Neuralstem Announces $2.1 Million Registered Direct Offering

On October 29, 2018 Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, reported that it has entered into definitive agreements with institutional investors for the purchase of 3,000,000 shares of its common stock, at a purchase price per share of $0.70, in a registered direct offering (Press release, Neuralstem, OCT 29, 2018, View Source [SID1234530381]). Additionally, Neuralstem has also agreed to issue to the investors unregistered warrants to purchase up to 3,000,000 shares of its common stock. The closing of the offering is expected to take place on or about October 29, 2018, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $0.75 per share of common stock, will be exercisable commencing six months following the issuance date and will expire five and one-half years from the issuance date.

The gross proceeds to Neuralstem, before deducting placement agent fees and other offering expenses, are expected to be $2.1 million. Neuralstem intends to use the net proceeds from this offering to further its clinical and preclinical programs, and for general working capital.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Neuralstem pursuant to a "shelf" registration statement on Form S-3 that was filed and declared effective by the Securities and Exchange Commission ("SEC") on June 23, 2017 and the base prospectus contained therein (File No. 333-218608). The offering of the shares of common stock will be made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement.

A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

Medicare Establishes Final Local Coverage Determination (LCD) for Use of the Oncotype DX® AR-V7 Nucleus Detect™ Test in Patients with Metastatic Castrate Resistant Prostate Cancer Effective December 10

On October 29, 2018 Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) reported that Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, has issued a positive final local coverage determination (LCD) for the Oncotype DX AR-V7 Nucleus Detect test (Press release, Genomic Health, OCT 29, 2018, View Source [SID1234530442]). The final LCD recommends Medicare coverage for use of the test effective December 10, 2018, throughout the United States to help determine which patients with metastatic castrate resistant prostate cancer (mCRPC) may benefit from continued androgen receptor signaling inhibitor (ARSi) therapy, such as enzalutamide, abiraterone and apalutamide, as well as those who are resistant who may benefit from chemotherapy.

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An estimated 50,000 men in the United States with advanced prostate cancer, of which approximately 25,000 have Medicare coverage, could benefit from knowing their AR-V7 status prior to selecting further treatment. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell-based liquid biopsy test that is commercially available in the United States through Epic’s partnership with Genomic Health. The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.

The test, commercially launched by Genomic Health on February 28, 2018, is supported by three clinical utility studies including two multicenter validation studies. Results from a Memorial Sloan Kettering Cancer Center-led validation study were published online on June 28, 2018, in JAMA Oncology, establishing the predictive benefit of the test. Additionally, new validation data from the PROPHECY study were presented on June 4, 2018, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"For men with advanced prostate cancer, these independent, blinded, multicenter studies demonstrated that the Oncotype DX AR-V7 Nucleus Detect test is a clinically validated and useful test that can predict therapeutic response and, through its use, extend life. Importantly, with this final Medicare LCD, approximately 50 percent of addressable patients in the United States can gain access to the test," said Murali Prahalad, Ph.D., President and CEO of Epic Sciences. "Receiving a positive, final LCD for the test less than a year after commercial launch speaks to the importance and impact that this test has in improving patient survival."

Prior to the Oncotype DX AR-V7 Nucleus Detect test, there was no clear consensus on the therapeutic sequencing after initial exposure to an ARSi therapy. The most challenging clinical decision in mCRPC is whether to start a second ARSi therapy or taxane chemotherapy. Detection of nuclear-specific AR-V7-positive circulating tumor cells as measured by the Epic Sciences approach indicates which patients are resistant to AR-targeted therapies, such as enzalutamide, abiraterone and apalutamide, as well as those who are likely to live longer when placed on chemotherapy rather than on ARSi therapy. Conversely, patients negative for nuclear-localized AR-V7 are likely to live longer with ARSi therapy than with chemotherapy.

The Oncotype DX AR-V7 Nucleus Detect test was developed using Epic’s proprietary No Cell Left Behind technology. Epic is delivering a portfolio of blood-based tests that are predictive of drug response in cancer and are clinically proven, personalized and focused on improving patient survival and healthcare economics worldwide.

About the Oncotype DX AR-V7 Nucleus Detect Test
Designed by Epic Sciences and based on results from multiple studies led by Memorial Sloan Kettering Cancer Center, the Oncotype DX AR-V7 Nucleus Detect test is the first and only liquid biopsy test of its kind that can potentially prolong the lives of men with metastatic castration-resistant prostate cancer (mCRPC) by helping their physician identify the most effective treatment. Through a blood draw, the test detects AR-V7 protein in the nucleus of circulating tumor cells utilizing Epic Sciences’ No Cell Left Behind platform to accurately identify patients who are resistant to androgen receptor (AR)-targeted therapies and who should instead switch to chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and is offered exclusively by Genomic Health. To learn more about the Oncotype DX AR-V7 Nucleus Detest test, visit www.OncotypeIQ.com and watch this video.

corporate presentations

On October 29, 2018 Cellular Biomedicine Group, Inc presented the presentations at the Advanced Cell Therapy Summit 2018 in Shanghai (Presentation, Cellular Biomedicine Group, OCT 29, 2018, View Source [SID1234530281]).

