kldo-8k_20211004.htm
false 0001751299 0001751299 2021-10-04 2021-10-04

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 4, 2021

 

KALEIDO BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-38822

 

47-3048279

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

65 Hayden Avenue Lexington, MA

02421

(Address of principal executive offices)

(Zip Code)

 

Registrant's telephone number, including area code: (617674-9000

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 Par Value

KLDO

NASDAQ Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 


 

 

Item 8.01 Other Events.

 

On October 5, 2021, the Company issued a press release announcing results evaluating Microbiome Metabolic Therapy (MMT™) candidate KB295 in its controlled non-IND clinical study K030 in subjects with mild-to-moderate ulcerative colitis, as well as related preclinical data. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

 

On October 5, 2021, the Company will host a conference call and webcast at 8:00 A.M. to provide an update on the Company’s corporate strategy, discuss the data and clinical development plans for KB295 and discuss the advancement of MMT KB109 in COPD. A copy of the deck attached hereto as Exhibit 99.1 will be utilized in the presentation.  An updated version of the Company’s corporate presentation will also be available in the investor relations section of the Company’s website at http://kaleido.com.

 

After much consideration, on October 4, 2021, the Company notified clinical sites of its decision to terminate its Phase 2 clinical trial of KB195 in subjects with urea cycle disorder with inadequate control on standard of care. The Company’s decision to terminate this clinical trial was based on a number of factors, including the significant impact of the COVID-19 pandemic on clinical trial enrollment, timelines and expenditures.

 

The information in this Form 8-K (including Exhibits 99.1, and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

 

Exhibit No.

 

Description

 

 

99.1

 

Kaleido R&D Day Presentation, dated October 5, 2021, furnished herewith

99.2

 

Press release issued by the Company, dated October 5, 2021, furnished herewith

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 


 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

KALEIDO BIOSCIENCES, INC.

 

 

 

Date: October 5, 2021

By:

 

/s/ Daniel Menichella

 

 

 

Daniel Menichella

 

 

 

Chief Executive Officer, President and Director

 

 

 

Slide 1

Kaleido R&D Day October 5, 2021 Exhibit 99.1 Company Logo©2021KALEIDO®1

Slide 2

Forward-Looking Statements This presentation also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our strategy, business plans and focus, including the therapeutic potential of our Microbiome Metabolic Therapy (MMT) candidates, the timing of initiation, completion and reporting of results of our clinical studies and our strategy, business plans and 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 presentation 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 presentation, including, without limitation, those related to planned clinical and preclinical studies and areas of interest, the preclinical and clinical development and safety profile of our MMT candidates and timelines associated with the programs for such MMT candidates, whether and when, if at all, our MMT candidates will receive approval from the U.S. Food and Drug Administration or other applicable regulatory agencies, if any, competition from other biotechnology companies, and other risks identified in our SEC filings, including the most recently filed 10-K. 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 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. ©2021KALEIDO®2

Slide 3

Today’s Agenda & Speakers Introduction to Kaleido’s MMT Platform Daniel Menichella President and CEO UC Update Preclinical Findings Johan van Hylckama Vlieg, Ph.D. CSO KB295 Clinical Data Mark Wingertzahn, Ph.D. SVP, Head of Development KOL Perspective Bruce Sands, M.D. Icahn School of Medicine at Mount Sinai COPD Update KB109 in COPD Mark Wingertzahn, Ph.D. SVP, Head of Development Partnership with the COPD Foundation Ruth Tal-Singer, Ph.D. President and CSO, COPD Foundation Closing Remarks Daniel Menichella President and CEO Q&A ©2021 KALEIDO® 3

Slide 4

Kaleido Snapshot Creating immunomodulators that target the gut microbiome Loss of immune homeostasis in the gut drives both local and systemic inflammation, which can lead to GI diseases, exacerbated infections and other devastating conditions and diseases Leveraging small molecules to systematically modulate the microbiome that acts as an upstream regulator of key pathways in immune-driven conditions and diseases A clinically translatable discovery platform to rapidly generate and test NCEs and backed by a robust IP portfolio Re-establishing Gut-Immune Homeostasis To Treat Major Conditions and Diseases Drugging the Microbiome not Replacing It To Promote Microbiome-Mediated Immune Modulation Safe, Effective, and Scalable Discovery and Manufacturing Platform ©2021 KALEIDO® 4

