Immune Therapeutics Inc. CEO Issues Letter to Shareholders Highlighting Significant Progress

Jan 05, 2015, 10:00 ET from Immune Therapeutics Inc.

ORLANDO, Fla., Jan. 5, 2015 /PRNewswire/ -- Immune Therapeutics Inc. (OTCBB: IMUN), a biopharmaceutical company focused on the development and commercialization of targeted immune  therapies, announced today that its Chief Executive Officer Noreen Griffin issued a letter to shareholders highlighting the significant progress the company has made toward its vision of becoming a leading developer of immune therapies. 

As we come to the end of 2014, I want to provide an overview of the accomplishments and the significant strides that Immune Therapeutics, Inc. is making toward our vision of becoming a leading developer of targeted immunotherapies.

Like you, I have been disappointed, as our stock price has continued to decline.  We are getting calls from shareholders and it is clear that there is a lot of concern and confusion. As some shareholders are only watching the stock price and consider no other information, it is easy to listen to rumors or to assume the worst.  As you read the following overview, you can see why we believe that our stock does not at all reflect the underlying value of the company.

Among other things, I will discuss the significant potential of our lead product candidate, Lodonal, in emerging nations, which we believe is one of the primary value drivers for Immune Therapeutics.  In addition, I will discuss the current status of the clinical trial process for Cytocom Inc.'s product candidates, IRT-103 (LDN) and IRT-101 (MENK). 

2014 Highlights:

  • Immune Therapeutics developed an oral adult low dose (1mg; 3mg; 4.5mg/day) formulation and pediatric oral liquid formulation (0.1 mg/kg/day) of Low Dose Naltrexone (LDN).  Formulations are required for Phase III trials and this work took most of 2014.   This drug will be used in all trials both in the US and overseas.
  • In December 2014, the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria granted us permission, with Dr. Afonja as principal investigator, to begin a 90-day bridging trial for HIV/AIDS. The objective of this bridging trial is to assure safety and tolerability as well as efficacy with the local population.  The estimated completion date of this bridging trial is April 2015.
  • In December 2014, we finalized the spin off of Cytocom to our shareholders. As part of the transaction, we retained exclusive rights to all international patents, in-country approvals, formulations, trademarks, manufacturing, marketing, sales, and distributions rights in emerging nations, including Africa, Central America, South America, Russia, India, China, Far East, and The Commonwealth of Independent States (former Soviet Union). 
  • Immune Therapeutics will continue to have access to existing clinical data as well as any new data generated by Cytocom during drug development
  • In December of 2014, we finalized the issuance of 126,868,174 shares of Cytocom common stock to our shareholders of record that provided evidence of share ownership by December 8, 2014.   In addition, Cytocom issued 140,000,000 shares of its common stock to Immune Therapeutics, which has allowed us to retain a 51% stake in Cytocom until such time as the funding for Cytocom closes.   
  • In July 2014, the Republic of Malawi approved Lodonal as an adjunct for the treatment of Cancer. The Brewer Group, Inc., a strategic partner, paid for the first shipment of Lodonal for Malawi but was unable to ship the drugs due to issues with the importation of Lodonal into Malawi.  Those issues have been resolved and The Brewer Group and PanAm Global Logistics, Inc., a company that will purchase and distribute Lodonal, will be able to ship Lodonal in January of 2015.
  • In May of 2014, we presented to audiences of doctors and scientists at the Pan-African Medical Doctors & Healthcare Conference immunotherapy solutions that enhance immune health such as, Low Dose Naltrexone, and LDN was accepted and endorsed by the healthcare professionals at the conference.  The endorsement by leading doctors is an important part of our overall strategy.

