MEI Pharma Reports Second Quarter Fiscal Year 2021 Results and Operational Highlights
"We remain well positioned and focused on advancing zandelisib toward commercialization to deliver an improved therapeutic option to people living with B-cell malignancies," said
Anticipated Calendar Year 2021 Drug Candidate Pipeline Developments
Zandelisib – PI3K delta inhibitor for the treatment of various B-cell malignancies
- Completion of enrollment in the Phase 2 TIDAL study evaluating zandelisib as a monotherapy for patients with relapsed or refractor follicular lymphoma followed by the reporting of top line clinical data from the Phase 2 TIDAL study.
- Initiation of a second arm in the Phase 2 TIDAL study enrolling patients with relapsed or refractory marginal zone lymphoma.
- Initiation of the Phase 3 study of zandelisib in combination with rituximab evaluating follicular and marginal zone lymphoma patients who received one or more prior lines of treatment; this study is intended to act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma.
- Clinical updates for the Phase 1b study of zandelisib, including the combination with zanubrutinib.
Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
- Program updates, including data from the Phase 1 program evaluating voruciclib.
ME-344 – tumor selective mitochondrial inhibitor
- Update plans for a potential Phase 2 pilot study of ME-344 in solid tumors.
Recent and Second Quarter Fiscal Year 2021 Corporate Highlights
- In
January 2021 , the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib (marketed as BRUKINSA®), developed by BeiGene, Ltd., enrolled the first patient in a disease specific expansion cohort. The phase 1b study arm evaluating the combination is conducted under a clinical collaboration with BeiGene to evaluate safety and efficacy for the treatment of patients with various relapsed or refractory B-cell malignancies.
- In
January 2021 , MEI announced that the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib in collaboration with BeiGene completed the safety evaluation stage in patients with B-cell malignancies and is expanding into disease specific B-cell malignancy cohorts. The Safety Review Committee recommended moving forward with a dosing regimen found to be generally well tolerated and active following a planned safety analysis.
- In
October 2020 , Kyowa Kirin Co. Ltd. and MEI announced that the first patient was dosed in the pivotal Phase 2 study of zandelisib in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström's macroglobulinemia (WM) inJapan . This Phase 2, multicenter is intended to support regulatory approval inJapan .
Second Quarter Fiscal Year 2021 Financial Results
- As of
December 31, 2020 , MEI had$180.1 million in cash, cash equivalents, and short-term investments with no outstanding debt.
- For the quarter ended December 31, 2020, cash provided by operations was $4.1 million compared to $10.5 million used in operations for the quarter ended December 31, 2019. Cash provided by operations in the 2020 period reflects
$20.9 million cash received from the Japanese taxing authorities as a refund of withholding tax associated with the Kyowa Kirin commercialization agreement signed inApril 2020 .
- Research and development expenses were $22.2 million for the quarter ended December 31, 2020, compared to $8.3 million for the quarter ended December 31, 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 $5.7 million for the quarter ended December 31, 2020, compared to $4.2 million for the quarter ended December 31, 2019. The increase primarily relates to general corporate expenses and personnel costs incurred during the quarter ended
December 31, 2020 .
- MEI recognized revenue of $9.2 million for the quarter ended December 31, 2020, compared to $1.0 million for the quarter ended December 31, 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, and reflect Kyowa Kirin's share of zandelisib costs which were
$9.9 million for the quarter endedDecember 31, 2020 .
- Net loss was $11.5 million, or $0.10 per share, for the quarter ended December 31, 2020, compared to net loss of $20.2 million, or $0.26 per share for the quarter ended December 31, 2019. The Company had 112,527,860 shares of common stock outstanding as of December 31, 2020, compared with 105,998,677 shares as of December 31, 2019.
- The adjusted net loss for the quarter ended December 31, 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
$18.5 million , compared to an adjusted net loss of$11.8 million for the quarter ended December 31, 2019.
About
Forward-Looking Statements
Under
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CONDENSED BALANCE SHEETS |
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(In thousands, except per share amounts) |
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2020 |
2020 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ 9,877 |
$ 12,331 |
|
Short-term investments |
170,267 |
170,299 |
|
Total cash, cash equivalents and short-term investments |
180,144 |
182,630 |
|
Receivable for foreign tax withholding |
- |
20,420 |
|
Prepaid expenses and other current assets |
13,888 |
5,594 |
|
Total current assets |
194,032 |
208,644 |
|
Operating lease right-of-use asset |
8,207 |
- |
|
Property and equipment, net |
1,641 |
1,084 |
|
Total assets |
$ 203,880 |
$ 209,728 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
$ 5,555 |
$ 2,437 |
|
Accrued liabilities |
11,102 |
6,090 |
|
Deferred revenue |
19,482 |
14,777 |
|
Operating lease liability |
873 |
- |
|
Total current liabilities |
37,012 |
23,304 |
|
Deferred revenue, long-term |
65,352 |
67,723 |
|
Operating lease liability, long-term |
7,842 |
- |
|
Warrant liability |
20,176 |
40,483 |
|
Total liabilities |
130,382 |
131,510 |
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Stockholders' equity: |
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Preferred stock, |
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none outstanding |
- |
- |
|
Common stock, |
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authorized; 112,528 and 111,514 shares issued and outstanding |
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at |
- |
- |
|
Additional paid-in-capital |
364,278 |
355,452 |
|
Accumulated deficit |
(290,780) |
(277,234) |
|
Total stockholders' equity |
73,498 |
78,218 |
|
Total liabilities and stockholders' equity |
$ 203,880 |
$ 209,728 |
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CONDENSED STATEMENTS OF OPERATIONS |
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(In thousands, except per share amounts) |
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(Unaudited) |
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Three Months Ended |
Six Months Ended |
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2020 |
2019 |
2020 |
2019 |
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Revenue |
$ 9,167 |
$ 1,008 |
$ 13,001 |
$ 2,165 |
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Operating expenses: |
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Cost of revenue |
494 |
641 |
1,003 |
1,329 |
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Research and development |
22,224 |
8,281 |
35,220 |
17,243 |
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General and administrative |
5,650 |
4,195 |
11,565 |
8,325 |
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Total operating expenses |
28,368 |
13,117 |
47,788 |
26,897 |
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Loss from operations |
(19,201) |
(12,109) |
(34,787) |
(24,732) |
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Other income (expense): |
|||||||
Change in fair value of warrant liability |
7,083 |
(8,439) |
20,307 |
830 |
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Interest and dividend income |
164 |
318 |
439 |
692 |
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Other income (expense) |
500 |
13 |
495 |
(1) |
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Net loss |
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Net loss: |
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Basic |
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Diluted |
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Net loss per share: |
|||||||
Basic |
$ (0.10) |
$ (0.26) |
$ (0.12) |
$ (0.30) |
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Diluted |
$ (0.16) |
$ (0.26) |
$ (0.30) |
$ (0.30) |
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Shares used in computing net loss per share: |
|||||||
Basic |
112,524 |
78,577 |
112,480 |
76,103 |
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Diluted |
114,461 |
78,577 |
114,709 |
76,103 |
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Reconciliation of GAAP Net Loss to Adjusted Net Loss |
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(In thousands) |
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(Unaudited) |
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Three Months Ended |
Six Months Ended |
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2020 |
2019 |
2020 |
2019 |
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Net loss |
|
|
|
|
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Add: Change in fair value of warrant liability |
(7,083) |
8,439 |
(20,307) |
(830) |
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Adjusted net loss |
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