Slide 5

The Untapped Therapeutic Potential of the Human Microbiome These metabolites positively impact important biological systems, like the immune system, cell division, and metabolism Only Kaleido can differentially shift the composition and functional output of the entire microbiome in a targeted manner Trillions of gut microbes exert tremendous influence on our body Microbes utilize complex carbohydrates like glycans, and produce bioactive metabolites like short chain fatty acids ©2021 KALEIDO® 5

Slide 6

Kaleido MMTs Modulate Immune Function Through the Microbiome Provides systematic framework for testing and candidate selection Dysbiosis Homeostasis Microbiome Metabolic Therapies Large Set of Synthetic Glycans Target The Microbiome Metabolite Modulation Butyrate Bile acids Propionate Lipids Acetate Nucleotides Ammonia Many more Alter Host Physiology Modulate Immune Function TNFα TLR activation IFNγ IFNβ Antigen presentation Tissue remodeling Chemokine receptors TNFR family activation ©2021 KALEIDO® 6

Slide 7

Kaleido Pipeline *KBXXX indicates a lead candidate has not yet been selected CANDIDATE PROGRAM PRE-CLINICAL FIRST-IN-HUMAN PHASE 2 PHASE 3 COLLABORATORS IMMUNE MEDIATED DISEASES KB295 Ulcerative Colitis KBXXX Psoriasis KBXXX Atopic Immune Disease RESPIRATORY & PATHOGENS KB109 COPD KB174 Pathogens/ HSCT IMMUNO ONCOLOGY KBXXX Solid Tumor Combination janssen COPD FOUNDATION THE UNIVERSITY OF TEXAS MD Anderson Cancer Center THE UNIVERSITY OF TEXAS MD Anderson Cancer Center ©2021 KALEIDO® 7

Slide 8

KB295 Summary 1 2 3 Data for KB295 provide validation of: Data show decreases in biomarkers of disease: Proceeding to Phase 2 – targeting 1H22 Preclinical findings Tolerability Decrease in inflammation Fecal calprotectin decreased by 69%* Fecal lactoferrin decreased by 69%* FimH decreased by 93%* IND/CTA preparation and Phase 2 protocol finalization underway Toxicology and manufacturing in progress *Median Decrease ©2021 KALEIDO® 8

Slide 9

Ulcerative Colitis Preclinical Data Johan van Hylckama Vlieg, Ph.D. Chief Scientific Officer Kaleido TM©2021 KALEIDO® 9

Slide 10

Ulcerative Colitis Vicious Cycle of Inflammation and Gut Microbiome Dysbiosis DYSBIOTIC MICROBIOME INFLAMED HOST EPITHELIUM UC drug development has focused on targeting host immune pathways Microbiome is a treatment target for the underlying cause of UC Anti-inflammatory drugs, immunosuppressors, and biologics all suffer from breakthroughs and significant side effects Possible to treat UC by decreasing pathobionts, increasing tolerogenic commensals, and restoring balanced SCFA production without engraftment issues Microbiome Dysbiosis Caruso et al. (2020) Nature Rev Immunol. 20:411; Miller and Baumler 2021 Annual Rev Immunol, Vol 39:1 ©2021 KALEIDO® 10

Slide 11

KB295 Has Potential to Disrupt the Inflammation Cycle CYTOKINE PRODUCTION (IL-23, TNFα, IL-1β, IL-6, IL-5, IL-17 Impaired epithelial integrity Increased cytokine production leads to inflammation Production of beneficial active metabolites (like SCFA) rescue gut homeostasis Tregs are stimulated to further dampen immune activation KB295 opportunity Suppresses pro-inflammatory pathobionts Increases production of key metabolites like SCFAs Restores immuno-homeostasis and appropriate Treg function INTESTINAL EPITHELIAL CELLS ↑ Restored epithelial integrity Caruso et al. (2020) Nature Rev Immunol. 20:411 Rooks and Garret. (2016) Nature Rev Immunol. 16:341. ©2021 KALEIDO® 11

Slide 12

KB295 Identified by Kaleido Human-Centric Microbiome Platform Readouts Metabolite production including SCFAs (metabolomics) Microbiome taxonomic changes (16S and WGS) Functional pathway and effector molecule analysis Assessment to identify optimal synthetic glycan candidate Biological Activity and Primary Pharmacology Assays ex vivo Microbiome incubated Human Microbiome Healthy donor and patient samples, including during clinical interventionSample sanaerobically with MMTsCulture System ©2021 KALEIDO® 12

