On May 15, 2018 Molecular Templates, Inc. (Nasdaq:MTEM) ("Molecular"), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported that its management will provide a corporate overview at the UBS Global Healthcare Conference, taking place May 21-23 at the Grand Hyatt New York hotel in New York City (Press release, Molecular Templates, MAY 15, 2018, View Source [SID1234526645]).

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Presentation Details

Date:
Time:
Location:
Webcast: Monday, May 21
8:00am Eastern Time
Ballroom IV
https://cc.talkpoint.com/ubsx001/052118a_as/?entity=70_OJGBE5X

On May 15, 2018 Astellas reported that Bernhardt G. Zeiher, M.D., F.C.C.P., F.A.C.P., ("Bernie"), was promoted to Chief Medical Officer (CMO), effective April 1, 2018 (Press release, Astellas Pharma US, MAY 15, 2018, View Source [SID1234526669]). Zeiher will continue serving as president of Development, while now also overseeing all other functions of Astellas’ Medical and Development (M&D) organization, including Clinical and Research Quality Assurance, Medical Affairs, Pharmacovigilance, Planning & Administration, and Regulatory Affairs.

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Reporting directly to Astellas president and CEO, Kenji Yasukawa, Ph.D., Zeiher will join the company’s top executive leadership team. He will continue to lead the organization from Northbrook, Ill., Astellas’ headquarters for M&D and its Americas operations.

In his new role, Zeiher will focus on further integrating and enhancing Astellas’ delivery of its global innovative pipeline and driving support for the appropriate use of its products.

"I am honored to lead the Astellas M&D organization during this critical time," said Zeiher. "As we embark upon a new Corporate Strategic Plan, it is my goal to continue and further implement the corporate vision of turning innovative science into value for patients."

Zeiher started his career at Astellas in 2010 as vice president and Therapeutic Area leader for Inflammation, Immunology and Infectious Diseases. He was promoted to senior vice president and Therapeutic Area Head for Immunology, Infectious Diseases and Transplant in 2012. Zeiher was later named executive vice president and Therapeutic Area Head when his organization was expanded to include the company’s CNS and Pain programs. Most recently, Zeiher was promoted to president of Development in 2015. Prior to joining Astellas, Zeiher served as the vice president of the Inflammation/Immunology therapeutic area at Pfizer.

He earned his Doctor of Medicine at the Case Western Reserve University School of Medicine, and completed an internal medicine residency at University Hospitals of Cleveland as well as a fellowship in Pulmonary and Critical Care Medicine at University of Iowa Hospitals and Clinics. Zeiher is a Fellow in the American College of Physicians and the American College of Chest Physicians. He has worked in the pharmaceutical industry since 1998

Genprex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genprex, 2018, MAY 15, 2018, View Source [SID1234527544]).

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On May 15, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2018 (Press release, Cleveland BioLabs, MAY 15, 2018, View Source [SID1234526615]).

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Cleveland BioLabs reported a net loss of $(1.2) million, excluding minority interests, for the first quarter of 2018, or $(0.11) per share, compared to a net loss, excluding minority interests, of $(1.7) million, or $(0.15) per share, for the same period in 2017. The decrease in net loss was primarily due to a non-cash adjustment to our warrant liabilities and reduced operating costs partially offset by reduced revenue.

As of March 31, 2018, the Company had $7.7 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is estimated to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The past quarter was one of important progress for the company and our Entolimod program. We continued our pursuit of a pre- Emergency Use Authorization ("pre-EUA") with the U.S. Food and Drug Administration ("FDA") and a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure."

"As previously reported, the company has received Day 120 review questions from EMA regarding the MAA for entolimod and a formal notification that responses to these questions should be submitted to the agency by September 14, 2018. Consistent with the FDA review of the company’s pre-EUA application, several of the EMA review questions focused on the comparability between the entolimod formulation used in prior safety and efficacy studies and the formulation proposed for commercialization. The analytical analysis of the specimens collected during an in-vivo biocomparability study in non-human primates to address these comparability questions is ongoing," added Dr. Kogan. "Other Day 120 questions from the EMA are generally similar to those discussed in the past with the FDA, and include questions on validation of various aspects of manufacturing, the animal-to-human dose-conversion strategy, and the human safety database."

