IMUN - Immune Therapeutics
- 37 North Orange Ave
Orlando, FL 32801
|Shareholders of Record ||773 || a/o Mar 31, 2017 |
Short Selling Data
|Short Interest ||12,968 (-49.32%) |
Oct 31, 2017
|Significant Failures to Deliver ||No |
| || || || |
| ||Authorized Shares ||500,000,000 ||a/o Oct 31, 2017 |
| ||Outstanding Shares ||383,531,959 ||a/o Oct 31, 2017 |
www.cytocom.com (subsidiary of IMUN - Cytocom will get eventual U.S. sales - if that ever happens - hopefully in 2-3 years?? IMUN owns 12.8% (or 11.3%?? not sure) of Cytocom as of June 30, 2017. LDN has already received various Phase 2 approvals in the United States, see www.cytocom.com/investors/)
www.fidson.com (partner in Nigeria for marketing and distribution)
http://www.acromaxdominicana.com/ (partner for manufacturing in Dominican Republic - contract in 8-k)
http://www.omaera.com/ (partner in Kenya for marketing and distribution)
8-k from 12/1/17: Shareholder letter - AHAR issues IMUN its first ever purchase order of $195,000
10-Q from 11/14/17: IMUN lists $214k in inventory. First time ever listing having inventory on a 10-q or 10-k in IMUN's history
8-k from 9/8/17: IMUN announces exclusive agreement with Omaera Pharmaceuticals for Lodonal in Kenya - valued at a minimum of $31m in revenue over 3 years - first purchase order contractually guaranteed by 11/22/17
Kenya Agriculture, Fish, and Food Authorities: Approved List of Suppliers, Human Drugs and Medicine - Omaera Pharmaceuticals is on the list
8-k from 8/25/17: IMUN hires new COO Rudy Williams and hires new CEO of Cytocom Dr. John H Abeles (Dr. John H Abeles will also be new senior executive advisor of IMUN)
10-Q from 8/14/17: IMUN records first GAIN ever in shareholder equity for a quarter, and achieves this on NO REVENUE (due to elimination of toxic debt)
8-k from 4/27/16: LDN is approved in Nigeria
"The NAFDAC approval follows the successful completion of a 90-day bridging study conducted by AHAR Pharma on behalf of the Company in conjunction with State Specialist Hospital in Asubiaro. That study, “ A Bridging Study to Evaluate the Effects of ‘Lodonal’ as an Immune-System regulating Agent in Subjects in which Their Immune System is Compromised: Lodonal in the Treatment of Subjects with Human Immuno-Deficiency virus (HIV), ” met the primary and secondary endpoints for both efficacy and safety.
Breakthrough Lodonal Results on HIV Patients:
The 90-Day Bridging Study was undertaken at the State Specialist Hospital in Asubiaro, Osogbo, Osun State, Nigeria and the primary objective of this Bridging trial was to confirm that Lodonal had a beneficial effect on the immune system of immune deficient patients and safety. This was a single center, open labeled, randomized, bridging study of a 150 people. The Treatment Group was treated with 4.5 mg of Lodonal nightly in conjunction with antiretroviral. The Control Group was treated with antiretroviral plus placebo . The primary endpoints were efficacy and safety determined by a minimum increase of 25% in the CD4 count with no adverse effects on quality of life.
The results yielded an average 44% increase in CD4 count in the Treatment Group compared with 11% increase for the Control Group and there was no adverse effect on quality of life or opportunistic infections during the trial. The Nigeria trial’s results were consistent with previous clinical trials of LDN.
Due to its favorable cost/benefit, the Company believes Lodonal has large market potential to be the first affordable non-toxic therapy of its kind. It is administered in a single oral dose daily making medical and drug compliance much easier and is designed to produce a significant reduction in opportunistic infections. In addition to affordably improving the quality of patients’ lives, it offers a compelling economic benefit to health care systems."
8-k from 5/23/17: LDN gets marketing approval in Nigeria
8-k from 11/2/16: Contract with IMUN's manufacturer in the Domincan Republic, Acromax Dominicana
8-k from 4/13/17: Debt restructuring to eliminate a very "toxic" note.
