In line with this prioritization, the Company’s Board of Directors (the “Board”) has authorized Dr. Daniel Teper to lead the Company’s oncology business within the Company’s Cytovia, Inc. subsidiary and to pursue a possible spin-off of Cytovia into a separate, stand-alone company independent from Immune. Cytovia will focus on the development and commercialization of novel immuno-oncology and hematology therapeutics, led by Ceplene, 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; Azixa and crolibulin, two phase 2 drug candidates with synergistic potential with immuno-oncology drugs; and a bispecific antibody platform to be supported by collaborative partnerships. Under the leadership of Dr. Teper, Cytovia will aim to grow into a global specialty biopharmaceutical company through these product candidates and the acquisition of 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, government grants and issuance of debt and equity.
A potential spin-off of Cytovia into a stand-alone company pursuing an independent path from Immune would provide several advantages:
- Allows current Immune investors to benefit from two distinct investment opportunities through proportional receipt of shares in Cytovia;
- Enables Cytovia to target new investors attracted to its specific oncology business profile and pursue distinct capital structures and capital allocation strategies; and
- Aligns Cytovia’s resources with its stated goals and tailors its business strategy to best address opportunities within its target market of oncology
The proposed restructuring strategy recognizes that our two operating divisions have evolved into distinct business and investment opportunities. 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”, said Dr Daniel Teper.
In connection with this restructuring, the Company’s Board has accepted the resignation of Dr. Daniel Teper as CEO of Immune, effective immediately, so that he may focus his efforts exclusively on leading Cytovia. The terms of the resignation are specified in a Separation Agreement entered into by and between Dr. Teper and the Company on April 21, 2017. Dr. Teper will remain a member of the Company’s Board and will focus his efforts, in conjunction with the Board, on developing and beginning execution of the plan to spin off Cytovia into an independent, stand-alone oncology business.
The Company’s Board has appointed Elliot Maza, JD, CPA as interim CEO, effective immediately, to serve until a new CEO of Immune is identified. Mr. Maza has served as a member of the Board and Chairman of the Audit Committee of the Board since January 14, 2015. Mr. Maza served as a consultant to the Company from November 2014 to January 2015. In connection with his appointment to the position of interim CEO, Mr. Maza will resign from the Audit Committee of the Board but will continue to serve as a director.
Dr. Monica E. Luchi, Executive Vice President Global Drug Development and Chief Medical Officer, will assume the title of President, Immune Pharmaceuticals Inflammatory Disease and Dermatology Division. Under the leadership of Mr. Maza and Dr. Luchi, Immune will focus its business 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 2 development in bullous pemphigoid and ulcerative colitis and with application for severe atopic dermatitis. Immune intends to continue to focus on the development of topical nano-cyclosporine for the treatment of atopic dermatitis and moderate psoriasis.