Executive Summary

Q3 FY2024 revenue was $0 as collaboration revenue from Kyowa Kirin was fully recognized in prior periods; net loss improved sequentially to $(9.1)M and EPS to $(1.37) from Q2’s $(11.1)M and $(1.66) as OpEx fell to $9.8M .
Cash, cash equivalents, and short-term investments were $56.6M at quarter-end, and management believes liquidity is sufficient for at least 12 months .
The Board unanimously prioritized development of voruciclib (CDK9 inhibitor) and decided not to proceed with a second return of capital to conserve cash and extend runway; clinical updates on voruciclib+venetoclax in R/R AML are expected during the remainder of calendar 2024 .
Clinical signals remained encouraging: in patients treated with voruciclib≥100 mg plus venetoclax, there were 2 CRi and 1 MLFS responses, biomarker evidence of Mcl‑1 decrease, and no overlapping toxicity with venetoclax; ME‑344 showed a 25% non-progression rate at Week 16 in mCRC Cohort 1, exceeding the pre-specified 20% threshold .

What Went Well and What Went Wrong

What Went Well

Voruciclib program gained momentum: expansion cohort at 300 mg completed enrollment; initial activity included complete responses (CRi) and MLFS, with anticipated Mcl‑1 decreases at ≥100 mg doses and no overlapping toxicity with venetoclax .
ME‑344 combination with bevacizumab in refractory mCRC exceeded the protocol’s 20% non-progression threshold (25% at Week 16), supporting biologic activity; combination was generally well-tolerated .
Cost discipline: R&D down to $5.2M (from $15.1M YoY) and G&A down to $4.6M (from $7.2M YoY), driving sequential improvement in net loss and EPS .

Quote: “We anticipate providing updates from the clinical trial evaluating voruciclib in combination with venetoclax in patients with relapsed/refractory AML…during the remainder of calendar 2024.” — David Urso, President & CEO .

What Went Wrong

Revenue dropped to $0 vs $5.9M in Q3 FY2023 as Kyowa Kirin deferred revenue was fully recognized in Q1 FY2024 and the agreement terminated in July 2023 .
Continued operating losses and negative operating cash flow ($32.5M over nine months), underscoring financing needs over time despite current runway .
Strategic choice not to proceed with a second capital return could disappoint some shareholders seeking near-term cash, though it preserves liquidity for clinical programs .

Financial Results

Metric	Q3 2023	Q2 2024	Q3 2024
Revenue ($USD Millions)	$5.894	$0.000	$0.000
Net Income (Loss) ($USD Millions)	$(15.438)	$(11.063)	$(9.127)
Diluted EPS ($)	$(2.32)	$(1.66)	$(1.37)
Total Operating Expenses ($USD Millions)	$22.285	$11.930	$9.829
R&D Expense ($USD Millions)	$15.104	$3.912	$5.220
G&A Expense ($USD Millions)	$7.181	$8.018	$4.609
Cash, Cash Equivalents & ST Investments ($USD Millions)	N/A	$59.5	$56.6
Net Income Margin %	N/M (Rev= $5.894; Net= $(15.438))	N/M (Rev= $0)	N/M (Rev= $0)

Notes: N/M = Not meaningful when revenue is zero or negative; cash balance presented as combined cash, cash equivalents, and short-term investments .

Segment breakdown: Single operating segment; no commercial sales to report .

KPIs

KPI	Q1 2024	Q2 2024	Q3 2024
Voruciclib AML combo – patients enrolled in dose escalation stage	Completed 300 mg cohort enrollment	Continued dose escalation; enrollment on track	29 patients; ≥100 mg cohort with 2 CRi, 1 MLFS; 14 SD; biomarker Mcl‑1 decreases; no overlapping toxicity
Voruciclib AML combo – dose expansion	Planned	Completed enrollment at 300 mg for 14/28 schedule	Dose expansion at 300 mg completed; additional 21/28 schedule being evaluated
ME‑344 + bevacizumab (mCRC) – Week 16 non-progression	Enrollment complete Cohort 1	Planned data in H1’24	25% non-progression; median PFS 1.9 months; combo well-tolerated

