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Any guess when the REDUCE IT trial results would be out ? The last patient visit was June 28, usually takes at least 7-12 week from there for results or in large trials more like 12 weeks. I am hence expecting results end Sept. Anyone think we get the results before Aug 17 option exp ?
Thanks
Probably worth $4-$5 a share at least, cash value is about $3.25 a share. Hopefully there will be some run up to PDUFA, bail out then, in the mean time could sell covered calls.
Agree options are not the greatest, but the the $5 PPS was without the expectation of a positive cUTI trial
Could someone please enlighten me about any upcoming catalysts, FDA submission etc. I own some cytr but have not paid much attention to the stock since it crashed after failed P3.
Thank you
If they ever get to start P3
I agree sell the news, also the stock is highly manipulated. The data looks good. Entirely in line with expectations as was discussed in the monthly conferences. The data is till Aug 4, the final data from them on will be presented at ASH
$heff is a clown, do opposite of what he flake does, you will make money.
http://www.mintpressnews.com/doctors-without-borders-takes-unprecedented-action-against-us-military/210168/
Cowen Offers Commentary on Two Biotech Stocks: MEI Pharma Inc (MEIP), Genocea Biosciences Inc (GNCA)
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Jason Cohen, Editor — October 7, 2015, 4:28 PM EDT
Cowen analysts came out today with an optimistic view on the oncology company MEI Pharma Inc (NASDAQ:MEIP) and vaccine development company Genocea Biosciences Inc (NASDAQ:GNCA), as the iShares Nasdaq Biotechnology ETF (IBB) tried to recover recent losses with gains of nearly 2% today.
MEI Pharma Inc
Cowen analyst Boris Peaker reiterated an Outperform rating on shares of MEI Pharma, after the company announced that data from its Phase II clinical studies of Pracinostat in elderly acute myeloid leukemia (AML) and previously untreated myelodysplastic syndrome (MDS) have been selected by the American Society of Hematology (ASH) Program Committee for oral presentation at the 57th ASH Annual Meeting & Exposition in Orlando on December 7, 2015.
Peaker noted, “We expect to see survival data at ASH and believe anything beyond 1 year warrants Phase III development.” Furthermore, “Also expected at ASH is the first look at Phase II MDS data. To date, all that has been reported was that the study of pracinostat in combination with Vidaza in front-line MDS had missed its primary CR endpoint. We would not dismiss this study completely as we expect to see important secondary endpoints at ASH including DOR, PFS and OS.”
“Given that shares are trading around cash, we believe any positive data here could be a significant catalyst for MEIP,” the analyst concluded.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Boris Peaker has a total average return of 22.2% and a 47% success rate. Peaker has a -37.6% average return when recommending MEIP, and is ranked #100 out of 3769 analysts.
As of this writing, out of the 6 analysts polled by TipRanks, 3 rate MEI Pharma stock a Buy, while 3 rate the stock a Hold. With a return potential of 256%, the stock’s consensus target price stands at $6.13.
The institutional holdings are upgraded mid next month every quarter. So the institutional holdings at the end of Sept 2015 (end 3rd quarter) will be updated around Oct 15, 2015.
After MEIP's crash in March, the only way they are going to get upgrades ( not that upgrades matter much in the current market) is if positive final phase 2 AML/MDS results are presented in Dec ASH conference. What is most important is the clarity if they are proceeding to Phase 3.
The upcoming conference in approx 3 weeks if of great importance when the results will be updated, as will be the final conference in Nov before ASH presentation. The ASH abstracts on-line will be available Nov 5 online.
Agree, the $7 target only values AML indication and so far does not put value on other drugs in pipeline. It also does not take into consideration MDS data which is looking good now.
Cantor Reiterates Buy on MEI Pharma Inc (MEIP) Following 2Q:15 Update; Sees 281% Upside for the Stock
http://www.smarteranalyst.com/2015/09/02/cantor-reiterates-buy-on-mei-pharma-inc-following-2q15-update-sees-281-upside-for-the-stock/
Institutions or big buyers since Friday
MEIP, Trading Below Cash, Could be the Next AQXP: $4 – $14 Target
http://www.storytrading.com/meip-trading-below-cash-could-be-the-next-aqxp-4-14-target/
Last week at the Wedbush PacGrowth Healthcare Conference, the CEO revealed new data points and had very positive remarks when discussing his company’s Phase 2 and Phase 1b drug trial data.
All three drug candidates in the clinic with data expected by the end of this year
MEIP Pharma trades significantly below enterprise value and should be trading at $4 TODAY
With $70 million in cash and 3 strong drug candidates in the pipeline, MEIP would be an attractive takeover candidate.
