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Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work
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TOPIC: Nano

Nano 14 Oct 2017 10:13 #10262

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So I am adding this OT post not for the company so much as it relates to nano encapsulation and how a relatively young CEO is able to raise money with known names while we always stumble with the lower echelon.

www.businessinsider.com/bill-gates-backed-exicure-gene-silencing-rna-treatments-2017-10

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Nano 26 Oct 2017 09:19 #10349

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Rodney Hedge and FAS

Some thoughts re recent departure of Marino, Hayden and Kleinh.

I personally think CYTX would not be profitable or even breaking even in the near term if the company remains solely a cell therapy company, while the Cytori KK has no outside help and the US/EU scleroderma trials would continue.

However, the CYTX nano medicine venture should potentially be a good cash cow - with just one entry product in EU, while the lipo taxo development would take longer time from here.

Even if CYTX's ATI 0918 is launched through a distributor (the least to expect), the potential revenue would still be sizeable and the company maybe able to float in black.

If the CYTX nano medicine venture would take a central stage in 2018 and beyond (supergeneric in the oncology arena), then the departure of the Marino, Hayden and Kleinh makes a lot of good sense. Marino would be replaced by a real physician with real oncology and Pk (pharmacokinetics) experiences (oncology is always different from general medicine and PK is handled by a separate and very specialized group with the the FDA). While CYTX KK will handle its own dealing with the Japanese FDA, CYTX needs a new regulatory affairs expert from the drug industry to deal with the FDA. CYTX US does not need a full time patent attorney. The works if any can be done outside of the company. Regarding corporate development, there are two members on the BOD who can do this kind of work.

What I can see is that CYTX is moving more and more into the real drug industry. I would not be surprised that they are looking for a Japanese partner for CYTX KK (or even a buyer). (If the latter assumption becomes reality, John Harris may leave the company or reassigned. Is this why Seijiro Shirahama is now the Chairman of CYTX KK ?). If CYTX KK is partnered with a stronger Japanese pharma/medical device company, the sales in Japan should grow faster.

Is this what GERN has done?

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Nano 26 Oct 2017 09:47 #10350

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Franshei,

Nice thoughts except that Cytori has failed to get a partner to move nano forward. According to Marc H. a partner was supposed to happen quickly, wasn't it? Looks to me like it won't happen. If this nano drug was so marketable, IMHO, a partner with deeper pockets and expertise in the area would have stepped up long before Cytori did. Never made any sense to me and so far my skepticism hasn't been disproven.

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Nano 26 Oct 2017 09:54 #10351

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franshei wrote: Rodney Hedge and FAS

Some thoughts re recent departure of Marino, Hayden and Kleinh.

I personally think CYTX would not be profitable or even breaking even in the near term if the company remains solely a cell therapy company, while the Cytori KK has no outside help and the US/EU scleroderma trials would continue.

However, the CYTX nano medicine venture should potentially be a good cash cow - with just one entry product in EU, while the lipo taxo development would take longer time from here.

Even if CYTX's ATI 0918 is launched through a distributor (the least to expect), the potential revenue would still be sizeable and the company maybe able to float in black.

If the CYTX nano medicine venture would take a central stage in 2018 and beyond (supergeneric in the oncology arena), then the departure of the Marino, Hayden and Kleinh makes a lot of good sense. Marino would be replaced by a real physician with real oncology and Pk (pharmacokinetics) experiences (oncology is always different from general medicine and PK is handled by a separate and very specialized group with the the FDA). While CYTX KK will handle its own dealing with the Japanese FDA, CYTX needs a new regulatory affairs expert from the drug industry to deal with the FDA. CYTX US does not need a full time patent attorney. The works if any can be done outside of the company. Regarding corporate development, there are two members on the BOD who can do this kind of work.

What I can see is that CYTX is moving more and more into the real drug industry. I would not be surprised that they are looking for a Japanese partner for CYTX KK (or even a buyer). (If the latter assumption becomes reality, John Harris may leave the company or reassigned. Is this why Seijiro Shirahama is now the Chairman of CYTX KK ?). If CYTX KK is partnered with a stronger Japanese pharma/medical device company, the sales in Japan should grow faster.


Franshei, excellent post - you could be right on the "marc" re a Japanese deal!

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Nano 26 Oct 2017 10:12 #10352

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Speculation as good as any I suppose franshei....however, it is also possible after the latest failure at lest some of the people WANTED out !
Marc gets his chance to spin in about 2 weeks.
RO awarded tomorrow.
Again, pure speculation, but could current weakness be to the fact that some thought something would break before the award ? I don't know. I still expect support to get the deal done though. Then we see where it trades. Oxford and lower burn still only buys so much time. What do they plan to sell for a measly $5 million ?

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Nano 26 Oct 2017 11:16 #10353

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myownhedgefund wrote: Again, pure speculation, but could current weakness be to the fact that some thought something would break before the award ? I don't know. I still expect support to get the deal done though. Then we see where it trades. Oxford and lower burn still only buys so much time. What do they plan to sell for a measly $5 million ?


Absolutely that weakness could be due to nothing breaking before the award - the $5 million s/b covered by the RO proceeds.

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Nano 26 Oct 2017 11:47 #10354

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***the $5 million s/b covered by the RO proceeds.***

Agree, it could be that simple.

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Nano 26 Oct 2017 12:26 #10355

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1. Hedge has commented some time earlier that a Japanese partnership may not necessarily bring in too much cash upfront.

I think this case may or may not be true, simply because Harris is bringing in only $ 1 per Q.

