Executive Summary

Matinas reported FY 2023 results alongside Q4 2023 updates: FY revenue was $1.10M, total costs/expenses $24.86M, and net loss $22.94M ($0.11/share); cash, cash equivalents and marketable securities were $13.8M at 12/31/23, with runway through Q3 2024 .
The major catalyst was final FDA alignment on the single Phase 3 ORALTO trial design for MAT2203 (oral amphotericin B) in invasive aspergillosis with limited treatment options, establishing a clear registration pathway and enabling active partnership discussions to fund and launch the trial .
Compassionate/Expanded Use Access Program continued to validate efficacy and safety: by Q4, 19 patients had been enrolled across major centers, with renal toxicity reversing after switching from IV amphotericin B and multiple complete clinical resolutions reported .
No Wall Street consensus estimates were available at the time of analysis (S&P Global data unavailable), so beats/misses cannot be assessed; investors should focus on regulatory clarity, partnership timing, and cash runway as primary stock drivers .

What Went Well and What Went Wrong

What Went Well
- Regulatory clarity: FDA agreed on the ORALTO Phase 3 registration trial design (non-inferiority primary endpoint with superiority-leaning secondary objectives), unlocking the path to Phase 3 and supporting partnership discussions. CEO: “A clear regulatory approval pathway for oral MAT2203 is a critical step toward future commercialization…” .
- Real-world validation: 19 patients enrolled in Expanded Access by Q4 with reversals of amphotericin-related renal toxicity after switching to MAT2203; several complete clinical resolutions and outpatient continuation supported the drug’s potential and favorable pharmacoeconomics .
- Platform progress: In vivo data showed oral LNC‑docetaxel matched IV efficacy with dramatically improved safety (no weight loss vs ~20% for IV) and successful oral delivery of biologically active small oligonucleotides in inflammation models .
What Went Wrong
- Revenue decline: FY 2023 revenue fell to $1.10M from $3.19M in 2022 due to lower collaboration revenues; overall net loss widened modestly to $22.94M .
- Runway pressure: Cash and marketable securities declined to $13.8M at 12/31/23; management reiterated runway through Q3 2024, increasing urgency for partnerships or non‑dilutive funding .
- Estimates visibility: No consensus estimates available and no formal financial guidance provided; reliance on partnership and regulatory milestones heightens binary event risk .

Financial Results

Quarterly trend (Q2–Q4 2023)

Metric	Q2 2023	Q3 2023	Q4 2023
Revenue ($USD Millions)	$0.00	$0.00	$0.00 (FY $1.096M – 9M $1.096M)
Net Loss ($USD Millions)	$(6.06)	$(6.06)	$(5.31) (FY $(22.94) – 9M $(17.63))
Cash & Marketable Securities ($USD Millions, period end)	$22.5	$18.2	$13.8

Notes: Q4 revenue and net loss are derived from FY 2023 and 9M 2023 figures disclosed in the company’s Q3 and year-end releases .

Annual YoY comparison

Metric	FY 2022	FY 2023
Revenue ($USD Millions)	$3.19	$1.10
Total Costs & Expenses ($USD Millions)	$27.78	$24.86
Net Loss ($USD Millions)	$(20.997)	$(22.942)
Net Loss/Share (Basic & Diluted)	$(0.10)	$(0.11)
Cash & Marketable Securities (12/31) ($USD Millions)	$28.76 (Cash $6.83 + Securities $21.93)	$13.76 (Cash $4.79 + Securities $8.97)

Segment breakdown: Not applicable; no reportable segments disclosed .
KPIs

KPI	Q2 2023	Q3 2023	Q4 2023
Compassionate/Expanded Use patients enrolled (cumulative)	8	12	19

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Through Q3 2024 (Q2’23 disclosure)	“Into the third quarter of 2024”	“Through the third quarter of 2024”	Maintained
MAT2203 Phase 3 (ORALTO) design	Registration trial	FDA feedback pending; LPAD pathway considered	FDA alignment on single Phase 3 design; non‑inferiority primary endpoint; superiority‑leaning secondary objectives (toxicity, survival, HEOR/QoL)	Clarified/upgraded
Funding approach	Phase 3 initiation	Pursuing BARDA and partnerships	Prioritizing partnership to launch Phase 3 quickly; dialogues active	Refocused toward partnership
Listing status	Ongoing	Previously at risk of noncompliance (low price)	Regained NYSE American compliance	Improved

