Endonovo Therapeutics Inc (ENDV)

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Potential Catalysts by End of Year and Beyond

I am reposting an older post of mine to have the ability to stickie it, as I feel an updated list of some possible catalysts couldn't hurt. In my opinion, there are quite a few things we can hopefully look forward to by the end of this year, if not early to mid-way into next year.

a) The A/S increased to 2.5 Billion, yet we haven't seen this updated or heard anything about why exactly this has happened, minus the "explanation" that was told to us in the filings.

Directly from PRE 14C 8/14/18 filing: "Our board of directors has determined that it is advisable and in the best interest of the Company to increase the number of authorized shares of our Common Stock in order to ensure that the Company will satisfy its obligations under the existing convertible notes issued by the Company. We currently have 366,118,767 shares outstanding and 137,175,073 shares reserved for issuance on conversion of various outstanding securities. Since a lender is entitled to increase his reserves but has elected not to do so, there are actually no shares available for other corporate purposes and the Board does not consider this adequate for general corporate purposes. Most of our outstanding convertible securities have conversion rates based on formulas that fluctuate based on the market price of our common stock and the required reservations therefor may increase in the future if the market price for our common stock decreases. The Company would be required to issue additional shares of our Common Stock upon conversion of such convertible notes and, under certain of those convertible notes, the Company is required to have in reserve certain quantities of authorized but unissued shares of our Common Stock. Generally, with respect to the convertible notes issued by the Company, both the quantity of shares of our Common Stock that the Company would be required to issue upon conversion and the quantity of authorized but unissued shares of our Common Stock that the Company is required to have in reserve increases if the market price of our Common Stock decreases. The newly authorized shares of Common Stock would be available for issuance from time to time as determined by our board of directors for any proper purpose, which may include, without limitation, the issuance of shares in connection with financing or acquisition transactions and other corporate opportunities. We have no present plans for the issuance or reservation of additional shares of common stock other than ongoing private placements and the convertible notes referred to above.

The Company, in the ordinary course of business, considers various possible means and strategies to expand its business, which may include, among other things, possible acquisitions of complementary businesses and other businesses. At the present time, the Company has not entered into any definitive agreement with any person or entity that entails any contemplated merger, consolidation, acquisition or similar business transaction, and there are no assurances that the Company will enter into any such transaction. The increase in the number of authorized shares of Common Stock of the Company as described in this Information Statement is for the purpose of addressing the obligations under existing convertible notes issued by the Company and for other corporate purposes generally, as described in the preceding paragraph, rather for any specific contemplated transaction(s). However, we do not have any present plans or agreements for any other business which would require the issuance of any of the additional shares being authorized."

link: http://ir.endonovo.com/all-sec-filings?page=3#document-6030-0001493152-18-011633

Since then, our dilution rate has stayed the same as far as it seems, 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) Looking to see updated OTC Page of information soon, as Craig stated it is usually updated around the end of the first week every month., that way we can confirm any change in the weekly rate.

b) The redesign of tPEMF devices for use in CNS Disorders, as that was stated to be a 2018 milestone. Specifically stated from 2018 Outlook PR that 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.

2018 Outlook 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.

Directly from 5/1/18 PR: "FDA Approval for the device used in the feasibility study would be necessary to secure an appropriate indication for Endonovo to market such device."

link: http://ir.endonovo.com/press-releases/detail/235/endonovo-therapeutics-highlights-feasibility-study-results

This leaves unanswered questions. From there, no plans are set forth. In the most recent annual report, a summary of methodology to enter the CNS market is laid out.

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.

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

Directly from link above: "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."

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.

And Lastly,

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

Directly from 2018 Outlook 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, I don't have a 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.

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 any previous run, today's buy/sell volume was insane end of day, and can truly say in just shy of my 2 years of being here, I have never seen that kind of resistance blown through with minimal amount of bid support.

Anyone who thinks that this movement is just a result of these paid articles like we had today, I suggest looking at the history of Market-watch, the amount of articles that have been released on us in this manner in the past, and how they never had any kind of impact on the PPS. The only real way to see them is by searching most recent ENDV news on google, doesn't really pop up anywhere else, at least from what I have seen.

link to today's article: https://www.marketwatch.com/press-release/biotech-market-is-rolling-and-these-companies-need-to-be-on-your-radar-2018-10-02

Yes, management has not come through with things in the past.
Yes, management has not been as transparent as we may like.
Yes. there are obviously many concerns and questions going forward
Yes, there are reasons to be hesitant and doubtful here,

BUT, this being said, I don't feel like many of us are giving these guys nearly enough credit if they truly are shaping this company with a long-term mindset. If we can build a base at these higher levels over time, with the earnings outlook growth in the coming year, as well as other near-term catalysts mentioned above, I think there is plenty to be optimistic about here.

Just think this board deserves some productive chatter here again, there are still quite a few good people here, as well as a few new people I'm sure. With all the action we have had in the last couple of months, our board definitely deserves to be more a little bit more productive than this.

Looking forward to tomorrow and beyond, CHEERS!