MEI Pharma(MEIP) - 2020 Q2 - Quarterly Report

PART I FINANCIAL INFORMATION This section details MEI Pharma, Inc.'s unaudited financial statements, management's analysis, market risk, and internal controls Item 1: Financial Statements (Unaudited) Unaudited financial statements show increased assets and equity from new financing, with net losses from warrant liability adjustments and reduced license revenue Condensed Balance Sheets as of December 31, 2019 and June 30, 2019 | Metric | December 31, 2019 (in thousands) | June 30, 2019 (in thousands) | Change (in thousands) | % Change | | :--------------------------------- | :------------------------------- | :--------------------------- | :-------------------- | :------- | | Total assets | $107,105 | $82,663 | $24,442 | 29.57% | | Total cash, cash equivalents and short-term investments | $103,881 | $74,489 | $29,392 | 39.46% | | Total liabilities | $29,820 | $34,733 | $(4,913) | -14.14% | | Total stockholders' equity | $77,285 | $47,930 | $29,355 | 61.25% | Condensed Statements of Operations for the three and six months ended December 31, 2019 and 2018 | Metric (in thousands) | 3 Months Ended Dec 31, 2019 | 3 Months Ended Dec 31, 2018 | 6 Months Ended Dec 31, 2019 | 6 Months Ended Dec 31, 2018 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenue | $1,008 | $2,048 | $2,165 | $2,536 | | Loss from operations | $(12,109) | $(11,848) | $(24,732) | $(21,881) | | Change in fair value of warrant liability | $(8,439) | $23,437 | $830 | $18,475 | | Net (loss) income | $(20,217) | $12,025 | $(23,211) | $(2,517) | | Basic EPS | $(0.26) | $0.17 | $(0.30) | $(0.04) | | Diluted EPS | $(0.26) | $(0.15) | $(0.30) | $(0.36) | - Revenue decreased by 50.7% for the three months ended December 31, 2019, and by 14.6% for the six months ended December 31, 2019, compared to the prior year periods[15] - The change in fair value of warrant liability shifted from a $23.4 million gain in Q2 2018 to an $8.4 million expense in Q2 2019, significantly impacting net income[15] Condensed Statements of Stockholders' Equity for the three and six months ended December 31, 2019 and 2018 | Metric (in thousands) | June 30, 2019 | Dec 31, 2019 | | :-------------------- | :------------ | :----------- | | Common Shares | 73,545 | 105,999 | | Additional Paid-In Capital | $279,148 | $331,714 | | Accumulated Deficit | $(231,218) | $(254,429) | | Total Stockholders' Equity | $47,930 | $77,285 | - Issuance of common stock contributed $48,451 thousand to additional paid-in capital during the three months ended December 31, 2019[18] - Accumulated deficit increased by $23.2 million from June 30, 2019, to December 31, 2019, primarily due to net losses[18] Condensed Statements of Cash Flows for the six months ended December 31, 2019 and 2018 | Cash Flow Activity (in thousands) | 6 Months Ended Dec 31, 2019 | 6 Months Ended Dec 31, 2018 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(24,559) | $(10,017) | | Net cash (used in) provided by investing activities | $(30,349) | $4,595 | | Net cash provided by financing activities | $53,956 | $861 | | Net decrease in cash and cash equivalents | $(952) | $(4,561) | | Cash and cash equivalents at end of the period | $8,638 | $8,748 | - Net cash provided by financing activities significantly increased to $54.0 million in 2019, primarily from a $48.5 million common stock offering[21][154] - Net cash used in operating activities increased by $14.5 million, reflecting higher costs in clinical development programs, particularly the ME-401 TIDAL study[21][152] Notes to Condensed Financial Statements Note 1. The Company and Summary of Significant Accounting Policies - MEI Pharma is a late-stage pharmaceutical company focused on oncology, with four clinical-stage drug candidates: ME-401, Voruciclib, ME-344, and Pracinostat[23][29] - The company has accumulated losses of $254.4 million since inception and expects to incur operating losses and negative cash flows for the foreseeable future[24] - As of December 31, 2019, cash, cash equivalents, and short-term investments totaled $103.9 million, believed to be