MEI Pharma Reports First Quarter Fiscal Year 2022 Results and Operational Highlights
-TIDAL Study Data on Track to be Reported by End of Calendar Year 2021-
-MEI Begins Second Fiscal Quarter with
“Fiscal year 2022 is off to an exciting start as we look towards reporting data from the follicular lymphoma cohort in the pivotal TIDAL study evaluating zandelisib in patients with follicular and marginal zone lymphomas which, subject to discussions with FDA, we intend to use to support the submission of our first New Drug Application,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “Beyond TIDAL, our development efforts include studies intended to expand the commercial opportunity for zandelisib in additional indications, like the Phase 3 COASTAL study evaluating follicular and marginal zone lymphoma patients after one prior line of therapy, and the Phase 2 CORAL study that will evaluate zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia. Our goal is to have zandelisib incorporated as a component of standard therapy across multiple B-cell indications.”
Dr. Gold continued: “We are also excited about development plans for our other pipeline candidates, such as evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and the potential of ME-344 plus bevacizumab in patients with colorectal cancer. And, with
First Quarter Fiscal Year 2022 Financial and Drug Candidate Pipeline Highlights
- Initiated COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
- Received a
$10,000,000 milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies triggered in August 2021 by the dosing of the first patient in the Phase 3 COASTAL study. - Triggered an additional
$10,000,000 milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies for the dosing in September 2021 of the first patient inJapan in the Phase 3 COASTAL study. The milestone payment was received in October 2021, and was recorded as a receivable in the company’s financial statements as of September 30, 2021.
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
- Report data from the Phase 2 TIDAL study by the end of calendar year 2021 from the follicular lymphoma cohort of the study. Data from the follicular lymphoma cohort of the Phase 2 TIDAL study data are intended, subject to discussions with the
U.S. Food and Drug Administration, to be submitted in support of an initial accelerated approval marketing application. - Initiate a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia in the first half of calendar year 2022.
- Provide an update from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib, including in expansion cohorts enrolling patients with relapsed or refractory mantle cell and follicular lymphomas in mid calendar year 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
- Program update at the 63rd Annual American Society of Hematology Annual Meeting, reporting safety and pharmacokinetic data from the monotherapy portion of the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor
- Initiate a Phase 2 study of ME-344 in relapsed colorectal cancer in the mid calendar year 2022.
Pracinostat – Oral HDAC Inhibitor
- MEI and Helsinn have mutually agreed to terminate the Helsinn License Agreement. MEI does not intend to develop pracinostat further for any use and does not anticipate any future material financial obligations regarding the compound.
First Quarter Fiscal Year 2022 Financial Results
- As of September 30, 2021, MEI had
$145.5 million in cash, cash equivalents, and short-term investments with no outstanding debt. - For the quarter ended September 30, 2021, cash used in operations was
$7.7 million , compared to$9.1 million for 2020. The decrease in cash used reflects the receipt of a$10.0 million milestone payment from Kyowa Kirin Co., partially offset by increased costs associated with our clinical development programs. - Research and development expenses were
$20.0 million for the quarter ended September 30, 2021, compared to$13.0 million for 2020. 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 COASTAL study, as well as increased personnel costs to support clinical trial activities. - General and administrative expenses were
$7.9 million for the quarter ended September 30, 2021, compared to$5.9 million for 2020. The increase primarily relates to personnel costs and general corporate expenses to support our activities, including preparation for commercial launch of zandelisib. - MEI recognized revenues of
