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."

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."

On January 3, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF) reported IPA will be in San Francisco during the J.P. Morgan 37th Annual Healthcare Conference events running from January 7-10, 2019 in San Francisco, California (Press release, ModiQuest Therapeutics, JAN 3, 2019, View Source [SID1234532474]).

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Thirty-seven years ago, J.P. Morgan launched Wall Street’s premier investor conference focused exclusively on companies defining the healthcare industry. The J.P. Morgan Healthcare Conference brings industry leaders, emerging fast-growth companies, and members of the investment community together in the largest healthcare investment symposium to deliver presentations to global investors. This year, J.P. Morgan expects more than 450 companies, both public and private, to deliver presentations to more than 9,000 attendees.

Networking at the small, adjacent summits occurring simultaneously to the J.P. Morgan Healthcare Conference in San Francisco is ideal for connecting investors with industry leaders. ImmunoPrecise Antibodies, Ltd. CEO and President, Jennifer Bath, will be in attendance along with Jason Orloske, Vice President of Operations. The team will also include Frederick Chabot, Contact Financial, Paul Andreola, IPA Board Director, and Pascal Nigen, Managing Partner at Alpha Bronze.

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.

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 it has exclusively licensed worldwide rights to a mesothelin-targeted chimeric antigen receptor T-cell (CAR T) immunotherapy for solid tumors from Memorial Sloan Kettering Cancer Center (MSK) (Press release, Atara Biotherapeutics, JAN 3, 2019, View Source [SID1234532388]). The most advanced program in Atara’s CAR T collaboration with MSK will focus on development of a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.

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"We are excited by the promising initial clinical results of the mesothelin-directed CAR T approach and believe mesothelin, an antigen well recognized as associated with aggressive solid tumors, is a promising target for developing a next-generation CAR T incorporating our PD-1 DNR technology," said Prasad S. Adusumilli, M.D., FACS, Deputy Chief of Thoracic Service, Director of Mesothelioma Program and Head of Solid Tumors Cell Therapy at the Cellular Therapeutics Center at MSK.

PD-1 DNRs are modified PD-1 receptors that lack inhibitory function and are designed to enhance CAR T efficacy in solid tumors without the need for development of a CAR T in combination with a PD-1 checkpoint inhibitor. Animal models have demonstrated that CAR T immunotherapies with a PD-1 DNR result in enhanced activity against solid tumors1.

"We look forward to collaborating with Atara to develop a next-generation mesothelin-targeted CAR T immunotherapy," said Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, and Head, Gene Expression and Gene Transfer Laboratory at MSK. "Our novel mesothelin 1XX CAR is designed to extend functional CAR T cell persistence by sustaining T cell effector functions without precipitating exhaustion, provides a complementary technology to tackle challenging tumor microenvironments."

Mesothelin is a solid tumor-associated antigen that is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer. Initial results from an ongoing MSK investigator-sponsored Phase 1 study (NCT02414269) of a mesothelin-targeted CAR T immunotherapy for patients with malignant pleural cancers were presented at the 2018 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting and support activity and safety in patients with advanced mesothelioma2,3. This ongoing Phase 1 dose-escalation study continues to accrue patients and enhanced response rates were observed when patients were subsequently treated with pembrolizumab, a PD‑1 checkpoint inhibitor. MSK is also investigating mesothelin-targeted CAR T cells for patients with advanced breast and lung cancer (NCT02792114). Additional results from these ongoing studies are expected to be presented at upcoming scientific congresses.

"Our CAR T strategy includes collaboration with investigators on cutting-edge technologies to advance programs with near-term clinical potential," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "Based on the encouraging MSK Phase 1 clinical experience, we are progressing a next‑generation, mesothelin‑targeted CAR T that leverages MSK technologies designed to further enhance responses in patients with mesothelioma and other advanced solid tumors. We are also developing three additional next-generation and off-the-shelf, allogeneic CAR T immunotherapies in oncology for patients with acute myelogenous leukemia (AML) and B-cell malignancies, leveraging Atara’s world-class T cell manufacturing capabilities and research expertise."

In the MSK investigator-sponsored Phase 1 study presented at the 2018 ASGCT (Free ASGCT Whitepaper) Annual Meeting, patients with malignant pleural cancers were administered a mesothelin-targeted autologous CAR T immunotherapy regionally into the chest cavity following cyclophosphamide pre-conditioning (NCT02414269). Of the six patients treated with CAR T cells following preconditioning cyclophosphamide who subsequently received checkpoint inhibitors, one showed a complete metabolic response (CMR), two had a partial response (PR) and one exhibited stable disease (SD). Mesothelin-targeted CAR T immunotherapy and PD-1 checkpoint inhibition was well-tolerated with no adverse events greater than Grade 2 and no on-target, off-tumor toxicity.

Financial terms of the agreement were not disclosed.

References
1Cherkassky L, et al. Human CAR T cells with cell-intrinsic PD-1 checkpoint blockade resist tumor-mediated inhibition. J Clin Invest. 2016 Aug 1;126(8):3130-44. doi: 10.1172/JCI83092. Epub 2016 Jul 25.
2Adusumilli PS, et al. A phase I clinical trial of malignant pleural disease treated with regionally delivered autologous mesothelin-targeted CART cells: safety and efficacy – a preliminary report. Abstract 342; 2018 ASGCT (Free ASGCT Whitepaper) Annual Meeting; Chicago, IL; May 16-19, 2018.
3Adusumilli PS, et al. Regional delivery of mesothelin-targeted CAR T cell therapy generates potent and long-lasting CD4-dependent tumor immunity. Sci Transl Med. 2014 Nov 5;6(261):261ra151. doi: 10.1126/scitranslmed.3010162.