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another art on oncologie
expected bavi trial start mid summer...
so cdmo can expect $8 mil plus milestone for trial start
https://www.biocentury.com/bc-extra/financial-news/2018-06-07/oncologie-raises-165m-dual-us-china-strategy
and trial manager from "well funded" startup
Job Purpose
This is an outstanding opportunity to join a well-funded startup company early in its trajectory. The successful candidate will be a vital part of helping to achieve the Oncologie, Inc. vision of transforming cancer therapies by attacking the tumor microenvironment through multiple pathways. We are seeking candidates who are passionate about improving human health through executing on efficient and effective operational goals, and who will participate in shaping the culture of a forward-thinking start-up company. The position reports into the Sr. Director of Clinical Operations.
Experience running trials in China preferred
yes ... the issue is time... i would be moving full speed ahead on the avid rev increase because that is where the value is by a factor of 5 to 6 imo... so some dilution now may be worth it with the sales multiple...
Oncologie and the China play... my guess is BP waiting in the wings... the value of the IP will be flushed out quicker in China... the value to CDMO will fly under the radar until those in the know know..
SK and crew could have been so close but needed one more lifeline from shareholders...
https://www.nature.com/news/china-announces-plans-to-fast-track-drug-approval-1.22888
https://www.bloomberg.com/news/articles/2017-10-09/china-launches-overhaul-of-drug-approval-in-win-for-big-pharma
i believe cdmo will be in several funds... lots of overlap... 3000, 2000 etc...
the real issue for me is revenue expansion via the vacant space. as soon as the when and how it will be paid are the next big questions. Oncologie just got funded by a VC firm. They have updated their website and note on their recent pr they plan on partnering and licensing the tech. The VC firm has some strong biotech exec's and no way ES and crew have anything to do with Oncologie. And note the UTSW trial with Keytruda is cosponsored by Merck. So CDMO should be getting the $8 mil and maybe some milestones and a bavi manuf contract. They filled the east coast business dev position and you don't hire or accept a job without capacity to sell. Lias said the exp space buildout will cost $30 mil.... I would not be surprised to see a small cap raise during the russell madness and demand for shares with some announcements on contracts. If not during Russell, then by the July CC. Expansion is the value driver and CDMO could help fund with their success.
Avid Bio in the prelim Russell list.
http://www.ftserussell.com/index-series/index-resources/russell-reconstitution?kui=XQCNodRagBxVtYFhD6qi5g
no idea... probably some funds picking up some now in anticipation. probably not a bad time to sell shares on rebalance day if they needed to raise capital for expansion (if needed). also, ronin can solidify his street cred as an effective change agent if SK gets skunked on his options. for example.. we tried to work with mgmt but they fought us all the way... mgmt lost and got tossed and ended up with nada.... won't hurt ronin's reputation on his next endeavor. SK did it to himself imo... i'd say he's in the pole position right now.
anybody notice 532 oct $5 calls today?
Interesting dynamics in play. Russell rebalance on June 22. $165 to $170 mil market cap should be the ballpark number. My WAG is 6 mil shares will be needed. Wall street is still wall street and games will be played to get shares. Also June 22 is SK option expiration date and if I can recall weighted avg $9 per share. Looks like a potential goose egg for SK... anybody feel sorry for him? I don't. And I don't expect current mgmt will do anything to help his cause. And if the current crew needs capital, it's probably for expansion which is a good thing long term. Looks like were coming up on class IV rapids. How will they navigate? Make the russell and get rid of 400k options?
https://en.wikipedia.org/wiki/International_scale_of_river_difficulty
the ip potential in the short run will amount to initial payment and milestones... maybe $8 mil plus say $5 mil for milestone of trial... so $13 mil wag and all proceeds go towards build out of vacant space... would not be surprised or disappointed w/ small capital raise (if needed) amid the russell game to kick the expansion off.. the quicker we get to the $200 mil rev potential the better and can't get there without the capacity in place...
a familiar face (or voice as he asked many q's on the cc's)
Dr. Pantginis is a Managing Director of Equity Research at H.C. Wainwright whose research focuses on the healthcare sector. Dr. Pantginis conducted more than seventeen years of healthcare equity research.
