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- **Nasdaq Compliance Achieved**: Regained listing with $1 bid price and $2.5M equity threshold.
- **Patent Portfolio Expanded**: 8 global patents, including microbiome-sparing class effect validation.
- **Cash Growth**: $5.9M (vs. $3.7M YoY) with $9M equity line remaining.
- **Cost Efficiency**: R&D down 67%, G&A down 28%, net loss halved to $2M.
- **Phase III Readiness**: Salvage trial expected soon, targeting secondary C. diff market.

**【CEO Summary Section】**
- **Regained Nasdaq Compliance**: Achieved $1 bid price and $2.5M stockholder equity thresholds, ensuring continued listing on Nasdaq.
- **Patent Milestones**: Secured Australian patent for DNA Pol IIIC inhibitors, joining 3 U.S., 1 Israeli, 1 Japanese, 1 Indian, and 1 EU patent. New colonic-microbiome data show microbiome-sparing class effect, reducing recurrence risk.
- **Clinical Trial Progress**: Phase III trial for ibezapolstat in secondary C. diff market (20-patient salvage trial) expected to start soon. Nature Communications published structural biology research confirming ibezapolstat's target binding.
- **Funding Efforts**: Raised $1.4M from warrant exercises and $1.7M via equity line, ending Q3 with $5.9M cash (vs. $3.7M YoY).

**【CFO Financial Commentary】**
- **Cash Position**: $5.9M (including $1.4M post-quarter) vs. $3.7M YoY, with $9M remaining on equity line.
- **Expense Reductions**: R&D down 67% ($0.4M vs. $1.2M) due to lower manufacturing and consulting costs. G&A down 28% ($1.6M vs. $2.2M) from reduced compensation and legal fees.
- **Net Loss Improvement**: $2M (vs. $2.8M YoY) driven by cost-cutting, despite Phase III trial preparation.

**【Q&A Key Highlights】**
- **FDA & Regulatory Strategy**: CEO expects Phase III data needed for safety database, ruling out Phase IIb-only approval. Tracking PASTOR Act and priority review voucher frameworks for potential partnerships.
- **Partnership Outlook**: CEO hints 'major news' by next call, targeting public-private partnerships for Phase III funding. Current OpEx steady at $1.6M/Q, with potential gradual reductions.
- **Clinical Strategy**: Microbiome-sparing data support ibezapolstat's efficacy in preventing recurrence, positioning for alternative regulatory pathways (e.g., conditional approval).

Acurx Pharmaceuticals, Inc. (ACXP) Q3 2025 Earnings Call Transcript

- **Clinical Triumph**: Ibezapolstat achieved 100% clinical cure in Phase IIb, outperforming vancomycin (70%-92%) and fidaxomicin (84%), with no recurrence and microbiome preservation.
- **Financial Resilience**: Reduced cash burn to $400K/month, with $6.1M in Q2 cash and $3.4M raised via equity and warrants.
- **Strategic Momentum**: Seeking government partnerships for Phase III funding, with potential 2025H2-2026 announcements. Phase III trials are protocol-finalized with FDA/EMA alignment.
- **Pipeline Strength**: New patent extends ACX-375C exclusivity to 2039, reinforcing potential for MRSA/VRE/DRSP treatments.
- **Cost Efficiency**: R&D expenses down 72% YoY, G&A down 26%, driven by reduced trial activity and share-based comp.

**【Management Opening Remarks】**
- CFO Robert Shawah highlighted the press release of Q2 2025 financial results and reminded listeners of forward-looking statements' risks. He noted the company's focus on capital preservation and strategic partnerships.

**【CEO Corporate Update】**
- **Patent Milestone**: Granted a new patent for DNA polymerase IIIC inhibitors, extending ACX-375C's exclusivity to 2039. This strengthens the pipeline for MRSA, VRE, DRSP, and anthrax treatments.
- **Capital Raising**: Closed a $12M equity line with Lincoln Park and executed a warrant inducement agreement, generating $2.7M in gross proceeds.
- **Clinical Success**: Published Phase IIb ibezapolstat data in *Lancet Microbe*, showing 100% clinical cure rates with no recurrence and microbiome preservation. This outperformed existing CDI treatments (vancomycin: 70%-92% cure; fidaxomicin: 84% cure) and highlighted resistance risks in current therapies.
- **Strategic Partnerships**: Collaborated with Leiden University on polymerase IIIC inhibitor mechanisms, presenting at FASEB. Also pursuing government partnerships for Phase III funding, with potential announcements in late 2025/2026.
- **Operational Efficiency**: Implemented 1-for-20 reverse stock split to maintain NASDAQ compliance and reduced cash burn to ~$400K/month.