sufficient for at least the next 12 months[24] Note 2. Fair Value Measurements | Metric | December 31, 2019 (in thousands) | June 30, 2019 (in thousands) | | :-------------------- | :------------------------------- | :--------------------------- | | Warrant liability (Level 3) | $(16,783) | $(17,613) | | Assumption | December 31, 2019 | June 30, 2019 | | :------------------ | :---------------- | :------------ | | Risk-free interest rate | 1.6% | 1.7% | | Expected life (years) | 3.4 | 3.8 | | Expected volatility | 59.1% | 56.8% | | Dividend yield | 0.0% | 0.0% | | Black-Scholes Fair Value | $1.04 | $1.10 | - The warrant liability is classified as Level 3 due to significant unobservable inputs, primarily volatility rate and estimated term[40] Note 3. License Agreements - KKC License Agreement for ME-401 in Japan includes a $10.0 million upfront payment and potential milestones up to $87.5 million plus royalties[45] - Helsinn License Agreement for pracinostat grants worldwide exclusive rights, with $20.0 million received and potential milestones up to $444 million plus royalties[48] - Presage License Agreement for voruciclib involves $2.9 million paid and potential payments up to $179 million plus royalties[50][51] Note 4. BeiGene Collaboration - Clinical collaboration with BeiGene to evaluate ME-401 in combination with zanubrutinib for B-cell malignancies, with study costs shared equally[53] Note 5. Revenue Recognition | Revenue Source (in thousands) | 3 Months Ended Dec 31, 2019 | 3 Months Ended Dec 31, 2018 | 6 Months Ended Dec 31, 2019 | 6 Months Ended Dec 31, 2018 | | :---------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | KKC License Agreement | $673 | $1,361 | $1,470 | $1,361 | | Helsinn License Agreement | $335 | $687 | $695 | $1,175 | | Total Revenue | $1,008 | $2,048 | $2,165 | $2,536 | - Deferred revenue as of December 31, 2019, was $6.2 million, with approximately $3.1 million expected to be recognized in the next 12 months[62] Note 6. Net (Loss) Income Per Share | Metric (in thousands) | 3 Months Ended Dec 31, 2019 | 3 Months Ended Dec 31, 2018 | 6 Months Ended Dec 31, 2019 | 6 Months Ended Dec 31, 2018 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net (loss) income - basic | $(20,217) | $12,025 | $(23,211) | $(2,517) | | Net loss - diluted | $(20,217) | $(11,412) | $(23,211) | $(25,954) | | Anti-Dilutive Shares (in thousands) | 3 Months Ended Dec 31, 2019 | 3 Months Ended Dec 31, 2018 | 6 Months Ended Dec 31, 2019 | 6 Months Ended Dec 31, 2018 | | :---------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Stock options | 10,929 | 8,160 | 10,930 | 7,967 | | Warrants | 16,062 | — | 16,062 | 8,093 | | Total anti-dilutive shares | 26,991 | 8,160 | 26,992 | 16,125 | Note 7. Commitments and Contingencies - No amounts have been accrued for potential future milestone payments under the Presage License Agreement, SBio Purchase Agreement, or CyDex License Agreement as of December 31, 2019[68][69][70] Note 8. Leases - Adopted ASU No. 2016-02, Leases, on July 1, 2019, using a modified retrospective basis[71] - As of December 31, 2019, the remaining lease liability for the current office was $0.3 million, with a right-of-use asset of $0.2 million[76] - A new lease agreement for 32,800 square feet of office space in San Diego, commencing June 1, 2020, has a total contractual obligation of approximately $11.5 million over its term[77] Note 9. Short-Term Investments | Investment Type | December 31, 2019 (in millions) | June 30, 2019 (in millions) | | :---------------- | :------------------------------ | :-------------------------- | | U.S. government securities | $95.2 | $64.9 | Note 10. Stockholders' Equity - Completed an underwritten registered offering in December 2019, issuing 32,343,750 shares of common stock for net cash proceeds of $48.5 million[79] - As of December 31, 2019, there are 16,061,602 outstanding warrants exercisable at $2.54 per share, expiring in May 2023, valued at $16.8 million[82] - As of December 31, 2019, $92.5 million aggregate value of securities remains available under the shelf registration statement[81] Note 