On May 3, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has engaged Voisin Consulting Life Sciences ("VCLS"), as an additional regulatory consulting firm and contract research organization ("CRO") to prepare for expansion of its clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, MAY 3, 2018, View Source [SID1234526079]).

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Moleculin engaged Voisin Consulting Life Sciences, headquartered in Paris, France to evaluate additional countries for the potential expansion of its AML clinical trial. VCLS is a multinational regulatory consulting firm and contract research organization with 150 life science professionals. The Moleculin engagement is intended to evaluate Australia and selected Western European countries to provide additional clinical sites.

"Now that our AML trial is underway, we are focused on expanding the opportunity for AML patients to participate in the trial," commented Walter Klemp, Moleculin’s Chairman and CEO. "Our strategy is to choose countries with the best possible balance between an efficient clinical trial authorization process, solid AML clinical trial experience and a population of qualified AML patients."

About Voisin Consulting Life Sciences

From discovery to product launch and life cycle management

AT Voisin Consulting Life Sciences (VCLS), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 150 employees, VCLS serves a broad range of developers and their investors.

For more information, visit www.voisinconsulting.com

On May 3, 2018 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three months ended March 31, 2018 (Press release, Odonate Therapeutics, MAY 3, 2018, View Source [SID1234526098]).

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As of March 31, 2018, Odonate had $195.2 million in cash, compared to $198.1 million as of December 31, 2017. This decrease in cash resulted primarily from net cash used in operating activities of $12.5 million, less net proceeds of $9.8 million from the sale of common stock to the underwriters in our initial public offering in connection with the exercise of their option to purchase additional shares of common stock. Odonate’s net loss for the three months ended March 31, 2018 was $16.9 million, or $0.69 per share, compared to $2.7 million, or $0.26 per share, for the same period in 2017.

"We are excited to have recently initiated CONTESSA, our Phase 3 study investigating tesetaxel in the treatment of locally advanced or metastatic breast cancer," said Kevin Tang, Chairman and Chief Executive Officer of Odonate. "Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life. We are hopeful that tesetaxel’s oral bioavailability, low pill burden, lack of history of hypersensitivity reactions and robust activity against chemotherapy-resistant tumors seen in prior studies may translate into significant benefits for patients."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; no history of hypersensitivity (allergic) reactions; and robust activity against chemotherapy-resistant tumors. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with locally advanced or metastatic breast cancer (MBC), tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (MBC). CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC, disease control rate assessed by IRC and patient-reported outcomes. To learn more, please visit www.contessastudy.com.

On May 2, 2018 Asterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that Edward Wirth III, M.D., Ph.D., Asterias’ Chief Medical Officer, will present previously announced 12-month safety and efficacy results for Cohort 2 (subjects with AIS-A grade cervical spinal cord injury and dosed with 10 million AST-OPC1 cells) from the company’s ongoing SCiStar Phase 1/2a study of AST-OPC1 in complete cervical spinal cord injury at the American Spinal Injury Association (ASIA) 2018 Annual Meeting, which is being held during May 2-4, 2018 in Rochester, Minnesota.
(Press release, Asterias Biotherapeutics, MAY 2, 2018, View Source;date=May+02%2C+2018&title=Asterias+Biotherapeutics+to+Present+Safety+and+Efficacy+Data+from+AST-OPC1+SCiStar+Study+at+the+American+Spinal+Injury+Association+%28ASIA%29+2018+Annual+Meeting+ [SID1234525939])
The details of the presentation are as follows:

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Title: 12-Month Safety and Efficacy Results from the SCiStar Study – A Phase 1/2a Trial of Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cells (AST-OPC1) in Patients with Subacute Cervical Spinal Cord Injury
Date: Thursday, May 3, 2018
Time: 8:00 am – 9:30 am CDT

On May 2, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that the company will host a conference call on Wednesday, May 9th, at 8:30 a.m. EDT to discuss its first quarter financial results and provide an operational update (Press release, Endocyte, MAY 2, 2018, View Source [SID1234525959]).

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Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company’s website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).

The webcast will be recorded and available on the Company’s website for 90 days following the call.

Website Information
Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document..

Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company’s website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).

The webcast will be recorded and available on the Company’s website for 90 days following the call.

Website Information
Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On May 2, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the Bank of America Merrill Lynch Health Care Conference 2018 on Tuesday, May 15, 2018 at 5:00 p.m. Pacific Time (Press release, Seattle Genetics, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346286 [SID1234525976]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section

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