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Matinas BioPharma Holdings, Inc. (MTNB)·Q2 2024 Earnings Summary

Executive Summary

  • Signed a non-binding term sheet for global licensing of oral MAT2203, advancing toward a definitive agreement and Phase 3 ORALTO initiation; management highlighted “dramatic increase” in physician requests for access as a key catalyst .
  • Q2 2024 financials: no revenue; total costs and expenses decreased to $5.8M; net loss improved to $5.7M ($0.02 per share) vs. $6.1M ($0.03) YoY; cash and marketable securities were $14.3M at quarter-end, supported by April’s $10M raise .
  • ORALTO timeline: company expects trial initiation in Q4 2024, with first-patient-first-visit more likely in 2025; ~24 months enrollment anticipated—timeline clarity is a near-term stock narrative driver .
  • LNC platform: continued progress with oncology and inflammation programs, but recent small oligonucleotide efficacy has been less consistent and oncology models showed weight loss at higher doses—optimization underway .
  • Street consensus (S&P Global) not available in current environment; comparative analysis vs. estimates cannot be provided—note unavailability explicitly.

What Went Well and What Went Wrong

What Went Well

  • Signed a non-binding term sheet with a single partner for global rights to develop and commercialize MAT2203; management is “very encouraged by this progress” and preparing for rapid ORALTO start post-deal .
  • Compassionate/Expanded Use Program momentum and efficacy: 31 patients enrolled (6 under evaluation), with 15 completed courses showing 8 complete responses and 7 improved; 7 aspergillosis patients treated with positive results .
  • Operating discipline: YoY OpEx down ($5.8M vs. $6.2M), net loss narrowed ($5.7M vs. $6.1M), and liquidity improved with $14.3M cash and marketable securities as of 6/30/24 following a $10M financing in April .

What Went Wrong

  • No revenue this quarter (and in the prior-year quarter), underscoring reliance on external partnerships and financing until commercialization .
  • LNC small oligonucleotide program showed “less consistent” therapeutic efficacy in follow-up studies—requires additional optimization before product candidate identification .
  • Oncology models (LNC-docetaxel and LNC-miriplatin) demonstrated tumor inhibition but also weight loss at higher doses and combinations; management is working to improve therapeutic index and attributes weight loss in part to cargo toxicity and dosing approach .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0
Total Costs and Expenses ($USD Millions)$6.2 $5.9 $5.8
Net Loss ($USD Millions)$6.1 $5.8 $5.7
EPS (Basic & Diluted, $USD)$(0.03) $(0.03) $(0.02)
R&D Expense ($USD Millions)$3.559 $3.446 $3.371
G&A Expense ($USD Millions)$2.600 $2.456 $2.468
Cash + Marketable Securities ($USD Millions)—$8.1 $14.3

Notes:

  • No segment reporting applicable.
  • Non-GAAP adjustments were not presented; results reflect GAAP measures .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ORALTO Phase 3 initiation2024Start Q4 2024 Initiate Q4 2024; FPFV more likely in 2025 Maintained start; clarified FPFV to 2025
ORALTO Enrollment DurationN/A—~24 months New detail
Cash RunwayThrough 2025Into Q2 2025 (from Q1 call) Not reiterated in Q2; liquidity $14.3M at 6/30/24 Maintained prior runway; updated quarter-end liquidity
Financial Guidance (Revenue, Margins, OpEx)2024None provided None provided Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q4 2023)Previous Mentions (Q-1: Q1 2024)Current Period (Q2 2024)Trend
MAT2203 partnershipEngaged in active dialogues to finalize partnership Negotiations progressing; targeted as a Q2 event Signed non-binding term sheet; diligence ongoing Positive progress toward definitive deal
ORALTO timing/designFDA alignment on non-inferiority design; ~65 sites; ~216 patients; primary endpoint 6-week mortality Goal to start in Q4 2024; FDA alignment secured Initiation expected Q4 2024; FPFV likely 2025; ~24-month enrollment Timeline clarity; FPFV slide to 2025
Compassionate/Expanded Use19 patients; reversal of AmBisome-induced renal toxicity; 8 complete resolutions 22 patients; ~1/3 aspergillosis; positive responses 31 patients; 8 complete response; 7 improved; rising requests Growing utilization and favorable outcomes
LNC oncology (docetaxel)Oral LNC-docetaxel comparable to IV efficacy; marked safety improvement; no weight loss in safety study In vivo efficacy; reduced tumor volumes; no toxicity signals Tumor inhibition confirmed; added weight loss at higher doses/combination; optimizing index Mixed; optimization required
LNC small oligosOral delivery with biological activity; cytokine reductions (IL-17A, TNFα) Successful oral delivery; strong interest; ASGCT/TIDES presentations Follow-up efficacy less consistent; more optimization needed Cautious; additional work needed
RegulatoryClear FDA alignment on Phase 3 ORALTO No need for additional FDA meeting; alignment in place Maintaining alignment; CRO prep underway Steady

