× CYTX Financial performance development

Q2 Results

10 Aug 2017 15:31 - 11 Aug 2017 06:01 #9800 by fas
Aug 10, 2017
SAN DIEGO, Aug. 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today announced its second quarter 2017 financial results and provided updates on its corporate activity and clinical development.
Second quarter 2017 net loss was $6.0 million, or $0.19 per share. Operating cash burn for the quarter was approximately $5.0 million. Cytori ended the quarter with approximately $9.0 million of cash and cash equivalents.

Selected Key Recent Highlights:

  • STAR trial top-line preliminary data announced. Despite missing primary and secondary endpoints, data showed clinically meaningful improvements in more severely affected patients with diffuse cutaneous scleroderma.

  • American Medical Association approved new category III CPT codes describing Cytori’s scleroderma therapy.

  • BARDA executed a $13.4 million contract option to fund the RELIEF burn trial.

  • Received U.S. FDA IDE approval for RELIEF, a thermal burn pilot trial application related to ongoing BARDA contract.
  • Q2 2017 Financial Performance

  • Q2 2017 and year-to-date operating cash burn was $5.0 million and $9.9 million, compared to $5.7 million and $10.7 million for the same periods in 2016, respectively.

  • Q2 2017 and year-to-date total revenues were $1.5 million and $3.1 million, compared to $2.8 million and $5.7 million for the same periods in 2016, respectively.

  • Cash and debt principal balances at June 30, 2017 were approximately $9.0 million and $14.2 million, respectively.
    Q2 2017 net loss was $6.0 million or $0.19 per share, compared to $6.4 million or $0.43 per share for Q2 2016.

  • Year-to-date adjusted net loss was $11.9 million, or $0.44 per share, and excludes a $1.7 million non-cash charge for in-process research and development expense from the Azaya Therapeutics asset acquisition, compared to $11.7 million or $0.84 per share for the same period in 2016.

  • Year-to-date GAAP net loss was $13.6 million or $0.50 per share, compared to $11.7 million or $0.84 per share for the same period in 2016.

  • “Based on ongoing analysis of our STAR trial data and observed clinically meaningful improvements in the diffuse cutaneous subgroup, we intend to meet with the US FDA as soon as possible for a post-trial meeting to chart next steps. It is important that our HabeoTM product ultimately be made available for these patients,” said Dr. Marc Hedrick, President and CEO of Cytori. “In addition, manufacturing validation for our ATI-0918 nanoparticle doxorubicin oncology product is on schedule for filing for EMA submission mid next year and other key trials continue to enroll, ideally completing enrollment of both, Scleradec-II and ADRESU by year end.”

    Selected Key Anticipated Milestones:

  • Complete analysis of STAR full dataset and subsequent meeting with FDA to determine next steps for Habeo clinical development for scleroderma hand dysfunction (Q3).

  • Begin enrollment of BARDA’s funded RELIEF burn trial (Q4).

  • Complete manufacturing activities required for submission of an MAA to the EMA for our recently acquired nanoparticle doxorubicin (Q4)
  • .

    2017 Financial Guidance - Updated

  • The Company expects full year 2017 operating cash burn to be higher than 2016, primarily due to the development of assets acquired from Azaya Therapeutics.

  • Updated operating cash burn forecasted to be within a range of $20 million to $23 million, a reduction from previously guided range of $26 million to $29 million.

  • Management Conference Call Webcast

    Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID:67113805.

    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

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    10 Aug 2017 19:59 #9801 by myownhedgefund
    Well I dont see any commentary on the call...I guess not much happened. Surprise there. I may get to it later tonight or maybe not until the weekend.
    A few comments from the release today.
    Note, only a quite glance but telling imho !
    YTD sales down 46%
    Cash 9 million, Debt 14.2 million (market cap 11.4 million from Yahoo)
    Reduced burn may gain them a little time into October.
    Everything else too late without a cash infusion !!!!!

