PAVmed(US:PAVM)2025-11-12 22:23Product Development and Partnerships - PAVmed's flagship product, EsoGuard, is undergoing a Medicare coverage reconsideration process with a complete clinical evidence package submitted in November 2024, including six new peer-reviewed publications[174] - The ENVET-BE study demonstrated a 2.4-fold increase in Barrett's Esophagus (BE) detection compared to performance goals, with a 2.7-fold increase in patients meeting ACG criteria[179] - PAVmed entered into a strategic partnership with The Ohio State University Comprehensive Cancer Center to enhance personalized cancer care using the Veris Cancer Care Platform[183] - An $8 million NIH grant was awarded to CWRU and University Hospitals for a five-year clinical study evaluating EsoCheck and EsoGuard for esophageal precancer detection[182] - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York, effective May 26, 2025, covering patients meeting established criteria[181] - PAVmed executed a letter of intent with Duke University to license endoscopic imaging technology for real-time detection of esophageal precancer[184] Financial Performance - In the three months ended September 30, 2025, revenue was less than $0.1 million, a decrease of $1.0 million compared to $1.0 million for the same period in the prior year, primarily due to the exclusion of Lucid's EsoGuard test results[206] - Cost of revenue for the three months ended September 30, 2025, was approximately $0.1 million, down from $1.4 million in the prior year, reflecting the absence of Lucid's results[207] - Sales and marketing expenses decreased to approximately $0.2 million in the three months ended September 30, 2025, from $2.9 million in the prior year, due to the exclusion of Lucid's results[208] - General and administrative expenses were approximately $3.5 million for the three months ended September 30, 2025, compared to $6.6 million in the prior year, also reflecting the exclusion of Lucid's results[209] - Research and development costs were approximately $1.1 million in the three months ended September 30, 2025, down from $1.5 million in the prior year, due to the exclusion of Lucid's results[210] - For the nine months ended September 30, 2025, revenue was less than $0.1 million, a decrease of $3.0 million compared to $3.0 million for the same period in the prior year, primarily due to the exclusion of Lucid's results[219] - Cost of revenue for the nine months ended September 30, 2025, was approximately $0.1 million, down from $4.8 million in the prior year, reflecting the absence of Lucid's results[220] - Sales and marketing expenses decreased to approximately $0.7 million in the nine months ended September 30, 2025, from $11.5 million in the prior year, due to the exclusion of Lucid's results[221] - General and administrative expenses were approximately $11.6 million for the nine months ended September 30, 2025, compared to $20.3 million in the prior year, reflecting the exclusion of Lucid's results[222] - Research and development costs were approximately $2.7 million in the nine months ended September 30, 2025, down from $5.1 million in the prior year, due to the exclusion of Lucid's results[224] Capital and Financing - PAVmed's corporate structure allows for tailored financing strategies for each subsidiary, enhancing capital-raising flexibility[172] - Veris Health raised approximately $2.5 million from the sale of 1,800,000 shares at $1.40 per share in June 2025, aimed at developing an implantable physiological monitor[185] - The Company issued 1,216,565 shares of common stock for net proceeds of approximately $0.8 million during the nine months ended September 30, 2025[242] - The Company completed an offering of 2,574,350 shares of common stock and pre-funded warrants, generating gross proceeds of $2.37 million[257] - The Company is required to maintain cash flow on a break-even basis and is in compliance with all covenants as of September 30, 2025[255] - The Company has the right to redeem Series C Preferred Stock at a price equal to 132.5% of the aggregate stated value plus accrued dividends[252] - The Series C Preferred Stock has a stated value of $1,000 per share and a preferred dividend rate of 7.875% per annum[246] - The initial fixed conversion price for Series C Preferred Stock is $1.068 per share, with temporary reductions to $0.40 agreed upon under certain conditions[249] - Upon a Triggering Event, holders can convert Series C Preferred Stock at an alternate conversion price, which is the lower of the fixed price or 80% of the VWAP[250] - The Series C Preferred Stock is senior to all other equity securities and holders are entitled to cash upon liquidation before common stock holders[247] - The Company has an additional one-time right to redeem a portion of Series C Preferred Stock with an aggregate stated value of at least $5 million[252] Investment and Valuation - The fair value of the Company's investment in Lucid was $31.6 million as of September 30, 2025, with an unrealized gain of $6.0 million recognized during the period[231] - The change in fair value of convertible debt resulted in an expense of approximately $0.4 million for the nine months ended September 30, 2025, compared to an expense of $2.5 million in the prior year[226] - A deemed dividend of $7.5 million was recognized due to the exchange of Lucid Series A and Series A-1 Preferred Stock for Series B Preferred Stock[232] Cash Flow and Liquidity - The Company experienced net income before noncontrolling interests of approximately $0.3 million and used approximately $3.7 million of cash in operations for the nine months ended September 30, 2025[235] - The Company ended the quarter with cash on-hand of $3.1 million as of September 30, 2025[235] - The Company is subject to financial covenants requiring available cash to equal or exceed $8.0 million at all times[240] Management and Governance - The Company granted Investors a 100% participation right in future equity offerings, subject to existing rights of debt holders[258] - Management fee income increased to approximately $9.5 million for the nine months ended September 30, 2025, up from $0.7 million in the prior year, reflecting an increase of $8.8 million[227] - The Veris Warrants have an exercise price of $1.40 per share and become exercisable six months after issuance[261]