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asmarterwookie

01/27/16 10:12 AM

#250546 RE: cjgaddy #250543

Love the human data on T-cell infiltration. Not envivo/exvivo.
Human data.

Just waiting for the data from Sunrise to see how good it really is.

wook
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cjgaddy

01/27/16 12:00 PM

#250572 RE: cjgaddy #250543

Awesome presentation by SK imo – extremely confident!

1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm


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eb0783

01/28/16 8:05 PM

#250738 RE: cjgaddy #250543

Colonel, thank you for your great moderator work on this board. Thank you for “recording” and saving all of these presentations and conferences for us.

The slides here are great! Notice #6 of 31. Do you see the windows lining that hall in the upper right corner? They are also designed to be removed and to be the right size to allow a future 2000L bioreactor to be handed through. It will be moved through on its side. The reactor room is designed with a 14 foot ceiling, unlike the 8 or 9 foot ceiling of the hallway. That is to allow for the 2000L bioreactor to be turned upwards and allow it to be set upright and be ready for service within a few hours. That is a “little” better than conventional multi-use reactors that take two or three weeks to clean, prepare and test before they are ready to use again. These guys KNOW what they are doing!! Kudos to PPHM management!

It was so slow today and most posts were so boring that I thought I would add some facts more interesting, a little meat.
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cjgaddy

01/29/16 9:28 AM

#250776 RE: cjgaddy #250543

SKing/1-18-16 explains PPHM's PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others, like: Axl MerTIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc etc. (maybe why Dr. Raymond Birge is spending lots of time with Dr.Brekken & Peregrine these days?? => http://tinyurl.com/j3whbx3 )

CEO S.King/1-18-16/NobleConf Slide11 7:54: “It turns out that the PS receptors are very well studied, and a number of companies are going after the individual receptors [ex: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8...], depicted on Slide11 as the little pacman symbols. But, the bottom-line is that other companies are going after the individual receptors – our approach is to go after the ligand itself, PS (phosphatidylserine). So, effectively by blocking PS with a good safety profile, we're now able to affect the entire PS-signaling pathway, and we think that's a real advantage over other approaches, since basically we can simultaneously impact the ability of PS to shutdown the immune system.”

1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
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I ASKED A SCIENTIST FRIEND TO EXPLAIN THIS FURTHER – HIS 1-28-16 REPLY:
“Look at SK's Slide11 at Noble/1-18-16. The apoptotic or tumor cells, also the blood vessel cells of tumors, have PS expressed on their surface, this is the ligand. All those other cells, macrophages, dentritic cells etc, have receptors that bind the ligand (PS) on their surface. So if you have an antibody (bavi) which binds to PS it blocks the binding of PS with ANY of those receptors on the cells on which those receptors are expressed. The alternative is to develop antibodies which bind to each of those receptors, so you would need to develop a lot of different antibodies to accomplish the same result, i.e. blocking the ligation (binding) of PS to all the receptors. This is also true for receptors that don't bind to PS directly. For example, the receptor MerTK binds to the protein Gas6 (its ligand), not to PS, but Gas6 in turn binds with PS on apoptotic cells. So you can block the activation of MerTK by blocking PS with bavi so that Gas6 can't bind to PS and complete the chain with MerTK.”

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BY MASSHYSTERIA 1-29-16 IHUB #250754
“...evidence is strongly mounting support your comments from complimentary sources. In a type of concurrence with importance of PS blockade - except across its receptors on the T-Cell side of things. Many are aware that TIM-3 & LAG-3 are 2 of several checkpoints that bind to PS. Not sure how many are aware that the rate of clinical trials evaluating these two checkpoint inhibitors is rising, and that multiple smaller scale trials are showing great results using that combo. That is driving the greater investment and expansion of trials. Why is that a good thing? All these combo trials are conducted by large pharma companies who are seeing supporting signals to increase investment. Peregrine holds the molecule that achieves the complimentary results (blocking at PS site) holistically and without having to chase a multitude of checkpoints that bind to PS to stop/reduce immune response. BP's excitement about TIM-3 and LAG-3 should be a very good cause for upbeat expectations from bavituximab, and a likely reason that world-class institutions and AZN are in the game. The beauty is having a single solution that blocks PS, vs. possibly dozens that block the several other T-Cell checkpoints with which it binds. Commercially, clinically and logistically, there is no better winner in this competition if one can do the work of many. Provided this mechanism works and is shown to do what so many diverse professionals seem to be suggesting - its becoming a game of timing and finesse. The more good news I hear from Industry on TIM-3 & LAG-3, the happier I get. Definitely happier now than 12mos ago.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120163782

