kldo-8k_20210114.htm
false 0001751299 0001751299 2021-01-14 2021-01-14

 

 

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): January 14, 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 7.01 Regulation FD Disclosure.

The Company is furnishing a corporate presentation, attached as Exhibit 99.1 to this Current Report on Form 8-K, which the Company intends to use from time to time in meetings with investors and others. The corporate presentation will also be available in the investor relations section of the Company’s website at http://kaleido.com.

Item 8.01. Other Events

On January 14, 2021, the Company issued a press release announcing interim results from 176 patients enrolled in its controlled non-IND clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109 when added to Supportive Self-Care for outpatients with mild-to-moderate COVID-19 disease. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

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

 

Corporate presentation of the Company, dated January 2021, furnished herewith

99.2

 

Press Release issued by the Company, dated January 14, 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: January 14, 2021

By:

 

/s/ Daniel Menichella

 

 

 

Daniel Menichella

 

 

 

Chief Executive Officer, President and Director

 

 

 

Slide 1

Leading a Novel Approach to Targeting the Microbiome NASDAQ: KLDO January 2021 Exhibit 99.1

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, the fact that interim results from KB013 may not accurately predict final results from KB013 and that such final results may not support continued development of KB109, 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.

Slide 3

Kaleido Biosciences in Brief Unique approach using synthetic glycans as modulators of the microbiome Act by targeting the resident microbiome as opposed to adding/subtracting micro-organisms Ability to induce large compound-specific microbial shifts to more favorable composition and metabolic output for therapeutic benefit Library of 1500+ diverse synthetic glycans designated Microbiome Metabolic Therapies (MMTsTM) Opportunities across broad range of therapeutic areas Small molecule modality is substantially de-risking microbiome therapeutics Increasing understanding of SAR allows targeted compound optimization and library expansion MMTs are related to a class of compounds “generally recognized as safe” (GRAS), allowing rapid progression from early discovery to clinical testing MMTs are NCE’s offering IP protection and development paths as small molecule drugs Ease and scalability of manufacture de-risking CMC Have rapidly generated multiple clinical and preclinical portfolio assets Clinical programs include mild-to-moderate COVID-19, Ulcerative Colitis, and Urea Cycle Disorders Additional preclinical programs include Immuno-Oncology and Cardiometabolic disease Strong potential for future expansion

Slide 4

The Kaleido Leadership Team

Slide 5

Synthetic glycan chemistry enables an extensive array of Microbiome Metabolic Therapies (MMTs) Target enzymes across taxa rather than only in specific species, driving ecosystem and metabolic output changes Related to a class of compounds that is Generally Recognized as Safe (GRAS), enabling rapid advancement into human clinical studies Extensive IP; NCEs when developed as drugs Orally administered with limited systemic exposure MICROBIOME METABOLIC THERAPIES (MMT™): Structurally diverse glycan ensembles that act as targeted and versatile modulators of microbiome community composition and metabolic output Chain Length Mono- Oligo- Poly- saccharide Our library of 1,500+ MMTs: + Multiple bond types + Branching Starting Monomers Almost unlimited diversity of chemical structures in this class

Slide 6

MMTs can act via multiple specific mechanisms in indications with strong clinical rationale for a microbiome-based approach The unique abilities of MMTs to… …make them potent polypharmacological therapeutic candidates Urea cycle disorders Hepatic encephalopathy MDR pathogen infection HSCT Immuno-oncology Ulcerative colitis COVID-19 Metabolic health Ammonia* (↓ NH3) Pathogen growth reduction/prevention Immune potentiation Immune homeostasis (↑ short chain fatty acids (SCFA); ↓ pro-inflammatory taxa) Anti-inflammation & metabolite reduction (↓ trimethylamine (TMA)) Indication areas MoA(s) *demonstrated in human subject study with 15N tracer

Slide 7

COVID-19 (KB109)

Slide 8

Glycans change Microbiome and SCFA Profiles, which are associated with Reduced Severity of Respiratory Viral Infections High butyrate associated with lower clinical respiratory tract infection, including coronavirus Haak et al, 2018 Blood. Trompette et al, 2018 Immunity Glycans protect against lethal Influenza infection Glycans protect against RSV infection SCFA (acetate) reduce impact of antibiotic treatment Antunes et al, 2019 Nature Communications.