**【CFO Financial Commentary】**
- **Cash Position**: $6.1M as of Q2, up from $3.7M at year-end, driven by $3.4M raised via equity line and warrant exercises.
- **Expense Management**: 
  - R&D: $0.5M (Q2) vs. $1.8M prior year, down 72% due to reduced trial costs.
  - G&A: $1.7M (Q2) vs. $2.3M prior year, down 26% from lower share-based comp.
- **Net Loss**: $2.2M (Q2) vs. $4.1M prior year, reflecting cost-cutting and reduced trial activity.

**【Q&A Highlights】**
- **Cash Preservation**: CEO David Luci confirmed Q2's $400K/month cash burn will continue, with plans for a small, low-cost clinical trial to be announced next quarter.
- **Partnership Outlook**: Government partnerships (e.g., NIH, BARDA) are prioritized, with potential 2025H2-2026 announcements. Private partnerships are also being explored.
- **Trial Readiness**: Phase III ibezapolstat trials are protocol-finalized with FDA/EMA alignment. Fill/finish manufacturing will begin when supply chain is optimized to avoid drug expiration risks.
- **Market Impact**: Ibezapolstat's potential to reduce CDI recurrence costs ($2.8B annually) positions it as a high-value antibiotic with strong commercial potential.


Acurx Pharmaceuticals, Inc. (ACXP) Q2 2025 Earnings Call Transcript

- **Breakthrough Clinical Data**: Ibezapolstat achieves 100% cure rate in Phase 2 with no recurrence, outperforming existing CDI treatments. 
- **Strategic Funding**: Secured $12M equity line and $3.6M Q1 raises, positioning for Phase 3. 
- **Cost Efficiency**: 52% net loss reduction through aggressive expense management. 
- **Regulatory Momentum**: Global patent coverage and aligned FDA/EMA Phase 3 guidance accelerate development.

**【CEO Summary Section】**
- **Clinical Trial Progress**: Received EMA guidance aligning with FDA for Phase 3 ibezapolstat trial, enabling international registration. Phase 2 data published in *Lancet Microbe* shows 100% clinical cure with no recurrence, preserving gut microbiota. 
- **Scientific Differentiation**: Studies demonstrate ibezapolstat selectively targets CDI without disrupting beneficial bacteria, outperforming vancomycin (42-71% sustained cure) and fidaxomicin (67% sustained cure). 
- **Patent Milestones**: Secured patents in Japan (2039 expiry) and India for DNA pol IIIC inhibitors, advancing ACX-375 development for MRSA, VRE, and anthrax. 
- **Funding Activity**: Raised $3.6M in Q1 via registered offerings; closed $12M equity line with Lincoln Park Capital. 

**【CFO Financial Commentary】**
- **Financial Health**: Ended Q1 with $4.6M cash, up from $3.7M. Net loss improved to $2.1M (-52% YoY) due to $1.7M expense reductions in R&D and G&A. 
- **Cost Management**: R&D down 63% to $0.6M (manufacturing, consulting cuts); G&A down 43% to $1.6M (consulting, share-based comp). 

**【Q&A Key Highlights】**
- **Strategic Pathways**: Exploring microbiome preservation as Phase 3 endpoint; evaluating Marty Makary's ultra-rare disease approval pathway for antibiotics. 
- **Funding Outlook**: Multiple avenues (BARDA, ARPA-H, Europe) in pursuit; awaiting Phase 3 funding to determine trial start. 
- **Expense Trajectory**: Anticipate continued cost cuts until Phase 3 begins; no specific timeline for trial启动.

Acurx Pharmaceuticals (ACXP)-13 May 25-2025 Q1 Earnings call transcript

- **Clinical Superiority**: IBZ achieves 96% cure rate vs vancomycin's 86%, with zero recurrences at 3 months. Microbiome data shows selective bacterial targeting.
- **Regulatory Momentum**: FDA/EMA aligned Phase 3 protocol; Japanese patent granted for MRSA/VRE drug candidate.
- **Funding Progress**: $3.7M cash; exploring gov grants and partnerships to fund Phase 3. No interim look; 2025 trial start with 2-year data readout.
- **Financial Efficiency**: 20% R&D cost reduction; net loss narrowed 3% YoY.

**【CEO Corporate Update】**
- **Clinical Milestones**: Phase 2b trial showed ibezapolstat (IBZ) achieved 96% clinical cure rate vs 86% for vancomycin, with 100% sustained cure at 1 month. Non-clinical studies demonstrate IBZ's microbiome-restorative properties, reducing recurrence risk.
- **Regulatory Progress**: Received FDA and EMA alignment on Phase 3 protocol, with EMA confirming regulatory pathway for EU marketing authorization. Japanese patent granted for DNA pol IIIC inhibitors, expiring 2039.
- **Funding Updates**: Completed $2.5M registered direct offering in Jan '25 and $1.1M in March '25. Exploring partnerships with government agencies and private sector for Phase 3 funding.