$13.4 million for the quarter ended September 30, 2021, compared to$3.8 million for 2020. The increase in revenue primarily related to the license agreement with Kyowa Kirin and reflects the recognition of fees allocated to research and development obligations. - Net loss was
$11.9 million , or$0.11 per share, for the quarter ended September 30, 2021, compared to net loss of$2.1 million , or$0.02 per share for 2020. The Company had 112,678,498 shares of common stock outstanding as of September 30, 2021, compared with 112,522,001 shares as of September 30, 2020. - The adjusted net loss for the quarter ended September 30, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was
$14.5 million , compared to an adjusted net loss of$15.3 million for 2020.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma's portfolio of drug candidates contains multiple clinical-stage assets, including zandelisib, currently in ongoing clinical trials which may support marketing approvals with the
Forward-Looking Statements
Under
MEI PHARMA, INC. CONDENSED BALANCE SHEETS (In thousands, except per share amounts) |
||||||||
September 30, |
June 30, |
|||||||
|
2021 |
|
|
2021 |
|
|||
(unaudited) | ||||||||
ASSETS |
||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
15,621 |
|
$ |
8,543 |
|
||
Short-term investments |
|
129,882 |
|
|
144,883 |
|
||
Total cash, cash equivalents and short-term investments |
|
145,503 |
|
|
153,426 |
|
||
Accounts receivable |
|
10,000 |
|
|
- |
|
||
Contract assets |
|
8,120 |
|
|
7,582 |
|
||
Prepaid expenses and other current assets |
|
3,739 |
|
|
3,809 |
|
||
Total current assets |
|
167,362 |
|
|
164,817 |
|
||
Operating lease right-of-use asset |
|
7,551 |
|
|
7,774 |
|
||
Property and equipment, net |
|
1,438 |
|
|
1,507 |
|
||
Total assets |
$ |
176,351 |
|
$ |
174,098 |
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
8,472 |
|
$ |
6,355 |
|
||
Accrued liabilities |
|
6,099 |
|
|
8,402 |
|
||
Deferred revenue |
|
14,837 |
|
|
14,609 |
|
||
Operating lease liabilities |
|
957 |
|
|
928 |
|
||
Total current liabilities |
|
30,365 |
|
|
30,294 |
|
||
Deferred revenue, long-term |
|
87,276 |
|
|
72,717 |
|
||
Warrant liability |
|
7,115 |
|
|
7,370 |
|
||
Operating lease liabilities, long-term |
|
19,768 |
|
|
22,355 |
|
||
Total liabilities |
|
144,524 |
|
|
132,736 |
|
||
Stockholders' equity: | ||||||||
Preferred stock, |
|
- |
|
|
- |
|
||
Common stock, |
|
- |
|
|
- |
|
||
Additional paid-in-capital |
|
371,516 |
|
|
369,171 |
|
||
Accumulated deficit |
|
(339,689 |
) |
|
(327,809 |
) |
||
Total stockholders' equity |
|
31,827 |
|
|
41,362 |
|
||
Total liabilities and stockholders' equity |
$ |
176,351 |
|
$ |
174,098 |
|
||
MEI PHARMA, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) |
||||||||
|
|
|
||||||
|
|
|
||||||
|
|
Three Months Ended |
||||||
|
|
|
2021 |
|
|
|
2020 |
|
Revenue |
$ |
13,387 |
|
$ |
3,834 |
|
||
Operating expenses: | ||||||||
Cost of revenue |
|
- |
|
|
509 |
|
||
Research and development |
|
19,953 |
|
|
12,996 |
|
||
General and administrative |
|
7,909 |
|
|
5,915 |
|
||
Total operating expenses |
|
27,862 |
|
|
19,420 |
|
||
Loss from operations |
|
(14,475 |
) |
|
(15,586 |
) |
||
Other income (expense): | ||||||||
Change in fair value of warrant liability |
|
2,587 |
|
|
13,224 |
|
||
Interest and dividend income |
|
8 |
|
|
275 |
|
||
Other expense |
|
- |
|
|
(5 |
) |
||
Net loss |
$ |
(11,880 |
) |
$ |
(2,092 |
) |
||
Net loss: | ||||||||
Basic |
$ |
(11,880 |
) |
$ |
(2,092 |
) |
||
Diluted |
$ |
(14,467 |
) |
$ |
(15,316 |
) |
||
Net loss per share: | ||||||||
Basic |
$ |
(0.11 |
) |
$ |
(0.02 |
) |
||
Diluted |
$ |
(0.13 |
) |
$ |
(0.13 |
) |
||
Shares used in computing net loss per share: | ||||||||
Basic |
|
112,677 |
|
|
112,435 |
|
||
Diluted |
|
113,917 |
|
|
114,957 |
|
||
MEI PHARMA, INC. Reconciliation of GAAP Net Loss to Adjusted Net Loss (In thousands) (Unaudited) |
||||||||
|
|
|
||||||
|
|
Three Months Ended |
||||||
|
|
|
2021 |
|
|
|
2020 |
|
Net loss |
$ |
(11,880 |
) |
$ |
(2,092 |
) |
||
Add: Change in fair value of warrant liability |
|
(2,587 |
) |
|
(13,224 |
) |
||
Adjusted net loss |
$ |
(14,467 |
) |
$ |
(15,316 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20211110005383/en/
David A. Walsey
MEI Pharma
Tel: 858-369-7104
Jason I. Spark
Canale Communications for MEI
Tel: 619-849-6005
Source: MEI Pharma, Inc.
ORIGINAL NASDAQ-SMALL:MEIP Business Wire