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TOPIC: Q3 2018 Results

Q3 2018 Results 14 Nov 2018 15:19 #12345

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Nov 14, 2018
SAN DIEGO, Nov. 14, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced Q3 2018 financial results and provided updates on corporate activities.

Q3 2018 net loss was $2.3 million, or $0.27 per share. Operating cash burn for Q3 was approximately $2.6 million. Cytori ended Q3 with approximately $6.8 million of cash and cash equivalents.

Cytori is developing its lead chemotherapy drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year. We previously completed a bioequivalence study against the European reference drug and are in the process of completing manufacturing-related activities to support the MAA. The Company also continues to evaluate potential commercial partnering opportunities for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing another chemotherapy drug, ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and intends to pursue FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

In the first half of 2019, Cytori expects a 1-year data readout from the 45 patient, multi-center, potential pivotal clinical trial in stress urinary incontinence conducted in Japan called ADRESU.

Later in 2018, Cytori expects a 6-month data readout from the 40 patient, French SCLERADEC II clinical trial in scleroderma patients.

Cytori is actively conducting the U.S. Phase I RELIEF trial in thermal burn injury trial sponsored by BARDA. Cytori completed a successful In-Process Review meeting with BARDA this past June.

Commercially, Cytori is focusing its efforts in Japan and continues to see favorable growth trends in the use of its cell therapy products approved under the Regenerative Medicine Law in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year-over-year growth in Celution® System consumable utilization.

Finally, Cytori recently received the first $1.0 million royalty milestone from Bimini Technologies, LLC (Bimini). In 2013, Cytori divested the Puregraft® product line that includes periodic royalty payments of up to $10.0 million and certain other economic benefits based on Bimini achieving gross profits milestones.

“A key corporate objective is to complete manufacturing support activities and seek European marketing authorization for ATI-0918, our lead oncology drug product. Furthermore, we have recently expanded development activities for the ATI-1123 phase II oncology program and its potential 505(b)(2) acceptability,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “In cell therapy, we are focused on continued revenue growth based on positive quarter-over-quarter and year-over-year consumable utilization trends. In the meantime, we are awaiting pivotal clinical data from our Japanese stress urinary incontinence trial."

Q3 2018 and year-to-date Financial Performance


  • Q3 2018 and year-to-date operating cash burn was $2.6 million and $9.5 million, compared to $4.0 million and $13.9 million for the same periods in 2017, respectively.

  • Q3 2018 and year-to-date product revenues were $0.9 million and $2.2 million, compared to $0.5 million and $2.0 million for the same periods in 2017, respectively.

  • Q3 2018 and year-to-date contract revenues were $0.5 million and $2.3 million, compared to $1.3 million and $2.9 million for the same periods in 2017, respectively.

  • Q3 2018 and year-to-date consumable utilization in Japan grew by approximate 90% and 70%, when comparing to the same periods in 2017, respectively.

  • Cash and debt principal balances at September 30, 2018 were approximately $6.8 million and $13.0 million, respectively.

  • Q3 2018 adjusted net loss was $4.0 million or $0.45 per share, compared to a net loss of $4.8 million or $1.39 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Q3 2018 net loss allocable to common stockholders was $4.8 million, or $0.55 per share.

  • Year-to-date 2018 adjusted net loss was $12.1 million or $1.73 per share, compared to $18.4 million or $6.22 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Year-to-date 2018 net loss allocable to common stockholders was $12.9 million, or $1.85 per share.

  • Selected Key Anticipated Milestones:


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

  • Seek FDA 505(b)(2) pathway applicability for ATI-1123 product.

  • Obtain Japan MHLW Class III approval for Celution® System consumables.

  • Report 1-year Japanese ADRESU pivotal clinical trial data for post-surgical male stress urinary incontinence
  • .

  • Enrollment update in the BARDA-funded U.S. RELIEF clinical trial.

  • Report French investigator initiated SCLERADEC II clinical trial data in scleroderma hand dysfunction.
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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 2018 Results 14 Nov 2018 15:49 #12346

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    Cash burn looks OK- product revenue pretty decent for a Q3- Barda lower than expected, but who cares.
    I am turning myself in and hopefully can read a transcript of the call 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:

    Q3 2018 Results 15 Nov 2018 04:40 #12347

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    fas wrote: Cash burn looks OK- product revenue pretty decent for a Q3- Barda lower than expected, but who cares.
    I am turning myself in and hopefully can read a transcript of the call tomorrow.

    /

    As expected, they have no solution to the Y/E Oxford $7 million requirement other than renegotiation - unbelievable????

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    Q3 2018 Results 15 Nov 2018 08:37 #12348

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    Simply pathetic! I see another RS in the future if they survive that long.

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    Q3 2018 Results 15 Nov 2018 09:37 #12349

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    b767cpt wrote: Simply pathetic! I see another RS in the future if they survive that long.


    B-7, my guess is that they get an extension from Oxford - the last thing that Oxford wants is to have to start selling off assets - jmho.

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    Q3 2018 Results 15 Nov 2018 10:47 #12350

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    From what I read in the Seeking Alpha Transcript of the call - link HERE - they provided a lot of clarity for the pathway forward.