Slide 13

Community-Wide Changes and Desired Modulation of Multiple Remission-Associated Taxa were Observed with KB295 Enterobacteriaceae Escherichia Shigella Salmonella Citrobacter Parabacteroides Eisenbergiella Fusicatenibacter sp Lachnospiraceae sp. Eubacterium sp Pathobiont Depletion Commensal Enrichment Bacterial genera *Differential abundance using 10 Human Microbiomes ©2021 KALEIDO® 13

Slide 14

Eran Blacher et al. J . Immunol  2017 KB295 Increased Key SCFAs in ex-vivo Model - Documented Immunomodulators ©2021 KALEIDO® 14

Slide 15

Summary of Key Preclinical Findings 1 2 3 UC is a vicious cycle of inflammation and microbiome dysbiosis KB295 demonstrated microbiome-wide changes, including key taxa in ulcerative colitis KB295 increased key SCFAs to reduce inflammation ©2021 KALEIDO® 15

Slide 16

Ulcerative Colitis KB295 Data Mark Wingertzahn, Ph.D. Head of Development KaleidoTM©2021 KALEIDO® 16

Slide 17

Opportunity to Address Gut Microbiome Dysbiosis in UC Mild-to-Moderate UC Moderate-to-Severe UC Late-Line Monotherapy ~1.5M patients4 ~900K patients5 Up to 85% have mild-moderate disease in a given year5,6 1. EvaluatePharma 2020 Worldwide Sales by Indication – Ulcerative Colitis. Accessed June 2021. 2. Xavier, R.J et al. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007. 3. ICER: Targeted Immune Modulators for Ulcerative Colitis: Effectiveness and Value. Oct 16 2020. https://icer.org/wp-content/uploads/2020/08/ICER_UC_Final_Evidence_Report_101620.pdf 4. Burisch, J et al. The Burden of Inflammatory Bowel Disease in Europe, Journal of Crohn’s and Colitis. 2013. 5. Crohn’s and Colitis Foundation of America. The Facts about IBD. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf 6. Singh S et al. AGA Technical Review on the Management of Mild to Moderate Colitis. Gastroenterology 2019. ©2021 KALEIDO® 17

Slide 18

KB295 Summary 1 2 3 Data for KB295 provide validation of: Data show decreases in biomarkers of disease: Proceeding to Phase 2 – targeting 1H22 Preclinical findings Tolerability Decrease in inflammation Fecal calprotectin decreased by 69%* Fecal lactoferrin decreased by 69%* FimH decreased by 93%* IND/CTA preparation and Phase 2 protocol finalization underway Toxicology and manufacturing in progress *Median Decrease ©2021 KALEIDO® 18

Slide 19

K030 Trial Design Open-Label, 8-week intake with 2-month extension in adults with mild-to-moderate UC to assess safety and tolerability of KB295 V1 V2 V3 V4 V6 D-14 D 1 D 30 D 14 D 44 D 56 D 84 V7 V5 D 140 V8 28 Days ≤14 Days Screening KB295 Intake (56 Days) 7 7 42 Days 80g (40g BID) 20g 40g Extension Follow-up Primary: Safety and tolerability Key Secondary: Evaluate effects of KB295 on gut microbiome composition Evaluate changes in SCCAI OBJECTIVES 18-75 years of age with confirmed diagnosis of UC (>6 months) Mild-to-moderate UC symptoms with 3-7 bowel movements per day within 1 week of screening with at least a 4-week history of UC symptomatology prior to Screening visit Subjects were to have remained on a stable medication regimen for UC for 2 weeks prior to randomization KEY ELIGIBILITY CRITERIA ©2021 KALEIDO® 19

Slide 20

Subject Disposition and Analysis Sets Enrolled (n=12) Intake Period 1: 20g (n=12) Intake Period 2: 40g (n=12) Intake Period 3: 80g (n=10) Discontinued (n=2) Subject Due to AE (1) Subject Due to Family Reasons Data Sets Analyzed Subject Demographics: 2/3 male, 1/3 female, with mean duration of UC 7.3 years Safety Set: All subjects enrolled (n=12) Evaluable Sets: - Subjects with evaluable FCP (n=11; complete data set) - Subjects with evaluable lactoferrin (n=6; pending analysis of additional 5 subjects) - Subjects with evaluable FimH (n=5, pending analysis of 5 additional subjects) Responder Set: Subjects with FCP reduction >50% (n=8) Completer Set: Subjects with complete intake and 28-day follow-up (n=6); 4 subjects still in washout ©2021 KALEIDO® 20

