Invasive Pulmonary Aspergillosis

Growing Body of Clinical Data from Ongoing Phase 2 Trial Suggests that Tacrolimus Inhalation Powder (TFF TAC) Could Represent an Important New Innovation for Optimizing Immunosuppressive Therapy in Lung Transplant Recipients Raised $6.0 Million to Support Continued Advancement of TFF TAC into Potentially Registrational Testing Company expects to receive feedback from FDA in Second Quarter Regarding TFF TAC Clinical Development Plan and Next Steps FORT WORTH, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), 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 2024 and provided a corporate update. “We continue to make significant progress in demonstrating that Tacrolimus Inhalation Powder (TFF TAC) has the potential to become an important new advancement in transplant medicine,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Following the positive physician feedback for our updated Phase 2 study presented at this year’s International Society for Heart and Lung Transplantation (ISHLT) meeting, we submitted a briefing book, inclusive of our proposed study plan, to the FDA. We expect to receive feedback from the FDA this quarter that will help guide our next steps in the clinical development pathway for TFF TAC. I am also pleased to note that we were able to secure additional financing following the close of the quarter to help us further advance TFF TAC toward registrational testing. Our Phase 2 study for TFF TAC continues to enroll additional patients, and we look forward to hosting a call and presenting updated data from the trial later this year.” Recent Clinical and Corporate Highlights: On May 1, 2024, the Company announced the closing of its previously announced $4.8 million public offering. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. This follows a $1.2 million public offering in March 2024.On April 15, 2024, the Company announced additional positive data from its ongoing Phase 2 study evaluating TFF TAC) for the prevention of organ rejection in lung transplant recipients. New gene expression analysis demonstrated normalization of rejection-related genes after treatment with TFF TAC.TFF TAC prevented rejection at 1/6 of oral tacrolimus dose and with 2/3 of oral tacrolimus systemic trough exposures4 out of 4 patients who completed the 12-week treatment have chosen to remain on TFF TAC by proceeding to the safety extension phaseThese new data were presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, in an oral presentation ISHLT 44th Annual Meeting at a late breaking clinical science abstract session, on April 13, 2024, in Prague, Czech Republic. On March 27, 2024, the Company hosted a conference call and webcast to present new data from the ongoing Phase 2 study of TFF TAC for the prevention of organ rejection in lung transplant recipients and from the Phase 2 study and the Expanded Access Program (EAP) of TFF Voriconazole (TFF VORI) for the treatment of invasive pulmonary aspergillosis (IPA) infections. On the call, our executive leadership team disclosed that: Eight out of eight patients (100%) successfully transitioned from oral Tacrolimus to TFF TAC in the study. There was no evidence of acute rejection. Four out of the four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceeded to the long-term extension of the trial. TFF TAC demonstrated favorable safety results with no mortality or discontinuations due to adverse events.The Company enrolled a total of nine patients in its TFF VORI clinical programs, inclusive of its ongoing Phase 2 study and the EAP. Five of six patients who had completed treatment by the data cut date achieved a clinical and mycologic response providing promising positive efficacy data. TFF VORI maintained an attractive safety profile with no IPA-related mortality or all-cause mortality. A replay of the call and webcast can be accessed here. In March 2024, the Company announced that it prioritized the development of TFF TAC based on the positive data from the ongoing Phase 2 study, the potential of this product to address a significant unmet need in lung transplant medicine, and the substantial market opportunity. With respect to TFF VORI, the Company announced that it is exploring strategic alternatives, including partnering opportunities, collaborations, and government-based funding sources to support its continued development.In January 2024, the Company presented data from the Phase 2 trial of TFF VORI at the Advances Against Aspergillosis & Mucormycosis (AAAM) Conference, which was held from January 25-27, 2024, in Milan, Italy. The data presented at the AAAM Conference were first disclosed by the Company in December 2023. These data showed that treatment with TFF VORI resulted in positive treatment outcomes while maintaining a favorable safety/tolerability profile. First Quarter 2024 Financial Results Balance Sheet Highlights As of March 31, 2024, TFF Pharmaceuticals cash and cash equivalents were approximately $3.2 million. On May 1, 2024, the Company completed a registered direct offering, receiving gross proceeds of $4.8 million before deducting offering expenses. Operating Results Research and Development (R&D) expenses were $3.6 million for the quarter ended March 31, 2024, a decrease of $0.4 million, or 12%, compared to $4.0 million for the quarter ended March 31, 2023. The net decrease of $0.4 million was primarily related to a decrease of $1.6 million in manufacturing and related expenses, offset by increases of $0.8 million in clinical and preclinical expenses and $0.3 million in compensation-related expenses.General & Administrative (G&A) expenses were $2.4 million for the quarter ended March 31, 2024, a decrease of $0.7 million, or 22%, compared to $3.1 million for the quarter ended March 31, 2023. The net decrease of $0.7 million was primarily related to decreases of $0.4 million in compensation-related expenses, $0.2 million in market research expenses and $0.1 million in insurance expenses.Net Loss: Net loss was $5.7 million for the quarter ended March 31, 2024, a decrease of $1.4 million, compared to a net loss of $7.1 million for the year ended March 31, 2023. ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGYTFF 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 PHARMACEUTICALSTFF 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 TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole 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 TAC into potentially registration-enabling studies; the expectation that the FDA will provide feedback in second quarter regarding TFF TAC clinical development and that any such feedback will be positive; the expectation that the initial data readouts for TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trial; 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 trial for 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 its TFF TAC candidate, (iii) the risk that the FDA will not provide feedback in second quarter regarding TFF TAC clinical development or that any such feedback will not be positive; (iv) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial, or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (viii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-Q filed with the SEC on May 14, 2024. 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 TFF PHARMACEUTICALS, INC.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For The Three Months EndedMarch 31, 2024 2023 Revenue$203,273 $51,429 Operating expenses: Research and development 3,555,862 4,018,659 General and administrative 2,438,304 3,119,216 Total operating expenses 5,994,166 7,137,875 Loss from operations (5,790,893) (7,086,446) Other income: Interest income, net 55,749 35,079 Total other income 55,749 35,079 Net loss$(5,735,144) $(7,051,367)Net loss per share, basic and diluted$(2.40) $(4.87) Weighted average common shares outstanding, basic and diluted 2,387,906 1,447,723 TFF PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS March 31,2024 December 31,2023 (Unaudited) ASSETS Current assets: Cash and cash equivalents$3,211,930 $5,478,113 Research and development tax incentive receivable 287,597 433,852 Prepaid assets and other current assets 1,362,989 1,678,353 Total current assets 4,862,516 7,590,318 Operating lease right-of-use asset, net 99,431 119,529 Property and equipment, net 1,879,696 1,999,781 Note receivable - Augmenta 2,337,219 2,310,000 Other assets 7,688 7,688 Total assets$9,186,550 $12,027,316 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$1,663,544 $958,442 Accrued liabilities 1,983,426 1,285,586 Deferred research grant revenue 140,000 101,000 Current portion of operating lease liability 84,300 83,512 Total current liabilities 3,871,270 2,428,540 Operating lease liability, net of current portion 10,856 31,742 Total liabilities 3,882,126 2,460,282 Commitments and contingencies Stockholders’ equity: Common stock 2,519 2,370 Additional paid-in capital 129,572,489 128,044,509 Accumulated other comprehensive loss (203,787) (148,192)Accumulated deficit (124,066,797) (118,331,653)Total stockholders’ equity 5,304,424 9,567,034 Total liabilities and stockholders’ equity$9,186,550 $12,027,316

Growing Body of Clinical Data from Ongoing Phase 2 Trial Suggests that Tacrolimus Inhalation Powder (TFF TAC) Could Represent an Important New Innovation for Optimizing Immunosuppressive Therapy in Lung Transplant Recipients Raised $6.0 Million to Support Continued Advancement of TFF TAC into Potentially Registrational Testing Company expects to receive feedback from FDA in Second Quarter Regarding TFF TAC Clinical Development Plan and Next Steps FORT WORTH, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), 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 2024 and provided a corporate update. “We continue to make significant progress in demonstrating that Tacrolimus Inhalation Powder (TFF TAC) has the potential to become an important new advancement in transplant medicine,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Following the positive physician feedback for our updated Phase 2 study presented at this year’s International Society for Heart and Lung Transplantation (ISHLT) meeting, we submitted a briefing book, inclusive of our proposed study plan, to the FDA. We expect to receive feedback from the FDA this quarter that will help guide our next steps in the clinical development pathway for TFF TAC. I am also pleased to note that we were able to secure additional financing following the close of the quarter to help us further advance TFF TAC toward registrational testing. Our Phase 2 study for TFF TAC continues to enroll additional patients, and we look forward to hosting a call and presenting updated data from the trial later this year.” RecentClinicalandCorporateHighlights: On May 1, 2024, the Company announced the closing of its previously announced $4.8 million public offering. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. This follows a $1.2 million public offering in March 2024. On April 15, 2024, the Company announced additional positive data from its ongoing Phase 2 study evaluating TFF TAC) for the prevention of organ rejection in lung transplant recipients. New gene expression analysis demonstrated normalization of rejection-related genes after treatment with TFF TAC. TFF TAC prevented rejection at 1/6 of oral tacrolimus dose and with 2/3 of oral tacrolimus systemic trough exposures 4 out of 4 patients who completed the 12-week treatment have chosen to remain on TFF TAC by proceeding to the safety extension phase These new data were presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, in an oral presentation ISHLT 44th Annual Meeting at a late breaking clinical science abstract session, on April 13, 2024, in Prague, Czech Republic. On March 27, 2024, the Company hosted a conference call and webcast to present new data from the ongoing Phase 2 study of TFF TAC for the prevention of organ rejection in lung transplant recipients and from the Phase 2 study and the Expanded Access Program (EAP) of TFF Voriconazole (TFF VORI) for the treatment of invasive pulmonary aspergillosis (IPA) infections. On the call, our executive leadership team disclosed that: Eight out of eight patients (100%) successfully transitioned from oral Tacrolimus to TFF TAC in the study. There was no evidence of acute rejection. Four out of the four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceeded to the long-term extension of the trial. TFF TAC demonstrated favorable safety results with no mortality or discontinuations due to adverse events. The Company enrolled a total of nine patients in its TFF VORI clinical programs, inclusive of its ongoing Phase 2 study and the EAP. Five of six patients who had completed treatment by the data cut date achieved a clinical and mycologic response providing promising positive efficacy data. TFF VORI maintained an attractive safety pro no IPA-related mortality or all-cause mortality. A replay of the call and webcast can be accessed here. In March 2024, the Company announced that it prioritized the development of TFF TAC based on the positive data from the ongoing Phase 2 study, the potential of this product to address a significant unmet need in lung transplant medicine, and the substantial market opportunity. With respect to TFF VORI, the Company announced that it is exploring strategic alternatives, including partnering opportunities, collaborations, and government-based funding sources to support its continued development. In January 2024, the Company presented data from the Phase 2 trial of TFF VORI at the Advances Against Aspergillosis & Mucormycosis (AAAM) Conference, which was held from January 25-27, 2024, in Milan, Italy. The data presented at the AAAM Conference were first disclosed by the Company in December 2023. These data showed that treatment with TFF VORI resulted in positive treatment outcomes while maintaining a favorable safety/tolerability profile. First Quarter 2024 FinancialResults Balance Sheet Highlights As of March 31, 2024, TFF Pharmaceuticals cash and cash equivalents were approximately $3.2 million. On May 1, 2024, the Company completed a registered direct offering, receiving gross proceeds of $4.8 million before deducting offering expenses. Operating Results Research and Development (R&D) expenses were $3.6 million for the quarter ended March 31, 2024, a decrease of $0.4 million, or 12%, compared to $4.0 million for the quarter ended March 31, 2023. The net decrease of $0.4 million was primarily related to a decrease of $1.6 million in manufacturing and related expenses, offset by increases of $0.8 million in clinical and preclinical expenses and $0.3 million in compensation-related expenses. General & Administrative (G&A) expenses were $2.4 million for the quarter ended March 31, 2024, a decrease of $0.7 million, or 22%, compared to $3.1 million for the quarter ended March 31, 2023. The net decrease of $0.7 million was primarily related to decreases of $0.4 million in compensation-related expenses, $0.2 million in market research expenses and $0.1 million in insurance expenses. Net Loss: Net loss was $5.7 million for the quarter ended March 31, 2024, a decrease of $1.4 million, compared to a net loss of $7.1 million for the year ended March 31, 2023. 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 TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole 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 TAC into potentially registration-enabling studies; the expectation that the FDA will provide feedback in second quarter regarding TFF TAC clinical development and that any such feedback will be positive; the expectation that the initial data readouts for TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trial; 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 trial for 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 its TFF TAC candidate, (iii) the risk that the FDA will not provide feedback in second quarter regarding TFF TAC clinical development or that any such feedback will not be positive; (iv) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial, or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (viii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-Q filed with the SEC on May 14, 2024. 