MEI Pharma Reports Fiscal Second-Quarter 2020 Results and Operational Highlights
"We're off to a good start in calendar year 2020. Our pipeline of clinical oncology candidates continues to advance, and the successful equity offering this past December gives us added resources to execute on our clinical strategy through key value-creating inflection points," said Daniel
Recent Highlights
- In
December 2019 , the Company completed a public offering of common stock resulting in net proceeds to the Company of approximately$48.5 million . - In
December 2019 , the Company amended the study protocol for TIDAL (Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), the Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.
- The amendment consolidates the remaining enrollment into the dosing arm in which patients receive ME-401 administered on the intermittent schedule ("
IS "). - The amendment was prompted by maturing data from the Phase 1b trial of ME-401 demonstrating that the
IS regimen is as active as the continuous daily dosing regimen, is associated with durable responses to date, and is also associated with improved tolerability. - Approximately 120 patients will be enrolled in the
IS arm and completion of enrollment is expected to complete in the summer of 2020.
- The amendment consolidates the remaining enrollment into the dosing arm in which patients receive ME-401 administered on the intermittent schedule ("
- In
October 2019 , the Company reported updated data from the ongoing Phase 1b study of ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta. The data demonstrate:
- Overall response rates of 78% in relapsed or refractory FL and 89% in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma ("CLL/SLL").
- Rates of Grade 3 adverse events of special interest related to ME-401 exposure were observed in <10% of patients dosed on an
IS . - Median duration of response was not reached in patients with FL or CLL/SLL on the
IS regimen. Median follow-up for FL and CLL/SLL patients was 9.2 months (range 3.4-20.7 months) and 7.4 months (range 2.6-14.7 months), respectively.
Fiscal Second-Quarter Fiscal Year 2020 Financial Results
- As of December 31, 2019, MEI had $103.9 million in cash, cash equivalents and short-term investments, with no outstanding debt.
- For the quarter ended
December 31, 2019 , cash used in operations was $10.5 million, compared to $7.2 million for 2018. - Research and development expenses were $8.3 million for the quarter ended December 31, 2019, compared to $9.1 million for 2018. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401.
- General and administrative expenses were $4.2 million for the quarter ended December 31, 2019, compared to $3.8 million for 2018. The increase primarily relates to increased headcount and increased professional services expenses to support our activities.
- Revenue was $1.0 million for the quarter ended
December 31, 2019 , compared to revenue of$2.0 million for the quarter endedDecember 31, 2018 . Revenue resulted from the recognition of fees allocated to research and development activities related to theHelsinn and Kyowa Kirin License Agreements. During the quarter endedDecember 31, 2018 , revenue also included$0.9 million from transfer of the license to Kyowa Kirin. - Net loss was $20.2 million, or $0.26 per share, for the quarter ended December 31, 2019, compared to net income of $12.0 million, or $0.17 per share for 2018. Net loss increased primarily as a result of a non-cash expense in the current quarter and a non-cash gain in the prior quarter related to changes in the fair value of the warrant liability associated with the May 2018 financing. The Company had 105,998,677 shares of common stock outstanding as of December 31, 2019, compared with 71,131,486 shares as of
December 31, 2018 . - The adjusted net loss for the quarter ended
December 31, 2019 , excluding a non-cash expense related to changes in the fair value of the warrants (a non-GAAP measure), was $11.8 million, compared to an adjusted net loss of$11.4 million for 2018.
About
Under
|
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CONDENSED BALANCE SHEETS |
|||
(In thousands, except per share amounts) |
|||
|
|
||
2019 |
2019 |
||
(unaudited) |
|||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 8,638 |
$ 9,590 |
|
Short-term investments |
95,243 |
64,899 |
|
Total cash, cash equivalents and short-term investments |
103,881 |
74,489 |
|
Common stock proceeds receivable |
- |
5,274 |
|
Prepaid expenses and other current assets |
2,564 |
2,435 |
|
Total current assets |
106,445 |
82,198 |
|
Intangible assets, net |
244 |
261 |
|
Property and equipment, net |
416 |
204 |
|
Total assets |
$ 107,105 |
$ 82,663 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||
Current liabilities: |
|||
Accounts payable |
$ 3,038 |
$ 4,787 |
|
Accrued liabilities |
3,835 |
4,559 |
|
Deferred revenue |
3,056 |
4,955 |
|
Total current liabilities |
9,929 |
14,301 |
|
Deferred revenue, long-term |
3,108 |
2,819 |
|
Warrant liability |
16,783 |
17,613 |
|
Total liabilities |
29,820 |
34,733 |
|
Stockholders' equity: |
|||
Preferred stock, |
- |
- |
|
Common stock, |
- |
- |
|
Additional paid-in-capital |
331,714 |
279,148 |
|
Accumulated deficit |
(254,429) |
(231,218) |
|
Total stockholders' equity |
77,285 |
47,930 |
|
Total liabilities and stockholders' equity |
$ 107,105 |
$ 82,663 |
|
|
|||||||
CONDENSED STATEMENTS OF OPERATIONS |
|||||||
(In thousands, except per share amounts) |
|||||||
(Unaudited) |
|||||||
Three Months Ended |
Six Months Ended |
||||||
2019 |
2018 |
2019 |
2018 |
||||
Revenue |
$ 1,008 |
$ 2,048 |
$ 2,165 |
$ 2,536 |
|||
Operating expenses: |
|||||||
Cost of revenue |
641 |
1,009 |
1,329 |
1,998 |
|||
Research and development |
8,281 |
9,066 |
17,243 |
15,197 |
|||
General and administrative |
4,195 |
3,821 |
8,325 |
7,222 |
|||
Total operating expenses |
13,117 |
13,896 |
26,897 |
24,417 |
|||
Loss from operations |
(12,109) |
(11,848) |
(24,732) |
(21,881) |
|||
Other income (expense): |
|||||||
Change in fair value of warrant liability |
(8,439) |
23,437 |
830 |
18,475 |
|||
Interest and dividend income |
318 |
436 |
692 |
890 |
|||
Other income (expense) |
13 |
- |
(1) |
(1) |
|||
Net (loss) income |
$ (20,217) |
$ 12,025 |
$ (23,211) |
$ (2,517) |
|||
Net (loss) income: |
|||||||
Basic |
$ (20,217) |
$ 12,025 |
$ (23,211) |
$ (2,517) |
|||
Diluted |
$ (20,217) |
$ (11,412) |
$ (23,211) |
$ (25,954) |
|||
Net (loss) income per share: |
|||||||
Basic |
$ (0.26) |
$ 0.17 |
$ (0.30) |
$ (0.04) |
|||
Diluted |
$ (0.26) |
$ (0.15) |
$ (0.30) |
$ (0.36) |
|||
Shares used in computing net (loss) income per share: |
|||||||
Basic |
78,577 |
71,124 |
76,103 |
71,005 |
|||
Diluted |
78,577 |
73,951 |
76,103 |
72,418 |
|||
|
||||||||
Reconciliation of GAAP Net (Loss) Income to Adjusted Net Loss |
||||||||
(In thousands) |
||||||||
(Unaudited) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
2019 |
2018 |
2019 |
2018 |
|||||
Net (loss) income |
$ (20,217) |
$ 12,025 |
$ (23,211) |
$ (2,517) |
||||
Add: Change in fair value of warrant liability |
8,439 |
(23,437) |
(830) |
(18,475) |
||||
Adjusted net loss |
$ (11,778) |
$ (11,412) |
$ (24,041) |
$ (20,992) |
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