Executive Summary

Q1 2024 delivered grant revenue of $0.57M, operating expenses of $9.35M, and a net loss of $8.39M ($2.83 per share); cash and short-term investments were $27.0M, with runway guided into Q1 2025 . Management reiterated upcoming data readouts for ONCT-534 in late Q2 2024 and ONCT-808 in mid-2024, positioning the stock for near-term clinical catalysts .
ONCT-534 dose escalation advanced: the fourth cohort (300 mg QD) is fully enrolled; escalation to 600 mg is expected pending safety review, with initial data targeted late Q2 2024 .
ONCT-808 CAR-T resumed enrollment after protocol amendments (tightened eligibility, enhanced infection monitoring, lower starting doses) following a prior grade 5 SAE at 3×10^6 cells/kg; prior signal at 1×10^6 showed 2 CMRs and 1 PR (Dec 4 cutoff) .
No product revenue yet; sequential OpEx roughly flat QoQ and down YoY as R&D moderated versus Q1 2023. CFO’s Q1 call remarks contained a “fourth quarter” slip for net loss, but figures matched Q1 press release .
Street consensus via S&P Global was unavailable (mapping error), so estimate comparisons cannot be made for Q1 2024; focus remains on clinical progress and cash runway catalyst window [GetEstimates error].

What Went Well and What Went Wrong

What Went Well
- ONCT-534 progressed swiftly: “fourth dosing cohort at 300 mg per day is fully enrolled… initial data readout expected in the latter part of the second quarter” .
- Renewed momentum in ONCT-808: “study… is open and enrolling patients” after safety-focused protocol amendments; updated clinical results expected mid-2024 .
- Operating discipline: Q1 OpEx of $9.35M vs $12.35M YoY; net loss narrowed to $8.39M vs $11.49M YoY; cash runway into Q1 2025 maintained . Q4 context highlighted R&D savings from winding down ZILO program .
What Went Wrong
- Safety event remains an overhang: prior grade 5 SAE at 3×10^6 cells/kg in ONCT-808 necessitated modified eligibility and lower starting doses (0.3×10^6, 0.6×10^6), potentially slowing dose finding .
- Revenue is grants only ($0.57M), reflecting pre-commercial profile; no product revenue to offset burn .
- Estimates visibility is limited: S&P Global consensus mapping unavailable for ONCT, constraining beat/miss framing and near-term trading signals from earnings versus Street [GetEstimates error].

Financial Results

Sequential trend (oldest → newest):

Metric	Q3 2023	Q4 2023	Q1 2024
Grant Revenue ($USD Millions)	$0.18	$0.30	$0.57
Total Operating Expenses ($USD Millions)	$10.57	$9.93	$9.35
R&D Expense ($USD Millions)	$7.48	$6.67	$6.06
G&A Expense ($USD Millions)	$3.09	$3.26	$3.29
Interest Income ($USD Millions)	$0.53	$0.47	$0.39
Net Loss ($USD Millions)	$(9.86)	$(9.16)	$(8.39)
EPS, Basic & Diluted ($)	$(0.17)	$(3.11)	$(2.83)
Weighted Avg Shares (Millions)	58.96	2.95 (post-split)	2.96

YoY comparison:

Metric	Q1 2023	Q1 2024
Grant Revenue ($USD Millions)	$0.20	$0.57
Total Operating Expenses ($USD Millions)	$12.35	$9.35
R&D Expense ($USD Millions)	$9.03	$6.06
G&A Expense ($USD Millions)	$3.32	$3.29
Interest Income ($USD Millions)	$0.66	$0.39
Net Loss ($USD Millions)	$(11.49)	$(8.39)
EPS, Basic & Diluted ($)	$(3.93)	$(2.83)
Weighted Avg Shares (Millions)	2.93	2.96

Balance sheet highlights:

Metric	Dec 31, 2023	Mar 31, 2024
Cash & ST Investments ($USD Millions)	$34.26	$27.03
Total Assets ($USD Millions)	$36.73	$29.14
Total Liabilities ($USD Millions)	$6.68	$6.22
Total Stockholders’ Equity ($USD Millions)	$30.05	$22.93
Shares Outstanding (Millions)	~2.9	~3.0

Segment breakdown (Q1 2024):

Revenue Component	Q1 2024
Grant Revenue ($USD Millions)	$0.57
Product/Other Revenue	Not disclosed (grants-only)

KPIs (clinical program progress):

KPI	Q3 2023	Q4 2023	Q1 2024
ONCT-534 Dose Escalation Status	First patients dosed; progressing per Bayesian design	Third cohort (160 mg) fully enrolled	Fourth cohort (300 mg) fully enrolled; 600 mg escalation planned pending SRC
ONCT-808 Initial Efficacy Signal	Program dosing underway	At 1×10^6: 2 CMR, 1 PR (Dec 4 cutoff)	Study reopened post amendments; mid-2024 update expected
ONCT-808 Safety/Protocol	—	Grade 5 SAE at 3×10^6; amendments agreed with FDA	Modified eligibility; infection monitoring; lower dose cohorts (0.3, 0.6×10^6)