    :cry: :evil: :puke: :bash:

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    11 Aug 2017 04:14 - 11 Aug 2017 04:43 #9802 by fas

    myownhedgefund wrote: Well I dont see any commentary on the call...I guess not much happened. Surprise there. I may get to it later tonight or maybe not until the weekend.
    A few comments from the release today.
    Note, only a quite glance but telling imho !
    YTD sales down 46%
    Cash 9 million, Debt 14.2 million (market cap 11.4 million from Yahoo)
    Reduced burn may gain them a little time into October.
    Everything else too late without a cash infusion !!!!!

    :cry: :evil: :puke: :bash:


    Agree- everything too little and too late.

    As customary, I was sound asleep when the call was held and limited myself this morning to reading the Seeking Alpha transcript which you can do too if you like- link HERE

    Key messages that were delivered were 1. they consider the STAR results as a successful P3 despite the SS failure in the primary and secondary endpoints in view of the "almost" SS in the diffuse arm and still see major value in the app. 2. they have to raise capital this year, which we all know.

    The first assessment I could agree with- it is clear to me that several injections (as already known from OA) can create a major placebo effect in the "limited" arm, but they should have known that. It all depends on the outcome of the FDA (and MLHW) meeting if this is continuing story. Of course- any potential partner would wait for that too.

    Kolbert smells money again apparently- he even compared the STAR results to the initial reaction on Genentech´s Avastin results...lol :grin:

    Partner money from Doxo is also some time away until the production tests are finished in San Antonio, so what is left is the capital market. The LPC deal cannot be used at present, but apparently has been tapped already this quarter before the STAR announcement. :whistle:

    Surprising- no announcement of stringent cutting of expenses, like lay-off´s or salary caps etc etc- just the pre-marketing plans for scleroderma have been scrapped for obvious reasons. That is the cause for the reduction in expense guidance for 2017 to 20-23 Mio. Very strange this all.

    Of interest- in Japan- customers have achieved approval to treat patients similar to the OA app for several other indications, amongst them periodontal disease and peripheral artery disease. Two obvious apps, which according to Lodge Research and Intelligence (:grin: ) have been developed by IIS clinics in Japan (and Europe) which remain unpublished.

    Anyway- it looks like Cytori will (again) get new ownership and former/present shareholders will (again) be robbed from their invested money.

    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

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    11 Aug 2017 07:04 #9803 by fas
    Continuing to think about my last post-

    I think we have an absolutely weird situation. Basically with a 9 mio market cap, the capital market is un-available - not only because of nasdaq rules, but also because no meaningful amount of money can be raised if those rules would not exist.

    Still- at Callan Road it seems to be business as usual- acting like there are no issues, besides acknowledgement that capital is needed.

    Are they living in a dream world?

    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

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    11 Aug 2017 09:25 - 11 Aug 2017 09:35 #9804 by franshei
    FAS and Hedge From the CC, I have some thoughts

    1. CYTX , as it stands with various half cooked projects, is still a "workable" company.

    2. It needs CASH to run the engine. Today's Maxim commentary on this subject is exactly what I have been thinking. CYTX should not go to the Street to raise fund at this low PPS. It is suicidal. Instead, they should go for a corporate strategic partner with a deep pocket for cash and guidance (instead of going on clueless).

    They should sell or partner Cytori KKK, the only valuable asset. Cytori KKK brings in only $ 4 - 5 million a year with only a few sales reps. If this subsidiary could bring in enough money till CYTX can sell lipo doxo, I think it is worth the efforts.

    3. Scelroderma is not dead. But, I think another phase 3 is needed in the diffuse cutaneous patients, where the placebo effects are not significant. FDA would likely ask for this for approval.

    Even so, if the Sclerodec 2 is positive, I would go for an EU approval filing and use the STAR data as supportive. I believe further followup for the STAR trial (for another 24 weeks) would generate statistical significance for Habeo among the diffuse cutaneous patients.

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    11 Aug 2017 10:09 - 11 Aug 2017 10:43 #9805 by franshei
    Fas and Hedge

    If I were Chris Calhoun (who still lives in San Diego), I would form a consortium to take control of CYTX. Not much money now.

