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MEI Pharma Reports Fiscal Year 2018 Results and Operational Highlights


SAN DIEGO, Aug. 30, 2018 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its fiscal year ended June 30, 2018.

"We begin the 2019 fiscal year in our strongest position ever, with progress across all four clinical-stage oncology candidates, and with particular focus on the planned initiation of the ME-401 Phase 2 accelerated approval study by year-end. With ME-401 joining pracinostat as the second candidate in a global study to support marketing authorization, along with our robust cash position, we are well situated to pursue our development strategy," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.

Dr. Gold continued, "We are also very pleased to report that in recent discussions with FDA on a ME-401 accelerated approval registration strategy, FDA expressed support of our proposed randomized Phase 2 trial in which we will evaluate continuous and intermittent dosing schedules in patients with relapsed or refractory follicular lymphoma.  As we execute on our plans to start this study around year-end, we also look forward to reporting additional progress across our pipeline over the coming quarters, including clinical data from our CDK9 inhibitor, voruciclib, and clinical updates on pracinostat and ME-344."

Fiscal Year 2018 and Recent Company Highlights

Financial

ME-401 - a next-generation selective oral inhibitor of PI3K delta

Pracinostat - an oral HDAC inhibitor (partnered with Helsinn Healthcare, SA)

Voruciclib - an oral, selective CDK inhibitor with robust CDK9 inhibition

ME-344 - a novel mitochondrial inhibitor

Operational Highlights

Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, August 30, 2018, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 47469059. The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.

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 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.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

MEI PHARMA, INC.

BALANCE SHEETS

(In thousands, except per share amounts)






June 30,


2018


2017





ASSETS




Current assets:




Cash and cash equivalents

$   13,309


$    8,458

Short-term investments

89,434


45,107

Total cash, cash equivalents and short-term investments

102,743


53,565

Prepaid expenses and other current assets

1,586


1,758

Total current assets

104,329


55,323

Intangible assets, net

296


331

Property and equipment, net

32


50

Total assets

$ 104,657


$  55,704









LIABILITIES AND STOCKHOLDERS' EQUITY



Current liabilities:




Accounts payable

$     3,643


$       585

Accrued liabilities

3,454


3,285

Deferred revenues

788


996

Total current liabilities

7,885


4,866

Warrant liability

46,313


-

Total liabilities

54,198


4,866





Commitments and contingencies (Note 9)








Stockholders' equity:




Preferred stock, $0.01 par value; 100 shares authorized; none outstanding

-


-

Common stock, $0.00000002 par value; 113,000 shares authorized; 70,406 and 36,772 shares issued and outstanding at June 30, 2018 and 2017, respectively.

-


-

Additional paid-in-capital

264,858


225,169

Accumulated deficit

(214,399)


(174,331)

Total stockholders' equity

50,459


50,838

Total liabilities and stockholders' equity

$ 104,657


$  55,704

 

MEI PHARMA, INC.

STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)






Years Ended June 30, 



2018


2017


2016








Revenues:














License revenue


$          -


$ 20,880


$          -

Research and development revenue


1,622


2,369


-



1,622


23,249


-








Operating expenses:







Cost of research and development revenue


3,383


5,000


-

Research and development


17,038


7,237


13,403

General and administrative


9,787


8,628


7,601

Total operating expenses


30,208


20,865


21,004








(Loss) income from operations


(28,586)


2,384


(21,004)








Other income (expense):







Change in fair value of warrant liability


(9,705)


-


-

Financing costs associated with warrants


(2,367)


-


-

Interest and dividend income


591


287


143

Income tax expense


(1)


(1)


(1)

Net (loss) income


$ (40,068)


$   2,670


$ (20,862)















Net (loss) income per share, basic


$     (0.97)


$     0.07


$     (0.61)

Net (loss) income per share, diluted


$     (0.97)


$     0.07


$     (0.61)








Shares used in computing net (loss) income per share:





Basic


41,431


36,813


34,400

Diluted


41,431


36,938


34,400

 

MEI Pharma Logo. (PRNewsFoto/MEI Pharma, Inc.)

 

SOURCE MEI Pharma, Inc.


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