Hyperfine (NasdaqGM:HYPR) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Good afternoon and welcome to Hyperfine's Third Quarter 2025 Earnings Conference Call. Currently, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gill Martin Group for introductory disclosure.Speaker0Thank you for join ...

Co-Diagnostics (NasdaqCM:CODX) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co-Diagnostics third quarter 2025 earnings webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press st ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $72.4 million, a significant increase from $6.4 million in Q3 2024, primarily driven by a BARDA contract awarded in June 2024 [16] - The company ended Q3 2025 with cash, cash equivalents, and investments totaling $28.8 million, with an expected cash runway extending into Q2 2027 due to the recent partnership with Dynavax [16] Business Line Data and Key Metrics Changes - The COVID-19 clinical program has seen a major partnership with Dynavax, which includes an upfront license fee of $25 million and potential future payments totaling up to $700 million [4][5] - The norovirus program reported positive phase I results, showing a 25-fold increase in GII.4 fecal IgA response and a 10-fold increase in GI.1 fecal IgA response over baseline [14][15] Market Data and Key Metrics Changes - The company acknowledges the ongoing prevalence of COVID-19 and the need for new solutions, indicating a sizable market opportunity despite a decrease in vaccination rates [35] - Norovirus remains a significant health concern, with an economic cost exceeding $10 billion in the U.S., highlighting the urgent need for effective vaccines [9] Company Strategy and Development Direction - The partnership with Dynavax is seen as a major milestone, validating the potential of the oral vaccine platform and providing critical non-dilutive capital [5][8] - The company aims to advance its pipeline of vaccines, including norovirus, flu, and HPV, while actively seeking strategic partnerships [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the collaboration with Dynavax, emphasizing its importance for advancing the COVID-19 program and the overall potential of the oral vaccine platform [17] - The company remains committed to securing partnerships for its other vaccine candidates, including norovirus, and anticipates initiating the next clinical trial in 2026 [10][16] Other Important Information - The company is focused on maintaining a strong cash position while exploring non-dilutive funding options and managing expenses prudently [16] - The next scheduled update will be during a webcasted fireside chat on November 18, where further questions from stockholders will be addressed [18] Q&A Session Summary Question: Why did Dynavax decide to reach a deal now instead of waiting for data from the Sentinel cohort? - Management indicated that the partnership was based on the scientific potential of the platform and the good fit between the companies, rather than solely on clinical data [22][23] Question: Can the company start the phase 2b trial for norovirus by itself with the additional funding? - Management expressed excitement about the validation from Dynavax and indicated ongoing discussions with potential partners for all assets, including norovirus [26][28] Question: How does the company view the current COVID season compared to last year? - Management noted that while fewer people are taking COVID shots, there remains a good market opportunity for oral vaccines, which offer advantages over traditional methods [35]

RenovoRx (NasdaqCM:RNXT) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker6Be a conference call operator today. Please note that today's call is being recorded, and all participants other than management are in listen-only mode. There will be a Q&A session following the management's presentation. I will now turn the call over to Walter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead. Thank you.Speaker0Thank you, Operator. Good afternoon, everyone, and welcome to RenovoRx ...

Cytosorbents (NasdaqCM:CTSO) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker3Good afternoon, ladies and gentlemen, and welcome to the CytoSorbents Corporation third quarter 2025 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 13th, 2025. I w ...

Trevi Therapeutics (NasdaqGM:TRVI) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Good afternoon and welcome to the Trevi Therapeutics third quarter 2025 earnings conference call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your phone. To withdraw ...

Bionano Genomics (NasdaqCM:BNGO) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker0Today, and welcome to the Bionano Third Quarter 2025 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Kelly Gura from Investor Relations. Please go ahead.Speaker2Thank you, Dee Dee, and good afternoon, everyone. Welcome to the Bionano Genomics Third Quarter 2025 Financial Results Conference Call. Leading the call today is Dr. Erik Holmlin, CEO ...

Nyxoah (NasdaqGM:NYXH) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker5Good day, and thank you for standing by. Welcome to the Nyxoah third quarter 2025 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star one-one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question ...

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $13.9 million, down from $44.9 million as of December 31, 2024, excluding net proceeds of approximately $94 million from a recent $100 million underwritten offering [19][20] - The net loss for Q3 2025 was $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share for Q3 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 totaled $4 million, a decrease of $7.1 million from $11.1 million in Q3 2024, primarily due to lower study costs [21] - General and administrative expenses for Q3 2025 were $6.3 million, down from $11.9 million in Q3 2024, driven by a decrease in stock-based compensation and administrative expenses [22] Market Data and Key Metrics Changes - The company is developing NDV-01 for non-muscle-invasive bladder cancer (NMIBC), which affects about 68,000 new patients annually in the U.S. and has a prevalence of approximately 744,000 patients [4][9] - Sopranalone is being developed for Prader-Willi syndrome, which has a U.S. prevalence of approximately 20,000 patients [5] Company Strategy and Development Direction - The company aims to advance two late-stage clinical programs: NDV-01 for NMIBC and Sopranalone for Prader-Willi syndrome, with both expected to initiate studies in the first half of 2026 [6][19] - The FDA has aligned on key elements of the phase 3 program for NDV-01, allowing for two distinct registrational tracks, which is seen as a significant de-risking milestone [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the NDV-01 clinical development program based on positive nine-month results and constructive discussions with the FDA [17] - The company is well-capitalized following a recent $100 million financing, which is expected to support operations into 2028 [6][20] Other Important Information - The company has established a clinical advisory board for NDV-01, chaired by a renowned urologic oncologist, to provide guidance for the pivotal program [8] - The company plans to initiate a proof of concept study for Sopranalone in the first half of 2026 [19] Q&A Session Summary Question: Can you help us understand the market opportunity for the two indications and the sequence of studies? - The refractory second-line BCG unresponsive population is about 8,000 patients annually, while the intermediate-risk population is estimated at 80,000 patients, with over half likely to receive adjuvant therapy [25][27] - Both trials are planned to start in Q2 2026, with the refractory study expected to provide three-month data by Q4 2026 and top-line data by Q2 2028 [29] Question: What potential pricing could look like? - Current therapies set a benchmark around $700,000 for the first year, and the company will base pricing on data and market reception [30][32] Question: How does the product's ease of use open up the market? - The new formulation allows for a five-minute installation without the need for specialized pharmacies, making it more accessible for community urologists [34][35] Question: What if the BRIDGE study succeeds? - If the BRIDGE study shows that gemcitabine and docetaxel are non-inferior to BCG, it could significantly expand the market opportunity for the product, especially in off-label use [36][38]

Evolv Technologies (NasdaqCM:EVLV) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker0Good afternoon and welcome to the Evolv Technology third quarter earnings results conference call. All participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Brian Norris, Senior Vice President of Finance and Investor Rela ...