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| Statement |
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| The first one I'd like to address is we've been asked, why develop next-generation chemotherapy instead of finding a new oncology treatment? As I stated when discussing the slides, our next-generation chemotherapy drugs represent a better treatment for cancer patients that will improve their survival and quality of life |
| As you can see the bottom -- at the bottom of the slide, from a corporate and investor perspective, having these next-generation chemotherapy drugs in our pipeline helps us to be more efficient in drug development, increases the probability of FDA approval, and differentiates our products from existing products and products presently in development |
| They are handled by the body differently, and it should provide a better benefit risk profile for approval |
| This is a very exciting time for Processa as we prioritize our efforts to focus on the next-generation chemotherapy drugs in our pipeline |
| An improvement in the side effect profile with the next-generation chemotherapies allows a given patient to have a better quality of life when on next-generation chemotherapy, and their cancer may potentially be exposed to even more cancer-killing molecules |
| The combination of our pipeline of next-generation chemotherapy drugs, our regulatory science approach that already includes the principles of Project Optimus, and our experience with the principles of Project Optimus in non-oncology FDA submissions are more reasons why we can more efficiently develop each of the next-generation drugs |
| With these drugs and the implementation of our regulatory science approach, including the principles of Project Optimus, these next-generation chemotherapy drugs can be more efficiently developed, have a greater probability of approval, and will be better treatment options than the existing FDA-approved drugs |
| And those patients would be receiving treatment with less side effects and potentially better efficacy to both increase their survival and their quality of life |
| These have included increasing Processa visibility by bringing on the IR/PR group to improve everything from our website to the number and quality of our presentations to include -- increase our presence on social media |
| We have a better probability of obtaining approval, and we can differentiate each NGC from its existing counterpart therapy |
| While displeased with our current valuation, we are focused on doing those things which we believe are all in our collective best interest and have the potential to create substantial value for Processa and its investors |
| These funds have strengthened our balance sheet, and we believe the cumulative $12.9 million will be sufficient to complete our active clinical trials and fund our operations into the third quarter of 2024 |
| Let me just briefly point to three key accomplishments in 2022 for our next-generation drugs |
| For our non-oncology drugs, which we hope to [outlicense] or find a partner, we've completed the Phase 2a 12852 gastroparesis trial in which 12852 had a positive effect on gastric emptying rate and a larger effect in placebo and improving gastroparesis symptoms |
| As Jim stated, at the end of 2022, we began to realize that it would be better for our investors if we focus on a few drugs rather than our portfolio of five drugs |
| You mentioned that you obviously see a better risk benefit profile at a 50% dose |
| We're also reaching out more to the oncology community, as I said, both physicians and patients, to make sure that Processa and our next-generation chemotherapy drugs are better known |
| Good evening |
| Thanks for joining us |
| And for those taking these drugs, less than 40% of patients typically have a positive response |
| A second question that we have been asked is what steps are you taking to enhance shareholder value? We've implemented a number of strategies to increase shareholder value, and we are in the process of launching more |
| Unidentified Analyst Great |
| Unidentified Analyst Great |
| Thank you for joining us |
| Thanks |
| Thanks for taking all my questions |
| Statement |
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| As I will explain, our operating cash flow is significantly less than our GAAP net loss, primarily due to several non-cash expenses |
| I want to close by saying that my management team and I are keenly aware of the underperformance of our stock in recent months |
| And for 499, we discontinued the trial due to enrollment difficulties, which is different from the published literature prior to starting the study |
| It doesn't prevent us from doing all that |
| Our GAAP net loss for the year ended December 31, 2022, was $27.4 million or $1.70 a share compared to a net loss of $11.4 million or $0.75 per share for the same period of 2021 |
| Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties |
| The increase in our net loss was primarily due to a one-time non-cash impairment of an intangible asset for $7.3 million, along with increased stock-based compensation and the clinical trial costs we incurred in our active clinical trials |
| So it doesn't prevent us from meeting the FDA -- with the FDA |
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