MEI Pharma(MEIP)
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MEI Pharma(MEIP) - 2023 Q4 - Earnings Call Transcript
2023-09-26 23:47
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 ...
MEI Pharma(MEIP) - 2023 Q4 - Annual Report
2023-09-26 20:11
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 ...
MEI Pharma(MEIP) - 2023 Q3 - Quarterly Report
2023-05-11 20:01
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 ...
MEI Pharma(MEIP) - 2023 Q2 - Quarterly Report
2023-02-09 21:01
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 ...
MEI Pharma(MEIP) - 2023 Q1 - Quarterly Report
2022-11-14 21:02
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)
MEI Pharma (MEIP) Investor Presentation - Slideshow
2022-09-16 21:19
On Target: Developing Best-in-Class Cancer Therapies September 12, 2022 Forward-Looking Statements This presentation contains, and our officers and representatives may from time to time make, statements that are "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include, among others, statements regarding our development strategy; potential advantages of our product candidates; the ...
MEI Pharma(MEIP) - 2022 Q4 - Earnings Call Transcript
2022-09-09 01:00
MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2022 Results Conference Call September 8, 2022 5:00 PM ET Company Participants David Walsey - Senior Vice President and Corporate Affairs Dan Gold - President and Chief Executive Officer Brian Drazba - Chief Financial Officer David Urso - Chief Operating Officer and General Counsel Richard Ghalie - Chief Medical Officer Conference Call Participants Stephen Willey - Stifel Robyn Karnauskas - Truist Yale Jen - Laidlaw & Co Nick Abbott - Wells Fargo Operator Good afternoon, an ...
MEI Pharma(MEIP) - 2022 Q4 - Annual Report
2022-09-08 20:01
Part I [Business](index=5&type=section&id=Item%201.%20Business) MEI Pharma is a late-stage pharmaceutical company focused on developing and commercializing novel cancer therapies - The company's portfolio consists of three clinical-stage drug candidates: **zandelisib** (PI3Kδ inhibitor), **voruciclib** (CDK9 inhibitor), and **ME-344** (mitochondrial inhibitor)[18](index=18&type=chunk) - MEI Pharma's business model focuses on **licensing or acquiring** promising cancer agents and then creating value through **development, commercialization, and strategic partnerships**[16](index=16&type=chunk)[17](index=17&type=chunk) Clinical Development Programs The company's clinical pipeline, led by zandelisib, advances through various phases for B-cell malignancies and solid tumors Clinical Pipeline Overview | Investigational Agent | Therapeutic Area | Status | | :--- | :--- | :--- | | **Zandelisib** (PI3Kδ Inhibitor) | Follicular & Marginal Zone Lymphomas | Phase 3 (COASTAL Study) | | | Relapsed/refractory FL/MZL | Phase 2 (TIDAL Study) | | | B-Cell Malignancies | Phase 1/1b (Combination Studies) | | **Voruciclib** (CDK9 Inhibitor) | B-Cell Malignancies & AML | Phase 1 (Dose & Schedule Trial) | | **ME-344** (Mitochondrial Inhibitor) | Solid Tumors (Colorectal Cancer) | Planned Phase 1b (with bevacizumab) | - Following **FDA feedback** discouraging a marketing application based on the **single-arm Phase 2 TIDAL study**, the company is focusing on the **randomized Phase 3 COASTAL study** to support global marketing applications for zandelisib[23](index=23&type=chunk)[25](index=25&type=chunk) - Data from the TIDAL study in follicular lymphoma (FL) showed a **70.3% overall response rate (ORR)** and a **35.2% complete response rate (CR)** in the primary efficacy population of 91 patients[22](index=22&type=chunk)[47](index=47&type=chunk) - Voruciclib is being evaluated in a **Phase 1 trial** as a **monotherapy and in combination with venetoclax** for **AML and B-cell malignancies**, with plans to initiate the combination study by the **end of calendar year 2022**[59](index=59&type=chunk)[60](index=60&type=chunk) - ME-344 is planned to advance into a **Phase 1b study** in **combination with bevacizumab** for **relapsed colorectal cancer** in the **first half of calendar year 2023**[71](index=71&type=chunk) KKC License, Development and Commercialization Agreement MEI Pharma and KKC have a global agreement for zandelisib, co-developing in the U.S. with profit sharing and KKC holding ex-U.S. rights - MEI and KKC will **co-develop and co-promote zandelisib in the U.S.**, **sharing profits and costs on a 50-50 basis**; **MEI will record all revenue from U.S. sales**[31](index=31&type=chunk) - KKC has **exclusive commercialization rights** for zandelisib **outside of the U.S.