MEI Pharma Reports Fiscal Third-Quarter 2020 Results and Recent Corporate Highlights
"Entering our fiscal fourth quarter, MEI is well positioned as we continue progress across our business, as highlighted by the recent grant of Fast Track designation by FDA for ME-401 and our newly announced global alliance with Kyowa Kirin," said Daniel
Recent Highlights
- In
April 2020 , the Company entered a global license, development and commercialization agreement to further develop and commercialize MEI's ME-401.
- MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the
U.S.
- MEI to book
U.S. sales on 50-50 profit and cost sharing.
- MEI to book
$100 million in an upfront cash payment to MEI.$582.5 million in potential development, regulatory and commercial milestones- Kyowa Kirin obtains exclusive commercialization rights ex-
U.S.
- MEI to receive escalating tiered royalty payments from mid-teens on ex-
U.S. sales.
- MEI to receive escalating tiered royalty payments from mid-teens on ex-
- MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the
- In
April 2020 ,
Cheryl L. Cohen , former chief commercial officer ofMedivation, Inc. and a product launch and commercialization veteran with over 25 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors. - In
March 2020 , the Company was granted Fast Track designation by theU.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Fiscal Third-Quarter Fiscal Year 2020 Financial Results
- As of March 31, 2020, MEI had $92.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Giving effect to the KKC Agreement, our cash, cash equivalents and short-term investments would have been
$192.8 million . - For the three months ended
March 31, 2020 , cash used in operations was $10.3 million, compared to $11.3 million for the same period in 2019. For the nine months ending March 31, 2020, cash used in operations was $34.9 million, compared to $31.4 million for 2019. The increase primarily relates to costs associated with our clinical development programs. - Research and development expenses were $9.0 million for the quarter ended March 31, 2020, compared to $9.1 million for 2019. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401, offset by increased clinical trial costs for the ME-401 TIDAL study and increased personnel and legal patent costs.
- General and administrative expenses were $3.9 million for the quarter ended March 31, 2020, compared to $3.6 million for 2019. The increase primarily relates to increased headcount to support our activities.
- Revenue was $1.2 million for the quarter ended
March 31, 2020 , compared to revenue of$1.2 million for the same period in 2019. Revenue resulted from the recognition of fees allocated to research and development activities related to theHelsinn and Kyowa Kirin Japan License Agreements. - Net loss was $4.3 million, or $0.04 per share, for the quarter ended March 31, 2020, compared to net loss of $17.4 million, or $0.24 per share for the same period in 2019. Net loss decreased primarily as a result of a non-cash gain in the current quarter and a non-cash expense 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 March 31, 2020, compared with 71,280,660 shares as of
March 31, 2019 . - The adjusted net loss for the quarter ended
March 31, 2020 , excluding a non-cash gain related to changes in the fair value of the warrants (a non-GAAP measure), was $12.1 million, compared to an adjusted net loss of$12.2 million for 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 |
2019 |
||
(unaudited) |
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ASSETS |
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Current assets: |
|||
Cash and cash equivalents |
$ 7,438 |
$ 9,590 |
|
Short-term investments |
85,360 |
64,899 |
|
Total cash, cash equivalents and short-term investments |
92,798 |
74,489 |
|
Common stock proceeds receivable |
- |
5,274 |
|
Prepaid expenses and other current assets |
2,604 |
2,435 |
|
Total current assets |
95,402 |
82,198 |
|
Intangible assets, net |
235 |
261 |
|
Property and equipment, net |
986 |
204 |
|
Total assets |
$ 96,623 |
$ 82,663 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
$ 2,492 |
$ 4,787 |
|
Accrued liabilities |
5,287 |
4,559 |
|
Deferred revenue |
2,478 |
4,955 |
|
Total current liabilities |
10,257 |
14,301 |
|
Deferred revenue, long-term |
2,817 |
2,819 |
|
Warrant liability |
9,051 |
17,613 |
|
Total liabilities |
22,125 |
34,733 |
|
Stockholders' equity: |
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Preferred stock, |
- |
- |
|
Common stock, |
- |
- |
|
Additional paid-in-capital |
333,256 |
279,148 |
|
Accumulated deficit |
(258,758) |
(231,218) |
|
Total stockholders' equity |
74,498 |
47,930 |
|
Total liabilities and stockholders' equity |
$ 96,623 |
$ 82,663 |
|
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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 |
Nine Months Ended |
||||||
2020 |
2019 |
2020 |
2019 |
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Revenue |
$ 1,244 |
$ 1,249 |
$ 3,409 |
$ 3,785 |
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Operating expenses: |
|||||||
Cost of revenue |
860 |
1,163 |
2,189 |
3,161 |
|||
Research and development |
8,963 |
9,071 |
26,206 |
24,268 |
|||
General and administrative |
3,864 |
3,631 |
12,189 |
10,853 |
|||
Total operating expenses |
13,687 |
13,865 |
40,584 |
38,282 |
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Loss from operations |
(12,443) |
(12,616) |
(37,175) |
(34,497) |
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Other income (expense): |
|||||||
Change in fair value of warrant liability |
7,732 |
(5,201) |
8,562 |
13,274 |
|||
Interest and dividend income |
382 |
462 |
1,074 |
1,352 |
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Other income (expense) |
- |
- |
(1) |
(1) |
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Net loss |
$ (4,329) |
|
|
|
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Net loss: |
|||||||
Basic |
$ (4,329) |
|
|
|
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Diluted |
$ (4,329) |
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|
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Net loss per share: |
|||||||
Basic |
$ (0.04) |
$ (0.24) |
$ (0.32) |
$ (0.28) |
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Diluted |
$ (0.04) |
$ (0.24) |
$ (0.32) |
$ (0.60) |
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Shares used in computing net loss per share: |
|||||||
Basic |
105,999 |
71,200 |
85,995 |
71,069 |
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Diluted |
105,999 |
71,200 |
85,995 |
72,011 |
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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 |
Nine Months Ended |
|||||||
2020 |
2019 |
2020 |
2019 |
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Net loss |
$ (4,329) |
|
|
|
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Add: Change in fair value of warrant liability |
(7,732) |
5,201 |
(8,562) |
(13,274) |
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Adjusted net loss |
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