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Matinas BioPharma Holdings, Inc. (MTNB)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was operationally steady with no revenue and a narrowed net loss; total costs fell to $5.9M from $6.7M YoY, driven by lower clinical, personnel, and admin expenses .
  • Cash runway extended meaningfully after April financing: $8.1M cash and securities at 3/31/24, plus $10.0M raised in April; management guides funding into Q2 2025 .
  • Regulatory path solidified earlier in 2024: FDA alignment on a single Phase 3 (ORALTO) for MAT2203, with enrollment expected 2H 2024; management now targets Q4 2024 start and continues active partnership negotiations with a Q2 2024 goal to finalize .
  • Platform progress in oncology and inflammation continued, with favorable in vivo data for oral LNC-docetaxel and oral delivery of small oligonucleotides; management highlighted reduced toxicity and targeted delivery as strategic differentiators .

What Went Well and What Went Wrong

What Went Well

  • “We remain on track with active partnership discussions to advance oral MAT2203 into the ORALTO trial in invasive aspergillosis,” underscoring momentum toward Phase 3 and commercialization .
  • CFO reiterated expense discipline: total costs and expenses down to $5.9M vs $6.7M YoY; net loss was $5.8M ($0.03/share) vs $5.5M ($0.03/share) YoY .
  • Positive platform data: oral LNC-docetaxel showed comparable tumor reduction to IV with dramatically improved safety (no weight loss vs ~20% with IV); strengthening the delivery platform in oncology .

What Went Wrong

  • No revenue reported in Q1 2024 versus $1.1M in Q1 2023, reflecting the sunset of collaboration revenues from BioNTech and Genentech; this widened reliance on financing/partnerships .
  • Cash and marketable securities declined to $8.1M at quarter-end from $13.8M at year-end before the April raise, demonstrating continued burn ahead of a partner or non-dilutive funding .
  • Partnership timing risk: management guided Q2 2024 to finalize MAT2203 partnering but acknowledged complexity and potential slippage to ensure optimal alignment (territories, manufacturing transfer, regulatory positioning) .

Financial Results

Quarterly Comparison (oldest → newest)

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.0 Not disclosed (company reported full-year) $0.0
Total Costs and Expenses ($USD Millions)$6.1 Not disclosed (company reported full-year) $5.9
Net Loss ($USD Millions)$(6.1) Not disclosed (company reported full-year) $(5.8)
Diluted EPS ($USD)$(0.03) Not disclosed (company reported full-year) $(0.03)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$18.2 (9/30/23) $13.8 (12/31/23) $8.1 (3/31/24)

YoY Q1 Comparison

MetricQ1 2023Q1 2024
Revenue ($USD Millions)$1.096 $0.0
Total Costs and Expenses ($USD Millions)$6.7 $5.9
Net Loss ($USD Millions)$(5.5) $(5.8)
Diluted EPS ($USD)$(0.03) $(0.03)

Segment Breakdown

SegmentQ1 2024 Revenue ($USD)
No commercial segments; clinical-stage (no revenue) $0.0

KPIs

KPIQ3 2023Q4 2023Q1 2024
Patients enrolled in MAT2203 Compassionate/Expanded Use12 19 22
FDA alignment on single Phase 3 (ORALTO)In-progress (FDA openness to superiority endpoint) Achieved; single Phase 3 agreed Reaffirmed; start targeted Q4 2024
Cash runway guidanceInto Q3 2024 Through Q3 2024 (pre-April raise) Into Q2 2025 (post-April raise)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Partnership for MAT2203Near-termPursue/advance discussions; no explicit timing Goal to finalize in Q2 2024; willing to slip to optimize terms Clarified timing window
ORALTO Phase 3 enrollment start20242H 2024 Q4 2024 targeted Narrowed start window
Cash runwayFunding horizonInto Q3 2024 Into Q2 2025 (after $10M April financing) Raised (extended)
Manufacturing transfer (Thermo Fisher)Program setupManufacturing/partner alignment ongoing Emphasized as part of partner deal to enable ORALTO Operational emphasis

