Welcome, Guest
Username: Password: Remember me
CYTX Financial performance development
  • Page:
  • 1

TOPIC: Q2 2018 Financial Results and Call

Q2 2018 Financial Results and Call 15 Aug 2018 12:49 #12182

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3358
  • Thank you received: 1116
Aug 14, 2018
SAN DIEGO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced Q2 2018 financial results and provided updates on corporate activities.

Q2 2018 net loss was $3.7 million, or $0.59 per share. Operating cash burn for Q2 was approximately $2.7 million. Cytori ended Q2 with approximately $3.1 million of cash and cash equivalents, or approximately $8.8 million pro-forma at June 30, 2018, when considering $5.7 million in net cash proceeds received from a public rights offering which closed on July 25, 2018.

Cytori is developing for manufacture its lead chemotherapeutic drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of demonstrating bioequivalence to the European reference drug. Our Nanomedicine team in San Antonio, Texas continues to complete activities in support of a Marketing Authorization Application (MAA) to be filed with the European Medicines Agency (EMA) next year. The Company also continues to engage potential commercial partners for ATI-0918 in Europe, Middle East, North Africa, North America, and Asia Pacific. Furthermore, for Cytori’s ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, the Company has requested an orphan drug designation from FDA for small cell lung cell cancer and is evaluating the FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

Our Cell Therapy team is awaiting data readouts from clinical trials in scleroderma and urinary incontinence and is actively conducting a clinical trial in thermal burns. 6 month data from the 40 patient, French SCLERADEC II clinical trial (scleroderma) is expected before the end of 2018 and 1 year data from the 45 patient, Japanese ADRESU clinical trial (urinary incontinence) is expected in early 2019. Finally, U.S. FDA has approved a protocol amendment for the RELIEF thermal burn injury trial sponsored by BARDA intended to facilitate enrollment. Cytori completed a successful In-Process Review meeting with BARDA this past June. Thus far, Cytori and BARDA have initiated 2 of 8-10 anticipated U.S. clinical sites.

In Japan, Cytori continues to see favorable growth trends in the use of its commercially approved cell therapy products in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year over year growth in consumable utilization.

“Our primary corporate objective is to file for European market approval for ATI-0918, our lead oncology drug product. We have also expanded the development of our pipeline drug, ATI-1123, in the U.S. and we are priming it for phase II evaluation.” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “We are also pleased with the quarter-over-quarter and year-over-year results of our commercial Cell Therapy efforts in Japan that are primarily focused on consumable utilization. This provides a growing business and infrastructure in anticipation of the SCLERADEC-II and ADRESU trials, in 2018 and 2019, respectively.”

Q2 2018 and year-to-date Financial Performance


  • Q2 2018 and year-to-date operating cash burn was $2.7 million and $6.8 million, compared to $5.0 million and $9.9 million for the same periods in 2017, respectively.

  • Q2 2018 and year-to-date total revenues were $1.6 million and $3.2 million, compared to $1.5 million and $3.1 million for the same periods in 2017, respectively.

  • Q2 2018 and year-to-date consumable utilization in Japan grew by over 70% and 60%, when comparing to the same periods in 2017, respectively.

  • Cash and debt principal balances at June 30, 2018 were approximately $3.1 million and $13.0 million, respectively.

  • Q2 2018 net loss was $3.7 million or $0.59 per share, compared to a net loss of $6.0 million or $1.94 per share for Q2 2017.

  • Year-to-date net loss was $8.1 million or $1.32 per share, compare to an adjusted net loss of $13.6 million or $5.04 per share for the same period in 2017, respectively.
  • Selected Key Anticipated Milestones:


  • Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.

  • Receive Orphan Drug Designation and 505(b)(2) pathway feedback from the U.S. FDA for ATI-1123.

  • Enroll burn patients in BARDA-funded U.S. RELIEF clinical trial.

  • Report 3 and 6 month French SCLERADEC II clinical trial data for scleroderma hand dysfunction.

  • Report 1 year Japanese ADRESU clinical trial data for post-surgical male stress urinary incontinence.
  • Please Log in or Create an account to join the conversation.

    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:

    Q2 2018 Financial Results and Call 15 Aug 2018 13:12 #12183

    • fas
    • fas's Avatar Topic Author
    • Offline
    • Moderator
    • Moderator
    • May the fat be with you
    • Posts: 3358
    • Thank you received: 1116
    The reported numbers are what one would expect- the revenues are what they are and cost control is decent- still the cash burn exceeding present means, considering Oxford.

