[Corporate Update and Strategic Review](index=1&type=section&id=Corporate%20Update%20and%20Strategic%20Review) MEI Pharma is actively reviewing strategic alternatives to maximize stockholder value while implementing cash preservation measures and maintaining a strong financial position [Evaluation of Strategic Alternatives](index=1&type=section&id=Evaluation%20of%20Strategic%20Alternatives) MEI Pharma is actively continuing its review of strategic alternatives initiated in July 2024, which includes potential out-licensing of its programs or M&A opportunities, with the stated goal of maximizing stockholder value - The company is continuing its review and evaluation of potential strategic alternatives, considering options such as out-licensing opportunities for existing programs and merger and acquisition opportunities[2](index=2&type=chunk) - Oppenheimer & Co., Inc. has been retained as the company's exclusive financial advisor to assist in this process[2](index=2&type=chunk) - There is no assurance that the exploration of strategic alternatives will result in any agreements or transactions. The company does not expect to disclose developments until the process is completed or disclosure is deemed appropriate or legally required[4](index=4&type=chunk) [Financial Position and Cost Management](index=1&type=section&id=Financial%20Position%20and%20Cost%20Management) As of March 31, 2025, MEI Pharma reported a cash and cash equivalents balance of $20.5 million with no outstanding debt, actively implementing cash preservation measures Cash Position as of March 31, 2025 | Metric | Value (USD) | | :---------------------- | :------------ | | Cash and cash equivalents | $20.5 million | | Outstanding Debt | None | - The company is continuing its cash preservation efforts, which include a reduction-in-force that is progressing in stages as its strategic direction evolves[3](index=3&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) MEI Pharma's financial position reflects decreased assets and equity from cash usage, with a reduced net loss driven by operating expense cuts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, MEI Pharma's total assets were $20.8 million, a significant decrease from $41.4 million on June 30, 2024, primarily due to cash usage and depletion of short-term investments Balance Sheet Comparison | Balance Sheet Item | March 31, 2025 (Unaudited, in thousands) | June 30, 2024 (Audited, in thousands) | | :------------------------------ | :------------------------- | :---------------------- | | Cash and cash equivalents | $20,472 | $3,705 | | Short-term investments | $0 | $34,640 | | **Total Assets** | **$20,779** | **$41,375** | | Total Liabilities | $1,238 | $8,355 | | **Total Stockholders' Equity** | **$19,541** | **$33,020** | - The company's short-term investments were fully depleted, decreasing from **$34.6 million** at June 30, 2024, to **zero** by March 31, 2025[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 FY2025, MEI Pharma reported no revenue and a net loss of $2.6 million, a smaller loss than the prior year due to significant operating expense cuts, while the nine-month period saw a net loss reversing prior year's income Q3 FY2025 vs Q3 FY2024 (Three Months Ended March 31, in thousands) | P&L Item (except per share) | Q3 FY2025 (in thousands) | Q3 FY2024 (in thousands) | | :-------------------------- | :---------- | :---------- | | Total Revenues | $0 | $0 | | Total operating expenses | $2,774 | $9,829 | | **Net (loss) income** | **($2,573)**| **($9,127)**| | **Net (loss) income per share** | **($0.39)** | **($1.37)** | Nine Months Ended March 31 (in thousands) | P&L Item (except per share) | FY2025 (in thousands) | FY2024 (in thousands) | | :-------------------------- | :----------- | :---------- | | Total Revenues | $0 | $65,297 | | Total operating expenses | $14,577 | $31,775 | | **Net (loss) income** | **($13,257)**| **$36,184** | | **Net (loss) income per share** | **($1.99)** | **$5.43** | - Operating expenses were significantly reduced year-over-year, with R&D expenses for the nine-month period dropping from **$12.6 million** to **$3.8 million** and G&A expenses decreasing from **$19.2 million** to **$10.7 million**, reflecting cost-cutting measures[11](index=11&type=chunk) [Company and Legal Information](index=1&type=section&id=Company%20and%20Legal%20Information) This section outlines MEI Pharma's focus on novel cancer therapies and details the report's forward-looking statements and associated risks [About MEI Pharma](index=1&type=section&id=About%20MEI%20Pharma) MEI Pharma is a pharmaceutical company focused on developing novel and differentiated cancer therapies, including its drug candidate voruciclib - MEI Pharma is a pharmaceutical company with a portfolio of drug candidates aimed at providing novel cancer therapies[6](index=6&type=chunk) - The company's pipeline includes voruciclib, an oral cyclin-dependent kinase 9 (CDK9) inhibitor[6](index=6&type=chunk) [Forward-Looking Statements](index=1&type=section&id=Forward-Looking%20Statements) The report contains forward-looking statements concerning the company's ability to execute a strategic transaction, preserve cash, and the potential outcomes of these efforts, cautioning that actual results could differ materially due to various risks - The report includes forward-looking statements regarding the company's ability to execute a strategic transaction, preserve cash, and the potential for stockholders to realize value[7](index=7&type=chunk) - Key risks and uncertainties include the ability to identify attractive strategic alternatives, retain key personnel, adequacy of capital resources, and the impact of economic conditions[8](index=8&type=chunk)

PART I FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The company's financial statements show a net loss of $13.3 million and reduced assets amid a strategic shift [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $20.8 million and stockholders' equity fell to $19.5 million due to cash usage Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (Unaudited) | June 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,472 | $3,705 | | Short-term investments | $0 | $34,640 | | Total current assets | $20,779 | $40,769 | | Total assets | $20,779 | $41,375 | | Total current liabilities | $1,238 | $8,355 | | Total liabilities | $1,238 | $8,355 | | Total stockholders' equity | $19,541 | $33,020 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a nine-month net loss of $13.3 million on zero revenue, a reversal from prior-year income Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Q3 2025 | Q3 2024 | 9 Months 2025 | 9 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $0 | $0 | $0 | $65,297 | | Research and development | $369 | $5,220 | $3,840 | $12,617 | | General and administrative | $2,405 | $4,609 | $10,737 | $19,158 | | (Loss) income from operations | $(2,774) | $(9,829) | $(14,577) | $33,522 | | Net (loss) income | $(2,573) | $(9,127) | $(13,257) | $36,184 | | Net (loss) income per share | $(0.39) | $(1.37) | $(1.99) | $5.43 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity declined to $19.5 million, primarily driven by the period's net loss of $13.3 million - Stockholders' equity fell to **$19.5 million** as of March 31, 2025, from **$33.0 million** at June 30, 2024, mainly due to the cumulative net loss for the period[15](index=15&type=chunk) - In the prior year, a cash