Avid Bioservices Inc (CDMO)

[dia76ca]

Catalysts?TIME forANOTHER POTENTIAL NEWS LIST forNEWBIES UPDATE (back by popular demand...for the sake of new investors.

There is a lot of news to come.....and there are many new investors since the Ebola news(see #19). No-one knows the exact timing of these potential catalysts...but every day we are one day closer.
For any detailed background information look at the great introduction section compiled by Cjgaddy!

1. Peregrine (PPHM) is unique amongst small biotechs in that it has a profitable CMO, Avid Bioservices. Annual revenues exceed $22 million and the gross Margin was 41% last year.(See cjgaddy post #183392 for details) (DONE)

2.In 2009 PPHM appointed Dr. Robert Garnick as Head of Regulatory Affairs. In his 24 years with Genentech(DNA) he was responsible for 20 new product FDA approvals. Dr. Garnick said of the Bavi Phase II NSCLC data..."I've seen a lot of Phase II and Phase III data, and this is as compelling Phase II data as I've ever seen." (DONE) The results of this trial may very well be even better than originally thought....actually an increase in MOS exceeding 133% (see cjgaddy post #174469) For an interesting analysis of the chance of success see CP's post #192518.

3. With Dr. Garnick's leadership PPHM received FDA approval for a Phase III second line NSCLC trial. (DONE)

4.This same Phase III NSCLC trial has now received FDA Fast Track approval. (DONE)

5. The FDA has agreed to 2 early event based look-ins. (DONE)

6. This Phase III trial has had a rapid "hockey stick" establishment of trial sites. 144 trial sites have been set up as of October 8. The original goal was "more than 100" (DONE)

7. Bavi Oncology partnership or partnerships.

8. Liver cancer IST results. The interim results released at a scientific conference in March showed 34 of 38 Phase II were enrolled. Good safety results ....one patient on trial for 18 months. Enrollment has now been completed.(DONE) More efficacy results to come.

9. Liver cancer partnership

10. Cotara partnership announcement

11. Breast cancer IST results published in an academic journal.

12. Breast cancer advancing in clinic

13. Ambulance Chaser Lawsuit ended? Cannot believe how this can be dragged out. The old maxim is true! "Justice delayed is justice denied."

14. CSM settlement

15. Betabodies preclinical

16. Bavi plus other immunotherapies preclinical results...we already have some very interesting Bavi plus Yervoy and Bavi plus PD-1 preclinical results. But there is more to come. Steve King has said that "...preclinical collaborations now number in the DOZENS." Trials include Bavituximab as well as variations such as PGN635(fully human),enhanced ADCC versions of PGN635, PGN632, betabodies and antibody drug conjugates...combined with...

a.anti-CTLA-4 (Yervoy)
b.anti-PD-1 (Nice results released at ITAC Aug.11 2014.Next in clinic?)
c.anti-PD-L1
d.anti-TGF-b
e.anti-IL-10
f.GM-CSF
g.IFN-a
h.IL-2
i.Provenge
j.other companies vaccines/Mabs/antivirals
k.appropriate TKI,PARP inhibitors
l.radiation plus androgen deprivation
m.anti-CD47 and anti-CD54. Preliminary Abstract presented at AAI May 2013. More to come?
n.IDO pathway inhibitors.
o. with PS receptor inhibitors(TIM-1,TIM-3,Axl,Gas6,etc.)

17. Bavi plus Yervoy clinical trial is underway (DONE)

18. Dr. Brekken announcements(publications,editorials,presentations). An article appeared in a prestigious EU publication in December. Immunology talk given on May 28.(DONE) More to come.

19. Another Govt. deal for viruses? HIV presentation in March raises this issue. On Oct.15 PPHM announced the publication of a peer-reviewed manuscript related to preclinical research demonstrating that the company's lead drug candidate bavituximab, a phosphatidylserine (PS)-targeting antibody, exhibits specific and strong binding to Ebola virions and Ebola virus (EBOV)-infected cells in vitro. These results will appear in the Vaccines and Therapies for Biodefense Agents special edition of the peer-reviewed Journal of Immunology Research in a manuscript titled: "Effective Binding of a Phosphatidylserine-Targeting Antibody to Ebola Virus Infected Cells and Purified Virions."(DONE). Ebola potential?