Slide 9

KB109 enriches SCFA and microbiome profiles associated with improved viral infection outcomes KB109 consistently depleted pathogens (Enterobacteriaceae and Enterococcaceae) and enriched commensal Parabacteroides across compositionally diverse fecal communities KB109 consistently increased the production of the SCFAs acetate, propionate, and butyrate in 8 fecal communities with diverse taxonomic composition Parabacteroides to the phylogenetic class Bacteroidia for which multiple taxa have been demonstrated to confer IL1-ß-mediated resistance to viral infections (Stefan et al., 2020, Cell 183, 1–13) KB109 was identified using a high-throughput screening cascade involving both in vitro and ex vivo methodologies. https://kaleido.com/wp-content/uploads/2020/10/KLDO-IDWeek-Poster-2020.pdf

Slide 10

A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients with Mild-to-Moderate COVID-19

Slide 11

*Non-IND Clinical Study conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of human effect. KB109 in COVID-19 Interim Analysis (IA) High propionate High acetate Multi-center, open label, controlled clinical study* Mild-to-moderate COVID-19 Two weeks administration Endpoints: Safety and tolerability, Time to resolution of symptoms, Biomarkers of the inflammatory response 350 outpatients Supportive self-care (control) IA N=87 Supportive self-care + KB109 IA N=89 Up to three weeks follow up Baseline characteristics were well matched between the groups, except for a higher proportion of patients reporting comorbidities at baseline, 45% KB109 + SSC vs 36% SSC alone.

Slide 12

Results: Favorable Safety and Tolerability Profile Largest study of MMTs conducted so far, leading to most comprehensive safety data set to date Well tolerated with no treatment-related SAEs Hospitalizations: 2 in KB109+SSC vs 3 in SSC alone arm One death due to COVID-19 after withdrawal from study in SSC alone arm More GI-related AEs reported in KB109+SSC arm (18% vs 3%) Similar to that seen in previous studies of MMTs All were mild/moderate None led to study discontinuation There were more GI symptoms reported at baseline in KB109 arm than SSC alone arm (47% vs 33%)

Slide 13

Natural History of Mild to Moderate COVID-19: Time to Resolution of Symptoms

Slide 14

13 Overall Symptoms 8 Cardinal Symptoms Natural History of COVID-19 Infection: SSC Alone Arms Comparing patients with and without comorbidities shows extended duration of symptoms, especially in patients with at least one comorbidity Proportion of Patients with Resolution Proportion of Patients with Resolution Median time to resolution of symptoms: No comorbidity = 14 days Comorbidity = 27 days Median time to resolution of symptoms: No comorbidity = 12 days Comorbidity = 27 days

Slide 15

Time to Resolution of Overall 13 COVID-19 Related Symptoms Cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness

Slide 16

Kaplan-Meier Curve Intake and Follow-up Period Time to Resolution of Overall 13 Symptoms Primary Analysis

Slide 17

13 Overall Symptoms Full Analysis Set Median time to resolution of symptoms: KB109 + SSC = 18 days SSC alone = 27 days

Slide 18

Time to Resolution of 8 Cardinal COVID-19 Symptoms Cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat

Slide 19

Kaplan-Meier curve Intake and Follow-up Period Time to Resolution of 8 Cardinal Symptoms Full analysis set

Slide 20

8 Cardinal Symptoms Full Analysis Set Median time to resolution of symptoms: KB109 + SSC= 15 days SSC alone = 27 days

Slide 21

13 Overall Symptoms 8 Cardinal Symptoms Natural History of COVID-19 Infection: SSC Alone Arms Comparing patients with and without comorbidities shows extended duration of symptoms, especially in patients with at least one comorbidity Proportion of Patients with Resolution Median time to resolution of symptoms: No comorbidity = 14 days Comorbidity = 27 days Median time to resolution of symptoms: No comorbidity = 12 days Comorbidity = 27 days Proportion of Patients with Resolution

