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TOPIC: Q1 2018 report

Q1 2018 report 10 May 2018 15:40 #11759

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May 10, 2018
SAN DIEGO, May 10, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today announced Q1 2018 financial results and provided updates on corporate development.

Q1 2018 net loss was $4.4 million, or $0.07 per share. Operating cash burn for Q1 was approximately $4.1 million. Cytori ended Q1 with approximately $5.9 million of cash and cash equivalents.

Cytori’s recently acquired nanomedicine facility in San Antonio, Texas is now actively manufacturing validation batches of ATI-0918, pegylated liposomal doxorubicin, in preparation for filing a Marketing Authorization Application with the European Medicines Agency. All key supply chain contracts are being established to produce final drug product. Cytori has also expanded its on-site analytical chemistry evaluation capability to meet all process validation requirements. To prepare commercially, we are having ongoing discussions with potential licensing partners for ATI-0918 distribution in Europe, Asia, and North America. The Company is also actively evaluating potential co-development partners for ATI-1123, protein-stabilized pegylated liposomal docetaxel, a new chemical entity for various cancer types.

Regarding Cytori Cell Therapy, Cytori announced the completion of enrollment in the European investigator-initiated clinical trial SCLERADEC-II with a planned data readout in 2H 2018. Cytori also announced completion of enrollment in the Japanese investigator-initiated ADRESU clinical trial for male stress urinary incontinence, for which data 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. The Company is currently in the process of initiating up to 10 sites in the U.S. for RELIEF.

“Our major corporate objective is to file for market approval in Europe for ATI-0918, our oncology drug product and a generic version of Caelyx®. Additionally, we are working to define the clinical and regulatory pathways for our nanomedicine products in China, where a substantial opportunity exists based on the evolution of drug standards to mirror those in the U.S.” said Dr. Marc Hedrick, President and CEO of Cytori. “Also, we are preparing for international trial readouts from the SCLERADEC-II scleroderma and ADRESU urinary incontinence trials, in 2018 or early 2019.”

Q1 2018 Financial Performance


  • Q1 2018 operating cash burn was $4.1 million, compared to $4.8 million for Q1 2017.

  • Q1 2018 total revenues were $1.6 million.

  • In Q1 2018, consumable utilization in Japan grew by more than 50% as compared to Q1 2017.

  • Cash and debt principal balances at March 31, 2018 were approximately $5.9 million and $13.0 million, respectively.

  • Q1 2018 net loss was $4.4 million or $0.07 per share, compared to a net loss of $7.5 million or $0.33 per share for Q1 2017.

  • Selected Key Anticipated Milestones:

  • Complete ATI-0918 manufacturing and regulatory activities required to prepare and file an application for EMA approval.

  • Enroll first patient in the BARDA funded U.S. RELIEF burn clinical trial.

  • Report of 12/24-week European SCLERADEC-II trial data for scleroderma hand dysfunction.

  • Report of 24/48-week Japanese ADRESU trial data for post-surgical urinary incontinence.
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    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:

    Q1 2018 report 10 May 2018 15:46 #11760

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    The numbers are in line with my expectations- I am turning myself in and will (hopefully) read the transcript tomorrow.

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    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:

    Q1 2018 report 10 May 2018 17:01 #11761

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    First two questions from Maxim - Jason K and Jason M. All lay-up questions and cheerleading. Habeo not moving forward in U.S. - Oh what a surprise. Looks like Maxim is trying to lift shares so they can float an equity offering.

