KLDO Kaleido Biosciences Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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KB109 (K031)
Mild-to-moderate COVID-19
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Phase 1
Phase 1
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KB109 (K032)
Mild-to-Moderate COVID-19
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Phase 1
Phase 1
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KB295
Ulcerative colitis (UC)
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Phase 2
Phase 2
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KB195 (UNLOCKED)
Urea cycle disorder (UCD)
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Phase 2
Phase 2
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Latest News
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LEXINGTON, Mass., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), today announced that Dan Menichella, Chief Executive Officer, will participate in a fireside chat at the virtual Piper Sandler 32nd Annual Healthcare Conference taking place November 30-December 3, 2020.
The presentation will be available for registered attendees via the Piper Sandler conference site during the conference until December 3, 2020, and will also be available November 30, 2020, on the Investors & Media section of the Kaleido website at https://investors.kaleido.com/events-presentations. An archived replay will be accessible for 90 days following the event.
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 potential upcoming corporate presentations. 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, 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.
Contacts
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
[email protected]Investors
Mike Biega
Solebury Trout
617-221-9660
[email protected]Media
Rich Allan
Solebury Trout
646-378-2958
[email protected]
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- Topline Data for KB109 for the Treatment of Mild-to-Moderate COVID-19 Expected in the First Quarter of 2021 -
LEXINGTON, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO) today announced financial results for the third quarter 2020 and provided a corporate update.
"Kaleido continues to build momentum with the development of interventions based on our Microbiome Metabolic Therapy, or MMT™, platform and evaluate the highly diverse applications of this approach," commented Dan Menichella, President and Chief Executive Officer of Kaleido. "In the past quarter, we initiated a study of KB295 in patients with ulcerative colitis, representing the fourth application of an MMT approach to enter the clinic. We continue to advance our pipeline and expect to nominate a candidate with potential for the treatment of cardiometabolic and liver diseases in 2021."
Company Highlights- The Company continues to enroll subjects in two non-IND clinical studies that are part of the ongoing COVID-19 development program evaluating KB109 when added to supportive self-care in outpatients with mild-to-moderate COVID-19 disease.
- In September, Kaleido dosed the first patient in a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis.
Anticipated Milestones
- Programs KB39 and KB174 will be featured during The Liver Meeting® 2020, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place Nov. 13-16, 2020.
- Preclinical data from the immuno-oncology programs are expected in the fourth quarter of 2020.
- Topline data from the multi-center (K031) clinical study of KB109 in outpatients with mild-to-moderate COVID-19 disease and top-line data from the study with Massachusetts General Hospital (K032) are expected in the first quarter of 2021.
- Topline date clinical study of KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC) are expected in mid-2021.
- Topline data from a Phase 2 clinical trial of KB195 in patients with UCD inadequately controlled on standard of care are expected in the second half of 2021.
Third Quarter 2020 Financial Results
For the third quarter 2020, Kaleido reported a net loss of $23.1 million, or $0.65 per common share, compared to $22.0 million, or $0.74 per common share, for the third quarter 2019. The 2020 third quarter net loss includes non-cash stock-based compensation expenses of $4.4 million, as compared to $2.9 million in the third quarter of 2019.
Research and development (R&D) expenses were $15.7 million for the third quarter 2020, compared to $16.2 million for the third quarter 2019. The third quarter decrease in R&D, as compared to the third quarter of 2019, was primarily driven by decreased external development, manufacturing, and research costs.
General and administrative (G&A) expenses were $7.2 million for the third quarter 2020, compared to $5.9 million for the third quarter of 2019. The third quarter 2020 increase in G&A, as compared to the third quarter of 2019, was primarily due to the modification of the vesting provision of stock options and restricted stock units related to the resignation of our former CEO.
As of September 30, 2020, the Company reported cash and cash equivalents of $54.5 million and has cash runway into the second half of 2021.
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 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.
