Since there seems to be a question on what will the move the stock, I will repost the 2009 catalyst list so that everyone can be updated on what can happen especially to keep new investors informed. Some of these catalysts have unfortunately happened and have had no affect at all. (laughably #14) This was last updated in May 2015 so Please feel free to update as needed as I am sure a lot has happened in the last 5 months.
Catalysts?TIME forANOTHER POTENTIAL-NEWS LIST forNEWBIES UPDATE (...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.
As an introduction to the science behind PS targeting you can look at the May 2012 presentation by the brilliant scientist who developed this technology, the late Dr. Phillip Thorpe(www.nyas.org/MediaPlayer.aspx?mid=25e51622-c908-46ef-bba1-95ca6a814eed). To see what has happened to the share price since that presentation you should look at the charts since May 2012 to the present. The sudden stock price decline in September of 2012 was caused by the discovery of sabotage in the CRO in Fargo North Dakota. The shadow of this event continues to hang over the stock price.
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." The expansion is expected to be completed by the middle of 2015.
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. 159 trial sites are now operational. The original goal was "more than 100". The average enrollment needed per site is now less than 3.75. (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) The interim results poster presented at ASCO/ASTRO/SSO on January 16, 2015 received this response from Roth's Joe Pantingis...
”Positive HCC Data are the Kickoff for IST Data Driven 2015”
"PPHM announced presentation of data from the Phase II IST of bavituximab with sorafenib in HCC at GI ASCO. These are promising data, particularly given the patient population and we believe they open the door to future randomized studies in HCC patients using bavituximab in combination with sorafenib as well as with anti-PD-1 inhibitors. Reiterate Buy.
PPHM announced data from the Phase II single-center, single-arm, open-label IST of bavituximab with sorafenib in 38 HCC patients at GI ASCO. The data showed that time to progression (primary endpoint) was 6.7 mos, disease control rate was 58% (22/38), 4-mo. PFS was 62%, DSS was 8.7 mos and median OS was 6.2 mos. Two patients (5%) achieved PR and 20 (53%) achieved SD. The drug combination was well tolerated and there were no autoimmune AEs reported.
We're impressed with the continued positive data coming out of this HCC study. Despite this being an open-label, single-arm study, these positive data are impressive given that these are heavily pre-treated patients with poor prognosis. Translational data from tumor biopsies of 6 patients from this study at SITC 2014 showed increased tumor infiltration of CD8+ T cells and induction of PD-1 expression in the tumor following treatment, giving additional support for combination study with anti-PD-1 inhibitors. These correlated with longer time on study and longer time to progression. With these promising data, we believe the door is open to future randomized studies in HCC patients using bavituximab in combination with sorafenib as well as with anti-PD-1 inhibitors. The pivotal Phase III SUNRISE study continues to enroll patients at over 150 global centers and we look forward to a data-driven 2015 with catalysts from multiple ISTs in NSCLC, breast cancer, melanoma, rectal adenocarcinoma and additional data from the Phase II IST in HCC. We believe that data from the Phase Ib of bavituximab with ipilimumab in melanoma will garner interest and increase visibility. This study, set to enroll up to 24 patients, should provide further support for combination of bavituximab with checkpoint inhibitors. We believe these ISTs will not only increase visibility for PPHM but also expand bavituximab's potential treatment profile.
We reiterate our Buy rating and $5 target. With Peregrine being a pivotal stage company, we view the risk/reward profile as favorable, and we believe visibility from the broadening bavituximab profile and partnering potential should drive the stock in 2015."
10. Cotara partnership announcement? Otherwise this is on the back burner.
11. May 29 2015 announcement of a new collaboration with Memorial Sloan Kettering. MSK is widely respected and we should expect some interesting news as this collaboration develops.
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. The Fargo CRO CSM settlement...is also delayed. How large will the settlement be?
15. Betabodies preclinical work is proceeding. The patent issue has been resolved. Betabodies are half the size of Bavituximab and have a 5 day half life compared to Bavi's one day.
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) 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 2013. 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). This study came as a surprise.
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.
PPHM THE COMPANY THAT CRIES WE ARE IN TALKS! All imo.
