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Marker Therapeutics, Inc. (MRKR)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 showed improved operating performance with Loss from Operations of $(2.31)M vs $(4.13)M in Q2 2023 and Net Loss from continuing operations of $(2.19)M vs $(4.10)M YoY, aided by higher grant income (+53% YoY) and sharply lower G&A (-55% YoY) .
  • Cash and equivalents were $7.80M at quarter-end, and management reiterated cash runway guidance into Q4 2025, inclusive of expected grant drawdowns .
  • Clinical momentum continued: APOLLO (MT-601 in lymphoma) reported sustained objective responses in 3/3 patients and no CRS/ICANS; NIH awarded a $2.0M SBIR grant to support the study, reinforcing external validation .
  • Guidance/timing updates: MT-401-OTS (AML/MDS) program initiation anticipated in Q4 2024; pancreatic MT-601 IND cleared with advancement pending non-dilutive funding .
  • Near-term catalysts: APOLLO safety/durability update expected in Q3, incremental grants inflows, and evolving capital access strategy (ATM program terminated) may influence sentiment and stock reaction .

What Went Well and What Went Wrong

What Went Well

  • Clinical efficacy and safety: “we continued to advance our Phase 1 APOLLO study…three out of three participants had objective responses…no significant treatment-related adverse events” .
  • Efficient cost structure and runway: “our extremely efficient structure, combined with our successful grant funding initiatives, are allowing us to maximize our cash runway” .
  • External validation and funding: NIH SBIR $2.0M award to support APOLLO; “highly competitive grant…reinforces the potential scientific merit” .

What Went Wrong

  • Cash burn and lower cash balance: Cash fell to $7.80M; net cash used in operating activities was $(7.41)M for the first six months of 2024 .
  • Ongoing reliance on grants (no product revenue): “We did not generate any revenue…from the sales or licensing of our product candidates” (grant income recognized as revenue) .
  • Rising outsourced clinical manufacturing spend with related-party exposure: Cell Ready expenses were $0.65M in Q2 and $1.84M YTD; $0.29M related-party payable outstanding at quarter-end .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Total Revenues ($USD)$762,658 $1,244,061 $1,169,236
Research and Development ($USD)$2,377,993 $2,575,015 $2,335,430
General and Administrative ($USD)$2,518,725 $1,218,063 $1,141,871
Total Operating Expenses ($USD)$4,896,718 $3,793,078 $3,477,301
Loss from Operations ($USD)$(4,134,060) $(2,549,017) $(2,308,065)
Interest Income ($USD)$35,080 $156,195 $115,388
Net Loss from Continuing Ops ($USD)$(4,098,980) $(2,392,822) $(2,192,677)
Diluted EPS - Continuing Ops ($USD)$(0.47) $(0.27) $(0.25)
KPIFY 2023Q1 2024Q2 2024
Cash and Equivalents ($USD)$15,111,450 $11,323,428 $7,800,464
Weighted Avg. Shares (Basic)8,809,382 8,901,962 8,918,233
Grant Income BreakdownQ2 2023Q2 2024
CPRIT ($USD)~$700,000 ~$700,000
FDA Orphan Products ($USD)~$100,000 ~$200,000
NIH SBIR ($USD)$0 ~$200,000

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Runway (Operating Expenses)Through Q4 2025Into Q4 2025 (Q1 2024) Into Q4 2025 (Q2 2024) Maintained
APOLLO Clinical Update Timing2H 2024 vs Q3 2024Update in 2H 2024 Update expected in Q3 2024/upcoming quarter Pulled forward/clarified
MT-401-OTS Program InitiationH2 2024 vs Q4 2024Initiation in H2 2024 Initiation anticipated in Q4 2024 Narrowed timing
Pancreatic MT-601 ProgramIND cleared; funding-dependentIND cleared; advance pending non-dilutive funding IND cleared; advance pending non-dilutive funding Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2024)Current Period (Q2 2024)Trend
APOLLO efficacy/safety (MT-601)Complete and partial responses; 3/3 objective responses; no CRS/ICANS Sustained objective responses; no CRS/ICANS; enrolling additional participants; Q3 update planned Improving/continued momentum
Non-dilutive funding$2M NIH SBIR to support MT-401-OTS $2M NIH SBIR to support APOLLO; additional NCI grant notice in June 2024 (pancreatic) Strengthening funding base
MT-401-OTS (AML/MDS)IND granted; inventory established; H2 2024 initiation Initiation anticipated Q4 2024 On track; timeline specified
Outsourced manufacturing (Cell Ready)MSA signed Feb 22, 2024 $0.65M Q2 and $1.84M YTD related-party expenses; ongoing work orders Operationalized; cost shift to variable
Cash runway/OpEx disciplineRunway into Q4 2025 Runway into Q4 2025; G&A down 55% YoY Stable runway; improved cost profile
Regulatory/designationsUSAN “neldaleucel” for MT-601 Same; pancreatic IND cleared Stable/advancing

Management Commentary

  • “The second quarter of 2024 was characterized by ongoing momentum in our clinical programs…three out of three participants had objective responses…treatment was well tolerated among all patients with no significant treatment-related adverse events” — Juan Vera, M.D., President & CEO .
  • “The financial performance in the past quarter demonstrates the benefits that we are seeing from our restructuring efforts…our extremely efficient structure, combined with our successful grant funding initiatives, are allowing us to maximize our cash runway” — Juan Vera, M.D. .

Q&A Highlights

  • Not applicable; no earnings call transcript was available in the documents reviewed for Q2 2024.

Estimates Context

  • Wall Street consensus via S&P Global was unavailable for Q2 2024; therefore, comparisons to consensus estimates are not provided.

Key Takeaways for Investors

  • Operating leverage improving: Total operating expenses fell 29% YoY in Q2 2024, driven mainly by G&A reductions (-55% YoY) while R&D remained tightly managed .
  • Revenue is grant-based, not commercial: Q2 revenue rose 53% YoY on higher CPRIT/FDA/SBIR grant recognition; there is no product sales revenue yet .
  • Clinical data remain encouraging: APOLLO reported 3/3 objective responses with favorable safety; a Q3 update on safety/durability is a key catalyst for the stock .
  • External validation and funding: The NIH SBIR $2M award for APOLLO adds non-dilutive resources and signals scientific merit; additional NCI grant notice in June 2024 supports pancreatic workstreams .
  • Outsourcing strategy now embedded: Cell Ready MSA is scaling clinical manufacturing; related-party expenses were $0.65M in Q2 and $1.84M YTD, shifting costs from fixed to variable while preserving runway .
  • Runway guidance maintained: Cash of $7.80M and reiterated runway into Q4 2025 reduces near-term financing overhang, though additional funding may be needed for broader development .
  • Near-term focus: Prioritize the APOLLO Q3 update and the MT-401-OTS initiation in Q4 2024 as events likely to shape sentiment and potential re-rating .