MEI Pharma, Inc. (MEIP)

[Aarin]

I am continuing to buy at these prices. It is a bargain under $3 and will be a $5 stock in less than 3 years.

[Aarin]

Back in at $3.02. I have a second buy order in @ $3.85.

[Aarin]

This is a pretty big deal for me. I sold 12K shares this morning. I will be back in when the price is better.

[bladerunner1717]

MEIP & partner Helsinn announce discontinuation of Phase III trial of Pracinostat for AML




Helsinn Group and MEI Pharma Discontinue the Phase 3 Study with Pracinostat in AML after Completing Interim Analysis
July 02, 2020 07:00 ET | Source: Helsinn Healthcare S.A.

Helsinn Group and MEI Pharma Discontinue the Phase 3 Study with Pracinostat in AML after Completing Interim Analysis
ugano, Switzerland and San Diego, USA, July 2, 2020 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, and MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announce that an interim futility analysis of the ongoing Phase 3 study of pracinostat in combination with azacitidine in patients with AML who are unfit to receive standard intensive chemotherapy, undertaken by the study Independent Data Monitoring Committee (“IDMC”), has demonstrated it was unlikely to meet the primary endpoint of overall survival compared to the control group. Based on the outcome of the interim analysis, the decision was made to discontinue the recruitment of patients and end the study. The decision was based on a lack of efficacy and not on safety concerns. Pending further evaluation, patients currently enrolled in other pracinostat studies will continue treatment.

About AML
Acute Myeloid Leukemia (AML) is a disorder of the blood and bone marrow caused by the uncontrolled proliferation of an abnormal hematopoietic cell of myeloid lineage. This results in a high circulating number of immature blood cells and replacement of normal bone marrow by malignant cells. AML has various subtypes, which are based on the type of cell from which the leukemia developed. It is typically a disease of older patients, with a median age at diagnosis of 67 years. Whilst the cure rate with intensive chemotherapy for AML patients who are 60 or younger is 35 to 40%, the rate is poor in older patients, typically not exceeding 15%.

About Pracinostat
Pracinostat is an oral histone deacetylase (“HDAC”) inhibitor that is being investigated in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia (“AML”) who are unfit for standard intensive chemotherapy. It is also being evaluated in a Phase II study in patients with high or very high-risk myelodysplastic syndromes (“MDS”). The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation for pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In addition, the FDA has granted Breakthrough Therapy Designation to the combination treatment.

In August 2016, Helsinn and MEI Pharma entered an exclusive license, development and commercialization agreement for pracinostat in AML and other potential indications. The agreement provides that Helsinn is primarily responsible for development and commercialization costs for pracinostat in AML and other indications, including MDS.
Pracinostat is an investigational agent and is not approved for commercial use in the U.S. or any other country worldwide.

Bladerunner

[realfast95]

WATCH for possible breakout above 4.36, no resistance in area just above.
Type: Continuation breakout from single resistance.
Target: 5.12,

[realfast95]

something is brewing, large blocks today

[bladerunner1717]

MEIP presents data at ASCO on its FOURTH clinical candidate for HER2-negative breast cancer. Comments welcome.

MEI Pharma Presents Clinical Results for ME-344 in Combination with Bevacizumab in Early HER2 Negative Breast Cancer Patients at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting
- Statistically significant biologic anti-tumor activity demonstrated as measured by a reduction in Ki67 in patients treated with ME-344 compared to an increase in patients receiving placebo -


MEI Pharma, Inc.
Jun 01, 2019, 09:00 ET

SAN DIEGO, June 1, 2019 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced data presented at ASCO 2019 from an investigator-initiated study of investigational ME-344 in combination with bevacizumab (marketed as Avastin®) in patients with early HER2-negative breast cancer. This study demonstrated proof of biologic anti-tumor activity as measured by a statistically significant reduction in Ki67, a measure of cell proliferation that is highly correlated with tumor response, in the group of patients treated with ME-344 compared to an increase in the group receiving saline.

"Data from this clinical study of ME-344 in combination with bevacizumab represents a potential novel approach to disrupting tumor metabolism and limiting tumor proliferation by inhibiting the heightened energy production necessary for cell division and cancer growth," stated the study principal investigator, Miguel Quintela-Fandino, M.D., Ph.D., Director of the Clinical Research Program, Centro Nacional De Investigaciones Oncologicas, Madrid, Spain. "These results offer evidence for the biologic antitumor activity of ME-344 in certain metabolic contexts and support further exploration of the mitochondrial inhibitor ME-344 in a therapeutic role, providing a potential novel mechanism that may improve patient outcomes in combination with antiangiogenic therapeutics such as bevacizumab."

The ME-344 ASCO 2018 poster can be accessed on the MEI Pharma website.

ME-344 Clinical Data
The clinical study was a multicenter, investigator-initiated, randomized, open-label trial evaluating ME-344 in a total of 42 patients with early HER2-negative breast cancer in combination with the vascular endothelial growth factor inhibitor bevacizumab. Patients were randomized one-to-one to either ME-344 plus bevacizumab or saline plus bevacizumab.

The primary objective of the study was to show proof of ME-344 biologic activity as measured by Ki67 reductions from day 0 to 28 compared to placebo. Secondary objectives included determining whether ME-344 biologic activity correlates with vascular normalization. The data demonstrate significant biologic activity in the ME-344 treatment group:

In ME-344 treated patients, mean absolute Ki67 decreases were 13.3 compared to an increase of 1.1 in the bevacizumab monotherapy group (P=0.01).

In ME-344 treated patients, mean relative Ki67 decreases were 23% compared to an increase of 186% in the bevacizumab monotherapy group (P < 0.01).

The mean relative Ki67 reduction in patients experiencing vascular normalization in the ME-344 treated patients was 33%, compared to an increase of 11.8% in normalized patients from the bevacizumab monotherapy group (P=0.09). Approximately one-third of patients in each arm had vascular normalization.

Treatment was generally well tolerated; two Grade 3 adverse events of high blood pressure were reported, 1 in each arm, and deemed related to bevacizumab.

About ME-344
ME-344 is a novel, tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. Treatment of tumor cells with ME-344 results in a rapid loss of ATP and cancer cell death. ME-344 demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study, and in preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death.

In addition to single-agent activity, ME-344 may also have potential in combination with antiangiogenic therapeutics. While antiangiogenics reduce the rate of glycolysis in tumors as a mechanism to block growth, tumor metabolism often shifts to mitochondrial metabolism to continue energy production to support continued tumor proliferation. In such cases of tumor plasticity in the presence of treatment with antiangiogenics, targeting the alternative metabolic source with ME-344 may open an important therapeutic opportunity.

About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com.

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[bladerunner1717]

MEIP crashes through its 52-week high today. Holding an analyst day tomorrow.

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[bladerunner1717]

SunTrust's analysis of MEIP

MEI Pharma initiated with a Buy at SunTrust SunTrust analyst Robyn Karnauskas initiated coverage of MEI Pharma with a Buy rating and $16 price target, saying the company has demonstrated strong risk-benefit profile in Phase 1 lymphoma trials and offers potential for accelerated approval in 3L FL. In addition to offering a potentially differentiated PI3K-delta inhibitor, the analyst believes that investors should consider a "base case $500M" peak-adjusted opportunity with potential upside from an over $3B opportunity across B-cell malignancies, along with MEI Pharma's pipeline beyond PI3K and its strong balance sheet.

Read more at:
https://thefly.com/landingPageNews.php?id=3101855


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[Aarin]

Friday's price in a new YEALY (+10 days) high for MEIP. On 5/21/19, MEIP hit a high of $3.41.
The chart says there is another 2-3 week run left in this stock.
Get in before everyone else discovers this gem!

