Product Development and Clinical Trials - TFF Pharmaceuticals has two product candidates in clinical trials: TFF Voriconazole Inhalation Powder (TFF VORI) and TFF Tacrolimus Inhalation Powder (TFF TAC), with Phase 2 trials initiated for both[20]. - TFF VORI is designed to treat invasive pulmonary aspergillosis, a severe fungal disease with a 30% mortality rate despite standard therapies[36]. - TFF VORI aims to treat invasive pulmonary aspergillosis (IPA) by delivering voriconazole directly to the lungs, potentially reducing serious side effects associated with traditional delivery methods[37]. - TFF TAC, a dry powder formulation of tacrolimus, is being developed to minimize systemic toxicities while maintaining local lung immune suppression for lung transplant patients[40]. - TFF VORI has completed a Phase 1 study in healthy volunteers and a Phase 1b study in asthma patients, with a Phase 2 clinical trial for IPA currently underway[39]. - The company completed Phase I human clinical trials for its TFF VORI and TFF TAC product candidates in 2021, with Phase 2 clinical trials currently underway for both[90]. - The company has gained FDA agreement on the 505(b)(2) regulatory pathway for its initial dry powder drug candidates, TFF VORI and TFF TAC, which are established off-patent drugs[114]. Regulatory Pathways and Compliance - TFF Pharmaceuticals plans to utilize the FDA's 505(b)(2) regulatory pathway to potentially lower development costs and timelines for its drug candidates[22]. - The 505(b)(2) regulatory pathway is being utilized for TFF's product candidates, potentially reducing development costs and timelines compared to traditional methods[52]. - The company intends to submit applications for its lead therapeutic candidates via the 505(b)(2) regulatory pathway, allowing reliance on existing studies for approval[73]. - Compliance with cGMP regulations is mandatory for manufacturing processes, which must be validated and controlled as clinical studies progress[66]. - The company is subject to significant regulatory requirements post-drug approval, including cGMP regulations and adverse drug experience reporting[80]. - The FDA may require post-marketing testing and risk minimization plans to monitor the effects of approved products[72]. - The approval process for new drugs involves multiple phases, including clinical trials that assess safety and efficacy, which can take many years and require significant resources[62]. Financial Performance and Funding - For the fiscal years ended December 31, 2022 and 2021, the company incurred a net loss of $31.8 million and $31.0 million, respectively, with an accumulated deficit of $97.1 million as of December 31, 2022[92]. - The company has not commenced revenue-producing operations and anticipates continued operating losses for the foreseeable future[92]. - The company plans to seek additional funds through various financing sources, including the sale of equity and debt securities, and licensing fees for its technology[94]. - The company reported a net change in cash and cash equivalents of $(17,182,357) for 2022[204]. - The independent auditor's report raised substantial doubt about the company's ability to continue as a going concern due to lack of revenue and significant losses[203]. - Grant revenue increased by 462% to $495,805 in 2022 from $88,161 in 2021[197]. - Research and development expenses decreased by 13% to $18,496,340 in 2022 from $21,300,865 in 2021[197]. - General and administrative expenses increased by 30% to $13,796,255 in 2022 from $10,573,954 in 2021[199]. Market Potential and Competitive Landscape - Approximately 40% of marketed pharmaceuticals worldwide are poorly water-soluble drugs, which the TFF platform aims to improve in terms of bioavailability and pharmacokinetics[19]. - The TFF platform has the potential to reformulate existing off-patent drugs for lung diseases, targeting a market with potential exceeding $1 billion for many candidates[21]. - The market for biologics was valued at approximately $430 billion in 2022 and is expected to reach $720 billion by 2027, presenting opportunities for TFF's technology[34]. - Approximately 52% of kidney transplant patients experience nephrotoxicity when using Prograf (tacrolimus), highlighting the need for safer alternatives like TFF TAC[41]. Intellectual Property and Licensing - The company holds an exclusive worldwide, royalty-bearing license to the patent rights for the TFF platform from the University of Texas at Austin, which is critical to its business model[96]. - TFF technology has been licensed from the University of Texas at Austin, covering 141 patents related to the TFF platform[58]. - The company is required to pay royalties of 2% of net sales from products covered by licensed patent rights[59]. - The company must comply with extensive regulations from agencies like the U.S. FDA, which could lead to fines or refusal of marketing applications if not adhered to[61]. Risks and Challenges - The company faces risks related to third-party reimbursement, as costs of product candidates may not be covered by payers, impacting potential revenue[81]. - The company may incur substantial liabilities from product liability lawsuits, which could limit the commercialization of its product candidates[108]. - The company is dependent on third parties for raw materials needed to manufacture its product candidates, which poses risks to production costs and supply reliability[107]. - The company may face challenges in recruiting and retaining effective sales and marketing personnel, impacting its ability to establish a sales infrastructure[102]. - The company faces risks related to the adoption of its TFF platform by potential licensees, including internal budgetary issues and willingness to pay upfront fees[98]. - The company may experience significant stock price volatility, which could lead to increased risk of securities class action litigation[165]. Operational Structure and Workforce - The company has a total of 15 employees, including executive officers, and aims to attract and retain talent through equity incentive plans[85][86]. - The company currently has no sales and marketing organization, which may hinder the successful commercialization of its product candidates[101]. - The company has established its own laboratory in Austin, Texas, to gain direct ownership of intellectual property developed in-house[33]. Miscellaneous - The COVID-19 pandemic has had a relatively insignificant impact on the company's operations, with only minor delays in clinical activities[100]. - The company has established a wholly owned Australian subsidiary for clinical research[194]. - The company has not submitted a New Drug Application (NDA) to the FDA or comparable applications to other regulatory authorities for any of its product candidates as of the report date[113]. - The company received a notice of delisting from Nasdaq on March 2, 2023, due to the closing bid price falling below $1.00 per share over a 30-day trading period[154].
TFF Pharmaceuticals(TFFP) - 2022 Q4 - Annual Report