8-K
false 0001262104 0001262104 2022-11-14 2022-11-14

 

 

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

November 14, 2022

Date of report (Date of earliest event reported)

 

 

MEI Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-50484   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 14, 2022, MEI Pharma, Inc. (the “Company”) issued a press release announcing its financial results for its first quarter ended September 30, 2022. 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.

(d) Exhibits.

 

Exhibit

No.

   Description
99.1    Press Release issued by MEI Pharma, Inc., dated November 14, 2022.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

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

 

    MEI PHARMA, INC.
Dated: November 14, 2022     By:  

/s/ Daniel P. Gold

    Name:   Daniel P. Gold
    Title:   Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

MEI Pharma Reports First Quarter Fiscal Year 2023 Results and Operational Highlights

— MEI Begins Second Fiscal Quarter with $138 Million in Cash —

SAN DIEGO – November 14, 2022 – MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended September 30, 2022, and highlighted recent corporate events.

“As we move through fiscal year 2023 and continue to assess FDA concerns regarding the risk benefit analysis of marketed PI3Kd inhibitors to treat indolent lymphomas, as well as the impact of these concerns and other global factors on our Phase 3 COASTAL study, we also look forward to reporting advances across our clinical development pipeline. This includes reporting updated data from multiple zandelisib studies at the ASH annual meeting in December, and also reporting advances in our other development programs, including initiation of a trial evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and a trial evaluating the combination of ME-344 plus bevacizumab in patients with relapsed and refractory colorectal cancer,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “We remain well capitalized with $138 million to advance our pipeline and continue operations for approximately two years.”

First Quarter Fiscal Year 2023 Recent Developments and Financial Highlights

 

   

Earlier in November, MEI Pharma and Kyowa Kirin announced the acceptance of three abstracts reporting data for zandelisib, an investigational phosphatidylinositol 3-kinase delta inhibitor in clinical development for the treatment of B-cell malignancies, to be presented at the upcoming American Society of Hematology 2022 annual meeting to be held December 10-13, 2022.

 

   

In September, we announced that Christine A. White, M.D. will be retiring as chair of the board. She will be replaced by board member Charles V. Baltic. This will be effective as of the Company’s fiscal 2023 annual meeting of shareholders. Additionally, in November, Cheryl L. Cohen also informed the Company that she will not stand for election to the board at the Company’s annual meeting of shareholders.

 

   

In July, MEI Pharma and Kyowa Kirin announced publication in The Lancet Oncology of data from Phase 1b clinical study of zandelisib in patients with relapsed or refractory B-cell malignancy.

Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

 

   

Report new zandelisib data at the American Society of Hematology Annual Meeting in December 2022, including a presentation of updated data from the follicular lymphoma cohort in the Phase 2 TIDAL study and a presentation of data from the Phase 1b study cohort evaluating zandelisib plus Brukinsa® (zanubrutinib) to treat indolent B-cell malignancies.

 

   

Dose the first patient in the Phase 2 CORAL study evaluating zandelisib plus Venclexta® (venetoclax) and rituximab in patients with chronic lymphocytic leukemia by year-end 2022.

Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

 

   

Dose the first patient cohort of voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia by year-end 2022 in the Phase 1 study.

ME-344 – Tumor selective mitochondrial inhibitor

 

   

Initiate a Phase 1b study evaluating ME-344 plus Avastin®(bevacizumab) in relapsed colorectal cancer patients in the first half of calendar year 2023.

First Quarter Fiscal Year 2023 Financial Results

 

   

As of September 30, 2022, MEI had $138.4 million in cash, cash equivalents, and short-term investments with no outstanding debt.


LOGO

 

   

For the quarter ended September 30, 2022, cash used in operations was $14.8 million, compared to $7.7 million used in operations for the quarter ended September 30, 2021. The increase in cash used in operations is due to the favorable impact of a $10.0 million milestone payment received from Kyowa Kirin in the comparable quarter in 2021 with no corresponding payment in 2022 and other changes in working capital balances.

 

   

Research and development expenses were $19.5 million for the quarter ended September 30, 2022, compared to $20.0 million for the quarter ended September 30, 2021. The decrease was primarily related to costs to support ongoing zandelisib and voruciclib studies.

 

   

General and administrative expenses were $7.5 million for the quarter ended September 30, 2022, compared to $7.9 million for the quarter ended September 30, 2021. The decrease primarily relates to lower personnel costs, professional services and general corporate expenses.

 

   

MEI recognized revenue of $8.7 million for the quarter ended September 30, 2022, compared to $7.8 million for the quarter ended September 30, 2021. The increase in recognized revenue relates to progress towards completion of our performance obligations, offset by decreased reimbursement of expenses under the license agreement with Kyowa Kirin.

 

   

Net loss was $16.6 million, or $0.12 per share, for the quarter ended September 30, 2022, compared to net loss of $17.5 million, or $0.16 per share for the quarter ended September 30, 2021. The Company had 133,260,865 shares of common stock outstanding as of September 30, 2022, compared with 112,678,498 shares as of September 30, 2021.

 

   

The adjusted net loss (a non-GAAP measure) for the quarter ended September 30, 2022, excluding non-cash expenses related to changes in the fair value of the warrants, was $17.7 million, compared to an adjusted net loss of $20.1 million for the quarter ended September 30, 2021.