2015 Strategic Goals:

  • New Management Team:  Negotiations with members of an experienced management team are virtually complete. The new management is expected to begin by the middle of January of 2014.
  • Conference Attendance: We intend to participate in a number of conferences both domestically and internationally about the value of Lodonal as an immunomodulator for the treatment of autoimmune diseases and cancer.  These conferences include VI Annual World Congress on Anti-Aging Medicine (A4M) in Mexico City February 13, 14 and 15, the 4th International Conference and Exhibition on Immunology in September in Houston Texas, The Complementary & Alternative Cancer Therapies conference February 26-28, in West Palm Beach, Florida, the Academy of Integrative Health & Medicine in San Diego California October 24 - 29, and the 23rd Annual World Congress on Anti-Aging Medicine, May 6-9, in Hollywood Florida.  We believe attendance at these conferences will help generate sales.   
  • International Regulatory Approval for Lodonal in 2015: We expect to obtain regulatory approval for Lodonal in some of the following countries in 2015: South Africa, Angola, Niger, Gabon, Egypt, Sri Lanka, and China. We believe the process will take between 4 to 12 months depending on the local authorities.
  • Establish Partnerships in Africa:  Our goal is to establish partnerships in Africa with large employers that maintain onsite clinics; there is increasing recognition that health creates wealth and advances GDP.  HIV and AIDS have had an enormous negative impact on labor and productivity. The vast majority of people living with HIV in Africa are of working age 15-49 years old.  We believe that Lodonal can be used as a prophylactic to avoid many of the standard opportunistic infections accompanied with HIV and cancer.
  • Funding Cytocom Clinical Trials:  If sales are sufficient, our  goal in 2015 is to commit financial resources to help fund Cytocom's clinical trials in the US to validate the use of LDN in a number of various indications. 

Clinical Studies:

  • We have spent the last 12 months obtaining approval from Nigeria and Malawi to begin our clinical development program for Lodonal. As indicated above, NAFDAC in Nigeria granted us permission to begin a 90-day bridging trial for HIV/AIDS and we expect to commence a 120-day bridging trial for cancer in the first quarter of 2015 in the Republic of Malawi.
  • On the regulatory front, Cytocom has held constructive dialogue with the FDA with respect to appropriate trial designs and study protocols for IRT-103 and IRT-101.
  • Cytocom's immediate focus will be on Crohn's Disease both in children and adults and we expect recruitment in both pharmacokinetic (PK) and Dosing Trials for IRT-103 (LDN) to begin this year.
  • In addition to the trial design, we recently initiated a Toxicologist and PK study in China for IRT-101 for the purpose of furthering our understanding of the effect of the pharmacokinetics of IRT-101. This will allow us to better understand the potential for drug interactions to further optimize treatment for Phase 3 development of IRT-101 for cancer in both the US and China.
  • In addition, the Company expects to begin a bridging trial for cancer in Malawi within the first quarter of 2015.

Our Strategy for Growth:

  • Over the past several months, we have worked aggressively to build the business both upward and outward. We have worked to build Immune Therapeutics into a multi-faceted leader in immuno therapies by exploring opportunities beyond HIV/AIDS and cancer in emerging nations.
  • Our goal and strategic vision is to build a diverse pipeline and to develop and commercialize novel drug treatments to improve the lives of patients suffering from chronic often life-threating disease.
  • To fulfill these near-term and long-term goals, we are happy to report that we have obtained a loan commitment for up to two million dollars of which the first half a million-dollar tranche closed in December 2014 and we expect the remaining funds to close by the end of January of 2015. The loan is straight debt and does not convert into equity and will be repaid from revenue over the next three years.
  • This loan is transformational for the company. It has allowed us to move ahead with our strategic goals to obtain international regulatory approval throughout Africa and other emerging nations.  
  • We anticipate revenues in 2015 from a number of sources including revenues from fees from the use of our formulation and patents and the sale of Lodonal in Nigeria, Malawi and Equatorial Guinea.
  • While we continue to execute this strategy in a capital efficient manner, we plan to fuel the growth of our company by evaluating strategic financing options as well as licensing opportunities that will increase shareholder value.

The Growth of Immune Therapeutics:

  • Finally, we have made an effort to build visibility and positive awareness of Immune Therapeutics by presenting at key investor and industry conferences internationally. As a complement to our ongoing partnering efforts, we are committed to enhancing communications with key investor groups in an effort to increase shareholder value by building appreciation for the Immune Therapeutics story.
  • Upon the completion of the bridging trial in Nigeria, we will be able to "fast track" the approval process in a number of African Nations that will accept NAFDAC approval of Lodonal for the treatment of HIV/AIDS.

Why HIV/AIDS?

