PAVmed(PAVM)
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PAVmed Inc. (PAVM) Shareholder/Analyst Call Prepared Remarks Transcript
Seeking Alpha· 2025-12-05 16:08
PresentationI call the Special Meeting of Stockholders of PAVmed Inc. to order. I am Lishan Aklog, the company's Chairman and Chief Executive Officer. Also present is Michael Gordon, the company's General Counsel; Eric Schwartz of Graubard Miller, outside counsel to the company; and Alwyn Burton of Continental Stock Transfer & Trust Company, the company's transfer agent. Eric will act as Secretary of the meeting. As you all know, we are holding this special meeting via live webcast. To help the meeting run ...
Biotech Momentum Builds In After-Hours Trading As BioAtla, Entero, And Sonnet Climb
RTTNews· 2025-12-01 03:29
Several small-cap biotech and healthcare stocks posted notable gains in after-hours trading on Friday, November 28, 2025, despite limited fresh news flow. Below is a roundup of the key movers.BioAtla Inc. (BCAB) shares surged in after-hours trading, climbing 13.94% to $1.03, after closing the regular session at $0.9040, up 6.27%. While there was no company-specific news on Friday, investors may still be reacting to BioAtla's November 21 announcement of financing agreements. The company entered into Pre-pai ...
PAVmed Inc. 2025 Q3 - Results - Earnings Call Presentation (NASDAQ:PAVM) 2025-11-14
Seeking Alpha· 2025-11-14 17:03
Group 1 - The article does not provide any specific content related to a company or industry, as it appears to be a technical issue regarding browser settings and ad-blockers [1]
PAVmed(PAVM) - 2025 Q3 - Earnings Call Transcript
2025-11-13 14:32
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $6 million for the third quarter, which includes a non-cash loss of $4.4 million due to changes in the fair value of equity investments [23][24] - Non-GAAP loss for the quarter was $446,000, primarily reflecting incremental contractor development costs for the Veris implantable device [24][25] - Cash burn rate for the third quarter was $900,000, which included approximately $500,000 in outside contractor development costs for the implantable device [20][25] Business Line Data and Key Metrics Changes - Lucid's revenue for the quarter was $1.2 million, with test volume exceeding 2,800, consistent with the target range of 2,500-3,000 tests [10][11] - Veris launched the commercial phase of its strategic partnership with OSU, targeting 1,000 patients in the first year for enrollment in a registry [12][14] Market Data and Key Metrics Changes - The company remains the largest shareholder of Lucid Diagnostics, owning approximately 23% of the common shares outstanding, with a 28% voting interest [21][22] - Lucid's stock price experienced a sequential reduction of $4.4 million, impacting the equity method investment balance [20][22] Company Strategy and Development Direction - The company aims to stabilize its corporate structure and balance sheet, with plans to operate as a diversified commercial life sciences company with multiple independently financed subsidiaries [5][6] - A licensing agreement with Duke University and the University of North Carolina for breakthrough endoscopic imaging technology is in the final stages, which could transform treatment for esophageal precancer [8][46] - The company is expanding its commercial offerings for Veris beyond remote patient monitoring to include clinical support services and AI-based clinical decision tools [17][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to complete its restructuring and reignite its broader vision, with several promising technologies in the pipeline [27][28] - The company is optimistic about the Medicare coverage for EsoGuard, which is seen as a significant milestone for Lucid [10][11] Other Important Information - The company has secured financing to support the development and FDA submission of Veris's implantable device, with a submission planned for 2026 [12][18] - The company is focused on building a clinical support team to enhance the efficiency of its platform and provide value-added services to commercial partners [16][42] Q&A Session Summary Question: Status of the implantable monitor development - Management confirmed that the development is progressing well with a new manufacturing partner, and the clinical requirements are modest, primarily involving a skin study [33][34][38] Question: Commercialization conversations with other cancer centers - Management indicated that they plan to start commercialization discussions with other centers in the first quarter after gaining experience with OSU [40][41] Question: Exclusivity and timing of the endoscopic imaging technology agreement - Management stated that a definitive license agreement is expected soon, and the technology will be developed within a separate subsidiary of PAVmed [46][48]
PAVmed(PAVM) - 2025 Q3 - Earnings Call Transcript
2025-11-13 14:32
