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TOPIC: Q3 17 Results

Q3 17 Results 09 Nov 2017 15:27 #10447

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Nov 09, 2017
SAN DIEGO, Nov. 09, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today announced its third quarter 2017 financial results and provided updates on its corporate activity and clinical development.

Third quarter 2017 net loss was $4.8 million, or $0.14 per share. Operating cash burn for the quarter was approximately $4.0 million. Cytori ended the quarter with approximately $4.8 million of cash and cash equivalents.

Selected Key Recent Highlights:


  • U.S. STAR scleroderma clinical trial data accepted for presentation at Systemic Sclerosis World Congress in February 2018.
  • BARDA executed a $13.4 million contract option to fund the U.S. RELIEF burn clinical trial.

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

  • Q3 2017 Financial Performance


  • Q3 2017 and year-to-date operating cash burn was $4.0 million and $13.9 million, compared to $4.6 million and $15.4 million for the same periods in 2016, respectively.

  • Q3 2017 and year-to-date total revenues were $1.8 million and $4.9 million, compared to $2.6 million and $8.4 million for the same periods in 2016, respectively.

  • Cash and debt principal balances at September 30, 2017 were approximately $4.8 million and $13.0 million, respectively.
    Q3 2017 net loss was $4.8 million or $0.14 per share, compared to $5.4 million or $0.26 per share for Q3 2016.

  • Year-to-date adjusted net loss was $16.7 million, or $0.57 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 $17.1 million or $1.06 per share for the same period in 2016.

  • Year-to-date GAAP net loss was $18.4 million or $0.62 per share, compared to $17.1 million or $1.06 per share for the same period in 2016.

  • “Based on the completed analysis of our STAR trial data, including the strong safety profile, clinically meaningful improvements in the diffuse scleroderma subgroup and the lack of approved treatments with this orphan condition, we intend to meet with the U.S. FDA as soon as possible to chart next steps.” said Dr. Marc Hedrick, President and CEO of Cytori. “Simultaneously, manufacturing validation for our recently acquired liposomal doxorubicin chemotherapy drug candidate, ATI-0918, a generic version of Caelyx®, is ongoing and on track for submitting an application to the European Medicines Agency next year while other key cell therapy trials, specifically SCLERADEC-II and ADRESU for scleroderma and stress urinary incontinence, respectively, march toward full enrollment.”

    Selected Key Near-Term Milestones:


  • Pursue meeting with U.S. FDA to determine next steps required to obtain Habeo™ Cell Therapy regulatory approval for scleroderma-associated hand dysfunction.

  • Begin enrollment of BARDA’s funded U.S. RELIEF burn clinical trial.

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

  • Complete enrollment of SCLERADEC-II and ADRESU clinical trials in France and Japan, respectively.

  • 2017 Financial Guidance - Updated

    The Company expects full year 2017 operating cash burn to be lower than 2016, primarily due to the restructuring announced in September 2017.
    Updated operating cash burn forecasted to be within a range of $17 million to $19 million, a reduction from previously guided range of $20 million to $23 million.

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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:

    Q3 17 Results 09 Nov 2017 15:43 #10448

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    Nothing to excite me here.

    I might stay up to listen to the call in view of its eminent importance. Than again I might tune out at some point, if it does not deliver anything than business as usual.

    In that case I will comment again tomorrow after reading the transcript.

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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:

    Q3 17 Results 09 Nov 2017 15:46 #10449

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    FAS

    As I have discussed, CYTX should find a white knight as soon as possible.

    As expected, summer sales in Japan is low.

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    Q3 17 Results 09 Nov 2017 15:59 #10450

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    franshei
    The horrible number aside......its the credibility of analyst that also know what you are saying and they still cant hit pathetically low sales numbers.
    The installed base still gets barely used.
    Now time to sell this RO...LOL !!!
    That's the fun we should be waiting for tonight.

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    Q3 17 Results 09 Nov 2017 16:13 #10451

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    Now, I strongly agree with FAS that all senior managers should cut their own salaries.

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    Q3 17 Results 09 Nov 2017 17:54 #10452

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    Less than $5,000,000 in cash and that was over a month ago. To what extent will Marc and his team put up their own money in the RO? Bankruptcy is looking like the most likely scenario now. Sad.

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    Q3 17 Results 09 Nov 2017 18:48 #10454

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    Hedrick did sound a little down at parts of the call. Maybe just tired.
    Looks like Oxford will get Azaya as well should default/BK occur.
    From tonights 10K
    >>>The Term Loan, as amended, is collateralized by a security interest in substantially all of the Company’s existing and subsequently acquired assets, including its intellectual property assets, subject to certain exceptions set forth in the Loan and Security Agreement, as amended.   The intellectual property asset collateral will be released upon the Company achieving certain liquidity level when the total principal outstanding under the Loan Agreement is less than $3 million. As of September 30, 2017, we were in compliance with all of the debt covenants under the Loan and Security Agreement.  <<<

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    Q3 17 Results 09 Nov 2017 19:53 #10457

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    The conference call is better than the PR. It adds some color. Hedrick sounds low. Harris is Ok and Girao tries to be upbeat.

    1. STAR. FDA meeting may come after Thanksgiving. I am glad Hedrick and his consultants will "fight" for registration filing, with an offer to do phase 4 (post marketing). I am sure Cytori has a written (pre meeting) document sent to the FDA with STAR and sclerodec 1 data and registration plan (with phase 4 offer). This document is not one or two pages long - often it is a booklet (up to several hundred pages with expert opinions/assessment).

    If the FDA would allow such a filing (after the pending face to face meeting), Cytori could easily strengthening the final approval with sclerodec 2 data if the French data is positive;

    Note: The reason why such a FDA meeting takes a long time to be held is: it takes a long time to prepare and review a pre meeting dossier. A lot of people are involved.

    Note: It looks like the FDA medical officers feel that patients with diffuse cutaneous scleroderma may benefit from cell therapy and have made some suggestions in this direction during the protocol planning.

    2. Plastic surgery is the biggest customer base in Japan and an equipment rental company is working with Cytori KK to lower the cost of medical treatment (self pay).

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    Q3 17 Results 10 Nov 2017 04:36 #10458

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    I did turn myself in without listening, since the call was a half hour later than usual- that is too late for me.

    Anyway- I did read the seeking alpha transcript this morning, which was pretty difficult to read since some sentences hardly made sense. Link : HERE

    First and foremost- I did not read anything about expected path to sustainability ( i.e. cash-flow break-even) nor of managerial financial sacrifices or participation intentions in the RO. Those facts - by definition- rules me out for participating in the RO despite having sufficient funds available for a change.

    What was of some interest-

    So to meet all these various objectives successfully, we conducted a substantial operational and financial restructuring and decreased our cash burn to match our strategy. Specifically, we reduced our headcount from 70 to approximately 35 employees, which are positioned equally throughout areas of business, about a 1/3 are in San Diego, about a 1/3 in Japan and about 1/3 in San Antonio. We substantially reduced our operating cash burn, which is reflected in our revised [indiscernible] guidance and that will be covered by Tiago later in the call.


    Pretty drastic I would say- appears at least San Diego is reduced to management and support staff and since they recently (October) moved into a 39.000 ft² new building- that building must be even emptier than Callan Road was in the past.

    Franshei was right on nano-

    ATI-0918 is the company's nearest term and lowest risk pathway to substantial revenue growth in overall profitability. We have validated the manufacturing facility and made upgrades in that facility for scalability. The manufacturing of key pharmaceutical intermediates and shipping validation is now ongoing. Our sterile full-finish vendor is identified and our agreement with them has been signed. We are early in the preparation process for our EMA submission and we are in active discussions with potential commercial partners.


    I believe I read in the prospectus that they have to increase the staff to 20 in San Antonio probably at the production stage, so before money starts rolling, besides partner upfronts. Yes- it does look like Azaya has to save Cytori now, since MyTomorrows isnt delivering (yet?) and Japan cannot sustain the business.

    The call must have been rather short, with only Kolbert asking confusing questions, which I did not understand anyway. (at least from the transcript)

    The most interesting to me, was the following statement-

    And actually, probably next week, we plan on updating our shareholders on the broader set of investigator-initiated trials that have going on around the world, likely in the capacity of an investor note.


    I think between John and I we know pretty much what is going on in respect of studies reported to clinicaltrials.gov. I am heavily curious to see what they will present and also very pleased that they finally are willing to lower their pants in this respect :grin:
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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:

    Q3 17 Results 10 Nov 2017 06:40 #10461

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    Fas
    You didn't laugh at JK's question on the therapeutic effect of blood tinged saline ? LOL

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    Q3 17 Results 10 Nov 2017 09:00 #10464

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    Scleroderma PMA filing.

    CYTX is entering the next step in FDA decision process: file-able PMA ?

    FDA is not a rigid agency. Decisions are made based on facts and reasons. I think Hedrick has a good chance to make a filing with limited claims for unmet medical needs with commitments to do phase 4 trials for claim expansion. I have done this before. FDA does not have to reject a PMA at this point.

    Then the next step is preparation for a submission (a long process, during this time new information can be added) and review (another long process). Company meets/corresponds with FDA throughout this year long process. FDA may make the final decision to approve or disapprove a PMA during the time when actual clinical data and other factors are carefully evaluated by VARIOUS REVIEWERS (from different departments).

    Let us hope for the best.

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    Q3 17 Results 10 Nov 2017 09:37 #10465

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    AZA Update

    With very limited cash on hand, AZA is making good progress: the pilot plant has now been validated and it is been scaled up. Looks like the analytical HPLC lab is now set up to do QA.

    The next step is liposomal compounding at different scales (this step may very well be ongoing), before stability testing (it is usually an ongoing process during different stages of compounding).

    Looks like Harris and his consultants (on the BOD) are talking to potential EU commercial partners.

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    Q3 17 Results 10 Nov 2017 09:40 #10466

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    Franshei, keep up the informative posts - do you intend to participate in the RO?

