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BioTime to Participate in The LifeSci Advisors Corporate Access Event in San Francisco, January 8 – 10, 2018

On December 20, 2017 BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology company developing and commercializing products addressing degenerative diseases, reported that Adi Mohanty, Co-Chief Executive Officer, and Russell Skibsted, Chief Financial Officer, will host institutional investor and partnering meetings, at the LifeSci Advisors Corporate Access Event taking place in San Francisco, January 8-10, 2018 (Press release, BioTime, DEC 20, 2017, View Source;p=RssLanding&cat=news&id=2323507 [SID1234522723]).

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One-on-one meetings with Mr. Mohanty and/or Mr. Skibsted may be arranged by registering through LifeSci Advisors, LLC, by making a request via e-mail at [email protected], or by contacting David Nakasone, Director of Investor Relations at BioTime, at 510-871-4188 or [email protected].

Bayer announces initiation of rolling submission of new drug application in the U.S. for Larotrectinib for the treatment of TRK fusion cancers (for specialized target groups only)

On December 20, 2017 Bayer reported that its collaboration partner Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company based in Stamford, CT, has initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib (Press release, Bayer, DEC 20, 2017, View Source [SID1234522722]). The NDA is being submitted for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments. Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. Loxo Oncology expects to complete the NDA submission in early 2018.

"The initiation of the rolling submission in the U.S. by Loxo Oncology is an important milestone, as it brings us one step closer to potentially being able to offer a much needed new treatment option for patients with TRK fusion cancers in the near future," said Robert LaCaze, Member of the Executive Committee at Bayer AG’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit.

About larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an analysis of 55 RECIST-evaluable TRK fusion adult and pediatric patients, larotrectinib demonstrated an 80 percent investigator-assessed overall response rate (ORR) and a 75 percent independently-reviewed confirmed ORR, across many different types of solid tumors. Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Loxo Oncology leads worldwide development and U.S. regulatory activities. Bayer leads ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

About TRK fusion cancer
TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH). For more information, please visit www.TRKtesting.com.

Cancers harboring genetic alterations
Scientists have long been working to better understand how a normal cell becomes a cancer cell to deliver better therapies with fewer side effects. Some people develop cancers that are caused by a single inappropriate DNA change, known as "oncogenic drivers." When a genetic test identifies a patient with an oncogenic driver, there is the potential for use of highly selective drugs that inhibit oncogenic drivers in cancer. While there has been made notable progress in improving outcomes for people living with cancer over the last several decades, there has been a growing interest in developing highly targeted medicines to treat cancer, to further maximize the patients’ clinical benefit. This development is supported by the increasing use of genetic testing in cancer clinical medicine and improving chemistry approaches to building highly selective inhibitors against single targets in the cancer cell.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes four marketed products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated

Alexion to Present at the Goldman Sachs Healthcare CEOs Unscripted Conference

On December 20, 2017 Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) reported that management will present at the Goldman Sachs Healthcare CEOs Unscripted Conference on Thursday, January 4, 2018 at 1:45 p.m. Eastern Time (Press release, Alexion, DEC 20, 2017, View Source [SID1234522720]).

An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Advaxis Reports Fiscal Year 2017 Financial Results and Provides a Business Update

On December 20, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported a business update and announces its financial results for the fiscal year ended October 31, 2017 (Press release, Advaxis, DEC 20, 2017, View Source [SID1234522719]).

Key 2017 Accomplishments

● Re-prioritization of the Company’s clinical programs to focus on four key areas: HPV-associated cancers, neoantigen therapy, disease focused hotspot and cancer antigen therapies and prostate cancer;
● Progress in the HPV-related cancer franchise, with important milestones including the initiation of patient dosing in Advaxis’ Phase 3 study, AIM2CERV and presentation of the ground-breaking GOG-0265 data;
● FDA acceptance of the IND for ADXS-NEO;
● Presentation of initial immunological and clinical data from the monotherapy arm of the ongoing Phase 1/2 study in prostate cancer at multiple medical meetings; and
● New clinical partnerships with Bristol-Myers Squibb and Sellas Life Sciences.

