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A Bay Area Guide to the 9th Circuit
Hi folks. I read this board a LOT so thank you for all of you collective wisdom and support over the last few years.
I’ve held pat after accumulating a more at 4 post NV ruling (although I do write covered calls). And today was no doubt a disappointing price move.
With that said. I lived in SF and had a career in tech. I’ve long felt the Nevada ruling was outrageous but here’s the deal that I remember when days like this come along:
The 9th Circuit is home to Silicon Valley. It permeates absolutely everything. While they may not give a rip about the 2nd amendment, they covet IP. It’s their life’s breath. I’d be hard pressed to see a world where they throw a major category of IP into the proverbial trash can. Our road has proved long, but I don’t see the 9th Circuit as the end of the road for AMRN. While they could throw us a curve ball, I don’t see a flat out loss. And that would be so AMRN, wouldn’t it? A victory with caveats.
Best wishes to all. Stay safe and strong
Totally on the same page. My initial post and response to you was from the point of concern of the recent price action.
I own this amazing stock because the discounted cash flow of future Vascepa sales is off the charts.
I feel like BB are a strong second to JT. They can likely come in with other bidders to the table in the event an initial offer is compelling but shy of Vascepa's likely potential.
Im with you. I think Vascepa is a $15+ billion annual drug (I think that's actually low).
I just think that unless a bidding war gets going, you're stuck below $50 until people wake up and realize how fast this drug is expanding share and saving lives.
IF we were to get a bidding war, I think it would be nuts. Crazy good.
But we got to get here first.
Here's to hoping that day is Monday
Sorry, but that's an idealistic view. Good luck convincing your board that you're going to pay $80 food something rational investors are valuing at $12. They'll either laugh at you, or more appropriately say, "fine, it might be worth $80, but let that company either let them faulter later and need is more (resulting in potentiality a more harmonious deal), or let them de risk this a bit by successfully filing, and getting further down the path.
Sure, maybe it goes to $40 in the meantime, but we still value it at $80, so that's fine.
If you've been in board rooms, there are a lot of reasons you so have issues buying something at $80 that traded at $12 a week ago.
Sure, this is a very special drug and anything can happen, but my point was more the difficulty arising from the recent price action at getting a deal done here vs post filing / approval / maybe FastTrack / approval, etc.
All those milestones, among others, derisk the deal.
So if PFE can only justify $40, and AMRN/BB won't take less than $80, then you just put together a timeline, acheive milestones, which drives up the share price, reducing the premium.
Easy to get sued or have your stock languish for years when you do a deal too early at a monstor premium.
I love AMRN, just trying to weigh M&a angles with a dose of realism.
Dan, I couldn't agree with you more. $40 is seems the best it can get in terms of cash here with no filing and a stock that traded at $12 a week ago today.
While my gut says a deal is a ways off, there's another part of me that sees PFE unwilling to watch AMRN tie up with a competitor on a Euro distribution deal.
Furthermore, PFE likely to view 400 reps as a total joke compared to their army and demonstrste how they can add value there, in marketing, as well as sourcing and distribution.
That's all secondary to the fact that that cardio is big turf for them. Lipitor, combo pill....
So I could see a scenario in which filing and European partnership discussions could warrant them making a move to tie up an asset that would be a crown jewel for them.
Oh yeah, and don't forget that they need growth. This is a perfect sized deal for them. Super meaningful to their lifecycle, pipeline & Financials without being done crazy sized deal they might struggle to digest & integrate...
Just my two cents as a finance guy
oil
Dan, I couldn't agree with you more. $40 is seems the best it can get in terms of cash here with no filing and a stock that traded at $12 a week ago today.
While my gut says a deal is a ways off, there's another part of me that sees PFE unwilling to watch AMRN tie up with a competitor on a Euro distribution deal.
Furthermore, PFE likely to view 400 reps as a total joke compared to their army and demonstrste how they can add value there, in marketing, as well as sourcing and distribution.
That's all secondary to the fact that that cardio is big turf for them. Lipitor, combo pill....
So I could see a scenario in which filing and European partnership discussions could warrant them making a move to tie up an asset that would be a crown jewel for them.
Oh yeah, and don't forget that they need growth. This is a perfect sized deal for them. Super meaningful to their lifecycle, pipeline & Financials without being done crazy sized deal they might struggle to digest & integrate...
Just my two cents as a finance guy
oil
Dan, I couldn't agree with you more. $40 is seems the best it can get in terms of cash here with no filing and a stock that traded at $12 a week ago today.
