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TOPIC: 2018 Earnings + Lorem Announcement

2018 Earnings + Lorem Announcement 01 Apr 2019 10:15 #12736

  • fas
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After some digestive activities- let us follow the flow of events by posting the earnings release first

Apr 01, 2019
Strategic focus on building a leading oncology company / Lorem Vascular cell therapy transaction yields $4MM

Letter of intent for ATI-0918 filed with EMEA


SAN DIEGO, April 01, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced its fourth quarter and year-end 2018 financial results and provided updates on corporate activities. Also announced was a transaction to divest certain cell therapy assets to Lorem Vascular of Melbourne, Australia yielding $4MM in non-dilutive funding to the Company.

Fourth quarter 2018 net loss was $2.2 million, or $0.16 per share. Operating cash burn for the fourth quarter of 2018 was approximately $2.5 million. Cytori ended the year with approximately $5.3 million of cash and cash equivalents.

“This transaction sale accomplishes a number of important objectives for the company,” said Dr. Marc Hedrick, Cytori President & Chief Executive Officer. “Most critically it allows us to further increase the focus on our clinical stage oncology pipeline while bringing in non-dilutive capital. We also are able to maintain our most valuable cell therapy assets, including Japan that has a forthcoming trial readout in our ADRESU trial.”

Our lead clinical stage asset, Doxorubicin Hydrochloride Cytori, formerly called ATI-0918, is an important potential therapy for Breast and Ovarian Cancer, Multiple Myeloma and Kaposi’s Sarcoma. Our current development program is focused in Europe where we believe there is a potential market opportunity of $120 million annually. In Q1 2019, Cytori submitted a letter of intent to file a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Doxorubicin Hydrochloride Cytori. Doxorubicin Hydrochloride Cytori is being developed as a generic version of Janssen’s Caelyx pegylated liposomal doxorubicin. The Company continues to evaluate potential development and commercialization partnering opportunities for Doxorubicin Hydrochloride Cytori with a focus on Europe and China. European approval and launch of Doxorubicin Hydrochloride Cytori is projected to be in late 2020.

Our second clinical stage oncology focused asset is ATI-1123, a phase II ready, patented, albumin-stabilized pegylated liposomal docetaxel. In 2018, the Company received an orphan drug designation from the U.S. FDA for the indication of small cell lung cancer and is pursuing a 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer an accelerated clinical timeline and lower development cost. The Company is exploring near term development strategies and intends to advance this program aggressively in 2019.

Cytori’s ADRESU pivotal urinary incontinence trial using Cytori Cell Therapy has completed enrollment and anticipates data read out in the second quarter of 2019. If the data is positive, Cytori intends to seek expedited approval and reimbursement for the Japanese market for this indication. In Q1 2019, Cytori received approval from the United States Food & Drug Administration to expand the enrollment criteria for its RELIEF clinical trial of intravenously delivered Cytori Cell Therapy for patients with severe burn injuries.

Q4 2018 and Full Year 2018 Financial Performance


  • Q4 2018 and full year operating cash burn was $2.5 million and $12.0 million, compared to $4.2 million and $18.1 million for the same periods in 2017, respectively
  • .Q4 201

  • Q4 2018 and full year product revenues were $0.4 million and $2.7 million, compared to $0.7 million and $2.7 million for the same periods in 2017, respectively.

  • Q4 2018 and full year contract revenues were $0.7 million and $3.0 million, compared to $0.9 million and $3.7 million for the same periods in 2017, respectively.


  • Q4 2018 adjusted net loss was $2.8 million or $0.20 per share, compared to a net loss of $4.3 million or $1.00 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 $0.6 million related to a change in fair value of warrant liability (a non gaap measure). Q4 2018 net loss allocable to common stockholders was $2.2 million, or $0.16 per share.


  • Full year 2018 adjusted net loss was $14.9 million or $1.71 per share, compared to $21.0 million or $6.48 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 $2.2 million related to a change in fair value of warrant liability (a non gaap measure). Full year 2018 net loss allocable to common stockholders was $15.1 million, or $1.74 per share.

  • Selected Key Anticipated Milestones:


  • Doxorubicin Hydrochloride Cytori: File Market Authorization Application to the European Medicines Agency in late 2019 or early 2020.


  • ATI-1123: Clarify the FDA 505(b)(2) pathway applicability and announce clinical development plan in mid 2019.


  • Cell Therapy Japan: Report ADRESU urinary incontinence pivotal clinical trial results in Q2 2019.

  • 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: 8766078.


    About Cytori

    Cytori is developing, manufacturing, and commercializing nanoparticle-delivered oncology drugs and autologous adipose-derived regenerative cell (ADRC) therapies within its Nanomedicine™ and Cell Therapy™ franchises, respectively. Cytori Nanomedicine™ is focused on the liposomal encapsulation of anti-neoplastic chemotherapy agents, which may enable the effective delivery of the agents to target sites while reducing systemic toxicity. The Cytori Nanomedicine™ product pipeline consists of Doxorubicin Hydrochloride Cytori, a pegylated liposomal doxorubicin hydrochloride for breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, a complex/hybrid generic drug, and ATI-1123 patented albumin-stabilized pegylated liposomal docetaxel for multiple solid tumors. Cytori Cell Therapy™, prepared within several hours with the proprietary Celution® System and administered to the patient the same day, has been shown in preclinical and clinical studies to act principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care. For more information, visit www.cytori.com .

