Anthrax

HALIFAX, Nova Scotia, March 12, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced a publication in the journal Frontiers in Bacteriology on the prevention of tularemia. Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers published a perspective manuscript “Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement”. “Appili has been developing ATI-1701, a biodefense vaccine, to protect warfighters from tularemia.” said Carl Gelhaus, Ph.D., Director of Non-Clinical Research of Appili Therapeutics. “With the help of our Ukrainian colleagues and U.S. Army physicians, we have assessed the potential risk for tularemia outbreaks in Ukraine, by reviewing the literature of previous wartime outbreaks in Eastern Europe. Many of the conditions for tularemia outbreaks now exist in Ukraine, and their warfighters need protection. We suspected that rodent populations would explode and carry tularemia into war-affected areas. Even as we were preparing the manuscript, “Mouse fever”, an infection of unknown etiology, was reported in news outlets, underscoring the urgency of making sure Ukrainians are protected from the risk of many infectious diseases, including tularemia. The acceptance and publication of this perspective article recognizes that the epidemiological, medical, military, and scientific tularemia experts should prepare to prevent and respond to tularemia outbreaks in wartime Ukraine.” The perspective manuscript explores the current war in Ukraine and the increased risk for outbreaks of tularemia. Several wartime tularemia outbreaks have been documented, as far back as the Siege of Stalingrad in WWII. Furthermore, F. tularensis was weaponized and stockpiled as an offensive agent, and experts consider tularemia to have a high potential use in a biological weapons attack. Russia administers its own tularemia vaccine, but that vaccine is not available in Ukraine. Furthermore, the legacy Russian vaccine is unlikely to meet the rigorous FDA and EMEA standards for safety and efficacy. ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with F. tularensis. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets, strengthening ATI-1701’s position as a potentially valuable vaccine that is urgently needed on the market. Appili is working hard to develop our ATI-1701 vaccine that could potentially help protect the Ukrainian people living in what United Nations Secretary-General Antionio Guterres described as “an epicenter of unbearable heartache and pain”. Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili adds “At Appili, we hope that our products can alleviate that kind of human suffering”. About ATI-1701 ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets. Appili secured a US$14M funding commitment for ATI-1701 from the United States Air Force Academy (“USAFA”), who is working in partnership with the Defense Threat Reduction Agency. These funds along with other potential funding sources, are anticipated to continue to advance the ATI-1701 program toward an IND submission to the FDA in 2025. About Appili Therapeutics Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit . Forward looking statements This news release contains “forward-looking statements”, including with respect to any potential outbreak of tularemia in the Ukraine, the funding commitment from USAFA, further anticipated milestones and the timing thereof and the Company’s development plans with respect to ATI-1701. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that ATI-1701 may never become an approved vaccine for the prevention or treatment of tularemia, and the other risks listed in the annual information form of the Company dated June 22, 2023, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at ). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. Media Contact: Jenna McNeil, Communications Manager Appili Therapeutics E: JMcNeil@AppiliTherapeutics.com Investor Relations Contact: Don Cilla, President and CEO Appili Therapeutics E: Info@AppiliTherapeutics.com

Oral NUZYRA Tablets Procured by BARDA were Manufactured in the United States as Part of the Company’s Onshoring InitiativeBOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, today announced positive top-line efficacy data for NUZYRA® (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death. In the study, a 100% survival rate was observed in omadacycline-treated NHPs at the end of the treatment period (30 days) and a survival rate over 90% was observed over the entirety of the 60-day observation period. All NHPs treated with placebo died due to anthrax within 10 days of exposure to B. anthracis. Top-line data from this study triggered an additional procurement of NUZYRA under the company’s Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts. “Positive top-line data from this study represents continued progress in our anthrax development program and further validates NUZYRA’s potential to effectively treat pulmonary anthrax,” said Randy Brenner, Paratek’s chief development and regulatory officer. “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil. We are grateful for BARDA’s continued commitment in our partnership to address national security threats and public health emergencies involving anthrax, and believe that these efforts further strengthen our nation’s commitment to address potential bioterrorism threats at a time when antibiotic resistance is a global concern.” A meeting with FDA will be planned for the middle of 2024 to align on the final studies required to support the sNDA submission for both anthrax treatment and PEP indications. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for Seysara® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and X.  About NUZYRA®NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. MEDIA CONTACT:Christine FanelleScient PRChristine@ScientPR.com215-595-5211

Emergent has several contracts with US government agencies for vaccines and therapeutics for various infectious diseases. Image Credit: Africa Studio / Shutterstock. The US Department of Defense (DoD) has awarded a procurement contract worth up to $235.8m to Emergent BioSolutions for an indefinite-delivery and indefinite-quantity (IDIQ) supply of BioThrax. As per the DoD contract, Emergent will supply BioThrax to all US military members who have a high risk of exposure to anthrax. The company will receive at least $20.1m for the initial five years ending on 30 September 2028. The contract allows for a five-year extension, with Emergent receiving at least $20m for each year, as per an 11 January press release. BioThrax is a pre-exposure adsorbed form of an anthrax vaccine. In December 2008, the US Food and Drug Administration (FDA) approved the five-dose schedule and intramuscular route of administration for BioThrax. Anthrax is an infectious disease caused by Bacillus anthracis , which occurs naturally in soil. The disease commonly affects domestic and wild animals. Humans can contract anthrax if they come in contact with infected animals or contaminated animal products. Emergent has several contracts with US government agencies for vaccines and therapeutics for various infectious diseases. In November 2023, the US Biomedical Advanced Research and Development Authority (BARDA) awarded Emergent a $75m contract for the supply of its post-exposure prophylactic anthrax vaccine, Cyfendus. In July 2023, Emergent signed a ten-year contract with BARDA for the advanced development, manufacturing scale-up, and procurement of Ebanga (ansuvimab-zykl). The monoclonal antibody was approved for treating Ebola virus disease by the FDA in 2020. The ten-year BARDA contract is divided into two option periods – the advanced development option valued at $121m, and the procurement option valued at $583m over five years. In May 2023, Emergent sold its travel vaccine portfolio , which included marketed vaccines for typhoid fever and cholera, and the Phase III Chikungunya vaccine candidate to Bavarian Nordic . In August 2023, Bavarian reported positive topline data from the Phase III study of its virus-like particle (VLP)-based chikungunya virus vaccine CHIKV VLP (PXVX0317) in adults and adolescents. The vaccine induced neutralising antibodies in 98% of the participants in the active group.