[Aarin]

This is great news! I still believe this is a $7-8 stock in 2022. When it gets near this price, it will be a buyout candidate which will add 50-100% to the share price.
Hold on share owners....people still don't know about MEIP. When they do=BLAST off!

[bladerunner1717]

SunTrust Robinson Humphrey initiates coverage of MEIP with $16 PT.

Bladerunner

[Aarin]

Lurkers! Get in now!
You better get into MEIP before it is too late. Once the volume starts to exceed the 3 month average, this stock will go PARABOLIC.

It should be a $7 stock in 2 years. I will take a 50% gain year over year any day.

[bladerunner1717]

Helsinn, MEIP's partner, reports updated Phase II data in high-risk MDS trial. Will have a poster at ASCO. Stock up 20% in AH. Comments?


Helsinn and MEI Pharma Announce Updated Clinical Data from the Phase 2 Study Evaluating Pracinostat in Combination with Azacitidine in Patients with High/Very-high Risk Myelodysplastic Syndromes

PR NewswireMay 13, 2020
- Data to be Featured in the American Society of Clinical Oncology Annual 2020 Virtual Scientific Program on May 29, 2020 at 8:00 a.m. EDT -
LUGANO, Switzerland and SAN DIEGO, May 13, 2020 /PRNewswire/ -- Helsinn Group, a Swiss pharmaceutical group focused on building quality cancer care and rare disease products, and MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced new data from the Phase 2 study evaluating pracinostat, an oral pan-histone deacetylase inhibitor (HDACi), in combination with azacitidine in patients with high and very-high risk myelodysplastic syndromes previously untreated with hypomethylating agents. The study results will be featured in a poster at the American Society of Clinical Oncology 2020 Virtual Scientific Program.

The new data from the Phase 2 study (n=64) demonstrated an estimated median overall survival (OS) rate of 23.5 months with a 1-year OS rate of 77%. The median follow-up was 17.6 months (range, 15.7–18.8) and the overall response rate (ORR) was 33% (21/64), all of which are complete responses (CR). The clinical benefit rate (CR, mCR plus hematologic improvement [HI], mCR with no HI, or HI with no mCR) was 77% (49/64). Twenty seven percent of patients (17/64) proceeded to a stem cell transplant while on study. Eleven percent of patients discontinued treatment because of adverse events. The most common grade ≥3 treatment emergent adverse events were hematologic, and included decreased neutrophil count (50%), anemia (39%), febrile neutropenia (34%), decreased platelet count (33%), thrombocytopenia (27%), and decreased white blood cell count (20%).

"Patients with high and very-high risk MDS currently have limited treatment options and poor outcomes," stated Ehab Atallah, M.D., Study Chair, Professor of Medicine, Medical College of Wisconsin. "These data are promising and I continue to be encouraged by my experience to date with the combination of pracinostat and azacitidine evaluated in this study. The potential to offer patients a new combination treatment option in MDS is exciting."

The poster, titled "Phase 2 study of lower-dose pracinostat plus azacitidine safety and efficacy in patients with high/very high-risk myelodysplastic syndromes," will be included in a poster session at the ASCO Virtual Scientific Program and will be available for on-demand viewing online beginning on May 29, 2020 at 8:00 a.m. EDT at https://meetings.asco.org/am/virtual-program. The poster will also be available for download via the MEI Pharma website.

The Phase 2 Study
The Phase 2 study is an open label, multicenter trial investigating a 45 mg dose of pracinostat in combination with the standard 75 mg dose of azacitidine in patients with high and very high-risk MDS who are previously untreated with hypomethylating agents.
The primary endpoints were safety and tolerability of pracinostat in combination with azacitidine and ORR, defined as CR plus partial response (PR). Overall survival was a secondary endpoint. All efficacy evaluable patients have been followed for at least one year to evaluate safety and efficacy.

About Higher Risk MDS
Higher risk MDS (high and very high risk in the IPSS-R classification) is a serious medical condition, with median survival of less than 18 months. The only curative therapy is allogeneic stem cell transplantation (SCT), however most patients with MDS are not candidates for SCT given their typically advanced age, comorbidities, and lack of a suitable donor. Standard therapy with HMAs in higher risk MDS provides modest responses, though azacitidine has been shown to improve survival when compared to conventional care regimens. Patients who do not respond to HMAs or progress after therapy with HMAs have a very poor outcome, with a median survival of less than one year.

About Pracinostat
Pracinostat is an oral histone deacetylase ("HDAC") inhibitor that is in a pivotal Phase 3 PRIMULA study in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia ("AML") who are unfit for intensive chemotherapy. It is also being evaluated in a Phase 2 study in patients with high or very high-risk myelodysplastic syndrome ("MDS"). The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation for pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In addition, the FDA has granted Breakthrough Therapy Designation to the combination treatment in AML.

In August 2016, Helsinn and MEI Pharma entered an exclusive license, development and commercialization agreement for pracinostat in AML and other potential indications. The agreement provides that Helsinn is primarily responsible for development and commercialization costs for pracinostat in AML and other indications, including MDS.
Berlin Chemie AG, the German company of the Menarini Group, has been granted exclusive licensing rights to commercialize pracinostat worldwide (excluding US, Canada, Japan and South America). Blanver has been granted the rights to register, promote, distribute and commercialize pracinostat in Brazil, while Varifarma, located in Buenos Aires, covers Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru, and Uruguay. Endo Ventures Limited and Paladin Labs Inc., an operating company of Endo, are responsible for the registration, distribution, sales, marketing, medical affairs, pricing and reimbursement activities in connection with pracinostat in Canada.
Pracinostat is an investigational agent and is not approved for commercial use in the U.S. or any other country worldwide.

About the Helsinn Group
Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisition to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with over 80 long-standing partners in 190 countries, who share our values. The Group's pharmaceutical business (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group's products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn Investment Fund was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.
Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company's strategic plan by a commitment to sustainable growth.
To learn more about Helsinn Group please visit www.helsinn.com

About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com.

Bladerunner

[Bean Bag]

I love me MEIP. I underwater right now but I continue to buy. Once more people start to look deeply at MEIP and see the potential revenues after we go to market internationally and then the US, MEIP will be a buyout target.
My target is $10 over the LT!
THANKS for posting the Alpha Article

[bladerunner1717]

Bullish article on MEIP (from "Seeking Alpha")

MEI Pharma Set To Explode With Announcement Of Lucrative Partnership
Apr. 27, 2020 6:00 AM ET|13 comments | About: MEI Pharma, Inc. (MEIP)



Summary
$250 million market cap is extremely low after signing a $700 million agreement with Kyowa Kirin, which gives $100 million upfront with 50-50 revenue sharing in the US and tiered royalties for ME-401.
Extensive drug pipeline for a small-cap biotech with 4 different candidates in which two are already partnered.

Analysts' price targets following partnership reflect 3-5 times upside.
It has been quite some time since my last stock recommendation. However, I have continued to be on the lookout for small-cap biotech stocks that are dramatically undervalued. With the pandemic leaving a lot of uncertainty in the markets, I have been looking not only for small-cap stocks with a lot of upside but also a substantial amount of cash on hand to fund operations and not have to dilute under poor market conditions. In the small-cap space, this is not easy to come by. However, MEI Pharma (MEIP) looks to be a hidden gem right now. I last recommended MEI Pharma almost 4 years ago when it was trading at a $50 million market cap. Although, the stock has quadrupled since then, the pipeline has gotten much better, and with the recent announcement of the mega deal with Kyowa Kirin, the small-cap company’s strategy has been validated and significantly derisked.

