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| Statement |
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| Our preclinical data demonstrated a favorable distribution of tacrolimus showing high concentrations of the drug and demand relative to systemic blood levels |
| We define success as the ability to transition patients from oral tacrolimus to TFF TAC, achieve to crawl on this blood levels that are approximately two-thirds to one-half of the patient's blood levels on oral tacrolimus, prevent rejection at these diminished tacrolimus blood levels while stabilizing kidney function |
| Results from the two compassionate use patients were also favorable |
| Assuming results from both trials are positive, we believe these initial data will serve as a major catalyst for our company by providing the strongest evidence to-date of how Thin Film Freezing can improve a drug safety and efficacy in two rare disease patient populations |
| And we've been able to demonstrate that the technology has utility in creating dry powder formulations for a variety of molecules like monoclonal antibodies, vaccines, RNAs, other biologics as well as small molecules |
| Generating positive results in our Phase 2 studies will further validate our technology and demonstrate how our lead pipeline assets, TFF VORI and TFF TAC represents significant improvements over the current standard of care |
| It's important to say that the program underscores the recognition of our technology with entities such as the NIH and our ability to create great like Thin Film Freezing formulations, which can be applied broadly including in this program for a universal off the shelf vaccine |
| Similar to TFF VORI, the decision to advance TFF TAC into Phase 2 testing was supported by strong preclinical and Phase 1 data, which demonstrated acceptable safety and tolerability and an attractive differentiated pharmacokinetic profile, compared to the oral tacrolimus |
| Like you mentioned, both voriconazole and tacrolimus are very well known |
| And through all of these efforts now, we see the active sites participating in prescreening very effectively |
| Our decision to advance the TFF VORI into Phase 2 testing was based upon acceptable safety and tolerability results in Phase 1 studies and positive efficacy results in two patients with pulmonary fungal infections treated with TFF VORI on a compassionate use basis |
| There are approximately 40,000 lung transplant patients globally, which will present a significant opportunity to introduce a therapy such as TFF TAC, with the potential to improve upon the current standard of care |
| But, Justin it's important to emphasize that it's too early to say whether any of these collaborations will result in a meaningful business opportunity for the company and review all of them as the potential upside to the tremendous potential TFF VORI and TFF TAC |
| The Phase 1A study with 65 healthy volunteers and the Phase 1B study with 16 mild asthmatics demonstrated that doses up to 80 milligrams twice a day were well tolerated and showed no signs of the toxicities commonly reported for oral and intravenous voriconazole |
| Because of that, our enrollment rate has increased very significantly |
| And again, Zamaneh, that seems that you're best positioned to answer that |
| In our Phase 1 study in healthy subjects, daily dosing of up to 5 milligrams in a single dose and 1.5 milligram in repeated doses were generally well tolerated |
| There are approximately 250,000 patients globally with invasive aspergillosis, which we believe represents a significant opportunity for TFF VORI |
| Based on the favorable results from the Phase 1 studies and the two compassionate of use patients, a Phase 2 study was initiated in Europe |
| Thin Film Freezing technology enables us to address this opportunity by delivering voriconazole directly into the lungs where the IPA infection results |
| Through localized delivery, we hope to drive efficacy, while minimizing the patient's systemic exposure and thus systemic toxicities and drug-drug interactions |
| Lung lesions improved, as shown on the chart to the far right and fungal infection cleared |
| Respectively, these two initiatives could significantly facilitate future fundraising efforts and ensure that we remain in compliance with NASDAQ listing requirements |
| Based on these accomplishments and subsequent progress, we continue to expect initial clinical data from the Phase 2 studies by year end |
| Patients with IPA have a 12-week mortality rate of approximately 30%, which clearly represents a significant unmet medical need for this rare disease |
| Thank you and good evening |
| As a result, we expect to provide immune suppression sufficient to prevent rejection of lower systemic exposures that is at lower cost of systemic toxicities |
| I would like to thank our shareholders for your continued support and confidence in TFF Pharmaceuticals, and we look forward to updating you on our progress throughout the rest of the year |
| Together we expect our Phase 2 trial try an EAP will provide meaningful evidence for the potential TFF VORI for the treatment of primary fungal infection |
| I think it's also worth mentioning once again, that relative to clinical programs involving new chemical entities, we believe that development risk associated with the TFF VORI and TFF TAC programs is significantly reduced, given the well-established historical data available for these molecules |
| Statement |
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| Not surprisingly, the high rates of toxicities and drug-drug interactions lead to a poor prognosis |
| The most common toxicities associated with voriconazole resulting in its discontinuation include liver toxicity, visual disturbances and rashes |
| Visual disturbances are quite uncomfortable for patients |
| Other potential serious toxicities or arrhythmias, QT prolongation and photo sensitivity |
| Liver function tests go up 3,4,5 times the upper limit of normal and at some point, physicians decide whether your patient has signs and symptoms of hepatic toxicity, this is getting too uncomfortable and they stop oral or intravenous voriconazole |
| The net loss for the third quarter of 2023 of $4.4 million, compared to a net loss of $7.3 million in the comparable period in 2022 |
| However, when administered orally or intravenously, voriconazole is associated with high rates of toxicity and drug-drug interaction |
| Once screening is completed, patient’s oral tacrolimus is stopped, and patients enter the 12-week treatment period with TFF TAC |
| However, there are well known significant toxicities associated with the oral and intravenous formulation |
| The $1.6 million decrease year over year is primarily results of reduced clinical and manufacturing expenses |
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