LOGO

 

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 U.S. Food and Drug Administration and other regulatory authorities globally. Each of MEI Pharma’s pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com. Follow us on Twitter @MEI_Pharma and on LinkedIn.

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. Statements included 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 zandelisib and our other 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; and the sufficiency of our cash, cash equivalents and short-term investments to fund our operations. 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; adverse effects on the Company’s business as a result of the restatement of our previously issued financial statements; the impact of the COVID-19 pandemic on our industry and individual companies, including on our counterparties, the supply chain, the execution of our clinical development programs, our access to financing and the allocation of government resources; 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.

Non-GAAP Financial Measures

To supplement our consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (“GAAP”), we provide investors with a non-GAAP financial measure, adjusted net loss, which we believe is helpful to our investors. We use adjusted net loss for financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons. We believe this non-GAAP financial measure provides useful information about our operating results, enhances the overall understanding of past financial performance and future prospects and allows for greater transparency with respect to metrics used by our management in its financial and operational decision-making.

The presentation of adjusted net loss is not meant to be considered in isolation or as a substitute for net loss, the directly comparable financial measure prepared in accordance with GAAP. While we believe adjusted net loss is an important tool for financial and operational decision-making and for evaluating our own operating results over different periods of time, we urge investors to review the reconciliation of this financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate our business.

We define adjusted net loss, adjusted to exclude non-cash expenses related to changes in the fair value of the warrants. We have presented adjusted net loss because we believe excluding the non-cash expenses related to changes in the fair value of warrants can produce a useful measure for period-to-period comparisons of our business.

Contacts:

David A. Walsey

MEI Pharma

Tel: 858-369-7104

investor@meipharma.com

Jason I. Spark

Canale Communications for MEI

Tel: 619-849-6005

jason.spark@canale.com


LOGO

 

MEI PHARMA, INC.

CONDENSED BALANCE SHEETS

(In thousands, except per share amounts)

 

     September 30,
2022
    June 30,
2022
 
     (unaudited)        

ASSETS

 

Current assets:

    

Cash and cash equivalents

   $ 14,653     $ 15,740  

Short-term investments

     123,714       137,512  
  

 

 

   

 

 

 

Total cash, cash equivalents and short-term investments

     138,367       153,252  

Unbilled receivables

     7,758       10,044  

Prepaid expenses and other current assets

     2,782       3,830  
  

 

 

   

 

 

 

Total current assets

     148,907       167,126  

Operating lease right-of-use asset

     13,052       9,054  

Property and equipment, net

     1,624       1,660  
  

 

 

   

 

 

 

Total assets

   $ 163,583     $ 177,840  
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

Current liabilities:

    

Accounts payable

   $ 8,418     $ 7,918  

Accrued liabilities

     9,216       10,820  

Deferred revenue

     4,500       4,834  

Operating lease liabilities

     1,301       871  
  

 

 

   

 

 

 

Total current liabilities

     23,435       24,443  

Deferred revenue, long-term

     89,973       90,610  

Operating lease liabilties, long-term

     12,381       8,771  

Warrant liability

     486       1,603  
  

 

 

   

 

 

 

Total liabilities

     126,275       125,427  
  

 

 

   

 

 

 

Stockholders’ equity:

    

Preferred stock, $0.01 par value; 100 shares authorized; none outstanding

     —         —    

Common stock, $0.00000002 par value; 226,000 shares authorized; 133,261 and 133,152 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively

     —         —    

Additional paid-in-capital

     428,091       426,572  

Accumulated deficit

     (390,783     (374,159
  

 

 

   

 

 

 

Total stockholders’ equity

     37,308       52,413  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 163,583     $ 177,840  
  

 

 

   

 

 

 


LOGO

 

MEI PHARMA, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended
September 30,
 
     2022     2021  

Revenue

   $ 8,730     $ 7,757  
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     19,463       19,953  

General and administrative

     7,486       7,909  
  

 

 

   

 

 

 

Total operating expenses

     26,949       27,862  
  

 

 

   

 

 

 

Loss from operations

     (18,219     (20,105

Other income (expense):

    

Change in fair value of warrant liability

     1,117       2,587  

Interest and dividend income

     480       8  

Other expense, net

     (2     —    
  

 

 

   

 

 

 

Net loss

   $ (16,624   $ (17,510
  

 

 

   

 

 

 

Net loss:

    

Basic

   $ (16,624   $ (17,510
  

 

 

   

 

 

 

Diluted

   $ (16,624   $ (20,097
  

 

 

   

 

 

 

Net loss per share:

    

Basic

   $ (0.12   $ (0.16
  

 

 

   

 

 

 

Diluted

   $ (0.12   $ (0.18
  

 

 

   

 

 

 

Shares used in computing net loss per share:

    

Basic

     133,255       112,677  
  

 

 

   

 

 

 

Diluted

     133,255       113,917  
  

 

 

   

 

 

 


LOGO

 

MEI PHARMA, INC.

Reconciliation of GAAP Net Loss to Adjusted Net Loss

(In thousands)

(Unaudited)

 

     Three Months Ended
September 30,
 
     2022     2021  

Net loss

   $ (16,624   $ (17,510

Add: Change in fair value of warrant liability

     (1,117     (2,587
  

 

 

   

 

 

 

Adjusted net loss

   $ (17,741   $ (20,097