It is shocking to me that the stock did not move more on announcing the deal. It initially jumped up to $3.64 per share but has fallen back to ~$2.40, which is where the shares were trading in early March before the deal. To be trading at a ~$250 million market cap after such a big deal for a small-cap stock is unheard of. The deal was for just one of its drug candidates, a phosphatidylinositol 3-kinase delta (PI3Kd) also known as MEI-401, which is in clinical development for the treatment of B-cell malignancies. Usually, deals involving small-cap biotechs are very light on upfront payments, and instead, are back-end loaded on milestones so that little risk is taken by large pharma. However, this deal stands out to me because of the hefty $100 million upfront cash payment, combined with the ability to get almost $600 million more in milestone payments. In addition, MEI Pharma retains 50% of sales in the US with cost sharing and tiered royalties overseas.

In my opinion, MEI Pharma is a steal at the current valuation with now ~$200 million of cash on hand, a very strong drug pipeline and a big-time partnership. With several catalysts on the horizon in the short term, I think the stock could easily double or triple from current levels.

Best-in-Class HemOnc Clinical Pipeline
It is rare to find a biotech with a $250 million market cap having such a diverse clinical pipeline. Most small-cap biotech companies have their hopes pinned on a single drug.

Source: April 2020 Corporate Presentation
Pracinostat
One of the most advanced drugs in the pipeline is Pracinostat, an HDAC inhibitor for the treatment of MDS and AML, which was licensed to Helsinn in 2016 for $20 million upfront and ~$450 million in milestone payments, along with tiered royalty payments on sales. The excitement of Pracinostat plus Azacitidine in elderly newly diagnosed AML patients stems from the Phase 2 clinical trial results, where complete remission was observed in 42% (21 of 50 patients) and median overall survival was over 19 months. This compares favorably to Azacitidine alone with a CR of 19.5% and a median OS of 10.4 months. Helsinn is now enrolling the Phase 3 clinical trial, which, in my opinion, has a high likelihood of success, as the responses seen to date have been some of the most durable ones ever documented in this patient population. In addition, Helsinn and MEI Pharma are in the process of completing a Phase 2 dose escalation study in MDS, which has already passed an interim analysis and should report out in the middle of this year.

Voruciclib
Voruciclib is a novel, oral CDK inhibitor that is fully owned by MEI Pharma and being looked at in numerous blood cancers. It has not only shown single agent activity but has the potential of overcoming Venetoclax resistance by inhibiting MCL1. Venetoclax does ~$1 billion in revenue annually. Phase 1 clinical trial updates should be available in 2020.

ME-344
ME-344 is a very unique compound, an isoflavone-derived mitochondrial inhibitor drug candidate with broad anti-tumor activity. The dose escalation Phase 1 clinical trial was published in the journal Cancer with impressive results on a variety of refractory/recurrent cancers. Importantly, over 70% of the patients had at least 3 prior therapies and were progressing. So this was considered a hard-to-treat cohort due to significant prior drug exposure. Upon evaluation, 38% (8/21) of patients experienced stable disease or partial response, with 7 of those patients' response being longer than their previous therapy. Several of the responses were dramatic.

Source: Bank of America Presentation 2015
In a separate Phase 1 clinical trial published at ASCO in 2019, ME-344, in combination with Avastin, showed impressive biological activity in early HER2-negative breast cancer and met the primary endpoint of showing a decrease in cellular tumor proliferation. Using a marker for proliferation, the study showed a mean relative decrease of 23% in the combination group compared to a 186% increase in the Avastin monotherapy group (P < 0.01). The study is ongoing. The compound is fully owned by MEI Pharma, and next steps have not been detailed to date.

ME-401
Last but certainly not least, ME-401, or PI3Kd, is the compound that has the most excitement around it, and MEI Pharma just signed the deal with Kyowa Kirin described above. Importantly, MEI Pharma and Kyowa Kirin had signed a deal in 2018 giving them exclusive rights to the drug in Japan, which resulted in a $10 million upfront payment. However, as the data has materialized over the last 2 years, Kyowa Kirin has obviously liked what they’ve seen and significantly increased its stake in the drug. With B cell malignancies being a billion-dollar-a-year market, PI3Kd is looking like the best-in-class PI3K drug compared to other FDA-approved drugs with significantly better response rates and, more importantly, less adverse side-effects which have hampered the uptake of others.


Source: April 2020 Corporate Presentation
The drug is currently being studied in a Phase 2 clinical trial for patients with relapsed or refractory follicular lymphoma, which the company was just awarded Fast Track designation for last month. In addition, several ongoing Phase 1 studies are evaluating ME-401 as a monotherapy and in combination with rituximab or zanubrutinib in B-cell malignancies.

Financials and Risks
Investors in small-cap biotech stocks know risks are high, as prices regularly swing wildly in either direction based on catalysts. With a healthy drug pipeline and a large cash position, I believe the risk at current levels is buffered. With already nearly $100 million of cash on hand, and now the addition of another immediate $100 million, MEI Pharma is well-funded. The company has no debt and a relatively low cash burn rate for a biotech at $10-15 million a quarter. With development costs now being shared for MEI-401, this should also free up some cash to get more aggressive in the progression of other drugs in the pipeline or even be opportunistic in acquiring other drug candidates.

Conclusion
MEI Pharma stands out as a hidden gem in the crowded, often overvalued small-cap biotech space. It is trading at almost cash levels with a broad clinical pipeline and a recently signed lucrative partnership with Kyowa Kirin that gives MEI Pharma a good chance of getting ME-401 to market. The stock is currently trading at a ridiculously low market cap of only ~$250 million. I might not be the only person that thinks MEI Pharma is a hidden gem on Wall Street. Following the deal, Wells Fargo slapped a $13 price target on the stock, representing 5 times its current level. Likewise, JonesTrading upped their price target to $9. As more investors become aware of the company, I don’t think it will be undervalued for long.

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[andrewflying]

What is your price target then? Just wonder. Thanks in advance.

[edwardport]

agree 100% with you

[bladerunner1717]

MEIP traded over 100X its average volume.

Old Wall Street adage: "Volume precedes price"

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[ClayTrader]

* * $MEIP Video Chart 04-14-2020 * *

Link to Video - click here to watch the technical chart video

[Hercules1]

$MEIP:


it has no business trading under $7 right now.

[edwardport]

YES, COULD HIT $3 AND THEN $4 REAL QUICK

[eur06]

I like it !!! I’ll add more if goes down to 2.8 !!!!

[dinogreeves]

MEIP will run to 5-6 dollars.

[bladerunner1717]

Insider buys at MEIP


MEI Pharma CFO bought 12,500 shares

CFO Brian G. Drazba bought 12,500 shares for $1.6 per share on Dec. 19. Since then, the stock price has increased by 17.5%. MEI Pharma has a market cap of $138.471 million and its shares were traded around $1.88. The company has a price-sales ratio of 24.42.

MEI Pharma announced its third-quarter results with revenue of $1.16 million and gross profit of $469,000, while the net loss was $2.99 million. The 2019 total revenue was $4.92 million, a 203% increase from 2018. The gross profit was $652,000, a 137% increase from the year prior. The net loss was $16.82 million.

CEO Daniel P. Gold bought 18,750 shares for $1.6 per share on Dec. 19. Director Thomas C. Reynolds bought 10,000 shares and Director Frederick W. Driscoll bought 62,500 shares. Since then, the stock price has increased by 17.5%.

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[bladerunner1717]

"Seeking Alpha" on MEIP

MEI Pharma: A $2 Biotech Concern With 9 Lives
Dec. 27, 2019 12:48 PM ET | About: MEI Pharma, Inc. (MEIP)
Bret Jensen

The Biotech Forum
Finding tomorrow's big winners in the lucrative biotech sector
(42,407 followers)
Summary
Today, we take a look at a small oncology concern based in San Diego called MEI Pharma.

The company has several 'shots on goal', strategic partnerships, and, recently, addressed its funding needs.

Below, I provide a quick analysis on this small-cap company and if it may finally reward its long-suffering shareholders.