    Of course that still can include a re-negotiation of the Oxford loan in view of timing, but all-in-all - at least for me- a lot more clarity and hope that things will work out in the end. :grin:

    Anyway- first thing first- share count and related market cap which defines (partially) also financing "boundaries"-

    As stated in the 10Q- there are 13.2 Mio shares OS, but also roughly 50% of Preferred C OS (and some Preferred B- including mine). That makes a market cap of 4.7 Mio at 41 cent as of 9-30, of which they can finance 1/3 on an annual basis. The Riley ATM was used for 1,5 Mio shares already (0,8$ Mio raised) so in view of the present PPS of 0,34 or lower. That allows hardly any more short-term outside financing - including Lincoln- which could raise significant outside money, since the calculation is rather simple.

    Cash on hand at 9-30 - 6,8 - add 1,0 Bimini + 0,2 Lincoln, you get 8,0 Mio available, deduct 2,5 Mio Q4 burn, 1,5 Mio Oxford Minimum balance and have calculated 4 Mio available funds at year-end. That is not enough to transfer 7 Mio to Oxford.

    Tiago was pretty clear where the funds should be coming from (Kolbert Q&A)

    Kolbert: Perfect. Thank you guys. So one last question, can you just give us some hints as to how active the BD is around ATI-0918 and clearly there's a hope to monetize that asset and bring non-dilutive capital into the Company. Can you just give us some idea of how the progress is going in terms of that effort? Thanks.

    Tiago Girão

    Yes. Anything about BD is always working problematic. But there is a lot of interest for that particular drug in Europe. You can imagine that there's – as I mentioned about a $120 million to perhaps as well over $200 million a year market opportunity with that drug.

    We think there is the opportunity to be the first or second generic. If we can monetize it in a way that we think it’s fair to the opportunity and shareholders in the near-term, we'll do it. However, we think that the longer we go, the closer we get to the goal line that the opportunities for that maybe improve as a little bit competition potentially for partners.

    So we're out there in the market aggressively talking about European licensure, but we'll wait for the right deal comes along. There's also interest in, call it tertiary market regarding that drug being a high quality U.S. maker drugs that it had a lot of stumbles were made in outside of the U.S., even in the U.S. Here is real opportunity to position that for outside of Europe, and there is some opportunities related to there. So we're actively engaged in weekly discussions with potential partners and developments related to that.


    So - it wont be Scleroderma after all- that is clear- but "tertiary" as Girao defines it- to me - in view of the past hints and discussions, this can only be a Chinese cooperation including some upfront money.

    The stakes are high and Hedrick/Girao still play a mean hand, by wanting "competition" in respect of European ATI-0918 suitors. I hope they know what they are doing.:whistle:

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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 2018 Results 15 Nov 2018 12:39 #12351

    • rodney.strongg
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    fas wrote: From what I read in the Seeking Alpha Transcript of the call - link HERE - they provided a lot of clarity for the pathway forward.

    Of course that still can include a re-negotiation of the Oxford loan in view of timing, but all-in-all - at least for me- a lot more clarity and hope that things will work out in the end. :grin:

    Anyway- first thing first- share count and related market cap which defines (partially) also financing "boundaries"-

    As stated in the 10Q- there are 13.2 Mio shares OS, but also roughly 50% of Preferred C OS (and some Preferred B- including mine). That makes a market cap of 4.7 Mio at 41 cent as of 9-30, of which they can finance 1/3 on an annual basis. The Riley ATM was used for 1,5 Mio shares already (0,8$ Mio raised) so in view of the present PPS of 0,34 or lower. That allows hardly any more short-term outside financing - including Lincoln- which could raise significant outside money, since the calculation is rather simple.

    Cash on hand at 9-30 - 6,8 - add 1,0 Bimini + 0,2 Lincoln, you get 8,0 Mio available, deduct 2,5 Mio Q4 burn, 1,5 Mio Oxford Minimum balance and have calculated 4 Mio available funds at year-end. That is not enough to transfer 7 Mio to Oxford.

    Tiago was pretty clear where the funds should be coming from (Kolbert Q&A)

    Kolbert: Perfect. Thank you guys. So one last question, can you just give us some hints as to how active the BD is around ATI-0918 and clearly there's a hope to monetize that asset and bring non-dilutive capital into the Company. Can you just give us some idea of how the progress is going in terms of that effort? Thanks.

    Tiago Girão

    Yes. Anything about BD is always working problematic. But there is a lot of interest for that particular drug in Europe. You can imagine that there's – as I mentioned about a $120 million to perhaps as well over $200 million a year market opportunity with that drug.

    We think there is the opportunity to be the first or second generic. If we can monetize it in a way that we think it’s fair to the opportunity and shareholders in the near-term, we'll do it. However, we think that the longer we go, the closer we get to the goal line that the opportunities for that maybe improve as a little bit competition potentially for partners.

    So we're out there in the market aggressively talking about European licensure, but we'll wait for the right deal comes along. There's also interest in, call it tertiary market regarding that drug being a high quality U.S. maker drugs that it had a lot of stumbles were made in outside of the U.S., even in the U.S. Here is real opportunity to position that for outside of Europe, and there is some opportunities related to there. So we're actively engaged in weekly discussions with potential partners and developments related to that.


    So - it wont be Scleroderma after all- that is clear- but "tertiary" as Girao defines it- to me - in view of the past hints and discussions, this can only be a Chinese cooperation including some upfront money.

    The stakes are high and Hedrick/Girao still play a mean hand, by wanting "competition" in respect of European ATI-0918 suitors. I hope they know what they are doing.:whistle:



    It will take a miracle to get anything done by y/e given CYTX's past track record - however, hope springs eternal!

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