Allograft Rejection

2024 marks 50 years of pediatric heart transplants and 35 years of pediatric lung transplants at Stanford Medicine PALO ALTO, Calif., July 11, 2024 /PRNewswire/ -- Stanford Medicine Children's Health is celebrating 50 years of pediatric heart transplants and more than 35 years of pediatric lung transplants. These milestones have a special significance, as Stanford was the site of the first successful human heart transplant in the United States, performed by cardiothoracic surgeon Norman Shumway, MD, PhD, in 1968. Continue Reading Stanford Medicine Children's Health celebrates decades of saving young transplant patients. "Every time we perform a pediatric heart or lung transplant, we are saving someone's life," said David Rosenthal, MD, medical director of Thoracic Organ Transplantation and director of the Pediatric Advanced Cardiac Therapies (PACT) program at Stanford Children's Health. "As one of the largest pediatric transplant programs in the country, it's amazing to think about the decades of collaboration between specialists around the institution and how we've been able to contribute many advances to the field. These advances have allowed us to take care of some of the smallest and most complex patients and give them another chance at life." In 1974, the first pediatric heart transplant at Stanford was performed for a teenager. Since then, the Stanford heart transplant program has completed more than 560 pediatric heart transplants—a higher volume than at many pediatric heart centers in the United States and the highest volume in the Western U.S. One of the more recent advances by the Stanford Children's team includes the heart transplant size-matching program. A Stanford Children's pediatric cardiologist pioneered the use of 3-D imaging software to better match donor hearts with children awaiting heart transplant to help expand the donor pool and reduce wait times. In 1988, Stanford physicians performed the institution's first pediatric lung transplant. The highly specialized transplant team has performed 98 pediatric lung and combined heart-lung transplants to date, treating more lung transplant patients than any other center on the West Coast. Most recently, to address an evolving need for young patients with severe pulmonary hypertension and advanced lung disease, Stanford Children's created the Center for Advanced Lung Therapies, giving children their best chance for survival while they wait for a lung or combined heart-lung transplant, or being offered advanced therapeutic treatments which can serve as a bridge to transplant. Its team approach and integration within the greater Stanford Medicine network gives patients access to novel therapies and treatments. "These milestones speak to our expertise, our long history of research, innovations, and procedures conducted in partnership with experts in the field," Dr. Rosenthal said. "Seeing our patients go from critically ill to living fulfilling lives is something I find gratifying and gives me a lot of optimism for the future of the field." Stanford Children's Pediatric Heart Transplant key facts 1974: First pediatric heart transplant at Stanford is performed for a teenager. 1984: Two-year-old Elizabeth Craze is the first small child to successfully receive a heart transplant at Stanford. She is one of the youngest heart transplant recipients on record and now Stanford's oldest living heart transplant survivor. Elizabeth has survived for 40 years with the same heart. 2004: The Pediatric Advanced Cardiac Therapies (PACT) program is established at Stanford Children's—the first combined pediatric heart failure and heart transplant program in the U.S. Yearly, the outpatient PACT clinic cares for more than 1,000 patients. 2004: A 5-month-old is the youngest child at the time to be placed on a Berlin Heart pump, enabling him to survive 55 days until a donor heart becomes available. 2010: Researchers find using an inexpensive blood test to be a faster, less intrusive way to identify transplant recipients' organ rejection before it impairs transplanted hearts. To date, the heart transplant team has performed more than 560 pediatric heart transplants and implanted more than 200 ventricular assist devices (VAD), which help extend patients' lives until they receive a donor heart. Key medical protocols to minimize stroke in VAD patients and use adult devices in pediatric devices were developed at Stanford. Stanford Children's Pediatric Lung and Heart-Lung Transplant key facts: 1988: Stanford surgeons perform the hospital's first pediatric lung transplant. Stanford Children's is the only pediatric program in the Western U.S. to consider lung and combined heart-lung transplantation for patients from infancy to early adulthood, even those who have developed respiratory failure months or years after prior surgery for congenital heart lesions and who are at high risk for future surgeries because of past, complex heart or lung surgeries. Stanford Children's is the only center in California, Nevada, and Oregon to be designated a Therapeutic Development Network Center by the Cystic Fibrosis Foundation. Stanford Children's is part of the International Pediatric Lung Transplant Collaborative and an ongoing participant in the first-ever National Institutes of Health collaborative study on the mechanisms of chronic allograft rejection. 2011: Surgeons perform the first pediatric lung-liver transplant at Lucile Packard Children's Hospital Stanford. 2016: A 14-year-old is the first pediatric heart-lung transplant patient in the Western U.S. to undergo a novel procedure to receive a shunt that assists his lungs to reduce the workload on his failing heart, acting as a bridge to transplant. This advanced lung therapeutic intervention helps him survive to transplant. 2013–23: Stanford Children's completes 25 lung and heart-lung transplants. Media Contact Katie Chen [email protected] (650) 465-4872 About Stanford Medicine Children's Health Stanford Medicine Children's Health, with Lucile Packard Children's Hospital Stanford at its center, is the Bay Area's largest health care system exclusively dedicated to children and expectant mothers. Our network of care includes more than 65 locations across Northern California and more than 85 locations in the U.S. Western region. Along with Stanford Health Care and the Stanford School of Medicine, we are part of Stanford Medicine, an ecosystem harnessing the potential of biomedicine through collaborative research, education, and clinical care to improve health outcomes around the world. We are a nonprofit organization committed to supporting the community through meaningful outreach programs and services and providing necessary medical care to families, regardless of their ability to pay. Discover more at stanfordchildrens.org. SOURCE Stanford Medicine Children's Health and Lucile Packard Children's Hospital Stanford