11. Share-based Compensation | Expense Category (in thousands) | 3 Months Ended Dec 31, 2019 | 3 Months Ended Dec 31, 2018 | 6 Months Ended Dec 31, 2019 | 6 Months Ended Dec 31, 2018 | | :------------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $743 | $554 | $1,524 | $1,184 | | General and administrative | $1,028 | $1,109 | $2,360 | $2,416 | | Total share-based compensation | $1,771 | $1,663 | $3,884 | $3,600 | - As of December 31, 2019, $6.9 million of unrecognized compensation expense related to unvested stock options is expected to be recognized over a weighted-average period of 1.7 years[87] Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations This section discusses MEI Pharma's oncology pipeline, increased operating losses from clinical trials, and bolstered liquidity from recent equity financing Overview and Recent Developments - MEI Pharma is a late-stage pharmaceutical company specializing in oncology, with a pipeline of four clinical-stage drug candidates[93] - The company's common stock is listed on the NASDAQ Capital Market under the symbol 'MEIP'[93] Clinical Development Programs ME-401: PI3Kd Inhibitor - ME-401 is an oral, once-daily, selective PI3Kd inhibitor in a Phase 2 TIDAL trial for relapsed or refractory follicular lymphoma, intended to support an accelerated FDA approval[96][97][110] - Updated interim Phase 1b data showed an 81% overall response rate in 73 evaluable r/r FL and r/r CLL/SLL patients, with responses appearing durable[106] - ME-401 was generally well-tolerated, with the intermittent dosing (IS) regimen showing improved tolerability compared to continuous dosing (CS); the TIDAL trial protocol was amended to continue enrollment in the IS regimen only[107][110] Voruciclib: CDK Inhibitor - Voruciclib is an orally administered CDK inhibitor with potent CDK9 inhibition, currently in a Phase 1b trial for acute myeloid leukemia (AML) and B-cell malignancies[111] - Pre-clinical studies demonstrated that voruciclib synergizes with venetoclax to induce apoptosis in AML cells by transiently downregulating MCL1[113][114] ME-344: Mitochondrial Inhibitor - ME-344 is a novel, tumor-selective mitochondrial inhibitor targeting the OXPHOS complex 1, involved in ATP production[118] - An investigator-initiated trial in HER2-negative breast cancer showed significant biologic activity (mean absolute Ki67 decreases of 13.3) when ME-344 was combined with bevacizumab[123][124] Pracinostat: HDAC Inhibitor - Pracinostat is an oral HDAC inhibitor in a pivotal Phase 3 global registration trial for newly diagnosed AML and a Phase 2 trial for high/very high-risk MDS[127] - It received FDA Breakthrough Therapy Designation in 2016 and EMA Orphan Drug Designation in 2018 for AML[128] - A Phase 2 trial of pracinostat plus azacitidine in elderly AML patients showed a median overall survival of 19.1 months and a 42% complete remission rate[128] Results of Operations Comparison of Three Months Ended December 31, 2019 and 2018 - Loss from operations increased slightly to $12.1 million in Q2 2019 from $11.8 million in Q2 2018[136] - Revenue decreased by 50.7% to $1.0 million in Q2 2019, primarily due to lower revenue from the KKC License Agreement[137] - Research and development expenses decreased to $8.3 million in Q2 2019, mainly due to reduced ME-401 drug manufacturing costs, partially offset by increased clinical trial costs for the TIDAL study[140] - A non-cash expense of $8.4 million was recorded in Q2 2019 due to a change in the fair value of warrant liability, compared to a $23.4 million gain in Q2 2018[142] Comparison of Six Months Ended December 31, 2019 and 2018 - Loss from operations increased to $24.7 million for the six months ended December 31, 2019, from $21.9 million in the prior year[143] - Revenue decreased by 14.6% to $2.2 million for the six months ended December 31, 2019, primarily due to lower revenue from the Helsinn License Agreement[144] - Research and development expenses increased to $17.2 million, mainly driven by a $4.2 million increase in ME-401 clinical trial costs for the TIDAL study, partially offset