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TOPIC: CYTX To Acquire Assets of Nano Particle Company Azaya

CYTX To Acquire Assets of Nano Particle Company Azaya 19 Jan 2017 06:08 #8560

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SAN DIEGO, Jan. 19, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) (the “Company” or “Cytori”) today announced it has entered into a definitive agreement (the “Purchase Agreement”) to acquire certain assets from privately held Azaya Therapeutics Inc., a leader in the research, development and manufacturing of nanoparticle and protein-stabilized liposomal therapeutics (the “Acquisition”). The Acquisition is subject to customary closing conditions, including obtaining third party consents and approvals and obtaining the approval of Azaya’s stockholders, and is expected to close on or prior to February 28, 2017. The Acquisition, if consummated, would provide Cytori with a proprietary liposomal nanoparticle technology platform that would expand and complement the Company’s leadership position in regenerative medicine.
Under the terms of the Purchase Agreement, at the closing of the Acquisition (the “Closing”), Cytori will issue $2 million in Cytori common stock up front, 25 percent of which will be subject to a 15-month escrow, and will also pay off approximately $2 million of Azaya’s trade payables. At the Closing, Cytori will also assume the obligation to make additional future payments to Azaya based upon (i) the achievement of certain commercialization milestones, (ii) receipt of revenue from certain licensing, sale or other transactions involving certain assets acquired from Azaya, and (iii) the achievement of certain product revenue goals. Under the terms of the Purchase Agreement, Cytori’s aggregate commercialization milestone payment obligations to Azaya will not exceed $16.25 million, and its aggregate royalty payment obligations to Azaya based on product revenues will not exceed $100 million. Further, Cytori’s obligation to pay Azaya certain license/sale or other transfer fees based on payments made to Cytori by the licensee, purchaser or other transferee of the assets will not exceed $50 million. Cytori will also undertake certain obligations pertaining to the registration of the shares issuable to Azaya at the Closing. Additionally, the Acquisition includes related intellectual property and a portfolio of investigational oncology therapies developed to meet the needs of large, underserved patient populations. Finally, at the Closing, Cytori will enter into a five-year lease for Azaya’s state-of-the-art, protein-stabilized nanoparticle manufacturing and development facility located in San Antonio, Texas, that has recently been upgraded in anticipation of commercial scale-up and manufacturing.
“Azaya’s technology and intellectual property present an exciting opportunity to marry Cytori’s cell therapy technology, which is currently in late-stage clinical trials, to a clinically proven and patented off-the-shelf pharmaceutical delivery system directly applicable to regenerative medicine,” said Marc H. Hedrick, M.D., President and Chief Executive Officer of Cytori. “We are working diligently with Azaya to consummate the Acquisition so that we can exploit the inherent unique synergies that are present and which we believe will allow Cytori to leap forward in its intended development of next-generation, ‘druggable’ regenerative medicine products. In addition, the Acquisition allows Cytori to cost-effectively expand our clinical pipeline with two promising oncology drugs that potentially have sizable, near-term, global licensing and revenue opportunities.”
Nanoparticle technology and liposomes have been used for over 20 years to improve delivery of a variety of pharmaceutical payloads throughout the body, due to liposomes’ ability to stabilize therapeutic compounds, overcome cellular and tissue uptake challenges, and improve biodistribution of compounds to target sites in vivo. The most common use of liposome is for the targeted delivery of cytotoxic drugs to tumors. Cytori research suggests that nanoparticle liposomal technology may be useful to deliver targeted regenerative therapies to sites of acute or chronic injury.