**[30](index=30&type=chunk) KKC Agreement Financial Terms | Term | Amount/Details | | :--- | :--- | | Upfront Payment | $100 million | | Potential Milestones | Up to ~$582.5 million (development, regulatory, commercial) | | Ex-U.S. Royalties | Tiered, beginning in the teens | | Milestones Received (FY2022) | $20 million (two $10M payments for COASTAL study initiation) | Competition The company faces intense competition from larger, more resourced pharmaceutical and biotechnology companies developing similar drug candidates - The company faces competition from **large pharmaceutical and biotechnology companies, universities, and research institutions** that may have **greater resources and experience**[74](index=74&type=chunk) - Competitors are developing products for the same indications, and some are **more advanced in development**, potentially **reaching the market sooner**[73](index=73&type=chunk) Intellectual Property MEI Pharma protects its proprietary technology through a global patent portfolio for its drug candidates, with key patents expiring between 2024 and 2037 Patent Portfolio Summary (as of report date) | Category | U.S. Issued | Foreign Issued | U.S. Pending | Foreign Pending | | :--- | :--- | :--- | :--- | :--- | | **Total** | ~36 | ~209 | 17 | 137 | - Key U.S. composition of matter patents for zandelisib are projected to expire in **January 2031 and December 2032**[76](index=76&type=chunk) - Key U.S. composition of matter patents for voruciclib are projected to expire between **April 2024 and December 2037**[77](index=77&type=chunk) - Key U.S. composition of matter patents for ME-344 are expected to expire in **March 2027 and November 2031**[80](index=80&type=chunk) Government Regulation The company's operations are subject to extensive FDA and international regulations, covering drug development, clinical trials, and approval processes - The FDA drug approval process is **extensive**, involving **preclinical studies**, an **Investigational New Drug (IND) application**, and **three sequential phases of human clinical trials** before submitting a **New Drug Application (NDA)**[88](index=88&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk) - Zandelisib has received **Fast Track designation** from the FDA for treating adult patients with **r/r follicular lymphoma** who have received at least two prior systemic therapies[115](index=115&type=chunk) - The company has also received **orphan-drug designation** for zandelisib for the treatment of follicular lymphoma, which may provide **financial incentives and a period of market exclusivity** if approved[21](index=21&type=chunk)[125](index=125&type=chunk) - The report notes **increasing scrutiny on the accelerated approval pathway**, with the **FDA and public favoring randomized trials over single-arm studies** to support approvals, which **directly impacted the development strategy for zandelisib**[113](index=113&type=chunk) Human Capital Management As of June 30, 2022, MEI Pharma had 102 employees and focuses on attracting and retaining talent through competitive compensation and a positive work environment - As of June 30, 2022, the company had **102 employees**[133](index=133&type=chunk) - The company's human capital strategy includes offering **competitive compensation, benefits, and stock options** to **attract and retain talent**[134](index=134&type=chunk)[135](index=135&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including Nasdaq delisting, geopolitical instability, funding needs, clinical trial uncertainties, regulatory hurdles, and internal control weaknesses - The company is **not in compliance with the Nasdaq minimum bid price requirement** of $1.00 per share and **could be delisted** if compliance is not regained[140](index=140&type=chunk)[144](index=144&type=chunk) - The **military conflict in Russia and Ukraine** has led to the **suspension of planned clinical trial sites** for the **COASTAL trial** in those countries, potentially **affecting recruitment timelines**[140](index=140&type=chunk)[152](index=152&type=chunk) - Final regulatory approval may be **delayed or prevented**, as highlighted by the **FDA's recommendation against filing for zandelisib based on single-arm data** and its **emphasis on randomized trials for PI3K inhibitors**[140](index=140&type=chunk)[185](index=185&type=chunk) - A **material weakness** was identified in **internal control over financial reporting** related to **revenue recognition**, leading to a **restatement of prior financial statements**; the company is **in the process of remediation**[142](index=142&type=chunk)[258](index=258&type=chunk) - The company **relies heavily on its collaboration with KKC** for the development and commercialization of zandelisib; **failure by KKC to meet its obligations could materially harm the program**[140](index=140&type=chunk)[167](index=167&type=chunk) [Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None [Properties](index=50&type=section&id=Item%202.