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 TFF PHARMACEUTICALS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For The Three Months Ended March 31, 2024 2023 Revenue $ 203,273 $ 51,429 Operating expenses: Research and development 3,555,862 4,018,659 General and administrative 2,438,304 3,119,216 Total operating expenses 5,994,166 7,137,875 Loss from operations (5,790,893 ) (7,086,446 ) Other income: Interest income, net 55,749 35,079 Total other income 55,749 35,079 Net loss $ (5,735,144 ) $ (7,051,367 ) Net loss per share, basic and diluted $ (2.40 ) $ (4.87 ) Weighted average common shares outstanding, basic and diluted 2,387,906 1,447,723 TFF PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS March 31, 2024 December 31, 2023 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 3,211,930 $ 5,478,113 Research and development tax incentive receivable 287,597 433,852 Prepaid assets and other current assets 1,362,989 1,678,353 Total current assets 4,862,516 7,590,318 Operating lease right-of-use asset, net 99,431 119,529 Property and equipment, net 1,879,696 1,999,781 Note receivable - Augmenta 2,337,219 2,310,000 Other assets 7,688 7,688 Total assets $ 9,186,550 $ 12,027,316 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,663,544 $ 958,442 Accrued liabilities 1,983,426 1,285,586 Deferred research grant revenue 140,000 101,000 Current portion of operating lease liability 84,300 83,512 Total current liabilities 3,871,270 2,428,540 Operating lease liability, net of current portion 10,856 31,742 Total liabilities 3,882,126 2,460,282 Commitments and contingencies Stockholders’ equity: Common stock 2,519 2,370 Additional paid-in capital 129,572,489 128,044,509 Accumulated other comprehensive loss (203,787 ) (148,192 ) Accumulated deficit (124,066,797 ) (118,331,653 ) Total stockholders’ equity 5,304,424 9,567,034 Total liabilities and stockholders’ equity $ 9,186,550 $ 12,027,316

Inhaled opelconazole observed to be generally well tolerated in this study as prophylaxis against pulmonary aspergillosis in lung transplant patients Discontinuations due to drug-related adverse events and drug-drug interactions lower in the opelconazole group vs standard of care Prevention and eradication of Aspergillus and Candida in the lungs observed with opelconazole monotherapy LONDON, April 15, 2024 (GLOBE NEWSWIRE) -- Pulmocide Ltd., (“the Company”) a late-stage biopharmaceutical company developing novel inhaled therapies for patients suffering from serious acute and chronic respiratory diseases, today announced topline results from the OPERA-S study: a Phase 2 safety and tolerability study in lung transplant patients receiving inhaled opelconazole monotherapy as prophylaxis against pulmonary aspergillosis. Opelconazole is an investigational inhaled triazole antifungal being developed to prevent and treat pulmonary aspergillosis. In this study, opelconazole was generally well tolerated with a low incidence of drug-related adverse events (AEs) and a low incidence of treatment-limiting respiratory AEs. Importantly, there were no dose reductions or discontinuations of opelconazole prophylaxis or of immunosuppressant medications due to opelconazole-related drug-drug interactions (DDIs). Despite the expected small numbers, there was evidence of prevention of pulmonary aspergillosis and of eradication in the lungs of both Aspergillus and Candida colonization with opelconazole monotherapy. In this open-label, active-controlled trial, 102 patients were randomized in the ICU after receiving a lung transplant in a 2:1 ratio to either inhaled opelconazole or standard of care (SOC) antifungal prophylaxis, and were treated for up to 12 weeks. The safety and tolerability of opelconazole, the main focus of this study, and the ability to remain on antifungal prophylaxis and immunosuppressive therapy, were summarized descriptively as the study was not statistically powered for between group comparisons. Results from this trial indicated that opelconazole was generally safe and well tolerated. The number of related adverse events occurring in ≥ 2% of opelconazole patients was low. These were cough (6.2%), nausea (4.6%) and respiratory tract irritation (3.1%), all of which were mild or moderate in severity. Importantly, respiratory AEs related to opelconazole were rarely treatment-limiting, leading to discontinuation in two out of 65 opelconazole patients. Drug-related AEs together with DDIs leading to discontinuation of the antifungal medication, or DDIs leading to discontinuation of an immunosuppressant medication, occurred less commonly in the opelconazole group (7.7%) versus in the SOC antifungal prophylaxis group (27.3%). Numerically, more opelconazole patients (72.3%) completed the 12 weeks of prophylaxis compared to the initial SOC antifungal treatment (69.7%). Three patients in the study died: one in the opelconazole group (1.5%) and two in the SOC group (6%). Efficacy in preventing breakthrough pulmonary Aspergillus disease and eradication of colonization were summarized descriptively as exploratory outcomes. As expected, given the relatively small sample size, the incidence of breakthrough fungal disease in the intent-to-treat population was low and similar between groups, in 4% of the opelconazole patients and in 