Management Commentary

  • “We have signed a nonbinding term sheet for the licensing of global rights to develop, manufacture and commercialize MAT2203... We are very encouraged by this progress.” – CEO Jerome Jabbour .
  • “The positive outcomes in [compassionate use] highlight the significant value of MAT2203 and bolster our confidence in the success of the ORALTO Phase III trial.” – CEO Jerome Jabbour .
  • “Total costs and expenses for the second quarter of 2024 were $5.8 million… The company did not report any revenue during either of these periods.” – CFO Keith Kucinski .
  • “We do think that we have confidence that the study can initiate in the fourth quarter of this year, but whether or not that results in a first patient first visit in 2024, that's probably safer for 2025… We still project that enrollment is going to take about 24 months.” – CEO Jerome Jabbour .
  • “Recent studies… demonstrated varying degrees of tumor growth inhibition… [but] resulted in additional weight loss… Additional work is ongoing to better understand and predict the efficacy of LNC-delivered chemotherapeutics.” – CEO Jerome Jabbour .

Q&A Highlights

  • Deal structure expectations: definitive agreement likely to include upfront payment, milestones, royalties, and partner support for development/manufacturing (e.g., Thermo Fisher tech transfer) .
  • ORALTO timing: initiation still targeted for Q4 2024; due diligence thorough to avoid CMC surprises; FPFV likely in 2025; ~24 months for enrollment .
  • Oncology weight loss interpretation: attributed to high-dose oral administration/gavage effects for docetaxel and agent-specific toxicity for miriplatin; formulation optimization and dose-splitting underway .
  • ORALTO design elements: 2-arm non-inferiority; step-down after 2 days IV amphotericin; 12-week treatment; primary endpoint 6-week mortality; key secondary endpoints include safety (superiority test), global response, and pharmacoeconomic impact .

KPIs

KPIQ1 2024Q2 2024
Compassionate/Expanded Use – Enrolled Patients (cumulative)22 31
Under Evaluation (requests)—6
Completed Treatment (cumulative)—15
Complete Response (cumulative)—8
Improved (cumulative)—7
Discontinued (cumulative)—2
Aspergillosis cases treated (cumulative)—7

Estimates Context

  • Street consensus (S&P Global) for Q2 2024 EPS and revenue was unavailable via our S&P Global access at the time of analysis; as a result, we cannot present a vs. estimates comparison for this quarter. If/when available, we will update the recap to reflect beats/misses relative to Wall Street consensus (Values retrieved from S&P Global).

Key Takeaways for Investors

  • Near-term catalyst: conversion of the non-binding term sheet into a definitive global licensing agreement for MAT2203; terms could include upfronts/milestones/royalties and partner-funded development/manufacturing—material to equity value .
  • Clinical narrative strengthening: increasing compassionate use enrollments with positive outcomes (8 complete responses, 7 improved) and rising physician demand support ORALTO prospects and potential broader label discussions at NDA .
  • Execution signal: ORALTO initiation remains targeted for Q4 2024 with FPFV likely in 2025; ~24-month enrollment suggests a multi-year path—timeline clarity is key for positioning and trade timing .
  • Financial positioning: reduced OpEx and improved net loss alongside $14.3M cash and marketable securities post-April financing provide runway to advance platform work while pursuing MAT2203 partnership .
  • Platform optionality with caveats: oncology and inflammation programs show promise, but recent weight loss in oncology models and less consistent oligo efficacy indicate formulation/dose optimization and risk management are necessary—monitor updates before underwriting incremental value .
  • No revenue/guidance: absence of top-line revenue and formal financial guidance keeps shares sensitive to binary events (partnership news, trial initiation, regulatory updates) and financing signals .
  • Risk framing: non-binding status, partner diligence, and CMC considerations can elongate timelines; however, FDA-aligned Phase 3 design and strong real-world signals help de-risk clinical execution .

Additional Q2 2024 Materials

  • Earnings press release and 8-K with financials and program updates .
  • Earnings call transcript (prepared remarks and Q&A) .
  • Webcast announcement (scheduling and access details) .