MEI Pharma Reports First Quarter Fiscal Year 2019 Results and Operational Highlights
"Fiscal 2019 is off to a strong start both financially and strategically, with more than
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 heldDecember 1-4, 2018 inSan 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 inJapan . 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 theJapan 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 theHelsinn 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 ofSeptember 30, 2018 , compared with 36,950,177 shares as ofSeptember 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
Under
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BALANCE SHEETS |
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(In thousands, except per share amounts) |
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|
|
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2018 |
2018 |
||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 6,118 |
$ 13,309 |
|
Short term investments |
84,646 |
89,434 |
|
Total cash, cash equivalents and short-term investments |
90,764 |
102,743 |
|
Prepaid expenses and other current assets |
3,671 |
1,586 |
|
Total current assets |
94,435 |
104,329 |
|
Intangible assets, net |
287 |
296 |
|
Property and equipment, net |
28 |
32 |
|
Total assets |
$ 94,750 |
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
$ 1,555 |
$ 3,643 |
|
Accrued liabilities |
2,489 |
3,454 |
|
Deferred revenue |
740 |
788 |
|
Total current liabilities |
4,784 |
7,885 |
|
Warrant liability |
50,207 |
46,313 |
|
Total liabilities |
54,991 |
54,198 |
|
Commitments and contingencies |
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Stockholders' equity: |
|||
Preferred stock, |
- |
- |
|
Common stock, |
- |
- |
|
Additional paid-in-capital |
268,700 |
264,858 |
|
Accumulated deficit |
(228,941) |
(214,399) |
|
Total stockholders' equity |
39,759 |
50,459 |
|
Total liabilities and stockholders' equity |
$ 94,750 |
|
|
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STATEMENTS OF OPERATIONS |
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(In thousands, except per share amounts) |
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Three Months Ended |
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2018 |
2017 |
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Revenues: |
|||
Research and development revenue |
$ 488 |
$ 283 |
|
Total revenues |
488 |
283 |
|
Operating expenses: |
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Cost of research and development revenue |
989 |
618 |
|
Research and development |
6,131 |
6,064 |
|
General and administrative |
3,401 |
2,488 |
|
Total operating expenses |
10,521 |
9,170 |
|
Loss from operations |
(10,033) |
(8,887) |
|
Other income (expense): |
|||
Change in fair value of warrant liability |
(4,962) |
- |
|
Interest and dividend income |
454 |
100 |
|
Income tax expense |
(1) |
(1) |
|
Net loss |
|
|
|
Net loss per share - basic and diluted |
$ (0.21) |
$ (0.24) |
|
Shares used in computing net loss per share: |
|||
Basic |
70,885 |
37,245 |
|
Diluted |
70,885 |
37,245 |
|
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Reconciliation of GAAP Net Loss to Adjusted Net Loss |
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(In thousands) |
|||
Three Months Ended |
|||
2018 |
2017 |
||
Net loss |
|
|
|
Add: Change in fair value of warrant liability |
4,962 |
- |
|
Adjusted net loss |
$ (9,580) |
|
|
Net loss per share - basic and diluted |
$ (0.21) |
$ (0.24) |
|
Adjusted net loss per share - basic and diluted |
$ (0.14) |
$ (0.24) |
|
Shares used in computing net loss per share: |
|||
Basic and Diluted |
70,885 |
37,245 |
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