Earnings Call Transcripts
Access detailed transcripts and key takeaways from company earnings calls
All Earnings Calls
Relmada Therapeutics Q3 2025 Earnings Call - NDV-01 Poised for Dual Registrational Path with Strong Phase 2 Data
Relmada Therapeutics reported encouraging nine-month Phase 2 results for NDV-01, a novel sustained-release gemcitabine-docetaxel formulation targeting non-muscle-invasive bladder cancer (NMIBC), with ...
- Relmada Therapeutics presented nine-month Phase 2 data for NDV-01 in NMIBC showing a 92% overall complete response rate at any time among 25 patients, with favorable safety and no progression to muscle-invasive disease.
- NDV-01 is a novel sustained-release intravesical formulation combining gemcitabine and docetaxel, designed for easier office administration without the need for specialized compounding, greatly expanding potential use beyond academic centers.
- FDA feedback secured alignment on two registrational pathways for NDV-01: one in high-risk BCG unresponsive NMIBC suitable for a single-arm trial, and a separate randomized trial in intermediate-risk NMIBC in the adjuvant setting.
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STRATA Skin Sciences Q3 2025 Earnings Call - Historic Expansion of CPT Codes Triples Patient Market Size
In Q3 2025, STRATA Skin Sciences continued restructuring for growth ahead of a pivotal CPT code expansion effective January 2027, broadening coverage from psoriasis to about 30 inflammatory and autoim...
- STRATA’s XTRAC excimer laser CPT codes are expanding effective January 1, 2027, to include ~30 autoimmune and inflammatory skin conditions beyond psoriasis, tripling the addressable patient population to over 30 million.
- The Centers for Medicare and Medicaid Services (CMS) has recognized both current and expanded codes in the 2026 Medicare Physician Fee Schedule Final Rule, validating the forthcoming reimbursement changes.
- STRATA is actively seeking to extend expanded code recognition to private insurers ahead of the 2027 official rollout.
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SeaStar Medical Q3 2025 Earnings Call - Encouraging Safety and Expanded Enrollment in NEUTRALIZE-AKI Trial with Growing Commercial Traction of Quellimune
SeaStar Medical's Q3 2025 call reveals promising safety data and a strategic decision to expand the NEUTRALIZE-AKI pivotal trial enrollment from 200 to 339 patients to enhance statistical power after ...
- SeaStar Medical added three top-ranked children’s medical centers to its commercial Quellimune customer base in Q3 2025.
- Quellimune therapy showed remarkable real-world survival results for 21 pediatric patients with life-threatening AKI and sepsis, with 76% surviving at 60 days and 71% at 90 days.
- Q3 net revenue from Quellimune sales was $183,000, up from $68,000 in Q3 2024, with a 45% revenue increase comparing six months ending Sept 30 vs. March 30, 2025.
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HeartBeam Q3 2025 Earnings Call - Preparing for Commercial Launch with Pending 12-Lead ECG FDA Clearance
HeartBeam detailed strong progress toward commercializing its pioneering portable, cable-free ECG system capable of synthesizing clinical-grade 12-lead readings. With foundational FDA clearance secure...
- HeartBeam received foundational FDA 510(k) clearance in Dec 2024 for its arrhythmia assessment system comprising device, app, portal, and algorithms.
- A second FDA 510(k) clearance for software synthesizing 12-lead ECG from 3D signals is expected by year-end 2025, a critical step for commercialization.
- The company achieved 93.4% diagnostic agreement in a pivotal VALID-ECG study comparing its synthesized 12-lead ECG to standard systems.
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CV Sciences Q3 2025 Earnings Call - Navigating Regulatory Headwinds while Advancing M&A and Product Innovation
CV Sciences reported $3.3 million in revenue for Q3 2025, down 10% sequentially and 16% year-over-year, impacted by temporary out-of-stock issues and challenging state regulations. Despite this, the c...