    I read the transcript from Seeking Alpha - link- HERE and had the impression the call was pretty short and with little new things.

    ATI-1123 looks rather promising but they need a partner- same for 0918 for Europe and there is a sense of urgency there because of upcoming competition.
    Scleradec II results will come sometime this year, ADRESU either late this year- more likely early next and need 1-1,5 year for approval until launch.

    So- the main thing I read was the Celution 800 upgrade, which will be used in RELIEF (Celution CCS-1) - the fact that consumables will be produced by a Company in San Antonio and there is several years of supply of CELASE and INTRAVASE in stock to serve customers before a new deal has to be negotiated.
    Looks like a move to San Antonio to me too at year-end for corporate HQ - since the Callan Road lease expires than.
    Anyway- indirectly this provides clarity on CTX2 - I received an anonymous mail from an obvious insider, who claimed that project has been written off years ago since the device simply did not work. Funny enough- Cytori announced its launch on the market in the summer of 2017. Deceit of SH?

    The use of CCS-1 in RELIEF simply also means that- yes- CTX2 has no future.

    I dislike the lack of communications on the subject, but from a business perspective I like it- maybe BARDA has to spend much more money on hardware in the future if RELIEF is successful and the substitution of a expensive device by a cheap one always was a mystery to me. Anyway- I am still re-cuperating from my trip and look forward to the A´s game tonight.

    Please Log in or Create an account to join the conversation.

    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:

    Q2 2018 Financial Results and Call 16 Aug 2018 05:06 #12184

    • myownhedgefund
    • myownhedgefund's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 2865
    • Thank you received: 204
    Forgot all about CTX2...LOL
    As far as BARDA and RELIEF trial....I thought they were just moving Celutions around to use for this trial...am I not remembering correctly ? If so, wouldn't BARDA just pay for the upgrade and given they have already paid extra for the delays due to their changes couldn't they have already paid for this ? A interesting question for management.
    Otherwise, without new capital, I currently figure they have until late November.

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 16 Aug 2018 07:52 #12185

    • rongside
    • rongside's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 388
    • Thank you received: 196
    I noticed on one of the recent Okyanos videos that they were using another machine, specifically the ICELLATOR from Tissue Genesis. 2 minute mark

    okyanos.com/adult-stem-cell-therapy/adult-stem-cell-procedure/

    www.tissuegenesis.com/products/

    I wonder what the reasoning was for the switch from Celution to the Icellator ????? I was aware that it had occured.

    Now I see that Tissue Genesis is selling into Japan/Asia via an agreement with a listed company (not huge)

    www.prnewswire.com/news-releases/tissue-genesis-llc-and-human-life-cord-japan-inc-announce-exclusive-agreement-to-advance-adult-stem-cell-therapies-in-asia-300545554.html

    All of the above raises a heap of questions which CYTX may well have a good answer for, if asked. eg.

    1. Do we have defendable patents?
    2. Is the Icellator inferior/superior to Celution in generating viable SVF ouput .......... should we ask Okyanos?
    3. How long before our sales in Japan go down - or up ........... and WHY?

    I believe ADRC work and that is why I have kept this stock for so long and kept on buying. At a personal financial level it has been a very painful disaster, although not mortal . I have always suspected that the failure in partnering was the inability of management to comprehend that they were incapable of dealing with a product that defied all conventional pharma business models ....... (1) it was too simple, ie easy to replicate, ie. hard to defend, (2) people (governments) would always balk at paying too high a price for their own cells, (3) FDA regulatory auhorities for too long did not know how to deal with this paradigm shift, (4) essentially the same ouput treated totally different conditions which could create a huge issue with regard differential pricing, and (6) they undertook the wrong trials and when they finally did scleroderma they dropped the ball by not going only for the diffuse group (Reynauds was never serious enough to justify lipo/cell treament and at what cost?????).

    The giveaway clue that CYTX management was truly floundering was when they bought Azaya. Even if it evenually works out, it was a ''tell'' (poker) that they had lost their conviction. The long game for them was simply to keep the paycheck coming. They didn't partner when they should have, and now who knows ........

    In my opinion this technology should be passed on to the public sector to develop as the private sector appears to either not be interested or does not see a way to monetize it.

    There is a paradox at play : On the one hand individuals all over the world are throwing money at charlatan stem cell practitioners for SVF, amniotic etc treaments, and yet the big boys have stayed away. :KO:

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 16 Aug 2018 09:03 #12186

    • myownhedgefund
    • myownhedgefund's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 2865
    • Thank you received: 204
    A 4th possible switch reason is the constant "going concern" issue.
    Pricing and "good enough" is another possible reason for a switch.
    Anyway, good post rongside, but don't expect real answers from real investors with this group !!!

