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Brandon Smaglo who gave the presentation in July at AACR gave a presentation on pancreatic cancer treatment at Baylor St Luke’s to hospital staff on 12/16. It had a conference call number to join in but I don’t think it’s archived anywhere. An earlier post had the link to the slides he went through on multi taa. Follow him on twitter and he posted a tweet a few days ahead of the presentation so had a chance to listen in.
Updates from Pancan ARM A trial as best I could decipher.
#1 PR 14 months progressed and passed away reported July AACR
#2 SD 6 months and progressed and passed away reported July AACR
#3 PR 14 months and progressed and off trial July AACR no update December
#4 SD 13 months and progressed and off trial July AACR no update December
#5 SD 5 months and progressed and off trial July AACR no update December
#6 SD 11 months from AACR presentation and not reported upon in December presentation
#7 CR 11 months July AACR and still CR 15 months December presentation
#8 SD 5 months July AACR and not reported upon in December presentation
#9 SD 6 months July AACR still SD 11 months December presentation GOOD
#10 Too early no report July AACR and December presentation SD 9 total months (3 chemo 6 w/TAA) GOOD
#11 Not presented in July AACR and December presentation SD 8 months (3 chemo 5 w/TAA) GOOD
#12 Not presented in July AACR and December presentation PR 7 months (3 chemo 4 w/TAA) GOOD
#13 Not presented in July AACR and December presentation went 6 months and had PD
#14 Enrolled but not dosed yet
#15 Enrolled but not dosed yet
Patients 6 and 8 both SD were on Gemcitabine and no update was provided from the original July data. All other patients still on trial were on Folfirinox and had December updates. Not sure why no update on Gemcitabine patients. Updates as I see it #7 continues in CR 15 months, #9 still SD 11 months passing median PFS and at OS, #10 SD 9 months passing Median PFS, #11 SD 8 months passing PFS, #12 PR 7 months passing PFS. #13 PD 6 months. Four new reported patients 1 PR, 2 SD, and 1 PD. Still early data but see progress.
The article on 11/16/18 was the date that Mayo announced that they received the $11M grant to run the trial that posted to clinicaltrials.gov just a few days ago. So Mayo received notice of the grant a little over a year ago and the trial is now ready to start and posted. Hope that makes sense. It was known that this trial would be starting and now appears ready to go. Hope that helps to clarify.
Looks to be the start of this trial funded by department of defense grant:
https://breastcancer-news.com/2018/11/16/department-of-defense-funds-tpiv110-phase-2-trial-breast-cancer-vaccine/
An good interview with David Easnor who is one of Marker’s Directors.
https://www.google.com/amp/s/cellculturedish.com/expediting-cell-and-gene-therapy-workflows/amp/
I have seen the same thing. I also think there the possibility a institutional investor or more than one wanted to start a position in MRKR but at similar prices to the offering price during the merger. I watch level 2 daily and ever since about 9/20 when the stock was recovering from the crash after pancan data anytime any buying pressure would show up it would be squashed. Continuous dropping the ask on low volume for a month and a half. As we sat here around 4 and below any time buys came in large sell orders on the ask would appear then disappear. Today at 10:15 I watched an ask of 11k shares at $4 flashed up and then disappeared about 30 times over the course of about 5 minutes. Once that order filled the stock has held. Gotta run but just my observations.
New study posted today for Mayo. There are two now posted. The original trial didn’t include mastectomy surgery but this one does. All the recent news articles on Mayo and the vaccine noted the first patient had surgery after receiving the vaccine.
https://www.clinicaltrials.gov/ct2/results?cond=&term=Mayo+AND+Dcis&cntry=&state=&city=&dist=
Notes enrollment for 43 patients in each. I would assume one for women who elect surgery and one for women who do not.
Was browsing over the Johnson & Johnson innovator website to see what other companies are part of JLabs. Of 391 pharmaceutical companies that are active in JLabs around the world there are 8 that are in phase 2 trials or later in cancer therapy. Only 3 of those 8 are public. MRTX, MRKR, & ONCT.
https://jlabs.jnjinnovation.com
https://www.markertherapeutics.com/tag/jlabs/
MRTX has been a rocket. One can dream of a chart like that one day.
Price dictates sentiment. Institutional investors put $70M of cash into this company exactly one year ago and other institutions have continued to add to the stock throughout the last year. As to lack of data releases; a majority of the trials that relate to Marker tech are being run by BCM and Mayo. The good is these trials are mostly funded by BCM and Mayo. The bad is we at at the mercy of these two institutions for info. They are not in the business of pandering to MRKR share price. But also means MRKR burns very little cash for these trials. Two weeks after pancan data is released Steve Elms of Aisling moves from a board observer to a seat on the board of directors. He and Joshua Bilenker both partners at Aisling started LOXO in 2013. Steve as chairman of the board and Joshua as CEO. Most know this was sold to Eli Lily for $8B. The day after Elms joined MRKR board Bilenker became interim head of early stage oncology at Eli Lily. I have to guess as partners at Aisling these guys talk fairly regularly. I’m not trying to call anything in the works but a guy like Elms is not going to join the board of a company to ride with them into bankruptcy.