    The consortium should consist of the present owners of Okyanos, K T Lim and Arab money managers. They can do better than what Dr. Xu is doing with KOOL.

    Obviously, a friendly takeover requires the approval of the board. Such a move would surely mean the removal of David Rickey and others. I think Hedrick may have to go as well.

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    11 Aug 2017 10:46 #9806 by fas

    franshei wrote: Fas and Hedge

    If I were Chris Calhoun (who still lives in San Diego), I would form a consortium to take control of CYTX. Not much money now.

    The consortium should consist of the present owners of Okyanos, K T Lim and Arab money managers. They can do better than what Dr. Xu is doing with KOOL.


    That is what we all should fear of course and what I already wrote about 20 months ago. Your earlier suggestion of a corporate partner with deep pockets has been eluding Cytori for the past 10 years, so it is not rational that they would succeed under acceptable terms in a period of great financial distress.

    But who knows- key is- something has to be cooking for Cytori to remain a going concern - I think we all agree that the capital markets are closed for them.

    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

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    11 Aug 2017 11:37 - 11 Aug 2017 11:40 #9807 by franshei
    FAS

    1. CYTX would be very dumb to go on with delisting and r/s. The market cap is now under $ 10 million. Further r/s would turn the market cap to be $ 1 million.

    2. There are not many choices for the company now. Even if it is a fire sale, it is a win win situation for all, including Rickey and Hendrick.

    3. If Calhoun and his friends can come in and turn this ship around with cash and new visions, after 3 years of meditation and planning. Let it be so. In business, there is no lasting enemies, but there is lasting mutual benefit.

    Just look at STEM, KOOL and many other examples.

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    11 Aug 2017 13:01 #9808 by fas

    franshei wrote: FAS

    1. CYTX would be very dumb to go on with delisting and r/s. The market cap is now under $ 10 million. Further r/s would turn the market cap to be $ 1 million.

    2. There are not many choices for the company now. Even if it is a fire sale, it is a win win situation for all, including Rickey and Hendrick.

    3. If Calhoun and his friends can come in and turn this ship around with cash and new visions, after 3 years of meditation and planning. Let it be so. In business, there is no lasting enemies, but there is lasting mutual benefit.

    Just look at STEM, KOOL and many other examples.


    Sure- however you make one big mistake. You do not really think, with the back up of Saudi capital, the take-over Company would be a listed one, would you?

    No- of course not- they would take the Company private and leave out current shareholders.

    For you who I believe stated one time that you owned > 250.000 shares pre-split, with I presume an acquisition cost of average 3-4 $ per share, like most of us old-timers, will have his 1 Million hard cash reimbursed with something around 20.000$ or so.

    Is that to your liking?

    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

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    11 Aug 2017 14:02 #9809 by franshei
    FAS

    Indeed, the longs have lost their shirts.

    I am trying to figure out how would the company going from here. Of course, I do not understand how the Arab money would do, if it is indeed the source of money.

    Several things are obvious wrong in this CC.

    1. The ATI 0918 project is behind schedule by at least 6 months. There is no internal know hows. We are dealing with a bunch of rookies. The "pilot" manufacturing site is till being set up and it still requires validation and FDA inspection. Bulk synthesis has not even begun. The analytical lab has just set up. If you listen carefully, Hedrick has some reservation if the stability tests would run on schedule.

    2. The partnership talks for ATI 0918 are still in very early stages. Actually, the company has often use "distributors", instead of "partners". There is a big difference between the two.

    3. ATI 1123 has now been highlighted. There is no in house qualified people to do oncology phases 1 - 3 studies. This is a very specialized clinical r/d area. Even most CROs cannot do them. Most oncology studies are directly or indirectly controlled by major cancer centers, NCI, EROTC, etc.

    4. Right now CYTX appears clueless in the search for survival. Even Jason K of Maxim is more blunt than ever before.

    This is why I think they need a white knight for cash and guidance.

