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 4101947. Additionally, the archived webcast will be available View Source

On April 2, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will give a corporate presentation at the H. C. Wainwright Annual Global Life Sciences Conference on Monday, April 9 at 10:40 a.m. CEST at Le Meridien Beach Plaza Hotel in Monte Carlo, Monaco (Press release, Tetraphase, APR 2, 2018, View Source [SID1234525121]).

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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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Live audio webcasts of the presentation will be available on the company’s website at View Source Archived presentations will be available for 30 days.

On April 2, 2018 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that it will hold its first-quarter 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, May 1 (Press release, Merck & Co, FEB 2, 2018, View Source [SID1234525122]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9499465. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9499465. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

On 2, April Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported the appointment of Carsten Thiel, Ph.D., as Chief Executive Officer. Timothy J. Miller, Ph.D., will remain President and assume the position of Chief Scientific Officer in charge of the company’s expanding clinical and preclinical research programs (Press release, Abeona Therapeutics, APR 2, 2018, View Source [SID1234525106]). Dr. Thiel most recently served as the Executive Vice President and Chief Commercial Officer of Alexion Pharmaceuticals, Inc. where he led global commercial operations bringing innovative and life-transformative therapies for rare diseases to patients.

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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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"The past year has been an extraordinary time in the history of Abeona, including significant progress in our clinical development programs and establishment of our new manufacturing facility in Cleveland," said Steven Rouhandeh, Executive Chairman of Abeona. "As CEO, Carsten Thiel brings a unique combination of extensive experience in research and global rare disease commercialization to Abeona. In his recent positions, he successfully created value by building cohesive talented teams, driving the commercial success of multiple products globally and fostering entrepreneurial culture; all key aspects that will be critical to our success in these areas in the years ahead. We are very grateful to Tim Miller for his vision and leadership that have brought us to this pivotal stage in our business growth."

Dr. Thiel brings 25 years of proven global biopharmaceutical industry experience, including rare and orphan diseases, to Abeona. Prior to leading his most recent position at Alexion, he served as its Senior Vice President, Europe/Middle East/Africa and Asia Pacific where he was responsible for driving Alexion’s global commercial operations in these regions, including maximizing the current rare disease portfolio as well as guiding the launch of anticipated new products and indications.

"I am thrilled to be joining Abeona during a period of major growth and momentum in the company’s range of promising development programs," said Dr. Thiel. "I look forward to bringing my experience in business development, biomedical research and commercialization to the outstanding Abeona team at a time when the company is ideally positioned to rapidly expand these areas."

Prior to joining Alexion, Dr. Thiel served as Vice President, Head of Europe at Amgen. In this role, he led regional operations and was responsible for multiple products in hematology/oncology, nephrology, and bone disorders, and prepared for new product launches in inflammation and cardiology. He also held various other senior leadership positions at Amgen, including General Manager, Germany, and General Manager, CEE, where he led all markets in Eastern Europe and established Amgen’s operations in Russia. He also served as Head of the Oncology franchise in Europe during the time of several blockbuster product launches. Prior to Amgen, Dr. Thiel held several sales and marketing leadership roles across Europe at Roche.

"As Abeona expands our innovative science and clinical research programs into new areas, I look forward to working more closely with our research and product development teams to fuel even greater success for developing novel gene and cell therapies," said Dr. Miller. "We welcome Carsten to our team at Abeona, and remain confident that our clinical advancements and strategic decisions have solidly positioned us to plan for many promising opportunities in global product commercialization and business strategy."

Dr. Thiel earned his doctorate in molecular biology & biochemistry at Max Planck Institute for Biophysical Chemistry in Goettingen, Germany.

On April 2, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that NERLYNX (neratinib) has been included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Central Nervous System Cancers for Breast Cancer patients with brain metastases (Press release, Puma Biotechnology, APR 2, 2018, View Source [SID1234525377]). The NCCN designated NERLYNX in combination with capecitabine as a category 2A treatment option and NERLYNX in combination with paclitaxel as a category 2B treatment option. Use, as designated for breast cancer patients with brain metastases, is outside the FDA approved indication for NERLYNX and considered investigational.

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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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"Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced breast cancer."

About Brain Metastases in Breast Cancer
Breast cancer is one of three types of cancers that are most likely to metastasize to the brain. Across all sub-types, approximately 10-15% of women with metastatic breast cancer develop brain metastases. This rate is as high as 30% for women with advanced HER2+ disease.

About National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.

About HER2-Positive Breast Cancer
Approximately 20% to 25% 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 a trastuzumab-based regimen experience recurrence.
IMPORTANT SAFETY INFORMATION
NERLYNX (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:
Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: 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, epistaxis, weight decreased and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS:
Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:
Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.
To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.