20. Imaging data update

21. New analyst coverage?

22. Institutional ownership increase?

23. Fast track for second line NSCLC announced in January.(DONE) AA and PR could follow.

25. Innovative Series E Preferred Convertible financing has now increased the companies cash to some $70 million. (DONE) More financing news to come. How is this related to trials and/or
partnerships?

26. Interim Phase 1b first line NSCLC data will be presented at MSTO on November 1.

27. A really huge catalyst would be an early approval of Bavi in the second line NSCLC indication because of a DMC decision based on exceptional results, or early approval based on the first or second event based look-ins!

COMING EVENTS.(for detailed updates see the stickies by cjgaddy)

Oct20-23/Avid(booth#1045): BioProcess Intl. (BPI) Conf. & Exhibition, Boston http://convention.bio.org/2014

Oct 30-Nov1: Multidisciplinary Symposium on Thoracic Oncology (MSTO), Chicago http://tinyurl.com/p2l43mt
...Sponsors: ASTRO, ASCO, IASLC, Univ/Chicago - Note: PPHM SAB/KOL'r Dr. David Carbone is now President-Elect of IASLC (see http://tinyurl.com/pxq4gc7 ).
...Per VP Joe Shan 9-9-14: “Data from the Ph.Ib IST Univ-Pitt. Bavituximab+CP/1stLine/Stage4/NSCLC” (PI=Liza Villaruz, MD)
…Nov1 10-10:30: Speaker Scott J. Antonia (PPHM SAB/KOL/Moffitt), “Immune …Modulation of Lung Cancer”

Nov3-5: BIO Europe 2014 (Europe’s largest partnering conf. - PPHM=presenting), Frankfurt http://www.ebdgroup.com/bioeurope/index.php

Nov6-9 SITC 2014 29th Annual-Mtg: http://tinyurl.com/k6q58be (SITC = The Society for Immunotherapy of Cancer http://www.sitcancer.org )
…Bavi+Sorafenib/Liver-Cancer IST/UTSW/Yopp “correlative studies” data ("translational data showing immune changes"), followup data from AntiPS+AntiPD1/Melanoma preclin. studies(Hutchins/Freimark), and 2 other posters about PS-targeting Mabs’ ability to “enhance activity of immune checkpoint inhibitors”. (4 Peregrine posters total)

Nov22: ESMO/I-O: Symposium on Immuno-Oncology 2014, Geneva http://tinyurl.com/ofljfgs
…11:30-11:50am, David Carbone, MD/PhD (Ohio-ST, PPHM KOL/SRB), session=”Advances in Cancer Immunotherapy; from Vaccines to Antibodies & Cell Therapies”, talk=”Immune Checkpoint Inhibitors in Lung Cancer”

Dec7-11/Avid(booth#319): IBC's Antibody Eng. & Therapeutics, HuntingtonBch http://www.ibclifesciences.com/AntibodyEng/overview.xml

~Dec9: FY'15/Q2 (q/e 10-31-14) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm

Dec12: 37th SanAntonio Breast Cancer Symposium (CTRC-AACR) http://tinyurl.com/ojdzezg
…Drs Hutchins/Freimark poster: “PS-Targeting Mabs Enhance Activity of Immune Checkpoint Inhibitors in Breast Tumors”

Jan29-30 2015: GTC’s 7th Immunotherapeutics & Immunomonitoring Conf., SanDiego http://tinyurl.com/lqnb3ou (GTC = Global Technolology Community http://www.gtcbio.com )
…Jan30 1:10-1:35pm, Dr. Bruce Freimark (PPHM’s Dir/PreClin.Res) speaks in session, “Combinatorial Immunotherapies”, title=TBA