Slide 22

Full analysis will further elucidate the role KB109 may play in allowing patients with comorbidities to recover more quickly Potential Clinical Implications 13 Overall Symptoms 8 Cardinal Symptoms Median time to resolution of symptoms: SSC No comorbidity = 14 days SSC + Comorbidity = 27 days KB109 + SSC + Comorbidity = 18 days Median time to resolution of symptoms: SSC No comorbidity = 12 days SSC + Comorbidity = 27 days KB109 + SSC + Comorbidity = 15 days Proportion of Patients with Resolution Proportion of Patients with Resolution

Slide 23

Preliminary Results from Interim Analysis Requires confirmation from full dataset Study is now fully enrolled with topline data expected for the full study in Q1 Favorable safety and tolerability profile with no new safety signals in the largest study of MMT No differences seen between KB109+SSC and SSC alone arms in patients who did not report a comorbidity at baseline First study to show protracted time to resolution of symptoms in mild to moderate COVID-19, particularly in patients with comorbidities Promising data showing reduction in time to resolution of symptoms in patients who report at least one comorbidity at baseline

Slide 24

Inflammatory Bowel Disease (KB295)

Slide 25

↓SCFA producing taxa and ↑ pathobionts are a key signature of UC-dysbiosis Ulcerative Colitis Linked to Microbiome Dysbiosis Microbiome Restoration Leads to Clinical Remission Clinical efficacy by targeting microbiome via FMT is Superior to Standard of Care p = 0.02 p = 0.02 p = 0.03 p = 0.51 Clinical Remission Paramsothy et al. (2017) Costello et al. (2017) Moayyedi et al. (2015) Rossen et al. (2015) SOC: 5-ASAs ~ 25% Chronic UC linked to microbiome dysbiosis: dependent on interaction of multiple components Sood et al. (2019) p = 0.03 Restoration of Function via FMT Leads to Clinical Remission Luminal microbiome antigens ↑permeability to luminal pathobiont antigens Increase inflammation and mucosal damage Genetic susceptibility Disease risk alleles (e.g. Nod2) Impair pathobiont clearance; Environmental triggers Diet, hormone use, stress, NSAIDS can upset balance between commensals and pathobionts Immune response Microbial- derived metabolites (e.g. SCFA) regulate immune tone

Slide 26

KB295 Rationale and Study in Ulcerative Colitis Increases SCFA production (ex vivo) Ongoing Clinical Study (Single Arm) Evaluate safety and tolerability Exploratory: Simple Clinical Colitis Activity Index (SCCAI) composite score, changes in microbiome taxa, SCFA levels in stool and biomarkers of inflammation (fecal calprotectin) Different Fecal Communities High propionate KB295 in mild-moderate UC ~30 patients 56-day administration Up to 2 weeks follow up Remote monitoring Reduces Enterobacteriaceae abundance (ex vivo) Relative abundance of Enterobacteriaceae

Slide 27

Key Expected Upcoming Milestones – by mid-2021 2020 COVID-19 (K031) study – Q1’2021 COVID-19 (K032) study – Q1’2021 Ulcerative Colitis (K030) study – mid-2021 Clinical Results* *Non-IND clinical studies

Slide 28

Pre-Clinical Programs Intellectual Property Financials

Slide 29

Advancing Our MMTs for Lead Identification Poised to Deliver Multiple Clinical-Ready Programs in 2021 Jeffrey Gordon, MD Glycan chemistry & utilization Gnotobiotic preclinical models combined with computational methods to further identify molecular pathways of how MMTs can modify functional configuration of the gut microbiome and its metabolic outputs

Slide 30

Robust Global IP Portfolio 14 U.S. and European Patents Issued and 150+ Pending Applications Worldwide 12 U.S. Patents + 2 EPO Patents: Glycan pharmaceutical compositions (U.S. and Europe) Methods to treat cancer (U.S.) Methods to treat pathogen infection (U.S.) Methods to treat obesity (U.S.) Methods to treat dysbiosis (U.S.) Methods to reduce ammonia (U.S.) Methods to treat diarrhea (U.S.) Catalyst compositions (U.S. and Europe) 150+ Non-Provisional Applications Pending, Worldwide in 20+ Regions/Countries Glycan compositions Methods of making glycans Methods to modulate short chain fatty acids Continued IP Expansion by Filing Patent Applications Directed to Pharmaceutical Compositions, Methods of Treatment and Methods of Manufacture