8-k from 3/14/17 - Debt restructuring with Florida Hedge fund
8-k/a from 3/17/17 - Debt restructuring with Florida Hedge fund - ammendment
8-k from 11/15/16 - Debt restructuring
8-k from 4/28/17: IMUN files NDA for LDN for HIV and Cancer in Kenya
PR from 5/31/17: IMUN signs MoU with Ivory Coast for LDN
PR from 10/26/16: IMUN files NDA for LDN for HIV, Cancer and as an Immune Booster with Senegal
PR from August 2015: Letter of Intent from Fidson Healthcare PLC - this publishing popped IMUN to just over $0.30 briefly
Stock Quote of Fidson Healthcare PLC - IMUN's supposed partner (LOI) for marketing / distribution in Nigeria - notice how the ticker has shot up since April
8-k from 4/13/16: IMUN Provides Drug Development Status on MENK (Methionine-Enkelphine) in China
8-k from 4/21/16: IMUN signs binding LOI to acquire Chinese CAR-T Technology and Clinical data
Nigeria Clinical Trials Registry - Lodonal - note that it still says "Pending". According to 8-k's, the drug is officially approved, so IMUN should be good on this
Low Dose Naltrexone Forum - Proboards
LDN Clinical Trials via ldninfo.org (has not been updated since 2013, but still a very nice list)
List of Clinical Trial Publications for LDN via clinicaltrials.gov
11 Facts about HIV in Africa
http://www.ldnafricaaids.org/ (has not been updated since late 2012)
http://www.ldnafricaaids.org/wp-content/uploads/2011/08/Traore-et-al-1.pdf (clinical study on LDN in Mali)
http://www.ldnafricaaids.org/?page_id=3 (the story of LDN and the late Dr. Bernard Bihari (passed away May 2010), the pioneer of low dose naltrexone - TNIB / IMUN acquired patents in late 2012/early 2013 - see 10-k)
The medicine your doctor never told you about (but should have)
Low-Dose Naltrexone (LDN): One of the RARE Drugs that Actually Helps Your Body to Heal Itself
My experience with Low Dose Naltrexone By David Gluck, MD (the story of a lifelong friend of Dr. Bernard Bihari, the pioneer of LDN)
We now have a NEW Senior Regulatory Advisor (see last page of powerpoint) who is (or was?) ALSO the Senior Regulatory Officer for the GATES FOUNDATION! - other than the powerpoint presentation from the LD Micro conference, there has not yet been any 8-k recognizing any of these new additions (Dr. John H Abeles, Rufus (Rudy) Williams, Vincent Ahonkhai).
PEPFAR - Department of Defense
Videos to watch on Low Dose Naltrexone
https://www.youtube.com/watch?v=Kz52KK5IhOc&t=1s (4 mins, CBS News - Wonder drug Low Dose Naltrexone?...very uplifting encouraging video about a woman's story on LDN)
In this 4 min video above, it states that no Big Pharma companies are backing LDN. This is correct, because it is off-label: 50-mg Naltrexone was approved by the FDA in the 80's. Thus, making it cheap because 50-mg Naltrexone is generic (50mg Naltrexone didn't work well for what it was approved for - heroin addicts, therefore it ended up becoming generic). Low dose naltrexone, 4.5mg, however, is patented, and studies have shown its effectiveness (44% increase in CD4 count in Nigerian trials, when they were searching for a minimum of 25% increase in CD4 count). And it's safe - very little side effects except for possible lucid dreams. But still, it's "cheap". Noreen says it will costs patients in Nigeria $.84 per day, $0.24 of which will be profit. The low cost is the reason why big pharma did not WANT to fund this drug. Because there has always been little research done on LDN, big pharma was happy keeping it that way. They knew that if LDN did ever gain traction as the go-to therapy for any given disease, it would make big pharma lose billions of dollars, if in fact LDN can replace more expensive drugs that the big pharma companies are selling. This could potentially make IMUN a potential acquisition target by big pharma in the future.