“This nanoparticle technology would provide Cytori with 2 new compounds that we believe are immediately partnerable on a global basis and one that has successfully completed all its clinical evaluation and that we expect could be launched in Europe in 2019,” said John Harris, General Manager of Cell Therapy and Regenerative Medicine at Cytori. “The Cytori and Azaya teams have been working together on this contemplated asset acquisition for a number of months, have complementary skill sets and, upon closing of the asset acquisition, are ready to move this program rapidly to key milestones in both the oncology and regenerative medicine space. Simultaneously, we will be focused on realizing the full clinical and commercial potential of our lead product, HABEO™ Cell Therapy (formerly ECCS-50), initially for treatment of scleroderma and planned readout mid year.”
As previously announced, the STAR (Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells) trial of HABEO Cell Therapy completed enrollment ahead of schedule in June 2016. A readout of primary endpoint 12-month data is expected in mid-2017, which may inform a Pre-Market Approval (PMA) submission to the U.S. Food and Drug Administration.
Azaya Therapeutics is based in San Antonio, Texas and has developed two nanoparticle drugs that have shown promise in their respective clinical programs to date. ATI-0918, the lead clinical candidate in the Azaya oncology portfolio, is an off-patent, complex, generic nanoparticle liposomal formulation of doxorubicin hydrochloride, a widely used chemotherapeutic agent often used to treat breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma.
"The proposed transaction with Cytori will put Azaya and its stockholders in a position to benefit from potential global commercialization of our ATI-0918 generic liposomal doxorubicin product that has been shown to be bioequivalent to Johnson & Johnson’s branded product in Europe, as well as further the clinical development of ATI-1123, our proprietary liposomal encapsulated docetaxel,” said Mr. John Kerr, Azaya's Chairman. “In addition, this transaction provides Azaya's stockholders, through Azaya’s ownership of Cytori shares, the ability to participate in any future success of Cytori's regenerative medicine portfolio."
In a completed clinical trial, ATI-0918 demonstrated bioequivalence to the reference drug for doxorubicin in Europe (marketed by Johnson & Johnson as Doxil® and Caelyx®). Cytori expects to begin manufacturing preparation of the drug upon closing the Acquisition and plans to file for EU regulatory approval of ATI-0918 in early 2018, and to seek commercialization partners for the drug. The Company is considering a follow-on study to demonstrate the bioequivalence of ATI-0918 to the reference drug in the U.S. (marketed by Sun Pharma as Lipodox).
According to independent industry research*, the doxorubicin market is expected to grow to approximately $1.4 billion worldwide by 2024 and has been underserved in recent years. Marketed generic formulations of doxorubicin have experienced frequent supply disruptions due to manufacturing issues at facilities outside of the U.S. Cytori intends to manufacture ATI-0918 in the acquired facility, which is located in San Antonio, Texas.
The Azaya portfolio also includes ATI-1123, a patented, nanoparticle-stabilized liposomal formulation of docetaxel, one of the most profitable and widely used chemotherapy agents with a current worldwide market of $1.3 billion. Azaya reported positive safety results for ATI-1123 in its Phase 1 study of 29 patients with solid tumor cancers who failed other therapies. After the Closing, Cytori, through partners, plans to proceed with Phase 2 clinical studies of ATI-1123 in multiple indications.
“As we look ahead in 2017 and beyond, Cytori is preparing for transformative growth driven by a broadened pipeline of specialty-pharma oriented therapies that carry the potential bring value to patients, physicians and shareholders,” noted Dr. Hedrick. “Over the past 2 ½ years, Cytori has strengthened its pharmaceutical development and manufacturing expertise at both the management and board levels to provide the competency and breadth of experience to identify and execute on strategic partnerships such as the transaction with Azaya. We are working to close this transaction with Azaya promptly. We look forward to providing additional financial guidance and commentary on the transaction in due course.”
Investor Conference Call Webcast
Cytori will host an investor update conference call at 8:30am EST today to further discuss the company’s announcement. 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: 56963876.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 06:44 #8561

