And now there is this.
Ocata is a promising biotech, but there is a lack of a solid valuations.
Cowen & Company initiated coverage with an OUTPERFORM ranking, but no price target.
Shareholders are frustrated with the share price and management, but those frustrations may be misplaced.
I present a method for valuing early stage biotech companies.
While it is speculative, the valuation range for Ocata shows a compelling investment opportunity.
While this may be risky, I am going to start off my first article by claiming something dramatic. Shareholders and followers of Ocata Therapeutics (NASDAQ:OCAT) are clueless about what it is worth and what the share price should be. Now before you run away, let me assure you that my goal here is to come up with a valuation based on realistic expectations and alleviate some of the frustration that shareholders feel. I am long OCAT and highly invested for my size of bank account. I strongly believe in the future of the company, but also want to maintain some degree of objectivity.
About a week ago, Cowen & Company initiated coverage of Ocata with an OUTPERFORM ranking. They did not however give a target price. The coverage and ranking were good news, but seemed to only further frustrate some shareholders. Most of the debate surrounding Ocata focuses on management and the share price while the biggest factors in their eventual success or failure, the clinical trials, are seldom discussed beyond "the science works" or "I believe in the science." Let's then only briefly touch on the science before we get to the good stuff.
Ocata will soon be starting Phase 2 trials using their Retinal Pigment Epithelium (RPE) Therapy for dry Age-related Macular Degeneration (AMD) and Stargard's Macular Degeneration (SMD). According to the National Institutes of Health, AMD is the leading cause of severe vision loss in people over 50 and SMD is the most common form of juvenile macular degeneration. Ocata claims there are approximately 1.8 million new cases of AMD per year in the US, and 90,000 patients currently with SMD in the US and EU.
Ocata's RPE Therapy is described in detail in their June 2015 corporate presentation. It states that the RPE layer in the eye is required for vision and maintenance of photoreceptor health, and that the loss of this RPE layer results in loss of vision. Ocata makes two statements to describe their treatment: "Ocata's therapeutic approach is to transplant [a] new RPE layer [to] help restore vision" and "Organ transplantation is well-established, our RPE products are simple micro transplants of support cells required for functioning infrastructure at the back of the eye."
The Phase 1 results published in The Lancet and Stem Cell Reports have been impressive. Phase 1 was officially a safety trial, and safety was observed, but there was also evidence of repair and restoration. Most of the patients showed improvement in visual acuity. For SMD, Ocata has pivotal trial status and advanced-therapy medicinal product (ATMP) classification in Europe. They already have orphan status and are meeting with the FDA to discuss a special protocol assessment (SPA).
Ocata is focused on Regenerative Ophthalmology and their AMD/SMD trials, but they have a number of other programs in development. They have Phase 1 approval to begin testing their RPE Therapy for Myopic Macular Degeneration (MMD), but haven't announced plans to start the trial. Pre-clinical work is being done replacing photoreceptors in the eye that could complement and enhance their RPE Therapy. They are looking to partner their blood platelet program, and are working on treatments for a number of autoimmune disorders. Part of their work on autoimmune disorders will be presented at the International Congress on Systemic Lupus Erythematosus in September.
Gypsy, why would someone have others join their scam? Risks being outed and reduces the pie. Makes no sense. But then again, gypsy's are known for being scammers.
Keep, I have nothing to base this assertion on except reasoning, but I think the delay in launching P2 is due to funding (now resolved for the short term) but more importantly the protocol change which requires each of the participating centers to review and adopt the change. CR ( Note to the librianian- this post is covered by copywrite laws. You may not reproduce this comment without the express, written consent of the author)
Zit - If you were running a dilution 'scam' would you add senior level folks that were eligible for options, grants etc? Why lessen your take? Poorly managed yes, a scam doubtful.
Zit - This shows your ignorance. $4 is meaningless in the context you're using. Fewer shares and $100 pps it could be either a bargain or a dud. And tell us when split adjusted the stock was $700.
Of course the company has potential but to ignor legitimate issues is plain stupid. All the wrenching done by some in response to the post doesn't change the fact that those types of questions are being raised and need to be answered. The best answer to technology questions is with trial results.
Kip, don't be a putz. The article with the comments that I posted came out yesterday. The response you noted has been out a few weeks. Am I a basher? Read my posts before you opine.
Kip, no matter how much frothing from the mouth (or cut and pastes of lay people) either side displays, the simple fact remains that not everything has been resolved around the technology - otherwise the company wouldn't need to be continuing trials. Additionally, there are non tech issue that need to be considered with Ocata. So questions like the ones raised in this article (I don't think much of the author but included it since he quotes supposed medical professionals) are helpful for anyone that is truly looking to make informed decisions.
Keep, the post isn't good nor bad - it's simply information. Just because these individuals raise questions about the results doesn't make them right, nor does it make the company a scam. There have been other independent views that have supported the science. If you truly think it's a scam you're a fool for staying invested in the stock and any loses are your fault.
The company will certainly have to address these and other issues.
real estate, they say the secret to success is location, location, location. In biotech investing, particularly early stage biotech, I would say it’s science, science, science. If you don’t believe in the science, it’s time to move on. I’ve hit that point with Ocata Therapeutics (OCAT). As previously posted, I reestablished a position about 30 days ago after over 4 years on my watch list. I still didn’t trust management, but the science seemed possible and the recent capital raise had lowered the stock price. Since that time, the experts have been lining up against Ocata and its science.
It started with a Lancet article, the very publication that published Ocata’s early results. What was basically a letter to the editor that was published, a leading expert in the field questioned Ocata’s trial results as published in the earlier paper. Two points in the rebuttal were significant. They were as follows and I quote,
“In a large natural history study of bilateral advanced dry age-related macular degeneration, we identified that nearly 20% of patients spontaneously improved by two or more lines of vision in their worse-seeing eye over time, despite the fact that the area of the scotoma had enlarged further.”
And, an even more direct statement about expectations of positive results,
“Transplantation of stem-cell derived retinal pigment epithelial cells cannot restore vision”
Next was a Nature article with this little snippet,
“A safety study has demonstrated it to be safe in the short term, but the expert doubted the clinical effectiveness, as the vast majority of patients with Stargardt macular dystrophy who may benefit from stem cell therapy need replacement of both RPE cells and photoreceptors and this technology only replaces RPE cells.”
Last, but not least, International Society For Stem Cell Research had an abstract with the following as it relates to cell suspension injection, Ocata’s method for delivering the cells,
“In many transplantation studies, includ
Nope, asking the Librianian, aka BC. And to keep you updated, that developmental drug company that got me looking into treatments for AMD went under quite some time ago.
Hey bearchit. Search your little files for something that explains which of those side effects were related to stem cells. Think ya can do that ya little librianian?
Far from a hunter - gatherer, that little injun is. Gathers up everyone else's posts and reconstitutes them and thinks that makes him look like one that's smart about wampum. He must have a large data storage plan.
On the ihub board you'll recognize Karly as the more cordial Captain Kirk.