dividend of **$1.75 per share**, totaling **$11.7 million**, was declared and paid in the quarter ended December 31, 2023[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash from investing activities offset operating cash use, resulting in a $16.8 million net increase in cash Cash Flow Summary for the Nine Months Ended March 31 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,383) | $(32,474) | | Net cash provided by investing activities | $35,150 | $29,596 | | Net cash used in financing activities | $0 | $(11,660) | | Net increase (decrease) in cash | $16,767 | $(14,538) | | Cash and cash equivalents at end of period | $20,472 | $2,368 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The company is evaluating strategic alternatives after discontinuing voruciclib development and has sufficient cash for 12 months - In July 2024, the Board initiated an evaluation of strategic alternatives, including a potential orderly wind-down, and **discontinued clinical development of voruciclib**[21](index=21&type=chunk) - The company sold its ME-344 asset to Aardvark Therapeutics on October 22, 2024, for an initial payment of **$0.5 million**, recognizing a gain of the same amount[96](index=96&type=chunk)[97](index=97&type=chunk) - The company terminated its lease agreement effective September 30, 2024, paying a termination fee of approximately **$11.1 million** in the fiscal year ended June 30, 2024[77](index=77&type=chunk) - As of March 31, 2025, the company had **$20.5 million** in cash and cash equivalents and believes this is sufficient to fund operations for at least the next 12 months[27](index=27&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift, cessation of clinical development, and resulting operational changes [Overview and Strategic Alternatives](index=26&type=section&id=Overview%20and%20Strategic%20Alternatives) The company is evaluating strategic alternatives, has discontinued voruciclib development, and reduced its workforce - On July 22, 2024, the company announced it would **evaluate strategic alternatives** to maximize stockholder value, including potential transactions or an orderly wind-down[101](index=101&type=chunk) - As part of the strategic review, the company **discontinued clinical development of voruciclib** and initiated a reduction-in-force (RIF) starting August 1, 2024[101](index=101&type=chunk) [Clinical Development Programs](index=26&type=section&id=Clinical%20Development%20Programs) All clinical development for voruciclib has ceased, the ME-344 asset was sold, and the zandelisib program was previously discontinued - Voruciclib, an oral CDK9 inhibitor, has **ceased all ongoing clinical trial efforts**[106](index=106&type=chunk)[122](index=122&type=chunk) - ME-344, a mitochondrial inhibitor, was **sold in October 2024**[125](index=125&type=chunk)[129](index=129&type=chunk) - The zandelisib (PI3Kδ inhibitor) program was **discontinued globally**, and the development and commercialization agreement with Kyowa Kirin was terminated in July 2023[145](index=145&type=chunk)[148](index=148&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses decreased significantly following the cessation of clinical activities and cost-cutting measures Comparison of Three Months Ended March 31 (in thousands) | Expense Category | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $369 | $5,220 | $(4,851) | (92.9)% | | General and administrative | $2,405 | $4,609 | $(2,204) | (47.8)% | Comparison of Nine Months Ended March 31 (in thousands) | Category | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $65,297 | $(65,297) | (100.0)% | | Research and development | $3,840 | $12,617 | $(8,777) | (69.6)% | | General and administrative | $10,737 | $19,158 | $(8,421) | (44.0)% | [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $20.5 million in cash, deemed sufficient for at least 12 months of operations - The company had **$20.5 million** in cash and cash equivalents as of March 31, 2025, and expects this to be sufficient to fund operations for at least the next 12 months[159](index=159&type=chunk)[160](index=160&type=chunk) - Net cash used in operating activities was **$18.4 million** for the nine months ended March 31, 2025, compared to **$32.5 million** in the prior-year period[161](index=161&type=chunk) - The company terminated its office lease on September 30, 2024, after paying a termination fee of **$11.1 million** in the fiscal year ended June 30, 2024, and has no further obligations[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, MEI Pharma is not required to provide this information - The company is not required to provide information for this item as it qualifies as a **smaller reporting company**[171](index=171&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal controls over financial reporting were effective - Based on an evaluation as of March 31, 2025, the principal executive officer and principal financial officer concluded that the company's **disclosure controls and procedures were effective**[172](index=172&type=chunk) - **No material changes** occurred during the fiscal quarter ended March 31, 2025, that affected the company's internal control over financial reporting[173](index=173&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[177](index=177&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's 2024 Annual Report - There have been **no material changes** in risk factors from those included in the 2024 Annual Report[178](index=178&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities - None[179](index=179&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No executive officers or directors have adopted, modified, or terminated any Rule 10b5-1 trading plans - No executive officers or directors adopted, modified, or terminated any **Rule 10b5-1 trading plans** during the nine months ended March 31, 2025[182](index=182&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including agreements and officer certifications

Financial Position - As of December 31, 2024, MEI Pharma had $23.7 million in cash and cash equivalents with no outstanding debt[5]. - The total stockholders' equity as of December 31, 2024, was $22.1 million, down from $33.0 million as of June 30, 2024[10]. Revenue and Expenses - For the six months ended December 31, 2024, the company reported total revenues of $0, compared to $65.3 million for the same period in 2023[11]. - Total operating expenses for the six months ended December 31, 2024, were $21.9 million, a decrease from $43.4 million for the same period in 2023[11]. - The net loss for the three months ended December 31, 2024, was $2.7 million, compared to a net loss of $11.1 million for the same period in 2023[11]. - The weighted-average shares used in computing net loss per share for the three months ended December 31, 2024, were 6.663 million[11]. Strategic Direction - The company is currently evaluating strategic alternatives, including out-licensing and merger opportunities, to maximize asset value for stockholders[2]. - Cash preservation efforts have been initiated, including a reduction-in-force, as the company's operational and strategic direction evolves[3]. - The company does not expect to disclose further developments regarding strategic alternatives until the evaluation process is completed[4]. Drug Development - MEI Pharma's drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 inhibitor, aimed at providing novel cancer therapies[6].