Slide 21

KB295 Was Well Tolerated No subjects reported product-emergent Serious Adverse Events 2 subjects discontinued study 1 subject due to UC exacerbation 1 subject due to family reasons 4 subjects had dose reduction 3 completed study Most frequently occurring Adverse Events were expected and consistent with the underlying disease or study product characteristics Changes in bowel habits, flatulence, headache ©2021 KALEIDO® 21

Slide 22

SCCAI (Simple Clinical Colitis Activity Index) SCCAI provides relevant information on tolerability in subjects with ongoing gut inflammation Units Symptom Score Bowel frequency day 13 0 46 1 79 2 9 3 Bowel frequency night 13 1 4 6 2 urgency of defecation hurry immediately incontinence 1 2 3 blood in stool trace occasionally frank usually frank 1 2 3 general well being very well slightly below par poor very poor terrible 0 1 2 3 4 ©2021 KALEIDO® 22

Slide 23

Fecal Calprotectin (FCP) Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. NICE guideline 2013.http://www.nice.org.uk/guidance/dg11; Menees B, Powell C, Kurlander J, et al. A Meta-Analysis of the Utility of C-Reactive Protein, Erythrocyte Sedimentation Rate, Fecal Calprotectin, and Fecal Lactoferrin to Exclude Inflammatory Bowel Disease in Adults with IBS. Am J Gastroenterol 2015; 110:444-54 Calprotectin accounts for about 60% of neutrophil cytosolic protein and is released into the feces, making it a biomarker of intestinal inflammation FCP < 200 μg/g > 200 μg/g Low inflammatory activity (e.g., IBS, or IBD in remission) Active organic inflammatory disease (e.g., IBD) za https://www.alpco.com/wp-content/uploads/2016/06/calprotectin-release-from-GI-tract.jpg. FCP is an established and valuable biomarker to monitor GI inflammation associated with UC calprotectin travels through GI tract calprotectin release from the GI tract©2021 KALEIDO® 23

Slide 24

KB295 Decreased Fecal Calprotectin in UC Subjects with a High Response Fecal calprotectin (FCP) is a biomarker of inflammation trend to reduction after study intake period 8 out of 11 Median Fecal Calprotectin Levels (Evaluable; n=11) P=0.067 -69% Median Reduction Fecal Calprotectin (ug/g) Median Fecal Calprotectin Levels (Responders*; n=8) P<0.008 -74% Median Reduction Fecal Calprotectin (ug/g) * Responder defined as FCP reduction >50% FCP decreased by 69% in evaluable population FCP decreased by at least 60% in 8 out of 11 participants and nearly 75% overall among responders bar graph©2021 KALEIDO® 24

Slide 25

KB295 Decreased Fecal Calprotectin (FCP) in Subjects with UC and Reduction Persisted During 28-Day Follow-Up FCP is a biomarker of inflammation trend to reduction after study intake period and 28-day follow-up Median Fecal Calprotectin Levels (Completed; n=6) P < 0.035 P < 0.035 Fecal Calprotectin (ug/g) 28-day follow-up is ongoing with four additional subjects to be observed ©2021 KALEIDO® 25

Slide 26

KB295 Resulted in 93% Median Decrease in FimH Depleted gene counts by metagenomic sequencing of stool samples before/after KB295 intervention FimH gene counts (n=5) FimH activates TLR4 signaling which induces pro-inflammatory cytokines FimH inhibition is an active target for IBD drug discovery KB295 is unique in targeting the gut microbiome to reduce FimH abundance Adapted from Sivignon et al. 2017. Expert Opinion on Therapeutic Targets 21:837-847 Adherent-Invasive Escherichia coli α Chevalier et al. Microbiome (2021) 9:176 Adherent Invasive Escherichia coli graphic©2021 KALEIDO® 26

Slide 27

Lactoferrin, an Inflammation Biomarker, Was Reduced Fecal Lactoferrin biomarkers of inflammation are reduced after study intake Fecal lactoferrin (n=6) Lactoferrin is produced by activated neutrophils associated with UC Lactoferrin decreased by mean value of 69.2% across participants Decreased by at least 50% in 5 out of 6 participants graph©2021 KALEIDO® 27