Prior to joining H.C. Wainwright, Dr. Pantginis worked as a Senior Research Analyst and Head of Biotechnology Research at ROTH Capital Partners. Dr. Pantginis also held senior positions at Merriman, Canaccord Adams, Commerce Capital Markets, JBHanauer and Ladenburg. Prior to his equity research career, Dr. Pantginis worked at Regeneron Pharmaceuticals, where he founded the Retroviral Core Facility.
Dr. Pantginis’ educational background includes both a Ph.D. and an M.S. in molecular genetics from the Albert Einstein College of Medicine as well as an MBA from Pace University.
FYI
Wainwright was co manager along with roth on feb 20 mil capital raise led by Wells Fargo
agree... and reading the sk severance agmt was a big tell imo... don't let the door hit you where the dog bit you and good bye and good riddens... was the inability of the old bod to do a deal tied to their entrenchment requirements? probably a factor imo... and no way would oncologie want SK services with all the old baggage imo... i spoke w/ the tappan folks at length last summer... they gave zero value to the ip and thought avid, once managed correctly, was a billion plus company...
i don't expect to see much news until after the russell which should reduce the available shares and the expiration of sk's options in about thirty days..
as for sk options, i think it is june 22... six months from resignation so i was off by a month... as for pr's... it seems like oncologie is wanting to fly below radar which makes sense... why draw attention at this time... and CDMO... wait until russell inclusion (if it happens) and expand instit base before giving updates via pr's... should get more bang for the buck with higher institutional base...
from dec 26 sec filing...
On December 26, 2017, Peregrine Pharmaceuticals, Inc. (the “Company”) announced that the Board of Directors appointed Roger J. Lias, Ph.D. to the
offices of President and Chief Executive Officer of the Company effective immediately. Dr. Lias, who is currently the President of Avid Bioservices, Inc., the
Company’s wholly-owned subsidiary, succeeds Mr. Steven W. King, who resigned as the Company’s President and Chief Executive Officer on December 22,
2017, to pursue other interests. The discussion contained in Item 5.02 of the Current Report on Form 8-K filed by the Company on September 14, 2017 relating to
Dr. Lias is incorporated into this Item 5.02 by reference. The Company and Dr. Lias did not enter into any new or additional compensatory arrangements in
connection with Dr. Lias’ appointment as President and Chief Executive Officer of the Company.
In connection with his resignation, Mr. King and the Company entered into a Severance Agreement and Mutual General Release (the “Severance
Agreement”) pursuant to which Mr. King will receive (i) continuation of his monthly base salary for a period of six months from the date of his resignation; (ii)
$5,000 in expense reimbursement; (iii) Company-paid continuation of medical benefits through COBRA for a period of twelve (12) months, or until Mr. King and
his family are eligible for coverage with another employer, whichever is earlier; (iv) immediate vesting of the unvested portion of an outstanding stock option
previously issued to Mr. King, representing the right to purchase 17,856 shares of common stock of the Company; and (v) a period of six months to exercise vested
stock options (unless any such stock option sooner terminates by its terms). The Severance Agreement includes a mutual waiver and release of claims and other
standard terms.
The foregoing description of the Severance Agreement is qualified in its entirety by reference to the complete text of the Severance Agreement, a copy of
which will be filed as an exhibit to the Company’s next Quarterly Report on Form 10-Q and is incorporated herein by reference.
very easy... the risk of the company has changed in the eyes of the investors so the yield requirement is lower ... just like a bond...
good question... maybe diaz can shed light..also being a sponsor of a trial does not make one an owner of the ip..
This is new and dif from the head and neck nccn trial that oncologie mentioned on website which is another merck/keytruda trial. So my guess is merck is an investor in oncologie given oncologie owns the IP now. So I would expect a milestone payment as well as follow up to the initial $8 mil. And possibly bavi manuf (unless they had enough to complete trial).
