MEI Pharma Reports First Quarter Fiscal Year 2021 Results and Operational Highlights
"As we move through fiscal year 2021, we are well-positioned and well-capitalized to achieve our goals across our pipeline. Importantly, we remain focused on advancing zandelisib toward commercialization with our partner Kyowa Kirin and establishing its potential as an important treatment option in multiple lines of treatment across various B-cell malignancies," said Daniel
First Quarter Fiscal Year 2021 Corporate Highlights
- In
September 2020 , MEI announced the appointment of
Brian T. Powl as senior vice president, marketing, a new role reporting to
David Urso , chief operating officer and general counsel.
Mr. Powl joined MEI from Celgene Corporation where he served as vice president, global commercial CAR T lead.
First Quarter Fiscal Year 2021 Financial Results
- As of
September 30, 2020 , MEI had$176.1 million in cash, cash equivalents, and short-term investments with no outstanding debt. Additionally, MEI had a receivable of$20.4 million from the Japanese taxing authorities that was withheld from the$100 million paid by Kyowa Kirin Co. under the terms of theApril 2020 global license, development and commercialization agreement. This receivable was received inOctober 2020 .
- For the quarter ended September 30, 2020, cash used in operations was $9.1 million compared to $14.1 million for 2019.
- Research and development expenses were $13.0 million for the quarter ended September 30, 2020, compared to $9.0 million for 2019. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 study, as well as increased personnel costs to support clinical trial activities.
- General and administrative expenses were $5.9 million for the quarter ended September 30, 2020, compared to $4.1 million for 2019. The increase primarily relates to personnel costs and general corporate expenses incurred during the quarter ended
September 30, 2020 .
- MEI recognized revenues of $3.8 million for the quarter ended September 30, 2020, compared to $1.2 million for the quarter ended September 30, 2019. The increase in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations, including a portion of Kyowa Kirin's share of zandelisib costs which were
$4.9 million for the quarter endedSeptember 30, 2020 . Revenue also includes recognition of fees allocated to performance obligations in accordance with the Helsinn License Agreement.
- Net loss was $2.1 million, or $0.02 per share, for the quarter ended September 30, 2020, compared to net loss of $3.0 million, or $0.04 per share for 2019. The Company had 112,522,001 shares of common stock outstanding as of September 30, 2020, compared with 73,654,927 shares as of September 30, 2019.
- The adjusted net loss for the quarter ended September 30, 2020, 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), was
$15.3 million , compared to an adjusted net loss of$12.3 million for 2019.
About
Forward-Looking Statements
Under
|
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CONDENSED BALANCE SHEETS |
|||
(In thousands, except per share amounts) |
|||
|
|
||
2020 |
2020 |
||
(unaudited) |
|||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 10,956 |
$ 12,331 |
|
Short-term investments |
165,179 |
170,299 |
|
Total cash, cash equivalents and short-term investments |
176,135 |
182,630 |
|
Receivable for foreign tax withholding |
20,420 |
20,420 |
|
Prepaid expenses and other current assets |
7,375 |
5,594 |
|
Total current assets |
203,930 |
208,644 |
|
Operating lease right-of-use asset |
8,420 |
- |
|
Property and equipment, net |
1,659 |
1,084 |
|
Total assets |
$ 214,009 |
$ 209,728 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||
Current liabilities: |
|||
Accounts payable |
$ 6,375 |
$ 2,437 |
|
Accrued liabilities |
5,537 |
6,090 |
|
Deferred revenue |
18,972 |
14,777 |
|
Operating lease liabilities |
602 |
- |
|
Total current liabilities |
31,486 |
23,304 |
|
Deferred revenue, long-term |
64,864 |
67,723 |
|
Warrant liability |
27,259 |
40,483 |
|
Operating lease liabilties, long-term |
8,072 |
- |
|
Total liabilities |
131,681 |
131,510 |
|
Stockholders' equity: |
|||
Preferred stock, |
|||
none outstanding |
- |
- |
|
Common stock, |
|||
authorized; 112,522 and 111,514 shares issued and outstanding |
|||
at |
- |
- |
|
Additional paid-in-capital |
361,654 |
355,452 |
|
Accumulated deficit |
(279,326) |
(277,234) |
|
Total stockholders' equity |
82,328 |
78,218 |
|
Total liabilities and stockholders' equity |
$ 214,009 |
$ 209,728 |
|
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CONDENSED STATEMENTS OF OPERATIONS |
||||
(In thousands, except per share amounts) |
||||
(Unaudited) |
||||
Three Months Ended |
||||
2020 |
2019 |
|||
Revenue |
$ 3,834 |
$ 1,157 |
||
Operating expenses: |
||||
Cost of revenue |
509 |
688 |
||
Research and development |
12,996 |
8,962 |
||
General and administrative |
5,915 |
4,130 |
||
Total operating expenses |
19,420 |
13,780 |
||
Loss from operations |
(15,586) |
(12,623) |
||
Other income (expense): |
||||
Change in fair value of warrant liability |
13,224 |
9,269 |
||
Interest and dividend income |
275 |
374 |
||
Other expense |
(5) |
(14) |
||
Net loss |
$ (2,092) |
$ (2,994) |
||
Net loss: |
||||
Basic |
$ (2,092) |
$ (2,994) |
||
Diluted |
$ (15,316) |
$ (2,994) |
||
Net loss per share: |
||||
Basic |
$ (0.02) |
$ (0.04) |
||
Diluted |
$ (0.13) |
$ (0.04) |
||
Shares used in computing net loss per share: |
||||
Basic |
112,435 |
73,628 |
||
Diluted |
114,957 |
73,628 |
|
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Reconciliation of GAAP Net Loss to Adjusted Net Loss |
|||||
(In thousands) |
|||||
(Unaudited) |
|||||
Three Months Ended |
|||||
2020 |
2019 |
||||
Net loss |
$ (2,092) |
$ (2,994) |
|||
Add: Change in fair value of warrant liability |
(13,224) |
(9,269) |
|||
Adjusted net loss |
$ (15,316) |
$ (12,263) |
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