%20Properties) The company leases approximately 45,100 square feet of office space in San Diego, California, under a lease agreement that expires in November 2029 - The company leases approximately **45,100 square feet** of office space in **San Diego, CA**, with the lease expiring in **November 2029**[287](index=287&type=chunk) [Legal Proceedings](index=50&type=section&id=Item%203.%20Legal%20Proceedings) The company reports that there are no legal proceedings - None [Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable Part II [Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=50&type=section&id=Item%205.%20Market%20for%20the%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) MEI Pharma's common stock trades on Nasdaq under 'MEIP', with 133.3 million shares outstanding as of September 2022, and no plans for cash dividends - The company's common stock is listed on the **Nasdaq Capital Market** under the symbol **'MEIP'**[291](index=291&type=chunk) - As of September 6, 2022, there were **133,260,865 shares** of common stock outstanding[292](index=292&type=chunk) - The company has **never paid cash dividends** and **does not plan to in the foreseeable future**[294](index=294&type=chunk) [[Reserved]](index=51&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=51&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In FY2022, revenue increased to $40.7 million, R&D expenses rose to $85.6 million, and the net loss was $54.5 million, with $153.3 million in cash and Nasdaq non-compliance noted Financial Highlights (Fiscal Years Ended June 30) | Metric (in millions) | 2022 | 2021 | | :--- | :--- | :--- | | Revenue | $40.7 | $34.8 | | Research and Development | $85.6 | $69.4 | | General and Administrative | $30.5 | $24.4 | | Loss from Operations | $(75.5) | $(60.4) | | Net Loss | $(54.5) | $(41.3) | - As of June 30, 2022, the company had **$153.3 million in cash, cash equivalents, and short-term investments**, which management believes is **sufficient to fund operations for at least 12 months**[331](index=331&type=chunk) - On May 9, 2022, the company received a notice from **Nasdaq for failing to meet the minimum $1.00 per share bid price requirement**, with a **compliance period ending November 7, 2022**[303](index=303&type=chunk)[304](index=304&type=chunk) Results of Operations In FY2022, revenue increased by $5.9 million, R&D expenses rose by $16.2 million to $85.6 million, and G&A expenses increased by $6.1 million - Revenue increased by **$5.9 million** in FY2022, primarily from **increased reimbursement of R&D expenses from KKC** for the zandelisib program[325](index=325&type=chunk) Research and Development Expenses by Program (in thousands) | Program | FY 2022 | FY 2021 | | :--- | :--- | :--- | | zandelisib | $54,764 | $46,052 | | voruciclib | $5,475 | $2,939 | | ME-344 | $2,915 | $960 | | Other | $22,487 | $19,447 | | **Total** | **$85,641** | **$69,398** | - General and administrative expenses increased by **$6.1 million** in FY2022 due to **higher personnel costs ($2.5M)**, **professional services ($2.0M)**, and **corporate overhead ($1.6M)**[327](index=327&type=chunk) Liquidity and Capital Resources As of June 30, 2022, the company had **$153.3 million** in cash, with net cash used in operations of **$48.7 million** and **$49.1 million** provided by financing activities Cash Flow Summary (Year Ended June 30, 2022, in millions) | Cash Flow Category | Amount | | :--- | :--- | | Net Cash Used in Operating Activities | $(48.7) | | Net Cash Provided by Investing Activities | $6.9 | | Net Cash Provided by Financing Activities | $49.1 | - During FY2022, the company raised **$48.7 million in net proceeds** from an **underwritten registered offering of common stock**[307](index=307&type=chunk)[336](index=336&type=chunk) - The company has an effective shelf registration statement with **$123.4 million available** and an **At-The-Market (ATM) facility with $60.0 million available** as of June 30, 2022[308](index=308&type=chunk)[309](index=309&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=58&type=section&id=Item%207a.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rates on its U.S. government securities, which is not considered material, and inflation's impact on clinical trial costs is noted - The company's market risk is primarily related to **interest rates** on its cash and investments, which are held in **U.S. government securities**; this risk is **not considered material**[345](index=345&type=chunk)[347](index=347&type=chunk) - Inflation is acknowledged to **increase clinical trial costs** but is **not believed to have had a material effect** on financial results for the fiscal years 2020, 2021, or 2022[348](index=348&type=chunk) [Financial Statements and Supplementary Data](index=59&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements for FY2020-2022 are presented, with critical audit matters noted for accrued expenses and