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    Q3 17 Results 10 Nov 2017 09:45 #10467

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    The odds of conditional approval on a secondary endpoint that DID NOT even meet statistical significance is a pipe dream, IMHO. Furthermore, I find it interesting that when they made the Azay deal in January, Marc clearly implied that a partner to commercialize the oncology product in the EU was imminent. That never happened yet no one brings this point up. What happened to that Board DIrector and his scheme who brought this deal to Marc? Biggest question, does Marc and crew have enough confidence to put up their own cash on this. They've certainly taken enough $$$ over the years, it's time to give back some of that unearned money back and and put their money where their mouths are.

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    Q3 17 Results 10 Nov 2017 09:55 #10468

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    Rodney

    Maxim is working very hard on this RO. Sent me a letter and made two phone calls. I think with or without me, Tiago Girao appears optimistic with the initial $ 5 to 10 million dollars from RO. Last time (a year ago), an rather unknown group made the RO a big success - it may happen again. As it was, the CYTX management will probably participate heavily.

    AZA again.

    The latest ASCO (American Society of Clinical Oncologists) magazine highlights CANCER DRUGs SHORTAGE as a cover page story. I think with experienced pharmaceutical scientists on hand, ATI 0918 progress is low risk.

    Regarding liposomal taxo for NSCL (non small cell lung cancer -most common among smokers), phase 2 trial can actually be conducted at UC San Diego and Scripp Institute (next door to CYTX; I had visited both places before). UC San Diego has a cancer treatment clinic.

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    Q3 17 Results 10 Nov 2017 11:27 #10470

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    franshei wrote: Rodney

    Maxim is working very hard on this RO. Sent me a letter and made two phone calls. I think with or without me, Tiago Girao appears optimistic with the initial $ 5 to 10 million dollars from RO. Last time (a year ago), an rather unknown group made the RO a big success - it may happen again. As it was, the CYTX management will probably participate heavily.

    AZA again.

    The latest ASCO (American Society of Clinical Oncologists) magazine highlights CANCER DRUGs SHORTAGE as a cover page story. I think with experienced pharmaceutical scientists on hand, ATI 0918 progress is low risk.

    Regarding liposomal taxo for NSCL (non small cell lung cancer -most common among smokers), phase 2 trial can actually be conducted at UC San Diego and Scripp Institute (next door to CYTX; I had visited both places before). UC San Diego has a cancer treatment clinic.



    I agree that management will likely participate heavily in the RO - I think the hope that folks like Hedrick would take a cut in pay was unrealistic (he is not a wealthy man and $600,000 does not go far in Ca.) - right now all of management's options are under-water and they are all working harder than ever to keep the Company viable!

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    Q3 17 Results 10 Nov 2017 16:17 #10474

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    Rodney

    Based on what I can read from the CC and various SEC filings since late July, Rickey and Hedrick are not ready (or not able to) sell the company presently. I think they are not call a quit yet, till such a time that they have to. Phrases like "to the best interest of the stock holders, or so" clearly suggest that they will do their own way.

    Note: Tiago Girao says something that cannot be found in the edited CC transcript: there will be some 2018 events or milestones coming ......... (probably "to benefit the stockholders"). I think this kind of saying common for Girao. I remember he said this before: "we are so close to marketing, why sell the company now". He is referring to the STAR study conclusion.

    I think CYTX will probably get a FDA permission to file the scleroderma PMA. Most companies would not be interested in limited claims, with promises for phase 4 trials (to expand the claims). Most companies think there is no money in limited claims. Yes, this is very true. But, in the case for CYTX, if they can get limited claims, it is symbolicly very, very important. When I worked for John Kapoor 30 years ago at Lyphomed and for Joseph Rubinfeld at SuperGen, I went for limited claims for gallium nitrate NDA and limited scopes for ED (an antiobesity drug) IND. Gallium nitrate's post approval sales was only $ 1 million a year, yet we were able to sell this NDA to Fujisawa for $ 250 million. Successful ED IND was able to bring $ 9 million from Israel Chemicals.

    I think if CYTX is not sold in the near future, ATI 918 is the only way (near to intermediate terms) to bring in sizeable revenue and some upfront money. Liposomal taxo needs a phase 2 NSCL study to bring a partner (open study, no need to have a control arm -needs stable disease, partial and complete responses).

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    Q3 17 Results 10 Nov 2017 16:24 #10475

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    Thanks Franshei - continue to keep this MB informed based on real life experience!!

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    Q3 17 Results 10 Nov 2017 18:39 #10477

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    franshei
    For the sake of argument if it doesn't go the route you propose as possible, why cant the FDA simply have CYTX do a small add on trial to get them to stat sig ? Remote sure but what do you think ?

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    Q3 17 Results 11 Nov 2017 08:38 #10478

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    myownhedgefund wrote: franshei
    For the sake of argument if it doesn't go the route you propose as possible, why cant the FDA simply have CYTX do a small add on trial to get them to stat sig ? Remote sure but what do you think ?


    Hedge- to be honest, I do not get all this speculation on the way forward, when Cytori spells it out themselves-

    Clearly - depending on the outcome of the FDA meeting there are 2 options as laid down in the slide of the prospectus- either way, assuming Cytori does not go bankrupt in the mean time, they will want to pursue whatever outcome-

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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:
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