On August 1, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the potential of the microbiome organ to treat disease and improve human health, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Kaleido Biosciences, AUG 1, 2019, View Source [SID1234540067]).
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"In the second quarter we made important progress with our pipeline and now have five clinical studies underway with our Microbiome Metabolic Therapy (MMT) candidates," said Alison Lawton, President and Chief Executive Officer of Kaleido. "We initiated Kaleido’s first Phase 2 clinical trial with the advancement of KB195 for urea cycle disorders (UCD) under an IND. For our KB174 program, we completed enrollment in a dosing study in healthy subjects and continued to progress our clinical study in patients with cirrhosis. We also advanced a third MMT, KB109, into a clinical study in patients colonized with multi-drug resistant pathogens. We look forward to a number of key milestones expected during the second half of the year, including data from three clinical studies in two different patient populations."
Recent Highlights
Received approval from regulatory authorities in the United Kingdom and Belgium for the Company’s clinical trial application (CTA) for its Phase 2 clinical trial of KB195 in UCD
Initiated the Phase 2 clinical trial evaluating KB195 in patients with UCD
Initiated a non-IND clinical study of KB109 in patients colonized with multi-drug resistant pathogens
Expanded Kaleido’s Scientific Advisory Board to include six leading experts in microbiology, chemistry and microbiome research across a variety of therapeutic areas:
Laurie H. Glimcher, M.D., President and CEO, Dana-Farber Cancer Institute, Director, Dana-Farber/Harvard Cancer Center, and Richard and Susan Smith Professor of Medicine, Harvard Medical School;
Robert Jenq, M.D., Assistant Professor in the Department of Genomic Medicine, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center;
C. Ronald Kahn, M.D., Head of the Section on Integrative Physiology and Metabolism, Past President & CEO, Joslin Diabetes Center, and Mary K. Iacocca Professor of Medicine, Harvard Medical School;
Laura L. Kiessling, Ph.D., Novartis Professor of Chemistry, Massachusetts Institute of Technology;
Max Nieuwdorp, M.D., Professor of Internal Medicine and endocrinologist, University of Amsterdam’s Faculty of Medicine (AMC-UvA); and
Peter J. Turnbaugh, Ph.D., Associate Professor, Department of Microbiology and Immunology, G.W. Hooper Research Foundation, and Investigator, Chan Zuckerberg Biohub, University of California, San Francisco.
Appointed Jerald Korn as General Counsel and Corporate Secretary
Members of Kaleido’s leadership team were featured speakers at the 4th Microbiome Movement – Drug Development Summit held June 26-28, 2019 in Boston
Anticipated Key Milestones
Safety and tolerability data from a non-IND clinical study of KB195 in patients with UCD accepted for presentation at the annual Society for the Study of Inborn Errors of Metabolism Symposium, Sept 3-6, 2019
Data from a non-IND clinical study of KB174 in healthy subjects to explore dosing expected in Q4 2019
Data from a non-IND clinical study of KB174 in patients with well-compensated cirrhosis expected in Q4 2019
Second Quarter 2019 Financial Results
For the second quarter ended June 30, 2019, Kaleido reported a net loss of approximately $24.6 million, or $0.83 per share, basic and diluted, compared to a net loss for the quarter ended June 30, 2018 of $12.3 million, or $2.57 per share, basic and diluted.
Total operating expenses for the quarter ended June 30, 2019 were $25.0 million compared to $12.4 million for the quarter ended June 30, 2018.
Research and development expenses for the quarter ended June 30, 2019 were $18.8 million, compared to $9.1 million for the quarter ended June 30, 2018. The increase in expense for the quarter was driven by an increase in external manufacturing and research costs to support the production of study material used in preclinical studies, human clinical studies, and clinical trials as well as clinical research organizations costs associated with MMT candidates for 2019.
General and administrative expenses were $6.2 million for the quarter ended June 30, 2019, compared to $3.2 million for the quarter ended June 30, 2018. The increase in general and administrative expenses compared to the same quarter last year was driven by increased professional services and employee-related costs as the Company continues to expand its infrastructure to support its growth.
Total operating expenses for the quarter ended June 30, 2019 include non-cash stock-based compensation expense of $2.4 million compared to $0.5 million of non-cash stock-based compensation expense for the quarter ended June 30, 2018.
Cash and cash equivalents were $100.0 million as of June 30, 2019.
About Microbiome Metabolic Therapies (MMT)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted glycans that are orally administered, have limited systemic exposure, and are selectively-metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples from healthy subjects and patients in an ex vivo setting, followed by advancing MMT candidates rapidly into non-Investigational New Drug (non-IND) clinical studies in healthy subjects and patients. These non-IND human clinical studies are conducted under regulations supporting research with food, measuring safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an IND or regulatory equivalent outside the U.S., and in Phase 2 or later development.