Endonovo Therapeutics Inc (ENDV)

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Potential Catalysts by End of Year.

In my opinion, there are quite a few things we can hopefully look forward to by end of this year, if not early into next year. I wrote quite a lengthy email to Andrew/Steve yesterday with a huge list of questions and concerns, and from there, I organized what in my opinion are possible catalysts we can expect here going forward, as well as other concerns that in my opinion can help get some useful dialogue going here again, all listed below. (Still can't believe this entire few weeks of the positive move so far and there has been so little board chatter)

a) The A/S increased to 2.5 Billion, and we haven't heard anything about why exactly this has happened. Since then, our dilution rate has stayed relatively the same, and as many have stated, it seems there may be some ulterior motive to a 5x increase. (All speculative, but should not be forgotten about)

I did express much concern in my email about this and the lack of reasoning for such a dramatic change, as well as the pairing of that news with the PR of National Distribution as well.

b) The redesign of tPEMF devices for use in CNS Disorders, as that was stated to be a 2018 milestone. Specifically stated from PR that in 2018, two clinical trials would be initiated, one in post-concussion syndrome and another in acute sport related concussions, both that state will initiate AFTER the redesign of these tPEMF devices.

In my opinion, since both clinical trial initiations and the redesign were slated to be a milestone of this year, I find it hard to believe that they will let the rest of 2018 go by without getting this done, or at least giving us an update on this. (They know they can get burned for not having accurate timelines) And if you are a long like me, I can imagine this is of great interest to you too. ENDV knows this redesign is critical, and I can't help but feel that we could hear something soon from this.

c) The initiation of a Pilot Clinical Trial for patients with relapsing forms of Multiple Sclerosis.

I expressed a couple questions about this, mainly pertaining to the fact that the PR does not state specifically whether or not this trial will commence BEFORE or AFTER the redesign. For Acute Concussions and Post Concussion Syndrome, both are specifically mentioned they will be initiated after the redesign, but not for this.

Since a 2018 milestone was to initiate this trial, I am also expecting to hear something pertaining to this and the redesign in the somewhat near future. Not sure if anyone has more educated input on whether or not a different device would be necessary for this.

d) Not EXPLICITLY slated to be 2018 milestone, but initiation of a clinical trial targeting Proteinuria in CKD patients. in 5/1/18 PR about positive feasibility study results, it states,"FDA Approval for the device used in the feasibility study would be necessary to secure an appropriate indication for Endonovo to market such device."

From there, no plans are set forth. As we found out in the last annual report, (quoted directly from 10-K)

"We are seeking to enter the CNS market via a Humanitarian Device Exemption (HDE), which is regulatory pathway for medical devices addressing rare diseases that occur in no more than 8,000 individual per year in the United States. The HDE pathway is the medical device equivalent of orphan drugs and is similar in both form and content to an FDA Pre-Market Approval (PMA). However, rather than being required to demonstrate safety and efficacy, the HDE pathway allows for medical devices to receive FDA Approval if they can demonstrate that their probable benefit outweighs their probable risk.

We will seek to enter the CNS market via a HDE for the treatment of encephalopathy in Lyme disease patients. Our FDA-Cleared Electroceutical Therapy is currently prescribed by a group of physicians to reduce neuroinflammation. We will seek to gather data from approximately 10 to 15 patients to support a Humanitarian Device Exemption from the FDA to reduce neuroinflammation in Lyme disease patients."

then, followed shortly after:

"If we are able to secure a Humanitarian Device Exemption for our Electroceutical™ Therapy from the FDA for the treatment of encephalopathy in Lyme disease patients, we will then pursue a “label expansion” strategy. This would entail entering the CNS market via the HDE pathway for the treatment of encephalopathy in Lyme disease patients and then applying to expand the label for our Electroceutical Therapy for other CNS disorders we are pursuing, including acute concussion, traumatic brain injury, post-concussion syndrome, multiple sclerosis and stoke. This strategy will require that we conduct several clinical trials simultaneously in order to fully benefit from pursuing a HDE pathway and label expansion strategy; such benefits include a potentially shorter and less costly regulatory process for our other CNS indications."

