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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR DELAWARE 51-0407811 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 11455 El Camino Real, San Diego, CA 92130 (Address of principal executive offices) (Zip Code) (858) 369-7100 (Registrant's telephone number, inc ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 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 ...

PART I FINANCIAL INFORMATION [Condensed Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Financial%20Statements) The company's quarterly financials show decreased assets and equity, with higher revenue but a continued net loss and increased cash burn [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets and stockholders' equity declined quarter-over-quarter, driven by a reduction in cash and short-term investments Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 (Unaudited) | Jun 30, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $138,367 | $153,252 | | Total current assets | $148,907 | $167,126 | | Total assets | $163,583 | $177,840 | | Total current liabilities | $23,435 | $24,443 | | Total liabilities | $126,275 | $125,427 | | Total stockholders' equity | $37,308 | $52,413 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Quarterly revenue increased year-over-year while operating expenses decreased, resulting in a slightly narrowed net loss Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Revenue | $8,730 | $7,757 | | Research and development | $19,463 | $19,953 | | General and administrative | $7,486 | $7,909 | | Loss from operations | $(18,219) | $(20,105) | | Net loss | $(16,624) | $(17,510) | | Net loss per share (Basic & Diluted) | $(0.12) | $(0.16) / $(0.18) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased significantly year-over-year, leading to a net decrease in cash for the quarter Condensed Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,782) | $(7,721) | | Net cash provided by investing activities | $13,735 | $14,993 | | Net cash used in financing activities | $(40) | $(194) | | Net (decrease) increase in cash and cash equivalents | $(1,087) | $7,078 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the clinical pipeline, liquidity, revenue sources from the KKC agreement, and a Nasdaq bid price deficiency - The company is a late-stage pharmaceutical firm with a portfolio of **three clinical-stage cancer therapies**: zandelisib, voruciclib, and ME-344[20](index=20&type=chunk)[24](index=24&type=chunk) - As of September 30, 2022, the company had **$138.4 million in cash**, cash equivalents, and short-term investments, which management believes is sufficient to fund operations for at least the next 12 months[22](index=22&type=chunk) - Quarterly revenue of **$8.7 million** was primarily derived from the license agreement with Kyowa Kirin Co, Ltd (KKC)[37](index=37&type=chunk) - The company received a **Nasdaq deficiency notice** for its stock price falling below the $1.00 minimum bid requirement, with compliance extended to May 8, 2023[75](index=75&type=chunk)[76](index=76&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical program shifts due to FDA guidance, financial results, liquidity, and a temporary supply chain issue [Clinical Development Programs](index=22&type=section&id=Clinical%20Development%20Programs) The clinical pipeline strategy has shifted for zandelisib due to FDA feedback, while other programs continue to advance - **Zandelisib:** Following FDA feedback discouraging a filing based on the single-arm Phase 2 TIDAL study, the company is focusing on the **ongoing randomized Phase 3 COASTAL study** for potential marketing applications[111](index=111&type=chunk)[113](index=113&type=chunk) - **Zandelisib Supply Chain Issue:** A temporary issue with zandelisib blister pack labeling has paused new patient enrollment, expected to **delay COASTAL enrollment by approximately three months**[141](index=141&type=chunk) - **Voruciclib:** A Phase 1 study is evaluating voruciclib in combination with venetoclax in patients with Acute Myeloid Leukemia (AML), expected to start by the **end of calendar year 2022**[148](index=148&type=chunk)[149](index=149&type=chunk) - **ME-344:** The company plans to advance ME-344 in a Phase 1b study for relapsed colorectal cancer in the **first half of calendar year 2023**[161](index=161&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Quarterly revenue grew year-over-year while both R&D and G&A expenses decreased, driven by lower study and compensation costs Comparison of Operations (in thousands) | Item | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Revenue | $8,730 | $7,757 | | Research and development expenses | $19,463 | $19,953 | | General and administrative expenses | $7,486 | $7,909 | - The decrease in R&D costs was primarily due to **lower costs for the zandelisib TIDAL study**, as enrollment was completed before the quarter[165](index=165&type=chunk) - The decrease in G&A expenses was mainly due to a **$1.0 million decrease in share-based compensation** and a $0.4 million decrease in external professional services and legal costs[167](index=167&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds sufficient cash for the next 12 months despite an increased operating cash burn and a history of losses - The company has **accumulated losses of $390.8 million** since inception and expects to incur future operating losses[169](index=169&type=chunk) - The increase in net cash used in operating activities from $7.7 million in Q3 2021 to **$14.8 million in Q3 2022** primarily reflects the non-recurrence of a $10.0 million milestone payment received in the prior year[171](index=171&type=chunk) - Future funding will likely be pursued through **equity or debt financing**, license agreements, or strategic partnerships[170](index=170&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 from interest rate fluctuations on its investments is not considered material - Market risk is primarily related to **interest rates on cash and short-term investments**[185](index=185&type=chunk) - The company mitigates default risk by using high-credit-quality financial institutions and investing in **U.S. government securities**[186](index=186&type=chunk) - The company does not consider the effects of interest rate movements to be a **material risk**[187](index=187&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to a material weakness in revenue recognition, with a remediation plan underway - Disclosure controls and procedures were deemed **not effective** due to a material weakness in internal control over financial reporting[189](index=189&type=chunk) - The material weakness is related to inadequate controls for evaluating and monitoring **revenue recognition from license agreements**[189](index=189&type=chunk) - A **remediation plan is being implemented**, which includes enhanced contract review and quarterly evaluation of revenue balances[191](index=191&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings for the period - None[195](index=195&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the last Annual Report - There have been **no material changes** in our risk factors from those included in our 2022 Annual Report[196](index=196&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 - None[197](index=197&type=chunk) [Exhibits](index=35&type=section&id=Item%206.%20Exhibits) The report lists all exhibits filed with the SEC, including officer certifications and XBRL data - Exhibits filed include **CEO and CFO certifications** (31.1, 31.2, 32.1) and Inline XBRL data files (101 series)[203](index=203&type=chunk)