Immune Pharmaceuticals Provides Update on Plan to Implement a Spin-off of Cytovia into a Separate Publicly Traded Oncology Company
Immune shareholders to receive additional pro rata shares in Cytovia
Immune Pharmaceuticals (NASDAQ: IMNP) ("Immune") today confirmed it is continuing to structure and pursue a spin-off of Cytovia, Inc. ("Cytovia"), its subsidiary dedicated to the development and commercialization of Oncology drugs and drug candidates, into a separate, stand-alone publicly-traded company. It is contemplated that a pro rata distribution of shares in Cytovia would be issued to Immune shareholders as a dividend. The spin-off is expected to create two independent publicly-traded companies with distinct strategic plans, leadership, growth strategies, and operational and development priorities.
The new Cytovia, will focus on the development and commercialization of novel immuno-oncology and hematology therapeutics to meaningfully improve cancer patients' lives. Cytovia aims to grow into a global specialty biopharmaceuticals company through potential acquisitions and rejuvenation of late-stage development or commercial-stage products. The initial core asset of Cytovia will be CEPLENE (histamine dihydrochloride) an immunotherapy treatment approved in Europe in combination with low-dose IL2 for remission maintenance in patients with Acute Myeloid Leukemia ("AML").
As previously disclosed in a press release and our current report on Form 8-K filed with Securities and Exchange Commission ("SEC") on June 15, 2017, Immune signed, on behalf of its subsidiary Cytovia, a definitive asset purchase agreement with Mylan to acquire the rights to Ceplene in the territories that Immune did not previously own; namely Asia, Europe, Middle East and Africa. The European Marketing Authorization allows us to commercialize in 30 EU countries and serves as the basis for approval in Latin America, Russia and other Eastern European countries and countries in the Middle East, Africa and Asia. The addressable market for remission maintenance of Acute Myeloid Leukemia patients that could be treated with Celine exceeds 10,000 patients in Europe, Russia and other Eastern European countries. The current reimbursement in Europe is $25,000 for a full course of treatment.
On July 11, 2017, Cytovia entered into a definitive licensing and commercialization agreement with Pint Pharma Int'l Ltd. for all the markets in Latin America. Pint will implement Early Market Access programs until full registration in those countries. The addressable Latin American market for Ceplene is estimated at 4,000 patients. Under the Pint agreement, Cytovia is eligible to receive 35% of net sales in Latin America subject to the terms contained therein. Additionally, Pint has committed to make a $4 million equity investment in Cytovia.
Cytovia is committed to further development of Ceplene in additional indications such as Myelo- Displasic Syndrome (MDS), also known as CMML ( chronic mono-myelocytic leukemia) for which a pilot clinical study has been initiated in Sweden.
Cytovia Strategic Plan
Cytovia expects that it will be well-positioned to establish itself as a "pure play" commercial stage specialty pharmaceutical company in the highly attractive immuno-oncology field, with an integrated pipeline portfolio.
Cytovia's strategic plan includes the following initiatives:
- Commercialize Ceplene in select territories directly and through partnerships with leading regional companies in other territories following the business model being implemented with Pint Pharma in Latin America
- Focus development resources toward an approval of Ceplene in the United States for remission maintenance in patients with AML as well as the extension of the use of Ceplene to new indications;
- Consider potential acquisitions and rejuvenation of synergistic late-stage development or commercial-stage immuno-oncology drugs;
- Realize the strategic potential of its pipeline, including through potential collaborative partnerships of its phase 2 drug candidates, Azixa and crolibulin, its bi-specific antibody platform technology and other early-stage drug candidates
Additional Information about the Proposed Cytovia Spin-off and Next Steps
The spin-off transaction is intended to take the form of a tax-free distribution to Immune's shareholders of common stock of a new publicly-traded Cytovia; however, as the proposed transaction progresses, or as we may receive SEC or other tax related comments, this structure may be revised accordingly. The stock distribution ratio and other matters, including the stock exchange on which the new Cytovia stock will be listed, will be determined at a later date. Immune will continue to be listed on the NASDAQ under its existing symbol, "IMNP."
More details about Cytovia, including pro forma financial information, will be disclosed in any Form 10 registration statement we file with the SEC in connection with the transaction. The initial filing of the Form 10 registration statement is expected to occur in the third quarter of 2017. The transaction is expected to be completed in 2017, subject to certain conditions and regulatory review, including the receipt of a favorable opinion from outside tax counsel, execution of inter-company agreements by Immune and Cytovia, the effectiveness of the Form 10 registration statement and final approval of the transaction by Immune's board of directors. The transaction will not require the approval of Immune's shareholders. The record date will be announced by the board of directors after the filling of the Form 10 and receipt of initial feedback from the SEC.
The transaction will allow Immune to become a pure play immuno-inflammation, clinical stage. development company with all resources being allocated to its lead assets, bertilimumab and nano- cyclosporin, with a special interest in Immuno-Dermatology. Immune's core assets are bertilimumab, a first-in-class human monoclonal antibody targeted at eotaxin-1, currently in phase 2 development in bullous pemphigoid and ulcerative colitis, with a planned phase 2 in severe atopic dermatitis, and a proprietary topical nano-cyclosporine for the treatment of atopic dermatitis and of moderate psoriasis.
Immune expects that the spin-off transaction will enhance the capitalization of the company and will allow for a focused deployment of resources to accelerate growth and thereby attract increased attention from institutional and other investors.
New York, NY., July 19, 2017
For further information, contact: email@example.com
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune's lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn's disease, severe asthma and Non- Alcoholic Steato-Hepatitis (NASH). Also, Immune's pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain.
Immune's oncology subsidiary, Cytovia, plans to develop and commercialize Ceplene® in combination with IL-2 for maintenance remission in AML. Additional oncology pipeline products include Azixa® and crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs™, which are novel technology platforms.
For more information, please visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.
This news release, and any oral statements made with respect to the information contained in this news release, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. Forward-looking statements include, among others, statements regarding the Company's ability to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
There can be no assurance that the Company will ever successfully complete its anticipated corporate restructuring, or that the Company will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. The Company may, at any time and for any reason until the proposed spin-off is complete, abandon the spin-off or modify its terms and conditions, or consider competing, alternate or complimentary transactions or offers by third parties at the discretion of Immune's board of directors. Factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that ongoing or future clinical trials will not be successful; the risk that our compounds under development will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct future trials or commercialize our product candidates on attractive terms, on a timely basis or at all; the risk that our product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and our other filings with the U.S. Securities and Exchange Commission.
You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharma.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein (including those relating to the corporate reorganization and exploration of strategic alternatives), whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Immune Pharmaceuticals Inc.
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