Microsoft Word - Sernova recommendation and add'l updates - Chris Temple

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You can get information anywhere. Here, you get KNOWLEDGE. SERNOVA Corp. – compilation of recommendation/updates BELOW is my initial recommendation of Sernova Corp. from a between-issues e-mail to Members, dated September 20, 2019; following that, a couple later pertinent updates— 2. NEW SPECULATIVE BUY: Sernova Corp. (TSXV-SVA; OTCQB-SEOVF) Having three of eight children beset by Type One diabetes, I have long followed London, Ontario-based Sernova and its progress toward the development of (for lack of a better technical term for the moment) an artificial pancreas. For time's sake I must put off a broader write-up (an accumulation of notes, discussions with management, etc) until the next regular issue which I plan to have out to you early next week. But I have been persuaded by a colleague today who has helped to augment my understanding and appreciation of Sernova that I really shouldn't let any grass grow under my feet before pulling the trigger here... What compels me to add Sernova IMMEDIATELY as a speculative BUY is that, a bit over two weeks ago, Vertex Pharmaceuticals (NASD-VRTX) paid $950 million for privately-held Semma Therapeutics (NEWS HERE.) Semma Therapeutics focuses on using stem cell-derived human islets as a possible cure for type 1 diabetes. Semma's research, etc. is NOWHERE near as far along as is Sernova's, whose U.S.D. market cap is under $40 million. You can learn more about Sernova's progress and rising visibility at ITS WEB SITE. In short, I do not believe we are very far away from a major announcement by Sernova that it, too, has a more engaged "big brother." There have been rumblings about that possibility for a while; and no doubt part of SVA's moving up recently to near a 52-week high (It's at C$0.26/share as of now) has to do with the Vertex-Semma news putting the possibility of something big with Sernova happening back on the table more. I URGE you to take some time to check out the company; again, I'll have a lot more color in the coming few days. But I just wanted to put this in front of you even before the weekend, for those of a mind to take at least an initial position today. MORE ON SERNOVA CORPORATION (From the Sept. 26, 2019 Issue) The idea that a major breakthrough in ending (for the most part) the scourge of Type One diabetes might be at hand is HUGE. Diabetes (all types) is the seventh-leading reported cause of death in America, where over 30 million people are afflicted in total of a worldwide total of over 400 million people. Of the number in America, some 1.3 million people have Type One; sometimes referred to as well as “Juvenile onset” diabetes, as this far worse form usually manifests itself in children/younger people. Ominously, it is no longer the case that this disease is just hereditary. The occurrence of Type One/juvenile onset in people whose family history is void of diabetes has exploded. It is expected that this will contribute to even more acceleration in Type One cases, to as many as five million people by 2050. And as you likely know, the regimen of care for Type One cases is far more involved and serious than for “Type two” that usually manifests later in life and can be largely negated in many cases due to diet, exercise and related lifestyle changes. Apart from LOTS of research into the causes of this growing epidemic, work has accelerated on finding some means to more fully mitigate the effects. As I have said previously within the contexts of discussing companies like Sarepta Therapeutics and Anavex Life Sciences https://nationalinvestor.com/ 2 especially, it is exciting to see medical science moving from coming up with better treatments for certain maladies to potential cures. And as I remarked again last week in adding Sernova Corporation to my recommendations, that they have now scored some initial successes in human trials for their regimen to mitigate diabetes is of special interest to Yours truly! Research work has gone on for some years now into various ways to negate the effects of Type One diabetes especially; from stem cell therapies to various versions of an “artificial pancreas.” To date, efforts that have made it to human trials have failed for one reason or another. By all appearances, Sernova has just broken that losing streak. Anchoring its regimen is a “cell pouch”; a device that can be implanted in the body and which (for present purposes in dealing with diabetes) is the home for cells that will produce insulin; something which the pancreas, of course, for diabetes patients no longer does at all, or in sufficient amounts. A number of ingredients must come together in the end for this cell pouch to be viable, and approved ultimately for development for diabetes patients: among them are safety (no issues or adverse effects from implantation), efficacy (that the cells introduced into the pouch work to meaningfully reduce the blood sugar level swings of diabetes, etc.) and that an overly burdensome NEW issue isn’t created in the process, of the body trying to reject this foreign pouch. Having already demonstrated the safety of its cell pouch in clinical work, Sernova scored perhaps its biggest-ever breakthrough in July, announcing—see https://sernova.com/press/#Press_Releases –in part that “. . .Sernova’s Cell Pouch transplanted with islet cells demonstrated initial safety, as well as key efficacy measures, including glucose- stimulated blood levels of C-peptide, insulin, and additional measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness.” This is the first time that any such in-human trials of any regimen reported such results of transplanted cells substantially reducing “sugar spikes” in the blood, leading to blood levels of the markers showing that insulin- production has been reinstated, etc. “I am pleased with these interim results in the first implanted patient,” said Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and the Sernova study’s principal investigator, in the July 17 news. “The first dose of islets transplanted into the Cell Pouch has shown safety and early indicators of potential efficacy. We found some glucose-stimulated C-peptide and insulin present in the bloodstream, which are the gold standard indicators of islet function. Our team continues the research and looks forward to reporting longer-term results in additional patients as the trial progresses.” https://nationalinvestor.com/ 3 And said Dr. Philip Toleikis, Sernova’s President and C.E.O., “The preliminary clinical data achieved in this patient with our pre-vascularized implanted Cell Pouch represent an early clinical validation for our regenerative medicine technologies as we