I do much more than just articles at The Biotech Forum: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »

Women and cats will do as they please, and men and dogs should relax and get used to the idea." - Robert A. Heinlein

I have had a few questions come up from followers around a $2 biotech stock called MEI Pharma (MEIP) in recent weeks. Given it has been a long time since I glance at this small oncology concern - which seems to have been around forever; today, we revisit this name and post our analysis in the paragraphs below:

Company Overview:
MEI Pharma is a small oncology concern based in San Diego. It is focused on developing various therapies for the treatment of cancer. The stock trades at $2.20 a share and has a market capitalization of just north of $200 million.

Pipeline:

Image result for Acute Myeloid Leukemia

The company's pipeline consists of four clinical-stage candidates, including one candidate 'pracinostat' in combination with Vidaza is in an ongoing Phase 3 global registration trial. The target for this combination therapy is treatment-resistant Acute Myeloid Leukemia or AML. MEI is fully partnered with Helsinn Group, a Swiss-based firm, for the development of pracinostat. Helsinn is paying all developmental costs for pracinostat. MEI Pharma is entitled to potential milestone payments of north of $400 million as well as royalties on commercial sales in the mid-teens. Some mid-stage data from another trial using pracinostat in combination with Vidaza to treat high-risk Myelodysplastic Syndrome or MDS which should be disclosed shortly.

Image result for Follicular Lymphoma

Another drug candidate 'ME-401', which is an oral P13K Delta inhibitor, is entering a clinical study to support an accelerated approval marketing application with the FDA. ME-401 is a monotherapy targeting relapsed/refractory Follicular Lymphoma in this trial. MEI Pharma owns all commercial rights outside of Japan where it is partnered with Kyowa Kirin.

Analyst Commentary & Balance Sheet:
Four analyst firms including BTIG and Oppenheimer have chimed in on MEIP so far in 2019. All have Buy ratings on the stock. Price targets range from $5.50 to $10.00 a share. JonesTrading was the last analyst firm to provide commentary on MEI Pharma when it initiated the shares as a new Buy with a $6 price target earlier this month.

The company ended the third quarter with just north of $65 million of cash and marketable securities on the balance sheet. In mid-December, MEI Pharma raised some $45 million via a secondary offering at $1.60 a share. The company burned through just over $14 million in the third quarter to fund all R&D and operational costs. Four insiders bought just under $170,000 in aggregate of the secondary offering. I would call that a 'token' amount at best, but it was some of the few insider buys in the equity of MEIP over the past five years.

Verdict:
MEI Pharma has some attractive traits for a developmental or 'Tier 4' concern. It has just addressed its funding needs. The company's pipeline also has multiple 'shots on goal' and key partnerships. Analyst support is fairly strong in this name as well despite not being able to get any compound over the 'finish line' of FDA approval to this point as a public company.



However, one can't look at the stock chart above and have high confidence the company is finally going to deliver on its promise. This concern is firmly in 'Ten-Year Rule' territory. Those who want to know more about MEI Pharma, there was a good investor presentation put out last month which it presented at the Stifel Nicolaus Healthcare conference.

Given this, I have no investment recommendation on MEIP. The only way I would even entertain a play on this name is via buy-write orders as options are available against the equity. In addition, MEIP seems to have more lives than the proverbial cat, so that could turn out to be a 'rinse, wash, and repeat' strategy that could work over the longer term with this name.

Owners of dogs will have noticed that, if you provide them with food and water and shelter and affection, they will think you are god. Whereas owners of cats are compelled to realize that, if you provide them with food and water and shelter and affection, they draw the conclusion that they are gods." - Christopher Hitchens

Bret Jensen is the Founder of and authors articles for the Biotech Forum, Busted IPO Forum, and Insiders Forum.


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MEIP closes public offering. MEIP now has a little over 100 million shares outstanding. They now should have approximately $100 million in cash at the end of this calendar year. The EV is around $60 million. They burn about $50 million a year. Their partner, Helsinn, pays for the Phase III trials in AML as well as the Phase II trial in MDS with Pracinostat, an HDAC inhibitor. The former is run by Helsinn and the latter is run by MEIP. MEIP's other three drugs in development are proprietary. All three are in the clinic. The most advanced is ME-401, a PIK3 Delta inhibitor, which is in a Phase II--potentially registrational--trial in FL and CLL/SLL.



MEI Pharma Announces Closing of Public Offering of Common Stock
PR Newswire PR Newswire•December 19, 2019
SAN DIEGO, Dec. 19, 2019 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, announced today that it has closed the underwritten public offering of 32,343,750 shares of its common stock, including 4,218,750 shares sold as a result of the exercise by the underwriters of their option to purchase additional shares, at $1.60 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $51,750,000.

The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, as well as for working capital and other general corporate purposes.

Stifel and Wells Fargo Securities acted as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. Copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [e-mail]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York NY 10152, by telephone at 800-326-5897 or by email at [e-mail]. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering is also available on the website of the SEC at www.sec.gov.

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* * $MEIP Video Chart 12-17-2019 * *

Link to Video - click here to watch the technical chart video

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News: $MEIP MEI Pharma Announces Pricing of Public Offering of Common Stock

SAN DIEGO , Dec. 17, 2019 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, announced today that it has priced the underwritten public offering of 28,125,000 shares of its common stock at $1.60 per sh...

Read the whole news MEIP - MEI Pharma Announces Pricing of Public Offering of Common Stock

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News: $MEIP MEI Pharma Announces Proposed Public Offering of Common Stock

SAN DIEGO , Dec. 16, 2019 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, announced today that it plans to offer shares of its common stock in an underwritten public offering.  In connection with...

Find out more MEIP - MEI Pharma Announces Proposed Public Offering of Common Stock

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MEIP (finally) breaks thru 200-day moving average ($2.00). We'll see if it can hold.

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Institutional investors sold almost 7 million shares last quarter. That will hold a share price down. Importantly, neither Perceptive Advisers nor BVF sold shares. Institutional ownership now under 60%.


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MEIP Chart

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News: $MEIP MEI Pharma to Present at the 2019 Wells Fargo Healthcare Conference

SAN DIEGO , Aug. 29, 2019 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late‐stage pharmaceutical company focused on advancing new therapies for cancer, today announced that Daniel P. Gold , Ph.D., president and chief executive officer, will present at the 2019 Wells Far...

In case you are interested MEI Pharma to Present at the 2019 Wells Fargo Healthcare Conference

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MEIP Investment Highlights:

*Four Clinical-Stage Programs; Multiple near-term Milestones in Oncology related areas

*Combination & Mono Therapies Targeting Multiple Pathways

*As of end of 1st Qtr. 2019, comapny has $93 million in Cash to achieve key Milestones across programs

*In Phase 3 Pivotal Trial for Acute Myeloid Leukemia w/ drug 'Pracinostat'(HDAC Inhibitor)

*In Phase 2 Accelerated Approval Trial with drug 'ME-401' for Follicular Lymphoma

*Early-Stage drug 'ME-344" targeting Breast Cancer

*Voruciclib(CDK Inhibitor) - B-Cell Malignancies and AML - Phase 1

*20,000 new U.S. Cases in 2018 for AML; HER2/breast Cancer - 200k new cases annually


Corporate Overveiw:

MEIP is a San Diego-based late-stage pharmaceutical company focused on building a leading oncology franchise. Itsportfolio of drug candidates contains four clinical-stage candidates, including one candidate in an ongoing Phase 3 global registration trial and another candidate that is entering a clinical study to support an accelerated approval marketing application with the U.S. Food and Drug administration.

Market Capitalization: $120 million
Current Price: $1.48
YTD H-L: $4.80 - $1.52
Symbol: MEIP

Website: www.meipharma.com

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MEI Pharma: Time To Reload At Key Support Level
Jun. 16, 2019
https://seekingalpha.com/article/4270462-mei-pharma-time-reload-key-support-level

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The 7 analysts offering 12-month price forecasts for MEI Pharma Inc have a median target of 7.00, with a high estimate of 11.00 and a low estimate of 5.50. The median estimate represents a +185.71% increase from the last price of 2.45.