Based on what CYTX is dressing up in recent times with possible successes in several clinical fronts, I think a Japanese deal may bring better upfront cash than what we are thinking, depending how skillful CYTX is able to convey how great this crown jewel would be if there are more local sales and marketing efforts. (TAP is CYTX's advisor and there must be another advisor representing the opposite party.)

I personally think CYTX can bring in at least $ 5 million if there is a deal. Actually, such a deal is probably being closed before the end of the year, otherwise Oxford would not allow CYTX to go virtually bare bone in the loan deal. Oxford knows something and we do not.

2. Re ATI 0918, no one would sign a deal with CYTX until the manufacturing is (at least nearly) completed in a FDA inspected facility and stability testing has started. I believe the San Antonio pilot plant is now up for running and liposomal compounding is in early stages (small batches with validated analytical HPLC support). The stability testing is a one year process at room/ambient temperatures and elevated temperatures. For EU FDA filing, they need at least 6 month data (with understanding that the one year data is coming).

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Nano 26 Oct 2017 13:35 #10356

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franshei

1. Where do you get $1 per Q ?

2. Agree, $5 million is a small figure and Oxford extended based on something but lets not forget it was win/win for Oxford with the extension. Either Cytori survives and payments on the most expensive loan known to man continues or a default and Oxford walks away with the patents along with what is left from BK court.

3. I still think a indication versus selling the business in Japan more likely.
4. Agree that San Antonio needs to be further along for a deal there...especially since Cytori can f**k up most anything !!!

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Nano 26 Oct 2017 13:36 #10357

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Franshei, the RO would satisfy the $5 million of net proceeds required before y/e.

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Nano 26 Oct 2017 14:59 #10358

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Hedge

$ 1 million or so per Q.
The following user(s) said Thank You: myownhedgefund

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Nano 26 Oct 2017 15:17 #10359

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Rodney

1. Where did Tiago Girao travel to recently (I mean overseas)? To Japan?

2. It look like to me that CYTX KK with Shirohama as Chairman is becoming set up as an independent company for joint venture. Would it happen to bring in a partnership and some upfront money? I personally hope so. To make CYTX KK attractive, maybe they can throw in the rest of Asia, except the Lorem territories (which can be brought into CYTX KK in the future). Lorem cannot really function without support from CYTX in many ways, if it is solely a celution system distributor.

3. Financially for the next 12 months (till ATI 0918 is in the market during 2019), I think they need money from all fronts RO, possible upfront payments from deals in Japan, EU (ATI 0918), BARDA , revenue from Japan (even if there is a partnership - under a partnership, the total Japanese revenue may increase) and even ATM. The cash burn will exceed $ 1 million per month.

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Nano 26 Oct 2017 15:37 #10360

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Franshei, Tiago has not answered any of my contacts - not sure where he is at present.

I think Q-3 and Q-4 are going to be stronger than expected. JMHO.

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Nano 26 Oct 2017 17:41 #10361

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Thanks franshei...I later realized you must have meant a million but thanks for the clarification.
I still don't get selling a piece of their only real place of sales...Japan. But I rarely agreed on how this company was run.
As far as Lorem territories...they didn't fulfill there contract...they really should be out but I doubt Cytori followed through to regain control.
Cash via ATM still off limits due to market cap I believe...a few bucks may have been raised via LPC north of $0.50.
I tend to lean with Fas that we are so close to Q3 filing that speculation has become mute.

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Nano 27 Oct 2017 08:27 #10362

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Nano medicine , in this case, is really liposomal delivery of cytotoxic drugs to reduce drug related toxicity. It is old science, but more than just grand old daddy. All the AZA drug products in the pipeline are not generic, but as we called them supergeneric (SUPG as we named SuperGen).

ATI 0918 is the easiest pathway on the AZA plate to reap profit (first in EU and then USA and China) and propel the cell therapy programs. Liposomal taxo development is not easy task for CYTX. Besides, the clinical development to NDA would take more than $ 100 million. A partner would only come if it shows convincing clinical responses in NSCL (as Hedrick has picked).

With the arrest of John Kapoor yesterday in Arizona for alleged crimes through INSYS. I go back and take a look what I have missed since our days together at Lyphomed (Kapoor's first major success in the drug industry). (Kapoor and I went to Buffalo around the same time and I came to Chicago to join him as his clinical r/d chief, 30 years ago.)

When we sold Lypomed to Fujisawa (1990s), now Astellas, Mr. Aoki did not want the liposomal portion of the business and gave back to Kapoor. With A. Rahman (lab scientist from Georgetown), NeoPharma was founded here at Lake Bluff. NeoPharma had almost the exact r/d pipeline as AZA. NeoPharma (under Kapoor, Tambi and Rahman) grew from a $ 1 million investment to a $ 44 pps company (do not remember the market cap) over a 10 year period. With NeoPharma stock as cash, Kapoor bought out INSYS several years ago (2013?). INSYS sells about $ 75 million of fentanyl and the net is only $ 5 million, yet the market cap of INSYS had been multi multi billion dollars at one time. (Note: Kapoor is a very shrewd and high risk taker, living on the edge between law and lawlessness. Throughout the years, he has attracted a lot of good people working for him, including the very famous oncologist Daniel VoHoff. Hedrick and Rickey and even my old boss Stan Crook are not John Kapoor - who is generally considered a black sheep.)

The first Lyphomed liposomal project with Vestar (now part of Gilead) is Ambisome -a great success.

I hope Hedrick would do the right things here with the AZA drug products pipeline (cash cow).

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Nano 27 Oct 2017 08:49 #10363

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Franshei, based on your last post, it would seem that you feel that either a significant partnership or outright sale of the liposomal taxo portion of the AZA business is the way to go - do I have that right and what are the chances of that in your opinion?

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