pursue safe, efficacious, and transformative treatments for patients with hypoglycemia unawareness in type-1 diabetes. With these data from our current clinical trial, in conjunction with our advancing hemophilia A, hypothyroid, and diabetes stem cell programs, we believe Sernova is closer to achieving significant advancements in regenerative medicine treatment.” Indeed, as Dr. Toleikis mentions, Sernova’s cell pouch regimen could one day be the backbone of stem cell and related regenerative therapies that would also target patients with hemophilia, thyroid disease and more. But for present purposes, of course, I’m watching this progress on diabetes. Though the company has received a fair bit of analyst and even broader media coverage over the last few years (see https://sernova.com/press/) the company/story remain largely unknown in the investment community. . . __________________________________________________________ From the issue dated October 21, 2019 Before diving into Ecuador and Cornerstone anew, I want to make sure I highlight the latest HUGE news out of Sernova Corp. of this past week (see https://sernova.com/press/#Press_Releases.) At least, it’s huge—and incredibly exciting—to anyone like me who has unfortunately had to learn the mechanics of Type One diabetes and understands what this latest progress means. Typically, when any of us have gone without food, etc. overnight you have what is called a “fasting blood sugar.” Both glucose levels and insulin are at their lowest levels in the blood during such times; as for insulin or its markers, they are virtually nonexistent. But as the company reported Wednesday, in the patient in its trial, C-peptide—a biomarker of transplanted beta cell insulin production—has now also been detected in the patient’s blood stream during this fasting time. The detection of fasting C-peptide in the bloodstream of the first patient, in addition to Sernova’s recent announcement of glucose-stimulated C-peptide and other early efficacy indicators, demonstrate a normalizing response of the Cell Pouch therapeutic cells to the body’s varied need for insulin production. This is an important step forward and evidence of ongoing islet engraftment within the Cell Pouch. “Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide levels in the patient’s bloodstream after recent transplant, not only following stimulation with a meal but also when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring islet survival and function within Sernova’s Cell Pouch,” said Dr. Piotr https://nationalinvestor.com/ 4 Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator, in the news release. “We look forward to reporting ongoing results in additional patients as the trial progresses.” ___________________________________________________________ From the issue dated November 29, 2019 -- Finally, I had forwarded to me a nice article from a Juvenile Diabetes Research Foundation publication on Sernova Corp. recently, which discussed the company’s progress; it’s at https://www.jdrf.ca/blog/early-results-from-sernova-indicate-insulin-production-in-people-with-type- 1-diabetes/. Though investors still by and large seem to be asleep, it’s encouraging for us getting involved here early on that Sernova has the eyes of such an important body as the JDRF on it. ___________________________________________________________ From the issue dated February 13, 2020-- Back to biotech, and a few comments on Sernova Corp. perking back up over the last several days (their management is among the several I’ll be meeting with downstate in a few days at NobleCon 16, the Noble Capital Markets’ symposium: see https://www.nobleconference.com/sixteen.) As the company’s President and C.E.O. Dr. Philip Toleikis said to me the other day when I joined a management call (and just ahead of some news the company put out, which has injected some life back into things after a long period of quiet), “2020 is going to be a very positive and important year for us for a variety of reasons. . .” Sernova is already the only company working on some version of an implantable “artificial pancreas” (technically not the most accurate term, but for sake of discussion) that has the core device (its patented and FDA- approved Cell Pouch) AND the only one showing efficacy of its implanted, insulin- producing cells IN HUMANS. And as Toleikis shared with me, the huge interest in Sernova from some three dozen meetings it had with other companies and scientists at the recent J.P. Morgan Healthcare Conference (well beyond past interest shown in the company) suggests that the industry is starting to “get” Sernova. https://nationalinvestor.com/ 5 To date, Toleikis has been of a mind to strengthen Sernova’s patent portfolio, make sure that its ongoing patient trials at the University of Chicago are progressing (additional patients are being enrolled now) and set the table for one or more major collaborations with large pharma or medical device companies. The goal is to be the first company to “marry” three elements of a completely functioning “artificial pancreas”: the pouch (check) therapeutic cells that work (just about a check now) and built-in immune protection. On the second of those, the company just announced (see https://sernova.com/press/#Press_Re leases) ongoing success with the survival and efficacy of insulin- producing islets within the Cell Pouch. Generally, the impression I got from management when we visited at length (and the understanding I hope to galvanize in a few days’ time when we visit on the sidelines of NobleCon 16) is that Sernova is to the point where its comfort level with its clinical progress and competitive/scientific advantages will allow it to be more aggressive than ever now. That will come in a few forms, which I’ll be elaborating on shortly. For now, if you’ve not done so at all or lately, visit https://sernova.com/ where the company has recently jazzed up the information on its web site. ____________________________________________________________________________________________________________________ Don't forget that those of you so inclined can follow my thoughts, focus and all daily ! ! ! * On Twitter, at https://twitter.com/NatInvestor * On Facebook at https://www.facebook.com/TheNationalInvestor * Via my (usually) daily podcasts/commentaries at http://www.kereport.com/ * On my You Tube channel, at https://www.youtube.com/channel/UCdGx9NPLTogMj4_4Ye_HLLA https://nationalinvestor.com/ 6 ______________________________________________________________________________________________________________ The National Investor is published and is e-mailed to subscribers from [email protected] . The Editor/Publisher, Christopher L. 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