While my gut says a deal is a ways off, there's another part of me that sees PFE unwilling to watch AMRN tie up with a competitor on a Euro distribution deal.
Furthermore, PFE likely to view 400 reps as a total joke compared to their army and demonstrste how they can add value there, in marketing, as well as sourcing and distribution.
That's all secondary to the fact that that cardio is big turf for them. Lipitor, combo pill....
So I could see a scenario in which filing and European partnership discussions could warrant them making a move to tie up an asset that would be a crown jewel for them.
Oh yeah, and don't forget that they need growth. This is a perfect sized deal for them. Super meaningful to their lifecycle, pipeline & Financials without being done crazy sized deal they might struggle to digest & integrate...
Just my two cents as a finance guy
oil
I'm going with the assumption that nothing is announced Monday, however, there is some chatter in the next two weeks that drives price to $25.
I think PFE comes in at $40 cash. 0.25 PFE equity per AMRN ADR, CVR of another 0.25 PFE based on some revenue target for 2020.
Of someone wants to counter that, they'll have to either pay $80 or significantly bump the cash.
I'd love Dan's royalties though. That would be hot....
That would be epic. Cramer is still here in SF, JT staying an extra day here would be bullish too.
Oh ok, then that might make sense. I turned to AMRN after that works have happened last year. So not aware of their cadence.
Thanks
They didn't do say when they would, so typically that means nothing.
So no analysts get to ask questions on a conference call? They just pack their bags and go to JPM?
Didn't add up in my mind. Thought it was poor form, personally.
When was the last time you remember them not doing a call?
I was surprised they did an earnings call right before AHA. So not doing one here when releasing 2019 guidance on a Friday night seemed super weird
Yes, and the JT quote at he end of the release as our "update"? That was weird.
Not having an earnings call at all? Weird.
What's AMRN'S history of not having calls at all? Been trading this for about a year, so deffer to you on that one, Tasty...
That's exactly, exactly right.
What is just as bad as the Friday night dump is the lack of an earnings call with Q&A.
I'm not happy with management right now.
I completely agree with this assessment
My personal opinion (and for full disclosure, AMRN is my largest position by far), is that there is no substantiation of this Jefferies meeting tomorrow.
Furthermore, if there was going to be an announcement, it would likely be prefaced by an 8-K. We don't have one yet, like we did on the secondary.
I'm of the opinion that they wouldn't use an I-Bank as a platform to announce a Euro partnership. Wouldn't be necessary (but that's just my two cents).
So I'm perplexed by this rumor because deals don't usually develop this way.
So this story line has been intriguing, but sadly I don't see how this would develop into a positive event.
I'd gladly entertain anyone who has a cogent theory as possible what this rumor could portend. Like I said, I'm very long.
Eager to hear more -- or a case where those is anything more than a nothing-burger
Thanks! Didn't think of the time needed to file together. The economics of doing the deal after approval are likely much better, however, I get it now. You have to file together to get the full benefit of the co-filer's muscle and finesse.
Thanks as always, Tasty
Tasty - can you expand on this thesis? The stock is trading like a great company without a clear near term catalyst in a bear market.
How do you delineate between the options of partnering now (Q4) vs Q1. They're filling before the end of Q1 in the US. Can you explain why moving the Euro partner now vs then would be potentially advantageous?
Just trying to flush out potential Dec catalysts because we've gotten into a trend where we are at best (in the best term) a market performer, with a ginormous long term opportunity.
Thanks, always read your insights on this board and find them valuable.
Tasty has a point here. This is the quietest week since the pre-data run up.
While it's certainly possible they are working to finalize a Euro deal before year end, I believe it's equally possible that the Company booked three consecutive appearances to address the data and Garner interest in the secondary.
While my book works benefit from the former, I think Tasty's observation is noteworthy.
Very quiet out there....
Agreed. It was also a small offering as compared to the market cap of the Company. So probably a very easy deal to sell.
What really spoke volumes yesterday was JT'S comment that the secondary created a fully funded plan. They can become cash flow positive on existing capital.
That leaves so many options open to management to maximize shareholder value.