Kaleido Biosciences, Inc. and Subsidiaries Condensed Consolidated Statement of Operations (Unaudited) (in thousands, except share and per share data) Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 Revenue: Collaboration revenue $ 482 $ — $ 732 $ — Operating expenses: Research and development 15,659 16,188 41,629 50,145 General and administrative 7,201 5,930 18,677 17,544 Total operating expenses 22,860 22,118 60,306 67,689 Loss from Operations (22,378 ) (22,118 ) (59,574 ) (67,689 ) Other (expense) income (753 ) 157 (2,030 ) 870 Net loss $ (23,131 ) $ (21,961 ) $ (61,604 ) $ (66,819 ) Net loss per share—basic and diluted $ (0.65 ) $ (0.74 ) $ (1.89 ) $ (2.76 ) Weighted-average common shares outstanding used in net loss—basic and diluted 35,554,128 29,856,233 32,605,592 24,224,359 Kaleido Biosciences, Inc. and Subsidiaries Condensed Consolidated Balance Sheet Data (Unaudited) (in thousands) September 30,
2020December 31,
2019Assets: Cash and cash equivalents $ 54,532 $ 71,241 Other assets 18,613 11,065 Total assets $ 73,145 $ 82,306 Liabilities and stockholders' equity Liabilities $ 37,244 $ 33,423 Stockholders' equity 35,901 48,883 Total liabilities and stockholders' equity $ 73,145 $ 82,306 Contacts
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
[email protected]
Investors
Lee M. Stern
Solebury Trout
646-378-2922
[email protected]Media
Joshua R. Mansbach
Solebury Trout
646-378-2964
[email protected] - The Company continues to enroll subjects in two non-IND clinical studies that are part of the ongoing COVID-19 development program evaluating KB109 when added to supportive self-care in outpatients with mild-to-moderate COVID-19 disease.
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Ex vivo data from candidate KB109, under evaluation in two clinical studies for COVID-19, to be presented at IDWeek 2020
Data from studies of KB39 and KB174 to be presented at The Liver Meeting® 2020, the AASLD Annual Meeting
LEXINGTON, Mass., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), today announced that data from its Microbiome Metabolic Therapy (MMT™) programs for hepatic encephalopathy, cardiovascular and liver disease, and COVID-19 disease have been accepted for poster presentations at upcoming scientific conferences. Data from the MMT program KB109, under evaluation in two clinical studies in the treatment of mild-to-moderate COVID-19 disease, will be featured at the Infectious Disease Society of America's Infectious Disease Week (IDWeek) 2020, taking place Oct. 21-25, 2020 in a virtual format. Candidates KB39 and KB174 will be featured during The Liver Meeting® 2020, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place Nov. 13-16, 2020, also in a virtual format.
"The results to be presented for KB109 will include its effect ex vivo on decreasing pathogens, increasing beneficial commensal bacteria, and increasing short chain fatty acid production supporting its potential in addressing viral respiratory infection by promoting appropriate immune function. In addition, we are pleased to present preclinical results for KB39 and expect to nominate an MMT therapy candidate with potential for development in the treatment of cardiometabolic and liver diseases in 2021," commented Katharine Knobil, M.D., Chief Medical Officer and Head of Research & Development at Kaleido. "Finally, additional analyses from our clinical study of KB174 in patients with well-compensated cirrhosis improve our understanding of the mechanism in the potential treatment of hepatic encephalopathy, and also help to explain the reductions in microbiome nitrogen metabolism observed in several studies. The attributes of KB174 and the strengths of an MMT approach continue to show excellent promise for this indication."
IDWeek 2020 Presentation:
Abstract Title: Development of a Novel Synthetic Glycan to Prevent Bacterial Infections and Ameliorate Respiratory Viral Infections (Poster #0610)
Lead Author: Jeffrey Meisner – Associate Director of Biology, Kaleido BiosciencesThe Liver Meeting® 2020 presentations:
Abstract Title: KB39, a novel synthetic glycan modulating the gut microbiome, decreases fatty liver and atherosclerosis in diet-induced murine models of non-alcoholic fatty liver and cardiovascular disease (Poster #616)
Lead Author: Yves Millet – Director of Biology, Kaleido BiosciencesAbstract Title: Community shift in the gut microbiome is a potential mechanism for reduction in gut microbiota-associated ammonia by the novel synthetic glycan, KB174, in patients with well-compensated cirrhosis (Poster #610)
Lead Author: Jonathan Lawrence – Director of Chemistry, Kaleido BiosciencesKey Highlights
- KB109 has demonstrated the ability to reduce the relative abundance of a diversity of pathogenic bacteria and increased commensal bacteria in human fecal communities. Ex vivo screening revealed that KB109 consistently increased short chain fatty acid (SFCA) production across multiple fecal communities.
- In mouse models, administration of KB39 resulted in a significant decrease in indicators of disease, including hepatic triglycerides, NAFLD activity score, blood triglycerides, total cholesterol, free fatty acids, LDL-C and VLDL-C. Effects of KB39 were associated with a 64 percent reduction in a mouse model of atherosclerotic plaque formation.
- Observations of dose-dependent shifts in microbiome composition and an increase in Parabacteroides bacteria in patients provide support for the mechanism for KB174 in reducing gut associated ammonia, potentially through promoting bacterial species known to ferment glycans and thereby outcompeting ammonia-producing bacteria.