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    11 Aug 2017 16:01 #9810 by fatboy
    Fas wrote:

    This is why I think they need a white knight for cash and guidance.


    They need a miracle and it ain't coming. This company is dead. I wish I could dance on the grave. I should be able to. It cost me more money than any of you would believe. I hate this fucking company.

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    11 Aug 2017 17:10 #9811 by franshei
    The exchange between Jason K and Hedrick can be considered very blunt and we can interpret our own ways.

    Jason seems to comfort Hedrick for being around during this difficult time (failure of a key study) and face the MUSIC!

    WOW! What music? Swan song?

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    11 Aug 2017 19:08 - 11 Aug 2017 21:53 #9812 by waddlingwillbologni
    What perhaps is not understood, is that Hedrick doesn't deserve consoling hugs from Kolbert just for staying around, but rather, pain and punishment. By staying around, he's simply robbing more people, draining more people's accounts. He's not doing it for patients. He's not doing it for shareholders. He's doing it because he knows he'll never see 600k a year again, ever. This is exactly why companies like this shouldn’t be permitted to publicly trade. By prolonging this mess, his greed will continue to garner the attention and hatred he deserves until the day he eventually buries himself. It happens all the time in many arenas of life. People need to know when to walk away. Like the killed drug dealer who just wanted a million more ...

    Franshei,
    All this time you spend speculating about "why not a partner", "why not a strategic partnership", "why not replace Hedrick", etc., have you ever considered that NOBODY wants to form a strategic partnership, NOBODY wants to replace Hedrick? Would you hang your hat on a pile of shit? Further, I have no idea why this board keeps speculating about Calhoun and Celactive when Hedrick has been quoted as saying there’s no involvement -- even he's not dumb enough to blatantly lie like that.

    Fas,
    Are they living in a dream world? I'm more inclined to believe it's a world where Hedrick and his crew of D-list doctors have everybody doped up on prescriptions such as Xanax and Fentanyl. Never assume someone's decency based solely on degrees. These are the type doctors telling women they may have breast cancer so they can charge their insurance companies for merely playing with their tits, torturing their minds.

    This company has been firing shots in the dark and throwing caution to the wind for as long as I've been acquainted. With other people’s money. Plain and simple. Careless. They’re just desperate, dumb, and indecent. There is no other way to flip this fiasco. A blinding glimpse of the obvious. Hopes and dreams, human nature's way of wishful thinking -- it's all bullshit. Face the facts, folks. This company sucks. Trust Waddles -- he's told you play by play what was going on up until the scleroderma trial failure and simultaneous acquisition. I believe I also told you about the OA failure in advance. The devil is in the details, and the details of this company are found with a focused analysis of the top people running it, i.e., nobody impressive and/or obsessive, at all. Absolutely ZERO intensity. Just the lay down and lazy type who got picked on all their lives. No balls. No obsessive compulsive plans or strategies geared by maniacs who play to win. None. Just little boy lies with a decent quality of life in sunny San Diego. On other people's dimes. Oh well.

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    12 Aug 2017 20:37 - 12 Aug 2017 20:40 #9820 by myownhedgefund
    OK...read the transcript for the Q2 call. I always prefer the live voice replay but just dont have the heart or time right now.
    I agree that they have the cash until December...maybe even year end if they are very lucky,
    The plan is all spin for the FDA.
    2 paths with LPC...either they come away with FDA news that gets the PPS back in line with the terms of the agreement to allow capital raises or another R/S in which case the deal is again viable with the new post split PPS. Neither option will fare well for existing shareholders.
    I see no partnership or partial sale of any kind in 2017.
    Somehow, they seem to think they will raise money through equity financing.

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    14 Aug 2017 09:56 #9821 by franshei
    Hedge

    Thanks for your top line readout on the CC.

    1. Should CYTX go for some kind of "secondary" at this low PPS, what and how would it be? Any speculation?

    2. If indeed there is a "draw" from the "self registered shares", the likely reason maybe simple: the company may not be able to find a good deal through a buyer at this time (not to be benefits of the stockholders).