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023, FY 2023)Current Period (Q1 2024)Trend
Partnering for MAT2203FDA openness to superiority composite endpoint; increased partner interest; BARDA white paper planned “On track” negotiations; Q2 timing goal; optimizing territories, manufacturing, regulatory/commercial positioning Advancing; timeline defined
FDA/regulatory pathwayPursued LPAD candidacy; strong FDA engagement; superiority endpoint under discussion Prior FDA alignment confirmed; ORALTO design set; no further FDA meeting required to start Phase 3 De-risked
Compassionate use outcomes12 patients; complete resolution in Candida case; expanding sites 22 patients enrolled; ~1/3 aspergillosis; positive responses; renal toxicity reversed after switch from AmBisome to MAT2203 Broadening evidence
LNC-docetaxel oncologyOral delivery reduced melanoma tumor size comparable to IV; no systemic toxicity Additional safety study: >8x total dose vs IV with no weight loss; supports reduced toxicity and targeted delivery Strengthening proof
Small oligonucleotide program (inflammation)Ex vivo/in vitro uptake; cytokine knockdown; psoriasis model signals Oral delivery with biological activity; ASGCT/TIDES presentations; more data expected in Q3 Continued execution
Funding/cash runwayInto Q3 2024; seeking non-dilutive funds/partners April $10M raise extends runway into Q2 2025; disciplined spend Improved liquidity

Management Commentary

  • “We remain on track with active partnership discussions to advance oral MAT2203 into the ORALTO trial…aim to secure one or more development and commercial partners…to maximize its value in multiple geographies.” — Jerome D. Jabbour, CEO .
  • “Subsequent to the close of the quarter, in April, we raised gross proceeds of $10 million…we believe our current cash resources are sufficient to fund planned operations into the second quarter of 2025.” — Keith Kucinski, CFO .
  • “Our studies have shown that oral LNCs can deliver docetaxel directly to tumor cells…reducing tumor volumes comparable to IV docetaxel…with no indications of toxicity.” — Jerome D. Jabbour .
  • “We completed a financing last month that strengthened our balance sheet and extended our cash runway into the second quarter of 2025…” — Jerome D. Jabbour .

Q&A Highlights

  • Partnership timing: Management reiterated Q2 target but emphasized optimizing deal quality (territories, manufacturing transfer to Thermo Fisher, and global commercialization alignment) over speed .
  • Expanded access: Approximately one-third of 22 patients had invasive aspergillosis; those completing treatment had positive responses, mirroring prior crypto and mucor success .
  • ORALTO start: No further FDA meeting needed; “locked and loaded”; goal to start Phase 3 in Q4 2024 .
  • Spending cadence: Expect consistent R&D/G&A; partner expected to pick up ORALTO and preclinical costs tied to NDA .

Estimates Context

  • Consensus comparison unavailable: Wall Street EPS and revenue consensus (S&P Global) could not be retrieved due to access limits; therefore, results cannot be benchmarked vs estimates in this recap. Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

  • Near-term catalyst: MAT2203 partnership announcement (guided for Q2 2024) would de-risk funding for ORALTO and likely re-rate the equity on execution confidence .
  • Regulatory clarity: FDA alignment on a single Phase 3 (ORALTO) materially reduces regulatory uncertainty; targeted Q4 2024 start provides a tangible timeline .
  • Liquidity improved: April $10M raise extends runway into Q2 2025, increasing flexibility to progress platform studies while negotiating partnering terms .
  • Clinical validation: Compassionate/Expanded Use data (22 patients) show favorable outcomes and renal safety vs IV AmBisome, strengthening the clinical narrative for MAT2203 .
  • Platform optionality: Oral LNC-docetaxel and small oligonucleotide delivery broaden strategic optionality in oncology and inflammation; potential for partner interest beyond MAT2203 .
  • Execution watchpoints: Partnership timing and trial start adherence to Q4 2024; continued disciplined spend until partner assumes ORALTO costs .
  • Trading implications: Stock sensitivity to partnership headlines and any Phase 3 start confirmation; upside if partners assume trial costs and provide non-dilutive funding support .