FORT WORTH, Texas, June 26, 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 announced that the Company has engaged Outcome Capital as a strategic advisor for the purpose of evaluating potential corporate partnerships and licensing opportunities. “We are pleased to announce this engagement with Outcome Capital, which is a well-recognized investment bank specializing in corporate advisory services to the life sciences industry,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Today’s announcement reflects the significant innovation and commercial potential of our two lead clinical assets, TFF VORI and TFF TAC, and we welcome the opportunity to work with Outcome Capital in evaluating select partnering or licensing opportunities that can bring significant value to our shareholders.” “In recent months, TFF Pharmaceuticals has made extraordinary progress in demonstrating how its leading formulation technology can be applied to generate innovative clinical-stage products with the potential to improve upon the current standard of care,” said Oded Ben-Joseph, Ph.D., MBA, Managing Partner of Outcome Capital. “We look forward to identifying and evaluating opportunities to realize the full potential value of TFF Pharmaceutical’s exciting Phase 2 assets.” About TFF TAC TFF TAC is an inhaled dry powder formulation of tacrolimus, a potent immunosuppressive drug. Oral tacrolimus is currently the first line calcineurin inhibitor used for prevention of rejection after solid organ transplantation but it is associated with many toxicities such as kidney toxicity, particularly when high doses are needed as is the case after lung transplantation TFF TAC delivers tacrolimus directly to the lung to yield improved lung immunosuppression at lower doses and systemic exposures compared to oral tacrolimus to improve efficacy and decrease systemic toxicities such as kidney toxicity. TFF TAC is delivered via an easy-to-use dry powder inhaler. 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 and tolerability including kidney function, acute allograft rejection and pharmacokinetics. 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 skin. SAFE HARBOR This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the innovation and commercial potential of the Company’s TFF VORI and TFF TAC product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that the Company may not realize the innovation and commercial potential of TFF VORI and TFF TAC through its collaboration with Outcome Capital or otherwise, (ii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (v) 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 May 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company 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

FDA Provided Constructive Feedback to Help Guide Next Steps in TFF TAC Clinical Development Company to Provide More Detailed Regulatory Update in 3Q 2024 FORT WORTH, Texas, June 24, 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 announced a regulatory update on the Company’s TFF TAC clinical program following its recent interaction with the U.S. Food and Drug Administration (FDA). In April 2024, the Company submitted a briefing book to the FDA to help guide the next steps in the clinical development pathway for TFF TAC. Following its review of the briefing book, the FDA concurred that mitigation or prevention of tacrolimus associated toxicities without placing the lung allograft at risk will be an important therapeutic benefit and provided constructive feedback and valuable guidance on the roadmap for advancement of TFF TAC. Based on this feedback, the Company does not expect a significant change to either its timelines or the estimated costs associated with the clinical advancement of TFF TAC. “The initial feedback from the FDA on the TFF TAC clinical program has provided us with additional clarity on how we can continue advancing this innovative product towards registrational testing,” said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “Over the next several weeks, we expect to receive additional guidance from the FDA, which should allow us to provide a more detailed regulatory update on the program in the third quarter of 2024.” About TFF TAC TFF TAC is an inhaled dry powder formulation of tacrolimus, a potent immunosuppressive drug. Oral tacrolimus is currently the first line calcineurin inhibitor used for prevention of rejection after solid organ transplantation but it is associated with many toxicities such as kidney toxicity, particularly when high doses are needed as is the case after lung transplantation. TFF TAC delivers tacrolimus directly to the lung to yield improved lung immunosuppression at lower doses and systemic exposures compared to oral tacrolimus to improve efficacy and decrease systemic toxicities such as kidney toxicity. TFF TAC is delivered via an easy-to-use dry powder inhaler. 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 and tolerability including kidney function, acute allograft rejection and pharmacokinetics. 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 skin. SAFE HARBOR This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expectation that the further guidance from the FDA concerning TFF TAC will be consistent with the FDA guidance received to date, the Company’s ability to progress TFF TAC towards registrational testing 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 guidance from the FDA concerning TFF TAC will not be favorably consistent with the guidance received to date, (ii) the risk that the Company may not be able to advance to registration-enabling studies for its TFF TAC candidate, (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 trial, or advance to the initiation of registration-enabling studies, for 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 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, (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 May 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company 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