**【CFO Financial Highlights】**
- **Cash Position**: $3.7M as of Q4 '24 (down from $7.5M in 2023) after raising $6.6M via ATM program.
- **Cost Management**: R&D expenses decreased 20% YoY ($5.4M vs $6M) due to reduced consulting costs. G&A expenses stable at $8.7M, with 6% share-based comp decline.
- **Net Loss**: $14.1M for full year '24 (-$0.87/share), narrowing from $14.6M (-$1.15/share) in 2023.

**【Q&A Key Takeaways】**
- **Phase 3 Enrollment**: 150 sites (50% EU, 30% US) targeting 2025 start. No interim look; 2-year timeline to top-line data.
- **Funding Strategy**: Prioritizing government grants and partnerships over private M&A. ATM program suspended during Jan '25 offering but reactiveable.
- **NASDAQ Compliance**: Management confident in maintaining listing despite current share price below $1 threshold.

Acurx Pharmaceuticals (ACXP)-18 Mar 25-2024 Q4 Earnings call transcript

Acurx Pharmaceuticals (ACXP)-13 Nov 24-2024 Q3 Earnings call transcript

Acurx Pharmaceuticals (ACXP)-9 Aug 24-2024 Q2 Earnings call transcript

Acurx Pharmaceuticals (ACXP)-15 May 24-2024 Q1 Earnings call transcript

- **Phase IIb Triumph**: Ibezapolstat achieved 96% cure rate with no safety issues, outperforming vancomycin in sustained cures (100% vs. 85.7%).
- **FDA Milestone**: End-of-Phase II meeting in April 2024 to lock Phase III design; targeting Q4 2024 trial start.
- **Financial Reality**: $14.6M net loss in 2023, driven by $6M R&D and $8.5M G&A expenses; $7.5M cash on hand.
- **Global Growth Strategy**: 100+ international sites for Phase III; exploring ex-U.S. licensing to mitigate financial risk.
- **Market Impact**: Potential $4.7B annual U.S. CDI cost savings; 10-year exclusivity if approved.


**【CEO Summary Section】**
- **Phase IIb Clinical Trial Success**: Ibezapolstat achieved a 96% clinical cure rate (100% in Phase IIa, 94% in Phase IIb) vs. vancomycin's 100% cure rate. No safety concerns noted.
- **Sustained Cure Data**: 100% of 15 patients remained cured at 30 days post-treatment, vs. 85.7% for vancomycin.
- **Microbiome Benefits**: Ibezapolstat preserved beneficial gut bacteria, reducing recurrence risk.
- **FDA End-of-Phase II Meeting**: Scheduled for April 2024 to discuss Phase III trial design and regulatory pathway.
- **Global Expansion**: Planning Phase III trials in 17 countries (100+ sites) to accelerate enrollment and support international filings.
- **Partnership Strategy**: Exploring licensing agreements for ex-U.S. territories; no commitments yet, but discussions ongoing.

**【CFO Financial Commentary】**
- **Cash Position**: $7.5 million as of Dec 31, 2023 (down from $9.1M in 2022); raised $4.5M post-year-end via ATM.
- **R&D Expenses**: $6M for 2023 (vs. $4.8M in 2022), driven by Phase IIb costs.
- **G&A Expenses**: $8.5M for 2023 (vs. $7.3M in 2022), due to increased professional fees and compensation.
- **Net Loss**: $14.6M for 2023 (vs. $12.1M in 2022), reflecting higher operational costs.

**【Executive Chairman's Remarks】**
- **Phase III Execution**: Targeting Q4 2024 start for first trial; second trial contingent on first trial success or partnerships.
- **Manufacturing Cost Efficiency**: Low manufacturing costs position ibezapolstat for competitive pricing.
- **Market Potential**: 500,000+ annual U.S. CDI cases, with 30,000 deaths annually; 10-year regulatory exclusivity if approved.

**【Q&A Highlights】**
- **Timeline for Phase III**: First trial to complete in Q2 2026; second trial contingent on first trial success or partnerships.
- **International Sites**: 100+ sites across 17 countries; leveraging COVID-era trial data to optimize enrollment.
- **Partnership Timing**: Most likely after first Phase III trial completion; territorial licensing preferred over M&A due to share price concerns.
- **Trial Design**: 90% similarity to Phase IIb; broader inclusion criteria for mild-moderate CDI patients.


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