Financial Performance - MEI Pharma reported an initial payment of $0.5 million and a reimbursement of $55,000 from the sale of ME-344, with potential future milestone payments up to $62.0 million based on regulatory and revenue achievements[104]. - The company recognized no revenue during the six months ended December 31, 2024, a decrease of $65.3 million compared to the same period in 2023 due to the recognition of all deferred revenue from the KKC Commercialization Agreement[153]. - As of June 30, 2023, the company had $64.9 million in aggregate deferred revenue related to the KKC Commercialization Agreement, with $64.5 million allocated to the U.S. License[148]. - Research and development expenses decreased by $3.6 million to $0.3 million for the three months ended December 31, 2024, compared to $3.9 million for the same period in 2023, primarily due to the cessation of all clinical studies[150]. - General and administrative expenses decreased by $4.9 million to $3.1 million for the three months ended December 31, 2024, compared to $8.0 million for the same period in 2023[151]. - Total research and development expenses for the six months ended December 31, 2024, were $3.5 million, down from $7.4 million in the same period in 2023[155]. - General and administrative expenses for the six months ended December 31, 2024, were $8.3 million, a decrease of $6.2 million compared to $14.5 million for the same period in 2023[156]. - Net cash used in operating activities for the six months ended December 31, 2024, was $15.1 million, compared to $29.5 million for the same period in 2023[160]. - The company had $23.7 million in cash and cash equivalents as of December 31, 2024, and expects to fund operations for at least the next 12 months[159]. - Net cash provided by investing activities for the six months ended December 31, 2024, was $35.2 million, an increase from $29.5 million in the same period in 2023[161]. - The company has accumulated losses of $398.9 million since inception and anticipates continued operating losses and negative cash flows for the foreseeable future[158]. Clinical Development - The company has ceased all ongoing clinical trial efforts for voruciclib following the exploration of strategic alternatives announced on July 22, 2024[107]. - Voruciclib completed a Phase 1 trial in patients with acute myeloid leukemia (AML) in combination with venetoclax, with 31% of patients achieving disease control at doses ≥ 100 mg[119]. - In a recent Phase 1 clinical trial, voruciclib was well tolerated at doses up to 200 mg, with no dose limiting toxicities reported[116]. - The median age of patients enrolled in the voruciclib and venetoclax combination study was 67 years, with a median of 2 prior therapies[118]. - Voruciclib demonstrated a reduction in Mcl-1 expression in approximately 50% of evaluable patients, supporting its potential as a therapeutic agent[120]. - The company has discontinued the clinical development of voruciclib while continuing certain nonclinical activities related to its drug candidate assets[102]. - Voruciclib was well tolerated at doses up to 300 mg with no dose limiting toxicities observed, and the most common grade 3 adverse event was myelosuppression associated with AML[121]. - In a study, 44% of patients showed a rebound of peripheral blast counts between Day 14 and Day 28 after stopping voruciclib while continuing venetoclax[122]. - Voruciclib demonstrated anti-tumor activity in a Phase 1 study with 100% response rate in BRAF/MEK naive patients, including two partial responses and one complete response[123]. - ME-344 is being developed to enhance biological activity and improve patient convenience, with a new formulation aimed at increasing commercial opportunity[125]. - In a Phase 1b study of ME-344 combined with bevacizumab, 25% of evaluable patients completed 16 weeks of therapy without disease progression, exceeding the 20% threshold[138]. - The median progression-free survival (PFS) in the first cohort of the ME-344 study was 1.9 months, with a 4-month PFS rate of 31.2%[138]. - Zandelisib development was discontinued outside Japan due to regulatory guidance, with all ongoing clinical studies being closed[144]. - KKC was granted a co-exclusive license for zandelisib, with an initial non-refundable payment of $100 million and potential milestone payments in Japan[146]. - ME-344 has shown potential to enhance venetoclax activity against AML, targeting metabolic vulnerabilities in resistant AML cells[142]. - The combination of ME-344 and bevacizumab demonstrated significant biologic activity, with mean relative Ki67 decreases of 23% in treated patients compared to an increase of 186% in the control group[138]. Strategic Alternatives - The company is evaluating strategic alternatives, including potential transactions and an orderly wind down of operations, to maximize asset value for stockholders[102]. - The strategic alternatives review may include out-licensing opportunities and merger and acquisition possibilities[102]. - MEI Pharma's leadership underwent changes, with the appointment of Justin J. File as Acting CEO following the departure of former executives[103].

[Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) MEI Pharma, Inc. announced its Q3 FY2024 financial results on May 9, 2024, with the accompanying information furnished rather than filed under the Exchange Act - The company issued a press release on May 9, 2024, to announce its financial results for the third quarter ended March 31, 2024[6](index=6&type=chunk) - The information in this Form 8-K and Exhibit 99.1 is furnished, not filed, under Section 18 of the Exchange Act[6](index=6&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details the exhibits accompanying the Form 8-K filing, primarily the press release on financial results List of Exhibits | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release issued by MEI Pharma, Inc., dated May 9, 2024 | | 104 | Cover Page Interactive Data File |

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The company's financial statements for the nine months ended March 31, 2024, reflect a shift to net income primarily from deferred revenue recognition and a decrease in total assets due to cash reductions [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a decrease in total assets and a significant reduction in total liabilities, primarily due to the recognition of deferred revenue Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2024 (Unaudited) | June 30, 2023 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $2,368 | $16,906 | | Short-term investments | $54,184 | $83,787 | | Total current assets | $59,366 | $107,528 | | **Total Assets** | **$71,260** | **$120,809** | | **Liabilities** | | | | Total current liabilities | $9,616 | $20,340 | | Deferred revenue, long-term | $0 | $64,545 | | Total liabilities | $20,231 | $96,185 | | **Total Stockholders' Equity** | **$51,029** | **$24,624** | - The significant decrease in total liabilities is primarily due to the recognition of long-term deferred revenue related to the terminated KKC agreement[10](index=10&type=chunk) - Cash, cash equivalents, and short-term investments decreased from **$100.7 million** at June 30, 2023, to **$56.6 million** at March 31, 2024, reflecting operational spending and an **$11.7 million** dividend payment[10](index=10&type=chunk)[22](index=22&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations show a significant increase in nine-month revenue due to deferred revenue recognition and a substantial decrease in operating expenses, particularly R&D Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | Nine Months Ended Mar 31, 2024 | Nine Months Ended Mar 31, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $0 | $5,894 | $65,297 | $47,359 | | Research and development | $5,220 | $15,104 | $12,617 | $49,880 | | General and administrative | $4,609 | $7,181 | $19,158 | $23,163 | | **Net (loss) income** | **$(9,127)** | **$(15,438)** | **$36,184** | **$(21,809)** | | Net (loss) income per share | $(1.37) | $(2.32) | $5.43 | $(3.27) | - The significant revenue of **$65.3 million** for the nine months ended March 31, 2024, is primarily due to the one-time recognition of **$64.5 million** in deferred revenue from the terminated KKC collaboration agreement[12](index=12&type=chunk)[70](index=70&type=chunk) - Operating expenses decreased significantly year-over-year, with R&D expenses for the nine-month period dropping by **74.7%** from **$49.9 million** to **$12.6 million**, largely due to the discontinuation of the zandelisib program[12](index=12&type=chunk)[157](index=157&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow analysis indicates a net decrease in cash and cash equivalents, primarily driven by operating activities and a significant dividend payment Cash Flow Summary for Nine Months Ended March 31 (in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(32,474) | $(41,182) | | Net cash provided by investing activities | $29,596 | $34,294 | | Net cash used in financing activities | $(11,660) | $(40) | | **Net decrease in cash and cash equivalents** | **$(14,538)** | **$(6,928)** | - Net cash used in operating activities for the nine months ended March 31, 2024, was **$32.5 million**, primarily driven by net income of **$36.2 million** offset by non-cash revenue recognition of **$64.9 million**[17](index=17&type=chunk)[165](index=165&type=chunk) - Financing activities in the nine months ended March 31, 2024, consisted almost entirely of an **$11.7 million** cash dividend payment to stockholders, as per the Cooperation Agreement[17](index=17&type=chunk)[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's pipeline focus, recent corporate agreements including a special dividend, the impact of the zandelisib program termination, and the sufficiency of current cash reserves for future operations - The company's pipeline focuses on voruciclib (CDK9 inhibitor) and ME-344 (OXPHOS inhibitor)[18](index=18&type=chunk) - On October 31, 2023, the company entered a Cooperation Agreement with Anson Funds and Cable Car Capital, which included a special cash dividend of **$1.75 per share** (**$11.7 million** total) paid on December 6, 2023[19](index=19&type=chunk)[22](index=22&type=chunk) - In April 2024, the Board decided not to proceed with a potential second return of capital to conserve resources and extend the company's operational runway[20](index=20&type=chunk) - As of March 31, 2024, the company had **$56.6 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations for at least the next 12 months[23](index=23&type=chunk) - The global license agreement with Kyowa Kirin (KKC) for zandelisib was mutually terminated on July 14, 2023, consequently, the remaining **$64.5 million** in long-term deferred revenue was recognized as revenue from collaboration agreements in the quarter ended September 30, 2023[67](index=67&type=chunk)[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift towards voruciclib and ME-344 development, the financial impact of the zandelisib program termination, and the company's liquidity position [Overview](index=21&type=section&id=Overview) The overview highlights the company's focus on cancer therapies, the impact of a Cooperation Agreement, and strategic decisions regarding pipeline prioritization and capital allocation - The company is a clinical-stage pharmaceutical company focused on developing cancer therapies, with a pipeline including voruciclib (CDK9 inhibitor) and ME-344 (OXPHOS inhibitor)[95](index=95&type=chunk) - A Cooperation Agreement with Anson Funds and Cable Car Capital resulted in an **$11.7 million** dividend payment, board changes, and the formation of a Capital Allocation Committee[96](index=96&type=chunk) - In April 2024, the Board decided to