Belcher Pharmaceuticals, Inc.

Tampa General Hospital breaks ground on new Taneja Surgical, Neuroscience & Transplant Tower, a symbol of innovation and a tribute to the generosity of the Taneja Family Foundation. TAMPA, Fla., April 15, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) today celebrated more than $120 million in charitable contributions over a two-year period to advance its vision to transform health care through innovation. The latest gift toward the $120 million milestone came from the Taneja Family Foundation and is the largest in the foundation's history. Continue Reading Tampa General Hospital (TGH) today celebrated more than $120 million in charitable contributions over a two-year period to advance its vision to transform health care through innovation. The latest gift toward the $120 million milestone came from the Taneja Family Foundation and is the largest in the foundation’s history. Tampa General leadership, community leaders and members of the Taneja family broke ground on the Taneja Surgical, Neuroscience & Transplant Tower. As part of the celebration, Tampa General leadership, community leaders and members of the Taneja family broke ground on the Taneja Surgical, Neuroscience & Transplant Tower, a medical pavilion in the heart of Tampa Bay, where patients will have access to best-in-class providers, the latest research therapies and state-of-the-art technologies. The tower bears the Taneja name in honor of the Taneja Family Foundation's contribution to the TGH Foundation. "Patients come to Tampa General for world-class care, and the addition of this new tower on our campus, thanks in part to the generosity of the Taneja family, enhances our ability to deliver the highest level of academic-based medicine," said John Couris, president and CEO of Tampa General Hospital. "The Taneja family shares our vision that through innovation, we can transform health care and improve patient outcomes. The new Taneja Surgical, Neuroscience & Transplant Tower will be an intersection of academics, research and clinical care that will elevate how we are able to treat patients with complex conditions." Construction on the Taneja Surgical, Neuroscience & Transplant Tower is expected to be completed in 2027, which will then serve as home for Tampa General's surgery, neuroscience and transplant service lines. The tower, which consists of a plaza level and 12 floors, will provide 144 patient beds, 32 operating suites and expanded intensive care unit (ICU) capacity. In addition, there will be space for education and training, emergency response and sterile processing, as well as two floors reserved for future growth. "As Tampa General's academic health system reaches new communities across the state of Florida, the demand for Tampa General's world-class care grows, too," said Drew Graham, chairman of the board of directors of Florida Health Sciences Center, under which Tampa General operates. "The new Taneja Surgical, Neuroscience & Transplant Tower will help us fill that demand, welcoming patients from near and far for treatments and care for the most complex health conditions. The state-of-the-art pavilion will reflect the world-class care our providers and teams deliver every day." "The Tanejas have built a successful business rooted in innovation, and their generous contribution is a testament to Tampa General's own commitment to innovation," said Gordon Gillette, chair of the board of trustees at Tampa General Hospital Foundation. Giving back to the community was instilled in Jugal Taneja, president and treasurer of the Taneja Family Foundation, from a young age. His father emphasized the importance of generosity and encouraged his growing family to pay it forward. When Taneja moved to the United States more than five decades ago, he had little to give others with just $8 in his own pocket and a family back home in India to support. Over the years, Taneja saved enough to bring his wife Manju to the United States. His career spanned from engineering to banking to venture capital. Through the ups and downs, he found ways to support the communities in which they lived and worked, lending his time and talents to benefit causes that were dear to his family. In 2010, Jugal and Manju Taneja together founded Belcher Pharmaceuticals, a company headquartered in Florida that focuses on innovating the development of complex genetic medications and antibiotics. Tragedy struck the family in 2015 when Jugal and Manju's son Mandeep was diagnosed with a brain tumor. He passed away in 2018. While Mandeep's life could not be saved, the Tanejas chose to pay it forward and invest their resources in others in need of specialized care. With their contribution to the TGH Foundation, the Taneja family is seeking to elevate impact, broaden research and provide unrivaled care to patients in need. Tampa General, the No. 4 transplant center in America and one of the nation's leading academic health systems, is a natural partner for the Taneja family. "We have lived the American Dream, and now we want others to have that same chance at life," said Jugal Taneja on behalf of himself, Manju and the family. "What better way to pay it forward than to give greater access to world-class care for those who need it most?" Through contributions from the Taneja Family Foundation, Jugal and Manju Taneja are creating a legacy that will have a meaningful impact for generations to come. The Taneja family has long supported innovative efforts by Tampa General Hospital. In 2020, the family's foundation helped Tampa General and the USF Health Morsani College of Medicine establish the Global Emerging Diseases Institute to fight infectious disease like COVID-19 during the pandemic. In 2019, the Taneja Family Foundation contributed to the University of South Florida to strengthen Florida's health care workforce and expand education programs at the College of Pharmacy. "There are no bounds to the generosity of the Taneja family," said Frann Leppla, vice president and chief philanthropy officer of the TGH Foundation. "By naming the new tower in their honor, we're celebrating their passion for innovation, their impact on our community and the exceptional care we offer at Tampa General. I know the Tanejas will serve as a source of hope and inspiration for many who walk through the future