Slide 28

K030 Results Bridge ex vivo Findings to UC Patients Pathobiont Enterobacteriaceae Commensal Parabacteroides KB295 enriched commensal Parabacteroides and depleted pathobionts Enterobacteriaceae Median relative abundance of Parabacteroides increased after intake in 4 out of 5 subjects Median relative abundance of Enterobacteriaceae decreased after intake in all 5 subjects ©2021 KALEIDO® 28

Slide 29

K030 Data Encourages Move to Phase 2 Clinical Study 1 2 3 K030 data Preclinical data Proceeding to Phase 2 – targeting 1H22 KB295 was well tolerated in subjects Decrease in biomarkers including FimH, FCP, and Lactoferrin KB295 selectively enriched commensal microbiota Decreases abundance of pro-inflammatory pathobionts Supports hypothesis that KB295 enriches for taxa producing specific SCFA Production of key SCFA and other bioactive metabolites results in reduction of UC-driven inflammation ©2021 KALEIDO® 29

Slide 30

Bruce Sands, M.D. Dr. Burrill B. Crohn Professor of Medicine Icahn School of Medicine at Mount Sinai Chief of the Division of Gastroenterology, Mount Sinai Former Medical Co-Director of the Crohn’s & Colitis Center Massachusetts General Hospital KB295 – A KOL’s Perspective ©2021 KALEIDO® 30

Slide 31

COPD KB109 Program Update Mark Wingertzahn, Ph.D. Head of Development Kaleido ©2021 KALEIDO®  31

Slide 32

Opportunity in Chronic Obstructive Pulmonary Disease COPD Current options offer limited benefit on inflammation No treatment targets microbiome Few oral options available have safety and tolerability issues for patients The Opportunity A maintenance treatment to reduce risk of acute exacerbations in COPD patients. Progressive, long-term disease caused by inflammation to lung airways 3rd leading cause of death worldwide ~250M suffer from COPD worldwide, exacerbations frequently results in hospitalization and increased mortality risk Current SoC include LABA/LAMA, ICS, and PDE-4 inhibitor © 2021 KALEIDO® 32

Slide 33

KB109 May Affect COPD Inflammation via Gut-Lung Axis KB109 has the potential to modulate the gut and immune system to lessen exacerbations and mortality risk KB109 COVID-19 trial demonstrated activity against the pathologies associated with respiratory viral infections by modulating the gut microbiome and host immune system Clinical data demonstrated improved recovery from viral infections for patients with comorbidities Phase 2a study planned to begin in 1Q22 in collaboration with the COPD Foundation Cyprian F, Sohail MU, Abdelhafez I, et al. SARS-CoV-2 and immune-microbiome interactions: Lessons from respiratory viral infections. Int J Infect Dis. 2021;105:540-550. doi:10.1016/j.ijid.2021.02.071 GI Tract Commensal Microbes SCFAs and Other Metabolites Acute Exacerbation Lungs Gut Inflammation © 2021 KALEIDO® 33

Slide 34

KB109 Enriches Specific Microbes Beneficial to Respiratory Viral Infection Clearance KB109 consistently depleted Enterobacteriaceae and Enterococcaceae pathobionts, and enriched commensal Parabacteroides across compositionally diverse fecal communities MMT selectivity takes advantage of carbohydrate-active enzyme disparity between commensals and pathobionts Enterococcus (e.g. Gram-positive VRE pathogen) Parabacteroides (target commensal) Genomics heatmap shows: E. faecium has a narrow set of GHs compared with Parabacteroides Parabacteroides has many GHs that E. faecium lacks Genomes Glycosyl Hydrolase (GH) Families © 2021 KALEIDO® 34

Slide 35

Proportion of Patients with Resolution Kaplan- Meier Curve IFN-γ and TNF-⍺ data from K031 subjects as K032 samples remain to be analyzed. Includes subjects with screening samples and at least one of D14 or D35 samples available. * p-value<0.05, Wilcoxon rank sum test on differences between cohorts Within-Subject Changes From Screening KB109 in COVID – Well Tolerated and Reduced Inflammation Given virus-agnostic properties of KB109 coupled with clinical and biomarker signals, KB109 will be advanced into an IND program exploring effects in COPD patients at risk for exacerbations Elevated TNFα leads to the development of inflammatory responses in asthma and COPD IFNγ levels are increased in COPD patients and further elevated during viral exacerbations © 2021 KALEIDO® 35

