UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 19, 2016 (July 18, 2016)
| IMMUNE PHARMACEUTICALS INC. |
| (Exact name of registrant as specified in its charter) |
| Delaware | 001-36602 | 52-1841431 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 430 East 29 th Street, Suite 940, New York, NY | 10016 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (646) 440-9310
| N/A |
| (Former name or former address, if changed since last report.) |
With Copies to:
Richard A. Friedman, Esq.
Andrea Cataneo, Esq.
Sichenzia Ross Friedman Ference LLP
61 Broadway, 32 nd Floor
New York, New York 10006
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 1.01. | Entry into a Material Definitive Agreement. |
On July 18, 2016, Immune Pharmaceuticals Inc. (the “Company”) entered into Amendment No. 1 to the License Option Agreement (the “Amendment”) with Novel Pain Therapeutics, LLC (“NPT”). The Amendment amends that certain License Option Agreement (the “Option Agreement”) between the Company and NPT dated May 15, 2016. Pursuant to the Option Agreement, the Company granted NPT a 60 day option to negotiate a definitive license agreement for the Company’s products AmiKet™ and Amiket™ Nano for the treatment of peripheral neuropathic pain (the “Products”). The Company previously disclosed the terms of the Option Agreement in its Quarterly Report for the quarter ending March 31, 2016 filed with the Securities and Exchange Commission on May 16, 2016.
The Amendment provides that, as a condition for entry into definitive agreements relating to the Products, (i) the Company shall form a new subsidiary (“New Sub”) to own the Products and related intellectual property and assets and (ii) NPT or its designees shall reimburse the Company up to $300,000 for amounts contributed to New Sub in research and development capital. NPT or its designees shall own the same percentage of New Sub as they would have owned of NPT had NPT issued membership interests to the Company and entered into a definitive license agreement with the Company as contemplated by the Option Agreement. The Amendment further provides that NPT or its designees shall invest up to $20 million in New Sub in tranches and on terms to be agreed upon by the parties, subject to entry into satisfactory definitive agreements relating to the ownership of New Sub and royalties related to the Products. The Amendment extends the term of the Option Agreement to September 15, 2016.
The foregoing description of the Amendment and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, which is filed as exhibit 10.1 to this Current Report.
| Item 8.01. | Other Events. |
On July 19, 2016 the Company issued a press release announcing entry into the Amendment. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits .
|
Exhibit No. |
Description | |
| 10.1 | Amendment No. 1 to License Option Agreement | |
| 99.1 | Press Release of Immune Pharmaceuticals Inc., dated July 19, 2016 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| IMMUNE PHARMACEUTICALS INC. | ||
| By: | /s/ Daniel G. Teper | |
| Name: | Daniel G. Teper | |
| Title: | Chief Executive Officer | |
Date: July 19, 2016
Exhibit 10.1
AMENDMENT NO. 1
TO
LICENSE OPTION AGREEMENT
This Amendment No. 1 to the License Option Agreement (the "Agreement") made and entered into as of the 18th day of July 2016, between Immune Pharmaceuticals Inc., a Delaware corporation (“Immune”) and Novel Pain Therapeutics, LLC., a New York limited liability company (“NPT”), both referred to hereinafter referred to as the "Parties."