3% of the SOC patients. In addition, opelconazole appeared to eradicate Aspergillus colonization in all six patients who entered the study already colonized. In two patients colonized prior to randomization with Fusarium and Penicillium, opelconazole also achieved eradication. Aspergillus colonization was also eradicated in the two SOC patients who were colonized at study entry. In addition, opelconazole eradicated Candida colonization of the airways in 12 of the 15 patients colonized at study entry (80%), providing additional evidence of opelconazole’s antifungal activity. In the SOC group, Candida colonization of the airways was eradicated in four of the six patients colonized at study entry (67%). One opelconazole patient (1.5%) and three SOC patients (9.1%) developed oral candidiasis during the study. “The data support that inhaled opelconazole was generally safe and well tolerated in this study when administered as monotherapy prophylaxis in lung transplant patients, a critically ill patient population with major pulmonary morbidity,” stated Dr. Lance Berman, Chief Medical Officer of Pulmocide. “Based on discussions with clinicians who care for lung transplant patients, it appears that a potent antifungal agent delivered directly to the lungs with a low discontinuation rate and a negligible risk for DDIs would be a promising alternative. We believe that the use of opelconazole as a prophylaxis agent in patients at risk of pulmonary aspergillosis warrants further investigation.” “As a physician who regularly treats these patients, I find the results to be very promising,” commented Dr. Shahid Husain, Professor of Medicine, Infectious Diseases, at the University of Toronto and who served on the study steering committee in addition to being an investigator in the trial. “If we can provide and maintain potent antifungal protection without having to compromise vital immunosuppressive therapy, then we may be able to further improve outcomes for our patients.” More detailed results from this study are expected to be provided at medical meetings and through peer-reviewed publication in the months ahead. About Opelconazole Pulmocide’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 pro anticipated to enhance efficacy with a low risk of adding to the toxicities and drug-drug interactions seen with systemic antifungal therapies. Opelconazole has the potential to be useful in a variety of conditions where Aspergillus has been implicated, including chronic pulmonary aspergillosis, patients with severe asthma complicated by allergic bronchopulmonary aspergillosis, and severe flu or COVID-19 complicated by invasive aspergillosis. Opelconazole also has the potential to be used as prophylaxis in immunocompromised patients at risk of developing pulmonary aspergillosis, most commonly patients with an underlying hematological malignancy or recipients of a stem cell or solid organ transplant. Opelconazole is being supplied within the UK for patients with serious or life-threatening pulmonary aspergillosis according to the MHRA’s Guidance Note 14 (the Specials program). 1 Although drawing definitive conclusions regarding efficacy and safety from this program is limited by the open-label, non-randomized, uncontrolled nature of the program, observations suggest that in this program, inhaled opelconazole was generally well tolerated and effective in treating these patients.2, 3, 4 These clinical observations were noted in patients who had failed, or were intolerant of, prior antifungal therapy. These treatment responses led to advancing the clinical development of this investigational product which is currently in a Phase 3 clinical trial in patients with Invasive Pulmonary Aspergillosis (IPA) who are not responding to antifungal therapy (the OPERA-T study).5 About Pulmonary Aspergillosis The incidence of pulmonary fungal disease has increased substantially over the past two decades with Aspergillus species being the most common pathogen.4 Invasive pulmonary aspergillosis is associated with high morbidity and mortality rates in immunocompromised 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.5 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.5 Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring a lifetime of antifungal treatment.5 About Pulmocide Pulmocide Ltd ( ) 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 Phase 3 product opelconazole is being developed initially for the treatment of invasive pulmonary aspergillosis. References: MHRA. (2014). The supply of unlicensed medicinal products (“specials”). Retrieved from Murray, A., Cass, L., Ito, K., et al. (2020). PC945, a Novel Inhaled Antifungal Agent, for the Treatment of Respiratory Fungal Infections. J Fungi (Basel), 6(4). Pagani, N., Armstrong-James, D., & Reed, A. (2020). Successful salvage therapy for fungal bronchial anastomotic infection after -lung transplantation with an inhaled triazole anti-fungal PC945. J Heart Lung Transplant, 39(12), 1505-1506. Singh, S., Moore, L. S. P., Mughal, N., et al. (2023). Novel inhaled antifungal for pseudomembranous Aspergillus tracheobronchitis complicating connective tissue disease. Thorax, 78(1), 110-111. Pulmocide Contact: Jennifer Giottonini Cayer Chief Business Officer and Head of Corporate Development Pulmocide Ltd jcayer@pulmocide.com Media Contact: Michael Tattory LifeSci Communications mtattory@lifescicomms.com