\nTFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the first quarter ended March 31, 2021, as well as provided a business update on recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Thursday, May 13, 2021, at 4:30pm EDT.\n<\/p>\n
\n\u201cWe continue to make progress with our clinical development programs: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder,\u201d said Glenn Mattes, President and CEO of TFF Pharmaceuticals. \u201cThis progress, along with better-than-expected clinical data, will allow us to initiate clinical trials designed to achieve registration for both of these important programs by the end of 2021.\u201d\n<\/p>\n
\n\u201cThe data we have seen from our Tacrolimus Inhalation Powder trial suggests that we can achieve efficacious immunosuppressive blood levels of tacrolimus with an inhaled, once-a-day, low-dose formulation,\u201d said Mattes. \u201cWe believe that inhaled tacrolimus\u2019 ability to reduce the fluctuations of bioavailability offers a compelling advantage over oral tacrolimus, as physicians often attribute the peaks and troughs of oral delivery with suboptimal efficacy and exacerbated side effects.\u201d\n<\/p>\n
\n\u201cWe have filed a US patent based on this once-a-day dosing development, which could have major implications for lung transplant patients, and potentially for heart, kidney and liver transplant patients as well,\u201d continued Mattes. \u201cBased on our recent research, we believe the peak yearly sales of tacrolimus in all four indications could exceed $1 billion dollars.\u201d\n<\/p>\n
\n\u201cThis quarter, we\u2019ve also made notable progress with a number of our strategic partners,\u201d said Mattes. \u201cOur collaborations with UNION therapeutics on niclosamide and Augmenta Bioworks on monoclonal antibodies are progressing on plan, and our partner in the cannabis space, PLUS Products, is seeing positive initial manufacturing data and strong market interest.\n<\/p>\n
\n\u201cAlso, our scientific collaboration partners at the University of Texas at Austin generated meaningful new data that continues to demonstrate the advantages of our Thin Film Freezing platform over other competing technologies,\u201d said Mattes. \u201cThis is true for both small molecule therapeutic applications, as well as high molecular weight biologics like proteins, including monoclonal antibodies, messenger RNA, and plasmid DNA, where our technology offers the only viable solution for dry powder reformulation.\u201d\n<\/p>\n
\n\u201cTo highlight these important scientific developments to as broad an audience as possible, we are pleased to announce that the Company will host a virtual Science Day in June,\u201d said Mattes. \u201cThis event will provide a scientific perspective on our Thin Film Freezing platform technology from external scientific key opinion leaders.\u201d\n<\/p>\n
\n\u201cThe growing portfolio of business development partnerships and the pace of our clinical and scientific progress continued to be impressive during the quarter,\u201d concluded Mattes. \u201cThis remains a testament to the outstanding efforts of our professionals, as well as the continued recognition that our technology can have game-changing consequences for the industry.\u201d\n<\/p>\n
Conference Call and Webcast Information <\/b><\/p>\n
\nThe Company will host a conference call today, Thursday, May 13, 2021, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:\n<\/p>\n
\nDomestic Dial-In Number: Toll-Free: (800) 816-3024
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International Dial-In Number (857) 770-0106
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Conference ID: 5777388\n<\/p>\n
\nThe call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals\u2019 Website, https:\/\/tffpharma.com<\/b><\/a> or directly at https:\/\/edge.media-server.com\/mmc\/p\/o4wvnbiv<\/b><\/a>. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.\n<\/p>\n Recent Clinical and Corporate Highlights:<\/b><\/p>\n TFF demonstrated that doses of 10, 20, 40, and 80 mg could be delivered twice daily using a dry powder inhaler device with no significant adverse events. Evaluation of the pharmacokinetic profile of the Voriconazole Inhalation Powder demonstrated that mean peak plasma voriconazole levels reached concentrations of 227 ng\/mL following repeated dosing at 80 mg twice daily for 7 days, without any reports of significant adverse events. Based on the results of the Phase 1 trial, the Company will study the 80 mg dose of Voriconazole Inhalation Powder for the upcoming pivotal trial where it will be compared to the oral form of voriconazole.<\/p>\n TFF has completed dosing in a GLP 13-week chronic toxicology study and has successfully completed the first of two dosing cohorts in asthma patients to evaluate safe dosing in patients with hyperreactive airways. There have been no serious adverse events reported in these cohorts. The Company is currently in active preparations for an end of Phase 1 meeting with the FDA, and we anticipate this meeting will be held after the dosing in this Phase 1b asthma study is complete. We then expect to initiate a pivotal clinical trial designed to demonstrate efficacy for treating patients with IPA or for preventing infection in patients at high risk for developing IPA infections.\n<\/li>\n<\/ul>\n We have also completed a GLP 26-week chronic toxicology study that will be used to support registration, and we remain on track to begin the pivotal trial work designed to demonstrate efficacy of inhaled tacrolimus for the prevention of lung allograft rejection. The enhanced bioavailability of inhaled tacrolimus, coupled with its ability to bypass the gastrointestinal tract, could also result in expanded therapeutic applications into other solid organ transplants where significant drug-drug interactions and food effects are a factor.\n<\/li>\n<\/ul>\n We continue to engage and collaborate with various government and defense contracting agencies in an effort to utilize the Company\u2019s TFF technology platform to formulate dry powder vaccines and therapeutics for delivery via reconstitution for lung or nasal inhalation. This includes our 3-year Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for biodefense countermeasures, and our early-stage universal influenza work with the University of Georgia\u2019s Center for Vaccines and Immunology, part of the NIH\u2019s Collaborative Influenza Vaccine Innovation Centers (CIVICs).<\/p>\n Strategic Business Development and Partnership Activities \u2013 Biopharmaceutical companies and research institutions: <\/b>Under our worldwide licensing agreement with UNION therapeutics for thin film freezing technology used in combination with niclosamide, our oral and powdered niclosamide formulations are moving forward to first-in-human trials. Recent data from UNION suggests that niclosamide is effective against the new prevalent British B.1.1.7 and South African B.1.351 COVID-19 variants.<\/p>\n “We are pleased with our ongoing collaboration with TFF Pharmaceuticals, and are happy to learn that the TFF niclosamide program is advancing through development,\u201d said Dr. Kim Kj\u00f8ller<\/span><\/strong>, Chief Executive Officer of UNION therapeutics. \u201cWe share the desire to provide much-needed therapeutics to COVID-19 stricken patients across the patient continuum.\u201d<\/p>\n In a second COVID-related collaboration, the worldwide joint venture between TFF and Augmenta Bioworks is now well underway. This innovative, first-of-its kind program will seek to apply our Thin Film Freezing technology to develop dry powder-based monoclonal antibodies targeting COVID-19.<\/p>\n “Our Joint Collaboration with TFF is right on track,\u201d said Christopher Emig, Ph.D., CEO and Co-founder of Augmenta Bioworks, Inc. \u201cWe are making great progress on our broadly neutralizing antibody therapy. We are looking forward to the results of our IND enabling studies and getting this much-needed therapeutic into the clinic as quickly as possible. Combining Augmenta’s discovery capabilities with TFF’s formulation and drug development expertise has been an incredibly fruitful partnership.”<\/p>\n Cannabis Development and Commercialization: <\/b>Our partner in the cannabis space, PLUS Products, has been producing thin film freezing formulations of cannabis and is planning to launch a new product based on this technology.<\/p>\n \u201cThe results on the preliminary manufacturing runs with the TFF technology have been even better than we had hoped,\u201d said Jake Heimark, CEO & Co-founder of PLUS Products. \u201cAnd the concept research on dry powder inhalation with the retail distribution channels in California has created a high level of interest in the product category.\u201d<\/p>\n Public Offering: <\/b>As announced previously on March 26, 2021,the Company closed on an underwritten offering of 2,140,000 shares of its common stock. Proceeds from the offering totaled approximately $30,000,000, before deducting underwriting discounts and other offering expenses. At the end of the quarter, with the net proceeds from this offering, the Company\u2019s liquidity included approximately $58.1 million in cash and cash equivalents.\n<\/li>\n<\/ul>\n Financial Results<\/b><\/p>\n \nFor the three months ended March 31, 2021, compared to the prior year:\n<\/p>\n About TFF Pharmaceuticals\u2019 Thin Film Freezing technology platform<\/b><\/p>\n \nTFF Pharmaceuticals\u2019 Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a \u201cBrittle Matrix Particle,\u201d which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments, the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.\n<\/p>\n About TFF Pharmaceuticals<\/b><\/p>\n \nTFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company\u2019s website at https:\/\/tffpharma.com.<\/a><\/p>\n SAFE HARBOR<\/b><\/p>\n \nThis press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company\u2019s TFF platform and its dry powder versions of various drugs, vaccines and biologics and the Company\u2019s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of any drugs, vaccines or biologics, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section \u201cRisk Factors\u201d included in the Company\u2019s 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.\n<\/p>\n TFF PHARMACEUTICALS, INC. \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n Three Months Ended \n\u00a0\n<\/p>\n<\/td>\n Three Months Ended \n\u00a0\n<\/p>\n \nGrant revenue\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n24,315\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n\u2014\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nOperating expenses:\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nResearch and development\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n5,278,252\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,235,542\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nGeneral and administrative\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,647,415\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,617,924\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal operating expenses\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n7,925,667\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n3,853,466\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nLoss from operations\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(7,901,352\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(3,853,466\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nOther income:\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nOther income\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n231,278\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u2014\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nInterest income\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n15,499\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n56,268\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal other income\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n246,777\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n56,268\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nNet loss\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(7,654,575\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(3,797,198\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nNet loss per share, basic and diluted\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(0.33\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(0.20\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nWeighted average common shares outstanding, basic and diluted\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n23,140,607\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n19,008,611\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n TFF PHARMACEUTICALS, INC. \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n March 31, December 31, \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n (Unaudited)<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nASSETS\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \nCurrent assets:\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \nCash and cash equivalents\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n58,055,122\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n35,300,805\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nPrepaid assets and other current assets\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,721,184\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,258,229\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal current assets\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n59,776,306\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n37,559,034\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nProperty and equipment, net\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,577,441\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,102,808\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal assets\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n61,353,747\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n38,661,842\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nLIABILITIES AND STOCKHOLDERS\u2019 EQUITY\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nCurrent liabilities:\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nAccounts payable\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n1,817,034\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n1,297,725\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nDeferred research grant revenue\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u2014\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n24,315\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal liabilities\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,817,034\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,322,040\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nCommitments and contingencies\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nStockholders\u2019 equity:\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nCommon stock\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n25,364\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n22,535\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nAdditional paid-in capital\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n101,535,068\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n71,648,453\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nAccumulated other comprehensive loss\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(89,496\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(51,538\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nAccumulated deficit\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(41,934,223\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(34,279,648\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nTotal stockholders\u2019 equity\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n59,536,713\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n37,339,802\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal liabilities and stockholders\u2019 equity\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n61,353,747\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n38,661,842\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210513005977\/en\/<\/a><\/span><\/p>\n Company Contacts:<\/b><\/p>\n \nGlenn Mattes \nKirk Coleman Investor Relations and Media Contact: KEYWORDS:<\/b> United States North America Texas<\/p>\n INDUSTRY KEYWORDS:<\/b> Research Clinical Trials Biotechnology Other Health Health Pharmaceutical General Health Other Science Science<\/p>\n\n
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UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n
\n<\/b>
March 31,
\n<\/b>
2021<\/b><\/p>\n<\/td>\n\n \n
\n<\/b>
March 31,
\n<\/b>
2020<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
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CONDENSED CONSOLIDATED BALANCE SHEETS<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n
\n<\/b>
2021<\/b><\/p>\n<\/td>\n\n \n
\n<\/b>
2020<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \n \n \n \n \n \n <\/tr>\n \n \n \n \n \n <\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n <\/p>\n
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President and CEO
\n
TFF Pharmaceuticals, Inc
\n
gmattes@tffpharma.com
\n<\/a>
737-802-1973\n<\/p>\n
\n
Chief Financial Officer
\n
TFF Pharmaceuticals, Inc.
\n
kcoleman@tffpharma.com
\n<\/a>
817-989-6358\n<\/p>\n
\n<\/b>
Paul Sagan
\n
LaVoieHealthScience
\n
psagan@lavoiehealthscience.com
\n<\/a>
617-865-0041\n<\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20210513005977\/en\/757396\/3\/TFF_Pharmaceuticals_Logo_JPEG.jpg\"){kind=logo}
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