SK ... you were so close but the shareholders finally had the horsepower to kick you out. All you had to do was a deal.
agree... expect to see some payments from oncologie including the $8 mil and some milestones... the chief biz officer has done deals w/ merck and novartis... the head and neck trial was mentioned and ido1 was a bust for merck and INCY.... so bp still looking for a pdl booster... and car-t is still in play w/msk stamp on it... would not be surprised if merck and novartis are investors in oncologie.... and if a trial kicks off, a bav manuf contract is in store.. and oncologie doesn't owe us squat in terms of info and they are not going to telegraph to the world what they are doing to appease old pphm shareholders...
as for CDMO... the new guy w/ his resume doesn't join unless there is a solid plan... russell around the corner and my est is 6 mil plus shares are needed... once the institutional shares have the forced buy-in, CDMO should be announcing the start of the expansion... there should be forces working to get some traction with SP and possibly a good time to fund what ever dif is needed for the expansion after oncologie payments (if any) and it should not be overly dilutive if you announce biz with the capital need...
and now is a good time to announce a qualified CFO and finish cleaning the hen house...
we are getting close and folks will want your shares... if one remembers the summer run up before the dose switch, all kinds of games we being played...
Yes ... SK and crew made some big bets with our money and lost. Some very poor self serving biz decisions on our dime. They were winning either way the coin landed. Then Ronin challenged them and SK put up a fight and lost. And he and the old BOD got tossed. There could be some residual IP value but if the IP wasn't freed from the old SK crew, we were back to square one with no money and zero credibility and zero institutional interest. And Avid was dying when it should have been going full blast. I wish there had been more interest from BP in bavi but at the time all eyes were on IDO1 as the go to pdl combo.... INCY lost $13 bil in mkt cap when the IDO1 dream busted. When bavi's best competition was Avastin, there were a lot fewer competitors. Now with I-O, there are hundreds of molecules that are being tested and the bloom is off the rose on any particular drug until the I-O question is fully answered. As for bavi, the golden goose got the wings clipped but as in monty python "I'm not dead yet" and the question now is whether SK gets a goose egg by the end of May. Also keep in mind as the IDO1's of the world go bust, it could make the survivors more valuable.
A nice milestone for a trial start and a contract for bavi will be fine for now. And note Oncologie's statement...
Our global team has deep scientific knowledge, extensive pharmaceutical experience as well as proven clinical and business acumen.
The only acumen the SK crowd had was how to fleece shareholders IMO.
Check out the experience and contacts...
Who is behind the curtain with the wallet?
https://www.linkedin.com/in/david-malek-b29934/
And the Joe Shan group pic on the website...
9-9-16/CC/JoeShan: “The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the 1st clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab (Merck’s Keytruda).” http://tinyurl.com/ktrfswj
Joe was running trials so if he helps Oncologie with the trials... great and good for Shan...
He was not leading the SK ES crowd... just wonder if SK gets skunked by the end of May...
For what? Poor mgmt decisions... and the travails of biotech?
Look at the pathway IDO1 ... a year ago it was the next best thing ....Incyte was in the catbird seat.... in a year over $13 bil market cap erased...
https://www.fiercebiotech.com/biotech/incyte-climbs-combo-data-for-ido-inhibitor-epacadostat
https://www.fiercebiotech.com/biotech/body-blow-for-incyte-as-merck-partnered-melanoma-trial-bombs
Note the latter part of the article...
Analysts at Bernstein said in a note to clients: "The failure of IDO adds to the list of disappointment with "second generation" IO drugs – promises by companies and KOLs that the industry was just scratching the surface with anti-PDx therapies have not come true, at least yet. This means that for now, PDx monotherapy, PDx+chemotherapy, and PDx+CTLA4 may end up continuing to be the dominant regimens (evidence in support of the latter continues to build)."
also note the new Oncologie website mentions Head and Neck trial which was phase 2 with Keytruda... doubt they would put that up without an update... and planned trials in Asia? With biomarker data? the IP is not dead but CDMO will only get a pieces of value as it moves forward... Ronin made the right call in getting CDMO going... they could not have pulled off trials and avid biz... any IP value will be gravy...
