On January 3, 2019 Avalon GloboCare Corp. (NASDAQ: AVCO), a leading global developer of cell-based technologies, reported that the Company and its wholly owned subsidiary, Avactis Biosciences, have entered into a joint venture and exclusive license agreement with Arbele Limited to co-develop next generation, transposon-based Chimeric Antigen Receptor (CAR)-T and CAR-Natural Killer (NK) cellular therapies (Press release, Avalon, JAN 3, 2019, View Source [SID1234609548]). These unique CAR vector constructs are non-virally engineered, possessing multiple therapeutic targets as well as unique "safety-switch" mechanisms. Based on Avalon’s extensive hospital network for cellular therapy, together with the Company’s established GMP bio-production facility in China (Epicon Biotech, Nanjing), this joint venture allows Avalon to accelerate the clinical development of more efficacious and safer CAR-T/CAR-NK therapies, such as those developed by Arbele.

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"We are very excited to establish this joint venture with Arbele Limited to accelerate our clinical programs in cellular therapy," stated David Jin, M.D., Ph.D., CEO and President of Avalon GloboCare Corp. "Arbele’s strong proprietary technology platform in designing and production of non-viral, transposon-engineered, multi-targeted CAR will allow us to generate next-generation, better and safer CAR-T and CAR-NK cellular therapeutics. This joint venture will strengthen our core technological capabilities, enrich our intellectual properties, as well as further establish our leadership in the field of cellular immunotherapy," added Dr. Jin.

On January 3, 2019 Immatics, a leading company in the field of cancer immunotherapy, reported that the United States Patent and Trademark Office has issued the 100th patent to Immatics (Press release, Immatics Biotechnologies, JAN 3, 2019, View Source [SID1234569547]).

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This is a significant achievement for the Company and demonstrates the breadth of Immatics’ innovation power and the quality of its science. Immatics’ strong patent portfolio enables the Company to develop its pipeline of cancer immunotherapies, to protect Immatics’ innovations and to safeguard the Company’s technology investments.

Immatics’ 100th patent (US Patent No 10,143,731) is directed against a peptide target discovered using the Company’s XPRESIDENT technology. The peptides identified by XPRESIDENT are presented by human leucocyte antigen (HLA) receptors on the surface of cells and are central to developing a range of novel powerful immunotherapies.

"Since its inception, Immatics has put a key focus on the development of its Intellectual Property estate, in order to protect our technology innovations in this highly competitive field", said Dr. Rainer Kramer, CBO of Immatics. "Being awarded the 100th issued US patent in the Life Science industry is fantastic, proving that our inventions move Immatics further to the forefront of the highly competitive field of Immunotherapy development."

Immatics’ patenting strategy ensures broad protection of the Company’s products, technologies and methods while still meeting the patentability requirements in the USA in a fast-paced environment.

On January 3, 2020 Kashiv Pharma, LLC, a pharmaceutical research and drug delivery company developing next-generation technologies, innovative medicines for patients with unmet medical needs and drug life-cycle management products, reported its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars of leading global brands in the fields of oncology and immunology (Press release, Kashiv BioSciences, JAN 3, 2019, View Source [SID1234563292]). Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey plus research and development and manufacturing facilities in Bridgewater and Piscataway, New Jersey, Chicago, Illinois and Ahmedabad, India.

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Established in 2010, Kashiv Pharma focuses on innovative drug delivery systems and specialty drug products for the treatment of various debilitating diseases. The company seeks to partner with established pharmaceutical firms to commercialize products at an appropriate stage of development by offering novel products based on the next generation of advanced drug delivery platforms. Kashiv has created several proprietary technology platforms under the leadership of Dr. Navnit Shah, a world-renowned pharmaceutical scientist, for extended and time-specific oral delivery of small molecules including a novel gastric retention system (GRANDE) and a chronobiological delivery system (KRONOTEC). These advanced drug delivery systems target the drug to its optimal absorption site and at a time when the body needs it the most for maximal therapeutic effect.

Currently based in Piscataway and Chicago, Adello Biologics has been working to develop high-quality, affordable biosimilars for patients worldwide. The company is advancing a pipeline of complex proteins and monoclonal antibodies with lead candidates in oncology and immunology.

As a result of the acquisition, Kashiv BioSciences’ broad business offering includes drug delivery platforms incorporating delayed release technology and gastric retention systems that improve the efficacy and safety of known drugs; a 505(b)(2) pipeline of seven development products targeting unmet clinical needs; biosimilars; prodrugs; and, as part of a development collaboration with Amneal Pharmaceuticals LLC, 10 approved generic products and an additional 13 generic products in advanced stages of development, including several complex generic products. Kashiv BioSciences’ medications will improve the lives of patients suffering from cancer as well as neuromuscular, movement and endocrine disorders, among other debilitating conditions, both in the U.S. and globally.

"The acquisition of Adello will create a fully integrated biosciences company with a strong platform for growth," said Chintu Patel, who will become CEO of Kashiv BioSciences. "The combined breadth of expertise in small and large molecules, peptides, proteins and monoclonal antibodies will enable us to develop products with meaningful clinical differentiation and a compelling value proposition for patients, physicians and payers."

