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Marker Therapeutics, Inc. (MRKR)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was a pivotal execution quarter: preliminary APOLLO Phase 1 data for MT-601 in post‑CD19 CAR‑T lymphoma showed a 78% objective response rate with 44.4% complete responses, and favorable safety (no ICANS; one Grade 1 CRS), strengthening clinical credibility .
  • Liquidity and runway improved meaningfully: cash and equivalents were $19.2M at 12/31/2024, and management guided funding into Q1 2026 (potentially longer with anticipated grants), extending prior quarter’s October 2025 runway .
  • Strategic financing secured $16.1M gross in December to support APOLLO expansion; investors included Blue Owl, NEA, and Aisling Capital, enhancing resources for clinical data collection .
  • Versus S&P Global consensus for Q4 2024, revenue of $2.25M missed $3.98M and EPS of -$0.42 missed -$0.22; as a grant‑funded, pre‑revenue biotech, variability largely reflects timing of grant recognition rather than product sales (no product revenue reported)*.
  • Pipeline breadth advanced: CPRIT awarded $9.5M for pancreatic cancer study; USAN/INN approved “neldaleucel” as MT‑601’s nonproprietary name, formalizing brand identity ahead of broader clinical development .

What Went Well and What Went Wrong

What Went Well

  • Strong early efficacy and clean safety: APOLLO cohort showed 78% ORR with 44.4% CR; “MT‑601 was well tolerated… no ICANS and one Grade 1 CRS,” per CMO; CEO emphasized “transformative treatment option” potential .
  • Strengthened funding mix: $16.1M private placement and over $13M in non‑dilutive grants (NIH SBIR and CPRIT) support lymphoma and pancreatic programs, reducing near‑term financing risk .
  • Regulatory/identity milestone: USAN/INN committees approved “neldaleucel” for MT‑601, helpful for trial visibility and future commercialization pathways .

What Went Wrong

  • Miss vs consensus: Q4 revenue $2.25M vs $3.98M estimate and EPS -$0.42 vs -$0.22 estimate; pre‑revenue model implies revenue dependency on grant timing rather than sales*, suggesting continued estimate uncertainty.
  • OpEx step‑up into year‑end: sequential operating expenses rose into Q4 (reflecting heightened clinical trial activity in 2H), consistent with earlier commentary on R&D ramp *.
  • Continued losses: FY 2024 net loss was $10.7M (vs $8.2M FY 2023); management remains focused on cash preservation and grant drawdowns to extend runway .

Financial Results

Quarterly comparison (grant revenue, pre‑revenue business)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD)$1,169,236 $1,926,020 $2,251,763*
Diluted EPS ($USD)$(0.25) $(0.26) $(0.42)*
Total Operating Expenses ($USD)$3,477,301 $4,325,893 $6,113,180*
Net Income Margin (%)(187.53%)*(119.84%)*(170.43%)*
Cash & Equivalents ($USD)$7,800,464 $8,999,664 $19,192,440

Year-over-year Q4 comparison

MetricQ4 2023Q4 2024
Revenue ($USD)$1,056,532*$2,251,763*
Diluted EPS ($USD)$(0.31)*$(0.42)*
Total Operating Expenses ($USD)$3,994,323*$6,113,180*
Net Income Margin (%)(265.31%)*(170.43%)*
Cash & Equivalents ($USD)$15,111,450 $19,192,440

Segment breakdown: Not applicable (no commercial segments disclosed; revenue comprises grant income) .

