[August 28, 2017] |
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Immune Pharmaceuticals Provides R&D and Business Update and Summary of Recent Financial Highlights
Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the "Company")
provided the following R&D and business update and summary of recent
financial highlights.
R&D Update
Immune continues to focus on the development of its two core assets: (1)
bertilimumab, a first in class, monoclonal antibody in Phase 2 clinical
development for Bullous Pemphigoid ("BP") an orphan autoimmune
dermatological condition affecting approximately 30,000 patients in the
United States, and Ulcerative Colitis ("UC") a chronic inflammatory
bowel disease (IBD) distinguished by inflammation of the large intestine
(rectum and colon); and (2) a topical nano-formulation of cyclosporine
for the treatment of psoriasis and atopic dermatitis, also known as
atopic eczema, an inflammatory skin disease.
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We continue to enroll subjects into the Phase 2 open label BP trial.
Six subjects have been enrolled, with a target enrollment of 12 to 15.
We look forward to the completion of this proof-of-concept study and
subsequent publication early in 2018. Our Orphan Drug Designation
application for bertilimumab in BP was filed in February 2017.
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We continue to enroll subjects into the Phase 2 placebo-controlled,
double-blind clinical trial of bertilimumab in UC. Seventeen subjects
have been enrolled, with a target enrollment of 42. We expect to
complete the study in the second quarter of 2018.
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We are developing an improved manufacturing process for bertilimumab,
using a proprietary and highly productive cell line, which will reduce
cost of goods significantly.
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We have initiated development of a sub-cutaneous delivery formulation
of bertilimumab.
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Dr. Tony Fiorino joined us as our Chief Medical Officer and Chief
Operating Officer.
Cytovia Spin-off Update
Progress continues on segregating our oncology assets into Cytovia, Inc.
and recruitment of a Cytovia management team in preparation of a
spin-off and a distribution of Cytovia's shares to Immune's shareholders.
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Dr. Daniel Teper was named Chief Executive Officer of Cytovia.
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Mr. Rama Rao, a former Novartis executive, was appointed as Cytovia's
interim Chief Financial Officer and Chief Operating Officer.
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Preparation is ongoing for filing a Form 10 registration statement
with the Securities & Exchange Commission ("SEC (News - Alert)") which allows for
Cytovia to register a class of securities with the SEC. Cytovia
anticipates applying for listing of its securities on an eligible
NASDAQ trading market at the appropriate time, which shall be subject
to satisfaction of the NASDAQ exchange listing criteria and approval.
We intend to distribute shares in the spun-off Cytovia Inc. to our
(Immune) shareholders as a dividend in proportion to each holder's
ownership of shares in Immune.
Second Quarter 2017 and Recent Financial Highlights
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Total cash and non-cash operating expenses of approximately $2.8
million for the quarter ended June 30, 2017 was reduced from total
expenses of approximately $2.9 million for the same period last year.
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During the six months ended June 30, 2017, net cash provided by
financing activities was $4.2 million. The proceeds from these
financings are enbling us to pursue our phase 2 trials and R&D
activities and refinancing transactions with strategic investors
and/or corporate partners.
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On June 15, 2017, we entered into an Asset Purchase Agreement with
Meda Pharma SARL, a Mylan N.V. company, to repurchase assets relating
to Ceplene (histamine dihydrochloride) including the right to
commercialize Ceplene in Europe and to register and commercialize
Ceplene in certain other countries, for a fixed consideration of $5.0
million payable in installments over a three-year period and an
additional $3.0 million contingent on achievement of certain sales
milestones. As a result of the acquisition, Cytovia owns worldwide
rights for Ceplene. Prior to the acquisition, Cytovia owned rights for
Ceplene in North America, Latin America and Israel.
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On July 7, 2017, we refinanced approximately $3 million of outstanding
senior secured debt owed to Hercules Capital, Inc. by issuing a senior
secured convertible promissory note with a similar principal amount,
thereby eliminating significant monthly cash amortization payments.
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On July 10, 2017, Cytovia entered into an exclusive licensing
agreement with Pint Pharma International S.A. ("Pint") a specialty
pharmaceutical company focused on Latin America and other markets, for
the marketing, commercialization and distribution of Ceplene
throughout Latin America. Pursuant to the Licensing Agreement, Cytovia
is entitled to (i) 35% of net sales in the Territory (ii) a milestone
payment of $0.5 million when net sales of Ceplene in the Territory
reach $10.0 million in any calendar year and (iii) a milestone payment
of $1.25 million when net sales of Ceplene in the Territory reach
$25.0 million in any calendar year. Pint Gmbh will separately enter
into an investment agreement, which will lead to an investment of $4
million into Cytovia. Also, Dr. Massimo Radaelli, Executive Chairman
of Pint, intends to join the board of Cytovia upon completion of the
investment and effective spin off of Cytovia from Immune.
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On August 24, 2017, Immune entered into definitive agreements with
several institutional investors for the sale of $858,000 in principal
amount of original issue discount convertible debentures. The proceeds
from the offering, before deducting fees and expenses, is
approximately $660,000. Maxim Group LLC acted as the sole placement
agent for the offering. The debentures will not be convertible until
Immune obtains shareholder approval for any such conversions. The
securities offered in the private placement have not been registered
under the Securities Act of 1933, as amended (the "Securities Act") or
any state securities law. Accordingly, the securities may not be
offered or sold in the United States except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements of the Securities Act and applicable state
laws. In connection with the contemplated sale of the securities, the
Company will rely upon the exemption from registration provided by
Section 4(a)(2) under the Securities Act of 1933, as amended, for
transactions not involving a public offering.
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.
Forward-Looking Statements
The statements in this news release made by representatives of Immune
Pharmaceuticals, Inc. relating to matters that are not historical facts,
including without limitation, those regarding future performance or
financial results, the timing or potential outcomes of research
collaborations or clinical trials, any market that might develop for any
of Immune's product candidates and the sufficiency of Immune's cash and
other capital resources, the continued development by Immune of
bertilumumab or its determination to seek Orphan Drug designation for
the pharmaceutical product of bertilimumab are forward-looking
statements that involve risks and uncertainties, including, but not
limited to, the likelihood that actual performance or results could
materially differ, that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, or Immune's ability
to fund such efforts with or without partners. Immune undertakes no
obligation to update any of these statements. Readers are cautioned not
to place undue reliance on these forward-looking statements, which speak
only as to the date hereof. Accordingly, any forward-looking statements
should be read in conjunction with the additional risks and
uncertainties detailed in Immune's filings with the Securities and
Exchange Commission, including those discussed in Immune's Annual Report
on Form 10-K, Quarterly Reports on Form 10-Q periodic reports filed on
Form 8-K.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170828005291/en/
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