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 Cydan reported the launch of Tiburio Therapeutics Inc. (Tiburio), a private biopharmaceutical company focused on developing treatments for rare neuroendocrine tumors and rare endocrine diseases (Press release, Cydan Development, JAN 3, 2019, View Source [SID1234553930]). Tiburio will advance two compounds licensed from Ipsen for the treatment of non-functioning pituitary adenoma (NFPA) (TBR-760) and for additional rare endocrine diseases (TBR-065). As part of the launch, Tiburio raised a $31M Series A financing that will fund the company’s lead compound, TBR-760, through human proof-of-concept for the treatment of NFPA and further clinical assessment of TBR-065 as a treatment for rare endocrine diseases. In conjunction with the Tiburio financing, Abraham N. Ceesay has been appointed chief executive officer of the company. Tiburio is the third orphan drug company launched by Cydan, an orphan drug accelerator dedicated to creating therapies to improve the lives of patients living with orphan diseases.

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"Patients suffering from rare neuroendocrine tumors and endocrine diseases represent a significantly underserved patient population due to the lack of effective treatment options," said Abraham N. Ceesay, chief executive officer of Tiburio. "TBR-760 and TBR-065 represent potential breakthroughs in the treatment of debilitating neuroendocrine diseases and we, at Tiburio, are intently focused on advancing these compounds for the benefit of patients. We will immediately begin Phase 2 enabling studies with TBR-760 and anticipate enrolling patients with NFPA in a Phase 2 study in the 2nd half of 2019."

The development of NFPA, which is a non-metastatic tumor in the pituitary gland in the brain, can result in life-altering and potentially life-threatening consequences for patients. Currently there are no approved therapies to treat these tumors and patients must undergo transsphenoidal surgery and/or radiation to remove or shrink the tumor. TBR-760 is a dopamine-somatostatin chimeric molecule that inhibits NFPA cell proliferation and has the potential to shrink or halt tumor growth. In prior clinical trials, TBR-760 has been shown to have a favorable safety profile.

"The agreement with Cydan to license these two innovative compounds to Tiburio expands upon the work we’ve done to advance them through Phase 2 trials, providing a foundation for their safety profile and mechanism of action," said Alexandre LeBeaut, MD, executive vice president, research & development and chief scientific officer, Ipsen. "The Cydan team’s expertise makes them a natural choice to partner with to ensure these programs can have impact for patients in need."

"Nonfunctioning pituitary adenoma can have a significant and lasting impact on patients, often requiring multiple surgeries to control tumor size, as well as radiation therapy. These invasive neurosurgeries are associated with high-risk complications," said Shi Yin Foo, MD, PhD, MMSc, chief medical officer of Cydan and acting chief medical officer of Tiburio. "There are no approved therapies and the current treatment options for these patients are invasive, risky, and often ineffective in the longer term. We can do better for patients and believe TBR-760 represents a potentially game-changing therapy for patients."

"TBR-760’s unique mechanism of action offers an exciting potential treatment for patients living with NFPA," said Chris Adams, co-founder and chief executive officer of Cydan. "Following an extensive review of the prior TBR-760 preclinical and clinical data, the Cydan team launched our third company, Tiburio, to execute a rapid clinical and regulatory program to bring this drug to patients in need."

Tiburio was granted an exclusive world-wide license to both TBR-760 and TBR-065. Ipsen will receive a minority ownership in the company as well as development and commercial milestone payments and royalties on sales. Tiburio is responsible for all future development and commercialization costs for both compounds. Additional financial terms were not disclosed.

Investment in the $31M Series A came from Cydan’s syndicate of leading life sciences investors, New Enterprise Associates, Longitude Capital, Lundbeckfonden Ventures, and Alexandria Venture Investments.

About NFPA

The pituitary gland, a master regulator of endocrine function, is located below the base of the brain. A nonfunctioning pituitary adenoma (NFPA) is a non-metastatic pituitary tumor that arise from gonadotroph cells in the pituitary. Patients often present with symptoms related to the size of the NFPA tumor, including headaches, vision problems, changes in milk production, weight change, menstrual changes, fatigue, sleep disruption, and depression or cognitive/behavioral changes.

Current treatment is limited to transsphenoidal surgery (TSS), which is performed through the nose and sinus passage, and/or radiation to halt the growth of these tumors. However, these two treatment options come with serious and high-risk consequences. In addition to these interventions designed to remove or reduce the size of the tumors, patients often require a complex set of medications to manage the endocrine disruption and other symptoms caused by the tumors and side effects of TSS and radiation.

In the U.S. there are approximately 5,000 new cases of NFPA that require TSS each year and 40-50% of these tumors will regrow within the first 5 years after surgery. Additionally, there are approximately 50,000 patients living with NFPA who may benefit from therapy to control tumor growth.

About Abraham Ceesay, CEO Tiburio

Mr. Ceesay has over 17 years of experience in leading biopharmaceutical companies and commercializing innovative therapeutic products. Prior to joining Tiburio, he served as chief operating officer at scPharmaceuticals where he developed and led all operational and commercial aspects of the company. Mr. Ceesay was integral in raising more than $140 million in private and public capital as well as closing the company’s initial public offering. Prior to joining scPharmaceuticals, he served as vice president, Sales, Marketing, and Commercial Operations at Keryx Biopharmaceuticals and spent four years at Ironwood Pharmaceuticals as Vice President of Marketing, and held responsibility for the management of the U.S. P&L, leadership of the Linzess brand team and co-promotion collaboration with Forest Laboratories/Allergan. Previously he was at Genzyme/Sanofi, initially as a field sales specialist and ultimately as the director, Renal Global Marketing, in which capacity he led the global launch of Renvela and held global marketing responsibility for the company’s renal franchise (Renagel, Renvela, Hectorol). Mr. Ceesay serves on the Board of Advisors for Life Science Cares and the Board of Directors for Food for Free. He holds a bachelor’s degree from Ithaca College, and a Master of Business Administration from Suffolk University’s Sawyer School of Management.