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Voruciclib+venetoclax AML – clinical data timing	CY2024	Initial safety/efficacy data in H1’24	Additional dose escalation/expansion data during remainder of CY2024	Maintained/updated timing
ME‑344 new formulation update	H1 CY2025	Develop new formulation; timing TBD	Update on formulation efforts in H1 CY2025	Set timing
Capital return (second distribution)	FY2024	Potential second return up to $9.33M per Cooperation Agreement	Board determined not to proceed to conserve resources/extend runway	Lowered
Liquidity runway	Next 12 months	Sufficient to fund at least 12 months	Sufficient to fund at least 12 months	Maintained

Earnings Call Themes & Trends

Note: No Q3 FY2024 earnings call transcript was available for MEIP in our document corpus [List: earnings-call-transcript none for 2024].

Topic	Previous Mentions (Q1 FY2024 and Q2 FY2024)	Current Period (Q3 FY2024)	Trend
Voruciclib program focus	Data expected early CY2024; dose escalation ongoing; strong investigator support	Board unanimously prioritizes voruciclib; expansion cohort at 300 mg completed; more data expected rest of CY2024	Strengthening focus
Venetoclax resistance/Mcl‑1 biology	Preclinical/clinical rationale reiterated	Anticipated Mcl‑1 decreases observed at ≥100 mg; mutation-agnostic strategy highlighted	Reinforced mechanistic validation
ME‑344 clinical path	H1’24 Cohort 1 readout planned	25% Week 16 non-progression; pivot to new formulation; H1 CY2025 update	Transition to formulation improvement
Capital allocation & returns	Special $1.75/share dividend paid Dec 2023 under Cooperation Agreement; ATM program established	No second capital return; conserve cash/runway	More conservative
Liquidity/runway & financing	12-month runway; may pursue future capital transactions	12-month runway reiterated; potential future capital transactions highlighted	Unchanged outlook

Management Commentary

Strategic message: “The clinical focus for the rest of the year will be voruciclib…We anticipate providing updates from the clinical trial evaluating voruciclib in combination with venetoclax in patients with relapsed/refractory AML…during the remainder of calendar 2024.” — David Urso, President & CEO .
Program positioning: “We believe that voruciclib in combination with venetoclax has potential, as a mutation-agnostic therapy, to benefit the largest number of patients with relapsed/refractory AML.” — David Urso .
Capital allocation: Board unanimously aligned on prioritizing voruciclib; enabling ME‑344 new formulation; not proceeding with second capital return to conserve resources and extend runway .

Q&A Highlights

No Q3 FY2024 earnings call transcript was available; no Q&A themes identified in the source documents [List: earnings-call-transcript none for 2024].

Estimates Context

Wall Street consensus (S&P Global) for Q3 FY2024 EPS and revenue was unavailable due to missing CIQ mapping for MEIP; therefore, we cannot assess beats/misses versus estimates at this time. If/when SPGI consensus becomes available, we will anchor comparisons to that dataset.

Key Takeaways for Investors

Liquidity is adequate near term (12+ months), with $56.6M in cash, equivalents, and short-term investments; sequential OpEx reductions improved quarterly loss/EPS despite zero revenue .
Clinical execution in AML is the core near-term catalyst: additional voruciclib+venetoclax data (responses, biomarker validation, safety) expected in the remainder of CY2024; dose expansion completed at 300 mg .
ME‑344 demonstrated activity in mCRC but strategy pivots to a new formulation with an H1 CY2025 update, reducing near-term readouts from that program .
Board’s decision to forego a second capital return extends runway and aligns capital with clinical priorities; expect cautious cash deployment and potential future capital raising .
With no estimates available, trading may be driven more by clinical updates and capital allocation decisions than quarterly financial prints; monitor R/R AML expansion cohort outcomes and any ATM usage .
Cost structure is resetting post-zandelisib discontinuation, with materially lower R&D and G&A versus prior year; continued discipline supports runway extension .
Risk profile remains typical for a clinical-stage biotech: financing needs over time, regulatory uncertainty, and dependence on trial outcomes; position sizing should reflect these dynamics –.

MEI Pharma, Inc. (MEIP)·Q3 2024 Earnings Summary