Slide 31

Corporate Information John Newman, Ph.D. Canaccord Genuity Gbola Amusa, M.D., CFA Chardan Terence Flynn, Ph.D. Goldman Sachs Gobind Singh JMP Securities LLC Jessica Fye J.P. Morgan Matthew Harrison Morgan Stanley Current Analyst Coverage: Cash and cash equivalents of $54.5 million* $50 million of availability under ATM program Long-term debt outstanding of $22.5 million* Funded into 2H 2021 – beyond expected COVID-19 and IBD study readouts 35,982,105 shares outstanding** * as of September 30, 2020 ** as of October 30, 2020 ~83 employees

Slide 32

Kaleido in Brief Highly differentiated approach Unique within the microbiome space Highly unique as a therapeutic modality overall Broad set of portfolio assets Platform makes use of compounds generally recognized as safe (GRAS) Ability to execute on near-term milestones Promising safety profile benefits Significantly improves processes for efficiency of clinical and regulatory path Clinical and preclinical programs in diverse areas Potential for future expansion from MMT approach Validation from clinical data in HE program Well-funded through two clinical data readouts in the next year

Slide 33

Appendix: COVID-19 Interim Analysis (KB109)

Slide 34

COVID-19 Study Interim Analysis: Baseline Characteristics (1)

Slide 35

COVID-19 Study Interim Analysis: Baseline Characteristics (2)

Slide 36

COVID-19 Study Interim Analysis: Most Commonly Reported Adverse Events

Slide 37

COVID-19 Study Interim Analysis: Most Common Symptoms at Baseline

Slide 38

COVID-19 Study Interim Analysis: Comorbidities Reported at Baseline

kldo-ex992_131.htm

 

 

Exhibit 99.2

 

Kaleido Biosciences Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-to-Moderate COVID-19

 

Preliminary analysis (n=176) demonstrates favorable safety and tolerability; data provide a strong signal of clinical benefit for subjects reporting one or more comorbidities

 

Topline data from full study population of 350 patients and results of second study of KB109 are expected in the first quarter of 2021

 

 

LEXINGTON, Mass., Jan. 14, 2021 – Kaleido Biosciences, Inc. (Nasdaq: KLDO), today announced positive interim results from the K031 non-IND controlled clinical study evaluating outpatients with mild to moderate COVID-19 disease. Patients in this non-IND clinical study were randomized within 48 hours of testing positive for COVID-19 to either receive Supportive Self Care (SSC) or SSC plus Microbiome Metabolic Therapy (MMT™) candidate KB109 for two weeks and then followed for an additional three weeks. The planned interim analysis comprised approximately half of the total study population (n=176) and showed that KB109 was well tolerated, with a safety profile consistent with previous studies of MMT candidates and no unexpected treatment-related adverse events. For subjects reporting one or more comorbidities, the median time to resolution of the thirteen overall COVID-19 related symptoms was 18 days with KB109 plus SSC and 27 days with SSC alone.

 

“This interim analysis, from the largest study conducted to date with an MMT candidate, reinforces the safety and tolerability previously observed with MMTs and provides a strong signal of clinical benefit for KB109,” commented Dan Menichella, President and Chief Executive Officer of Kaleido. “The study reveals that many patients with mild-to-moderate disease, and particularly those patients with a comorbidity, experience symptoms for a period of weeks. This study shows the significant burden experienced by these patients and we look forward to reporting the full dataset later this quarter.”

 

“These exciting and relevant data are in line with what we are seeing in the COVID-19 literature and suggests that the microbiome plays a role in this disease,” said John P. Haran, M.D., Ph.D., associate professor of emergency medicine, microbiology & physiological systems and clinical director of the UMass Center for Microbiome Research at the University of Massachusetts Medical School. “There is increasing evidence supporting the biological plausibility that microbiome restoration has a significant impact on different diseases and seeing an influence in COVID-19 patients with comorbidities aligns with this emerging science.”

 

Summary of Interim Results

KB109 demonstrated a favorable safety and tolerability profile with no unexpected treatment-related adverse events or discontinuations related to treatment.

