Invasive Pulmonary Aspergillosis

FORT WORTH, Texas, Jan. 24, 2024 (GLOBE NEWSWIRE) -- TFF 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 announced that the Company will present data from the Phase 2 trial of Voriconazole Inhalation Powder (TFF VORI) for the treatment of invasive pulmonary aspergillosis at the upcoming Advances Against Aspergillosis & Mucormycosis (AAAM) Conference, which will be held from January 25-27, 2024, in Milan, Italy. Data being presented at the AAAM Conference were first disclosed by the Company in December 2023. Presentation Details: Presentation Title: “TFF VORI in invasive pulmonary aspergillosis” Presenter: Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals Date: Friday, January 26th Time: 8:10 am CEST SESSION 6: BREAKFAST SESSION ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products. ABOUT TFF PHARMACEUTICALS TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by over 170 patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at . SAFE HARBOR This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF VORI and TFF TAC into potentially registration-enabling studies; the expectation that the initial data readouts for TFF VORI and TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trials and related EAP; and the benefits of the Company’s TFF platform. 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 further data from the ongoing Phase 2 clinical trials and related EAP for TFF VORI and TFF TAC will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF VORI and TFF TAC candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and related EAP, or advance to the initiation of registration-enabling studies, for TFF VORI and TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. 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. InvestorRelationsContact: Corey Davis, Ph.D. LifeSci Advisors (212) 915-2577 cdavis@lifesciadvisors.com Source: TFF Pharmaceuticals, Inc.

LONDON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Pulmocide Ltd., (“the Company”) a late-stage biopharmaceutical company developing opelconazole for patients suffering from serious acute and chronic respiratory diseases, today announced that Dan Burgess, Chairman and CEO, will present a corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 from 5:00pm – 5:25pm PT in San Francisco. About OpelconazolePulmocide’s investigational product, opelconazole, is a potent novel azole therapy specifically designed for inhaled use to maximize the amount of drug in the lung while providing minimal systemic exposure. This profile is anticipated to enhance efficacy with a low risk for adding to the toxicities and drug-drug interactions seen with systemic antifungal therapies. Under the United Kingdom’s Special Needs provision, opelconazole was found to be generally well tolerated and demonstrated remarkable clinical responses. In this program, patients with a variety of different clinical profiles who had failed previous antifungal treatment options responded well when opelconazole was added to their treatment regimen. Opelconazole has the potential to be useful in a variety of conditions where Aspergillus has been implicated, including chronic pulmonary aspergillosis, cystic fibrosis, severe asthma, allergic bronchopulmonary aspergillosis, chronic pulmonary obstructive disease, severe flu, and post-COVID-19-associated lung damage. A late-stage clinical program has been initiated to support registration in patients who have failed prior therapy for invasive pulmonary aspergillosis (IPA). The safety and efficacy of opelconazole is currently under evaluation in a Phase 3 clinical trial in patients with refractory IPA. Enrollment in a Phase 2 prophylaxis safety study in lung transplant recipients was recently completed with data expected in the first quarter of 2024. About Pulmonary AspergillosisThe incidence of pulmonary fungal disease has increased substantially over the past two decades with Aspergillus species being the most common pathogen.1 Invasive pulmonary aspergillosis is associated with high morbidity and mortality rates in immuno-compromised patients including those undergoing hematological stem cell or solid organ transplantation (particularly lung transplants) and some patients in critical care, including those with COVID-19 or influenza-associated pulmonary aspergillosis.2 Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcomes in patients with chronic obstructive pulmonary disease.2 Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring a lifetime of antifungal treatment.2 About PulmocidePulmocide Ltd (www.pulmocide.com) is a late-stage biopharmaceutical company focused on the development of a novel inhaled azole therapy for patients at risk of developing serious complications associated with aspergillosis, such as immunocompromised patients and those with severe pulmonary diseases. The company is currently focused on acute and chronic treatments for pulmonary aspergillosis and its lead product opelconazole is being developed initially for the treatment of invasive pulmonary aspergillosis. References Where Aspergillosis Comes From, Centers for Disease Control and Prevention, accessed 12 October 2023Kousha M. et al: Pulmonary aspergillosis: a clinical review. Eur Respir Rev, 2011; 20(212):156-174 For further information, please contact: Pulmocide Contact:Jennifer Giottonini CayerChief Business Officer and Head of Corporate DevelopmentPulmocide Ltdjennifer@pulmocide.com Media Contact:Michael TattoryLifeSci Communications mtattory@lifescicomms.com