Steven Elms of Aisling Capital joins the board.
Also not a single insider and original Marker owner has sold any of the boatload of shares they received with the merger. John Wilson, Ann Leen or Juan Vera.
Looks like ALLO wanted Malcom Brenner on their SAB as well.
Looks like some decent call option activity today in August and October expirations for a stock that doesn’t have much option activity yet.
READY, FIRE, AIM oops. From the 8k sounds like they had trial design, a couple early trial outcomes but not the actual data in the submission. ASCO doesn’t allow trial outcomes in trial in progress submissions and BCM probably didn’t have the time or even have the full data organized to present. Sounds like BCM got a little ahead of themselves but was excited about early results they were seeing.
Speculation but ever since 3/27 the day before the business update volume in general has been well above the first 3 months of the year. New disclosures continue to show institutions adding not selling. My hunch is also that new institutions want in and market makers are providing their institutional clients good service by filling their larger orders slowly without letting the price run up too quickly compared to just throwing orders out there in the market place.
Plenty of talk on pancreatic trial (20 new enrolled patients since the start of the year total now 30) and AML but they did also push out the goal post for interim analysis on ovarian vaccine from the end of Q2 to the end of 2019. Good call imo
Another 230k shares added by Vanguard in January. Now close to 1.2M shares held
Sweet, thanks for the follow up on that.
Also off Bloomberg. Should update on other websites soon. It’s a pain in the butt but you can go into the holdings on Vanguards website and the do list every holding in their fund. You will find MRKR currently in the Total Stock Index, Extended Market Index and HealthCare fund. I would guess it’s on EDGAR well.
Vanguard should update at 955k shares as of 12/31 shortly as well
Bloomberg terminal at work, disclosure popped up there yesterday. I’m sure it’s on EDGAR sec filing website as well.
Phantom, spot on with the timing of the Baker Bros filing. Good call
Was seeing some different numbers on Vanguard ownership so went to their website to look up fund holdings:
Total Stock Index is close to 550k shares
Extended Market Index 340k shares &
Healthcare fund holding 50k shares
Much higher than the 387k I saw at an earlier date.
Hi Phantom, I easily could have missed this from the company and you may not know the answer but would seem odd they roll rhabdomyosarcoma patients to a pancreatic cancer trial. The intervention is the same so I guess possible. Thanks for all your input through the years here.
The trial was for rhabdomyosarcoma in children. Sarcoma is cancer of soft tissue (such as muscle), connective tissue (such as tendon or cartilage), or bone. Rhabdomyosarcoma usually begins in muscles that are attached to bones and that help the body move.
https://clinicaltrials.gov/ct2/show/NCT02239861?term=Ann+leen&rank=1
The trial started 4/15 and had a primary completion date of 12/17 and study completion date of 10/18. In January last year this was changed to 10/18 and 12/18 and then just last month the actual primary completion date stayed the same but the study end date was moved out to 12/24 I assume to continue to monitor the patients that are in the trial. It’s complete conjecture on my part but the trial has been running for almost 4 years, I would guess they have a decent view into whether the treatment has had much effect on solid tumors. I also am curious as to why Marker has made no mention of this trial but its using the same treatment in the pancreatic and breast trials noted in their pipeline. Every other Baylor trial that is using Marker tech has been mentioned at some point in various presentations and is listed in Markers pipeline except this one. One could make all types of speculation about this but I assume we’ll find out one day.
NCT02239861 Study completion date moved out 6 years to 12/24. Primary completion date still was 10/18. This appears to be the first trial in solid tumors that lead to the trial in breast and pancreatic. Curious to see if this shows up at ASCO in early June. Marker has never mentioned this trial but using the same technology and run by Anne Leen and other on the SAB.
Here is a video Keith Knutson did as a live Q&A chat on breast cancer and vaccines MRKR has licensed.
https://connect.mayoclinic.org/webinar/video-qa-about-breast-cancer-research/?date=1548115200&utm_source=facebook&utm_medium=sm&utm_content=post&utm_campaign=mayoclinic&geo=national&placementsite=enterprise&mc_id=us&cauid=100502&linkId=62153353
Hopefully their investment in MRKR is as lucrative as LOXO
https://www.google.com/amp/s/www.bloomberg.com/amp/news/articles/2019-01-10/ex-banker-walks-into-a-conference-walks-out-with-480-million
Statnews chat with Jim Allison in 5 min
https://www.statnews.com/2018/10/17/live-chat-nobel-laureate-james-allison-cancer-immunotherapy/
And this is on only 200k of volume
Read a bit more of the merger agreement. If interested in the history of how all this came to be check out page 50 of the SEC filing. Peter Hoang, John Wilson and Ali Behbahani of NEA first met in the spring of 2017 before Peter even accepted the CEO position at Tapimmune. The next 20 pages document all interactions up to June 12th 2018 when the $70M financing was finalized. Also of interest Tapimmune had met with 2 other companies regarding a potential merger. Alos check out the financial analysis of each company by Nomura on pages 66-73. On the very low end they valued the combined company at $328M and $980M on the high end. There was one further analysis that used comparable transactions which pushed close to $1.5B. There will be 44,748,542 shares when the merger closes. This does not include warrants.
