Immune Pharmaceuticals said today it will pursue a possible spin-off of its oncology subsidiary Cytovia in a restructuring intended to refocus the parent company on inflammatory disease and dermatology, as well as bolster its finances.

Cytovia will focus on developing and commercializing novel immuno-oncology and hematology therapeutics, led by Ceplene® (histamine dihydrochloride), an immunotherapy treatment in late-stage development in combination with low-dose interleukin 2 (IL-2) for the remission maintenance of patients with acute myeloid leukemia. On Thursday, Immune Pharma licensed Latin America rights to Cytovia’s lead candidate Ceplene to Pint Pharma, in return for Pint investing $4 million into Cytovia.

Also in Cytovia’s pipeline are Azixa® (verobulin) and crolibulinTM, two Phase II drug candidates that are believed to have synergistic potential with immuno-oncology drugs, and a bispecific antibody platform to be supported by collaborative partnerships.

Cytovia aims to grow into a global specialty biopharmaceutical company by developing and commercializing its current pipeline candidates, as well as acquiring additional late-stage or commercial-stage oncology products. Cytovia intends to raise sufficient capital to support R&D investment through product licensing and partnership transactions, as well as government grants, debt, and equity, Immune Pharma said.

Cytovia will be led by Daniel Teper, Ph.D., MBA, who is resigning as CEO of Immune Pharma—which said he will remain a member of the company’s board, and work with the board to develop and execute a spinoff plan for Cytovia.

“The proposed restructuring strategy recognizes that our two operating divisions have evolved into distinct business and investment opportunities,” Dr. Teper said in a statement. “The potential Cytovia spin-off will establish each division as a separate company with a focused strategy and will enable each company to enhance its business focus, better align its resources to achieve strategic priorities, target investors attracted to its unique business profile, and ultimately unlock significant value for both companies.”

Succeeding Dr. Teper as an interim CEO of Immune Pharma will be Elliot Maza, J.D., CPA, pending appointment of a permanent successor. Maza has served as a member of the board and chairman of the audit committee of the board since January 2015, and served as a consultant to the company from November 2014 until he joined the board. Maza will resign from the audit committee but will continue to serve as a director.

Monica E. Luchi, M.D., evp, global drug development and CMO, will serve as president of Immune Pharma’s Inflammatory Disease and Dermatology Division.

Following the spin-off, Immune Pharma said, it will refocus on immuno-inflammation in general, and immuno-dermatology in particular, by developing its core asset, bertilimumab, a first-in-class human monoclonal antibody in Phase II development for bullous pemphigoid and ulcerative colitis and with application for severe atopic dermatitis. Immune Pharma said it intends to continue to focus on the development of “NanoCyclo” topical nano-cyclosporine for the treatment of atopic dermatitis and moderate psoriasis.

The restructuring comes as Immune Pharma works to stave off delisting from NASDAQ—an effort complicated, the company acknowledged, when the exchange on April 18 called out the company for failing to have filed its Form 10-K Annual Report for 2016.

“The Company is working to complete the 2016 Form 10-K and will file it as soon as practicable,” Immune Pharma said today in a separate statement.

Immune Pharma already faced delisting for failing to maintain a minimum $1 stock price for 30 consecutive trading days. As a result, NASDAQ will not give Immune Pharma 60 days to submit a plan to regain compliance, though the company has until May 10 to request a stay of the suspension of its listing.


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