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    Q1 2018 report 10 May 2018 20:28 #11762

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    Well good thing Fas went to bed...sound quality out of Cytori was terrible.
    A few points:
    Fas good call on the consumable revenue !!! However, all is not so rosey imho.
    Consumables reported as a 50% increase but those revenues only translated into a 23% increase in revenue. Heavy discounting/poor margin just to get small increases in revenue.
    Cash Burn $4.1 million but should be $3 million something per Q going forward for the year
    ATI-0918 testing proceeding. Head count there now at 13 but going to 20. Near the end of the call analyst Yale Jen addresses some of the issues and I continue to believe that the conversation reflects no partner for that product anytime soon and sounded to me like best case launch is 2020.
    They also tried to head off competition talk and different formulations but was very hard to understand the conversation due to the sound quality but JK was pushing as they had the best. Who knows.
    On the loan issue they said they are looking for some sort of relief....but couldn't say more on the matter.
    RELIF trial enrolling sites...looking to enroll first patient....I guess its progress...snoozer for me right now.
    No talk of pending raise, cash timelines or R/S...nor did I expect there to be.
    As WST alluded to...skipping the JK and JM, Q and A looses little in real info imho. D'Silva from B Riley and Yale Jen from Laidlaw were the other 2 analyst on the call. No other questions presented or asked by ...say by people who actually own the company.
    I didn't take any notes....so I think I covered everything I wanted to share.
    It was a standard call.
    Big thing is the cash issue first !!!!

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    Q1 2018 report 11 May 2018 08:03 #11763

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    Thanks Hedge-

    Seeking Alpha have had a transcript in the past quarters, but not this time around. Probably the bad sound quality which you referred to. I will wait a few days to see if Cytori comes up with an edited transcript, otherwise I will listen to it next week when I have more time and will post my comments, if any.

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    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:

    Q1 2018 report 11 May 2018 11:23 #11765

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    fas wrote: Thanks Hedge-

    Seeking Alpha have had a transcript in the past quarters, but not this time around. Probably the bad sound quality which you referred to. I will wait a few days to see if Cytori comes up with an edited transcript, otherwise I will listen to it next week when I have more time and will post my comments, if any.


    Fas, the SA transcript is now available.

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    Q1 2018 report 11 May 2018 12:41 #11766

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    rodney.strongg wrote: Fas, the SA transcript is now available.


    Yeah - I saw the mail and just finished reading it.

    First- it read like that these guys have no worries in this world. Pretty upbeat and solely thinking (and talking) long-term and as if there would be no cash issues. Amazing.
    Contrary to the other writers in this topic I found the Q&A sessions very inspiring. Notably the China opportunity on 0918 was rather intriguing and I had to think about Franshei a lot when I read this.Being of Chinese ancestry and a friend of Girao, maybe he dissappeared because of some liaison here? Could very well be.

    Anyway- the ADRESU discussion being an open trial versus the usual placebo thing in the US was quite inspiring too, on top that reimbursement and approval go hand-in-hand in Japan.

    There were more positive things but I will come back to them next week sometime, since as a retiree I am pretty stressed right now.

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    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:

    Q1 2018 report 11 May 2018 13:23 #11767

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    fas wrote:

    rodney.strongg wrote: Fas, the SA transcript is now available.


    Yeah - I saw the mail and just finished reading it.

    First- it read like that these guys have no worries in this world. Pretty upbeat and solely thinking (and talking) long-term and as if there would be no cash issues. Amazing.
    Contrary to the other writers in this topic I found the Q&A sessions very inspiring. Notably the China opportunity on 0918 was rather intriguing and I had to think about Franshei a lot when I read this.Being of Chinese ancestry and a friend of Girao, maybe he dissappeared because of some liaison here? Could very well be.

    Anyway- the ADRESU discussion being an open trial versus the usual placebo thing in the US was quite inspiring too, on top that reimbursement and approval go hand-in-hand in Japan.

    There were more positive things but I will come back to them next week sometime, since as a retiree I am pretty stressed right now.


    Fas, good points and I totally agree - unbelievable re their seemingly lack of worry and "business as usual" attitude - I would have liked to have seen greater hope for raising cash near-term before another RO becomes necessary, but that appears doubtful unless one of the potential partnerships is closer to fruition than they made it seem (likely the reason for today's pullback imo).

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