doors of the Taneja Surgical, Neuroscience & Transplant Tower." The plans for the Taneja Surgical, Neuroscience & Transplant Tower were first revealed in December before the Tampa City Council, where they received unanimous support from community leaders. The tower will be a 565,000-square-foot building adjacent to Tampa General's main campus on Davis Islands. This pavilion will be a pillar of the Tampa Medical & Research District, which is anchored by Tampa General and USF Health Morsani College of Medicine. The district boasts a variety of health care organizations from academics and clinical care to research and biotechnology, all of which contribute to Tampa's growing health care ecosystem, making the region a global destination for world-class care. Public access around the building will be preserved during construction so that residents and visitors can walk the perimeter of the Tampa General campus on the island and enjoy the beauty of the new space. ABOUT TAMPA GENERAL HOSPITAL Tampa General Hospital, a 981-bed, not-for-profit, academic health system, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2023-24 Best Hospitals, with six specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – in the top 100 nationally in the 2023 America's Best Employers for Women and top 25 in Florida in the 2023 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit of approximately $240.3 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Muma Children's Hospital at TGH, the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes TGH North which is comprised of three hospitals and several outpatient locations in Citrus and Hernando counties, 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Outpatient Center, TGH Virtual Health, and 21 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to . Media Contact: Amanda Bevis (202) 680-9262 cell [email protected] SOURCE Tampa General Hospital

Time to maximum blood concentration (median Tmax) for Anaphylm was 10 minutes with a range of 5 to 20 minutesEarly drug exposure at 10 minutes (partial area under the curve, or pAUC0-10min) for Anaphylm was similar to Auvi-Q® (epinephrine injection) auto-injector 0.3mg and over 4 times higher than epinephrine 0.3mg manual injection, while lower than both EpiPen® (epinephrine) auto-injector 0.3mg and the generic equivalent productPharmacodynamic effects were observed as early as 2 minutes for both Anaphylm and the auto-injectorsTarget range for comparing Anaphylm to approved epinephrine formulations was successfully identified for upcoming pivotal studyCompany continues to expect to submit the protocol for the pivotal study to the FDA in third quarter 2023 WARREN, N.J., May 31, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today released topline clinical data from recent pilot studies that were completed following the End-of-Phase 2 meeting with the FDA. The studies included examining (1) differences in pharmacokinetic (PK) results based on changes to administration instructions, (2) additional repeat dose data on Anaphylm, and (3) the differences between approved auto-injectors. “These data continue to show rapid absorption of epinephrine during the critical first ten minutes following administration of Anaphylm. As our scientific advisors and the FDA have previously stated, anaphylaxis is a serious condition that must be treated quickly. Simply put, every minute matters during a severe allergic reaction,” said Daniel Barber, Chief Executive Officer of Aquestive. “We are pleased to share the latest clinical results from our recent pilot studies confirming the rapidity of epinephrine delivery as we continue the progression of our Anaphylm development program. We expect to submit the protocol for our pivotal PK trial to the FDA during the third quarter 2023 for the Agency’s review and comments.” David Golden, M.D., allergist-immunologist and Associate Professor of Medicine at Johns Hopkins University, stated, “The latest clinical data for Anaphylm demonstrate that the sublingual film continues to deliver the pharmacokinetic and pharmacodynamic effects needed for the most effective treatment of anaphylaxis and to prevent the progression of anaphylactic reactions. We know that early and high levels of epinephrine are critical in the treatment of this life-threatening condition.” Single Administration Pilot PK StudyThe Company recently completed a single dose PK study of Anaphylm 12mg in healthy subjects with revised administration instructions. Anaphylm was applied to the sublingual mucosa and held in place until dissolved with no prescribed salivary hold time. The study resulted in a geometric mean maximum epinephrine concentration (Cmax) of 400pg/mL and a median Tmax of 10 minutes, with a Tmax range of 5 minutes to 20 minutes. This is the fastest median Tmax result to date for the Anaphylm development program. These results demonstrate meaningful improvements from previous administration instructions as the Company continues to optimize film administration. Importantly, Anaphylm’s epinephrine levels were significantly higher than epinephrine levels from the epinephrine 0.3mg manual injection from previous study data, at all timepoints within the first 10 minutes following dosing. Based on interactions with the FDA, the Company continues to believe that similarity to approved auto-injectors during the first 10 minutes following administration is preferred. All but one of the subjects receiving Anaphylm exceeded epinephrine concentrations of 100pg/mL by 15 minutes following dosing. In the same study, multiple pharmacodynamic markers were monitored including systolic blood pressure. A median increase of 22mmHg in systolic blood pressure was observed at 2 minutes following dosing, with a significant change from baseline maintained for 1 hour following dosing. There were no significant adverse events reported during the study and Anaphylm continues to be safe and well-tolerated by subjects. Pilot Crossover PK Study Comparing Different Auto-injectors and Epinephrine 0.3mg Manual Injection, Including a Repeat Dose of AnaphylmGiven that manual epinephrine injections are rarely used outside of a clinical office setting, the Company conducted a pilot PK study to compare three different auto-injectors to the 0.3mg manual injection (Belcher Pharmaceuticals). These auto-injectors