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Approximately 40 percent of the patients reported at least one comorbidity at baseline.

The presence of comorbidity lengthened the time to resolution of symptoms, even in mild to moderate COVID-19 disease. In the SSC alone arm, median time to resolution of the thirteen overall COVID-19 related symptoms in patients with no comobitities was 14 days as compared with 27 days in patients with at least one comorbidity.

No difference in median time to resolution of symptoms was observed with KB109 plus SSC for the overall population, although small differences between the arms were observed during the follow-up period.

Median time to resolution of the thirteen overall COVID-19 related symptoms for patients with one or more comorbidity at baseline was 18 days for the KB109 plus SSC group as compared with 27 days with SSC alone.

Kaleido also evaluated eight cardinal COVID-19 related symptoms as defined by the Centers for Disease Control and Prevention, which showed median time to resolution of symptoms among patients with one or more comorbidity at baseline was 15 days for the KB109 plus SSC group as compared with 27 days with SSC alone.

 

The K031 study of 350 subjects is fully enrolled with results expected in the first quarter of 2021. Topline data from a smaller 50 subject study of KB109 is also expected in the first quarter of 2021.

About the Potential Role of the Microbiome in COVID-19

COVID-19 infection has been associated with activation of an inappropriate inflammatory cascade, which in some patients can cause an abnormally aggressive immune response that can lead to pneumonia and respiratory failure. Metabolites such as short chain fatty acids (SCFAs) produced by the microbiome through utilization of glycans are modulators of the immune response and therefore could play a role in limiting this inflammatory cascade.

In preclinical models, increased SFCAs and/or SFCA-producing taxa, have been shown to influence immune pathways, mitigate immune pathology, and improve survival and morbidity associated with severe respiratory viral infections.1,2 Commensal microbiota composition critically regulates the generation of virus-specific CD4 and CD8 T cells and antibody responses following respiratory influenza virus infection.3

In-human data also support the role of SCFAs in reducing the impact of viral infections. In patients undergoing hematopoietic stem cell transplants who have contracted respiratory viral infections, including coronavirus, the presence of SCFA-producing taxa has been associated with a significantly reduced risk of progression to lower respiratory tract infections, which can have substantial morbidity in this patient population.4 KB109 is Generally Recognized as Safe (GRAS) and was selected for evaluation in these COVID-19 clinical studies based on its demonstrated ability to increase production of SCFAs as well as to promote commensal bacteria and reduce pathogenic bacteria ex vivo.

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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 rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.  

About Kaleido Biosciences

Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health. 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 the therapeutic potential of our MMT candidates, the timing of initiation, completion and reporting of results of 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 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 fact that interim results from KB013 may not accurately predict final

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results from KB013 and that such final results may not support continued development of KB109, the clinical development and safety profile of our MMT candidates and their therapeutic potential, whether and when, if at all, our MMT candidates will receive approval from the U.S. Food and Drug Administration 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-Q, 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.

___________________________________________________________________________

1.

Antunes, K.H., et al. Microbiota-derived acetate protects against respiratory syncytial virus infection through a GPR43-type 1 interferon response. Nat Commun. 2019, 10, 3273.

2.

Trompette, A., et al. Dietary Fiber Confers Protection against Flu by Shaping Ly6c- Patrolling Monocyte Hematopoiesis and CD8+ T Cell Metabolism. Immunity. 2018, May 15;48(5):992-1005.e8.

3.

Ichinohe, T., et. al.  Microbiota regulates immune defense against respiratory tract influenza A virus infection. Proceedings of the National Academy of Sciences. Mar 2011, 108 (13) 5354-5359.

4.

Haak, B.W., et al. Impact of gut colonization with butyrate-producing microbiota on respiratory viral infection following allo-HCT. Blood. 2018. 131, 2978-2986.

 

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Contacts

Kaleido Biosciences

William Duke, Jr.
Chief Financial Officer

617-890-5772

william.duke@kaleido.com

 

Investors

Mike Biega

Solebury Trout

617-221-9660

mbiega@soleburytrout.com

 

Media

Rich Allan
Solebury Trout

646-378-2958

rallan@soleburytrout.com  

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