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $6 million for the third quarter, which includes a non-cash loss of $4.4 million due to changes in the fair value of equity investments [23][24] - Non-GAAP loss for the quarter was $446,000, primarily reflecting incremental contractor development costs for the Veris implantable device [24][25] - Cash burn rate for the third quarter was $900,000, which included approximately $500,000 in outside contractor development costs for Veris [20][24] Business Line Data and Key Metrics Changes - Lucid's revenue for the quarter was $1.2 million, with test volume exceeding 2,800, consistent with the target range of 2,500-3,000 tests [10][11] - Veris launched the commercial phase of its strategic partnership with OSU, targeting 1,000 patients in the first year for enrollment in a registry [12][14] Market Data and Key Metrics Changes - The Medicare contractor meeting in September was successful, with experts endorsing Medicare coverage for EsoGuard, marking a significant milestone for Lucid [10][11] - PAVmed remains the largest shareholder of Lucid, owning approximately 23% of the common shares outstanding, although it no longer has voting control [21] Company Strategy and Development Direction - The company aims to stabilize its corporate structure and balance sheet, with plans to operate as a diversified commercial life sciences company with multiple independently financed subsidiaries [5][6] - PAVmed is pursuing additional technologies, including a partnership with Duke University for an endoscopic imaging technology for esophageal precancer [8][46] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's positioning to capitalize on Lucid's market opportunities and the potential for Medicare coverage [9][10] - The company is focused on expanding its commercial offerings and enhancing its value proposition through clinical support services and AI-based clinical decision tools [17][43] Other Important Information - The company has restructured its debt, exchanging about 80% of its outstanding debt for new Series C preferred equity [19] - The development of the Veris implantable device is progressing well, with a clear regulatory pathway established for FDA submission [34][38] Q&A Session Summary Question: Status of the implantable monitor development - Management confirmed that the development work has relaunched with a new manufacturing partner and that the clinical requirements for FDA submission are modest [33][34] Question: Timing for commercialization conversations with other cancer centers - Management indicated that they plan to start expanding commercial activities to other centers in the first quarter after gaining experience with OSU [40][41] Question: Exclusivity and timing of the endoscopic imaging technology agreement - Management stated that a definitive license agreement is expected soon, and the technology will be developed within a separate subsidiary of PAVmed [45][46]
PAVmed(PAVM) - 2025 Q3 - Earnings Call Transcript
2025-11-13 14:30
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $6 million for the third quarter, which includes a non-cash loss of $4.4 million due to changes in the fair value of equity investments [23][24] - Non-GAAP loss for the quarter was $446,000, primarily reflecting incremental contractor development costs for the Veris implantable device [23][24] - Cash burn rate for the third quarter was $900,000, which included approximately $500,000 in outside contractor development costs for the implantable device [20][24] Business Line Data and Key Metrics Changes - Lucid's revenue for the quarter was $1.2 million, with test volume exceeding 2,800, consistent with the target range of 2,500-3,000 tests [9][10] - Veris launched the commercial phase of its strategic partnership with OSU, targeting 1,000 patients in the first year for enrollment in a registry [12][13] - The company has secured financing to support the development of the Veris implantable device, with a planned FDA submission in 2026 [12][13] Market Data and Key Metrics Changes - Medicare contractor meeting in September was successful, with experts endorsing Medicare coverage for EsoGuard, indicating a positive outlook for future revenue [10][11] - The company remains the largest shareholder of Lucid Diagnostics, holding approximately 23% of common shares, which reflects a significant influence despite no longer having voting control [21] Company Strategy and Development Direction - The company aims to stabilize its corporate structure and balance sheet, with ongoing efforts to build a diversified portfolio of independently financed subsidiaries [5][6] - Plans to expand the commercial offering of Veris beyond remote patient monitoring, incorporating clinical support services and AI-based clinical decision tools [17][40] - A licensing agreement for breakthrough endoscopic imaging technology is in the final stages, which will be developed under a separate subsidiary [8][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to complete restructuring efforts and reignite broader visions for innovation [27][28] - The company is