KPIs (clinical program highlights)

KPIQ3 2024Q4 2024
APOLLO ORR (first assessment)Preliminary activity reported; update expected Q4 2024 78% (7/9 patients) ORR; CR 44.4%
APOLLO SafetyWell tolerated; no ICANS in City of Hope data No ICANS; one Grade 1 CRS; no DLTs
Long-term follow-upOngoing3 patients with 6–12 months follow‑up (CR/PR)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayAs of Q3 2024Fund operating expenses into Oct 2025 Fund operating expenses into Q1 2026; anticipated additional grants could extend further Raised runway
APOLLO data disclosureQ3 2024 → Q4 2024Update on safety & durability during Q4 2024 Additional insights via webinar in Q2 2025; further data in 2H 2025 Timeline extended/clarified
MT‑601 pancreatic program startQ2 2024Expect to start clinical program in 2025 Launch anticipated in 2H 2025 Narrowed to 2H 2025
MT‑401‑OTS AML/MDS initiationQ2 2024Anticipates initiation in Q4 2024 Anticipates initiation in 2H 2025 Delayed

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available in our document catalog; themes are derived from quarterly press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
R&D executionContinued APOLLO enrollment; City of Hope preliminary efficacy; IND cleared for pancreatic; SBIR grants APOLLO data: 78% ORR, 44.4% CR; durability follow‑up; additional enrollment; webinar planned Q2 2025 Improving evidence base
Funding mix$2M NIH SBIR (lymphoma); $2M NIH SBIR (pancreatic) $9.5M CPRIT (pancreatic) and $16.1M private placement Strengthened liquidity
Safety profileNo ICANS in reported sites; tolerated well No ICANS; one Grade 1 CRS; no DLTs Consistently favorable
Regulatory/identityIND cleared pancreatic; OTS pathway updates USAN/INN “neldaleucel” for MT‑601 Formalized naming
Runway & costsReorg impact; OpEx efficiencies; runway into Q4/OCT 2025 Runway into Q1 2026; focus on cash preservation Extended runway

Management Commentary

  • “Preliminary data from our Phase 1 APOLLO study showed encouraging safety and efficacy… With a 78% objective response rate and favorable safety profile, we believe MT‑601 has the potential to provide a transformative treatment option…” – Juan Vera, M.D., President & CEO .
  • “Infusion of MT‑601 was well tolerated in all study participants, with no observation of ICANS and one reported Grade 1 CRS… 7 out of 9 patients achieved objective responses (78%)… with 4 patients demonstrating complete response (44.4%).” – Monic Stuart, M.D., CMO .
  • “We also strengthened our financial position through a strategic private placement and additional non‑dilutive funding from the NIH and CPRIT… focus remains on cash preservation and disciplined execution…” – Juan Vera, M.D. .

Q&A Highlights

  • No analyst Q&A available; no Q4 2024 earnings call transcript was found in our document catalog.

Estimates Context

How Q4 2024 results compared to S&P Global Wall Street consensus

MetricConsensusActualResult vs Consensus
Revenue ($USD)$3,982,000*$2,251,763*Bold miss: revenue below by $1,730,237
EPS ($USD)$(0.22)*$(0.42)*Bold miss: EPS below by $0.20

Context:

  • As a pre‑revenue biotech, reported “revenue” is grant income; estimate variance likely reflects grant recognition timing rather than commercial performance (no product revenue disclosed) .

Key Takeaways for Investors

  • Clinical validation is strengthening: early APOLLO efficacy and clean safety profile support the MT‑601 thesis in a high‑unmet need post‑CD19 CAR‑T lymphoma segment .
  • Liquidity risk moderated: $16.1M private placement plus >$13M non‑dilutive grants extended runway into Q1 2026; expect further grants to potentially extend further .
  • Near‑term catalysts: APOLLO data webinar (Q2 2025), further clinical data in 2H 2025; formal “neldaleucel” naming aids trial visibility .
  • Execution watch‑items: operating expense trajectory as trials scale; monitor enrollment pace and durability outcomes as the dataset matures .
  • Pipeline optionality: CPRIT‑funded pancreatic program initiation in 2H 2025 could broaden the addressable market; MT‑401‑OTS timeline shift to 2H 2025 requires continued funding discipline .
  • Trading implications: stock likely reacts to incremental APOLLO efficacy/safety updates and financing cadence; limited revenue visibility means headlines around clinical milestones and grants drive narrative.
  • Estimates alignment: given grant‑based revenue, consensus volatility is expected; focus on clinical milestones and cash runway rather than quarterly “beats/misses.”*

Footnotes:

  • Values marked with an asterisk (*) were retrieved from S&P Global.