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So...... who are you Rodney? Good call.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 06:44 #8562

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If you thought you had seen it all, you can still be surprised, since Cytori can come up with things totally unexpected.

From my first "chewing" of the announcement, I think the off-patent liposomal cancer compounds are just the dessert in the deal. Target must have been the Protein Stabilized Liposome (PSL) platform technology, which can deliver to targets in the body.

With other words- the cells stay nicely in the hand, but tend to spread all over the place for targets which are more centralized in the body and not at the end of the extremities and PSL can possibly keep them at the target????

In that case- would make all sense in the world.:grin:

Looking forward to the CC.

Below is the factsheet on the acquisition

File Attachment:

File Name: CytoriAzaya_Factsheet_011817.pdf
File Size: 2,077 KB
Attachments:

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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:

CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 07:03 #8563

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Fas, this HUGE news - now we need some cash partners to avoid using the LP deal - stay tuned!

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 07:15 #8564

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I think this deal puts an end to the allogeneic vs. autologous model argument. I don't understand this yet technology but it is clear that Cytori saw the writing on the wall with this late attempted move to off the shelf.. Question is whether there is enough time and resources to pivot. Time will tell.

“Azaya’s technology and intellectual property present an exciting opportunity to marry Cytori’s cell therapy technology, which is currently in late-stage clinical trials, to a clinically proven and patented off-the-shelf pharmaceutical delivery system directly applicable to regenerative medicine,” said Marc H. Hedrick, M.D., President and Chief Executive Officer of Cytori. “We are working diligently with Azaya to consummate the Acquisition so that we can exploit the inherent unique synergies that are present and which we believe will allow Cytori to leap forward in its intended development of next-generation, ‘druggable’ regenerative medicine products. In addition, the Acquisition allows Cytori to cost-effectively expand our clinical pipeline with two promising oncology drugs that potentially have sizable, near-term, global licensing and revenue opportunities.”

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 07:26 #8565

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WST, is that the best that you can do? Unbelievable!!!

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 07:40 #8566

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I think this is about the direct delivery of exosomes with regard to the regmed component of this although there were no details given.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 08:17 #8567

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Just to also quote Hedrick from the call...

This changes nothing (repeat nada niente) to the current Cytori Cell Therapy technology, which he considers to be the best there is (me too), just provides a broader platform of technologies and near term opportunities, fitting to the present organization and in particular to a Board member (Ronald martell) and other staff recently added to the organization.

The PSL technology would add an aspect to regenerative medicine on a pre-clinical i.e. development level, whereby the obvious thought would be to encapsulate AUTOLOGOUS ADRCs and through some newly designed signaling and targeting regimes safely deliver them to the organs and tissues which are in need of repair.

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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:

CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 08:27 #8568

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...whereby the obvious thought would be to encapsulate AUTOLOGOUS ADRCs and through some newly designed signaling and targeting regimes safely deliver them to the organs and tissues which are in need of repair.


I doubt it Fas, I suspect they will be attempting to encapsulate the extracellular vesicles, including exosomes, that emanate from stem cells. I'm sure you know that these are chemical messengers that signal native cells to repair. I doubt they will try to encapsulate the cells themselves. Capricor is already working on an exosome therapy. I believe this type of therapy would then become more like a drug than a cell therapy. Either way it's a hell of a long way off.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 08:42 #8569

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Rodney Strong,

Some people are paid to be here for a good reason.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 08:49 #8571

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Franshei, not sure that I understand your post, but if you are suggesting that I am paid for posting, then shame on you!

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 08:59 #8572

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Wall Street Titan wrote:

...whereby the obvious thought would be to encapsulate AUTOLOGOUS ADRCs and through some newly designed signaling and targeting regimes safely deliver them to the organs and tissues which are in need of repair.


I doubt it Fas, I suspect they will be attempting to encapsulate the extracellular vesicles, including exosomes, that emanate from stem cells. I'm sure you know that these are chemical messengers that signal native cells to repair. I doubt they will try to encapsulate the cells themselves. Capricor is already working on an exosome therapy. I believe this type of therapy would then become more like a drug than a cell therapy. Either way it's a hell of a long way off.