prioritize voruciclib development and a new ME-344 formulation, while also deciding against a potential second capital return to extend the operational runway[99](index=99&type=chunk) [Clinical Development Programs](index=22&type=section&id=Clinical%20Development%20Programs) This section details the progress and strategic decisions for voruciclib, ME-344, and the discontinuation of the zandelisib program - **Voruciclib (CDK9 Inhibitor):** Currently in a Phase 1 trial in combination with venetoclax for patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML), where the combination was well tolerated with no dose-limiting toxicities observed up to **300 mg**, and three out of 20 patients treated at doses of **100 mg** or more achieved a response (2 CRi, 1 MLFS)[102](index=102&type=chunk)[115](index=115&type=chunk)[117](index=117&type=chunk) - **ME-344 (OXPHOS Inhibitor):** The company is developing a new formulation to increase biological activity and improve patient convenience, following encouraging data from a Phase 1b study in metastatic colorectal cancer, where the combination with bevacizumab exceeded a predetermined progression-free survival threshold[121](index=121&type=chunk)[134](index=134&type=chunk)[136](index=136&type=chunk) - **Zandelisib (PI3Kδ Inhibitor):** Global development was discontinued as a business decision following FDA guidance that made the ongoing Phase 3 COASTAL trial unfeasible, leading to the termination of the global license agreement with KKC in July 2023 and MEI regaining full global rights[140](index=140&type=chunk)[142](index=142&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of revenues and expenses, highlighting the impact of the zandelisib program discontinuation on R&D spending Comparison of Three Months Ended March 31, 2024 and 2023 (in thousands) | Metric | Q3 2024 | Q3 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $5,894 | $(5,894) | (100.0)% | | Research and development | $5,220 | $15,104 | $(9,884) | (65.4)% | | General and administrative | $4,609 | $7,181 | $(2,572) | (35.8)% | Comparison of Nine Months Ended March 31, 2024 and 2023 (in thousands) | Metric | YTD 2024 | YTD 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | $65,297 | $47,359 | $17,938 | 37.9% | | Research and development | $12,617 | $49,880 | $(37,263) | (74.7)% | | General and administrative | $19,158 | $23,163 | $(4,005) | (17.3)% | R&D Expense Breakdown by Program (Nine Months Ended March 31, in thousands) | Program | 2024 | 2023 | | :--- | :--- | :--- | | zandelisib | $417 | $27,634 | | voruciclib | $1,570 | $1,859 | | ME-344 | $4,396 | $1,053 | | Other | $6,234 | $19,334 | | **Total R&D** | **$12,617** | **$49,880** | - The increase in nine-month revenue was due to recognizing all remaining deferred revenue from the terminated KKC agreement, while the sharp decrease in R&D expenses reflects the discontinuation of the zandelisib program, with spending now focused on ME-344 and voruciclib[157](index=157&type=chunk)[159](index=159&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position is discussed, including current cash reserves and future capital requirements for ongoing operations and clinical development - As of March 31, 2024, the company had **$56.6 million** in cash, cash equivalents, and short-term investments[163](index=163&type=chunk) - Management believes current resources are sufficient to fund operations for at least 12 months from the report's issuance date[163](index=163&type=chunk) - Net cash used in operating activities for the nine months ended March 31, 2024 was **$32.5 million**[165](index=165&type=chunk) - Future capital requirements will depend on the progress of clinical trials, regulatory outcomes, and potential new collaborations[164](index=164&type=chunk)[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its cash and investments, which is mitigated by a conservative investment strategy focused on capital preservation - The company's market risk is primarily related to interest rates on its cash and short-term investments, which consist of U.S. government securities[173](index=173&type=chunk) - The company does not consider the effects of interest rate movements to be a material risk to its financial condition[175](index=175&type=chunk) - Risk is mitigated by investing in high-credit-quality financial instruments and limiting exposure to any one institution[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2024, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[176](index=176&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[177](index=177&type=chunk) [PART II OTHER INFORMATION](index=33&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides other required information, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[180](index=180&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes in risk factors from those included in the 2023 Annual Report on Form 10-K - There have been no material changes in risk factors from those included in the 2023 Annual Report[181](index=181&type=chunk) [Other Part II Items](index=33&type=section&id=Other%20Part%20II%20Items) The company reported no unregistered sales of equity securities, no defaults upon senior securities, and no other material information under Item 5 for the quarter - Item 2: No unregistered sales of equity securities[182](index=182&type=chunk) - Item 3: No defaults upon senior securities[183](index=183&type=chunk) - Item 5: No director or officer adopted, modified, or terminated a Rule 10b5-1 trading plan during the quarter[186](index=186&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, and Inline XBRL documents[188](index=188&type=chunk)