MEIP is very similar to AQXP, Aquinox Pharma who’s stock first sold off significantly on disappointing trial news, and now was up as much as 1000% earlier this month
When I was writing this article the 1985 Dire Straits classic “Money for Nothing” kept playing over and over again in my head. Maybe it was because MEI Pharma is very similar to that song, where you get the “Money for Nothing and the Drugs for free.” Specifically at time of writing, MEI Pharma has a market cap of $54 million USD and as of last quarters 10Q they had $70.5 million in cash on their balance sheet. MEIP is currently trading below cash as it was so oversold and left for dead. Investors think it failed a phase 2 test because of early disappointing data in ONE portion of its phase 2 trial. The same thing happened to AQXP and look where that stock is today. The street hears “failed drug trial” which has tainted the stock, when in actuality that is far from the case. MEI Pharma also has a number of short term catalysts upcoming, including positive Phase 2 and Phase 1 data, with its lead drug ready for Phase 3 trials commencing as soon as Q4.
MEI Pharma’s lead drug candidate Pracinostat, is currently in Phase 2 studies. Pracinostat is a leukemia drug that is being tested against 2 different types of leukemia’s; Mydelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). MDS is a condition that occurs when the blood-forming cells in the bone marrow are damaged. This damage leads to low numbers of one or more types of blood cells. AML is a type of cancer of the blood and bone marrow that affects immature blood cell growth. The Acute Myeloid Leukemia (AML) therapeutics market was USD 239.3 million in 2011 and this market is forecasted to reach USD 731.1 million in 2018. GlobalData estimates that the global myelodysplastic syndrome (MDS) market was valued at $652.6m in 2010 and forecasts it to grow at a Compound Annual Growth Rate (CAGR) of 12.2% to reach $1.5 billion by 2017
On March 23, 2015 MEI Pharma announced that it’s lead Phase 2 drug candidate Pracinostat, when combined with Celgenes azacitidine (which is marketed as Vidaza), for MDS did not show an improvement in complete response (CR) compared to azacitidine alone. The combination of the 2 drugs caused more frequent side effects of fatigue and diarrhea, and more patients withdrew from the study, depleting the sample size. Without taking Pracinostat’s AML trial and MEI Pharma’s other portfolio of drugs into consideration, investors hit the exits, shares sold off on the news and MEIP stock plummeted 226% overnight. Recent data released by the company at last weeks conference, now say for MDS patients that were able to tolerate the combination of the drugs for greater than 4 cycles were able to achieve prolonged progression free and overall survival, compared to azacitidine alone.
Pracinostat for (AML) is also in phase 2 and its numbers for AML are approaching fantastic! In new data presented by CEO Daniel P. Gold at the Wedbush conference just last week, the CR rate increased from 20% to 42%, the 60 day mortality dropped from 17% to 10%, and the one-years survival rate increased from 40% to 60%. Overall survival is increasing every month now. At the conference, Dr. Gold even mentioned that there is talk of starting the Phase 3 AML trial, but he wanted to get the last bid of data from this trial first.
MEI Pharma also owns lung and ovarian cancer drug candidate ME-344, which is in phase 1b clinical testing. On May 4, MEI Pharma issued a press release with positive findings in which Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma stated “ME-344 has demonstrated broad and potent anti-tumor activity in a number of pre-clinical studies, followed by promising single-agent activity in the clinic.” MEI Pharma owns exclusive worldwide rights to all of its drug candidates, including ME-344
The third drug in MEI Pharma pipeline is PWT143 which is indicated for Hematologic Cancers and has shown superior pre-clinical activity compared to other delta inhibitors including Idelalisib, marketed as Zydelig by Gilead. Zydelig sales are estimated to be $1.2 billion by 2020. Did I mention MEI Pharma owns exclusive rights to all of its drug candidates? Also revealed at the conference last week, Dr. Gold stated that the First-in-human study of PWT143 was initiated in June 2015. Data from the study will be released by 4Q 2015 with plans for its Phase 1 study to begin 1Q 2016.
Financials
MEI Pharma is a clinical development biotech company so, like most, its current revenue is limited. On its first quarter 2015 10Q, the company had 0 revenues and an operating loss of 8.9 million or .27 per share. The good news is that they have 70.5 million cash on their balance sheet and zero debt. The company has a cash burn rate of 5 million a quarter so they have enough cash to finance them through 2016.
Social Sentiment
MEIP has limited chatter on Stock Twits and Twitter. One active Stock Twit user has written a couple of bullish articles for Seeking Alpha in the past year.