No revenue, margin, OpEx, OI&E, tax, dividend, or segment financial guidance was provided .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2023 and Q3 2023)	Current Period (Q4/FY 2023 call)	Trend
Regulatory path for MAT2203	FDA signaled high bar for first‑line NI trial; pivot to LPAD and high‑need populations	Final FDA alignment on single Phase 3 ORALTO design; NI primary with superiority-leaning secondaries; global ~216 pts across ~65 sites	Improving
LPAD and label strategy	LPAD pathway discussed; potential restricted label, external/best‑available control considered	LPAD remains core; study design includes HEOR/QoL to support value proposition	Consistent
Compassionate use outcomes	8 patients; first pediatric success; normalization of renal function; outpatient continuation	19 patients by Q4; multiple complete resolutions; consistent reversal of amphotericin nephrotoxicity	Strengthening
Partnerships/funding	Seeking BARDA and partnerships; cash runway into Q3’24	Active partnership talks prioritized to fund Phase 3 and commercialization; regained listing compliance	Advancing
LNC platform expansion	In vitro RNAi delivery; oral LNC‑docetaxel efficacy in vivo	Oral LNC‑docetaxel safety at >8x IV dose with no weight loss; oral small oligo biologic activity in colitis/psoriasis	Broadening

Management Commentary

CEO on regulatory progress: “A clear regulatory approval pathway for oral MAT2203 is a critical step toward future commercialization … Reaching agreement with FDA on the design of the ORALTO registration trial … elevated our confidence … We are actively pursuing partnership opportunities to advance MAT2203 into Phase 3 as quickly as possible.” .
CFO on FY results and cash: “Revenue for 2023 was $1.1 million … Total costs and expenses for 2023 were $24.9 million … Net loss for 2023 was $22.9 million … Cash, cash equivalents and marketable securities as of December 31, 2023 were $13.8 million.” .
Strategic positioning: “We project that the market for MAT2203 … could reach peak sales in the U.S. alone of over $400 million annually … We are actively engaged in partnership discussions … to advance MAT2203 into Phase III as quickly as possible.” .
Platform validation: “In vivo study data … showed … oral LNC‑docetaxel … comparable to IV‑docetaxel with no apparent toxicity … healthy mice administered oral LNC‑docetaxel at doses more than 8x greater than IV‑docetaxel showed no weight loss, versus ~20% peak weight loss with IV.” .

Q&A Highlights

Trial design and comparator: Management emphasized the control arm remains IV amphotericin-based standard of care; composite therapeutic success endpoint (including need to change therapy due to toxicity) strengthens positioning for superiority readthroughs without changing control .
Market opportunity: “We estimate … a $300 million market alone in the U.S. just for [limited treatment option] invasive aspergillosis” with potential to expand into other invasive fungal infections .
LPAD timing: LPAD designation is determined at NDA filing/approval, not pre‑declared; management believes criteria are well matched to MAT2203’s target population .
ORALTO timing and HEOR: ~216 patients across ~65 sites in 11 countries; expected 22–24 months enrollment, topline ~Feb 2027 if started late 2024; secondary endpoints include hospitalization days, rehospitalization, infusion days, and QoL to support pricing and access .

Estimates Context

Consensus for Q4 2023 revenue and EPS was unavailable due to S&P Global data access limits at the time of analysis; therefore, we cannot assess beats/misses versus Wall Street estimates .
Implication: Near-term investor modeling should focus on operating burn, cash runway, and milestone timing (Phase 3 start, partnership) until broader coverage and estimates resume.

Key Takeaways for Investors

Regulatory de-risking: Final FDA alignment on ORALTO Phase 3 design materially reduces program uncertainty and is a clear setup for a partnership catalyst to fund and start the trial .
Clinical validation: Compassionate/Expanded Access outcomes (renal safety, outpatient continuity, multiple complete responses) reinforce the potential for favorable efficacy and HEOR outcomes in the trial and commercial setting .
Platform upside: LNC‑docetaxel safety/efficacy profile and oral small oligo activity broaden optionality beyond anti‑infectives, creating partnering and pipeline value levers .
Cash and runway: $13.8M in cash and marketable securities with runway through Q3 2024 heightens urgency for non‑dilutive capital via partnership; watch timing of transaction updates .
Stock drivers: Near-term catalysts include a MAT2203 partnership announcement, Phase 3 site initiations/enrollment progress, and additional LNC platform data in oncology/inflammation .
Risk balance: Pre‑revenue profile and limited runway create financing risk; however, regulatory clarity and real-world data support a more constructive risk‑reward into partnership milestones .

Appendix: Source Documents Reviewed

8‑K 2.02 “Reports 2023 Financial Results and Provides a Business Update” (Q4/FY2023) – March 27, 2024 .
FY2023 Earnings Call (other-transcript) – March 27, 2024 .
8‑K 2.02 “Reports Third Quarter 2023 Financial Results” – November 8, 2023 .
Q3 2023 Earnings Call – November 8, 2023 .
8‑K 2.02 “Reports Second Quarter 2023 Financial Results” – August 9, 2023 .

Disclaimer: Estimates from S&P Global were unavailable at the time of analysis; no estimate-based comparisons are provided. Values drawn from company documents are cited accordingly.

Matinas BioPharma Holdings, Inc. (MTNB)·Q4 2023 Earnings Summary