Wednesday, January 04, 2017 10:21:35 AM
From last presentation
http://www.meipharma.com/sites/default/files/meip_presentation_-_stifel_nov_2016_-_final_2_0.pdf
FINANCIAL HIGHLIGHTS
$58.9 million in cash as of September 30, 2016
Net loss of $4.5 million for three months ended September 30, 2016
No debt
36.8 million shares outstanding
CASH per share: $1,7
PIPELINE
1. Pracinostat
http://investor.meipharma.com/2016-12-05-Helsinn-Group-and-MEI-Pharma-Report-Prolongation-of-Survival-Results-from-Phase-2-Clinical-Study-of-Pracinostat-and-Azacitidine-in-Acute-Myeloid-Leukemia
Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced final results from a Phase 2 clinical study of the investigational drug candidate Pracinostat and azacitidine in elderly patients with acute myeloid leukemia (AML) who were not eligible for induction chemotherapy, including evidence of prolongation of survival in the overall population and across a number of patient subgroups.
In an oral presentation at the American Society of Hematology (ASH) Annual Meeting on Saturday, Dr. Guillermo Garcia-Manero, MD Anderson Cancer Center, principal investigator of the study, reported a median overall survival of 19.1 (95%CI: 10.7-26.5) months, one-year survival of 62% and a complete response (CR) rate of 42%.
Conclusion from ASH meeting
http://www.meipharma.com/sites/default/files/ash_2016-pracinostat-aza_aml_-_final.pdf
i. Pracinostat + azacitidine is well tolerated in elderly AML
ii. Prolong survival in the overall population and in patient subsets defined by cytogenetics risk group, de novo or secondary AML, age and ECOG performance status
iii. Results compare favorably to the Phase 3 study of azacitidine in a similar AML patient population
iv. Marrow remission typically achieved within the first 2 cycles, but prolonged exposure required in some patients to maximize response
v. Site recruitment is ongoing for a global Phase 3 study of Pracinostat + Azacitidine in newly diagnosed
vi. AML patients unfit for intensive induction chemotherapy
Recently deal with Helsinn:
i. Exclusive licensing, development and commercialization agreement for Pracinostat in AML and other hematologic diseases
ii. Helsinn responsible for funding global development and commercialization
iii. $20 million in near-term cash payments
iv. $15 million upfront + $5 million on Mar 1, 2017 or upon dosing of first patient in Phase III study
v. Up to $444 million in regulatory and sales-based milestones
vi. Tiered royalty payments in U.S. and selected territories
vii. Agree to share cost of Phase II study to explore optimal dosing regimen of Pracinostat + azacitidine in high and very high risk MDS
viii. MEI responsible for study conduct, expected to start in 1H 2017
ix. $5 million equity investment from Helsinn (avg pps $ 1,91)
2. ME-401
i. Potent and highly selective oral PI3K delta inhibitor
ii. Superior pre-clinical activity compared to the approved drug Zydelig®
iii. On-target binding affinity (KD) >30 times greater
iv. First-in-human, single ascending dose study completed
v. Superior PK/PD profile to Zydelig®
vi. PK confirms once-daily dosing
vii. Potential for wide therapeutic window
3. ME-344
i. Mechanism of action directly targets mitochondrial OXPHOS complex I1, resulting in rapid loss of cellular energy (ATP)
ii. Evidence of single agent activity in Phase I dose-escalation study in refractory solid tumors2
iii. Exciting pre-clinical data demonstrating interplay between tumor cell glycolysis and mitochondrial metabolism in combination with VEGF inhibitors3,4
iv. Investigator-sponsored study in combination with Avastin® in HER2- breast cancer now open for enrollment
INTELLECTUAL PROPERTY
Pracinostat
4 issued U.S. and 77 issued foreign patents ? 2 U.S. and 8 foreign applications pending
Composition of matter to May, 2028 in U.S.
May, 2033 with up to 5 years patent term restoration in U.S.