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TESARO Announces Achievement of ZEJULA Prostate Cancer Development Milestones by Janssen

On October 29, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc. (Janssen) (Press release, TESARO, OCT 29, 2018, View Source [SID1234530297]). The milestones are related to Janssen’s ongoing GALAHAD trial, which is assessing niraparib monotherapy for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. Data from the trial are anticipated to support global regulatory filings in 2019.

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In addition, data from the Phase 1b BEDIVERE trial were recently presented at the European Society of Clinical Oncology (ESMO) (Free ESMO Whitepaper) and demonstrated the safety and tolerability of combining niraparib with abiraterone acetate + prednisone (AA-P) in men with mCRPC. Data from the BEDIVERE trial will be used to inform the dosing regimen in a future Phase 3 trial that will assess the clinical benefit of niraparib in combination with AA-P in mCRPC patients.

TESARO entered into a global prostate collaboration and license agreement with Janssen in 2016, through which Janssen received rights to develop and commercialize niraparib for patients with prostate cancer worldwide, except Japan. Under the terms of the agreement, TESARO is eligible to receive development, regulatory and commercial milestones, in addition to royalty payments.

About the Janssen GALAHAD Clinical Trial
GALAHAD is an ongoing Phase 2, open-label, single arm trial designed to evaluate the safety and efficacy of niraparib monotherapy (300mg daily) in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies progressing on/after taxane-based chemotherapy and androgen receptor targeted therapy. Patients are enrolled in the study based on their DNA-repair deficiency status.

About the Janssen BEDIVERE Clinical Trial
BEDIVERE is an ongoing Phase 1b, open-label, dose-selection study with dose expansion designed to evaluate the safety of niraparib in combination with AA-P in men with metastatic castration-resistant prostate cancer (mCRPC) who may or may not have had DNA-repair anomalies.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

NIH Awards Grant for Research on Apexian’s APX3330 as Treatment for Cancer Cachexia

On October 29, 2018 Apexian Pharmaceuticals reported that researchers will continue to explore the impact of Apexian’s target molecule, APX3330, on cancer cachexia with additional grant funding from the National Institutes of Health (NIH) National Cancer Institute(NCI) (Press release, Apexian Pharmaceuticals, OCT 29, 2018, View Source [SID1234530421]). Cancer cachexia is weight loss with chronic inflammation and defective metabolism, which causes roughly one third of all cancer deaths. It is particularly prevalent in pancreatic ductal adenocarcinoma (PDAC), which has a dismal five-year survival rate.

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Dr. Mark R. Kelley, Apexian Chief Scientific Officer and the Betty and Earl Herr Professor of Pediatric Oncology Research at the Indiana University Simon Cancer Center; Dr. Melissa Fishel, Research Associate Professor, Wells Center for Pediatric Research; and Dr. Teresa Zimmers, Associate Professor of Surgery at the Indiana University School of Medicine, have been working to define mechanisms of cachexia stemming from treatment in PDAC, as well as for identifying mechanism-driven, targeted anti-cachexia therapies.

"The goal of this research is to determine the anti-cachexia potential of Ref-1 inhibition, HIF-1a inhibition, or the combination in mouse models of PDAC," said Dr. Kelley. "APX3330 has proven effective at inhibiting Ref-1, and has been safe and well tolerated when taken by patients with advanced cancers in our Phase 1 clinical study."

Previous studies support Ref-1 as a target in PDAC, on-target effects of APX3330, and the use of APX3330 as a clinical agent in cancer. This study will focus on demonstrating improvement in fat/muscle mass and PDAC cachexia symptoms using APX3330. Positive results from this study would lead to immediate clinical trials using APX3330 to prevent or reverse PDAC cachexia.

"Dr. Kelley’s research on APX3330 as a Ref-1 inhibitor continues to offer promise as a treatment for cancer and cancer-related issues like cachexia and cancer chemotherapy-induced neuropathy," said Steve Carchedi, CEO of Apexian Pharmaceuticals. "As we complete our Phase I trial, we continue to aggressively pursue additional therapeutic uses for APX3330 and build on our pipeline of novel, first in class molecules."

The NIH grant of $227,554 pushes Kelley’s grant budget for research on Ref-1 inhibitors to nearly $700,000 just in 2018.