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 16 Aug 2018 15:51 #12187

    • b767cpt
    • b767cpt's Avatar
    • Offline
    • Gold Boarder
    • Gold Boarder
    • Posts: 303
    • Thank you received: 4
    Back to pre RS levels of 0.31 in just a few months, reflected in today’s market cap of 1.9 mil, 18 plus mil prior to RS. This would be funny if it wasn’t so horrific, unless you’re short.
    Could someone please educate me on the advantage of keeping this on NASDAQ and watching this totally implode the market value instead of letting it fall to the pinks until these guys figure out what the hell they are doing, if ever?

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 18 Aug 2018 07:34 #12194

    • fas
    • fas's Avatar Topic Author
    • Offline
    • Moderator
    • Moderator
    • May the fat be with you
    • Posts: 3358
    • Thank you received: 1116

    rongside wrote:
    I wonder what the reasoning was for the switch from Celution to the Icellator ????? I was aware that it had occured.

    Now I see that Tissue Genesis is selling into Japan/Asia via an agreement with a listed company (not huge)


    All of the above raises a heap of questions which CYTX may well have a good answer for, if asked. eg.

    1. Do we have defendable patents?
    2. Is the Icellator inferior/superior to Celution in generating viable SVF ouput .......... should we ask Okyanos?
    3. How long before our sales in Japan go down - or up ........... and WHY?
    :


    John- as you know- the switch came after Black Beret Life Science acquired Okyanos early 2017. You might re-call too that I was astonished when I learned that the Isolex 1200 from Tissue Genesis was patented just like Celution and Cytori opted not to challenge the patent.

    My personal guess is that there is a major pricing difference in consumables- possibly they even use a standard product for digestion. Thereto - Tissue Genesis major income source were military contracts and the Houston folks clearly had major ties and contacts to the military.

    On the Japanese sales front- the Celution 800 I believe was priced > 500.000$ in Japan- in the past the new installations were the major source of income- now its only consumables. I believe Cytori Japan can survive on their own cash-flow.

    Please Log in or Create an account to join the conversation.

    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:

    Q2 2018 Financial Results and Call 18 Aug 2018 10:57 #12196

    • rodney.strongg
    • rodney.strongg's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 1363
    • Thank you received: 19

    myownhedgefund wrote: A 4th possible switch reason is the constant "going concern" issue.
    Pricing and "good enough" is another possible reason for a switch.
    Anyway, good post rongside, but don't expect real answers from real investors with this group !!!


    "but don't expect real answers from real investors with this group" - I find your comment very insulting, particularly as it relates to Fas who has dedicated a portion of his life to this subject matter, and to maintaining this so-called "group"- not like you to be quite so vicious and inconsiderate!

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 18 Aug 2018 20:02 #12197

    • myownhedgefund
    • myownhedgefund's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 2865
    • Thank you received: 204
    RS
    You are Clearly one of the most entertaining people I have ever come across on the internet. :write:

    "group" means management...as in Cytori Management. :bash:


    Oh boy...LOL

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 19 Aug 2018 06:17 #12199

    • rodney.strongg
    • rodney.strongg's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 1363
    • Thank you received: 19

    myownhedgefund wrote: RS
    You are Clearly one of the most entertaining people I have ever come across on the internet. :write:

    "group" means management...as in Cytori Management.


    Why did you insert "from real investors" in your prior post - not a logical reference to a Company's management???:bash:

    Please Log in or Create an account to join the conversation.

    Q2 2018 Financial Results and Call 19 Aug 2018 18:54 #12201

    • myownhedgefund
    • myownhedgefund's Avatar
    • Offline
    • Platinum Boarder
    • Platinum Boarder
    • Posts: 2865
    • Thank you received: 204
    Ugh.
    Perhaps the wording could have been a bit better.
    "From" should have been "for.
    We are the "real investors"...not the analyst that ask the same BS or as I like to say "scripted questions"

    So don't expect Cytori management to answer real, pertinent questions from the actual investors of the company.

    Please Log in or Create an account to join the conversation.

    • Page:
    • 1
    Time to create page: 0.104 seconds

    Copyright Information

    Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
    This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

     

     

    Shared Spreadsheet Links

    DOV´s Revised Projections for the Periods 2017 until 2020

    Shareble link : HERE

    Fas Kuiters Websites