ME-401 (formerly PWT143)
2 issued U.S. patent
1 U.S. and 21 foreign applications pending
Composition of matter to Dec. 2032 in U.S., excluding patent term restoration
ME-344
3 issued U.S. and 18 issued foreign patents ? 3 U.S. and 7 foreign applications pending
Composition of matter to March, 2027 in U.S.
March, 2032 with up to 5 years of patent term restoration in U.S.
CATALYSTS
Pracinostat
Initiation of Phase III study in newly diagnosed AML, ≥75 years or unfit for intensive chemotherapy (Q1 2017)
Initiation of Phase II dose optimization study in high & very high risk MDS (1H 2017)
ME-401
Phase Ib study in CLL & fNHL open for enrollment
Early cohort data from Phase Ib study in CLL & fNHL (Q2 2017)
ME-344
HER2-negative breast cancer study open for enrollment
Results from HER2-negative breast cancer study (Q4 2017)
INSTITUTIONAL OWNERSHIP: 16% (funds have increased their positions per last SEC form 4).
At Q3’s end, a total of 6 of the hedge funds tracked by Insider Monkey held long positions in this stock, a gain of 100% from one quarter earlier. With hedgies’ sentiment swirling, there exists an “upper tier” of notable hedge fund managers who were increasing their holdings meaningfully (or already accumulated large positions).
Of the funds tracked by Insider Monkey, Jim Simons’ Renaissance Technologies has the biggest position in MEI Pharma Inc (NASDAQ:MEIP), worth close to $2.1 million. Coming in second is Iguana Healthcare Management, led by Stuart Weisbrod, which holds a $0.5 million position. Other hedge funds and institutional investors with similar optimism comprise Millennium Management, one of the 10 largest hedge funds in the world, Gregory Fraser, Rudolph Kluiber, and Timothy Krochuk’s GRT Capital Partners, and Ken Griffin’s Citadel Investment Group. We should note that GRT Capital Partners is among our list of the 100 best performing hedge funds, which is based on the performance of their 13F long positions in non-micro-cap stocks.
Insider Ownership: 16% (no activities in the last months).
Average target price for analysts: $ 2,30
Recent MEIP News
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/19/2024 09:20:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/19/2024 09:05:07 PM
- MEI Pharma Reports Fiscal Year End 2024 Cash Position • Business Wire • 09/19/2024 08:01:00 PM
- MEI Pharma Engages Oppenheimer & Co. Inc. to Assist in Evaluating Strategic Alternatives • Business Wire • 08/12/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 08:05:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 08:05:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/22/2024 09:25:09 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/22/2024 08:06:33 PM
- MEI Pharma to Consider Strategic Alternatives • Business Wire • 07/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 08:00:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/21/2024 05:00:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/20/2024 08:00:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 08:02:15 PM
- MEI Pharma Reports Third Quarter Fiscal Year 2024 Results and Operational Highlights • Business Wire • 05/09/2024 08:02:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:00:47 PM
- MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344 • Business Wire • 04/11/2024 12:02:00 PM
- MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients • Business Wire • 04/11/2024 12:00:00 PM
- MEI Pharma to Present at the Stifel 2024 Virtual Targeted Oncology Forum • Business Wire • 04/10/2024 12:00:00 PM
- MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia • Business Wire • 03/26/2024 12:00:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/29/2024 05:15:45 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/21/2024 09:00:17 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 02/20/2024 10:33:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/13/2024 10:05:14 PM
- MEI Pharma Reports Second Quarter Fiscal Year 2024 Results and Operational Highlights • Business Wire • 02/13/2024 10:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/17/2024 09:00:08 PM
Lingerie Fighting Championships Signs Broadcast Deal With Maybacks Global Entertainment • BOTY • Sep 26, 2024 9:00 AM
Maybacks Global Entertainment and Lingerie Fighting Championships Enter Into Broadcast And Revenue Sharing Agreement • AHRO • Sep 26, 2024 8:30 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM