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, Inc. (NASDAQ:TFFP) Q3 2022 Earnings Conference Call November 14, 2022 5:00 PM ET Company Participants Corey Davis - LifeSci Advisors Glenn Mattes - President, CEO & Director Dale Christensen - Head, Clinical Development Kirk Coleman - CFO, Treasurer & Secretary Robert Williams - Technology Inventor & Special Advisor Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Vernon Bernardino - H.C. Wainwright & Co. Michael Okunewitch - Maxim Group Operator Greetings, and welc ...

Financial Performance - Total current assets decreased to $16,978,994 as of September 30, 2022, down 56.4% from $38,837,951 as of December 31, 2021[18]. - Grant revenue for the three months ended September 30, 2022, was $87,586, a 75.2% increase compared to $50,000 for the same period in 2021[20]. - Total operating expenses for the nine months ended September 30, 2022, were $24,599,037, an increase of 13.4% from $21,766,422 in the same period of 2021[20]. - Net loss for the nine months ended September 30, 2022, was $24,396,828, compared to a net loss of $20,988,943 for the same period in 2021, reflecting a 16.5% increase in losses[20]. - Cash and cash equivalents at the end of the period were $13,147,090, a decrease of 61.1% from $33,794,672 at the beginning of the period[22]. - Stockholders' equity decreased to $18,022,526 as of September 30, 2022, down 53.5% from $38,737,059 as of December 31, 2021[18]. - The company reported a net loss per share of $0.29 for the three months ended September 30, 2022, compared to $0.34 for the same period in 2021[20]. - For the nine months ended September 30, 2022, the Company reported a net loss of $24.4 million and negative cash flow from operations of $19.6 million[24]. - As of September 30, 2022, the Company had an accumulated deficit of $89.7 million and cash and cash equivalents of $13.1 million[24]. - The Company sold 104,011 shares of its common stock at an average price of $5.96 per share, resulting in net proceeds of approximately $405,000[24]. Research and Development - The company is focused on the development of inhaled dry powder drugs for pulmonary diseases and is in the clinical research stage with its initial product candidates[23]. - The Company plans to increase research and development activities, leading to higher cash utilization and payroll expenses as it hires additional staff[26]. - The Company recorded a research and development tax incentive receivable of $949,168 as of September 30, 2022[43]. - The percentage of eligible research and development expenses reimbursable under the Australian Tax Incentive is 43.5% for the periods ended September 30, 2022 and 2021[42]. - The Company has three product candidates under development: TFF Voriconazole Inhalation Powder, TFF Tacrolimus Inhalation Powder, and TFF Niclosamide Inhalation Powder, with ongoing Phase 2 clinical trials for TFF Voriconazole and TFF Tacrolimus[88]. - The TFF technology platform aims to improve the solubility of poorly water-soluble drugs, which constitute approximately 33% of major pharmaceuticals worldwide[87]. - The company is engaged in a collaboration with UNION therapeutics A/S to develop a dry powder formulation of niclosamide, alongside testing of other dry powder formulations for various applications[89]. - The company plans to focus on developing inhaled dry powder formulations for pulmonary diseases, targeting a market potential ranging from $100 million to over $500 million for several off-patent drugs[90]. - The company has entered into a joint development agreement with Augmenta Bioworks for COVID-19 therapeutics, but further development has been suspended[97]. - The company is exploring dry powder formulations of CBD and aluminum salt vaccines in partnership with pharmaceutical companies[93]. Clinical Trials and Regulatory Challenges - TFF Vori, an inhaled dry powder version of Voriconazole, completed Phase 1 trials in July 2020 and initiated a Phase 2 trial in 2022, with individual patient data expected in Q1 2023[1]. - TFF Tac-Lac, an inhaled dry powder version of tacrolimus, completed Phase 1 trials in September 2021 and began Phase 2 trials in 2022, with data anticipated in H1 2023[1]. - TFF Niclosamide, an inhaled dry powder formulation, completed Phase 1 trials in Q1 2022, but further progress is pending review of results and market opportunities[1]. - COVID-19 has caused delays in Phase 2 clinical trials for TFF Vori and TFF Tac-Lac, highlighting the pandemic's impact on operations[139]. - The company has not submitted an NDA to the FDA or comparable applications to other regulatory authorities for any of its product candidates as of the report date[154]. - The company expects to conduct Phase I and Phase II studies for TFF Vori and Phase I and Phase IIb/IIIa studies for TFF Tac-Lac prior to filing for marketing approval[155]. - The regulatory approval process is expensive and can take many years, with no assurance of success[157]. - The company may face significant delays and costs in obtaining foreign regulatory approvals, which could hinder the introduction of product candidates in certain countries[174]. - The FDA's orphan drug designation could provide potential exclusivity for products intended to treat rare diseases, but there is no guarantee that the designation will be granted[175]. - The company anticipates that third-party payors may limit coverage and reimbursement for new therapeutic products, impacting future revenues[186]. Financial Strategy and Funding - The Company expects to seek additional funding through equity and/or debt securities, and licensing fees for its technology[26]. - The company has entered into an Open Market Sale Agreement with Jefferies LLC to potentially raise up to $35.0 million through the sale of common stock[120]. - The company may face significant restrictions on its operations if it raises additional funds by issuing debt securities[211]. - If the company raises additional capital through equity securities, existing stockholders may experience substantial dilution[211]. - The company has not paid dividends in the past and has no immediate plans to do so, intending to reinvest all earnings to cover operating costs and remain competitive[216]. Risks and Challenges - The business model is heavily reliant on patent rights licensed from the University of Texas at Austin, with potential loss of these rights posing a significant risk to operations[134]. - The company currently lacks a sales and marketing organization, which may hinder the successful commercialization of product candidates[140]. - There is a reliance on third-party manufacturers for product candidates, with potential risks related to regulatory approvals and quality control[142]. - Product liability risks are present due to clinical testing, with potential substantial liabilities affecting commercialization efforts[149]. - The company has insurance coverage for clinical trials but lacks product liability insurance, which may inhibit future commercialization[151]. - Information technology system failures or security breaches could disrupt operations and lead to loss of proprietary information[152]. - The company may face challenges in obtaining adequate market acceptance for its product candidates, which could limit revenue generation[162]. - The company may rely on know-how and trade secrets for technology protection, which are difficult to enforce and protect[199]. - The company could face patent infringement claims from third parties, which may lead to costly litigation and impact its commercialization efforts[201]. - The company's stock price may decline if analysts publish unfavorable research or cease coverage, affecting trading volume[208]. Corporate Structure and Compliance - The company is classified as an "emerging growth company" under the JOBS Act of 2012, which allows it to take advantage of reduced disclosure requirements[212]. - The company will maintain its "emerging growth company" status for up to five years unless revenues exceed $1.07 billion or the market value of its common stock held by non-affiliates exceeds $700 million[214]. - The company is required to provide a report on management's assessment of internal control over financial reporting starting with its annual report for the fiscal year ended December 31, 2020[215]. - There is a risk that the company may not be able to maintain effective internal controls over financial reporting, which could lead to a loss of investor confidence[215]. - The company has chosen to take advantage of all benefits available under the JOBS Act, but this may make its common stock less attractive to some investors[213]. - The company is not required to comply with auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act while it remains an emerging growth company[216].

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TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Corey Davis - LifeSci Advisors Glenn Mattes - President, CEO & Director Kirk Coleman - Chief Financial Officer Dale Christensen - Director of Clinical Development Chris Cano - Chief Operating Officer. Bill Williams - University of Texas at Austin Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Daniel Carlson - TW Research Group Michael Okunewitch - Maxim Group Operat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-39102 TFF PHARMACEUTICALS, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or o ...

| --- | --- | --- | --- | --- | --- | --- | |-------------------------------------------------------------------|-------|-------|-------|-------|-------|--------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Better Delivery, Better Therapy: Powerful Drug Delivery Solutions | | | | | | | | Corporate Investor Presentation May 2022 | | | | | | Nasdaq: TFFP | 1 Safe Harbor Statement SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This document contain ...

TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Corey Davis - LifeSci Advisors Glenn Mattes - President, CEO & Director Kirk Coleman - CFO, Treasurer & Secretary Christopher Cano - COO & VP, Business Development Bill Williams - University of Texas, Austin Dale Christensen - Head, Clinical Development Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Daniel Carlson - TW Research Yuan Zhi - B. Riley Securities Richard De ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-39102 TFF PHARMACEUTICALS, Inc. (Exact name of registrant as specified in its charter) | Delaware | | --- | (State or other jurisdiction ...

TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) Q4 2021 Earnings Conference Call March 24, 2022 4:30 PM ET Company Participants Corey Davis - LifeSci Advisors Glenn Mattes - President and CEO Dale Christensen - Director of Clinical Development Bill Williams - University of Texas, Austin Kirk Coleman - CFO Chris Cano - COO Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Daniel Carlson - TW Research Group Operator Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Fourt ...