SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 20, 2020
Immune Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction
|2431 Aloma Ave #124 Winter Park, FL 32792|
|(Address of principal executive offices)|
(Issuer’s telephone number)
(Former name, former address and former fiscal year, if changed since last report)
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 provision (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))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
ITEM 7.01 Regulation Fair Disclosure
Effective as of March 17, 2020, the Immune Therapeutics, Inc., a Florida Company signed a binding letter of intent with a private company Cytocom, Inc that sets forth the preliminary terms and conditions of a potential collaboration agreement for the development of Lodonal™ and IRT-101 for use against COVID-19.
ITEM 8.01. OTHER EVENTS
On March 20, 2020 Immune Therapeutics, Inc. issued a press release announcing a letter of intent that was signed with Cytocom, Inc. to develop Lodonal™ and other drugs for COVID-19. Immune Therapeutics and Cytocom are planning to work with federal agencies to seek fast-track approval using Lodonal™ as a way to prevent or treat COVID-19 in high-risk groups who are infected with 2019-nCoV at clinical research centers across the country. IMUN is currently designing studies using Lodonal™ and IRT-101 as a monotherapy or in conjunction with other potential treatments.
The press release also stated that the Company is in the process of finalizing its development program for ITX401 for pancreatic cancer and that the Company anticipates submitting a request in April for a Type C meeting with the FDA to discuss the phase III clinical program for ITX401 treatment of pancreatic cancer. IMUN also expects to initiate testing on the use of Lodonal™ and ITX401 with other approved cancer drugs like Keytruda® and Opvido® in partnership with CYTO to determine the probability of enhancing the safety and efficacy of these already approved cancer drugs.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
|10.1||Letter of Intent dated March 17, 2020|
|99.1||Press release dated March 20, 2020|
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 hereunto duly authorized.
Immune Therapeutics Inc
|By:||/s/ Michael K Handley|
|Michael K. Handley|
|Chief Executive Officer|
|Date:||March 20, 2020|
17 March 2020
Ms. Noreen Griffin
President & Chief Executive Officer
3001 Aloma Ave., Winter Park, FL 32792
SUBJECT: BINDING LETTER OF INTENT
Dear Ms. Noreen Griffin:
Immune Therapeutics Inc. (“IMUN”) and Cytocom, Inc. (“CYTO”) have been discussing a possible collaboration between the two companies to create a program to develop Lodonal™ (IRT-103) and IRT-101 as a therapeutic intervention for COVID-19 infections and also as a potential prophylactic agent to attenuate the spread of the disease. Both parties are interested in entering into a definitive collaboration agreement (the “Agreement”) between IMUN and CYTO to combat the COVID-19 pandemic.
In order to expedite the development and execution of the Agreement, we propose signing of this Letter of Intent (“LOI”) we enter into an exclusive period of negotiation for one hundred and twenty (120) days to complete the definitive Agreement. Accordingly, on behalf of IMUN, I am pleased to provide you with this binding LOI.
1. Collaboration. The goal of this collaboration is to leverage IMUN ’s expertise in drug development, regulatory and clinical trials to assist CYTO in bringing Lodonal™ and IRT-101 to market as a therapeutic intervention for COVID-19 and also as a prophylactic agent to attenuate the spread of the disease.
2. Consideration. For consideration for IMUN ’s assistance in their drug development programs, CYTO agrees to the following:
2.1 Michael Handley will assume the role of Interim CEO of CYTO.
2.2 IMUN will collaborate with CYTO on the development of Lodonal (IRT-103) and IRT-101 for the therapeutic intervention of COVID-19 in patients and also as a prophylactic agent to attenuate the spread of the disease (in addition to other potential indications as the parties will agree on from time-to-time).