Institutional investors control 41.73% of the outstanding shares in MEIP. This represents a greater percentage of ownership than at almost any other company in the Pharmaceuticals: Other industry. Additionally, during the quarter ended March 2019, these large investors purchased a net $846.2 thousand shares.

https://money.cnn.com/quote/shareholders/shareholders.html?symb=MEIP&subView=institutional

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MEIP ME-401 data at ASCO


MEI Pharma Presents Updated Clinical Data from the ME-401 Monotherapy and in Combination with Rituximab Phase 1b study in Patients with Follicular Lymphoma at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting
PR Newswire PR Newswire•June 3, 2019
-- 80% overall response rate in patients with relapsed or refractory follicular lymphoma --

-- Intermittent dosing schedule demonstrates comparable overall response rates with lower rate of delayed Grade 3 adverse events compared to continuous dosing schedule --

SAN DIEGO, June 3, 2019 /PRNewswire/ -- MEI Pharma, Inc. (MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced that updated data presented at ASCO 2019 from a Phase 1b study of investigational ME-401, a selective oral inhibitor of PI3K delta, demonstrate an 80% overall response rate in patients with relapsed or refractory (r/r) follicular lymphoma (FL) (n= 50). Additionally, the data demonstrate:

Comparable overall response rates, ranging from 75% to 83%, across patient groups receiving ME-401 as a monotherapy or in combination with rituximab, and in patient groups dosed with ME-401 once daily on a continuous schedule (CS) or on an intermittent schedule (IS) of once daily for the first 7 days of a 28-day cycle after 2 months of continuous dosing.
A lower rate of delayed, grade 3 adverse events (e.g. 8.7% diarrhea/colitis for IS dosing) observed in patients in the IS group.
Durable responses in both CS and IS groups with no median yet reached.
The ME-401 ASCO 2019 poster can be accessed on the MEI Pharma website.

Andrew D. Zelenetz, M.D., Ph.D., Principal Investigator of the Phase 1b study and Professor of Medicine at Weill Cornell Medical College, Medical Director of Quality Informatics at Memorial Sloan Kettering Cancer Center, and Chair of the National Comprehensive Cancer Network's Non-Hodgkin Lymphoma Guideline Panel, commented: "ME-401 is a second generation PI3K inhibitor specific for the delta isoform that has excellent activity in CLL and FL. This class of drugs has been associated with immune related toxicities which are also seen with ME-401 dosed continuously. However, we explored a novel dosing strategy with intermittent drug exposure (one week on, 3 weeks off) that appears to markedly reduce toxicity and maintain efficacy. If validated, this could expand the role of PI3K in B-cell malignancies. A prospective randomized phase 2 trial is underway comparing intermittent to continuous dosing aiming to confirm these preliminary findings."

"The Phase 1b data remain very encouraging and support the further investigation of ME-401 for patients with relapsed or refractory follicular lymphoma," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "ME-401 further represents a unique opportunity to more broadly leverage the utility of PI3K as a central component of B-cell signaling and potentially offer a treatment option across multiple B-cell malignancies either as a monotherapy or in combination with other therapies."

MEI has initiated a global 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, now labeled the TIDAL study '(Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.

ME-401 Phase 1b Clinical Study
The ongoing Phase 1b clinical study is evaluating ME-401 as a monotherapy and in combination with rituximab or with zanubrutinib in patients with r/r B-cell malignancies. Over 85 patients have been enrolled to date, including 54 patients with r/r FL reported on in the ASCO 2019 poster. Sixty-five percent (35/54) of r/r FL patients had 2 or more prior lines of therapy. Of the 50 evaluable r/r FL patients, 52% (26/50) were a group of FL patients with progression of disease within 24 months (POD24) of initial immunochemotherapy, which typically have a poor prognosis compared to other r/r FL patients.

ME-401 was administered once daily at 60 mg for 2 28-day cycles and then on an intermittent schedule of once daily dosing for the first 7 days of each subsequent 28-day cycle (i.e. the intermittent schedule or IS). A previous cohort of monotherapy patients in the study was treated with ME-401 administered continuously once daily or were switched to the intermittent schedule in later cycles.

The overall response rate in patients with r/r FL was 80% (40/50), with 20% (10/50) achieving a complete response. Patients receiving monotherapy achieved a 79% (30/38) overall response rate and patients receiving ME-401 in combination with rituximab achieved an 83% (10/12) overall response rate. The group of patients receiving IS dosing achieved a 75% (15/20) overall response rate and patients receiving the CS dosing achieved an 83% (25/30) overall response rate. The response rate among POD24 patients was 92% (24/26).

Evaluable R/R FL Patients

Overall Response

All groups (N = 50)

CR

40 (80%)

10 (20%)

By treatment arm

ME-401 monotherapy (N = 38)

ME-401 + rituximab (N = 12)

30 (79%)

10 (83%)

By schedule

IS Group (N = 20)

CS Group (N = 30)

15 (75%)

25 (83%)

The majority of responses, 88% (35/40), had an objective response by the first two treatment cycles and the achieved responses, to date, are durable; neither median duration of response nor median progression-free survival has been reached. Median follow-up for duration of response in the IS group is 8.8 months (range:1.9-15.5) and 8.3 months in the CS group (range:3.0-25.8). Median follow-up for progression free survival is 5.5 months in the IS group (range:0.9-15.5) and 6.5 months in the CS group (range:0.9-25.8). Four patients in the IS group and 2 patients in the CS group that were switched to IS dosing experienced progressive disease and reverted to CS dosing to continue treatment.

ME-401 was generally well-tolerated and no grade 4 or grade 5 adverse events have been observed in the Phase 1b study. Among drug related grade 3 adverse events of special interest, the most common are diarrhea/colitis at 8.7% (2/23) on IS dosing and 16.1% (5/31) on CS dosing, and rash with none on IS dosing and 12.9% (4/31) on CS dosing. Four patients, each on the continuous schedule, discontinued due to an adverse event.

The rate of the development of delayed, grade 3 adverse events was improved in patients on the intermittent dosing schedule. There were no isolated grade 3 elevations in ALT and AST; such elevations were transient and in each case were associated with grade 3 diarrhea or rash.

Adverse Events of
Special Interest

Grade 3

CS Group

(N = 31)

IS Group

(N = 23)

Diarrhea/colitis

5 (16.1%)

2 (8.7%)

Rash, all types

4 (12.9%)

0

ALT increased

2 (6.5%)

1 (4.3%)

AST increased

2 (6.5%)

0

Pneumonia

2 (6.5%)

0

Mucositis

1 (1.9%)

0

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 cancers. 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. An ongoing, global, Phase 2 study is evaluating 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 new drug application with the U.S Food and Drug Administration.

About MEI Pharma
MEI Pharma, Inc. (MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com.

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MEIP ME-344 at ASCO

June 1, 2019 9:00 AM
MEI PHARMA PRESENTS CLINICAL RESULTS FOR ME-344 IN COMBINATION WITH BEVACIZUMAB IN EARLY HER2 NEGATIVE BREAST CANCER PATIENTS AT THE 2019 AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING
- Statistically significant biologic anti-tumor activity demonstrated as measured by a reduction in Ki67 in patients treated with ME-344 compared to an increase in patients receiving placebo -
SAN DIEGO, June 1, 2019 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced data presented at ASCO 2019 from an investigator-initiated study of investigational ME-344 in combination with bevacizumab (marketed as Avastin®) in patients with early HER2-negative breast cancer. This study demonstrated proof of biologic anti-tumor activity as measured by a statistically significant reduction in Ki67, a measure of cell proliferation that is highly correlated with tumor response, in the group of patients treated with ME-344 compared to an increase in the group receiving saline.