A new 13G was filed last week by Frigate Ventures LP who disclosed a 5% stake or 1,715,000 share holding.
Technicals
MEIP has traded in a range between $1.60 -$2.00 since June. The current 50day moving average is $1.72 and the 200 day is a perfect $3.60. The MACD crossed above the signal line last week and remains above it. 3 month average trade volume is 567k
Valuation
The AML therapeutic market is estimated to be $731 million by 2018. Based on the data numbers revealed at last week’s conference I think MEIP is well on its way to tap 50% of that which is $366 million
The MDS therapeutic market is estimated to be 1.5 billion by 2017. A conservative share for MEIP would be 10% or $150 million.
PWT143 looks to be superior to Gliead’s Zydelig who’s estimated 2020 sales are 1.2 billion. A discounted 20% of that is $240 million.
I couldn’t identify a market share for ME-344 because it was not specific enough, so at this stage I applied 100 million mkt share. I estimate MEI Pharma’s 2020 market share to its drug pipeline to be $856 million. Applying discounted cash flows to that using 50% and the 2Q cash estimate of $65 million gives an appropriate market cap 12 months from now of $493 million MEI Pharma has 34,160,000 shares outstanding. A 12 month price target of $14.43 which is 801% higher than where the stock trades at today which is $1.60/ share
Mkt Share Est Discount MEIP estimated 2020 Mkt Share
(millions) (millions)
AML therapeutic $731 50% $366
MDS therapeutic $1,500 10% $150
PWT143 $1,200 20% $240
ME-344 $1,000 10% $100
$856
DCF: 50%
$428
Cash est. 2Q: $ 65
Appropriate Mkt Cap: $493
Acquisition is another possibility. If Pracinostat makes Celgene’s Vidaza more effective, it makes perfect sense and would be easy for CELG to acquire MEIP at current levels.
Trade Plan
I already hold a position and will add more on dips. It should break through the 50day moving avg of $1.72 and then go over $2. The next conference MEIP presents at is the Wells Fargo Healthcare Conference on Sept 9-10. I’m expecting MEIP to appreciate rapidly this fall as data is slowly released leading up to the major hematology conference ASH which is Dec 5 – 8, 2015.
Frigate Ventures Lp New Position in Mei Pharma, Inc
Read more: http://www.octafinance.com/mei-pharma-inc-frigate-ventures-lp-bought-new-stake/144159/#ixzz3iSQbSdAi
New investors with 1,715,000 share ownership Form SC13G
http://www.streetinsider.com/SEC+Filings/Form+SC+13G+MEI+Pharma%2c+Inc.+Filed+by:+Frigate+Ventures+LP/10797668.html?si_email_click=2015081011
Correction: Option grants not buys ....
Massive MEIP inside Buys on 7/28/15 :
CFO got 90 k shares on 7/28/15, Chief medical officer 112,500 shares, Senior VP got 112,500 shares, President and CEO got 307,500 shares. This is in addition to their prior holdings.
Insider buys by Zech Thomas, Baltic Charles V. III, Cann Leah Rush, GOLD DANIEL P PHD, Glover Nicholas, Mass Robert D, Reynolds Thomas C, Urso David M and White Christine Anna totaling about 757,000 shares if I calculated correctly.
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Baltic+Charles+V.+III/10762916.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Zech+Thomas+M./10762903.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Cann+Leah+Rush/10762923.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+GOLD+DANIEL+P+PHD/10762929.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Glover+Nicholas/10762928.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Mass+Robert+D./10762932.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Reynolds+Thomas+C/10762933.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+Urso+David+M/10762938.html?si_email_click=2015072918
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Jul+28+Filed+by:+White+Christine+Anna/10762939.html?si_email_click=2015072918
Can any one tell me when the next catalyst for cytr is due ? I think it is Ongoing P2 brain cancer (GBM) & Kaposi’s sarcoma trials w/ additional data expected during 2H15, but don't know exactly about when data will be released. Would appreciate if anyone has that info.
Conference next week is of considerable importance, updates on AML patients can be expected. There have refractory MDS data coming up too in the next few months and other studies
No action this month, hopefully starts moving up in May
Agree, this is not going much lower, will start moving well in May, would not surprise me if we see $3-$3.50 prior to June 11
No way today or this week, I don't expect to see $3 before next month. Upcoming catalysts for MEIP. Four Catalysts are stacked up in a row beginning May 21.