Note: CFO’s Q1 call referenced “Net loss for the fourth quarter,” but the amounts correspond to Q1 2024; press release confirms Q1 metrics .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through Q1 2025	“Projected into 2025”; CFO: into Q1 2025 (Mar)	Into Q1 2025 (May)	Maintained/clarified
ONCT-534 Initial Clinical Data	Q2 2024	Initial readout in Q2 2024	Initial readout latter part of Q2 2024	Maintained (timing refined)
ONCT-534 Additional Readouts	Q4 2024	Additional data in Q4 2024	Additional data in Q4 2024	Maintained
ONCT-808 Clinical Data Update	Mid-2024	Mid-2024 update	Mid-2024 update	Maintained
Enrollment Status (ONCT-808)	2024	Protocol amendments to improve safety	Study open and enrolling	Improved operational status
Capital Markets/Listing	Jan 2024	Reverse split planned	1-for-20 reverse split effected Jan 8, 2024	Executed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2023, Q4 2023)	Current Period (Q1 2024)	Trend
ONCT-534 dose escalation and data timing	First patients dosed; third cohort fully enrolled; initial data 1H/Q2 2024	Fourth cohort (300 mg) fully enrolled; plan to escalate to 600 mg; initial data late Q2 2024	Accelerating; closer to readout
ONCT-808 efficacy/safety and protocol	2 CMRs, 1 PR at 1×10^6; grade 5 SAE at 3×10^6; amendments with FDA; lower doses (0.3, 0.6)	Enrollment resumed; eligibility tightened; infection monitoring; mid-2024 data	Risk-managed progression
Cash runway/OpEx discipline	Runway into 2025; R&D reductions from ZILO wind-down	Runway into Q1 2025; Q1 OpEx down YoY	Maintained discipline
Regulatory status	FDA fast track designation for ONCT-534 (Oct 2023)	Continued engagement with SRC/IRBs; alignment with FDA on 808	Stable regulatory momentum
Market opportunity (534)	Potential ~$1B in post-ARPI mCRPC; multibillion in earlier lines	Reinforced mechanism targeting LBD, N-terminal, and splice variants	Narrative consistent; mechanism-focused

Management Commentary

“We are encouraged by the fast pace of execution for our clinical programs… optimistic… that the 300 mg dose may be within the active dose range for antitumor activity.” — James Breitmeyer, President & CEO .
“Our dose escalation… ONCT-808… is open and enrolling patients. Protocol changes… modified eligibility criteria, increased monitoring for early infection, and evaluating lower doses have now been implemented.” — Company statement .
“Our grant revenue was $0.6 million… total operating expenses… $9.3 million… net loss… $8.4 million… approximately 3.0 million shares… $27.0 million in cash… and no debt.” — Press release .
“We would… have some data from the 600-milligram cohort by the time we announce results.” — Management during Q&A .
“We continue to be encouraged by the initial response signals… and we look forward to reporting additional clinical data… including those who have relapsed after CD19 CAR T treatment.” — Management .

Q&A Highlights

ONCT-534 dose escalation specifics: Cohort 4 (300 mg) comprises 3 patients; SRC review mid/late May; escalation to 600 mg expected if safety permits, aiming to include early data by late Q2 .
Efficacy expectations for 534: Management expects activity beyond typical ARSI-to-ARSI switching due to dual-domain interaction and splice variant targeting (e.g., AR-V7) .
ONCT-808 durability and safety: Team expressed enthusiasm about response durability in heavily pretreated CD19 CAR-T failures; tightened eligibility (no bulky disease, lower age limit), enhanced infection monitoring to mitigate non-tumor mortality risks .
Phase II design for ONCT-808: Protocol allows inclusion of CD19 CAR-T failures; expansion contingent on Phase I signals .
Addressable market for 534: Management suggested ~$1B potential in post-ARPI mCRPC, with multi-billion potential if moving to earlier lines (hormone-sensitive PCa), subject to clinical validation .

Estimates Context

We attempted to retrieve S&P Global Wall Street consensus for Q1 2024 (EPS and revenue), but ONCT’s CIQ mapping was unavailable, so consensus comparisons cannot be provided at this time (SpgiEstimatesError). As a result, there are no beat/miss determinations versus Street for Q1 2024 [GetEstimates error].

Key Takeaways for Investors

Near-term catalysts: Initial ONCT-534 data late Q2 2024 and ONCT-808 mid-2024 update; positioning for event-driven trading around readouts .
Clinical momentum: 534 escalated to doses likely in the active range; potential to show activity in AR-mutant and splice variant populations where ARSIs fail .
Managed risk in CAR-T: 808 amendments target improved safety without altering addressable market; prior efficacy at 1×10^6 supports continued development .
Cash runway sufficient through Q1 2025; liquidity and no debt support execution through key data windows, though burn remains significant for a pre-revenue biotech .
Watch for dosing decisions: SRC outcomes (534 600 mg; 808 lower cohorts) and any signs of response or tolerability that could accelerate expansion or alter dose strategies .
Valuation driver: Absent product revenue and Street estimates, stock narrative hinges on clinical proof-of-concept; a positive efficacy signal in mCRPC could validate management’s market opportunity framing .
Technical/structural: 1-for-20 reverse split implemented in January 2024; maintained Nasdaq compliance and lower share count may impact trading dynamics in catalyst windows .

Citations:

Q1 2024 press release and financials:
Q1 2024 earnings call transcript, remarks and Q&A:
Q4 2023 press release/call:
Q3 2023 press release/call:

Oncternal Therapeutics, Inc. (ONCT)·Q1 2024 Earnings Summary