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TOPIC: Q3 results and CC

Q3 results and CC 06 Nov 2014 15:58 #2608

  • fas
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Hi guys- I am checking in at my usual time now- so that means you will listen to Thiago and marc by ourselves and I will be sleeping...

Have fun :happy: :bang:

Selected Q3 Highlights
-Received FDA approval to begin a US IDE trial on patients with knee osteoarthritis with enrollment scheduled to begin in 2015;
-BARDA executed a significant contract extension option for ongoing research and development activities required to enable a pilot clinical trial of Cytori Cell Therapy in thermal burn treatment;
-Reported publication of six month outcomes from a 12 patient investigator-initiated study of scleroderma in the Annals of the Rheumatic Diseases;
-Received FDA approval to resume ATHENA trial enrollment;
-Completed enrollment in a 20 patient feasibility study for the treatment of patients with anterior cruciate ligament (ACL) injuries in Spain.
“Over the preceding two quarters, Cytori has substantially reduced expenses and completed a comprehensive review of its strategy,” said Dr. Marc Hedrick, President & CEO of Cytori. From this point forward, the Company will focus its clinical efforts on indications that can provide at least phase II clinical data in the near term. At this point for Cytori, controlled and rigorously obtained phase II clinical data is the optimal way to create corporate value in our view. In addition, the Company will focus its sales efforts first on profitability and positive contribution margin. All other corporate activities will be substantially scaled back or eliminated.”
Financial Performance
Total product and contract revenues for the third quarter of 2014 were $ 1.1 million, consisting of $ 0.5 million in product revenues and $ 0.6 million in contract revenues. This compares to $ 2.7 million in combined product and contract revenues for the third quarter of 2013, consisting of $ 1.6 million of product revenues and $ 1.1 million of contract revenues. Gross profit was $ 0.2 million in the third quarter of 2014 compared to $ 0.7 million in the third quarter of 2013.
Research and development expenses, excluding share-based compensation, were $ 3 million in the third quarter of 2014 compared to$ 4.5 million in the second quarter of 2014 and $ 4 million in the third quarter of 2013. Sales and marketing expenses, excluding share-based compensation, decreased to $ 1.3 million from $ 1.8 million in the second quarter of 2014 and $ 1.6 million in the third quarter of 2013. General and administrative expenses, excluding share-based compensation, decreased to $ 3.4 million in the third quarter of 2014 compared to $ 4.2 million in the second quarter of 2014 and $ 3.8 million in the third quarter of 2013.
“Concurrent with our more focused strategy, we are in a time of aggressive expense reduction. Our third quarter operating cash burn decreased to .2 million, compared to $ 9.2 million in the second quarter of 2014, these expense reduction measures are expected to save over $ 8 million in operating cash burn per year,” said Dr. Hedrick. “Based on the recent $ 12 million option exercised by BARDA, clarity on the new regenerative medicine law in Japan, and our recent history, we anticipate relative revenue growth in the fourth quarter of 2014 and thereafter.”

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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 results and CC 06 Nov 2014 16:07 #2609

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Clinical Pipeline
Cardiovascular Disease
The US phase II ATHENA trial of Cytori Cell Therapy on patients with heart failure has been on clinical hold since May 2014 over a concern following reports of cerebrovascular ischemia in 3 patients. During this time, a thorough investigation, both clinical and preclinical, was completed. The full report was submitted to the FDA on September 19, 2014. During this period, the Company found no data to suggest that Cytori technology led to these adverse events. In fact, the data generated strongly supported previous data from the Company and its users regarding the safety of the Celution® System and its cellular output. The FDA response to the Company’s submission was received on October 22, 2014 and noted they had no subject protection concerns and Cytori was free to proceed with the trials with the protocol amendments proposed by Cytori.
Currently the ATHENA phase II trials have enrolled a total of 31 patients (28 of 45 in ATHENA and 3 of 45 in ATHENA II). Based on the enrollment thus far, minimal loss of statistical power and the fact that during the delay the Company has made substantial progress on it next generation Celution® system, the Company has determined the most prudent course of action is to stop enrollment at 31 patients and analyze unblinded six month data. The 31st patient will reach the planned 6 month time-point this month. An analysis of the complete and verified 6 month data should be available early in 2015 for review and planning next steps.
In July, Cytori signed and announced a contract with the National Heart, Lung and Blood Institute (NHLBI) to provide its technology to study adipose-derived regenerative cells (ADRCs) in the therapy of patients with end-stage heart failure already on a left ventricular assist device or LVAD in a trial called CELVAD. Recently, the NHLBI informed Cytori that initiation of a cell therapy trial on patients with LVADs will be delayed citing concerns around the feasibility related to treatment of LVAD patients, evolving nature of LVADs, endpoint selection, and the cost and complexity of the study. We will provide updates on the outlook for this trial when we are notified.
Orthopedic Disease
Cytori has received approval by the FDA to begin a US IDE pilot (phase II a/b) clinical trial of Cytori Cell Therapy in patients with osteoarthritis affecting the knees to be called ACT-OA. A total of 90 patients will be enrolled in this randomized, double-blind, placebo controlled clinical trial and followed for one year. The study, which is anticipated to begin enrollment in 2015, will examine the safety of Cytori Cell Therapy and several efficacy endpoints including symptom relief, function and activity level. Data should be available in 2016.
“As part of our strategic review, we have considered a number of new clinical opportunities based in large part on likelihood of clinical and commercial success. Osteoarthritis affects 16% of adults in the US over 45 years of age and guideline recommended treatments are relatively limited,” said Dr. Hedrick. “Coupled with a strong feasibility data set, we have decided to move this indication forward and bring to an end our RECOVER hamstring repair trial in the US as it did not meet our new internal criteria to proceed.”
Thermal Burn & Radiation Injury: BARDA Contract Revenue
In August 2014, Cytori received formal notification that BARDA has executed a contract option to fund research, development, regulatory, clinical and other tasks required for initiation of a pilot clinical trial of the Celution® System in thermal burn injury for a total of approximately $ 12.1 million. Upon IDE approval by the FDA, BARDA anticipates exercising Option 2 funding to cover costs associated with execution of a pilot clinical trial, currently estimated at approximately $ 8.3 million, bringing the combined value to up to $ 20.4 million.

