IMUN - Immune Therapeutics
- 37 North Orange Ave
Orlando, FL 32801
|Shareholders of Record ||773 || a/o Mar 31, 2017 |
Short Selling Data
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| ||Authorized Shares ||500,000,000 ||a/o July 17, 2017 |
| ||Outstanding Shares ||334,037,491 ||a/o July 17, 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 13.3% of Cytocom as of March 31, 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 - potentially also for manufacturing in the future? See their newly built plant)
http://www.acromaxdominicana.com/ (partner for manufacturing in Dominican Republic - contract in 8-k)
8-k from 4/27/16: LDN is approved 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. This 8-k may have marked the inflection point on the graph of IMUN
8-k from 4/28/17: IMUN files NDA for LDN for HIV and Cancer in Kenya
8-k from 5/23/17: LDN gets marketing approval in Nigeria
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 partner for marketing / distribution in Nigeria - notice how the ticker has shot up since April on no published news (According to Bloomberg), could also have something to do with new plant they built
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
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).
Videos to watch on Low Dose Naltrexone
https://www.youtube.com/watch?v=YtDxpA52NvU (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."
The following link contains an important Powerpoint presentation. Page 8 of the presentation is a key page. As of March 31, 2017, IMUN owns a 13.3% stake in Cytocom, which has been diluted down from an original 55% stake when the spinoff occured in 2014.
***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
- "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."