Cytori Therapeutics Inc (CYTX - NASDAQ - $0.59 )
Target Price: $7.00
Enrollment in ACT-OA: US Phase II Trial for Knee Osteoarthritis
Cytori announced that the first patient has been treated in its FDA-approved trial assessing the effect of its adipose-derived, point-of-care cell therapy fraction for osteoarthritis of the knee. The patient was treated by Dr. Peter Hanson, Medical Director of Orthopedic Surgery at Sharp Grossmont Hospital.
ACT-OA is a Phase II, FDA-approved, randomized, double-blind, placebo-controlled trial in n=90 patients evaluating the efficacy and safety of Cytori’s autologous adipose-derived therapy ECCO-50 (Cytori’s therapeutic under study). The trial tests both a low dose and a high dose vs. placebo, and will be conducted over 48 weeks. The randomization will be 1:1:1 between the control, low dose, and high dose groups. The primary endpoint will be pain on walking as measured by the Knee Injury and Osteoarthritis Outcome Score at 12 weeks. Secondary endpoints assessed will include pain, joint function, magnetic resonance imaging, and adverse events.
Conclusion: We see Cytori more focused now on shorter trials that have the potential to provide real proof-of-concept (POC) data in late 2015 and early 2016.
The New Cytori: Lean and Focused. Cytori is waiting for PII POC data to create a value inflection before the company commits to a clinical pathway. Focusing on indications that meet the hurdle, such as OA and Scleroderma, and not those that don't (hamstring injuries), while seeking a partner for others (CV).
Thermal Burns and BARDA. The BARDA contract is worth up to $106M in non-dilutive capital. A $12M contract option was recently executed, and another $8M will come following completion of the pilot clinical trial for burn injury and IDE approval.
Scleroderma and Osteoarthritis. Cytori continues to diversify the ADRC therapeutic indication with movement in the scleroderma trial. The scleroderma space has 70,000 patients in the US, and Cytori believes that they can take a large market share relatively easily for this unmet need. In osteoarthritis (knee), Cytori is currently evaluating ADRCs in the RECOVER (phase I/II) trial, which is expanding from 10 patients to 90 in 2015. The company has also received approval for an IDE trial in osteoarthritis, which is expected to enroll in 2015.
Urinary Incontinence and Japan. Currently, the Japanese government-sponsored pivotal clinical trial is being reviewed by the MHLW and should commence enrolling in 2015. Also, the new regenerative medicine legislation should favor Cytori, as the ADRCs are already approved as an autologous, POC therapy. This could set the stage for Cytori to capture significant revenues in Japan, a country with four million urinary incontinence patients. Success in Japan could aid in clinical development here in the US (25 million patients).
Valuation. We assume Cytori will be successful in scleroderma and multiple other indications utilizing ADRCs (thermal burns, stress urinary incontinence, and osteoarthritis). We apply a 25% risk cut to our therapeutic model and a 30% discount to financial models for FCFF, discounted-EPS, and SOP to arrive at our new $7.00 price target.
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The following user(s) said Thank You: d9dozrman, keysman
i got a very strange feeling because after 15 years because I sold all of my shares (+/- 200k) with 55% loss those last 2 days on the pump to 0.64$...
after 15 years i have NO shares anymore in Cytx ...i never thought i could do this....but i have my reasons and i decided to never buy any shares anymore of CYTX till they resolved their cash problem...maybe we open at 1$ one day when they announce partnership with upfront cash or they got a great financing deal (lol) but i don't care if i miss this...90% chance is that we get an awful deal again at 0.4$ or lower for Sabby or other crooks so my bets are that after the pr of financing we will be much lower...after financing deal that will resolve the cash issue for a longer time then i'm again a buyer...i think also a 1/10 or 1/20 r/s is coming after the financing...good luck to you all...and i know we have so much good things in the pipeline those next months(china,japan,athena results,lorem,barda,...) but we have those pipelines(and others that are already gone) already 10 years or more...i have had it...no cash=no future and declining sharesprice...resolve the cash issue and I'm all in...
Certainly everyone can sympathize with your frustrations. Where and why this pop came from is anyone's guess. No gaps and it has held closes above $0.52 (so far).
Since I am in full "show me" state of mind I am reading little into it at this time.