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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:

    2018 Earnings + Lorem Announcement 01 Apr 2019 10:32 #12737

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    So- if I understand this correctly- another CC will be held at 05.30 pm (when I am asleep) to further discuss the events of today.

    I understand now why the French Scleroderma trial "was put on the back-burner" and the focus re-directed to ADRESU. All fine- as long as Cytori remains to have the non-exclusive IP on cell-therapy, to use in druggable advances in liposomal technology- that is all that matters to me now. The rest I can swallow- during my lifetime there will most likely be no changes in governmental nutrition recommendations and people will get fatter and develop more cancer- so that is the direction we are heading- sounds morbid, but reality pure.

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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:

    2018 Earnings + Lorem Announcement 02 Apr 2019 03:31 #12745

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    The announcement in the 8K of the CC after the bell probably was written way in advance and erroneous, since they probably had to release earnings and 10K in Q1 according to SEC rules, so had to do this early CC exercise before trading in Q 2 started. Anyway- you can read the transcript of the call at Seeking Alpha - link Here

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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:

    2018 Earnings + Lorem Announcement 02 Apr 2019 03:35 #12746

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    For completeness sake here the 8K on the Lorem transaction-

    On March 30, 2019, Cytori Therapeutics, Inc. (the “Company”) and its subsidiary, Cytori Therapeutics, K.K., entered into an Asset and Equity Purchase Agreement (the “Purchase Agreement”), dated as of March 29, 2019, with Lorem Vascular Pte. Ltd., (“Lorem”), pursuant to which, among other things, Lorem agreed to purchase the Company’s UK subsidiary and the Company’s Cell Therapy assets, excluding such assets used for Japan or relating to the Company’s contract with the Biomedical Advanced Research Development Authority (“BARDA”). The Company will continue its Cell Therapy business in Japan and its ongoing research under the BARDA contract.

    Under the terms of the Purchase Agreement, the Company will receive $4.0 million, consisting of amounts paid for the UK subsidiary and Cell Therapy assets, as well as the repayment of intercompany receivables from the Company’s UK subsidiary. Entry into the Purchase Agreement satisfies the requirement for the Company to enter into an asset sale agreement with minimum unrestricted net cash proceeds to the Company of $4.0 million under the Loan and Security Agreement, dated May 29, 2015, as amended, with Oxford Finance LLC and the lenders party thereto.

    Lorem is currently the exclusive licensee for the Company’s Cell Therapy products in all fields of use in China, Hong Kong, Singapore, Malaysia and Australia under the terms of the Amended and Restated License and Supply Agreement dated January 30, 2014, by and between the Company and Lorem. This License and Supply Agreement will be terminated upon the consummation of the transactions under the Purchase Agreement.

    Pursuant to the Purchase Agreement, the Company’s Lease Agreement entered into on April 2, 2010, with HCP Callan Rd, LLC will be assigned to Lorem, subject to the consent of HCP Callan Rd, LLC.

    Both the Company and Lorem have made customary representations, warranties and covenants in the Purchase Agreement, which is subject to termination by either the Company or Lorem upon the occurrence of specified events. The transaction is expected to close on or before April 30, 2019, subject to the satisfaction or waiver of various conditions.

    The Purchase Agreement has been filed with this Current Report on Form 8-K to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company or Lorem. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such Purchase Agreement, and may be subject to important limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Purchase Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors.

    The foregoing description of the Purchase Agreement and the transactions contemplated thereby is subject to and qualified in its entirety by reference to the full text of the Purchase Agreement, a copy of which is attached as Exhibit 2.1 hereto and the terms of which are incorporated herein by reference.

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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:

    2018 Earnings + Lorem Announcement 02 Apr 2019 11:29 #12749

    • b767cpt
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    I take it that Lorem now owns any potential benefit from the French trial?

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    2018 Earnings + Lorem Announcement 02 Apr 2019 14:02 #12750

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    Except in Japan

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    2018 Earnings + Lorem Announcement 03 Apr 2019 20:01 #12761

    • SH
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    Looking at the Nagoya ADRESU study, is 10% responders greater than 50% urinary pad reduction the threshold for conditional approval? Looks like Japan wants to push forward with approvals. Read the 2017 paper looks like 5/14 patients saw 50 percent reduction. Hope this is meaningful on larger scale (45 patients)
    Thoughts anyone of serious nature?

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    2018 Earnings + Lorem Announcement 04 Apr 2019 19:48 #12765

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    It seems to me that wound healing works quite heal with stem cells such as Avita shows. But I still think cytori can address deeper healing via injection. The cytokines and growth factors are just as key. Avita would have more work to do to address that. But avita has done a great job so far with focus. That being said, I think measuring absorption of pads is a much more quantitative and cleaner readout than pain. Could be faster as well. The data suggests 1 year is enough to show benefit. iMHO

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