MEI Pharma Reports First Quarter Fiscal Year 2018 Results
"In this first quarter of the new fiscal year we announced an important milestone with the dosing of the first patient in the pivotal Phase 3 study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. In addition, we announced that we had further strengthened our oncology clinical pipeline with the addition of the clinical-stage cyclin-dependent kinase (CDK) inhibitor voruciclib," said
Upcoming Milestones
Pracinostat
- Expecting results from Stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS) in the first half of 2018.
ME-401
- Expecting to initiate combination study with Rituxan® in indolent lymphoma & diffuse large B-cell lymphoma (DLBCL) in the fourth quarter of 2017.
- Expecting results from proof-of-concept study in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma to be presented at a scientific meeting in the first half of 2018.
Voruciclib
- Expecting to initiate Phase1/2 single-agent study in relapsed/refractory B lymphocyte malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta™) in the second quarter of 2018.
ME-344
- Expecting interim results from the proof-of-concept study in human epidermal growth factor receptor 2 (HER2) negative breast cancer in combination with bevacizumab (marketed as Avastin®) in the first half of 2018.
Financial Highlights
- As of
September 30, 2017 ,MEI Pharma had$47.0 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into calendar year 2019. - Cash used in operating activities was
$6.6 million for the three months endedSeptember 30, 2017 , compared to cash provided by operating activities of$8.8 million for 2016. Included in cash expenditures for the three months endedSeptember 30, 2017 was$1.9 million cash paid for the voruciclib acquisition. Included in the cash provided by operating activities in 2016 is the$15 million upfront payment fromHelsinn for pracinostat. - Research and development expenses, including cost of research and development revenue, were
$6.7 million for the three months endedSeptember 30, 2017 , compared to$2.7 million for 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat. - General and administrative expenses were
$2.5 million for the three months endedSeptember 30, 2017 , compared to$2.7 million for 2016. The decrease was primarily due to professional service costs incurred in 2016 related to theHelsinn license agreement. - Revenues were
$0.3 million for the three months endedSeptember 30, 2017 , compared to$1.1 million in 2016. The decrease is related to activities performed pursuant to theHelsinn license agreement. - Net loss was
$8.8 million , or$0.24 per share, for the three months endedSeptember 30, 2017 , compared to a net loss of$4.3 million , or$0.12 per share for the three months endedSeptember 30, 2016 .
About
Under
|
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CONDENSED BALANCE SHEETS |
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(In thousands, except per share amounts) |
|||
|
|
||
2017 |
2017 |
||
(unaudited) |
|||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 6,958 |
$ 8,458 |
|
Short term investments |
40,065 |
45,107 |
|
Total cash, cash equivalents and short-term investments |
47,023 |
53,565 |
|
Prepaid expenses and other current assets |
641 |
1,758 |
|
Total current assets |
47,664 |
55,323 |
|
Intangible assets, net |
322 |
331 |
|
Property and equipment, net |
45 |
50 |
|
Total assets |
$ 48,031 |
$ 55,704 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
$ 751 |
$ 585 |
|
Accrued liabilities |
2,767 |
3,285 |
|
Deferred revenues |
947 |
996 |
|
Total current liabilities |
4,465 |
4,866 |
|
Commitments and contingencies |
|||
Stockholders' equity: |
|||
Preferred stock, |
- |
- |
|
Common stock, |
- |
- |
|
Additional paid-in-capital |
226,685 |
225,169 |
|
Accumulated deficit |
(183,119) |
(174,331) |
|
Total stockholders' equity |
43,566 |
50,838 |
|
Total liabilities and stockholders' equity |
$ 48,031 |
$ 55,704 |
|
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CONDENSED STATEMENTS OF OPERATIONS |
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(In thousands, except per share amounts) |
|||
(Unaudited) |
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Three Months Ended |
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2017 |
2016 |
||
Revenues: |
|||
Research and development revenue |
$ 283 |
$ 1,096 |
|
Total revenues |
283 |
1,096 |
|
Operating expenses: |
|||
Cost of research and development revenue |
618 |
1,094 |
|
Research and development |
6,064 |
1,646 |
|
General and administrative |
2,488 |
2,680 |
|
Total operating expenses |
9,170 |
5,420 |
|
Loss from operations |
(8,887) |
(4,324) |
|
Other income (expense): |
|||
Interest and dividend income |
100 |
55 |
|
Income tax expense |
(1) |
(1) |
|
Net loss |
|
|
|
Net loss per share, basic |
$ (0.24) |
$ (0.12) |
|
Net loss per share, diluted |
$ (0.24) |
$ (0.12) |
|
Shares used in computing net loss per share: |
|||
Basic |
37,245 |
35,747 |
|
Diluted |
37,245 |
35,747 |
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