Showing Lytle the door is a material event.
AACR 2018
Rachel Geise, Sadna Budhu, Jedd Wolchok, Taha Merghoub
Ludwig MSK 1:00 - 5:00 PM Section 33, poster board 29 Poster Session
PO.IM02.03 - Immune Mechanisms Invoked by Therapies 1
2767 / 29 - Phosphatidylserine targeting and radiation
improves survival in a mouse tumor model resistant to
checkpoint blockade
Ludwig Cancer on Twitter_ _Rachel Giese, Taha Merghoub and Jedd Wolchok of Ludwig MSK with their poster at #AACR18 on combining radiotherapy with an antibody against an immunosuppressive molecule to tackle #melanoma that resists checkpoint blocade
https://twitter.com/i/moments/986605034162049027
Rachel Giese, Taha Merghoub and Jedd Wolchok of Ludwig MSK with their poster at #AACR18 on combining radiotherapy with an antibody against an immunosuppressive molecule to tackle #melanoma that resists checkpoint blockade pic.twitter.com/HR27Luc2ca
— Ludwig Cancer (@Ludwig_Cancer) April 16, 2018
My guess is we see at least one more card played with the IP. MSK at AACR three years in a row with PPHM bavi w car-t will lead to a trial with a car-t player imo. So a trial milestone is probably in store for CDMO... if trial works, the lights stay on for the IP and more milestones for CDMO.
Ronin saved our butts by kicking SK and crew out the door. Maybe SK can sell some stereos w/ Pohl.
My guess is the SP rises when Russell games begin. WAG of about 6 to 8 mil shares needed for russell players including all the knock off funds emulating russell. Then another capital raise to fund expansion of vacant space... $30 mil.... hopefully settle in the $7 to $9 range.... assumes near full capacity on existing capacity and commitments for vacant capacity...($90 mil revs x 6 times sales over 70 mil shares) these deals have follow on commitments if drugs meet targets... and what happens if oncologie gets traction.. MSK (particularly JW) doing third yr at aacr with bavi? bavi will either be bought out or partnered w/ milestones coming to avid... and manufact commitments for bavi....
Oncologie will make the big score if bavi works and we'll get a free paid trip to vegas ..... Ronin makes a 5 bagger or more.... You have to say current mgmt team is performing.... less bs talk and more action versus all bs talk and no action...
and SK watches his options evaporate... avg $9 per share going away late May.... you can't say we didn't warn SK about improving BOD... and the BOD brings him down...
old mgmt screwed themselves by being greedy and running out of friends and no institutional support because of the BOD.... just when the party was starting... like running out of beer for the big show...
pigs get fat, hogs get slaughtered...
My source says the tech is in good hands. Oncologie is a private firm and my guess is that they could care less about a website and telegraphing to the world what they plan on doing. Do you think they give a rat's arse about cdmo retail shareholders? We're not on their make happy list. Would I have preferred BP paid a bunch more on the front end? Yes. But a small firm focused on a few shots on goal versus a BP with hundreds of shots on goal? Look at what happened to INCY last week (and Newlink) and the entire IDO theory.... even the sure things hit bumps....
I would prefer Dr. Benjamin spends the time and money advancing the drug. If it works, we make derivative money as it helps cdmo. A fancy website adds zero value at this juncture.
Would love to see $10 mil raised to start expansion…. Milestones over the year should cover some as well… You can’t sell capacity you don’t have… expect contract announcements in conjunction with expansion or why need to expand? … and shakeout retail… they are not building expansion if the biz ain't there..
$30 mil in construction gets $100 mil capacity and at 5 to 6 times sales (or higher) translates $500 to $600 mil value.... duh... just keep dilution as low as possible... and margins will improve with higher revs over lower avg fixed costs and G&A... these guys are running a biz and taking no prisoners...
And customers are locking in suppliers for long term relationships... go big or go home...
Tappan buys more ... up to 9.9% of company. eom...
looks like she is pulling her granddaughter's hair from behind her back and forcing a smile... probably made her eat all her vegetables at dinner...
in addition to contacting the FBI, SEC, FDA, CIA and Interpol, maybe add child protective services as well...