WITNESSETH :
WHEREAS, on May 15, 2016, the Parties entered into a License Option Agreement;
WHEREAS, NPT targets September 15, 2016 for finalizing and entering into the transactions contemplated by the Agreement, as amended hereby;
WHEREAS, the parties desire to include other provisions that will become part of the definitive agreements contemplated by the Agreement, as amended hereby (“Definitive Agreements”);
NOW, THEREFORE, in consideration of and for the mutual promises and covenants contained herein, and for other good and valuable consideration, the receipt of which is hereby acknowledged, the License Option Agreement is hereby amended as follows:
1. A new Section 3, entitled Newly Established Terms , shall follow Section 2, General Terms and Condit ions, and shall read as indicated below:
3. Newly Established Terms
| 3.1 | As a condition to entering into the Definitive Agreements, Immune shall either form a pain and neurology subsidiary, or, subject to NPT’s approval, shall utilize an existing subsidiary (“Pain/NeuroCo”), which entity will own Amiket and other pain and/or neurology assets. NPT and/or its founders, investors and/or designee(s) shall be issued shares in Pain/NeuroCo at such times and in such amounts so as to achieve the same degree of ownership in Pain/NeuroCo as they would have had in NPT, net of Immune’s agreed upon stake as set forth in the Agreement, had NPT issued interests to Immune and NPT entered into the license agreement with Immune as originally contemplated by the Agreement. |
| 3.2 | Additionally, as a condition to entering into the Definitive Agreements, Immune shall be reimbursed from the capital contributed to Pain/NeuroCo by or through NPT or its designees up to $300,000 in R&D expenses. |
| 3.3 | NPT or its designees, as a syndicate of experienced healthcare investors, will invest up to $20M in tranches to be agreed upon by the Parties into Pain/NeuroCo, subject to entering into satisfactory documentation relating to Pain/NeuroCo, including a Stock Purchase Agreement, Shareholders Agreement and Royalty Agreement with Immune. |
| 3.4 | Additionally, a new partner has been identified and is in negotiations either to merge into Pain/NeuroCo or to contribute IP and/or other assets that will be acquired by Pain/NeuroCo. |
The License Option (also known as the Option Period), as modified hereby, is hereby extended to September 15, 2016.
This agreement shall be construed and interpreted in accordance with the laws of the State of New York without giving effect to the conflict of laws rules thereof or the actual domiciles of the parties.
Except as amended hereby, the terms and provisions of the Agreement shall remain in full force and effect, and the Agreement is in all respects ratified and confirmed. On and after the date of this agreement, each reference in the Agreement to the "Agreement", "hereinafter", "herein", "hereinafter", "hereunder", "hereof", or words of like import shall mean and be a reference to the Agreement as amended by this agreement.
This agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which taken together shall constitute a single Amendment.
IN WITNESS WHEREOF, the parties hereto have executed this agreement as of the date first stated above.
| THE COMPANY: | ||
| IMMUNE PHARMACEUTICALS INC. | ||
| By: | /s/ Daniel G. Teper | |
| Daniel G. Teper | ||
| Its: Chief Executive Officer | ||
| NOVEL PAIN THERAPEUTICS, LLC | ||
| By: | /s/ Mark Fawer | |
| Mark Fawer | ||
| Its: Managing Member | ||
| 2 |
Exhibit 99.1
IMMUNE Pharmaceuticals to Form Pain and Neurology
Spin Off Company around AmiKet
IMMUNE and NPT targets closing date of September 15, 2016.
New York, July 19, 2016 -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) (“Immune”) , a biopharmaceutical company focused on the development of targeted therapeutics for the treatment of inflammatory diseases and cancer, announced today that it has entered into an amended agreement with NPT, a syndicate of experienced healthcare investors, on July 18, 2016. According to the amended agreement Immune will form a pain-neurology subsidiary, which will own AmiKet® intellectual property. NPT plans to make the first tranche of its investment into the new subsidiary upon closing based on the pre-agreed terms. The parties have agreed to a target closing date of September 15, 2016.
Dr. Daniel Teper, CEO of Immune commented: “This is an important step towards realizing the significant value of AmiKet® for Immune’s shareholders, and will allow the company to focus on its core immunology and immuno-oncology pipeline.”
For full disclosure please refer to the Form 8-K filed on July 19, 2016.
About Immune Pharmaceuticals Inc.:
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH (an inflammatory liver disease). Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's oncology pipeline includes Ceplene®/IL-2 approved in Europe and Israel for maintenance remission in AML, Azixa® and crolibulin, Phase II-ready vascular disrupting agents, and novel technology platforms; bispecific antibodies and targeted nanotherapeutics, NanomAbs. Immune's additional pipeline includes AmiKet Nano™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharmaceuticals.com, the content of which is not a part of this press release.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release 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. 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. Factors that may cause actual results or developments to differ materially include, but 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 clinical trials for bertilimumab or AmiKet® will not be successful; the risk that bertilimumab, AmiKet® or compounds arising from our NanomAbs program 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 the Phase III trials for AmiKet® on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared 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 and 10-Q and our annual report on Form 10-K for the year ended December 31, 2015 and 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.immunepharmaceuticals.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, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Immune Pharmaceuticals Inc.
For further information: Anna Baran-Djokovic, Immune Pharmaceuticals Inc., 646.481.5058, anna.baran@immunepharma.com.