- CV Sciences generated $3.3 million in Q3 2025 revenue, down 10% sequentially and 16% year-over-year due to out-of-stock issues and restrictive state regulations.
- The company achieved a strong gross margin of 48.5%, maintaining profitability potential despite revenue pressures.
- Adjusted EBITDA loss shrank to $118,000, signaling cost control success and nearing positive cash flow.
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CytoSorbents Corporation 3Q 2025 Earnings Call - Advancing DrugSorb ATR U.S. Approval Amid German Sales Restructuring
CytoSorbents Corporation reported third quarter 2025 revenue of $9.5 million, up 10% year-over-year, driven by strong distributor and direct market sales outside Germany, though the German market decl...
- 3Q 2025 revenue reached $9.5 million, a 10% increase YoY or 4% constant currency growth.
- Trailing 12-month core product sales grew to $37 million from $33.8 million in prior year.
- Distributor and partner sales grew 14% to $15.6 million, direct sales outside Germany increased 24%.
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Tenon Medical Q3 2025 Earnings Call - Strategic Acquisition and Product Launch Spur Record Revenue Growth
Tenon Medical's third quarter results revealed robust momentum driven by the strategic acquisition of Cyvanage's Symmetry and Symmetry Plus sacroiliac joint fusion technologies, adding breadth to its ...
- Tenon Medical achieved record Q3 2025 revenue of $1.2 million, up 32% year-over-year, driven by increased Cadmium system procedures and early Cyvanage Symmetry product sales.
- The company completed a strategic asset acquisition of Cyvanage’s Symmetry and Symmetry Plus sacroiliac joint fusion technologies, expanding its product portfolio and market reach.
- Symmetry Plus received FDA 510(k) clearance post-quarter, enabling a minimally invasive lateral surgical approach complementing Cadmium’s inferior-posterior approach.
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Red Cat Holdings Q3 2025 Earnings Call - Record Revenue Growth and Strategic Expansion into USVs
Red Cat Holdings reported a blockbuster Q3 2025 with revenues soaring 200% sequentially to $9.6 million, driven by accelerated adoption of its drone and robotic systems primarily for U.S. defense and ...
- Q3 2025 revenues hit a record $9.6 million, up 200% from Q2 2025, showing rapid acceleration in product adoption.
- Full-year 2025 revenue guidance lowered to $34.5-$37.5 million due to six to seven weeks shipment delay caused by evolving Army contract requirements.
- Limited-Rate Initial Production (LRIP) contract expanded to $35.1 million, underscoring military confidence in Black Widow drone system.
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Co-Diagnostics Q3 2025 Earnings Call - Pivotal Strategic Moves in India and MENA Set Stage for Growth
Co-Diagnostics delivered a transformative update in its Q3 2025 earnings call, spotlighting strategic advances that could redefine its trajectory. The company is actively preparing a SPAC transaction ...
- Co-Diagnostics is exploring a SPAC transaction for its Indian joint venture Cosera Diagnostics to unlock value and raise growth capital.
- The Comera joint venture with Arabian Eagle targets expansion into Saudi Arabia and 18 additional MENA countries with localized manufacturing.
- Comera Diagnostics aligns closely with Saudi Vision 2030, focusing on technology localization and healthcare innovation in the Middle East.
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TechPrecision Corporation FY 2026 Q2 Earnings Call - Navigating Complex Defense Contracts Amidst Modest Revenue Growth
TechPrecision Corporation reported a cautious yet tangible improvement in its fiscal 2026 second quarter financials, with consolidated revenue inching up 2% to $9.1 million and gross profit surging by...
- Fiscal 2026 Q2 consolidated revenue rose 2% to $9.1 million versus prior year, signaling modest top-line growth.
- Gross profit increased by $1.4 million, translating into a significant 16 percentage point year-over-year gross margin improvement.
- Raynor segment revenue declined slightly by $0.4 million to $4.4 million but posted strong $1.6 million operating profit with improved margin drop-through.
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