Slide 36

New Collaboration with the COPD Foundation Collaboration Partnership with leading experts in the Foundation and its COPD360Net® Joint clinical development support No financial obligations Advantages Leverage expertise to support trial design Provide access to top clinical sites Support trial enrollment through the Foundation’s network Collaboration to explore KB109’s potential to correct dysbiosis and prevent significant disease burden related to respiratory infections in people with COPD © 2021 KALEIDO® 36

Slide 37

Ruth Tal-Singer, Ph.D. President and Chief Scientific Officer COPD Foundation Former VP of Medical Innovation, GSK Value Evidence and Outcomes, at GSK Former Industry Chair of COPD Biomarker Qualification Consortium Partnership with the COPD Foundation © 2021 KALEIDO® 37

Slide 38

Kaleido Pipeline *KBXXX indicates a lead candidate has not yet been selected © 2021 KALEIDO® 38

Slide 39

Q&A © 2021 KALEIDO® 39

Slide 40

Kaleido in Brief An Exceptional Team Leading A Novel Approach to Targeting the Microbiome Daniel Menichella President and Chief Executive Officer Former CEO,CureVac AG Jerald Korn, J.D. Chief Operating Officer, Tesaro Johan Van Hylckama Vliag, Ph.D. Chief Scientifin Officer Former VP for Microviome & Human Health Innovation, Chr. Hansen Kimberly Hocknell SVP, Techincal Operations Former Director of GMP Facilities and systems, LFB Mark Wingertzahn, Ph.D. SVP, Head of Development Former Head of Clinical Development, GSK William Duke Chief Financial Officer Former CFO, Pulmatrix Commanding the Microbiome Small molecule approach,using synthetic MMT glycans to modulate the immune system via the gut Advancing Comprehensive Pipeline Scalable discovery and manufacturing platform supporting a robust pipeline of MMts to address Several indications including UC, COPD and psoriasis Poised For Growth New Phase 2 clinical trials in UC and COPD planned for 1h22, and continuing to grow strategic partnerships with notable instititions, companies and foundations © 2021 KALEIDO®40

kldo-ex992_114.htm

 

 

Exhibit 99.2

Kaleido Biosciences Announces New Clinical and Preclinical Data Supporting Advancement of KB295 to a Phase 2 Clinical Study in Mild-to-Moderate Ulcerative Colitis

KB295 reached its primary endpoint demonstrating favorable safety and tolerability profile

 

Reduction in key ulcerative colitis biomarkers correlated with disease activity and inflammation - fecal calprotectin, fecal lactoferrin, and FimH - observed at end of study

Virtual R&D Presentation, highlighting the ulcerative colitis and chronic obstructive pulmonary disease programs, to be held today at 8:00 a.m. ET

LEXINGTON, Mass., October 5, 2021 (GLOBE NEWSWIRE) -- 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 topline data from the non-IND/CTA clinical study evaluating KB295, a novel Microbiome Metabolic Therapy (MMT™), in mild-to-moderate ulcerative colitis (UC). The primary objective of safety and tolerability was achieved as KB295 was well tolerated and no safety concerns were observed. In the study, subjects receiving KB295 experienced a reduction in three biomarkers, fecal calprotectin (FCP), fecal lactoferrin, and FimH that are known to be associated with UC disease activity. These results are complemented by preclinical studies conducted with Kaleido’s unique translational ex vivo platform using human donor-derived microbiome communities.

Highlights from the Topline KB295 Dataset for Mild-to-Moderate in UC

Clinical Data Observed at the End of an Eight-Week Intake Period

 

Achieved primary objective of safety and tolerability with KB295 being well tolerated across subjects (n=12) with no product-emergent serious adverse events reported

 

Observed a meaningful reduction in three key biomarkers: FCP, fecal lactoferrin, and FimH, known to be strongly correlated with inflammation and disease activity:

 

o

Median FCP levels decreased by 69% in subjects with evaluable FCP (n=11), and 74% in subjects identified as responders (8 of 11); responders were defined as those subjects with FCP reduction greater than 50%

 


 

 

 

o

Fecal lactoferrin decreased by a median of 69% in subjects with currently available samples (n=6), including five out of six subjects with a reduction of at least 50%

 

o

FimH decreased by a median of 93% in subjects evaluated with currently available samples (n=5)

 

o

Further fecal lactoferrin and FimH analysis is expected as additional subject samples become available