"Data from this clinical study of ME-344 in combination with bevacizumab represents a potential novel approach to disrupting tumor metabolism and limiting tumor proliferation by inhibiting the heightened energy production necessary for cell division and cancer growth," stated the study principal investigator, Miguel Quintela-Fandino, M.D., Ph.D., Director of the Clinical Research Program, Centro Nacional De Investigaciones Oncologicas, Madrid, Spain. "These results offer evidence for the biologic antitumor activity of ME-344 in certain metabolic contexts and support further exploration of the mitochondrial inhibitor ME-344 in a therapeutic role, providing a potential novel mechanism that may improve patient outcomes in combination with antiangiogenic therapeutics such as bevacizumab."

The ME-344 ASCO 2018 poster can be accessed on the MEI Pharma website.

ME-344 Clinical Data
The clinical study was a multicenter, investigator-initiated, randomized, open-label trial evaluating ME-344 in a total of 42 patients with early HER2-negative breast cancer in combination with the vascular endothelial growth factor inhibitor bevacizumab. Patients were randomized one-to-one to either ME-344 plus bevacizumab or saline plus bevacizumab.

The primary objective of the study was to show proof of ME-344 biologic activity as measured by Ki67 reductions from day 0 to 28 compared to placebo. Secondary objectives included determining whether ME-344 biologic activity correlates with vascular normalization. The data demonstrate significant biologic activity in the ME-344 treatment group:

In ME-344 treated patients, mean absolute Ki67 decreases were 13.3 compared to an increase of 1.1 in the bevacizumab monotherapy group (P=0.01).
In ME-344 treated patients, mean relative Ki67 decreases were 23% compared to an increase of 186% in the bevacizumab monotherapy group (P < 0.01).
The mean relative Ki67 reduction in patients experiencing vascular normalization in the ME-344 treated patients was 33%, compared to an increase of 11.8% in normalized patients from the bevacizumab monotherapy group (P=0.09). Approximately one-third of patients in each arm had vascular normalization.
Treatment was generally well tolerated; two Grade 3 adverse events of high blood pressure were reported, 1 in each arm, and deemed related to bevacizumab.

About ME-344
ME-344 is a novel, tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. Treatment of tumor cells with ME-344 results in a rapid loss of ATP and cancer cell death. ME-344 demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study, and in preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death.

In addition to single-agent activity, ME-344 may also have potential in combination with antiangiogenic therapeutics. While antiangiogenics reduce the rate of glycolysis in tumors as a mechanism to block growth, tumor metabolism often shifts to mitochondrial metabolism to continue energy production to support continued tumor proliferation. In such cases of tumor plasticity in the presence of treatment with antiangiogenics, targeting the alternative metabolic source with ME-344 may open an important therapeutic opportunity.

About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com.

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Joseph Edelman's PERCEPTIVE ADVISORS likes MEIP


2 Biotech Stock Picks From Legendary Investor Joseph Edelman
GuruFocus.com•April 12, 2019
- By Ryan Vanzo


While famed value investors like Warren Buffett (Trades, Portfolio) and Seth Klarman (Trades, Portfolio) get most of the attention, there are plenty of other portfolio managers that have similar long-term track records. Joseph Edelman, the founder of Perceptive Advisors, is one such investor.



Since its inception in 1999, Edelman's portfolio has generated annual returns in excess of 30%. Down years have been rare. You may not have heard of him since he only manages a few billion dollars. Buffett's Berkshire Hathaway (BRK-A)(BRK-B), for comparison, has a market value of more than $500 billion.

Perceptive Advisors focuses exclusively on the biotech sector, meaning it needs to keep its asset base small. If its portfolio grows too large, it won't be able to invest in many of the smaller companies in the space. While it holds interests in many multibillion-dollar companies, Edelman has dozens of positions that have market caps of under $500 million.

While the limited size of these opportunities likely will never bring Edelman worldwide fame, they're still large enough for most individual investors to follow his best ideas. Here are two of his most intriguing picks, aggregated using Perceptive Advisors' 13-F filings.

Foamix Pharmaceuticals Ltd. (FOMX)

Small-cap biotech stocks are nearly always mispriced, sometimes grossly so. This year, Foamix has multiple milestones that could drive 300% in upside, even using conservative estimates.

The company has two lead drug candidates: FMX101 and FMX103. I suggest you read my full write up for the details, but in total, these drugs could easily generate $300 million in annual sales. Edelman often uses a 3 times peak sales multiple to value potential drugs, though he will occasionally use multiples as high as 6 times sales.

Applying a conservative 3 times sales multiple produces a $900 million potential valuation for Foamix. With a current valuation of just $200 million, the investment case seems very attractive.

That's probably why Perceptive Advisors bought 1,554,400 shares last quarter, bringing its total holding up to 4,661,824 shares, nearly 9% of the company. With an average purchase price of around $5.50, this is a great way to follow Edelman's bet given the stock is currently trading under $4 a share.

MEI Pharma Inc. (MEIP)

With a market cap of $240 million, MEI Pharma is another small-cap in Edelman's portfolio. These stocks are tiny, but often rise by 1,000% or more if the thesis plays out.

Last quarter, Perceptive Advisors took a brand new 4,400,440-share stake in MEI Pharma, representing more than 5% of the entire company. What's so intriguing about this stock?

MEI Pharma currently has around $100 million in net cash, allowing it to reinvest in its drug programs without needing to take additional financing for at least 12 to 24 months. Within that time frame, multiple key events should take place.

MEI Pharma has two drug candidates worth considering, Pracinostat and ME-401, both of which are in their pivotal trials, meaning if the readouts are successful, they could be ready for sale within one year.

Pracinostat is an oral compound for treating advanced hematologic diseases like acute myeloid leukemia and myelodysplastic syndrome. While the trials studying efficacy in MDS are in Phase II, Pracinostat is deep into a Phase III study for AML. There are around 20,000 new cases of AML annually in the U.S.

Currently, Azacitidine is the standard of care. With this drug, the median overall survival is only 10.4 months. For high-risk populations, it's less than seven months.

Pracinostat has been tested on hundreds of patients in multiple Phase I and Phase II trials. In the latest trial with around 50 patients, the overall median survival was an astounding 19.1 months.

If this success can be replicated in the ongoing Phase III trial, it would become the clear go-to standard of care for AML. Additionally, it would be likely that the drug could be successfully used for other indications like MDS, compounding its value.

MEI Pharma sold the rights to this compound for $440 million in development, regulatory and sales milestones. In addition, the company will retain royalties in the mid-teens. In total, if Pracinostat is a success, it would give this stock 300% to 700% upside.

Results aren't expected until May of 2021, but patient investors could be getting a steal at current prices. Edelman seems to agree given his recent buying behavior.

ME-401 could provide more near-term upside. It's a single agent meant to treat Follicular Lymphoma. The science is a bit more complex, but results could come as soon as late 2020. With a $1 billion market potential, this drug provides great optionality to the de-risked Pracinostat bet.

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MEIP at Oppenheimer.

https://www.veracast.com/webcasts/opco/healthcare2019/71108367263.cfm?0.803261767781


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Updated Price Target by Analyst Oppenheimer. $7

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re: MEIP

Perceptive Advisors, a very savvy biotech hedge find, established a new position by buying 4,440,440 shares last quarter.