were Auvi-Q (epinephrine) 0.3mg auto-injector, EpiPen (epinephrine) 0.3mg auto-injector, and the generic equivalent to EpiPen (Teva Pharmaceutical USA). These data will also be used to help identify the appropriate auto-injector(s) and PK values for comparing Anaphylm’s performance in the upcoming pivotal study. The geometric mean Cmax levels for EpiPen, generic epinephrine auto-injector, and Auvi-Q were 628, 573, and 646pg/mL, respectively, while the median Tmax times were 10, 15, and 30 minutes, respectively. As a comparison in the same study, the geometric mean Cmax level for epinephrine 0.3mg manual injection was 344pg/mL with a median Tmax of 50 minutes. In another arm of this study, the Company also completed a repeat dose study with subjects given a second dose 25 minutes after the initial dose. Importantly, minimal administration instructions were utilized potentially simulating non-compliance to Anaphylm’s expected administration instructions. Consistent with the Company’s previous repeat dose study, Anaphylm produced a median Tmax of 8 minutes when re-administered after 25 minutes. Cmax and overall exposure were comparable to the auto-injectors demonstrating that a second dose of Anaphylm can be used effectively at a later time period, as needed. There were no significant adverse events reported during any arms of this study. A presentation containing additional information about this topline data is available on the Events and Presentations page within the Investor page of the Aquestive website. About AnaphylaxisAnaphylaxis is a serious systemic hypersensitivity reaction that is rapid in onset and potentially fatal. As many as 49 million people in the United States are at chronic risk for anaphylaxis. Lifetime prevalence is at least 5%, or more than 16 million people in the United States. Direct costs of anaphylaxis have been estimated at $1.2 billion per year, with direct expenditures of $294 million for epinephrine, and indirect costs of $609 million. The frequency of hospital admissions for anaphylaxis has increased 500–700% in the last 10–15 years. Of patients who previously experienced anaphylaxis, 52% had never received an epinephrine auto-injector prescription, and 60% did not have an auto-injector currently available. The most common causes of anaphylaxis are foods (such as peanuts), venom from insect stings, and medications. Epinephrine injection is the current standard of treatment intended to reverse the severe manifestation of anaphylaxis, which may include skin rash, throat swelling, respiratory difficulty, gastrointestinal distress, and loss of consciousness. About Anaphylm™ Anaphylm (AQST-109) is a polymer matrix-based epinephrine prodrug candidate product administered as a sublingual film that is applied under the tongue for the rapid delivery of epinephrine. The product is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. About Aquestive TherapeuticsAquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by our licensees in the U.S. and around the world. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a proprietary product pipeline focused on treating diseases of the central nervous system and for the treatment of severe allergic reactions, including anaphylaxis. For more information, visit Aquestive.com and follow us on LinkedIn. Forward-Looking StatementsCertain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by the FDA; the potential benefits Anaphylm could bring to patients, and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on the Company’s business including with respect to its clinical trials including site initiation, enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approval of Anaphylm; pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution; and ongoing availability of an appropriate labor force and skilled professionals. These forward-looking statements are based on the Company’s current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of its product development activities and clinical trials for Anaphylm; risk of the Company’s failure to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm; risk of the Company’s failure to address the concerns identified in the FDA End-of-Phase 2 meeting for Anaphylm, including the risk that the FDA may require additional clinical studies for FDA approval of Anaphylm; risk of delays in or the failure to receive FDA approval of Anaphylm and there can be no assurance that we will be successful in obtaining FDA approval of Anaphylm; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing and revenues from operations, to satisfy all of the Company’s short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund future clinical development activities for Anaphylm; risk of the rate and degree of market acceptance of our product candidate Anaphylm; risk of the success of any competing products; uncertainties related to general economic, political, business, industry, regulatory, financial and market conditions and other unusual items; and other risks and uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in its Annual Report on Form 10-K, in its Quarterly Reports on Form 10-Q, and in its Current Reports on Form 8-K filed with the Securities and Exchange Commission. In addition, topline and interim data from clinical trials may not be indicative of final results, and the results of early clinical trials may not be indicative of the results of later clinical trials. Moreover, nonclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in nonclinical and clinical trials have nonetheless failed to obtain marketing approval of their products. There is a risk that additional nonclinical and/or clinical safety studies will be required by the FDA or that subsequent studies will not match results seen in prior studies. As a result, topline data should be viewed with caution until the final data are available. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this Current Report on Form 8-K, whether as a result of new information, future events or otherwise, except as may be required by applicable law. Readers should not rely upon this information as current or accurate after its publication date. PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners. Investor Inquiries:ICR WestwickeStephanie Carringtonstephanie.carrington@westwicke.com646-277-1282