Treatment with TFF VORI resulted in positive treatment outcomes based on clinical, mycologic and radiologic responses while maintaining a favorable safety/tolerability profile, with no all-cause mortality, no invasive pulmonary aspergillosis (IPA)-related mortality, and no TFF VORI discontinuations due to an adverse event (AE) Successful transition of all four patients from oral tacrolimus to TFF TAC, leading to significant lowering of tacrolimus blood levels with no clinical evidence of acute rejection; all patients who completed Part A (study treatment period) of the trial chose to remain on TFF TAC and advance to Part B (extension study) TFF TAC was well tolerated, with no mortality and no TFF TAC discontinuations due to an AE; kidney function was maintained in all patients treated with TFF TAC Based on the promising Phase 2 data for both products, the Company plans to accelerate the initiation of registration-enabling studies Company to hold conference call and webcast this morning at 8:30 am ET to review data FORT WORTH, Texas, Dec. 19, 2023 (GLOBE NEWSWIRE) -- TFF 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 announced positive initial data from the Company’s ongoing Phase 2 trials of TFF VORI and TFF TAC, along with clinical data from the ongoing TFF VORI Expanded Access Program (EAP). “Today is truly a remarkable moment in the history of TFF Pharmaceuticals, as these initial clinical data clearly demonstrate the efficacy and favorable safety and tolerability of TFF VORI and TFF TAC in two rare disease indications with high unmet medical need. These compelling results also demonstrate the successful clinical application of our ground-breaking technology platform,” said Harlan Weisman, M.D., President and Chief Executive Officer of TFF Pharmaceuticals. “Based on these highly encouraging efficacy and safety data, we have made the decision to accelerate the development of TFF VORI and TFF TAC into registration-enabling studies, given the unequivocally positive results from these initial data. Looking ahead, we expect to present additional clinical data in the first quarter of 2024 to further support the advancement of TFF VORI and TFF TAC into registration-enabling studies.” “These initial data provide compelling evidence that both TFF VORI and TFF TAC have game-changing potential in the treatment of their respective rare disease indication, IPA and prevention of rejection after lung transplantation,” said Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals. “With respect to TFF VORI, the initial data from the Phase 2 trial and our EAP clearly demonstrate a positively differentiated safety and tolerability profile from the standard-of-care, first-line therapy, oral voriconazole, based on the available historical data. The efficacy results are equally remarkable with treatment response seen in all patients. Initial results from the TFF TAC study are also impressive. Patients treated with TFF TAC did not experience clinically acute rejection at significantly reduced blood tacrolimus levels. Additionally, the patients maintained their kidney function and chose to remain on TFF TAC long term.” TFF VORI - initial Phase 2 and EAP data The ongoing Phase 2 trial of TFF VORI is an open-label, randomized (3:1) study evaluating treatment with TFF VORI versus oral voriconazole over a 13-week period in patients with IPA. Trial endpoints include safety, tolerability, clinical response, mycologic response, radiologic response, and all-cause mortality. The initial efficacy data presented below include patients from the Phase 2 trial and the Company’s EAP who received at least 8 weeks of therapy with either TFF VORI (N=5) or oral voriconazole (N=1). Safety data included all TFF VORI-treated patients (N=7) and oral voriconazole-treated patients (N=2). Of note, three of the five patients who were treated with TFF VORI for at least 8 weeks had a diagnosis of chronic lung allograft dysfunction (CLAD), which is a lung disease caused by chronic rejection, from the immune system attacking the transplanted lungs. CLAD is a significant cause of morbidity and mortality after lung transplantation and can be exacerbated by infections, further deteriorating the patient’s condition. The patient treated with oral voriconazole for at least 8 weeks did not present with CLAD. Efficacy Of the five patients treated for at least 8 weeks with TFF VORI: All five patients achieved a clinical responseAll five patients achieved a mycologic responseThree of four patients with pre- and post-treatment chest CT achieved a radiologic responseNo need for continued anti-fungal use after treatment with TFF VORI in all five patients Safety No all-cause mortalityNo IPA-related mortalityNo TFF VORI discontinuation due to an AEMajority of treatment emergent adverse events (TEAEs) deemed unrelated to TFF VORIMajority of TEAEs were Grade 2 or lower in severityNo hepatic toxicityNo visual disturbances TFF TAC - initial Phase 2 data The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety/tolerability, kidney function, and acute allograft rejection. The initial data presented below are from the first four patients enrolled in the trial. Efficacy Of the four patients enrolled in the TFF TAC Phase 2 study: All four patients were successfully transitioned from oral tacrolimus to TFF TACSuccessfully lowered tacrolimus blood levels to 1/2 to 2/3 of the levels on oral tacrolimus in all four patientsNo clinical evidence of acute rejection No signs and symptoms suggestive of acute rejectionNo use of pulse corticosteroidsNo deterioration in spirometryNo chest X-ray findings suggestive of acute rejection All three patients who completed Part A chose to remain on TFF TAC and proceeded to Part B. Safety No mortalityNo TFF TAC discontinuation due to an AEMajority of TEAEs were Grade 2 or lower in severityMaintenance of kidney function Conference Call and Webcast Information The Company will host a conference call today, Tuesday, December 19, 2023, at 8:30 AM Eastern Time, to discuss initial data from its ongoing Phase 2 trials of TFF VORI and TFF TAC. To participate in the conference call, please utilize the following information: Domestic Dial-In Number: Toll-Free: 1-877-407-3982 International Dial-In Number: 1-201-493-6780 Conference ID: 13743007 Call me™: LINK (will be made active 15 minutes prior to the scheduled start time) The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1647021&tp_key=9bea30319a 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. ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products. ABOUT TFF PHARMACEUTICALS TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by over 170 patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com. SAFE HARBOR This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF VORI and TFF TAC into potentially registration-enabling studies; the expectation that the initial data readouts for TFF VORI and TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trials and related EAP; and the benefits of the Company’s TFF platform. 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 further data from the ongoing Phase 2 clinical trials and related EAP for TFF VORI and TFF TAC will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF VORI and TFF TAC candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and related EAP, or advance to the initiation of registration-enabling studies, for TFF VORI and TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. 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. Investor Relations Contact:Corey Davis, Ph.D. LifeSci Advisors (212) 915-2577cdavis@lifesciadvisors.com Source: TFF Pharmaceuticals, Inc.