by decreased drug manufacturing costs[147][148] - A non-cash gain of $0.8 million was recorded for the six months ended December 31, 2019, from the change in fair value of warrant liability, compared to an $18.5 million gain in the prior year[150] Liquidity and Capital Resources - The company has accumulated losses of $254.4 million and anticipates continued operating losses and negative cash flows[151] - As of December 31, 2019, cash, cash equivalents, and short-term investments totaled $103.9 million, deemed sufficient to fund operations for at least the next 12 months[151] - Net cash provided by financing activities significantly increased to $54.0 million for the six months ended December 31, 2019, primarily from a $48.5 million common stock offering[154] Contractual Obligations - The current office lease expires in May 2020 with approximately $0.3 million in remaining contractual obligations[156] - A new office lease commencing June 1, 2020, and expiring January 2028, has a total contractual obligation of approximately $11.5 million[157] - No amounts have been accrued for potential future milestone payments under the Presage, SBio, or CyDex license agreements as of December 31, 2019[158][159][160] Critical Accounting Policies and Management Estimates - No material changes in significant accounting policies or critical accounting estimates since June 30, 2019, except for the adoption of ASC 842, Leases[161] Recent Accounting Pronouncements - Refer to Note 1 for details on adopted accounting standards, specifically ASU No. 2016-02, Leases[162][37] Item 3: Quantitative and Qualitative Disclosures about Market Risk Market risk primarily stems from interest rates on cash and short-term investments, managed through high-credit quality U.S. government securities - Primary market risk exposure relates to interest rates on cash balances and short-term investments[163] - Short-term investments consist solely of U.S. government securities with maturities of three to twelve months[163] - Management does not consider the effects of interest rate movements to be a material risk to the company's financial condition[165] Item 4: Controls and Procedures Management confirmed the effectiveness of disclosure controls and procedures as of December 31, 2019, with no material changes in internal control - Disclosure controls and procedures were evaluated and deemed effective as of December 31, 2019[166] - No material changes in internal control over financial reporting occurred during the period covered by this report[167] PART II OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, exhibits, and official signatures Item 1: Legal Proceedings No legal proceedings were reported for the period covered by this Quarterly Report on Form 10-Q - No legal proceedings were reported[168] Item 1A: Risk Factors There have been no material changes to the risk factors previously disclosed in the company's 2019 Annual Report - No material changes in risk factors from those included in the 2019 Annual Report[169] Item 2: Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported for the period - None reported[170] Item 3: Defaults upon Senior Securities No defaults upon senior securities were reported for the period - None reported[171] Item 4: Mine Safety Disclosures Mine safety disclosures are not applicable to the company's operations - Not applicable[172] Item 5: Other Information No other information was reported for the period - None reported[173] Item 6: Exhibits This section lists all exhibits filed with the Quarterly Report, including required certifications from executive officers and XBRL-related documents - Includes Rule 13a-14(a) or Rule 15d-14(a) Certifications of Principal Executive Officer and Principal Financial Officer[175] - Includes XBRL Instance Document and Taxonomy Extension documents[175] SIGNATURES The Quarterly Report was officially signed on behalf of MEI Pharma, Inc. by Daniel P. Gold, President and Chief Executive Officer, on February 6, 2020 - The report was signed by Daniel P. Gold, President and Chief Executive Officer, on February 6, 2020[178]