https://www.youtube.com/watch?v=FDCn0JWv6Io (59 mins; very informative documentary telling the story of LDN)
https://www.youtube.com/watch?v=pg1T0bKxx9E [11 mins; a woman gives a detailed explanation of how LDN has helped her - 4 month update (not doing so well) and 1 year update (doing much better)]
https://www.youtube.com/watch?v=rll1A3aFhjc (79 mins; "[the late] Dr Bihari [the pioneer of low dose naltrexone] is Interviewed about Low Dose Naltrexone LDN for Normalizing Immune System Function")
https://www.youtube.com/watch?v=r4quvjDiXcY (60 mins; LDN & Cancer - The Game Changer)
https://www.youtube.com/watch?v=l8sWzoLtop4 (29 mins; LDN as a treatment for Autoimmune disease)
Books on Low Dose Naltrexone (great reviews on Amazon)
Upcoming Catalysts (expected)
-From May 23rd 8-k: "Initial contracts expected shortly". IMUN will be reporting contracts with Fidson Healthcare PLC (hopefully), as well as organizations that will help with the funding of purchase orders (still unclear what is exactly the deal?) - from the June 12th Powerpoint 8-k, "Collaboration NGO, Foundation, PEPFAR, PATH, NACA, NCA, HMO, GATES LOCAL DISTRIBUTION".
-From May 23rd 8-k: "Company expected to strengthen management team". Note that on the June 12th 8-k, on the final page, there was mention of three new officers / advisors in Dr. John H. Abeles, Rufus (Rudy) Williams, and Dr. Vincent Ahonkhai (senior regulatory officer for the Gates Foundation). As we haven't seen a specific 8-k regarding these new additions (have only seen this Powerpoint which is likely not official), it appears as if there should still be a separate announcement in an 8-k.
-From June 12th 8-k: "Sales [in Nigeria] by end of Q3 2017", as well as "AHAR Pharma LTD Nigeria - Telemedicine operational by July 2017", from "Lodonal - Commericialization Steps" Powerpoint slide.
-From April 28th 8-k: “The [NDA for Kenya] was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distributi on agreement.” concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.
Patent and Subsidiary Acquisition (from the 10-k)
The Company entered into a share exchange agreement on April 24, 2012 to acquire all of the outstanding shares of TNI BioTech IP, Inc. (“TNI IP”), a biotechnology firm incorporated in Florida and formed to acquire patents related to the treatment of cancer and HIV/AIDS and autoimmune diseases, using Met-enkephalin (“MENK”) and Naltrexone (“LDN”). The goal of TNI IP’s management was to enable mankind and civilization to combat fatal diseases by activating and mobilizing the body’s own immune system using TNI IP’s patented use of MENK. The first patents acquired by TNI IP were acquired from Dr. Nicholas P. Plotnikoff and Professor Fengping Shan in 2012. TNI IP was acquired in exchange for 20,250,000 shares of the Company’s common stock, of which 8,000,000 shares were issued to Dr. Plotnikoff for the acquisition of patents and the remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their TNI IP shares. The goodwill arising on the acquisition of TNI BioTech IP, Inc. was valued at $98,000,000 and license agreements arising from the acquisition of TNI IP were valued at $16,006,000.
- "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."
From the 10-k... https://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11967147
The Company has been developing active forms of immunotherapies through the acquisition of patents, IND Applications, clinical data and all proprietary technical information, know-how, procedures, protocols, methods, prototypes, designs, data and reports which are not readily available to others through public means, and which were owned, generated or developed through experiments or testing by Dr. Plotnikoff, Professor Shan, Dr. Bernard Bihari, Dr. Ian S. Zagon, Dr. Jill Smith, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky.
The Company’s management believes that to be successful, it was imperative to not only acquire all of the intellectual property and patents but also the scientist(s) behind their development. To date, the Company has been able to acquire many of the patents and intellectual property it was seeking, and has also been able to team up with some of the leaders in the field of immunology, experts such as the late Dr. Ronald Herberman (1940-2013), Dr. Angus Dalgleish and Dr. Joseph Fortunak.
