DURECT Corporation Announces Investor Call to Provide Corporate Update

On Janaury 3, 2019 DURECT Corporation (Nasdaq: DRRX) reported that interested parties to listen to a corporate update conference call that will be broadcast live over the internet on Monday, January 7, 2019 at 8:00 am Eastern Time (5:00 am Pacific Time) (Press release, DURECT, JAN 3, 2019, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2382096 [SID1234532457]).

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A live audio webcast of the presentation will be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

Ohr Pharmaceutical, Inc. Announces Merger Agreement with NeuBase Therapeutics, Inc.

On January 3, 2019 Ohr Pharmaceutical, Inc. ("Ohr") (Nasdaq: OHRP) reported that it has entered into a definitive merger agreement with NeuBase Therapeutics, Inc. ("NeuBase"), under which the stockholders of NeuBase would become the majority holders of the combined company (Press release, Ohr Pharmaceutical, JAN 3, 2019, View Source [SID1234556172]). The proposed merger will create a public company focused on advancing NeuBase’s peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) technology platform for the development of therapies to address severe and currently untreatable diseases caused by genetic mutations.

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Upon closing of the transaction, the combined company will change its name to "NeuBase Therapeutics, Inc." and propose its trading symbol on the NASDAQ be changed to "NBSE". The executive team of NeuBase will serve as the executive team of the combined company, led by Dietrich A. Stephan, Ph.D. as Chief Executive Officer.

"We are excited to enter into a definitive merger agreement with NeuBase, a company with a powerful technology and pipeline that has the potential to address multiple unmet medical needs across a range of serious genetic diseases," said Jason Slakter, M.D., Chief Executive Officer of Ohr Pharmaceutical. "Following a comprehensive review of strategic alternatives, Ohr’s Board of Directors concluded that the proposed transaction with NeuBase is in the best interest of our stockholders. The proposed merger will provide an opportunity to create value as an innovative, science-driven company with a proprietary technology platform utilizing advanced gene silencing techniques. We intend to hold a special meeting of Ohr shareholders in the first half of 2019 to vote on this merger."

"The proposed merger with Ohr signals the next stage of growth for NeuBase," added Dr. Dietrich Stephan, Chief Executive Officer of NeuBase Therapeutics. "The company’s new therapeutic modality has the potential to address a wide range of germline and somatic diseases caused by inappropriate expression and change-of-function mutations of genes. Our technology has significant potential advantages over currently available antisense and small molecule approaches to gene silencing, including high selectivity for targets, cell membrane and blood brain barrier permeability, early data indicating no immune response and a low cost of goods. These characteristics are essential for scalability in addressing a wide range of genetic diseases, including cancer. We are initially developing this exciting platform for RNA gene silencing in Huntington’s disease and myotonic dystrophy, with additional future, high value RNA silencing indications."

NeuBase’s modular PATrOL technology platform is being developed to treat a multitude of rare genetic diseases. The systemically-deliverable PATrOL therapies have the potential to improve upon current gene silencing treatments by combining the advantages of synthetic small molecule approaches with the precision of antisense technologies. NeuBase’s development is currently focused on severe neurological disorders such as Huntington’s disease and myotonic dystrophy, where blood-brain barrier penetration and broad tissue distribution are critical. In some cases, such as Huntington’s disease, systemic administration may ameliorate both CNS and non-CNS pathology, a benefit that current intrathecally administered therapies cannot achieve.

About the transaction
On a pro forma basis and based upon the number of shares of Ohr common stock to be issued in the merger, current Ohr stockholders will own approximately 20% of the combined company and NeuBase stockholders will own approximately 80% of the combined company, after accounting for the additional NeuBase financing transaction. The actual allocation will be subject to adjustment based on Ohr’s and NeuBase’s cash balance at the time of closing and the amount of the additional financing consummated by NeuBase at or before the closing of the merger. Certain members and affiliates of the board of directors and management of Ohr and Neubase have indicated an intent to invest in the additional NeuBase financing transaction.

The proposed transaction has been approved by the board of directors of both companies. The merger is subject to the approval of Ohr shareholders at a special meeting of shareholders, which is expected to occur in the first half of 2019, along with the satisfaction or waiver of other customary conditions.

This communication does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Roth Capital Partners, LLC is acting as financial advisor to Ohr for the transaction and Troutman Sanders LLP is serving as legal counsel to Ohr. Allele Capital Partners, LLC at Tribal Capital Markets, LLC is acting as financial advisor and Paul Hastings LLP is serving as legal counsel to NeuBase.

Additional Information about the Merger and Where to Find It
In connection with the Merger, the Company intends to file relevant materials with the Securities and Exchange Commission (the "SEC"), including a registration statement on Form S-4 that will contain a prospectus, joint proxy and information statement. Investors and security holders of the Company and NeuBase are urged to read these materials when they become available because they will contain important information about the Company, NeuBase and the Merger. The joint proxy statement, information statement, prospectus, and other relevant materials (when they become available), and any other documents filed by the Company with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by the Company by directing a written request to: Ohr Pharmaceutical, Inc., 800 Third Avenue, 11th Floor, New York, NY, Attention: Corporate Secretary. Investors and security holders are urged to read the joint proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the Merger.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in the Solicitation
The Company and its directors and executive officers and NeuBase and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger will be included in the joint proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of the Company is also included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2018 and the proxy statement for the Company’s 2018 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site (www.sec.gov) and from the Company, Attn: Corporate Secretary, at the address described above.

