Latest news with #INO
Yahoo
6 days ago
- Business
- Yahoo
Inovio Pharmaceuticals Inc (INO) Q2 2025 Earnings Call Highlights: Strategic Advances and ...
Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Inovio Pharmaceuticals Inc (NASDAQ:INO) is on track to submit its BLA for INO 3,107 in the second half of 2025, with the goal of file acceptance by year-end. The company has completed the design verification testing of its Selecttra 5 PSP device, a key milestone for regulatory progress. INO 3,107 has been granted breakthrough therapy designation by the FDA, allowing for a rolling submission of the BLA. Clinical data from INO 3,107 has been published in reputable journals, supporting its potential as a preferred treatment for RRP. Inovio Pharmaceuticals Inc (NASDAQ:INO) has significantly reduced its operating expenses by 31% year-over-year, demonstrating fiscal responsibility. Negative Points Inovio Pharmaceuticals Inc (NASDAQ:INO) experienced a decrease in cash equivalents and short-term investments, from $94.1 million at the end of 2024 to $47.5 million by mid-2025. The company anticipates an operational net cash burn of approximately $22 million for the third quarter of 2025. There is uncertainty regarding the potential need for an advisory committee meeting for the BLA submission, which could impact timelines. The company faces competition from other treatments in the RRP space, which could affect market share and enrollment in confirmatory trials. Inovio Pharmaceuticals Inc (NASDAQ:INO) has not provided specific guidance on the size of its commercial organization, which may impact its ability to effectively launch INO 3,107. Q & A Highlights Warning! GuruFocus has detected 5 Warning Signs with INO. Q: Are you anticipating having an advisory committee meeting for the BLA submission of INO 3,107? A: Dr. Mike Sumner, Chief Medical Officer, stated that based on interactions with the FDA, there has been no indication that an advisory committee meeting will be necessary. The overall risk-benefit data presented does not suggest a requirement for such a meeting, although the final decision rests with the agency. Q: How does the upcoming regulatory decision for a competitor affect Inovio's launch plans for INO 3,107? A: Dr. Jackie Shea, President and CEO, highlighted significant differences between Inovio's program and the competitor's, including trial design and technology. Inovio's focus is on a placebo-controlled confirmatory trial, and the differences in technology and trial design suggest distinct paths for each product. Q: Was there any delay in the DV testing for the Selecttra 5 PSP device, and how does it impact the BLA submission timeline? A: Dr. Jackie Shea confirmed that while the DV testing involved multiple external vendors and was complex, the overall timeline for the BLA submission remains on track for the second half of the year, with file acceptance expected by year-end. Q: What is the strategy for a redosing approach for INO 3,107 based on recent data? A: Dr. Mike Sumner explained that Inovio plans to implement a redosing strategy, likely involving annual dosing, to enhance the clinical effect and maintain the reduction in surgeries for RRP patients. This approach leverages the strengths of their DNA medicine platform. Q: How does Inovio plan to address potential enrollment challenges for the confirmatory trial if a competitor's product is approved? A: Dr. Mike Sumner noted that the trial is designed to recruit 100 patients across 20 sites in the U.S., and despite potential market competition, there remains a sizable population of patients who may not have immediate access to the competitor's product due to insurance coverage and other factors. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
13-05-2025
- Business
- Yahoo
Inovio: Q1 Earnings Snapshot
PLYMOUTH MEETING, Pa. (AP) — PLYMOUTH MEETING, Pa. (AP) — Inovio Pharmaceuticals Inc. (INO) on Tuesday reported a loss of $19.7 million in its first quarter. On a per-share basis, the Plymouth Meeting, Pennsylvania-based company said it had a loss of 51 cents. The drugmaker posted revenue of $65,300 in the period. Its adjusted revenue was $65,000. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on INO at Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-03-2025
- Business
- Yahoo
Inovio Pharmaceuticals Inc (INO) Q4 2024 Earnings Call Highlights: Strategic Advances Amid ...
Release Date: March 18, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Inovio Pharmaceuticals Inc (NASDAQ:INO) has resolved the manufacturing issue with the single-use array component of the Selectra device, which is crucial for their BLA submission for INO 3,107. The company plans to begin the BLA submission process in mid-2025, with the goal of FDA acceptance by the end of the year. Clinical data for INO 3,107 shows significant and durable clinical benefits, with a reduction in the need for surgeries for RRP patients. Inovio Pharmaceuticals Inc (NASDAQ:INO) has made progress in developing their DNA encoded monoclonal antibody technology, showing durable in vivo production in humans. The company has reduced operational expenses by 22% from 2023 to 2024, demonstrating effective cost management. Inovio Pharmaceuticals Inc (NASDAQ:INO) experienced delays in resolving the manufacturing issue, which took longer than initially expected. The company reported a net loss of $107.3 million for the full year of 2024, indicating ongoing financial challenges. Cash and cash equivalents decreased significantly from $145.3 million in 2023 to $94.1 million in 2024, raising concerns about financial sustainability. The company needs to initiate a confirmatory trial before the BLA submission, which could pose additional challenges and delays. There is uncertainty regarding the long-term epidemiology and market size for RRP, as vaccination rates and disease prevalence could impact future demand. Warning! GuruFocus has detected 6 Warning Signs with INO. Q: For the BLA submission request for INO 3,107, do you need to meet with the FDA, or is it just a written request? A: (Dr. Mike Sumner, Chief Medical Officer) We held a pre-BLA meeting with the FDA before resolving the single-use array issue. We had good alignment on the remaining modules, so we don't need another meeting. We plan to request the rolling submission in mid-2025. Q: Regarding the stability test for the device, is it a single test or a series of tests, and who conducts them? A: (Dr. Mike Sumner, Chief Medical Officer) We need to repeat several tests for verification, which are conducted by an external testing house. This includes external certification required for our BLA. Q: Can you provide insights into the durability of in vivo antibody production from the DMAP technology? A: (Dr. Jackie Shea, President and CEO) The DMAP technology has shown durable antibody production, with levels stable for 72 weeks. We are exploring inducible or repressible promoters for future trials to control expression. Q: What are the commercial assumptions for INO 3,107, and how do you see it positioned against competitors? A: (Dr. Jackie Shea, President and CEO) INO 3,107 has a strong product profile with durable efficacy and a patient-centric regimen. It can be administered in a doctor's office without the need for surgery during dosing. We are confident in its competitive positioning. Q: How should we think about the redosing strategy for INO 3,107, and what is the long-term outlook for the RRP market? A: (Dr. Mike Sumner, Chief Medical Officer) We are still deciding on the redosing strategy, aiming to reduce surgeries to zero. The RRP market remains significant, especially in adults, as vaccination rates are not yet high enough to impact adult cases significantly. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
