Immune Therapeutics, Inc. (OTCQB:IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone Lodonal as standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 400 patients in several clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint.
Immune Therapeutics, Inc. is a biotechnology company developing and seeking to commercialize patented therapies in emerging nations that combat chronic, life-threatening diseases by stimulating or rebalancing the immune system.
Our technology platform is based on two interrelated cytokine drug therapies-Low-Dose Naltrexone (LDN) and Methionine Enkephalin (MENK)-which work by triggering opioid receptors on immune cells to activate various cells of the immune system.
- 37 North Orange Ave
Orlando, FL 32801
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| ||Authorized Shares ||500,000,000 ||a/o Sep 30, 2016 |
| ||Outstanding Shares ||241,128,131 ||a/o Nov 14, 2016 |
Immune Therapeutics Issues Special Letter to Shareholders
Jan 30, 2017
OTC Disclosure & News Service
Company Expects to Report Initial Revenues in First Half of 2017 and Achieve Profitability by Year-End
Company to Host Investor Conference Call to Discuss Positive Developments
ORLANDO, Fla., Jan. 30, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN), a clinical-stage company developing novel therapies for the treatment of immuno-inflammatory diseases and cancer, today issued a Special Letter to Shareholders from its Chief Executive Officer, Noreen Griffin, which summarizes some of the Company’s achievements in 2016 and, more importantly, discusses its growth outlook for 2017 and beyond. The Company will be hosting an investor conference call, which will include a question and answer session, to discuss today’s Special Letter to Shareholders. Dial-in information for the call is provided below.
Special Investor Conference Call Information
The conference call to discuss today’s Special Letter to Shareholders will be held today, Monday, January 30, at 11 a.m. Eastern, 8 a.m. Pacific.
DIAL-IN: (Toll Free) (866) 682-6100; (International): (862) 255-5401
WEB-CAST: IMUN Investor Conference Call
Please dial-in 10 minutes prior to the conference call to assure you are placed into the call on time.
Replay Number (Toll Free): 877-481-4010
Replay Number (International): 919-882-2331
Replay ID: 10214
Teleconference Replay Available Until: Feb 9, 2017 at 11:59 PM
Following is Text of the Special Letter to Shareholders
“Dear Fellow Shareholder:
Simply stated, by every measure, the outlook for the coming year is the most exciting in our Company’s history. In the first half of 2017, I fully expect we will reach commercialization with one or more of our proprietary drugs. This will enable us to generate the high-margin revenue growth and earnings we have worked so diligently towards for several years.
Confidence continues to build in our company as, in 2016, our ‘insider’ management and major shareholders continued to add to their IMUN position through both open market purchases and direct investments into the Company.
2016 was a year of important progress for Immune Therapeutics. As a pioneer in these treatments, our clinical and human trials took us across the world from the US and Europe to Central America and Africa. We tested novel drugs in numerous, highly regulated jurisdictions while working to market these low-cost medicines to treat HIV and cancer. This was quite a challenging feat.
I am pleased to report your company ended 2016 far stronger operationally and financially than when it began, and starts 2017 with its strongest momentum ever. Before I discuss our outlook and goals for 2017, I would like to summarize some of the key achievements of 2016.
Immune Therapeutics 2016: Year of Important Progress
- Lodonal Clinical Trials Completed, New Supplier, Nigerian Drug Approval Won In 2016, we completed the clinical human trials on LodonalTM for HIV in Nigeria, by exceeding primary and secondary endpoints by a substantial margin, and earned approval of its drug regulatory agencies. Lodonal is the first safe, affordable, non-toxic therapy for emerging market patients with compromised immune systems.
To the best of our knowledge, we are the only company that has ever advanced a non-FDA drug, or generic, through an approval process in an emerging market. This is a major accomplishment, one that bodes well for our numerous other initiatives that are similar in nature.
Commercialization of Lodonal was delayed by about three quarters as we replaced our Lodonal manufacturer in Nicaragua in favor of Dominican Republic (“DR”)-based Acromax Dominicana, which is ISO and cGMP certified. We determined the political landscape in Nicaragua was shifting in the wrong direction and, rather than risk a major, costly supply chain disruption after commencing distribution, your Board made the prudent decision to make the change now when it is far more manageable. This necessitated a new round of regulatory approvals in the DR, with its Minister of Health approving Lodonal for the treatment of HIV/AID’s, cancer and various autoimmune and inflammatory diseases.
- ECOWAS Market Penetration in Africa. Capitalizing on our years of hard-earned success in Nigeria, we have made strong progress penetrating markets in numerous other countries in the region to establish new markets that enable us to serve many more millions of patients.
As the largest economy in West Africa, our Lodonal approval in Nigeria allows us to fast track all of the 15 countries in West Africa. Senegal has accepted our New Drug Application for Lodonal. We are seeking approval for three indications. We are on schedule for drug approval in many of the countries that make up the Economic Community of West Africa States (“ECOWAS”) and expect to solidify several of them in 2017.
We have two new Lodonal clinical trials, one completed, one in process. Subject to final regulatory marketing and registration requirements, Lodonal itself is now approved in three countries and we are actively working to leverage our position in Nigeria by gaining approval in a fourth and fifth West African country.
- New IP. In 2016, we filed for three new patents surrounding Lodonal and Met-Enkephalin (“MENK”), and published our research in six medical journals.