Day 2 of MEI conference data:
MEI Pharma Presents Clinical Data from Ongoing Phase 1b Study of ME-401 in Patients with Indolent B-Cell Malignancies at the 2018 American Society of Hematology Annual Meeting
- Data Support Complementary Potential of Intermittent and Continuous Dosing Schedules as Means to Optimize Clinical Risk-Benefit Ratio in Relapsed/Refractory Follicular Lymphoma Patients -
- MEI Advancing ME-401 into Phase 2 Study Around Year-end 2018 to Pursue Accelerated Approval Strategy -
-------pasted from IR email this morning-----
SAN DIEGO, Dec. 2, 2018 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that results from an ongoing Phase 1b study support the complementary potential of intermittent and continuous dosing schedules of ME-401, a selective phosphatidylinositol 3-kinase ("PI3K") delta inhibitor, to optimize the clinical risk-benefit ratio in patients with relapsed/refractory follicular lymphoma. The data demonstrate that ME-401, as both a single agent and in combination with rituximab, continues to be associated with overall high objective response rates. In addition, low rates of Grade 3 immune-related adverse events (irAEs) were observed in patients on the intermittent dosing schedule while maintaining a high level of clinical response. These data are being presented today at the 2018 American Society of Hematology (ASH) Annual Meeting.
The data announced today continue to support the rationale for MEI's planned Phase 2 study that evaluates both a continuous (CS) and intermittent (IS) dosing schedule of ME-401 as a means to enhance the drug candidate's clinical profile and thus potentially deliver improved benefits to patients. The Phase 2 study is expected to start around year-end and is intended to support MEI's accelerated approval registration strategy if successful.
Patients in the Phase 1b study received ME-401 as a single agent (dosed on the CS or IS) and in combination with rituximab (dosed on the IS only) to explore treatment options for patients with B-cell malignancies. The IS dosing regimen consists of 60 mg given continuously, once-daily, for the first 2 cycles followed by 60 mg given on days 1-7 of a 28-day cycle and results showed:
As a single agent, 76% objective response rate in patients with relapsed or refractory follicular lymphoma (FL), and 100% in all patients with chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL).
In combination with rituximab, 78% objective response rate in patients with FL.
Median duration of response has not been reached. The lead patient has a duration of response of approximately 20 months and the median follow-up is 9.3 months.
Low rate of irAEs; 4 irAEs were reported in 36 patients administered the IS, with all cases occurring in the first 2 cycles following the switch to IS.
89% of patients switched to IS remain on therapy.
Disease control was maintained in 72% of these patients.
70% of patients who resumed on the continuous daily dosing schedule (CS) recaptured a response after progressing on IS.
The ME-401 ASH 2018 poster can be accessed on the MEI Pharma website.
"The data presented today are very supportive of our rationale to investigate both a continuous and intermittent dosing regimen as part of our Phase 2 study evaluating ME-401 in follicular lymphoma and may also help advance its complementary potential to deliver improved benefits to patients in combination with other modalities," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "While advances have been made in the treatment of B-cell malignancies, there remains a significant need for innovative therapies across a range of indications and patient populations not addressed by current therapeutic options; we believe the emerging clinical profile of ME-401, as both a single agent or in combination, holds the potential to deliver improved clinical benefit to patients with B-cell diseases."
ME-401 Phase 1b ASH 2018 Data
ME-401 is being evaluated in an ongoing Phase 1b dose escalation study in patients with relapsed or refractory B-cell malignancies. Through October 2018, 60 patients were enrolled across three groups:
Group 1 included 31 patients with relapsed FL (n = 22) or CLL/SLL (n = 9) who received ME-401 CS at doses ≥60 mg per day in the dose escalation phase of the study. Beginning in December 2017 a total of 17 patients from Group 1 (FL=9, CLL/SLL=8) advanced to the IS after in cycle 4 or later cycles.
Group 2 included 16 patients with relapsed FL (n = 9), diffuse large B-cell lymphoma (n = 5), marginal zone lymphoma (MZL, n = 1), and CLL (n = 1) who received rituximab 375 mg/m2 x 8 doses over 6 months and ME-401 dosed under the IS regimen after receiving ME-401 60 mg daily for the first two cycles.
Group 3 may enroll up to 30 patients with relapsed FL/CLL/SLL in an expansion cohort of ME-401 using the IS regimen after receiving ME-401 60 mg daily for the first two cycles. In this group, 13 patients were enrolled to date with one FL patient reaching the Cycle 6 disease assessment as data cut off.
The median number of prior therapies of patients in the study is two and 50% of patients enrolled were ≥ 3rd line of therapy. Responses are assessed after 2 cycles (58 days) and 6 cycles, and then every 6 cycles. Ninety-two percent of all patients were previously treated with an anti-CD20 antibody.
Objective Response Rates
The objective response rate of patients across all groups with FL is 76% (29/38) and for CLL/SLL is 100% (11/11).