2.3 IMUN will be responsible for filing New Drug Application for Lodonal and IRT-101 with the FDA.
2.4 IMUN will be responsible Type C Meeting with the FDA on behalf of CYTO.
2.5 IMUN will be responsible for providing final briefing package and protocols for COVID-19 prophylaxis and treatment.
2.6 IMUN will provide funding for COVID-19 treatment and prophylaxis under the Agreement
2.7 IMUN will develop and file the IND for Lodonal and IRT101 for the prophylaxis and treatment of COVID-19.
3. Collaboration Agreement. IMUN will draft the Collaboration Agreement (the “Agreement”) among IMUN and CYTO, and the parties will continue to negotiate, in good faith, the terms thereof.
4. Due Diligence. CYTO will continue to extend its full cooperation to IMUN and its development team. IMUN, its management team, scientists and clinicians shall to have full access to CYTO’s data, protocols and reports for Lodonal™ or IRT-101 use.
5. Public Announcements. Subject to applicable law, neither party hereto shall make any additional public announcement relating to this transaction until the signing of the collaboration agreement, and any announcements made thereafter will be mutually agreed upon and jointly made by the parties.
6. Filings and Applications. Each party shall continue to cooperate fully with the other party in furnishing any necessary information required in connection with (i) the preparation, distribution and filing with the Securities and Exchange Commission (“SEC”), in each case, if necessary, of a proxy statement, an information statement, and any other filing or document required by the SEC, and (ii) the preparation, distribution and filing of any filings, applications and notices which may be required by other federal, state and local governmental or regulatory agencies or stock exchanges in any jurisdiction, including the United States and Canada.
7. Brokers. Neither IMUN , CYTO, nor any of their officers, directors, employees or stockholders has retained or used, and none of them will retain or use, the services of any broker, finder or investment banker which would result in the imposition of a fee or any other compensation of any kind to any third- parties in connection with this LOI or the collaboration agreement.
8. Responsibility and Costs. Each party will be responsible for their own costs and expenses associated with the transactions contemplated hereby, including, but not limited to, legal fees and costs, and the costs associated with obtaining shareholder, governmental and other third-party approvals. Also, CYTO will be responsible the funding of the developmental work, including but not limited to, clinical trials, GMP manufacturing and regulatory filings.
9. Exclusivity. In consideration of IMUN ’s undertaking the effort of , CYTO agrees that for a period of one hundred and twenty (120) days after the date hereof, it shall not consider, seek or solicit, negotiate with, or engage anyone to seek, solicit, or negotiate on behalf of CYTO or its stockholders, or provide or cause to be provided information to, any third party in connection with any proposal or offer with respect to the acquisition of CYTO, or all or substantially all of its assets.
10. Governing Law/Jurisdiction. This Letter of Intent shall be governed by, and construed in accordance with, the laws of the State of Florida, without regard to such State’s principles of conflicts of law. The parties’ consent to the jurisdiction of the courts of the United States and Florida located in such state for the resolution of any dispute relating to this LOI.
11. Confidentiality. IMUN and CYTO have strict respect for the significant value of each other’s confidential information. IMUN and CYTO are parties to a Confidential Nondisclosure Agreement dated 17 March 2020 (“CDA”). By the execution hereof, IMUN and CYTO agree that the CDA are and remain in effect in accordance with the respective terms, and they reaffirm their respective rights and duties thereunder. If both parties enter into the Agreement, the Agreement will supersede the CDA.
12. Third Parties. This Letter of Intent is intended for the sole and exclusive benefit of the parties hereto and their respective successors and controlling persons, and no other person, firm or corporation shall have any third-party beneficiary or other rights hereunder.
13. Approval and Authority. The individuals signing this LOI on behalf of the parties have all authority needed to execute this document on their respective behalves.
14. Binding Provisions. Notwithstanding the non-binding nature of this LOI, Sections 9 “Exclusivity” and 11 “Confidentiality” hereof are binding upon the parties and shall be enforceable by them.