In addition to development and clinical activities in Option 1 and Option 2, BARDA may later choose to fund a thermal burn pivotal trial through the FDA approval submission process (Option 3), and fund further development activities related to thermal burn compromised by concomitant radiation exposure (Option 4). Cytori plans to submit preclinical data from the base period of the contract for publication this year.
Scleroderma
Based on promising clinical outcomes from SCLERADEC I, a pilot trial using Cytori Cell Therapy to treat disabling hand manifestations of scleroderma (published recently in the Annals of Rheumatic Diseases), Cytori has agreed to support a follow up confirmatory trial in France. The confirmatory trial called SCLERADEC II will be a multicenter, randomized, double-blind, and placebo controlled trial of a single dose of ADRCs or placebo in 40 patients. The trial will have a crossover arm and will use a validated primary endpoint called the Cochin Hand Function Scale. The study is planned to begin enrollment in 2015 and data should be available in 2016. The Company intends to work alongside the investigators and scleroderma advocacy groups to seek reimbursement should the trial show effectiveness of the therapy.
Urinary Incontinence
Cytori has agreed to provide support in the form of device and consumables to a planned Japanese investigator/government sponsored trial of Cytori Cell Therapy for male urinary incontinence. This trial is based on the previously published feasibility trial conducted at Nagoya University in Japan that demonstrated improvements in leakage, urethral closure, and patient quality-of-life assessment in men with urinary incontinence following radical prostatectomy for prostate cancer. The primary funding and support of the trial will come from the Japanese Ministry of Health, Labor and Welfare and the Nagoya University and therefore is not primarily a Cytori sponsored clinical trial. We will report when the protocol is finalized and the timetable for the trial is available. If efficacy is shown is this trial, the investigators intend to seek regulatory claims for this indication and reimbursement for the therapy.
Product Revenue
As part of the year end 2013 financial review, Cytori changed the timing of revenue recognition for new customers. As a result of this change, Cytori has approximately $ 1.7 million of unrecognized orders, consisting of products shipped prior to September 30, 2014, which are anticipated to be recognized in the fourth quarter of 2014. Based on the current unrecognized orders, total product revenue for the year should be concentrated in the last quarter of the year. In addition, expanded activities of its partners including Lorem Vascular, Okyanos and Bimini should provide growth opportunities in 2015. Specifically, Cytori anticipates filing for Chinese regulatory approval by the end of 2014.
Board of Directors Transition
E. Carmack Holmes, M.D., 76, will be retiring from the Company’s Board of Directors, effective December 31, 2014. Dr. Holmes has been a member of Cytori’s Board of Directors since 2003. “I am eternally grateful for Professor Holmes and his many years of leadership and advice on Cytori’s Board. He is a true gentleman and friend and has been a tireless advocate of Cytori over the years,” said Dr. Hedrick.
Forthcoming Activities and Milestones
During the remainder of 2014 and early into 2015, Cytori intends to: finalize ATHENA and analyze the data, start the ACT-OA trial, wind down the RECOVER trial, support the initiation of its scleroderma and urinary incontinence trials in Europe and Japan respectively, file for CFDA class I approval, complete the next phase of the Celution® development program, and work with BARDA and FDA to plan our forthcoming thermal burn trial, among other activities. Financially, we intend to continue to improve our financial position through combination of activities including: additional expense reductions, profitable revenue growth, additional capital raise, partnerships, debt restructure or further debt term modification.

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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 results and CC 06 Nov 2014 16:21 #2610

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500K of product revenue..LOLOL !!!
Even if you count the deferral ....next to no one is using the tech.

Scleroderma....I bet 3 years from today they still wont have reimbursement.

SUI...Japan is so thrilled with this indication they are allowing Cytori to provide all the Celutions and consumables.

Cardiac...one can read Fas' comments today. Lets just say it wont be saving the day anytime soon if ever !!!

Another board member to "retire" and more lay-offs coming...that projects strength of the future...LOL ! Lets hope they wont be a Wales as Crayon Jones made a special trip to have a cupcake. :evil:

So now we need to consider if a 1:5 reverse split will be enough.

Fas to address a comment you made on the other thread today...the tech may survive and even be used some day...doesnt mean Cytori will. We are not dead but we are certainly on life support. :cry:

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Q3 results and CC 06 Nov 2014 16:25 #2613

  • fatboy
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But Hedge they are still deferring income. It will be realised in the 4th quarter! Thats what they "saad" last quarter.

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