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MEIP reports 2nd quarter fiscal year results


Current 2.72 Average 9.07
Low 7.00 High 11.00
Initiated H.C. Wainwright: to Buy 12/20/2018
Upgrade Stifel Nicolaus: Hold to Buy 7/27/2018
Initiated SunTrust Robinson Humphrey: to Buy 7/13/2018
Upgrade Wells Fargo: Market Perform to Outperform 6/6/2018
Initiated Laidlaw & Co.: to Buy 4/12/2018
Initiated Oppenheimer: to Outperform 5/25/2017
Company Profile
3611 Valley Centre Drive
Suite 500
San Diego, CA 92130
United States
858-369-7100
http://www.meipharma.com Sector: Healthcare
Industry: Drug Manufacturers - Specialty & Generic
Full Time Employees: 32

MEI Pharma, Inc., a pharmaceutical company, focuses on the clinical development of novel therapies for the treatment of cancer. The company's clinical drug candidate includes Pracinostat, an oral available histone deacetylase inhibitor for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome. Its clinical development portfolio also includes ME-401, an oral inhibitor of phosphatidylinositide 3-kinase delta for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or follicular lymphoma; ME-344, an isoflavone-derived mitochondrial inhibitor for the treatment of HER2-negative breast cancer; and Voruciclib, an oral cyclin-dependent kinase inhibitor. The company has a license, development, and commercialization agreement with Helsinn Healthcare SA for the development, manufacture, and commercialization of Pracinostat; and license agreement with Presage Biosciences, Inc. to develop, manufacture, and commercialize Voruciclib, a clinical-stage, oral, and selective cyclin-dependent kinase inhibitor; and related compounds.

It also has a clinical collaboration agreement with BeiGene, Ltd. to evaluate the safety and efficacy of ME-401 in combination with BeiGene's zanubrutinib, an investigational BTK inhibitor for the treatment of patients with B-cell malignancies. The company was formerly known as Marshall Edwards, Inc. and changed its name to MEI Pharma, Inc. in July 2012. MEI Pharma, Inc. was founded in 2000 and is based in San Diego, California.


MEI Pharma Reports Second Quarter Fiscal Year 2019 Results and Operational Highlights
PR Newswire PR Newswire•February 7, 2019
-- MEI Remains in Strong Position as ME-401 Advances to Global Phase 2 Study to Support FDA Accelerated Approval --

SAN DIEGO, Feb. 7, 2019 /PRNewswire/ -- MEI Pharma, Inc. (MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its second quarter ended December 31, 2018.

"MEI remains in a strong position to continue to build on the clinical data presented at ASCO 2018 and at ASH 2018 across our pipeline of four clinical-stage oncology candidates – including two candidates in clinical studies that may support future submissions for potential marketing approval by FDA," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In particular, ME-401 continues to attract increasing notice from physicians for its emerging clinical profile, and there's been a heightened scientific focus on PI3K delta as a target with the potential to mechanistically match BTK inhibition in importance for targeting B-cell malignancies."

Upcoming Milestones and Recent Program Highlights

Upcoming Milestones

Dosing of the first patient in the global Phase 2 study to support accelerated approval of ME-401 in relapsed or refractory follicular lymphoma in the first calendar quarter of 2019.

Updates and presentations of clinical data from the ME-401 clinical development program, including at select 2019 medical/oncology meetings.
Initial clinical results from the ongoing Phase 1 study of voruciclib, including single agent dose ranging data and results from the combination with venetoclax in patients with B-cell malignancies and relapsed and refractory acute myeloid leukemia, by end of 2019.

Results from the investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin®) in patients with breast cancer at a medical/oncology meeting mid-year.

Pracinostat results from the Phase 2 clinical trial evaluating patients with myelodysplastic syndrome, including response and 1-year survival, expected to be available by the end of 2019.
Clinical Development Highlights

In December 2018, the Company opened the first clinical trial sites in its Phase 2 study that will evaluate both a continuous (CS) and intermittent (IS) dosing schedule of ME-401 in patients with third-line follicular lymphoma. The Phase 2 study is intended to support MEI's accelerated approval registration strategy, if successful.

In December 2018, at the 2018 American Society of Hematology Annual Meeting, the Company presented data from three clinical programs:
In October 2018, MEI entered into a clinical collaboration to evaluate the safety and efficacy of MEI's ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene's zanubrutinib, an investigational Bruton's tyrosine kinase ("BTK") inhibitor, for the treatment of patients with B-cell malignancies.

Corporate Highlights

In November 2018, MEI entered into a license, development and commercialization agreement granting Kyowa Hakko Kirin ("KHK") exclusive rights to develop and commercialize ME-401 in Japan. Under the terms of the agreement, MEI received a $10.0 million upfront payment and is eligible to receive up to $87.5M in additional development and commercialization milestones, and royalties on sales.
Financial Highlights

As of December 31, 2018, MEI had $93.4 million in cash, cash equivalents and short-term investments, with no outstanding debt.

For the three months ending December 31, 2018, cash expenditures for operating activities were $7.2 million, compared to $4.7 million for 2017. For the six months ending December 31, 2018, cash expenditures for operating activities were $20.0 million, compared to $11.3 million for 2017. The increase in cash used for the six months ended December 31, 2018 primarily relates to changes in working capital associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 study.

Research and development expenses were $9.1 million for the quarter ended December 31, 2018, compared to $3.4 million for the same period in 2017. Research and development expenses primarily reflect increased costs associated with the development of ME-401.

General and administrative expenses were $3.8 million for the quarter ended December 31, 2018, compared to $2.4 million for the same period in 2017. The increase primarily relates to increased salary and share-based compensation associated with increased headcount, and increased professional services expenses.

The Company recognized revenues of $2.0 million for the quarter ended December 31, 2018, compared to $0.4 million for the same period in 2017. The increase is related to new license revenues from our agreement with KHK, and to higher levels of research and development activities performed pursuant to the Helsinn license agreement.

Net income for the quarter ended December 31, 2018, was $12.0 million, or $0.17 per share compared to a net loss of $6.1 million, or $0.16 per share for the same period in 2017. The Company had 71,131,486 shares of common stock outstanding as of December 31, 2018, compared with 37,052,361 shares as of December 31, 2017.
The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended December 31, 2018, was $11.4 million.
About MEI Pharma

MEI Pharma, Inc. (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 chronic lymphocytic leukemia (CLL) or FL, and voruciclib, an oral, selective cyclin-dependent kinase (CDK) inhibitor shown to suppress myeloid leukemia cell differentiation protein (MCL1), a known mechanism of resistance to B-cell lymphoma (BCL2) inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-initiated study in combination with bevacizumab for the treatment of 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.

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H.C. Wainwright initiates MEIP with a "buy." Price target= $10

Analysts at H.C. Wainwright initiated coverage on MEI Pharma Inc
MEIP 1.94%
with a Buy rating. The price target for MEI Pharma is set to $10. MEI Pharma shares closed at $2.11 on Wednesday.


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[ChrisInSF]

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.

[ChrisInSF]

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.

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MEIP reports 1st quarter, 2019 (Fiscal) results. Close to $100 million in cash


MEI PHARMA REPORTS FIRST QUARTER FISCAL YEAR 2019 RESULTS AND OPERATIONAL HIGHLIGHTS

-- MEI on Track to Initiate ME-401 Phase 2 Accelerated Approval Study Around Year-End --

SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its first quarter ended September 30, 2018.

"Fiscal 2019 is off to a strong start both financially and strategically, with more than $90 million in cash and investments on our balance sheet at the start of the quarter, $10 million additional cash due under the recently executed Japan licensing agreement with Kyowa Hakko Kirin, a new clinical collaboration with BeiGene, and progress in preparations to start the ME-401 Phase 2 study around year-end," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "With the planned start of the ME-401 Phase 2 study, we will have two ongoing clinical trials with the potential to support FDA marketing approval."

Dr. Gold continued: "We are also excited by our continued progress in the other programs across our pipeline, including interim data from the Phase 2 study of pracinostat in MDS, the evaluation of our CDK9 inhibitor, voruciclib, in B-cell malignancies and data from the investigator-initiated study of ME-344 in breast cancer."