15. Next Steps. Negotiation Period will begin upon execution of this document. IMUN will prepare a first draft of the Agreement. Following the signing of this LOI, the Agreement will be negotiated (the Negotiation Period). The Negotiation Period will begin at the signing of the LOI and will end when the Agreement is fully signed. It is foreseen that the Negotiation Period will last for one hundred and twenty (120) days, however it is noted that this period may be longer than one hundred and twenty (120) days, depending on the efficiency of both parties in the activities to be conducted during the Negotiation Period. If the Parties haven't executed the Agreement by the end of the Negotiation Period, the Parties may mutually agree to extend the Negotiation Period upon the payment of appropriate consideration. Both parties agree to negotiate the Agreement in good faith, as expeditiously as reasonable
This letter is intended to constitute an offer that is binding upon acceptance. Except as specified above, neither party is under any obligation with respect to the subject matter hereof until such time that both parties have executed the Agreement and related agreements, if any, and all conditions set forth therein have been satisfied.
If the foregoing represents your understanding of the terms of our preliminary agreement, please sign this LOI on the below-designated line and return a copy to the undersigned no later than 5:00 p.m. (Eastern time) on 18 March 2020.
|CYTOCOM, INC.||IMMUNE THERAPEUTICS, INC.|
|Signature of Authorized Officer||Signature of Authorized Officer|
|Noreen Griffin (CEO and President)||Michael K. Handley (CEO & President)|
|Name of Authorized Officer (Title)||Name of Authorized Officer (Title)|
|Date Signed (day/month/year)||Date Signed (day/month/year)|
Immune Therapeutics, Inc. to Collaborate with Cytocom, Inc. to Develop Therapies for COVID-19
By Corporate News, News, Press Releases
Immune Therapeutics, Inc. Signs Binding Letter of Intent to Collaborate with Cytocom, Inc. to Develop Lodonal™ and Other Drugs for COVID-19; Other Drug Development Programs Also Moving Forward
ORLANDO, Florida, March 20, 2020 – Immune Therapeutics, Inc. (OTC: IMUN) (“Immune” “IMUN” or the “Company”), Immune Therapeutics, Inc., a late-stage clinical biopharmaceutical company focused on the development and commercialization of highly innovative therapies for use in oncology, immunology and anti-inflammatory disease today announced the signing of a binding letter of intent to collaborate with Cytocom, Inc. (“Cytocom” or “CYTO”) for the development of Lodonal™ and IRT-101 for use against COVID-19, the disease caused by the new corona virus originating from Wuhan, China which is also called 2019-nCoV.
Immune Therapeutics and Cytocom are planning to work with federal agencies to seek fast-track approval using Lodonal™ as a way to prevent or treat COVID-19 in high-risk groups who are infected with 2019-nCoV at clinical research centers across the country. IMUN is currently designing studies using Lodonal™ and IRT-101 as a monotherapy or in conjunction with other potential treatments.
According to a press briefing on Thursday, March 19th President Donald Trump along with the FDA Commissioner Dr. Stephen Hahn and the U.S. Corona Virus Task Force Team announced that to help speed up the pace of testing drugs that could help treat the symptoms of COVID-19, they have directed the Food and Drug Administration to “Eliminate outdated rules and bureaucracy so work can proceed rapidly, quickly and fast…we have to remove every barrier.” Immune and Cytocom believes that this will fast track the approval process.
Bob Buckheit, PhD, CEO of ImQuest Life Sciences and a member of the scientific advisory board of IMUN stated “While research on specific direct-acting antiviral drugs to treat 2019-nCoV is accelerating, the need for the evaluation of host-directed therapies are also urgently needed. In several clinical studies, Lodonal™ has been shown to modulate immune system function by decreasing elevated inflammatory responses associated with viral infections like HIV and H1N1 Influenza. Thus, there is a compelling biomedical rationale to test Lodonal™ both as a therapeutic intervention for COVID-19 infection in patients and as a prophylactic agent to attenuate the spread of the disease. ImQuest is uniquely posited to work with Immune and Cytocom on this project. “
“COVID-19 threatens the health and lives of the elderly, immune-compromised and those with underlying health concerns. Immune Therapeutics is initiating a series of studies while seeking regulatory guidance for fast-track designation and approval of Lodonal™ for COVID-19 during this national emergency,” stated Roscoe Moore, Jr., D.V.M, M.P.H, Ph.D., D.Sc., Former U.S. Assistant Surgeon General, who serves on the Board of Advisors for the Institute of Human Virology, University of Maryland Medical School and is the Chairman of Board of Immune Therapeutics, Inc.