PART I FINANCIAL INFORMATION [Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Unaudited financial statements detail the company's financial position, operations, equity, and cash flows, highlighting the KKC agreement termination, expense reductions, and a special dividend [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased, liabilities significantly reduced due to deferred revenue recognition, and stockholders' equity increased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2023 (Unaudited) | June 30, 2023 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $5,174 | $16,906 | | Short-term investments | $54,306 | $83,787 | | Total current assets | $66,172 | $107,528 | | **Total Assets** | **$78,538** | **$120,809** | | **Current Liabilities** | | | | Total current liabilities | $8,038 | $20,340 | | Deferred revenue, long-term | $— | $64,545 | | **Total Liabilities** | **$19,050** | **$96,185** | | **Total Stockholders' Equity** | **$59,488** | **$24,624** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for three months due to zero revenue, while six-month net income increased from one-time deferred revenue recognition, with R&D and G&A expenses significantly decreasing in both periods Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | Six Months Ended Dec 31, 2023 | Six Months Ended Dec 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $— | $32,735 | $65,297 | $41,465 | | Research and Development | $3,912 | $15,313 | $7,397 | $34,776 | | General and Administrative | $8,018 | $8,496 | $14,549 | $15,982 | | (Loss) Income from Operations | $(11,930) | $8,926 | $43,351 | $(9,293) | | Net (Loss) Income | $(11,063) | $10,253 | $45,311 | $(6,371) | | Net (Loss) Income per Share | $(1.66) | $1.54 | $6.80 | $(0.96) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased to $59.5 million, driven by net income, partially offset by an $11.7 million special cash dividend - A special cash dividend of **$1.75 per share**, totaling **$11.7 million**, was declared and paid during the quarter ended **December 31, 2023**[14](index=14&type=chunk)[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $29.5 million, offset by investing activities, with financing activities using $11.7 million for dividends, resulting in a net cash decrease Cash Flow Summary for the Six Months Ended December 31 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(29,546) | $(29,052) | | Net cash provided by investing activities | $29,474 | $24,269 | | Net cash used in financing activities | $(11,660) | $(40) | | **Net decrease in cash and cash equivalents** | **$(11,732)** | **$(4,823)** | | Cash and cash equivalents at end of period | $5,174 | $10,917 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail significant events and accounting policies, including the Cooperation Agreement, KKC agreement termination, workforce reduction, and sufficient liquidity for the next 12 months - Entered into a **Cooperation Agreement** with **Anson Funds** and **Cable Car Capital**, resulting in a special cash dividend of **$1.75 per share** (**$11.7 million** total) paid on **December 6, 2023**[20](index=20&type=chunk)[22](index=22&type=chunk) - The company believes its cash, cash equivalents, and short-term investments of **$59.5 million** as of **December 31, 2023**, are sufficient to fund operations for at least the **next 12 months**[23](index=23&type=chunk) - The global license agreement with **Kyowa Kirin (KKC)** for **zandelisib** was mutually terminated on **July 14, 2023**. This resulted in the recognition of the remaining **$64.5 million** in long-term deferred revenue during the quarter ended **September 30, 2023**[69](index=69&type=chunk)[72](index=72&type=chunk) - A staggered workforce reduction affecting an aggregate of **51% of employees** was implemented, resulting in one-time employee termination benefit charges[61](index=61&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operational results, highlighting the clinical pipeline, strategic shifts, and the financial impact of the KKC agreement termination [Overview](index=26&type=section&id=Overview) MEI Pharma, a clinical-stage company, focuses on cancer therapies with a pipeline including voruciclib and ME-344, and believes current cash is sufficient for at least 12 months following a Cooperation Agreement - The company's pipeline is focused on **voruciclib** (oral **CDK9 inhibitor**) and **ME-344** (intravenous **OXPHOS inhibitor**)[98](index=98&type=chunk) - A **Cooperation Agreement** was executed with activist investors, leading to a **$1.75 per share** dividend, appointment of new directors, and formation of a Capital Allocation Committee[100](index=100&type=chunk)[104](index=104&type=chunk) - Management asserts that cash on hand is sufficient to fund operations for at least **12 months** and through key clinical data readouts for **voruciclib** and **ME-344**[99](index=99&type=chunk) [Clinical Development Programs](index=27&type=section&id=Clinical%20Development%20Programs) Clinical development focuses on voruciclib (Phase 1, data expected Q1 2024) and ME-344 (Phase 1b, data expected H1 2024), following the discontinuation of the zandelisib program - **Voruciclib** (**CDK9 Inhibitor**): Currently in a **Phase 1** trial for **AML** and **B-cell malignancies**, both as a monotherapy and in combination with venetoclax. Clinical data from the dose escalation portion is expected in **Q1 2024**[103](index=103&type=chunk)[111](index=111&type=chunk) - **ME-344** (**OXPHOS Inhibitor**): Being evaluated in a **Phase 1b** study in combination with bevacizumab for relapsed **colorectal cancer**. Safety and efficacy data from the first cohort is expected in **H1 2024**[101](index=101&type=chunk)[129](index=129&type=chunk) - **Zandelisib** (**PI3Kδ Inhibitor**): Global development was discontinued following FDA guidance discouraging filings based on single-arm trial data. The development and commercialization agreement with **KKC** was terminated on **July 14, 2023**[132](index=132&type=chunk)[134](index=134&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Three-month revenue was zero due to KKC termination, while six-month revenue increased from one-time deferred revenue recognition, with R&D and G&A expenses significantly decreasing in both periods R&D Expenses by Program (in thousands) | Program | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | Six Months Ended Dec 31, 2023 | Six Months Ended Dec 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | zandelisib | $(58) | $8,265 | $391 | $19,871 | | voruciclib | $523 | $428 | $188 | $1,161 | | ME-344 | $1,385 | $64 | $2,605 | $849 | | Other | $2,062 | $6,556 | $4,213 | $12,895 | | **Total R&D** | **$3,912** | **$15,313** | **$7,397** | **$34,776** | - The decrease in R&D and G&A expenses was primarily due to the discontinuation of the **zandelisib** program and significant reductions in workforce[140](index=140&type=chunk)[141](index=141&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - The increase in revenue for the six-month period was due to the recognition of all remaining deferred revenue (**$64.5 million**) associated with the terminated **KKC** Commercialization Agreement[143](index=143&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $59.5 million in cash and investments, deemed sufficient for the next 12 months, with net cash used in operations at $29.5 million, and a potential second capital return - The company held **$59.5 million** in cash, cash equivalents, and short-term investments as of **December 31, 2023**[148](index=148&type=chunk) - Net cash used in operating