BLCM CFO resigned today. Their prior general counsel moving to TPIV with the merger. Wonder if we’ll be seeing a new CFO as well.
Peter Hoang was the Managing Director of Office of Innovations University of Texas MD Anderson Cancer Center 2012-2014. This is all walking distance to Baylor College of Medicine, Texas Children’s Hospital, and Houston Methodist. Prior this all his positions were in M&A on the bank side. He is on the other side of the transaction as CEO of a company now. But clearly made close connections with these institutions and was there when Baylor/Marker clinical trials were starting and ongoing. Just some thoughts as I agree the value their technology will add to Tapimmune has taken center stage over the vaccines. But it also wouldn’t make sense for Marker to give up 50% the combined company if they felt the vaccines were a dead end. In the end you get company with a diverse immunotherapy pipeline where if something fails down the road your not a one trick pony. Cash burn for TPIV products is low given the grants and Mayo. Definitely an interesting transaction. I am estimating there will be about 32M shares after the merger. On the redchip call he mentioned 6M shares issued to the healthcare syndicate and the estimate funding was $25M. You can do math around all sorts of scenarios but at today’s price of $6 that would mean a company with a market cap of $192M and $35M cash. If it’s the next Kite well it’s cheap. If it’s the next Galena it’s expensive. Also of those 32M shares 6M would be held by the syndicate, 13M by Marker all of which are locked for 180 days, Eastern has $3.6M and the rest of the institutions and insiders at Tapimmune own approximately another 2.5M. So of the shares at that point 25M would be held by institutions and insiders with a good portion locked up for 180 days. You would have about 78% ownership of shares in those groups.
Vanguard now at 137K shares. Just saw as an update from my post on 5/13. Look to have added another 47k shares in March. Not earth shattering but continued progress of larger institutional ownership. Considering all of the shares eventually that will be owned by Marker shareholders are VC , institutional, and founders. Smaller percentage of shares after merger going to be in retail hands. Also there’s the 180 day lock up on insider sales after merger complete.
Here’s the trials I could find we pick up with this. This whole deal didn’t just come together overnight. I think this has been part of the new CEO plan all along with his connections at these hospitals in TX and now have Ken Moseley former Bellicum general counsel as a advisor to the company as well. The background on the rest of the new mgmt/advisors is impressive imo. John Wilson CEO of Marker and also Wolf Wilson developed the product GREX that is mentioned in the slides.
Wolfwilson.com
TPIV gets a more diversified pipeline with very promising technology. Marker now gets to be a public co which if the technology they have is as promising as it was presented they can make themselves and TPIV shareholders a nice payday. New company would have 12 clinical trials and 6 Phase 2 trials. Take note of the collaborators and hospitals in these. Treatments helping kids at children’s hospital.
NCT03093350 Breast cancer Phase 2
https://clinicaltrials.gov/ct2/results?cond=&term=Nct03093350&cntry=&state=&city=&dist=
NCT03192462 Pancreatic cancer
Phase 1
https://clinicaltrials.gov/ct2/show/NCT03192462?cond=Nct03192462&rank=1
NCT0229184 MM Phase 1
https://clinicaltrials.gov/ct2/show/NCT02291848?term=Nct02291848&rank=1
NCT02494167 AML MDS Phase 2
https://clinicaltrials.gov/ct2/show/NCT02494167?term=Nct02494167&rank=1
NCT01333046 Hodgkin & non-Lymphoma Phase 1
https://clinicaltrials.gov/ct2/show/NCT01333046?term=Nct01333046&rank=1
NCT02239861 Rhabdomyosarcoma Phase 1 Primary Completion date is 10/18
https://clinicaltrials.gov/ct2/show/NCT02239861?term=Nct02239861&rank=1
NCT 0247570 Leukemia Phase 1 Primary completion date 4/18.
https://clinicaltrials.gov/ct2/show/NCT02475707?term=Nct02475707&rank=1
This is in coordination with them attending ASGCT meeting in Chicago on Wednesday-Friday of this week.
https://annualmeeting.asgct.org/am18
Ann Leen, Juan Vera, and Cliona Rooney are all showing as speakers.
Marker raised $20M in 2017 from VC. The call didn’t mention how much they have today but here are two links.
https://pitchbook.com/profiles/company/183373-93
https://www.fiercebiotech.com/biotech/tapimmune-to-merge-baylor-adoptive-t-cell-startup-marker