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11-2014: “Phosphatidylserine receptors: Enhancers of Enveloped Virus Entry & Infection”
http://www.sciencedirect.com/science/article/pii/S0042682214004206
“Six PVEERs have been identified to date: TIM-1, TIM-4, Gas6 or Protein S/Axl, Mer, and Tyro3, and MFG-E8/integrin avB3 & avB5. “

9-2015/Mucosal Immunology: “The Axl Receptor Tyrosine Kinase is a Discriminator of Macrophage Function in the Inflamed Lung”
http://www.nature.com/mi/journal/v8/n5/full/mi2014129a.html
“The TAM receptor family of receptor tyrosine kinases (Tyro3, Axl and MerTK) mediates the non-inflammatory removal of apoptotic cells by phagocytes through the bridging phosphatidylserine-binding molecules growth arrest-specific 6 (Gas6) or Protein S.”
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11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”

BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
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cjgaddy

01/31/16 9:30 AM

#251085 RE: cjgaddy #250543

Ao q/e10-31-15, HALO at 56%, other U.S. custs at 41%. (the q/e 7-31-15 split was 84%-15%).

Avid's New Customer – hints from 9/2014 on – definitely hit the revenue stream in FY16Q2(qe 10-31-15). We do not know who this new customer is at this point. ...And on 12-10-15, Rob Garnick disclosed, “We are already contemplating our options to increase further our mfg. capacity [beyond Myford=Avid II]”, due to ”what appears to be a growing opportunity in this important area of our business.”
 
Q/E10-31-15 Q/E7-31-15 FY4-30-15 FY4-30-14
Halozyme 56% 84% 79% 91%
Cust-A U.S. 41% 15% 12% 1%
Other Custs 3% 1% 9% 8%

• 9-9-14 PR/P.Lytle: "Avid has been successful in expanding its client roster, while also continuing to evaluate options that would create new mfg. capacity...” http://tinyurl.com/ktrfswj
• 9-9-14 CC/S.King: “Avid has begun 2015 strongly… and the expansion of our client base…” http://tinyurl.com/ktrfswj
• 12-10-14 CC/S.King(Q&A): “The bottom line is that we have seen expansion of our mix of customers, which is absolutely driving a lot of the need for considering new capacity...”
...P.Lytle: “this facility can more than double our existing capacity.” http://tinyurl.com/kmdgq8t
• 6-17-15 PR/S,King: “We've seen tremendous interest for production in the new facility, both from new & existing clients.” http://tinyurl.com/pnlquu3

FOOTNOTE - 12-10-15 CC: http://tinyurl.com/jkp885g
12-10-15 ROB GARNICK: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.”
12-10-15 STEVE KING(Q&A): “The [further Avid] expansion really is driven by our existing and new clients that have come in, and so obviously primarily that’s driven in the bulk drug substances area not necessarily the fill/finish area. So that'll probably be the primary focus; we have considered and eventually would like to move into the fill/finished business, it's just we’ve been so busy expanding our drug substances business, we really haven’t had the option to do that. For the question of space, there’s space in the current buildings that we’re in, but we’re also looking at other opportunities nearby that fit the same model as we did for the Myford facility and allows us to most efficiently grow the business. At the end of the day it will be a business decision and we’ll take on space as needed to expand the business. Again, it’s all really right now supported by the client base, which has had an extremely positive response to the Myford facility and that’s really driving we think even beyond what we expected going into it.
...G.Zavoico: ”Would you finance that further expansion as sort of debt against the revenue coming in or are you just keeping all your options open for that?”
STEVE KING: “We’re keeping our options wide open. At this point, we’ll do what’s best for the business itself. It’s a nice growing backlog of future revenue, it’s really a change in the way the Avid business can be viewed, as more a long-term go-forward business. So, we just need to make the right business decision based on the cost of capital, whatever avenue that takes, and then we’ll make the right decision.”

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Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q2(qe 10-31-15), per the 10-31-15 10-Q ( http://tinyurl.com/ocrtkuj ) issued 12-10-15.
• Total Revs since May’06: ($148.1mm/Avid + $24.1mm/Govt + $2.4mm/Lic.) = $174.7mm
• 12-10-15: FY'16 (May'15-Apr'16) Avid revs guidance raised to $35-40M from $30-35M.
Deferred-Revs at 10-31-15 total $9.7mm, UP from $8.3mm at 7-31-15.
Cust.Deposits at 10-31-15 total $14.9mm, UP from $9.6mm at 7-31-15.
Avid’s Gross-Profit over last 3 qtrs: $14.1mm on revs of $28.2mm (GP%=50%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
  
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%

FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*

*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.