false000126210400012621042023-11-092023-11-09

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 09, 2023

 

 

MEI Pharma, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-41827	51-0407811
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
11455 El Camino Real, Suite 250
San Diego, California				92130
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 858 369-7100

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.00000002 par value		MEIP		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

---

 

Item 2.02 Results of Operations and Financial Condition.

On November 9, 2023, MEI Pharma, Inc. (the “Company”) issued a press release announcing its financial results for its first quarter ended September 30, 2023. The text of the press release is included as an exhibit to this Current Report on Form 8-K. The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description
99.1		Press Release issued by MEI Pharma, Inc., dated November 9, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

---

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:	November 9, 2023	By:	/s/ Justin J. File
			Justin J. File Chief Financial Officer and Secretary

 

---

 

 

MEI Pharma Reports First Quarter Fiscal Year 2024 Results and Operational Highlights

SAN DIEGO – November 9, 2023 – MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address know resistance mechanisms to standard-of-care cancer therapies, today reported results for the quarter ended September 30, 2023 and highlighted recent corporate events.

 

“Our ongoing clinical studies evaluating the combination of voruciclib, our CDK9 inhibitor, with Venclexta in relapsed/refractory AML patients and ME-344, our mitochondrial inhibitor, combined with Avastin in metastatic colorectal cancer patients, continue to have strong investigator support and cohort enrollment remains on track in each program,” said David M. Urso, president and chief executive officer of MEI Pharma. “We expect to report data from the dose escalation portion of the Phase 1 clinical trial evaluating voruciclib in combination with venetoclax in early calendar 2024, and data from the first cohort of patients in Phase 1b clinical trial evaluating ME-344 in the first half of 2024.”

 

First Quarter Fiscal Year 2024 and Recent Highlights

 

 

Expected Drug Candidate Pipeline Developments

 

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study

---

 

 

 

ME-344 – Mitochondrial inhibitor in Phase 1b Study

 

First Quarter Fiscal Year 2024 Financial Results

 

 

 

 

 

 

---

 

 

 

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.

 

About MEI Pharma

MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage pharmaceutical company committed to developing novel and differentiated cancer therapies. We build our pipeline by acquiring promising cancer agents and creating value in programs through development, strategic partnerships, out-licensing and commercialization, as appropriate. Our approach to oncology drug development is to evaluate our drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs to provide improved patient benefit. The drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 ("CDK9") inhibitor, and ME-344, an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway. For more information, please visit www.meipharma.com. Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn.

 

Forward-Looking Statements

 

Certain information contained in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding: the potential, safety, efficacy, and regulatory and clinical progress of our product candidates, including the anticipated timing for initiation of clinical trials and release of clinical trial data and our expectations surrounding potential regulatory submissions, approvals and timing thereof, our business strategy and plans; the sufficiency of our cash, cash equivalents and short-term investments to fund our operations; and our ability to fund future capital returns. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to our failure to successfully commercialize our product candidates; the availability or appropriateness of utilizing the FDA’s accelerated approval pathway for our product candidates; final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; costs and delays in the development and/ or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; uncertainty regarding the impact of rising inflation and the increase in interest rates as a result; potential economic downturn; activist investors; our inability to maintain or enter into, and the risks resulting from, our dependence upon collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual

---

 

 

property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use.

 

Contacts:

David A. Walsey

MEI Pharma

Tel: 858-369-7104

investor@meipharma.com

 

 

 

 

 

 

 

---

 

 

 

MEI PHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value amounts)
	September 30,				June 30,
	2023				2023
	(Unaudited)				(Audited)
ASSETS
Current assets:
Cash and cash equivalents	$	3,372			$	16,906
Short-term investments		78,830				83,787
Unbilled receivables		—				85
Prepaid expenses and other current assets		6,220				6,750
Total current assets		88,422				107,528
Operating lease right-of-use asset		11,600				11,972
Property and equipment, net		1,229				1,309
Total assets	$	101,251			$	120,809
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	3,220			$	6,134
Accrued liabilities		4,289				12,461
Deferred revenue		—				317
Operating lease liability		1,055				1,428
Total current liabilities		8,564				20,340
Deferred revenue, long-term		—				64,545
Operating lease liability, long-term		11,326				11,300
Total liabilities		19,890				96,185
Stockholders' equity:
Preferred stock, $0.01 par value; 100 shares authorized; none outstanding		—				—
Common stock, $0.00000002 par value; 226,000 shares authorized; 6,663 shares    issued and outstanding at September 30, 2023 and June 30, 2023		—				—
Additional paid-in-capital		430,984				430,621
Accumulated deficit		(349,623	)			(405,997	)
Total stockholders' equity		81,361				24,624
Total liabilities and stockholders' equity	$	101,251			$	120,809

 

 

---

 

 

MEI PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
		For the Three Months Ended September 30,
		2023				2022
Revenues:
Revenue from customers		$	752			$	8,730
Revenue from collaboration agreements			64,545				—
Total revenues			65,297				8,730
Operating expenses:
Research and development			3,485				19,463
General and administrative			6,531				7,486
Total operating expenses			10,016				26,949
Income (loss) from operations			55,281				(18,219	)
Other income (expense):
Change in fair value of warrant liability			—				1,117
Interest and dividend income			1,094				480
Other expense, net			(1	)			(2	)
Total other income, net			1,093				1,595
Net income (loss)		$	56,374			$	(16,624	)
Net income (loss) per share - basic and diluted		$	8.46			$	(2.49	)
Weighted-average shares used in computing net income (loss)     per share - basic and diluted			6,663				6,663

 

---