So long story short, IN MY OPINION, we are due to hear something from this entire strategy laid out, hopefully sometime in the near future. The initiation of a human clinical trial beginning in Critical Limb Ischemia definitely should not be forgotten about as well.

Definitely raised much concern in my email about the fact that investors have not heard anything since positive results were released in 2/12/18 PR, and we deserve an update on exactly what the plan is for this part of the pipeline regardless.

e) Possible Licensing, Distribution and Partnership opportunities in International Markets. Stated in 2018 outlook PR as well as 10-K as a goal. Quoted from the PR, "Endonovo plans to commercialize its CE-Marked and FDA-Cleared Electroceutical™ therapy in China, Japan, Korea and other international markets. Endonovo has already initiated dialogue with potential licensees, distributors and joint venture partners in Asia. Endonovo will further look to establish distribution agreements and licenses in the Unites States for cosmetic surgery and orthopedic indications or explore the establishment of its own sales and marketing channels."

The fact that U.S. Distribution agreements was the ladder part of this goal, and we achieved those first, gives me intuition that we hopefully should see something soon that allows us to enter these international markets.

f) (ALL SPECULATIVE) Possible submittal of ENDV's device into FDA's Innovation Challenge.

Again, all speculative, but I can't help but feel that this challenge is all but perfect for Endonovo and their business strategy. Endonovo tweeted the link to the news release at the end of August, which states that the application period is between June 1st and September 30th, and selected applicants will be announced in November.

Link to news release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm

"Developers accepted into the challenge will receive enhanced interactions with FDA review divisions during the development and evaluation of the proposed product. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application. In most cases,

The agency anticipates that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application."

I reached out about this, but for obvious reasons doubt they will be anything but tight lipped on this matter. Fairy tale thought (maybe this could be a big key to their goals) and if by the slim chances that we were selected, I truly could not see a situation in where our PPS would not go absolutely parabolic.

g) Beginning of any "redeeming of outstanding convertible notes” as Alan Collier stated in the 2018 Outlook PR.

h) Possible Up-List company stock onto a National Stock Exchange

From PR, "Now having completed this acquisition, we are looking to position the company for continued growth by redeeming our outstanding convertible notes and uplisting the company onto a national stock exchange where we can increase shareholder value."

Obviously don't have a lot of faith right now in either of these two goals, but both were still explicitly stated as goals, so again in my opinion, something to not forget about.

Both of these concerns were a very big focal point of my email, as we all know there is no realistic way an up-list can happen currently, and there is no sign of any redeeming of convertible notes happening on the horizon unfortunately. I expressed a lot about how in my opinion, Endonovo is loosing a good bit of credibility with what they say they expect and what is actually occurring (these two being perfect examples), as well as ShareIntel being another example.

From looking at PR patterns from the past, there was definitely a more solid form of transparency via PR's at least, in terms of note and financing information. I addressed this, as well as the continual spending of $70,000 on "paid market awareness" articles that get released, and how as a long term investor, these give much less confidence in the company than more PR's would do that simply address some updates on a few of their endeavors, and spending more money on actually getting their data more heavily into the scientific community, via possible meetings and relevant conferences. (Another thing stated last year, I asked for an update on this as well)

I feel like there is plenty that can happen at a whims notice here, and the argument that there are no catalysts to be thinking about in the near-term doesn't seem to be too accurate. Also, the continued price action is nice to see, and something still seems different than it has in the past, today's buy/sell volume was a nice sight.

Would love input from any of you on more concerns/questions I am forgetting about that can be asked and discussed here as well! PM me your email if interested in hearing a little bit more about what I hear back, not really wanting to share all that on the board. Point of this is to get people thinking and emailing the company themselves with these concerns. The more we press IR, the more likelihood of us getting an update in return. It was cool to see that Andrew is taking my questions to management as he wants to answer them accurately. (told me this early today) Either way, they are responsive and I for one can definitely appreciate that.