optimistic about the prospects of new technologies and partnerships, including those with Duke University and UNC [8][28] Other Important Information - The company has transitioned to a new development and manufacturing partner for the implantable device, which is progressing well [32] - The regulatory strategy for the implantable device is clear, with minimal clinical data required for FDA submission [35] Q&A Session Summary Question: Status of the implantable monitor development - Management confirmed that development is progressing well with a new partner and that minimal clinical trials are required for FDA submission [31][32] Question: Commercialization conversations with other cancer centers - Management indicated that they plan to start commercialization discussions with other centers in the first quarter after initial volume at OSU [36][38] Question: Exclusivity and timing of the endoscopic imaging technology agreement - Management confirmed that a definitive license agreement is expected soon, with development work to begin immediately after signing [42][46]
PAVmed(PAVM) - 2025 Q3 - Earnings Call Presentation
2025-11-13 13:30
Lucid Diagnostics - EsoGuard revenue reached $1.2 million in Q3 2025, with a test volume of 2,841[9] - A MolDX Contractor Advisory Committee (CAC) meeting unanimously endorsed Medicare coverage for EsoGuard[9] - The company strengthened its balance sheet by netting approximately $27 million in proceeds from an underwritten public offering of common stock[9] Veris Health - Veris Health launched the commercial phase of its strategic partnership with OSU[11] - The company relaunched implantable physiological monitor development, targeting a 2026 FDA 510(k) submission[11] Financial Performance - The company's cash reserves were $3.103 million in 3Q25, a decrease of $901 thousand from $4.004 million in 2Q25[16] - Equity method investments in Lucid were valued at $31.615 million in 3Q25, down $4.383 million from $35.998 million in 2Q25[16] - Revenue plus management fee income was $3.155 million in 3Q25, a decrease of $991 thousand compared to $4.146 million in 3Q24[18] - The company reported a net loss of $6.011 million in 3Q25, a significant change from a net income of $60.711 million in 3Q24[18] - Non-GAAP adjusted loss was $(446) thousand in 3Q25, compared to $(5,439) thousand in 3Q24[18] - Shares outstanding increased to 23.1 million in 3Q25 from 20.1 million in 2Q25[16]
PAVmed(PAVM) - 2025 Q3 - Quarterly Results
2025-11-13 13:00
Financial Performance - Lucid Diagnostics recognized $1.2 million in EsoGuard Esophageal DNA Test revenue for Q3 2025, processing 2,841 EsoGuard tests[5] - PAVmed's operating expenses for Q3 2025 were approximately $4.8 million, including stock-based compensation expenses of $0.4 million[9] - The GAAP net loss attributable to common stockholders for Q3 2025 was approximately $6.3 million, or $(0.29) per common share on a diluted basis[9] - Non-GAAP adjusted loss for Q3 2025 was approximately $0.4 million, or $(0.02) per common share[9] Cash and Funding - PAVmed had cash and cash equivalents of $3.1 million as of September 30, 2025, compared to $1.2 million as of December 31, 2024[9] - PAVmed strengthened its balance sheet with a public offering of common stock, netting approximately $27.0 million in proceeds[5] - The ability to secure additional funding as needed is essential for ongoing operations and product development[17] Strategic Partnerships and Innovations - Veris Health launched the commercial phase of its strategic partnership with The Ohio State University James Cancer Hospital, advancing the deployment of the Veris Cancer Care Platform[5] - The company signed a letter of intent with Duke University to license groundbreaking endoscopic esophageal imaging technology, adding a potential growth engine to its innovation pipeline[4] - Veris Health is preparing for a planned 2026 FDA 510(k) submission for its implantable physiological monitor[5] Market Potential and Challenges - Medicare Contractor Advisory Committee unanimously supported Medicare coverage for EsoGuard, indicating strong market potential[5] - PAVmed and Lucid's management acknowledges risks and uncertainties that could impact future results, including stock price volatility and market conditions[17] - The companies face challenges in research and development, particularly regarding the costs and timelines for regulatory submissions[17] - Regulatory authorities' satisfaction with clinical and preclinical study designs and results is crucial for product clearance[17] - Market acceptance of PAVmed and Lucid's products post-clearance is a significant factor for future success[17] - New risks and uncertainties may emerge, complicating future predictions[17]
PAVmed(PAVM) - 2025 Q3 - Quarterly Report
2025-11-12 22:23
Product 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]
PAVmed Q3 2025 Earnings Preview (NASDAQ:PAVM)
Seeking Alpha· 2025-11-12 16:03
Group 1 - The article does not provide any specific content related to a company or industry [1]