2017: Focus on Revenues, Trials, IP and Achieving Profitability
Our key goals for 2017 include:
- Revenue and Cash Flow. We expect to commercialize Lodonal in Nigeria, and other West African nations during the first half of 2017. Our internal projections indicate this will generate several million dollars in revenue, at a healthy gross margin, for growing positive cash flow. That cash flow will fund conducting other clinical trials and securing regulatory approvals in other African Nations for additional indications including malaria, opportunistic infections and cancer. Our goal is to be able to fully self-fund our growth by the end of 2017.
NAFDAC Marketing Approval. Drug approval does not provide marketing approval, but with the approval of Lodonal by the DR Minister of Health we can now finalize our application for marketing with Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC). The final remaining step is for NAFDAC officers to complete a GMP audit of the facility in Santo Domingo, and this is anticipated by mid-2017. With that, we fully expect to begin distribution and sales in Nigeria with other West African countries to follow.
Cytocom. Cytocom Inc. is our affiliate clinical-stage pharmaceutical company focused on advancing IRT-103 (US FDA designator for ‘Lodonal’). It is responsible for the development of our patented therapies with the FDA and EMA. It will lead the US and EMA (“European Medical Association”) clinical trials on IRT-103 including for Crohn’s disease.
We have quietly made solid progress advancing Cytocom toward our next major goal, which is to finance it as a standalone entity, possibly publicly traded depending on its capital market valuation and profile.
- Advance IMUN’s Growing Drug Pipeline. We have started our second clinical for Lodonal as an adjunct treatment for cancer in Malawi, which is slated for completion in mid-2017, with results to be published in the second half of the year. We also plan a bridging trial with MENK for cancer in Nigeria, capitalizing on our strong relationship with NAFDAC -– amongst other clinical trials being developed or planned.
Increase the IP Portfolio. We will continue to protect the value of our clinical research by building intellectual property value as an asset, thus erecting barriers to entry. We filed two new patents surrounding Lodonal in 2016.
Establish a Solid Base of Operations in China. Our Chief Science Officer and Vice Director of the Institute of Immunology, China Medical University in Shenyang, China have been treating patients with MENK and our new cocktail therapy throughout 2016 with positive results. Now that our patents are filed for the cocktail, we plan to publish results in 2017 as part of a larger initiative to advance clinical trials, and establish a solid beachhead in this nation of 1.4 billion people as a gateway to Asia. Our goal is to open our cancer clinic in China to treat patients by year-end 2017.
Reinforce the IMUN Management Team and Boards. As we grow, and our opportunities increase, we plan to add highly accomplished executives to our management team and boards from the fields of science, medicine, pharmaceuticals and finance to help drive the Company’s growth.
2017: IMUN Poised for Success
As this summary of our operational and financial highlights indicates, your company has numerous, highly valuable pharmaceutical assets, IP, industry relationships and initiatives that address massive markets making strong progress. With all successes come challenges.
That is the nature of the pharmaceutical industry. It is also part and parcel of doing business in Africa. We have chosen to enter and open the pharmaceutical industry -- in Africa -- where we are determined to make a positive impact on the health and wellness of its people and leave a lasting legacy on behalf of Immune Therapeutics and its shareholders.
Despite the many bumps in the road, as a major IMUN shareholder, I have never been more confident that we are on the precipice of bringing to fruition our years of hard work.
Thank you for your ongoing confidence and support.
Chief Executive Officer
Immune Therapeutics Clears Critical Regulatory Hurdle for Lodonal in Kenya
Mar 17, 2017 http://www.otcmarkets.com/stock/IMUN/news/Immune-Therapeutics-Clears-Critical-Regulatory-Hurdle-for-Lodonal-in-Kenya?id=153643&b=y
Immune Therapeutics, Inc. Further Strengthens Balance Sheet as it Prepares for Commercialization
Mar 15, 2017 http://www.otcmarkets.com/stock/IMUN/news/Immune-Therapeutics--Inc--Further-Strengthens-Balance-Sheet-as-it-Prepares-for-Commercialization?id=153435&b=y
Immune Therapeutics Signs Distribution MOU for Lodonal in Kenya; Company Plans to Open Kenya for Lodonal in 2017
Mar 08, 2017 http://www.otcmarkets.com/stock/IMUN/news/Immune-Therapeutics-Signs-Distribution-MOU-for-Lodonal-in-Kenya--Company-Plans-to-Open-Kenya-for-Lodonal-in-2017?id=152931&b=y
IMMUNE THERAPEUTICS STRENGTHENS BALANCE SHEET; Reiterates Outlook for Positive Cash Flow by Mid Year
Feb 09, 2017 http://www.otcmarkets.com/stock/IMUN/news/IMMUNE-THERAPEUTICS-STRENGTHENS-BALANCE-SHEET--nbsp-Reiterates-Outlook-for-Positive-Cash-Flow-by-Mid-Year?id=150868&b=y
Immune Therapeutics Clears Critical Certification Milestone
Feb 02, 2017 http://www.otcmarkets.com/stock/IMUN/news/Immune-Therapeutics-Clears-Critical-Certification-Milestone?id=150331&b=y
Immune Therapeutics Redeems $656,250 Convertible Note; Company Actively Working to Strengthen Balance Sheet by Year End http://www.otcmarkets.com/stock/IMUN/news/Immune-Therapeutics-Redeems--656-250-Convertible-Note--Company-Actively-Working-to-Strengthen-Balance-Sheet-by-Year-End?id=144922&b=y