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. No-one knows the exact timing of these potential- catalysts...or how the market will react...but every day we are one day closer. For 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).On the Dec.2014 CC management announced that they are "MORE than doubling" AVID capacity to handle BOTH increased commercial business and to prepare for "...Bavi market introduction."

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. 152 trial sites have been set up as of December 19. The original goal was "more than 100". The average enrollment needed per site is now less than 4. (DONE)

7. Bavi Oncology partnership or partnerships.

8. Liver cancer IST results. The interim Bavi/Sorafenib results released at a scientific conference in March of 2014 showed good safety results ....and one patient on trial for 18 months. Enrollment has now been completed.(DONE) An interim results poster will be presented at ASCO/ASTRO/SSO on January 16, 2015. Abstracts will be released at 5pm ET on Monday January 12, 2015. An oral presentation will occur on March 28, 2015. So far the interim data from this small open label study seem to lead to a 25-50% increase in TTP. The study is small and more data will be presented in March.

9. Liver cancer partnership

10. Cotara partnership announcement

11. Breast cancer IST results published in an academic journal. The article has been submitted. Publication date is determined by the journal however it could happen in Q1 of 2015.

12. Breast cancer advancing in clinic. They have spoken of the possibility of two trials...one Bavi/Taxanes and the other possibly Bavi/with another immunotherapy agent.

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...is also delayed. Could result in award in the 10's of millions.

15. Betabodies preclinical work is proceeding. The patent issue has been resolved and soon will be finalized.

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) This is an open label trial and will be in it's 10th month in late January. As it is an open label trial, interim results could be announced at any time. Dr. Hutchins pointed out that 60-80% of Yervoy monotherapy patients are "non-responders". He said that preclinical studies point to the possibility of turning Yervoy "non-responders into responders."

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 2014.(DONE) AA and PR could follow.

25. Innovative Series E Preferred Convertible financing has now increased the companies cash to some $60 million. (DONE) More financing news to come. How is this related to trials and/or
partnerships?

26. Interim Phase 1b first line NSCLC data was presented at MSTO on October 30. The Bavi/pemexetred/carboplatin combination produced PFS data very close to historical averages...but ORR data of 35% and MOS data of 12.2 months which are 55% and 24% above historical averages.(DONE)

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)

Jan15-17: Gastrointestinal Cancers Symposium (ASCO/ASTRO/SSO), SanFran http://tinyurl.com/q5dyruw

…Jan16 12-2pm/poster: Adam C. Yopp/Poster (MD/UTSW/Dallas): Ph.2 Data from Bavi+Sorafenib Liver IST

Jan27-29/Avid: WCBP 19th Symposium on the Interface of Regulatory & Analytical Sciences, WashDC http://www.casss.org/?page=WCBP1500

Jan29-30: GTC’s 7th Immunotherapeutics & Immunomonitoring Conf., SanDiego http://tinyurl.com/lqnb3ou (GTC = Global Technolology Community http://www.gtcbio.com )

…Jan30 2:25-2:50pm, Dr. Bruce Freimark (PPHM’s Dir/PreClin.Res) speaks in session=“Combinatorial Immunotherapies”: "Blockade of PS Enhances the Anti-tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Inflammatory Cells in the Tumor Microenvironment”

Mar25-28: Society of Surgical Oncology's 68th Annual Cancer Symposium (SSO’15), Houston http://tinyurl.com/q667hua

…Mar28 12:45pm/Oral-Pres: Adam C. Yopp (MD/UTSW/Dallas), Ph.2 Data) from Bavi+Sorafenib Liver IST, ”A Phase II Study of Bavituximab & Sorafenib in Advanced Hepatocellular Carcinoma (HCC)”

Mar30-Apr2/Avid/Booth114: IBC's Biopharm. Dev. & Prod. Week, Huntington Beach http://www.ibclifesciences.com/BDPWeek