KKC revenue recognition, showing total assets of **$177.8 million** and a net loss of **$54.5 million** in FY2022 - The independent auditor identified **two critical audit matters**: 1) **Estimation of accrued pre-clinical and clinical trial expenses**, and 2) **Revenue recognition for the KKC License, Development and Commercialization Agreement**[356](index=356&type=chunk)[360](index=360&type=chunk) Balance Sheet Summary (as of June 30, in thousands) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $153,252 | $153,426 | | Total Assets | $177,840 | $174,098 | | Total Liabilities | $125,427 | $124,632 | | Total Stockholders' Equity | $52,413 | $49,466 | Statement of Operations Summary (Year Ended June 30, in thousands) | Account | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Revenue | $40,697 | $34,796 | $27,756 | | Total Operating Expenses | $116,181 | $95,220 | $53,453 | | Net Loss | $(54,454) | $(41,314) | $(47,173) | | Net Loss Per Share (Basic) | $(0.44) | $(0.37) | $(0.52) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=82&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None [Controls and Procedures](index=82&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of June 30, 2022, due to a material weakness in revenue recognition, with a remediation plan underway - Management concluded that disclosure controls and procedures were **not effective** as of **June 30, 2022**[466](index=466&type=chunk) - A **material weakness** was identified related to the **inadequate design and implementation of controls for revenue recognition** concerning the **KKC license agreement**, which was **in the process of remediation** as of June 30, 2022[472](index=472&type=chunk) - The company is implementing a **remediation plan** that includes **enhanced contract review** and **more detailed review of its revenue recognition models**[473](index=473&type=chunk) [Other Information](index=83&type=section&id=Item%209B.%20Other%20Information) The company reports no other information - None [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=83&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable Part III [Directors, Executive Officers and Corporate Governance](index=84&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the proxy statement, and the company has a Code of Business and Ethics - The required information is **incorporated by reference** from the company's **proxy statement**[481](index=481&type=chunk) - The company has adopted a **Code of Business and Ethics policy** applicable to all directors and employees[480](index=480&type=chunk) [Executive Compensation](index=84&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item regarding executive compensation is incorporated by reference from the company's definitive proxy statement - The required information is **incorporated by reference** from the **Proxy Statement**[482](index=482&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=84&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item regarding security ownership is incorporated by reference from the company's definitive proxy statement - The required information is **incorporated by reference** from the **Proxy Statement**[483](index=483&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=84&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item regarding related transactions and director independence is incorporated by reference from the company's definitive proxy statement - The required information is **incorporated by reference** from the **Proxy Statement**[484](index=484&type=chunk) [Principal Accountant Fees and Services](index=84&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The information required for this item regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement - The required information is **incorporated by reference** from the **Proxy Statement**[485](index=485&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=85&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists financial statements and provides an index of all exhibits filed with the Form 10-K, including key corporate and contractual documents - This section references the **Financial Statements under Item 8** and lists **all exhibits filed with the report**[488](index=488&type=chunk)[490](index=490&type=chunk) [Form 10-K Summary](index=86&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary - None
MEI Pharma(MEIP) - 2022 Q3 - Quarterly Report
2022-05-23 20:17
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) 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 of incorporation or organization) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1 ...
MEI Pharma(MEIP) - 2022 Q2 - Quarterly Report
2022-02-10 21:01
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, 2021 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 ...