Recent Program Highlights and Upcoming Milestones

Upcoming Milestones

MEI will present data from three clinical stage drug development programs at the 2018 American Society of Hematology (ASH) Annual Meeting to be held December 1-4, 2018 in San Diego:

Updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma (FL) and other indolent B-cell malignancies.

Data from an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).

Results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro.

MEI plans to initiate the Phase 2 study to support accelerated approval of ME-401 in relapsed or refractory FL around year-end of calendar 2018.

MEI expects to report updates regarding the ongoing voruciclib Phase 1 study at medical meetings in 2019.

MEI expects to report additional data from the investigator-sponsored Phase 1 study evaluating ME-344 at medical meetings in 2019.
Clinical Development Highlights

In October 2018, MEI announced a clinical collaboration to evaluate the safety and efficacy of MEI's ME-401, an investigational phosphatidylinositol 3-kinase (PI3K) delta inhibitor, in combination with BeiGene's zanubrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of patients with B-cell malignancies.

In July 2018, the Company discussed with FDA a ME-401 monotherapy accelerated approval strategy in patients with relapsed or refractory FL. Informed by the discussions with the FDA, the Company is advancing ME-401 into a Phase 2, single-agent study for the treatment of adults with relapsed or refractory FL. The Phase 2 study is intended to support accelerated approval and is planned to begin around the end of 2018. Accelerated approval of ME-401 will be subject to FDA review of the improvement provided by ME-401 over other therapies available at the time of the regulatory action.

Corporate Highlights

In November 2018, MEI announced the execution of a license development and commercialization agreement granting Kyowa Hakko Kirin exclusive rights to develop and commercialize ME-401 in Japan. Under the terms of the agreement, MEI will receive a $10.0 million upfront payment and is eligible to receive up to $87.5M in additional development and commercialization milestones, and royalties on sales.

In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso is also continuing as the Company's general counsel and head of corporate development.
Financial Highlights

As of September 30, 2018, MEI had $90.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Additionally, a $10 million upfront payment is due under the Japan license agreement executed with Kyowa Hakko Kirin.

Research and development expenses were $6.1 million for the quarter ended September 30, 2018, compared to $6.1 million for the same period in 2017. Research and development expenses reflect increased costs for the development of ME-401, offset by a reduction in expenses related to voruciclib, as the prior year amounts included acquisition costs for voruciclib.

General and administrative expenses were $3.4 million for the quarter ended September 30, 2018, compared to $2.5 million for the same period in 2017. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses.
The Company recognized revenues of $0.5 million for the quarter ended September 30, 2018, compared to $0.3 million for the same period in 2017. The increase is related to higher levels of research and development activities performed pursuant to the Helsinn license agreement.

Net loss for the quarter ended September 30, 2018, was $14.5 million, or $0.21 per share compared $8.8 million, or $0.24 per share for the same period in 2017. The Company had 71,115,444 shares of common stock outstanding as of September 30, 2018, compared with 36,950,177 shares as of September 30, 2017.

The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended September 30, 2018, was $9.6 million, or $0.14 per share.

Cash expenditures for operating activities were $12.8 million for the quarter ended September 30, 2018, compared to $6.6 million for 2017. The increase in cash used for the three months ended September 30, 2018 primarily relates to changes in working capital associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 accelerated approval study.

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 chronic lymphocytic leukemia (CLL) or FL, and voruciclib, an oral, selective cyclin-dependent kinase (CDK) inhibitor shown to suppress myeloid leukemia cell differentiation protein (MCL1), a known mechanism of resistance to B-cell lymphoma (BCL2) inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-initiated study in combination with bevacizumab for the treatment of 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.

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MEIP gets a partner for ME-401 in Japan


MEI Pharma and Kyowa Hakko Kirin Announce License Agreement to Develop and Commercialize ME-401 in Japan

PR NewswireNovember 5, 2018
MEI to Receive $10 Million Upfront Payment, Plus Milestones and Tiered Royalty Payments

SAN DIEGO, and TOKYO, Nov. 5, 2018 /PRNewswire/ -- MEI Pharma, Inc. (MEIP) and Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, "Kyowa Hakko Kirin"), today announced the execution of a license agreement granting Kyowa Hakko Kirin exclusive rights to develop and commercialize ME-401 in Japan ("License Agreement"). ME-401 is MEI's phosphatidylinositol 3-kinase ("PI3K") delta inhibitor being developed by MEI for the treatment of patients with B-cell malignancies. MEI is planning to initiate a Phase 2 study to evaluate patients with follicular lymphoma that is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.

Under the terms of the License Agreement, MEI will receive a $10 million upfront payment and is eligible to receive additional development and commercialization milestones totaling up to $87.5 million. MEI is also eligible to receive tiered double-digit royalties extending into the mid-teens. The agreement grants Kyowa Hakko Kirin exclusive rights to ME-401 to develop and commercialize ME-401 in Japan. The initial indication for development and regulatory approval under the agreement is relapsed or refractory follicular lymphoma.

"Kyowa Hakko Kirin is a well-regarded leader in the development and commercialization of hematology and oncology therapies in Japan," said David M. Urso., J.D., Chief Operating Officer of MEI Pharma. "This agreement is important for MEI as an opportunity to expand the development of ME-401 as a potential best-in-class PI3K delta inhibitor outside of the U.S. and is consistent with our strategy to optimize value through partnering opportunities abroad while developing capabilities for domestic commercialization."

"I am delighted to enter into an agreement with MEI Pharma for the development and commercialization of ME-401 in Japan," said Wataru Murata, Executive Officer, Director of Corporate Strategy & Planning Department. "We believe that ME-401 will be an important drug candidate in our oncology pipeline."

Kyowa Hakko Kirin plans to initiate a Phase 1 study in Japan in 2019.
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.

About MEI Pharma
MEI Pharma, Inc. (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 BCL2 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.

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MEIP forms clinical collaboration with Beigene for ME-401



MEI Pharma and BeiGene Announce Clinical Collaboration to Evaluate ME-401 in Combination with Zanubrutinib in Patients with B-Cell Malignancies
PR Newswire PR NewswireOctober 11, 2018
SAN DIEGO and CAMBRIDGE, Mass. and BEIJING, Oct. 11, 2018 /PRNewswire/ -- MEI Pharma, Inc. (MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced a clinical collaboration to evaluate the safety and efficacy of MEI's ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene's zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies.

"We are excited to be working with BeiGene to explore the potential of ME-401 in combination with zanubrutinib," said Robert Mass, M.D., chief medical officer of MEI Pharma. "Combinatorial approaches to fighting difficult to treat cancers historically have proven to be important in the delivery of better treatments to patients, and we believe that the data observed to date for ME-401, with its unique pharmaceutical properties, and for zanubrutinib support the evaluation of the combination for the treatment of patients with various B-cell malignancies."

"Zanubrutinib is a potentially differentiated BTK inhibitor that is being globally developed in a number of B-cell malignancies both as a monotherapy and in combination. We look forward to exploring this interesting combination in patients with B-cell malignancies," commented Jane Huang, M.D., chief medical officer, hematology, at BeiGene.

Under the terms of the clinical collaboration agreement, MEI will amend its ongoing Phase 1b trial to include evaluation of ME-401 in combination with zanubrutinib in patients with B-cell malignancies.

Study costs will be shared equally by the parties, and MEI will supply ME-401 and BeiGene will supply zanubrutinib. MEI will retain full commercial rights for ME-401 and BeiGene will retain full commercial rights for zanubrutinib.

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-401as 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.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton's tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.

About MEI Pharma
MEI Pharma, Inc. (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 BCL2 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.

About BeiGene
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 1,300 employees in China, the United States, Australia and Switzerland, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation.


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