Yes- that is possible too- since most of the therapeutic action being paracrine, one also just could send the cytokines or other particles which would have to same impact as cells under this mechanism.

That would possibly create two ADDITIONAL platform tech types- guided cytokines and ADRCs which are "manipulated with growth factors in order to add cell trans-differentiation to the mechanism of therapeutic action.

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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:

CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 09:12 #8573

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Yeah, I read an article about these companies mushrooming like Stem cell companies did 10 years ago.

It's one way to keep that carrot dangling on that string... 10 years and counting.

Good luck all, back to life.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 09:22 #8574

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Fas, your enthusiasm for the deal seems to be less than overwhelming - yes it's a big and complicated change, but I believe (including my gut) that it is an extremely positive TURNING POINT in the future of CYTX. Looking forward to DOV's take on the deal.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 10:09 #8575

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Fas, said:

"That would possibly create two ADDITIONAL platform tech types- guided cytokines and ADRCs which are "manipulated with growth factors in order to add cell trans-differentiation to the mechanism of therapeutic action."


Fas, if you are saying that ADRCs will not be encapsulated the statement above then we are agreement. I'll also note that Marc used the term "cell free" in describing the next phase of this "cutting edge" regmed technology. That would rule out ADRC encapsulation.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 10:33 #8576

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Wall Street Titan wrote: Fas, said:

"That would possibly create two ADDITIONAL platform tech types- guided cytokines and ADRCs which are "manipulated with growth factors in order to add cell trans-differentiation to the mechanism of therapeutic action."


Fas, if you are saying that ADRCs will not be encapsulated the statement above then we are agreement. I'll also note that Marc used the term "cell free" in describing the next phase of this "cutting edge" regmed technology. That would rule out ADRC encapsulation.


Yes- that is what I was saying- guided cytokines, not ADRCs- so I guess we agree.

Rodney- I know business is money and chemo-therapy probably means money, although science and BP should be ashamed of themselves, that they so far did not find anything useful against cancer and ignored the auto-immune bolstering opportunities for over 30 years.
I regard Cytori Cell Therapy as holistic, since without any side-effects and perfectly safe. To partially own - as a cancer survivor who refused chemo and is (now) perfectly healthy- a Company which is in the business to develop that crap, is not very appealing to me.

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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:

CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 10:46 #8577

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Fas, I understand your point, but it is not as if CYTX is giving-up on cell therapy - this acquisition is complimentary in some respects, and to the extent that it is not, that portion s/b viewed as a monetary means (through sales and partnerships) of making CYTX successful primarily as a stem-cell therapy company. JMHO.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 11:23 #8578

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Rodney Strong

Sorry to be negative.

The conference call is not good.

Hedrick and his team present are not oncology r/d and marketing experts and when the cc touches onto cancer, they do not really know the subject well to answer questions in a meaningful way.

Secondly, they have not bring out the advantages of marrying nanotechnology from AZA and the CYTX stem cells r/d.

The conference call is very vague.

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 11:31 #8579

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Beat me to it franshei although I didn't even bother to listen to the call.

RS seems to be the only one excited by this deal but to me it confirms current flaws of the Cytori company we knew. Better news needed that shows a actual solving of problems with the caveat that perhaps some are NOT solvable.

Niche player

I guess we see what the close brings if the is any late interest in what so far today has been a sell event !

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CYTX To Acquire Nano Particle Company Azaya 19 Jan 2017 11:44 #8580

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Hedge,

Look at the background of the CEO of Azaya: www.azayatherapeutics.com/about/management-team . Can anyone explain why he wouldn't partner directly with big pharma as opposed to signing up with Cytori? Jason Kolbert called it "exciting" and "out of the box thinking" but I don't see how Marc Hedrick will have success in licensing cancer drugs when Azaya couldn't do it on their own. $6,000,000 bump in cash burn in 2017 without new licensing money. Someone please explain.

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