On January 28, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the pricing of a public offering of 15,217,392 shares of its common stock, offered at a price to the public of $0.23 per share, for gross proceeds of approximately $3.5 million, before deducting placement agent fees and other offering expenses payable by Cancer Genetics (Press release, BioServe Biotechnologies, JAN 28, 2019, View Source [SID1234534253]). The offering is expected to close on or about January 31, 2019, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The offering is being conducted as a "best efforts" offering and the placement agent is not obligated to purchase any securities.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts required by its lenders, and if any proceeds remain available, to pay certain costs previously incurred in connection with its strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement and accompanying prospectus to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 28, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will report its fourth-quarter and year-end 2018 financial results — and provide 2019 guidance — after market close Monday, Feb. 25 (Press release, Diplomat Speciality Pharmacy, JAN 28, 2019, View Source [SID1234532919]). A conference call and live webcast will follow at 5 p.m. ET.

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Shareholders and other interested parties can listen to the conference call live by dialing 833.286.5805 (647.689.4450 for international callers). Participation code 2672528 will start working about 15 minutes before the call. A live webcast will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. An audio recording and related materials will be available online for approximately 90 days.

On January 28, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that an overview of the Company’s proprietary Lm platform and new information regarding the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens), will be presented during a plenary session at the Immuno-Oncology 360° conference on February 6, 2019 (Press release, Advaxis, JAN 28, 2019, View Source [SID1234532920]). The conference is being held at the Crowne Plaza Times Square in New York City; the plenary session begins at 4:00 p.m. ET and the Advaxis presentation is scheduled to begin at 4:40 p.m. ET.

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The presentation will be made by Andres A. Gutierrez, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Advaxis, and Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. Advaxis intends to issue a news release on February 6, 2019, that summarizes the presentation by Drs. Gutierrez and Petit.

ADXS-NEO, the Company’s personalized neoantigen program, is in an ongoing Phase 1 dose-escalation study to treat a variety of cancers. ADXS-HOT is the Company’s off-the-shelf program and consists of several different drug constructs which target hotspot or shared neoantigens, and other antigens. The first drug construct from this program is ADXS-503, or HOT-Lung, for the treatment of non-small cell lung cancer. ADXS-503 is expected to enter the clinic this quarter.

On January 28, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis ("OM"), reported the publication of a preclinical study using the lead compound from its lantibiotics program, OG716, in the peer reviewed journal, Antimicrobial Agents and Chemotherapy (Press release, Oragenics, JAN 28, 2019, View Source [SID1234532923]).

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The preclinical study demonstrated that following oral administration of the maximum feasible dose of OG716 in hamster models, there were no observable toxicities nor observable side effects, nor was there any effect on intestinal motility. Treatment of animals infected with C. difficile resulted in a dose-dependant survival, and no recurrence at the upper dose tested. Further, researchers observed that the compound remained constrained only in the gastrointestinal tract. Lantibiotics, including OG716, are a novel class of peptide antibacterial compounds naturally produced by a variety of Gram-positive bacteria. Oragenics’ lantibiotic library offers a large pipeline for the development of novel antibiotics in several indications.

"The publication of this study offers additional validation for the safety and tolerability of our lantibiotic program, while simultaneously confirming the potential for our lead candidate for the treatment of CDAD," stated Alan Joslyn, Ph.D., President and CEO of Oragenics, Inc. "There exists a dire need for new approaches to fighting antibiotic-resistant infections, and we believe the continued development of our lantibiotic program is one of those potential solutions. We look forward to providing continued updates on the development of OG716 as they become available."

The manuscript is available on-line at View Source

About Lantibiotics and OG716

OG716 is a molecule derived from Oragenics’ lantibiotic discovery and characterization platform that has shown positive results in nonclinical testing including efficacy in an animal model for Clostridium difficile infection in enteritis. Lantibiotics are a class of antibiotic compounds with novel mechanism of action, prized for their ability to overcome antibiotic-resistant infections. With resistant strains on the rise, particularly healthcare-acquired infections (HAI), the need for these potent lantibiotic agents is critical. Oragenics is pursuing the commercial-scale production of a lantibiotic for use as an antimicrobial.

On January 28, 2019 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, reported that the University of Chicago has dosed the first patient in an investigator-sponsored Phase 2a clinical trial evaluating EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Evelo Biosciences, JAN 28, 2019, View Source [SID1234532941]). EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

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This open-label clinical trial, led by Dr. Jason J. Luke, M.D., FACP, will evaluate the safety, tolerability, and efficacy of EDP1503 in combination with KEYTRUDA in up to 70 patients with metastatic melanoma who are previously untreated or who have relapsed following treatment with an anti-PD-1 inhibitor. Evelo will provide and retain all rights to EDP1503.

Patients will receive daily EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of the trial, and potential alterations to the intestinal microbiome. Evelo anticipates initial clinical data from the trial in the second half of 2020.

In preclinical studies orally delivered EDP1503 shows activation of multiple clinically validated systemic immune pathways which are complementary to and potentially synergistic with checkpoint inhibitors. Effects include increased CXCL9 and CXCL10 production in the tumor microenvironment, augmentation of NK and T cell infiltration to the tumor site as well as upregulation of MHC Class I expression in tumors.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.