Vast Therapeutics (formerly Novoclem) Announces Results Showing Eradication of all In Vitro Tested Multi-Drug Resistant Bacteria and a 99% Reduction of Nontuberculous Mycobacteria (NTM) in Animal Model.

DURHAM, N.C., May 22, 2018 /PRNewswire/ -- Vast Therapeutics, Inc., formerly Novoclem Therapeutics, Inc. (the Company), a preclinical stage pharmaceutical company focused on delivering the power of nitric oxide (NO) in a synthetically derived powder-based form, announced today that the Company's first controlled NO-release powder based drug candidate, BIOC51, has proven to be effective in substantially reducing the bacterial load of nontuberculous mycobacteria (NTM) in the lungs of mice in a study carried out in partnership with Colorado State University. 

Dr. Mark Schoenfisch, President and CSO of Vast Therapeutics is credited with pioneering this macromolecular NO-release technology. He stated, "We are excited to have BIOC51 perform at the levels proved in our study.  Achieving a 99% reduction in bacterial count and exceeding the performance of standard of care antibiotics validates our in vitro testing results.  Furthermore, the study confirms that our drug was delivered safely without observable adverse side effects." 

In vitro, BIOC51 has eradicated every bacteria pathogen that we have tested to date, including over 19 families of both Gram-positive and Gram-negative bacteria, 24 distinct strains of Pseudomonas aeruginosa, and 35 antibiotic-resistant strains deemed superbugs by the Center of Disease Control and World Health Organization because of their severe threat to public health.  The Company credits its proprietary water-soluble NO-releasing biopolymer capable of delivering NO safely and at bactericidal levels for extended periods.

Dr. Schoenfisch continued, "Our timed released drug candidate is more effective than conventional antibiotics and gas-based NO therapies, both of which have efficacy and ease-of-use limitations. In particular, today's drugs are susceptible to antibiotic resistance because they generally function via a single mode of action that bacteria mutate to overcome. We believe our water-soluble powder-based drug candidate avoids this mode of resistance due to the innate characteristics of NO itself and its multiple modes of action."

CEO Neal Hunter said, "We are thrilled to have taken the next step in confirming the power of our technology.  The coupling of in vivo results with apparently being the first in the world to achieve this breadth of in vitro eradication exceeds our expectations. It heightens our responsibility to move our druggable nitric oxide into the clinic. Ultimately, we will likely choose to selectively partner this technology to address many potential applications for other patients in need." Mr. Hunter continued, "We look forward to making a difference in reducing the bacterial burden in patients with lung infections, particularly for those in critical need, like patients with cystic fibrosis."

Reflecting the broad-spectrum activity of its nitric oxide-based anti-infective technology, the Company also announced a name change to Vast Therapeutics, Inc.  Mr. Hunter commented, "Our original name was related to a specific goal in cystic fibrosis.  While we remain dedicated to CF as our initial indication, our results point toward a much broader capability in the respiratory and general anti-infective spaces."

The Company is based in the Research Triangle Park area of North Carolina and runs a leveraged drug development model using a small team with high quality service contractors and suppliers.

For more information about Vast Therapeutics see www.vasttherapeutics.com.

About Mark Schoenfisch, PhD

Mark Schoenfisch, PhD, is both Professor of Chemistry at the University of North Carolina at Chapel Hill and President & Chief Scientific Officer at Vast Therapeutics. He is the inventor of multiple macromolecular nitric oxide-release systems and an active entrepreneur, guiding these technologies from research discoveries in his academic lab to manufacturing and clinical trials. With 20 years of experience working with nitric oxide chemistry, he has published more than 100 peer-reviewed articles on the synthesis, characterization, and application of nitric oxide-modified biomaterials. Known for his broad expertise spanning chemistry, pharmaceutical sciences, and medicine, Dr. Schoenfisch regularly serves on scientific review panels for the National Institutes of Health. He co-founded Novan, Inc. (NOVN) and helped successfully guide the company to its September 2016 IPO as a member of its Board of Directors.

About Neal Hunter

Neal Hunter, Chairman of the Board and CEO of Vast Therapeutics, has a 25-year track record of successfully raising capital for and building technology companies in both the public and private markets beginning as a Co-founder of Cree, Inc. (CREE). Mr. Hunter served multiple roles at Cree, including as the public company CEO and Chairman from 1994 to 2001 and then Chairman until 2005. He was also instrumental in the creation and start-up of LED Lighting Fixtures, Inc. which he co-founded in 2005 to accelerate the use of LEDs in general illumination applications and sold in 2008 for over $100M. In total, Mr. Hunter has been either co-founder, founder, co-founding investor or founding investor in over ten significant start-up ventures in the areas of semiconductor materials and devices, aesthetic materials, software, commercial and residential real estate, LED lighting systems and life sciences. Mr. Hunter's proven expertise in technology transfer, from inception of innovations to the creation of market-changing products, has led to the transition to his new role as Managing Director of KnowBio, LLC, an RTP based incubator for platform based medical technology and biotechnology companies. Vast Therapeutics, Inc. and PhotonMD, Inc. are two companies that have emerged from the KNOW Bio platform.

About BIOC51
BIOC51 is a novel polyglucosamine biopolymer covalently modified with N?diazeniumdiolate nitric oxide (NO) donors to facilitate spontaneous (without the need of enzymes) and controlled NO release. The level of NO release from BIOC51 has proved sufficient for eradicating planktonic and biofilm-based bacteria and can be delivered to the lungs as a dry powder or solution (e.g., nebulization).

About Vast Therapeutics, Inc.

Vast Therapeutics, a subsidiary of KNOW Bio, LLC, formerly known as Novoclem Therapeutics, Inc., is an innovative, preclinical-stage pharmaceutical company focused on helping people who suffer from severe respiratory diseases to breath better and live life more fully. The Company is initially focused on developing a nitric oxide-based drug to treat cystic fibrosis patients battling chronic Pseudomonas aeruginosa infections. The Company anticipates submitting an lnvestigational New Drug application and initiating First-in-Human clinical trials in 2019. More info available at www.vasttherapeutics.com.

Forward-looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important  factors that could cause actual results to differ materially include: risks associated with the drug development process; reliance on key personnel; the early stage of our business and our need to raise additional capital to complete development of our drug candidates; competition; and other risks described in other Company press releases and presentations. KNOW Bio and VAST Therapeutics assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Media Contact:
Niki Franklin
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Darlene Dendy, Director of Administration
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Investor Contact:
John Oakley, Chief Financial Officer
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SOURCE Vast Therapeutics, Inc.