Michael K. Handley, CEO of Immune Therapeutics, Inc. said, “We have known that Lodonal™ has demonstrated efficacy in the treatment of a variety of viruses. Specifically, we have seen anti-viral effects from Lodonal™ and IRT-101 in HIV patients. Clinical data has shown that Lodonal™ and IRT-101 decreases the replication of the H1N1 influenza virus. We believe the same mechanism of action of modulating the immune system function, while also decreasing inflammation, will work well to mitigate the spread of COVID-19 in addition to treating those who are already infected. We are excited to partner with Cytocom to help bring this much needed therapy to stem the COVID-19 pandemic.”
Immune Therapeutics is also in the process of finalizing its development program for ITX401 for pancreatic cancer. IMUN anticipates submitting a request in April for a Type C meeting with the FDA to discuss the phase III clinical program for ITX401 treatment of pancreatic cancer. IMUN also expects to initiate testing on the use of Lodonal™ and ITX401 with other approved cancer drugs like Keytruda® and Opvido® in partnership with CYTO to determine the probability of enhancing the safety and efficacy of these already approved cancer drugs.
About Immune Therapeutics, Inc.
Immune Therapeutics, Inc. is a late-stage clinical biopharmaceutical company focused on the development and commercialization of highly innovative therapies for use in oncology, immunology and anti-inflammatory disease. Immune Therapeutics is actively developing T-cell activation immunotherapies in combination with other drug candidates to achieve immunomodulation in patients with cancer, auto-immune disease and inflammatory diseases.
About Cytocom, Inc.
Cytocom, Inc is a private late-stage biopharmaceutical company focused on the development of T-cell activation immunotherapy, to treat life-threatening infections, representing a fundamentally new treatment approach in the infectious disease and autoimmune market that are designed to overcome key issues associated with current therapies, including serious adverse events (“SAE”), drug resistance, short duration of response, negative impact on the human microbiome, and lack of differentiation between treatment alternatives.
ABOUT ImQuest Life Sciences, Inc.
ImQuest Life Sciences, Inc. is a leading drug discovery and development company with a highly focused strategy of developing a proprietary portfolio of novel therapeutic agents to target infectious disease and cancer. Our business model is to commercialize exciting new drugs with unique mechanisms of action both independently as well as in partnership with other pharmaceutical companies.
The ImQuest Life Sciences pipeline includes exclusive licenses to highly potent compounds for the treatment of Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Virus (HBV, HCV), Influenza, including Drug- and Antibiotic-Resistant Microorganisms, and Cancer. They are strategically developing Topical Microbicides to prevent the transmission of HIV and other Sexually Transmitted Infectious (STI) organisms.
ABOUT Global Viral Network of the Institute of Human Virology at the University of Maryland School of Medicine
The Institute of Human Virology (IHV) is the first center in the United States—perhaps the world—to combine the disciplines of basic science, epidemiology and clinical research in a concerted effort to speed the discovery of diagnostics and therapeutics for a wide variety of chronic and deadly viral and immune disorders, most notably HIV, the cause of AIDS.
Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland and the University of Maryland Medical System, IHV is an institute of the University of Maryland School of Medicine and is home to some of the most globally-recognized and world-renowned experts in the field of human virology.
FORWARD LOOKING STATEMENTS
This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company’s filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company’s filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.
Michael K. Handley
(888) 613-8802 Ext. 100