activities for the six months ended **December 31, 2023**, was **$29.5 million**[150](index=150&type=chunk) - A potential second return of capital, not to exceed **$9.33 million**, may be authorized by the Board depending on the outcome of the **ME-344 Phase 1b** trial[153](index=153&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate exposure on cash and short-term investments, which management does not consider material - The company's market risk is primarily from interest rate fluctuations on its cash and short-term investments[160](index=160&type=chunk) - The company mitigates risk by investing in high-credit-quality financial institutions and **U.S. government securities**, and does not consider interest rate risk to be material[161](index=161&type=chunk)[162](index=162&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of December 31, 2023, with no material changes in internal control over financial reporting - As of **December 31, 2023**, the **CEO and CFO** concluded that the company's disclosure controls and procedures were effective[163](index=163&type=chunk) - No changes occurred during the fiscal quarter ended **December 31, 2023**, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[164](index=164&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - There are no legal proceedings to report[167](index=167&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the company's 2023 Annual Report on Form 10-K were reported - No material changes in risk factors from the **2023 Annual Report on Form 10-K** were reported[168](index=168&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities[169](index=169&type=chunk) [Defaults upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[170](index=170&type=chunk) [Other Information](index=34&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - There is no other information to report[172](index=172&type=chunk) [Exhibits](index=35&type=section&id=Item%206.%20Exhibits) Exhibits filed with the Form 10-Q include certifications by the CEO and CFO, and various agreements such as the Termination Agreement with Kyowa Kirin and the Cooperation Agreement - Exhibits filed include the **Termination Agreement** with **Kyowa Kirin**, the **Cooperation Agreement**, and officer certifications[175](index=175&type=chunk)

PART I FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis for the period [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q3 2023 reflect increased revenues and net income, driven by deferred revenue recognition, alongside decreased assets and liabilities, and higher stockholders' equity [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant decrease in total liabilities and an increase in stockholders' equity, primarily due to deferred revenue recognition Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 (in thousands) | June 30, 2023 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $3,372 | $16,906 | ($13,534) | | Short-term investments | $78,830 | $83,787 | ($4,957) | | **Total Assets** | **$101,251** | **$120,809** | **($19,558)** | | Total current liabilities | $8,564 | $20,340 | ($11,776) | | Deferred revenue, long-term | $0 | $64,545 | ($64,545) | | **Total Liabilities** | **$19,890** | **$96,185** | **($76,295)** | | **Total Stockholders' Equity** | **$81,361** | **$24,624** | **$56,737** | - The significant decrease in total liabilities and corresponding increase in stockholders' equity is primarily due to the recognition of **$64.5 million** in long-term deferred revenue following the termination of the KKC Commercialization Agreement[10](index=10&type=chunk)[70](index=70&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations shows a significant shift to net income driven by substantial revenue recognition and reduced operating expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 (in thousands) | Three Months Ended Sep 30, 2022 (in thousands) | | :--- | :--- | :--- | | Total Revenues | $65,297 | $8,730 | | Research and development | $3,485 | $19,463 | | General and administrative | $6,531 | $7,486 | | **Income (loss) from operations** | **$55,281** | **($18,219)** | | **Net income (loss)** | **$56,374** | **($16,624)** | | **Net income (loss) per share** | **$8.46** | **($2.49)** | - The company reported a net income of **$56.4 million** for the quarter, a stark contrast to the **$16.6 million** net loss in the prior-year period, driven by the recognition of **$64.5 million** in revenue from the terminated KKC collaboration agreement[13](index=13&type=chunk)[70](index=70&type=chunk) - Operating expenses decreased significantly to **$10.0 million** from **$26.9 million** year-over-year, primarily due to a sharp reduction in research and development expenses from **$19.5 million** to **$3.5 million**[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow from operations increased due to non-cash revenue recognition, leading to a net decrease in cash and equivalents Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended Sep 30, 2023 (in thousands) | Three Months Ended Sep 30, 2022 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,491) | ($14,782) | | Net cash provided by investing activities | $4,957 | $13,735 | | Net cash (used in) provided by financing activities | $0 | ($40) | | **Net decrease in cash and cash equivalents** | **($13,534)** | **($1,087)** | | **Cash and cash equivalents at end of period** | **$3,372** | **$14,653** | - Net cash used in operating activities was **$18.5 million**, an increase from **$14.8 million** in the prior year, primarily driven by operating expenses as the large reported net income included a **$64.9 million** non-cash recognition of deferred revenue[19](index=19&type=chunk)[145](index=145&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes include a Cooperation Agreement with investors, the company's liquidity position, and the termination of the KKC collaboration agreement - On October 31, 2023, the company entered a Cooperation Agreement with Anson Funds and Cable Car Capital, which includes a special cash dividend of **$1.75 per share**, a potential second return of capital, and board changes[23](index=23&type=chunk)[90](index=90&type=chunk) - As of September 30, 2023, the company had **$82.2 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations for at least the next 12 months[26](index=26&type=chunk) - The global License, Development and Commercialization Agreement with Kyowa Kirin Co., Ltd. (KKC) for zandelisib was terminated on July 14, 2023, resulting in the recognition of the remaining long-term deferred revenue of **$64.5 million** as revenue from collaboration agreements