Management Commentary

"2017 was a year of change for Advaxis as we evolved into a more focused and disciplined enterprise, and we have made significant progress with our clinical programs," stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. "We’re fortunate that as immuno-oncology continues to evolve, the flexibility of our proprietary Lm Technology platform allows Advaxis to continue to adapt and introduce highly innovative programs."

"We refined our clinical strategy to concentrate on four distinct franchises and conducted a thorough review of the business with the entire Advaxis team to implement tactics to enhance value. We are confident that this diversification strategy holds significant potential to create shareholder value while developing much-needed targeted cancer therapies for patients in need.

"As we move into our fiscal 2018, our focus will be on executing our strategy while driving additional efficiencies throughout the organization. We expect to achieve a number of value-creating milestones that will position Advaxis for continued growth and expansion throughout the year and beyond. Our management team is committed to delivering for our shareholders and unlocking the full potential of our Lm Technology platform," Mr. Lombardo concluded.

Balance Sheet Highlights

As of October 31, 2017, Advaxis had cash, cash equivalents and investments of $70.9 million. The Company used approximately $76.9 million in cash to fund operations during fiscal 2017, mainly attributed to funding strategic development programs and related personnel and infrastructure to support the company’s progress and growth.

Following the close of the fiscal year, the Company reported approval for a $4.8 million tax credit from the NJEDA’s NOL program. The Company expects to receive $4.5 million in cash by the end of their fiscal Q1 2018.

In 2017 the Company completed an in-depth review of all spend and has eliminated programs that were not supportive of its strategic goals. Due to this increased discipline, the Company has returned to the historical quarterly burn rate of approximately $20 million in the fourth quarter of 2017, excluding partnership reimbursement and other cash receivables. Moving into 2018, the Company will continue to be disciplined and expects its cash burn to decrease from its 2017 level, as there were several one-time costs in 2017 related to preparation for the regulatory filing of axalimogene filolisbac in Europe and related infrastructure costs, which are not anticipated to recur.

Throughout fiscal 2018, Advaxis plans to continue to invest in its core clinical programs and expects its current cash position will be sufficient to fund its business plan into fiscal 2019.

Financial Highlights for Fiscal Year 2017

The net loss for the fiscal year ended October 31, 2017 was $93.4 million or $2.31 per share based on 40.5 million shares outstanding. This compares with a net loss for fiscal 2016 of $73.6 million or $2.08 per share based on 35.4 million shares outstanding.

Research and development expenses for fiscal 2017 were $71.9 million, compared with $48.8 million for fiscal 2016. The $23.1 million increase was primarily a result of continued investment in support of the Company’s preclinical and clinical development programs. In addition, the Company had higher third-party costs related to its HPV franchise primarily supporting the AIM2CERV Phase 3 clinical program, preparations for the planned EU submission for conditional approval, start-up activities related to the ADXS-DUAL program and ADXS-PSA Phase 1/2 trial support. The increase also reflects higher headcount to support the research and development initiatives.

General and administrative expenses for fiscal 2017 were $38.7 million, compared with $31.7 million for fiscal 2016. The increase was largely attributable to non-cash stock-based compensation expense, which increased by $6.7 million year-over-year. The Company expects G&A expenses in the near term to remain comparable to current levels, exclusive of the impact of non-cash stock awards and one-time expenses.

Conference Call and Webcast Information

Advaxis’ senior management will host a conference call to review financial results, provide a business update and answer questions. The conference call and live audio webcast will begin at 10:00 a.m. Eastern time on Thursday, December 21, 2017.

To access the conference call please dial (844) 348-6133 (domestic) or (631) 485-4564 (international) and refer to conference ID 4682169. A live and archived audio webcast of the call will be available on the Company’s website at www.ir.advaxis.com/news-events.

For those unable to participate in the live conference call or webcast, a recording will be available beginning two hours after the call ends. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide conference ID 4682169.

AbbVie to Present at the 36th Annual J.P. Morgan Healthcare Conference

On Decemeber 20, 2017 AbbVie (NYSE: ABBV) reported that it will participate in the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2018 (Press release, AbbVie, DEC 20, 2017, View Source [SID1234522718]). Richard A. Gonzalez, chairman and chief executive officer, will present at 10:30 a.m. Central time.

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.