Further Financial Results

Revenue for the first quarter of 2018 decreased to $0.2 million compared to $0.6 million for the first quarter of 2017. The decrease was primarily due to decreased revenue from our Joint Warfighter Medical Research Program contract from the Department of Defense for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the first quarter of 2018 decreased to $1.3 million compared to $1.4 million for the first quarter of 2017. The reduction in research and development costs is primarily due to reductions in entolimod for biodefense applications partially offset by increases in the entolimod family of compounds for oncology.

General and administrative costs for the first quarter of 2018 decreased to $0.7 million compared to $0.8 million for the first quarter of 2017. This decrease was primarily attributable to reductions in personnel and other operating costs in connection with cost savings efforts to streamline operations.

On May 15, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present results from eight studies at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held June 1 to 5, 2018 in Chicago, Ill (Press release, Myriad Genetics, MAY 15, 2018, View Source [SID1234526646]). Abstracts of the Company’s presentations will be available at: abstracts.asco.org on May 16 at 5:00 p.m. EDT.

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"We look forward to presenting exciting new discoveries at ASCO (Free ASCO Whitepaper) that we believe will expand the reach of personalized medicine for patients with cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "Importantly, our presentations will focus on new advances in predicting breast cancer recurrence and the need for chemotherapy, the role of hereditary cancer testing in preventing cancer or optimizing treatment plans, and novel companion diagnostics for helping guide medication selection for patients with breast or ovarian cancers."

A list of Myriad presentations at ASCO (Free ASCO Whitepaper) 2018 are below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #ASCO18.

Title Presenter Abstract Number Day/Time Myriad Product

Oral Presentation

Validation of a Combined Residual Risk Score
for Healthy Unaffected Women Presenting to Breast
Cancer (BC) Screening Centers Kathryn Dalton Presentation 1507 Sunday, June 3, 2018: 8:00-11:30 a.m. CDT. riskScore

Poster Presentations

Predicting Expected Absolute Chemotherapy
Treatment Benefit in Women with Early-Stage
Breast Cancer using a 12-Gene Expression
Assay William Gradishar Abstract 525 Saturday, June 2, 2018: 8:00-11:30 a.m. EndoPredict

In Silico Evaluation of the 12-gene molecular
score (EndoPredict) and the Recurrence Score
(Oncotype DX) as Predictors of Response to
Neo-adjuvant Chemotherapy in Estrogen
Receptor Positive (ER+), HER2 Negative
(HER2-) Breast Cancer Hatem Soliman Abstract 539

Saturday, June 2, 2018: 8:00-11:30 a.m. CDT. EndoPredict

Promoting Colorectal Cancer (CRC) Screening
after Multiplex Genetic Testing and Genetic
Counselling Gregory Idos Abstract 1582 Saturday, June 2, 2018: 1:15-4:45 p.m. CDT.

Myriad myRisk

Promoting Breast Cancer Screening after
Multiplex Genetic Panel Testing (MGPT) and
Genetic Counselling Gregory Idos Abstract 1581 Saturday, June 2, 2018: 1:15-4:45 p.m. CDT.

Myriad myRisk

Evaluation of Homologous Recombination
Deficiency (HRD) status with pathological
response to carboplatin +/- veliparib
in BrighTNess, a randomized phase 3 study in
early stage TNBC Melinda Telli Abstract 519 Saturday, June 2, 2018: 3:00-4:15 p.m. CDT. myChoice HRD

Locus-specific loss of heterozygosity (LOH) in
BRCA1/2 mutated (mBRCA) ovarian tumors
from the SOLO2 (NCT01874353) and Study 19
(NCT00753545) clinical trials Kirsten Timms Abstract 5563 Monday, June 4, 2018: 1:15-4:45 p.m. CDT.

myChoice HRD
About EndoPredict
EndoPredict is a second-generation, multigene prognostic test for patients diagnosed with ER+, HER2- early-stage breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer panel uses validated technologies and algorithms in an 850 step laboratory process to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information, please visit: View Source

About riskScoreTM
riskScore is a clinically validated algorithm that predicts a women’s remaining 5-year and lifetime risk of developing breast cancer. The algorithm combines the analysis of over 80 well-studied genetic markers and the Tyrer-Cuzick model to accurately estimate breast cancer risk for woman of European descent. For more information, please visit: View Source

About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. For more information, please visit: View Source