Pre-Clinical Data from Ex-Vivo Studies

 

Ex-vivo data demonstrated community-wide changes and desired modulation of multiple remission-associated taxa

 

Total short chain fatty acid (SCFA) production increased in ex-vivo studies to levels that are pharmacologically relevant to UC

Anticipated Milestones

 

Observations from both preclinical and clinical data support the Company’s plans to initiate a phase 2 study, under an Investigational New Drug (IND) application and Clinical Trial Application (CTA), with KB295 for mild-to-moderate UC patients in the first half of 2022

 

Manufacturing and toxicity work has commenced to support future studies under CTA and IND applications

“The data we shared today highlight the potential of our MMT platform and its ability to work with a person’s microbiome as opposed to replacing it,” said Dan Menichella, President and Chief Executive Officer of Kaleido. “Ulcerative colitis is largely driven by gut microbiome dysbiosis, and KB295 modulates microbiome composition and metabolic output, thereby driving immune activity both locally and systemically to restore gut immune homeostasis in those with UC. We are excited about the data package and look forward to advancing KB295 in a phase 2 ulcerative colitis study under an IND.”

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 study was designed to evaluate the safety and tolerability of KB295 with other exploratory assessments including changes in microbiome composition, SCFA levels in stool and biomarkers of inflammation (fecal calprotectin and lactoferrin and FimH). The trial was originally designed to enroll 30 subjects at a single site in Ireland, however, due to COVID-19 related enrollment impacts, 12 subjects were enrolled, primarily from Ireland. 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 the currently available samples from the first six subjects that entered the study.

UC is an inflammatory bowel disease that can cause debilitating symptoms, including abdominal pain, bowel urgency and diarrhea. Evidence shows that a feature of UC is alteration of the gut microbiome, including an increase in inflammatory bacteria and decrease in commensal microbe diversity and short chain fatty acids, which interfere with the normal immune response. Major scientific advances have demonstrated that the microbiome is a legitimate intervention target in the management of this disease.

Conference Call and Webcast Information
Kaleido management will host a conference call with accompanying slides today at 8:00 a.m. ET. Analysts and investors are invited to participate in the conference call by dialing (833) 423-0448 from the U.S. and Canada or (956) 394-3566 internationally and using the conference ID 5754389. The live webcast can be accessed on the investor page of Kaleido’s website at investors.kaleido.com. A replay of the webcast will be available on Kaleido’s website approximately two hours after the completion of the event and will be archived for at least 30 days.

The agenda will feature an update on the Company’s corporate strategy, data from the non-IND study evaluating KB295 in mild-to-moderate UC as well as supportive preclinical data, and data supporting the advancement of KB109 into COPD. The program will also feature presentations by Bruce Sands, M.D., Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Ruth Tal-Singer, Ph.D., President and Chief Scientific Officer of the COPD Foundation.

About Ulcerative Colitis
Ulcerative colitis (“UC”) is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. Those ulcers produce pus and mucus, cause abdominal pain and result in the need to frequently empty the colon. Although UC is the result of several factors that are not yet well understood, abnormal immune response, genetics, microbiome, and environmental factors all contribute to the disease. UC can occur at any age, though most people are diagnosed prior to their mid-30s. In the United States, approximately one million people are affected with UC, and reported symptoms include loose stool and urgent bowel movements, bloody stool, abdominal cramps and pain, and persistent diarrhea accompanied by abdominal pain and blood in the stool.

 


 

 

There is no known curative treatment for UC. Treatment is multifaceted and includes the use of medication, alterations in diet and nutrition, and sometimes surgical procedures to repair or remove affected portions of a patient’s gastrointestinal tract. Several types of medication can be used to suppress UC symptoms (induce remission) and decrease the frequency of symptom flares (maintain remission) including anti-inflammatory drugs, immunosuppressants, and biologics. UC is often a progressive disease meaning that over time patients respond less to a specific medication and need to progress to other treatments. Current therapies, such as anti-inflammatory drugs, immunosuppressants, and biologics can also be associated with significant side effects. There is a clinical need for new therapeutic options with durable efficacy and an improved safety profile.

 

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 patients. 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 Biosciences
Kaleido 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 clinical study plans and timelines, regulatory plans, and the 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 Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
william.duke@kaleido.com

Investors and Media
Kotaro Yoshida
Argot Partners
212-600-1902
kaleido@argotpartners.com