Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| Statement |
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| We believe the FAP-310 trial data is compelling, and the new registration trial could lead to the approval of Flynpovi |
| We are excited to build stockholder value as we move ahead in 2023 and onward by executing against our milestones |
| So we're making great progress |
| We are excited to regain the worldwide rights to Flynpovi for FAP patients and believe our internal expertise, experience with health authorities, relationship with FAP experts throughout the US and Europe, and our commitment to FAP patients and their families in combination with the positive results from the prior FAP-310 trial, this gives a solid foundation for designing and executing a successful registration trial that has the potential to impact patients with FAP globally |
| This approach will help achieve global regulatory approval and a successful launch of Flynpovi in the global market |
| Having all three regions, Asia Pacific, Europe, and North America enrolling, with the recent release that South Korea enrolled its first patient, it's highly encouraging as we continue to advance the trial with the interim analysis expected in early 2024 |
| We are excited for the opportunity to test and validate our therapy in type 1 diabetes and the potential of this Phase II trial to provide better treatment options for this patient population |
| DFMO has been shown to be well tolerated and can influence immune cells to promote a more immune-friendly tumor microenvironment |
| By leveraging Panbela's extensive experience with FAP and in designing global registration trials, the team can develop a high-quality trial protocol that meets the standards of regulatory agencies and is designed to efficiently and effectively demonstrate the potential safety and efficacy of Flynpovi in the treatment of FAP |
| In summary, we have made tremendous progress in Q1 and year to date |
| So we feel pretty confident that we'll be able to get this protocol together and through the regulatory bodies, hopefully very soon |
| We are confident that the new FAP registration trial will have the potential to provide a non-surgical treatment option in both physicians and their patients with FAP |
| We are excited to have the first patient enrolled in the Phase II trial for CPP-1X-T led by Indiana University School of Medicine and funded by the Juvenile Diabetes Research Foundation or JDRF, the leading global organization advancing life-changing breakthroughs for type 1 diabetes |
| I think that gives us much more sure footing as we look to see how we can best maximize that asset through collaborations, partnerships, et cetera |
| The addition of SBP-101 improved the survival of mice treated with any of the three current -- any of the three chemotherapeutics |
| That sounds like a good first step |
| So as we look at this, one of the things that we thought would be -- put us in the best possible position is to secure the approval from both FDA and EMA on a global registration of protocol |
| We expect this new registration trial will focus on FAP patients who have intact lower gastrointestinal anatomy and will build upon the positive result results from the FAP-310 trial that were published in the New England Journal of Medicine by Burke et al |
| And as I mentioned in my comments, we have a great deal of expertise as well as the relationships with the FAP community, both patients and KOLs |
| The SBP-101 and doxorubicin combination might have the greatest survival time with a 265% increase in median survival compared to untreated animals |
| Since there are currently no approved drug therapies for the treatment of FAP, this therapeutic option has the potential to impact this urgent unmet global need for patients with FAP |
| We will continue to focus our cash on those items in our plan, which will drive value for our stockholders such as the ASPIRE trial |
| The poster concludes that the treatment of mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden |
| The poster highlights the efficacy of SBP-101 in combination with the standard-of-care chemotherapy agents used to treat platinum-resistant ovarian cancer |
| We plan to advance this program while maintaining our current cash burn and will evaluate opportunities to maximize the value of this asset |
| Good afternoon |
| Jonathan Aschoff Thank you very much |
| Turning to familial adenomatous polyposis or FAP, in April, we learned that we will gain the North American rights to develop and commercialize Flynpovi, which is the combination of eflornithine and sulindac in patients with FAP as a result of the pending termination of the licensing agreement between Cancer Prevention Pharmaceuticals or CPP and One-Two Therapeutics Assets Limited |
| Medicines that meet the EMA's orphan designation criteria may qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, product assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization |
| Thank you very much |
| Statement |
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| Net loss in the first quarter of 2023 was $5.1 million or $0.65 per diluted share compared to a net loss of $3.7 million or $10.91 per diluted share in the first quarter of 2022 |
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