Lock her up...
here's what happens when BP wants to do a deal...
https://finance.yahoo.com/news/bristol-myers-pay-1-85-120746008.html
Oncologie has some work to do before any interest from BP (if ever) ...
just think of where bavi would be if all the money that went to a corrupt BOD was actually applied to the science...
if your looking for the courts to help you, good luck. ES CJ and DP got their pay reduced to $400k and agreed to a babysitter by the court before being tossed out by Ronin.
now where did all the value expectations from the company come from? SK ramblings about partner interest, compelling data, astronomical yady ya..
and DP owning 40 shares and the BOD and SK taking cash over shares... mgmt open buys over the years?
and the NCCN trials where the company paid for them? the value expectations to the shareholders were set by the previous crowd with the primary motivation of staying in power without oversight... and that probably factored into any BP interest...
The science had tremendous potential and was squandered by penny stock hustlers that were more interested in avoided accountability and collecting oversize paychecks... PS is starting to get traction but being associated with penny stock scammers did not help the cause.
I am glad someone stepped up and is willing to spend up to $200 mil to advance the ball.
I would love to see more info on the buyer and hopefully that will come soon.
Let's face it... biotech is a jungle... as to the potential buyer.. (this is not a done deal folks)... as long as they have the cash that is verifiable and the capability to advance the IP as soon as possible, i don't care ... is it new? wow that is bad... someone creating an entity to chase I-O assets...
could it be BP with one of their investment arms and wants a low profile so as not to signal interest in PS?... don't know
could it be VC that sees an potential investment now that biomarkers are known... don't know
could it possibly be ES, CJ and DP doing an end around? doubt it unless the new buyer wants a BOD with no biotech exp and a history of raping companies imo... don't know but not likely.... ES and crew had zero leverage in leaving company other than here are the keys but don't come after us.. SK pretty much the same IMO...
could it be Ronin stealing the tech? doubt it... they probably prefer more front end to get CDMO going... i don't know but not likely
could it be SK stealing the IP? doubt it cause he has 400k options at $9 and this deal doesn't help him unless major milestone hits before 5/22/18... not likely.... is he needed by the buyer? doubt it unless they are selling carrots
so lets get a bunch of lawyers and threaten to blow the deal up...
ihub has become a waste of time with basically zero value
Yes. Brand new. Mission statement: steal ip from cdmo
The old crew had 10 plus years to do it and didn't get it done. The new crew would have much preferred a larger front end... doesn't sound like there was much of a bidding war does it? And the deal is not done yet... be careful cause sometimes folks will say it ain't worth the hassle.
If it's such a steal would not BP jump in before it's too late? ... Sorry but all our "astronomical" expectations come from someone that preferred cash over shares.. do the math on that one...
No more expenditures... $100 mil in milestones (prob some within the first year which could fund Avid expansion) vs $70 mil out for development and mid teen royalty rates...
Keep in mind the massive amount spent on bavi development was mostly wasted with min return with trial failure data...
Here's something to consider... how quickly fortunes can change in biotech..
Hung was a hero w/ Medivation and now ?
https://www.fiercebiotech.com/biotech/after-a-string-failures-axovant-ceo-hung-resigns-along-a-host-others
The option to go it alone as usual would have resulted in massive dilution for pennies on the dollar and made Avid even weaker. Adults took control before it was too late. And all the while the old BOD fought hard to keep Ronin away, sold massive shares for pennies on the dollar and totally screwed up the russell rebalance by doing the RS after rebalance date which would have boosted SP. The same mgmt team that agreed to lower their pay to just $400k per year in the DS settlement.
And the level of interest from BP? What were the demands SK made to BP in terms of the old crew maintaining their moat and no oversight? Probably had something to do w/ negotiations and level of interest.
The current mgmt team is doing what they can to right the ship.
At the same time, if Dart or any of the old crew are involved, investors should know about it with details. If it's a clean slate of investors willing to bet $200 mil on bavi, just thank your luck stars.