KLDO Kaleido Biosciences Inc

Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, today announced that the topline data obtained with KB295, a novel Microbiome Metabolic Therapy (MMT™), in mild-to-moderate ulcerative colitis (UC), will be presented virtually at the 2022 Crohn’s and Colitis Congress.

“The data show the direct effect of administering KB295 includes enriching diverse, beneficial commensal microbiota and restoring balanced SCFA production, while depleting harmful pathobionts in order to suppress inflammation and restore gut homeostasis,” said Dan Menichella, President and Chief Executive Officer of Kaleido. “This proof-of-principle clinical study also continues to clearly demonstrate that KB295 leads to decreases in important disease-associated biomarkers of intestinal inflammation. Kaleido has also been analyzing data from the full dataset, including the follow-up period, and looks forward to presenting that data at an upcoming medical meeting.”

KB295 was evaluated in an exploratory, open-label, single arm non-IND clinical study in subjects with mild-to-moderate UC. Subjects received KB295 for eight weeks, titrated up to 40g twice daily and then entered a two-week follow-up period. The primary objective of the study was to evaluate the safety and tolerability of KB295. Secondary objectives of the study were to evaluate changes in disease-associated biomarkers of intestinal inflammation including FCP, lactoferrin, and FimH, and change in composition of the gut microbiome. Primary pharmacology data were generated with Kaleido’s unique translational ex vivo platform using human donor-derived microbiome communities as well as microbiome and biomarker read-outs on samples from subjects that entered the study.

The Company will present the poster “The Synthetic Glycan KB295 Optimizes Microbiome Composition and Function in Ulcerative Colitis: Results from a Proof of Principle Human Study” on January 21. The poster will be made accessible for attendees and will also be made available on the Events and Presentations page of the Company’s website at https://investors.kaleido.com/events-presentations.

About Microbiome Metabolic Therapies (MMT™) Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’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, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates into clinical studies in healthy subjects and subjects. These human clinical studies may be conducted under regulations supporting research with food, evaluating safety and tolerability and impact on the microbiome. For MMT candidates that are developed as therapeutics, the Company currently conducts and will conduct clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., often in Phase 2 or later development.

About Kaleido BiosciencesKaleido Biosciences is a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis. The Company has built a proprietary product platform to enable the rapid and cost-efficient discovery and development of novel Microbiome Metabolic Therapies (MMT™). MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes. Kaleido is advancing a broad pipeline of MMT candidates with the potential to address a variety of diseases and conditions with significant unmet patient needs. To learn more, visit https://kaleido.com/.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Company’s business focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth of our pipeline of product candidates, the strength of our proprietary product platform, the efficiency of our discovery and development approach, the clinical development and safety profile of our MMT candidates and their therapeutic potential, whether and when, if at all, regulatory agencies will approve our IND application or clinical trial applications for KB295 or KB109, whether and when, if at all, our MMT candidates will receive approval from the U.S. Food and Drug Administration or other regulatory agencies and for which, if any, indications, competition from other biotechnology companies, and other risks identified in our SEC filings, including our most recent Form 10-K, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contacts:

Kaleido BiosciencesWilliam Duke, Jr.Chief Financial Officer617-890-5772william.duke@kaleido.com

Investors and MediaKotaro YoshidaArgot Partners212-600-1902kaleido@argotpartners.com