As a single agent, 76% (22/29) objective response rate in patients with FL and 100% (10/10) in patients with CLL and SLL.
In combination with rituximab, 78% (7/9) objective response rate in patients with FL.
Duration of Response
In FL and CLL/SLL patients, the median follow-up is 9.3 months (range, approximately 2.1 to 19.5 months) with no median yet reached.
Across all groups, failure-free survival (i.e. no disease progression on the continuous dosing schedule) in FL and CLL/SLL has not reached a median yet; median follow-up is 6.9 months (range 0.4 to 21.1 months).
72% of patients across all groups on the IS regimen have not experienced disease progression with a median follow-up of 7.9 months (range, 0.8 to 10.5 months).
Of the 10 patients that progressed on the IS regimen, 70% of patients retreated with daily dosing recaptured disease response.
Rates of irAEs
Of the 36 patients who switched to IS, only 11% (4/36) experienced an irAE after the switch. All 4 reported cases of irAEs occurred in the first 2 cycles after the switch to the IS regimen.
About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase ("PI3K") delta inhibitor; PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors. It is being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401 as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The Phase 2 study is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.
First of three days of data.
Below is cut & paste from IR email this morning
——————-
SAN DIEGO, Dec. 1, 2018 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced preclinical data presented at the 2018 American Society of Hematology (ASH) annual meeting demonstrating that voruciclib, MEI's orally available CDK9 inhibitor, synergistically induced apoptosis at clinically relevant concentrations when combined with venetoclax (marketed as Venclexta®) in human derived acute myeloid leukemia (AML) cells lines and patient samples. Voruciclib is currently being evaluated in a Phase 1b dose ranging study in patients with B-cell malignancies.
The data presented today demonstrate the synergistic induction of apoptosis of voruciclib when combined with venetoclax via the transient downregulation of MCL1 in multiple AML cell lines and patient samples. Inhibition of CDK9 blocks the production of MCL1, which is an established resistance mechanism to the BCL-2 inhibitor venetoclax.
"This study evaluating the synergistic activity of voruciclib in AML cells builds on existing preclinical data demonstrating similar activity in other B-cell malignancies, including diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and reinforces the significant clinical utility voruciclib may hold when combined with inhibitors of BCL-2 in B-cell disease," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "As we progress in our ongoing Phase 1 study, we look forward to selecting the voruciclib clinical dose to evaluate in combination with venetoclax to clinically assess synergies and the opportunity for combination treatments across multiple indications."
The voruciclib ASH 2018 poster can be accessed on the MEI Pharma website.
About Voruciclib
The CDK family of proteins are important cell cycle regulators. CDK9 is a transcriptional regulator of the myeloid leukemia cell differentiation protein ("MCL1"), a member of the family of anti-apoptotic proteins which, when elevated, may prevent the cell from undergoing cell death. Inhibition of CDK9 blocks the production of MCL1, which is an established resistance mechanism to the B-cell lymphoma ("BCL-2") inhibitor venetoclax.
CDK9 is also a transcriptional regulator of MYC, a transcription factor regulating cell proliferation and growth which contributes to many human cancers and is frequently associated with poor prognosis and unfavorable patient survival. Targeting MYC directly has historically been difficult, but CDK9 is a transcriptional regulator of MYC and is a promising approach to target this oncogene.
In August 2018 MEI dosed the first patient in a dose ranging Phase 1b clinical trial of voruciclib as a single agent in patients with relapsed and/or refractory B-cell malignancies after failure of prior standard therapies to determine the safety, preliminary efficacy and maximum tolerated dose. We also plan to evaluate voruciclib in combination with venetoclax to assess synergies and the opportunity for combination treatments across multiple indications.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. The Company's portfolio of drug candidates includes pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. Pracinostat is also being developed in combination with azacitidine for the treatment of patients with high and very high-risk myelodysplastic syndrome (MDS). MEI Pharma's clinical development pipeline also includes ME-401, a highly differentiated oral PI3K delta inhibitor currently in a Phase 1b study in patients with relapsed refractory follicular lymphoma or CLL, and voruciclib, an oral, selective CDK inhibitor shown to suppress MCL1, a known mechanism of resistance to BCL-2 inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-initiated study in combination with bevacizumab evaluating patients with HER2-negative breast cancer. Pracinostat, ME-401, ME-344 and voruciclib are investigational agents and are not approved for use in the U.S. For more information, please visit www.meipharma.com.