1. A major short cashing in
2. Leaked positive news/rumor
3. Pump to let Sabby get the last of his shares out before the next financing
4. Absolutely nothing.
Time will tell where we go from here.
I wish you luck on your future investments either here or elsewhere !!!
You know hedge , I can think of no other reason then misery loves company that we sit here jerking ourselves off thinking something is coming of this. I don't mean to be crass but it's al been and continues to be bullshit. There is abosolutely nor reason to speculate on this. Cytori os going to run away from no one. This went from a company with a fighting chance to a penny stock. Still waiting for that imediate impact from Japan,something anything,when is next call?
I know that many people here are under water / -60% or more...
The pain is high and the negative emotion play a key role. So many missed opportunities, nearly bancrupt...
Can Hedrick learn out of the past management mistakes and make it better ? i think yes he can. He has the negartive experience and he can learn, he is a well educated guy.
But in my career of loosing money with shares (and i lost enough) the question is for me - Is the share prize high or low? I think the prize is low -- 50 Mio Market Cap -- athx has 200 Mio. I hope that the deal with sabby is that the next offering is not at 0.5. Perhaps at 1$ 30 Mio shares. !$ p, i think low...
rothco...you have a way with words...but as I posted on this thread I am reading little into this latest pop even though I have a full position on. BTW I have no plans to buy additional shares no matter how cheap it gets or what positive (LOL) news comes. In Japan, until officially informed otherwise, I believe they have no plan for Japan. Just to stumble along as usual and "hope" something happens.
Old Young Fox...Hedrick's new skin is thin and can easily be shed back to the old ways. Poor management is hard to change imho.
agamenus...Everyone knows or should know its one name that controls Sabby despite how the filings distribute the shares. Otherwise, your post is in keeping with me disagreeing with pretty much everything you post.
The following user(s) said Thank You: Old Young Fox
old fox, Cytori's $50M market cap is low for a company with a very promising Phase III scleroderma among all the other good shit.. However, Enterprise value is more relevant as it includes the debt which is the biggest problem as we all know. Until Cytori removes the dilution risk everything with regard to the stock price is non-sustainable noise. On the other hand, Athersys is in much better shape financially and a $200 million market cap is a steal if stroke results are good as I suspect they will be, There is a vast amount of independent data related to the spleen's role in stroke, which is the target of the Athersys therapy. These data, some in actual stroke patients, supports the likelihood of efficacy in an indication without a therapy after the first few hours following onset. I expect $4.00 in ADVANCE of the results. On the bright side for CYTX, look at HART.... doubled after recent capital raise. HART is an extremely risky regmed company and the business model is poor, IMHO. Yet they successfully pulled off a capital raise.
The following user(s) said Thank You: Old Young Fox
Wall Street Titan: the biggest problem with Cytori for years seems to be a death spiral of a constant need for cash and then dilutive financing. The Athersys CEO made a wise move last February (I think it was February) to raise plenty of cash. The Cytori CEO did not make the same wise move. With the steady flow of good news and data, and the last two weeks of price movement, it seems possible now, however, that other investors will save Cytori from itself and unlock its real value.
agamemnus, yes cash is the main problem but there have been too many screw-ups year after year and bloated payrolls. Putting $20,000,000 of debt on the books was also a mistake with such a short maturity. Luckily, the new CFO is a keeper and has brought some financial discipline and contols into the picture. What kills me is that there is more evidence that the technology works than most any other cell therapy. Not to mention the hundreds of clinics in the U.S. using SVF with lesser technology. They will be in the driver's seat if they can dig out of this hole without too much more damage.
but the only winner is Sabby here...there are probably selling all their sharers with 30-40% gain ....they are investors in Cytx for a few months and they take the gain the longs should have...i should have waited longer to sell today but hey i haven't seen a PR about their cash problem...that is what i'm waiting for...if they can have a partnership deal with upfront cash i 'm a buyer of the stock or even if they could get 50 million $ or more with a dilution offering, i would also buying...the big difference is that in case 1 i'm buying at 1.5$ or more and in case 2 at 0.4$ or lower...we will see.congrat for those that bought in the 40's and are selling now but i bet all the longs keep their shares and are waiting till more news comes out...i hope for you that it's case one but it think honestly (after following Cytx all those years) we are watching an orchestrated pump and dump where sabby can unload with big profit before he will be involved in another offering...