in the quarter[67](index=67&type=chunk)[70](index=70&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic realignment to focus on clinical assets voruciclib and ME-344, significant capital return to shareholders, and the financial impact of the terminated KKC agreement and reduced R&D expenses [Overview](index=21&type=section&id=Overview) The company, a clinical-stage pharmaceutical firm, realigned its focus on two key cancer therapies and entered a Cooperation Agreement with investors - The company is a clinical-stage pharmaceutical firm focused on developing cancer therapies, with a pipeline including voruciclib (CDK9 inhibitor) and ME-344 (mitochondrial inhibitor)[98](index=98&type=chunk) - Following a realignment in December 2022, the company reduced its workforce by **61%** to focus on its two clinical assets, voruciclib and ME-344[98](index=98&type=chunk) - A Cooperation Agreement was signed on October 31, 2023, with Anson Funds and Cable Car Capital, resulting in a **$1.75 per share** dividend, board changes, and the formation of a Capital Allocation Committee[99](index=99&type=chunk)[103](index=103&type=chunk) [Clinical Development Programs](index=22&type=section&id=Clinical%20Development%20Programs) The company is advancing voruciclib and ME-344 in clinical trials, while discontinuing the zandelisib program - **Voruciclib (CDK9 Inhibitor):** Currently in a Phase 1 trial for AML and B-cell malignancies, both as a single agent and in combination with venetoclax, with clinical data expected in early calendar 2024[103](index=103&type=chunk)[110](index=110&type=chunk) - **ME-344 (Mitochondrial Inhibitor):** Being advanced in a Phase 1b study in combination with bevacizumab for relapsed colorectal cancer, with safety and efficacy data from the first cohort expected in the first half of calendar 2024[115](index=115&type=chunk)[126](index=126&type=chunk) - **Zandelisib (PI3Kδ Inhibitor):** Global development was discontinued following FDA guidance discouraging a filing based on single-arm trial data, and the development and commercialization agreement with KKC was formally terminated on July 14, 2023[131](index=131&type=chunk)[133](index=133&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) The company's operations show a significant revenue increase due to deferred revenue recognition and a substantial decrease in R&D expenses Revenue Comparison (in millions) | Period | Revenue (in millions) | Change (in millions) | Reason | | :--- | :--- | :--- | :--- | | Q3 2023 | $65.3 | +$56.6 | Recognition of deferred revenue from terminated U.S. License with KKC | | Q3 2022 | $8.7 | | Cost sharing from KKC agreement | Research & Development Expenses (in thousands) | Program | Q3 2023 (in thousands) | Q3 2022 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | zandelisib | $449 | $11,606 | ($11,157) | | voruciclib | ($335) | $733 | ($1,068) | | ME-344 | $1,220 | $785 | $435 | | Other | $2,151 | $6,339 | ($4,188) | | **Total R&D** | **$3,485** | **$19,463** | **($15,978)** | - The decrease in R&D expenses was primarily driven by an **$11.2 million** reduction in zandelisib costs due to the program's discontinuation[139](index=139&type=chunk) - General and administrative expenses decreased by **$1.0 million**, mainly due to lower personnel costs from reduced headcount, partially offset by increased professional fees related to stockholder activities[140](index=140&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains sufficient liquidity to fund operations for at least 12 months, with future capital requirements impacted by the Cooperation Agreement - As of September 30, 2023, the company had **$82.2 million** in cash, cash equivalents, and short-term investments[142](index=142&type=chunk) - Management believes current resources are sufficient to fund operations for at least **12 months** from the report's issuance date[142](index=142&type=chunk) - Future capital requirements will be impacted by the Cooperation Agreement, which mandates a dividend payment of **$1.75 per share**, reimbursement of up to **$1.2 million** in legal fees, and a potential second capital return of approximately **$9.33 million**[148](index=148&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's market risk primarily stems from interest rate fluctuations on U.S. government securities, mitigated by high-credit-quality institutions, and is not considered material - The company's market risk is primarily related to interest rates on its cash and short-term investments[156](index=156&type=chunk) - Investments are limited to U.S. government securities, and deposits are held with high-credit-quality financial institutions to mitigate default risk[156](index=156&type=chunk)[157](index=157&type=chunk) - The company does not consider the effects of interest rate movements to be a material risk[158](index=158&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective[159](index=159&type=chunk)[160](index=160&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[161](index=161&type=chunk) PART II OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[164](index=164&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's 2023 Annual Report - There have been no material changes in risk factors from those included in the 2023 Annual Report[165](index=165&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[165](index=165&type=chunk) [Defaults upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[166](index=166&type=chunk) [Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[167](index=167&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None[168](index=168&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including the KKC Termination Agreement and the Cooperation Agreement with investors - Key exhibits filed include the Termination Agreement with Kyowa Kirin Co., Ltd. and the Cooperation Agreement dated October 31, 2023[171](index=171&type=chunk)

MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2023 Earnings Call Transcript September 26, 2023 5:00 PM ET Company Participants David Walsey - SVP, Corporate Affairs David Urso - President & CEO Jay File - CFO Richard Ghalie - CMO Conference Call Participants Yale Jen - Laidlaw & Company Stephen Willey - Stifel Operator Good day and welcome to the MEI Fiscal Year-End Earnings Call. My name is Gary and I will be the conference facilitator today. All participants will be in a listen-only mode. After today's prepared remar ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-50484 MEI Pharma, Inc. (Exact name of registrant as specified in its charter) DELAWARE 51-0407811 (State or other jurisdiction ...