1. AML 6 month phase 2 trial data on all 50 patients, Abstract on -line May 21, presentation at EHA June 11-14 where there may be further update. Plans to begin pivotal P3 AML trial in JUN15
2. Phase 2 refractory MDS data expected July- Aug 2015
3. ME-344 (mitochondrial inhibitor IV anti-cancer agent)--P1B Trial, ClinicalTrials.gov ID NCT02100007 w/ results expected mid-2015 (2-3Q15 estimate) for open-label P1B trial in combination w/ HYCAMTIN (topotecan) for treatment of small cell lung & ovarian cancers. In OCT14 dosed first pt in cohort expansion stage of trial
4. PWT143: PI3K delta inhibitor anti-cancer agent which is expected to begin clinical trials during 1H15
6. Complete MDS data phase 2 in DEC 2014
The 6 month AML follow up on all 50 patients will be posted on-line on May 21. Presentation is June 11-14 might get more updates in that meeting. With just a month to go before results,expect Meip to run up to at around $3 range, positive result should give it another boost
http://www.ehaweb.org/congress-and-events/20th-congress/key-information/
Cant get more bullish than that
If full AML data in June is as good as the interim data so far, MIEP is certainly worth double. If not, your point is well taken.
Bottom confirmation, should move up to $2-$3 range next month, expect hopefully a bit higher than $3 before June EHA meeting. Should get some update next month at Needham on April 14-15. Then, there will be one in May and the real target is around June 12 with AML data.
Why would the buy at $3.12 ?
Form 4 MEI Pharma, Inc. For: Mar 24 Filed by: VIVO VENTURES VII, LLC
http://www.streetinsider.com/SEC+Filings/Form+4+MEI+Pharma%2c+Inc.+For:+Mar+24+Filed+by:+VIVO+VENTURES+VII%2c+LLC/10406844.html?si_email_click=2015032615
You were not the only one wrong, if that is a consolation.
Agree, I never expected more than 40-50% drop max. Unreal
It is just - dead ...
Are you so sure of the MDS data ?
Considering recent AML data was good, if MDS data this month is not good, how much PPS drop could be expected, considering more data is coming up in June ? Any predictions or up and down based on MDS data this month ?
Thanks
Could some one please clarify ? I was under the impression that data expected this month is already released. I thought next data release was in June 2015. Would appreciate is someone would correct me.
Thanks
http://www.smarteranalyst.com/2015/03/06/roth-capital-maintains-buy-mei-pharma-inc-following-mei-004-phase-ii-update/
March 6, 2015 9:53 AM EDT by Jason Cohen, Editor in Exclusively Published • Healthcare • Insights • Top 50 Analysts
Roth Capital’s healthcare analyst Joseph Pantginis weighed in with a few insights on MEI Pharma (NASDAQ:MEIP), after the company provided an update from its MEI-004 Phase II study of pracinostat in frontline AML.
The analyst rates the stock a Buy with a $14 price target, which represents a potential upside of 147% from where the stock is currently trading.
Pantginis noted, “We believe these continued signs of efficacy in elderly AML patients speak to pracinostat’s clinical activity. As six month followups continue for the remainder of patients, MEIP is preparing for initiation of the Phase III study in frontline AML, expected to begin in June 2015, at which point full data from the two Phase II studies in frontline AML and MDS are expected. Recall that the study will enroll ~450 patients and will randomize patients at 1:1 ratio for treatment with either pracinostat + azacitidine or placebo + azacitidine. The accepted primary endpoint for accelerated approval is CR with OS being the endpoint needed for full approval.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Joseph Pantginis has a total average return of 18.9% and a 60.7% success rate. Pantginis has a -15.8% average return when recommending MEIP, and is ranked #29 out of 3505 analysts.
http://www.smarteranalyst.com/2015/03/06/roth-capital-maintains-buy-mei-pharma-inc-following-mei-004-phase-ii-update/
Tanking hard after hours $5.05. I had sold $6 puts, which I thought expired worthless after close today. Will I get the shares assigned ?
Does anyone know when the bench trial decision of STEM vs CUR trial going to be rendered ?
Thanks
Anyone has any idea what is going on with the STEM case ? Waiting for new on it to take a position, not sure if that is the way to do it
this stock is in a really bad shape. Is $0.80 gonna hold ?
A delisting notice is sent if stock trades below $1 for 30 consecutive days, company has 180 days to be compliant, an additional 180 days extension is automatic if market cap is above $1 million, after that there is an appeals process. In worst case scenario if this stock continues to be below $1 till Jan 2016, delisting could be possible or a reverse split would be needed to avoid it. Hopefully a year is more than enough for the stock to get back above $1 for 10 consecutive days and compliance is restored and cycle begins once again.