TFF Pharmaceuticals Announces Positive Preclinical Data from Bivalent Universal Influenza Vaccine Candidates Manufactured by TFF Following Intranasal Immunization

TFF-dry powder HA antigen vaccine candidates induced neutralizing antibody titers in ferrets against H1 and H3 influenza strains

Ongoing funded work to assess additional influenza strains

FORT WORTH, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) - TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the "Company" or "TFF Pharmaceuticals"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announces positive preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses. The data were produced in collaboration with Dr. Ted Ross, Global Director of Vaccine Development at Cleveland Clinic.

"These preliminary data suggest that the intranasal administration of the TFF-dry powder hemagglutinin (HA) antigen vaccine candidates is highly immunogenic and produces protective antibody titers in ferrets," said Dr. Harlan Weisman, TFF Pharmaceuticals Chief Executive Officer. "These data support continued development of a shelf-stable mucosal universal influenza vaccine that could be effective regardless of which strain emerges in any year and that could be self-administered."

The experiments conducted by Dr. Ross demonstrated that TFF-dry powder HA antigen vaccine candidates induce neutralizing antibody titers in ferrets against H1 and H3 influenza strains. No response was observed in animals vaccinated with mock vaccine.

The ferret model is the gold standard to study host immune responses and evaluate influenza vaccine and antiviral therapies due to similarities with humans. Pre-immune female ferrets received TFF-dry powder HA antigen vaccine for intranasal (IN) delivery with various mucosal adjuvants that can elicit both cellular and antibody immune responses. Mock vaccine (adjuvant only) was used as a control. Serum was collected to assess neutralizing antibody titers against influenza A viruses for H1N1 and H3N2 subtypes.

Ongoing studies will assess neutralizing antibody titers against a panel of 13 influenza A viruses isolated between 2006-2018 for H1N1 and 2012-2019 for H3N2 subtypes. After viral challenge, ferrets will be monitored daily for clinical signs and symptoms and antibody titers. These positive results will allow TFF to select an adjuvant for advanced development of a universal influenza vaccine candidate that will be delivered as a dry powder designed to protect against greater than 75% of the circulating influenza strains.

This work is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under a previously awarded Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine using the Company's Thin Film Freezing technology.

The goal of this program is to advance a vaccine candidate to IND and early clinical trials. If successful, a TFF-formulated universal flu vaccine has the potential to generate several billion dollars in annual sales, presenting a highly attractive out-licensing opportunity for the company.

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.

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 potential development of a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses, using its TFF technology. 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's collaboration with Cleveland Clinic may not lead to the successful development of a dry powder multivalent universal influenza vaccine, (ii) the risk that the Company may not be able to obtain additional working capital with which to continue its current operations and clinical trials as and when needed, (iii) success in early phases of pre-clinical and clinical 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, and (vi) 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 August 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.

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