Ohr Pharmaceutical financial results for the fiscal year ended September 30, 2018:

For the fiscal year ended September 30, 2018, the Company reported a net loss of approximately $13.2 million, or ($0.23) per share, compared to a net loss of approximately $23.8 million, or ($0.53) per share in the fiscal year ended September 30, 2017.
For the fiscal year ended September 30, 2018, total operating expenses were approximately $13.9 million, consisting of $3.6 million in general and administrative expenses, $4.3 million of research and development expenses, $1.1 million in depreciation and amortization, $0.7 million in loss on impairment of goodwill, $5.3 million in loss on impairment of intangible assets, and $1.2 million in gain on settlement of liabilities. This compares to total operating expenses of $23.8 million in the fiscal year ended September 30, 2017, comprised of approximately $5.3 million in general and administrative expenses, $17.4 million in research and development expenses, $1.2 million in depreciation and amortization, and $0.1 million in gain on settlement of liabilities.
At September 30, 2018, the Company had cash and cash equivalents of approximately $3.8 million, compared to cash and equivalents of approximately $12.8 million at September 30, 2017.

Atara Biotherapeutics Announces Planned Chief Executive Officer Transition

On January 3, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Isaac Ciechanover, M.D., plans to step down as the Company’s President and Chief Executive Officer (Press release, Atara Biotherapeutics, JAN 3, 2019, View Source [SID1234532387]). The Board of Directors has initiated a search for his successor. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.

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"Isaac is a visionary founder and CEO who started Atara in honor of his mother to transform the lives of patients with serious medical conditions," said Carol G. Gallagher, Pharm. D., Atara’s lead independent director. "Over the past six years, Isaac has dedicated himself to building Atara into a leading T-cell immunotherapy company. Atara’s collaboration with MSK announced today furthers the Company’s vision to develop ground-breaking CAR T immunotherapies. We on the board wish to thank Isaac for his extraordinary leadership and look forward to his continued contribution to advancing new medicines and improving patient lives."

Dr. Ciechanover commented, "It has been a privilege to lead Atara from its founding and through its transformation into a leading late-stage development company with world-class manufacturing capabilities. The dedicated and talented Atara team is now advancing rapidly toward commercializing the first-off-the-shelf, allogeneic T-cell immunotherapy. I look forward to working with the Board to transition a successor who can build on all our success and guide Atara in the years ahead."

Moleculin Announces Positive Data for its Pancreatic Cancer Drug Candidate

On January 3, 2019 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 in preliminary animal studies, a second of its lead drugs, WP1732, has demonstrated enhanced activity in combination with checkpoint blockade antibodies in pancreatic cancer (Press release, Moleculin, JAN 3, 2019, View Source [SID1234532405]).

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"After our sponsored research demonstrated that WP1066 was able to enhance immune checkpoint activity in a pancreatic cancer animal model," commented Walter Klemp, Moleculin’s Chairman and CEO, "we were optimistic that we could show similar potential results in our water soluble, WP1732 drug candidate. This is significant for several reasons. It shows that this is a consistent capability across our platform of STAT3 inhibitors and it further supports independent research suggesting that STAT3 may be a key to enabling checkpoint blockade activity in otherwise resistant tumors. Importantly, though, when you couple this with our recent findings that WP1732 accumulates disproportionately in the pancreas, we believe it points to WP1732 as a potentially pivotal new approach to treating pancreatic cancer. Expansion of the WP1732 and WP1066 in vivo studies is in progress."

Genprex to Present at Biotech Showcase™ 2019 in San Francisco

On January 3, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that it will present at Biotech Showcase 2019, to be held January 7–9, during the most important week in healthcare finance at the Hilton San Francisco Union Square (Press release, Genprex, JAN 3, 2019, View Source [SID1234532421]).

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Genprex will present at Biotech Showcase as follows:

Date: Monday, January 7, 2019

Time: 3:30pm (PST)

Room: Franciscan A (Ballroom Level)

Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San Francisco, CA

Genprex is pioneering a new approach to treating cancer–based upon a novel proprietary technology platform–that includes the company’s initial product candidate, Oncoprex immunogene therapy. The company holds a portfolio of 30 issued patents, and two pending patents covering its proprietary platform technologies–and it has seen tremendous promise from pre-clinical research and clinical trials of those technologies at the University of Texas MD Anderson Cancer Center.

The Clinical and pre-clinical research conducted to date indicates that Genprex’s lead candidate, Oncoprex, is synergistic with and may enhance the efficacy of commercially approved and highly successful epidermal growth factor receptor (EGFR) inhibitors and immune checkpoint inhibitors. To date, multiple clinical trials have demonstrated potential for the intravenous, systemic delivery of Oncoprex, which is comprised of the tumor suppressor gene TUSC2 (also known as FUS1) encapsulated in a lipid nanovesicle.

"Genprex stands at the forefront of the new age in the fight against cancer, and I am immensely proud to be with a company operating in that position," said Rodney Varner, CEO of Genprex. "In my three decades of professional experience, I’ve never worked with another company that has the innovative, dedicated, and multi-faceted talent we have at Genprex. It is inspiring to work with such a tireless group in such a revolutionary sector of the biomedical field."

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

"We are delighted that Genprex will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is the perfect platform for life science companies to showcase their innovation and seek out their next deal. We are thrilled to, once again, be hosting what we believe will be the great strategic networking opportunity of 2019."