TFF Pharmaceuticals and Felix Biotechnology Sign Letter of Intent for a Collaboration, Development and License Agreement

Felix Biotechnology would obtain worldwide license for Thin Film Freezing technology to develop a novel, bacteriophage-based biotherapeutic

Proposed terms provide for upfront payments, clinical development milestone and commercial milestone payments to TFF Pharmaceuticals of up to $281 million, as well as negotiated royalty payments

AUSTIN, Texas–(BUSINESS WIRE)–TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, and Felix Biotechnology, Inc., a clinical stage, biotherapeutic-based antibiotic development company, today jointly announce that both companies have entered into a letter of intent (LOI) which reflects the parties’ non-binding agreement in principle to negotiate and enter into a Collaboration, Development and License Agreement (CDLA).

Under this proposed CDLA agreement, Felix Biotechnology would obtain a worldwide license to TFF Pharmaceuticals’ Thin Film Freezing technology to develop and manufacture dry powder formulations of a novel, bacteriophage-based biotherapeutics for inhalation delivery directly to the lungs of patients. Under the terms of the proposed CDLA and in exchange for the license to the TFF technology, Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix biotherapeutics. A definitive CDLA is subject to the mutual agreement of the parties and a number of conditions, including Felix Biotechnology’s successful completion of a Series A financing.

“We are very excited to be pursuing an agreement with Felix Biotechnology, a company on the leading edge of developing bacteriophage therapies that initially are targeting bacterial lung infections,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “We believe the reformulation of these unique, complex biologics using our TFF technology would represent a first-of-its-kind breakthrough and could provide a more effective and targeted delivery mechanism to the deep lung of patients. We look forward to working towards a final agreement and seeing this breakthrough technology advance into the clinic and beyond.”

“Our goal at Felix is not only to develop but also to deploy innovative solutions to tackle the growing and unmanaged challenge of antibiotic resistant bacterial infections. We currently deliver our generalized phage therapy directly to the lung via nebulization, and have done so successfully in humans. Our lead asset, targeting Pseudomonas infections in the lungs of CF patients is currently being evaluated in a double-blind, placebo-controlled trial at Yale in 36 patients,” said Rob McBride, CEO of Felix Biotechnology. “We are excited to continue developing cutting edge and effective phage delivery solutions to our patients and our collaboration with TFF represents an important next step for us on this path.”

“Bacteriophages, which are bacterial viruses that infect specific strains of a single bacteria species, are highly relevant as therapeutic alternatives to antibiotics because of the prevalence of multidrug resistance to antibiotics,” said Robert O. (Read more…) Williams III, Division Head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and an inventor of TFF Pharmaceutical’s Thin Film Freezing technology.

“The challenge, historically, of delivering bacteriophages is that their formulations have not been well optimized, limiting their shelf-life and subsequent potency. Many of these formulations also require cold-chain storage,” continued Williams. “We have demonstrated that Thin Film Freezing can convert liquid bacteriophage into a dry powder that can be stored at typical room temperatures. This dry powder form of the bacteriophage can then be administered by intranasal/inhalation delivery to the lungs, or by injection after reconstitution at the point-of-use.”

In May of 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Felix Biotechnology supplied various phage product materials to TFF Pharmaceuticals for compatibility and feasibility testing. TFF Pharmaceuticals was successful in formulating dry powder formulations of the Felix phage products, which exhibited superior aerosol properties for lung delivery. Based on this successful formulation work and confirmatory in-vitro testing, which included titer testing and neutralization testing, both parties agreed to begin negotiating a licensing arrangement.

About Felix Biotechnology, Inc.

Felix Biotechnology is a clinical stage, biotherapeutic-based antibiotic development company with technology from Yale University and UC Berkeley, focused on accelerating the development and deployment of non-traditional biotherapeutic-based antibiotics targeting urgent microbial challenges in patients who can’t wait. Their engineering and discovery platforms generate therapies that overcome key limitations of traditional phage therapy approaches (bacterial resistance and phage specificity). This allows for the deployment of generalized phage therapy that kill specific bacterial infections while preserving healthy microbiome function. For more information, please visit our website at https://www.felixbt.com, or follow us on Twitter at https://twitter.com/felixbiotech.

About TFF Pharmaceuticals’ Thin Film Freezing technology platform

TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US 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 nonbinding letter of intent with Felix Biotechnology, the proposed negotiation and execution of a definitive Collaboration, Development and License Agreement (CDLA), the potential success of the proposed collaboration between TFF and Felix Biotechnology, TFF’s potential receipt of milestone and sales-based payments from Felix Biotechnology, the benefits of the Company’s TFF platform and its dry powder formulations of niclosamide and other materials, and the Company’s plans to add to its existing pipeline of product candidates and license its technology to third-parties. 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 TFF Pharmaceuticals may not be able to conclude a CDLA with Felix Biotechnology; (ii) if the parties can conclude a CDLA, the risk that results obtained in dry powder formulation and in vitro testing of the Felix phage products may not be indicative of results obtained in future preclinical or clinical trials; (iii) the risk that TFF Pharmaceuticals’ dry powder formulation of the Felix phage products may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iv) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (v) the risk that TFF Pharmaceuticals and Felix Biotechnology may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of the Felix phage products, , (vi) the risk that few, or none, of the milestone or sales and sales-based payments from Felix Biotechnology will be satisfied and TFF will receive little, or none, of such milestone and sales-based payments, (vii) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (viii) 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 (ix those other risks disclosed in the section “Risk Factors” included in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.

Contacts

TFF Pharmaceuticals:
Glenn Mattes

President and CEO

TFF Pharmaceuticals, Inc.

[email protected]
737-802-1973

Kirk Coleman

Chief Financial Officer

TFF Pharmaceuticals, Inc.

[email protected]
817-989-6358

Investor Relations and Media Contact:
Paul Sagan

LaVoieHealthScience

[email protected]
617-953-4779

Felix Biotechnology:
Robert McBride

CEO

Felix Biotechnology

[email protected]