HIV/AIDS still remains one of the three global public health threats. This disease results in substantial morbidity, mortality, negative socioeconomic consequences, and human suffering. Despite the significant increase in financial support and recent progress in addressing HIV/AIDS, many obstacles and unmet priorities remain.

Disease-specific interventions must be developed to ensure successful treatments of this disease.  Apart from human suffering, the associated high adult mortality caused by HIV/AIDS, negatively impacts the socioeconomic development in some countries, especially in Nigeria and South Africa.

Adopting a treatment regimen for life that involves taking daily medication with potential side effects, presents many challenges that must be overcome if patients are to successfully remain on treatment. If drug resistance occurs through failure to adhere to antiretroviral treatments (ARVs), far more expensive second line therapy may be necessary. In some cases drug-resistant strains of HIV are transmitted, which can impact national treatment programs. Drug resistance has been found to be more prevalent the longer a country has provided antiretroviral therapies. 

We believe Lodonal can provide an alternative in areas where patients have stopped taking their therapies due to side effects, or cost; Lodonal has been shown in trials to lessen the toxic side effects of ARVs.  In those areas of the country where people must travel monthly for a medical check up (and lose a day's pay) Lodonal can cost-effectively provide the ability to slow the progression of the disease without any toxic side effects. 

Nigeria:  In Nigeria, over 3.6 million people are living with HIV/AIDS, with the annual number of new infections for adults at 323,000 and 57,000 for children. Currently, only 600,000 people receive HIV treatment.  The number of people living with HIV is only an estimate, as very few Nigerians know their HIV status. 

South Africa:  Based on a wide range of data including the household and antenatal studies, UNAIDS estimated that HIV prevalence was 17.3% among 15-49 year olds at the end of 2011. The high and low estimates were 16.6% and 18.1%, respectively. This implies that around 5.6 million South Africans were living with HIV at the end of 2011, including 460,000 children under 15 years old.  By October 2012, only two million people were receiving ARVs.  Again, the biggest problem is compliance, as people are required to take pills, 2 to 3 times a day at specific times and many times with food with considerable toxic side effects. Lodonal in contrast is taken only once per day, does not have to be taken with food, and has no toxic side effects.

Why an adjunct to cancer treatment?

Cancer is now one of the leading causes of death in developing countries. Already there are more deaths in the world from cancer than from AIDS, TB and Malaria combined. Specifically in Africa, facilities for the diagnosis and treatment of cancer are minimal and in most cases there aren't any cancer control programs in place.

It is estimated that sub-Saharan Africa will see approximately a million new cancer cases this year and it is predicted that the number of new cases will double within the next decade. Additionally, due to low cancer awareness in Africa, it is estimated 80% of all patients with cancer will not be seen until the cancer is in the advanced stage of the disease. 

Even if the cancers were detected in the early stages, there is inadequate access to effective treatment.  Therefore, there is an urgent need of safe, effect low cost treatments especially when you have to consider that anyone on chemotherapy must have a healthy immune system.

In Conclusion

As we continue to execute on our corporate strategy, I would like to thank you personally for your continued support of Immune Therapeutics' management team, development strategy, and corporate vision. We plan to provide regular updates on key clinical milestones, management changes and other corporate developments and look forward to sharing our successes with you, our shareholders.

Sincerely,

Noreen Griffin

About the Company

The Company is a biotechnology company working to combat chronic, life-threatening diseases through the activation and modulation of the body's immune system using our patented and licensed immunotherapy. Our immunotherapies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release includes various "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which represent our expectations or beliefs concerning future events. Statements containing expressions such as "believes," "anticipates," "intends," or "expects," used in this press release and in Disclosure Statements and Reports filed with the Over The Counter Markets through the OTC Disclosure and News Service are intended to identify forward-looking statements. By their nature, forward-looking statements involve risks and uncertainties that could cause actual results to materially differ from those anticipated in the statements. The most significant of these uncertainties are described in our Form 10-K and Form 10-Q reports filed with the Securities and Exchange Commission.. Although we believe our expectations are based upon reasonable assumptions within the bounds of our knowledge of our business and operations, there can be no assurances that actual results will not differ materially from expected results. We caution that these and similar statements included in this press release are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof.

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SOURCE Immune Therapeutics Inc.