Dr. Plotnikoff is the inventor behind a number of patents granted for cancer treatments and an adjunct to patents for autoimmune diseases including: European Patent United Kingdom, Germany, France, Ireland EP 1401471 BI Methods for inducing sustained immune response; Russian Patent Russian Federation patent number 2313364; The Patent Office of the People’s Republic of China, Application No.: 200810165784.8 China Patent CN1015113407 A The Patent Office of the People’s Republic of China ISSN: 1006-2858 CN 21-1349/R; Patent Agencies Government of India Patent, Application number 1627/KOLNP/2003 number 220265 an Enkephalin Peptide Composition; and the US Patent Pending, US Patent Application 10/146.999 e (the “Plotnikoff Patents”). The Patent Cooperation Treaty (“PCT”) enables a U.S. applicant to file a single application, known as “an international application,” in a standardized format in English in the U.S. Receiving Office (the U.S. Patent and Trademark Office) that is acknowledged as a regular national or regional filing in any state or region that is party to the PCT.
The Company entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff on March 4, 2012, wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in the Plotnikoff Patents to the Company. The Company received all the production formulations and technology designs from Dr. Plotnikoff necessary for the manufacturing, formulation, production and protocols of the MENK treatment of cancer and HIV/AIDS. As consideration for entering into the Sale of Technology Agreement, Dr. Plotnikoff received 8,000,000 shares of common stock, a royalty of a single-digit percentage on all sales of MENK and was granted the position of Non-Executive Chairman of the Board of Directors.
In addition to the above patents, we also signed an exclusive licensing agreement for all of the intellectual property developed at Pennsylvania State University by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer. The patents cover methods and formulations related to the treatment and prevention of cancers. More specifically, the present inventions describe the use of drugs that interact with opioid receptors (naltrexone, naloxone and the pentapeptide MENK) to inhibit and arrest the growth of cancer. Such efficacy has been discovered to be partially due to the functional manipulation of the zeta opioid receptor through exogenous and endogenous MENK. This receptor has been determined to be present in a variety of cancers, including pancreatic, ovarian, liver, head and neck, and colon cancer. US Patent Numbers 6,737,397, CA 2,557,504, US 20010046968 , US 6737397 , US 6136780 , US 20080015211 , US 20070053838 , US 8003630 ,US 20110123437 , US 7807368 , US 7576180 , US 7517649 , US 20080146512 , US 7122651 , US 20060073565 , US 20050191241 , Patent No 8,003,630.
We also acquired the licensing rights to the patent portfolio and intellectual property developed by Dr. Bernard Bihari relating to treatments with drugs that interact with opioid receptors such as LDN and MENK for a variety of diseases and conditions including malignant lymphoma, chronic lymphocyctic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, and chronic infections due to the Epstein-Barr virus and a treatment method for humans infected with HTLV-III (AIDS) virus including patients clinically diagnosed as suffering from HIV/AIDS and those suffering from ARC. The licensed rights include all reissues or modifications, reexaminations, or other related U.S. patent filings directed to the same subject matter and the use of U.S. Patent Number 6,586,443 , U.S. Patent Number 6,384,044 , U.S. Patent Number 6,288,074 , U.S. Patent Number 5,356,900 , U.S. Patent Number 5,013,739 , U.S. Patent Number 4,888,346 .
Once the Company acquired the above patents, it was then able to sign a licensing agreement to acquire the exclusive patent rights for the intellectual property of the licensors, Dr. Jill Smith and LDN Research Group, LLC, whose members include Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The patents cover methods and formulations for the treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. Endogenous opioids and opioid antagonists at low doses have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues. US Patent No. 6,136,780, Patent No. US 7879870. The Company then negotiated with Dr. Jill Smith to arrange the transfer of the Orphan Drug Designation for the use of naltrexone for the treatment of pediatric Crohn’s disease with the FDA. Dr. Smith has since transferred the IND to the Company, and the FDA acknowledged that the Company is now the sponsor for this IND. In September 2014, the Company and the licensors jointly agreed to terminate the license agreement, and in place thereof, have the licensors grant a similar license in their patent rights to Cytocom Inc. pursuant to a Patent License Agreement between the licensors, Cytocom Inc. and the Company with substantially similar terms as set forth in the original license agreement. Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock to the licensors and the Company guaranteed the obligations of Cytocom Inc. to the licensors under the agreement.