Presentations from the IDWeek conference will be available Oct. 21, 2020, and presentations from the AASLD annual meeting will be available on Nov. 13, 2020, at the Company's website at https://kaleido.com/publications-and-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 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., 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 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.
Contacts
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
[email protected]Investors
Lee M. Stern
Solebury Trout
646-378-2922
[email protected]Media
Rich Allan
Solebury Trout
646-378-2958
[email protected] -
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LEXINGTON, Mass., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), today announced an update to its ongoing COVID-19 clinical development program evaluating KB109 when added to supportive self-care (SSC) in outpatients with mild-to-moderate COVID-19 disease. Updated projections for enrollment of the multi-center K031 clinical study of approximately 350 patients indicated that top-line data will be available in the first quarter of 2021. Previous projections had indicated the potential availability of top-line data from the study in the fourth quarter of 2020.
"We are encouraged by the potential for KB109, a novel glycan developed with our MMT approach, to influence clinical outcomes in patients with COVID-19," commented Michael Bonney, Executive Chair of Kaleido. "This delay in our timeline for the K031 study, while unexpected, is understandable given the dynamic nature of this emergent disease and the nature of its spread in different geographies. Results of our K032 clinical study of KB109 in approximately 50 patients with mild-to-moderate COVID-19, conducted in collaboration with Massachusetts General Hospital, continue to be expected in the first quarter of 2021. Guidance for our other programs is unchanged, with data from our study of KB295 in ulcerative colitis expected in mid-2021, results with KB195 in urea cycle disorder expected in the second half of 2021. With our clinical studies, we have instituted protocols to allow for virtual visits to reach patients who may not be near a study site or when needed in order to minimize the impact of disease transmission on study enrollment. In addition, we continue to expect preclinical data from our immuno-oncology, cardiometabolic and liver diseases programs this quarter (the fourth quarter of 2020)."
Additional information about the K031 study of MMT therapy KB109 in outpatients with mild-to-moderate COVID-19 infection is available at https://clinicaltrials.gov/ct2/show/NCT04414124. Information about the K032 study is available at https://clinicaltrials.gov/ct2/show/NCT04486482.
A patient may be eligible for enrollment in these studies if an initial positive COVID-19 test result is received and the patient remains symptomatic.
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 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., 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 and the timing of completion and reporting of results of clinical studies. 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, 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.
Contacts
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
[email protected]Investors
Lee M. Stern
Solebury Trout
646-378-2922
[email protected]Media
Rich Allan
Solebury Trout
646-378-2958
[email protected] -
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LEXINGTON, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, announced that Daniel Menichella has been appointed President and Chief Executive Officer and a member of the company's Board of Directors, effective October 13, 2020. Mr. Menichella succeeds Alison Lawton, who stepped down to attend to a family health matter but continued to work with the Company in the Office of the CEO alongside Executive Chair Mike Bonney.
"I'm excited to welcome Dan to Kaleido and am confident his extensive experience helping companies advance product candidates, execute meaningful business development partnerships, and build strong cultures will help Kaleido fulfill its great potential," said Mike Bonney. "I look forward to working closely with Dan to ensure a smooth transition as I return to my role as an active and involved Board Chair."
Mr. Menichella is an experienced Chief Executive Officer, having been hired as CEO of CureVac Inc.'s US subsidiary in January 2017 before taking over as CEO of the international company in June of 2018. Prior to that, Mr. Menichella was Chief Business Officer at several companies, including Bamboo Therapeutics from 2015-2016, Applied Genetic Technologies Corporation (AGTC) from 2013-2015 and Zyngenia, Inc. from 2011-2013. Mr. Menichella also led Business Development and Corporate Strategy functions at Talecris Biopharmaceuticals from 2007-2011 and at Merck KGaA from 2002-2007. He earned his Bachelor of Arts from Harvard University and his Master of Business Administration from the University of North Carolina at Chapel Hill.
"I am thrilled to join Kaleido at such an exciting time in its evolution," said Mr. Menichella. "With a strong product platform and multiple key milestones anticipated between now and the end of 2021, I look forward to continuing to build upon our leadership in the microbiome space and finding new ways to treat disease and improve human health."
"On behalf of the Board of Directors and employees of Kaleido, we want to recognize Alison's meaningful contributions over her near three years leading the Company," said Mike Bonney. "Alison will be stepping down from the Board coincident with Dan's start, and has agreed to be available to Dan for advice and counsel, as he moves into the CEO role."
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., in Phase 2 or later development.
About Kaleido BiosciencesKaleido 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 our clinical and preclinical 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 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 form 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.
Contacts
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
[email protected]
InvestorsLee M. Stern
Solebury Trout
646-378-2922
[email protected]Media
Rich Allan
Solebury Trout
646.378.2958
[email protected]