    Realistically, the cell therapy portion of the company has very little value, without some kind of government full approval. In Japan, I think the company has really tried hard to sell its products and yet the revenue is only about $ 1 million per Q.

    The AZA ATI 0918 manufacturing (including plant validation) and then 6 months to 1 year of stability are still very iffy. Why iffy? Company has no good track record and the current San Antonio facility requires a lot of staffing and procedure strengthening. Currently, this pilot plant is located in a strip mall (not really a place for making carcinogenic drugs). It is very, very hard to attract qualified pharmaceutical scientists to this location.

    AZA does not really have a good reputation in San Antonio - AZAYA Tech is still a going concern in Tx - some kind of alternative medicine/life style company.

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    14 Aug 2017 11:04 #9822 by myownhedgefund
    franshei
    I don't see anyone doing a Maxim style deal sub $1.00
    LPC needs to be above $0.50 to tap...much higher imho to get real benefit of volume sales.
    Either way...how much time will they buy themselves ? History suggest 6 months +/-

    To me, the plan sounded clear...FDA meeting then go from there depending on the result and PPS.
    I am assuming we will know more come Sept.

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    14 Aug 2017 13:02 #9823 by franshei
    Hedge

    CYTX has a good discussion re STAR data readout and some aspects of a FDA meeting.

    The management makes two important points: 1. more detail STAR data and top line data readout may differ - worse or better, hard to guess; 2. CYTX does not believe STAR data would win a FDA approval.

    Obviously, the pending FDA meeting is still far off. FDA would require a STAR data/study summary brochure and company plan to review, before scheduling such a meeting (FDA does not want to waste time). During this meeting, CYTX needs to bring their consultant experts. After the meeting, FDA would take a least a month before a company response.

    VCEL has a CA study in about 120 patients for treatment and placebo. The study was completed and analyzed (for over one year). The study is considered positive, by meeting the primary endpoints. They will meet with the FDA end of September. Even though VCEL has priority review status and inclusive consideration under the 21st century FDA acts, the company is not 100% certain if their product would be approved with current data. Even though the VCEL study is considered robust, a product partnership is still pending.

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    14 Aug 2017 13:10 #9824 by myownhedgefund
    So you don't think Cytori will have the additional data analyzed by the end of next month ?

    I was thinking it would be to their benefit to disclose (assuming they can find something positive at least in their eyes) it ASAP.

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    14 Aug 2017 14:16 #9825 by franshei
    Hedge

    It is very hard to read the tea leaves now. Over the years, I have tried to look into the positive side.

    Actually, CYTX has always been very evasive. Tiago has always been very vague. Remember the first r/s came to all us as a big surprise, then there were so many secondary offerings each time with ridiculous prices. Taigo told people many times warrants' hedge nature killed the PPS. It looks like the company may still issue more warrants in each new secondary.

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    14 Aug 2017 15:40 #9826 by myownhedgefund
    Positive has certainly been hard over the years as there was so much to see that was obviously being done wrong...at least imho and it was often easy to see before each new disaster struck. Still, I did have hope that somehow the science would win out. In the very early days I even had hope that CC would grow into the role. That said, and having spoken with many top level corporate exec's over the years. I pretty much always felt one on one conversation was not worth my time here.

    As far as the first R/S, I thought it could have been as much as 1:20...they settled at 1:15 thinking it as enough to save them from sub $1 ever again....DOV was upset and thought 1:10 was enough. None of it matters now anyway. I still think another R/S is their best option if they want to try survival. Especially now based on your comments on FDA response times ! At least then the LPC deal avoids warrants. That still only saves them so much due to NASDAQ rules and dilution % so I feel Maxim will again play a role. In which case will we again be looking at 100% warrants to go with the offering ? Who knows.
    So, I am right back to my assessment post transcript read....if they do raise funds it will be at record low pricing and not fare well for existing shareholders.

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