The Company originally acquired the patents and intellectual property from Dr. Smith and LDN Research Group, LLC because management believed clinical trials involving LDN held great promise for the millions of people worldwide with autoimmune diseases or disorders, central nervous system disorders or those who face cancer. Management also believed it could be the first low-cost, easy to administer therapy with minimal to no side-effects for the treatment of HIV/AIDS, autoimmune diseases and immune disorders, in particular Crohn’s disease, multiple sclerosis, and/or fibromyalgia.
Dr. Nicholas Plotnikoff, Professor Fenping Shan and Noreen Griffin recently filed a Provisional Application for a Utility Patent US Application No. 62/296,759 Method for Inducing a Sustained Immune Response, which was assigned to the Company in March 2016. U.S. Patent and Trademark Office has issued the Official Filing Receipt in connection with this application, and accorded a filing date of February 18, 2016 during its pendency in the USPTO.
...The Company is working with the agencies to obtain local approval for the therapies for each modality that we intend to market for. We believe this will reduce our risk due to The Agreement on Trade Related Aspects of Intellectual Property Rights (“TRIPS”) which is an international agreement administered by the World Trade Organization (“WTO”). TRIPS allows emerging nations to manufacture drugs around existing patents.
Quote from Wikipedia article:
Access to essential medicines
The most visible conflict has been over AIDS drugs in Africa. Despite the role that patents have played in maintaining higher drug costs for public health programs across Africa, this controversy has not led to a revision of TRIPS. Instead, an interpretive statement, the Doha Declaration, was issued in November 2001, which indicated that TRIPS should not prevent states from dealing with public health crises. After Doha, PhRMA, the United States and to a lesser extent other developed nations began working to minimize the effect of the declaration.
A 2003 agreement loosened the domestic market requirement, and allows developing countries to export to other countries where there is a national health problem as long as drugs exported are not part of a commercial or industrial policy. Drugs exported under such a regime may be packaged or colored differently in order to prevent them from prejudicing markets in the developed world.
In 2003, the Bush administration also changed its position, concluding that generic treatments might in fact be a component of an effective strategy to combat HIV. Bush created the PEPFAR program, which received $15 billion from 2003–2007, and was reauthorized in 2008 for $48 billion over the next five years. Despite wavering on the issue of [compulsory licensing], PEPFAR began to distribute generic drugs in 2004-5.
From 3/15/17 publishing...
"Immune Therapeutics CEO Applauds President Trump’s Initiatives for Pharmaceutical Reform
The Company noted that the characteristics of Lodonal, namely its affordability and ability to receive regulatory approval in countries like Kenya, Nigeria and Senegal can provide, the type of solutions that President Trump would like to see implemented by pharmaceutical companies around the globe.
“I applaud President Trump and the measures he is taking to ensure the cost of drugs decrease first by increasing competition and second hopefully reducing the time it takes for a potential drug to hit the market. Immune Therapeutic’s goal since its inception has always been to provide affordable non-toxic therapies and we are proud to have been one of the first biotech companies at the forefront of this movement. We believe our strategy of providing affordable non-toxic sustainable health care therapies for autoimmune diseases as well as HIV and cancer, could propel Immune Therapeutics as an innovative, disruptive, player in the pharmaceutical industry. It is finally time for a change and we are looking forward to supporting President Trump’s and Congress’s initiatives in this arena,” concluded Ms. Griffin."
https://www.pepfar.gov/press/releases/2017/272760.htm ***The following Powerpoint is copy and pasted from the June 12th 8-k. It was presented at the LD Micro Conference on June 7th*** https://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=12122447
Recent News from PEPFAR (that should hopefully be related to IMUN, but there is no indication of that in the article)
And here are a few of the important slides from www.cytocom.com/investors/
IMUN owns 12.8% (or 11.3%?? not sure)
of Cytocom as of June 30, 2017. Keep in mind that Cytocom is a private company, and these Powerpoints have not been updated since 2015 it looks like. They could be further along (possibly past Phase 2) and we likely wouldn't know about it until they update the IMUN shareholders. We were quoted this in mid March 2017 (see 8-k/a in March), which means we are likely further along then this Powerpoint indicates... "Following Launch of Lodonal, Management to Provide Greater Detail Over Pipeline of its Various Drugs in the Approval Process both with the FDA and Internationally"