KLDO Kaleido Biosciences Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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KB295
Ulcerative colitis (UC)
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
KB109
Chronic obstructive pulmonary disease (COPD)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 1Q 2022.
|
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KB109 (K031)
Mild-to-moderate COVID-19
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Phase 1
Phase 1
|
Pivotal trial planned.
|
|
KB195 (UNLOCKED)
Urea cycle disorder (UCD)
|
Phase 2
Phase 2
|
Phase 2 trial ongoing.
|
Latest News
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LEXINGTON, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, today announced that CEO Dan Menichella will participate in a fireside chat at the Morgan Stanley 19th Annual Virtual Global Healthcare Conference at 2:45PM ET on Thursday, September 9.
The webcast of the presentation will be made available in the Investors & Media section of Kaleido's website at https://investors.kaleido.com/events-presentations. An archived replay will be available 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/.Contacts:
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
william.duke@kaleido.comInvestors and Media
Kotaro Yoshida
Argot Partners
212-600-1902
kaleido@argotpartners.com
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--On track to report topline data from a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis by end of third quarter--
--Kaleido and the COPD Foundation to collaborate on the development of KB109 in patients with COPD; plan to initiate Phase 2 clinical study in first quarter 2022--
--Additional data from an observational clinical study of KB109 in patients with mild-to-moderate COVID-19 expected by end of third quarter--
LEXINGTON, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, today reported financial results for the second quarter ended June 30, 2021.
"We have made considerable progress so far this year across our dynamic and diverse clinical pipeline of novel, targeted Microbiome Metabolic TherapyTM (MMT) candidates. We continue to advance KB295 in patients with mild-to-moderate ulcerative colitis and anticipate reporting topline data from the clinical study by the end of the third quarter," said Dan Menichella, President and Chief Executive Officer of Kaleido. "This quarter, we also expect to report data from the observational clinical study evaluating COVID-19 symptoms in 'Long Hauler' patients that participated in our prior COVID-19 clinical studies."
Continued Mr. Menichella: "Additionally, we are proud to have announced a strategic collaboration with the COPD Foundation, an organization uniquely qualified to aid us in our mission to improve the lives of patients suffering from COPD. Our KB109 program will be greatly enhanced with support from the COPD Foundation, and we look forward to a productive and mutually beneficial partnership that leverages the strong data from our COVID-19 studies to explore treatment of COPD, the most prevalent chronic respiratory illness, impacting over 250 million people worldwide. While we are prioritizing COPD based on our assessment of the unmet need and commercial opportunity, we will continue to evaluate development opportunities for KB109 in COVID-19 with partners and government agencies."
Recent Program and Corporate Highlights
- Topline data from the non-IND clinical study of KB295 in patients with mild-to-moderate ulcerative colitis (UC) are expected by the end of the third quarter.
- Additional data from the observational clinical study of KB109 in patients with mild-to-moderate COVID-19 are expected by the end of the third quarter.
- In August, Kaleido announced a collaboration with the COPD Foundation that is on track to initiate a Phase 2 clinical study of KB109 in patients with chronic obstructive pulmonary disease (COPD) in the first quarter of 2022.
Second Quarter Financial Results
Kaleido reported a net loss of $23.9 million, or $0.56 per common share, for the second quarter of 2021 compared to $18.9 million, or $0.59 per common share, for the same period in 2020. The second quarter net loss includes non-cash stock-based compensation expenses of $2.4 million, as compared to $2.8 million in the second quarter of 2020.
Research and development (R&D) expenses were $17.6 million and $12.8 million for the three months ended June 30, 2021 and 2020, respectively. The increase was primarily due to an increase in production of material for use in our clinical studies.
General and administrative (G&A) expenses were $5.8 million and $5.6 million for the three months ended June 30, 2021 and 2020, respectively. The increase was primarily due to increased facility operating costs that were attributed to general and administrative functions.
As of June 30, 2021, the Company reported cash and cash equivalents of $72.0 million and has cash runway into the second quarter of 2022.
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, including, but not limited to, statements regarding the timing of initiation, completion and reporting of results of clinical studies, and our anticipated regulatory filings, strategy, business plans and focus. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in our stock price, changes in market conditions and satisfaction of customary closing conditions related to the public offering and those risks more fully discussed in the section entitled "Risk Factors" in Kaleido's annual report on Form 10-K for the fiscal year ended December 31, 2020, which is available at www.sec.gov, as well as discussions of potential risks, uncertainties, and other important factors in Kaleido's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Kaleido's views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Kaleido undertakes no duty to update this information unless required by law.
Kaleido Biosciences, Inc. and Subsidiaries
Condensed Consolidated Statement of Operations (Unaudited)
(in thousands, except share and per share data)Three Months Ended
June 30,Six Months Ended
June 30,2021 2020 2021 2020 Revenue: Collaboration revenue $ 211 $ 250 $ 508 $ 250 Operating expenses: Research and development 17,633 12,833 34,818 25,970 General and administrative 5,785 5,559 11,245 11,476 Total operating expenses 23,418 18,392 46,063 37,446 Loss from Operations (23,207 ) (18,142 ) (45,555 ) (37,196 ) Other (expense) income, net (682 ) (780 ) (1,376 ) (1,277 ) Net loss $ (23,889 ) $ (18,922 ) $ (46,931 ) $ (38,473 ) Net loss per share—basic and diluted $ (0.56 ) $ (0.59 ) $ (1.14 ) $ (1.24 ) Weighted-average common shares outstanding—basic and diluted 42,538,563 31,880,672 41,123,435 31,106,977
Kaleido Biosciences, Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)June 30, 2021 December 31, 2020 Assets: Cash and cash equivalents $ 71,979 $ 46,222 Other assets 12,311 13,122 Total assets $ 84,290 $ 59,344 Liabilities and stockholders' equity Liabilities $ 34,024 $ 38,848 Stockholders' equity 50,266 20,496 Total liabilities and stockholders' equity $ 84,290 $ 59,344 Contacts:
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
william.duke@kaleido.comInvestors and Media
Kotaro Yoshida
Argot Partners
212-600-1902
kaleido@argotpartners.com
- Topline data from the non-IND clinical study of KB295 in patients with mild-to-moderate ulcerative colitis (UC) are expected by the end of the third quarter.
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LEXINGTON, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, today announced a strategic collaboration with the COPD Foundation to study KB109 in patients with chronic obstructive pulmonary disease (COPD). The collaboration will partner Kaleido with the COPD Foundation's leading experts in its Digital Health and Therapeutics Accelerator Network, COPD360Net, to support joint clinical development starting with a Phase 2a trial of KB109, a novel Microbiome Metabolic Therapy (MMT™), in COPD.
An expanding body of research indicates that immune and inflammatory responses in the lung are in part driven by the gut microbiome – via the so-called gut-lung axis – making the gut microbiome a potential therapeutic target in COPD. KB109's clinical potential to target the gut-lung axis and improve outcomes in respiratory viral diseases was demonstrated in a study of mild-to-moderate COVID-19 patients. Its mechanism of action is pathogen agnostic, suggesting it could address a wide range of chronic respiratory diseases driven by inflammation or respiratory infections. COPD is the most prevalent chronic respiratory illness, impacting over 250 million people worldwide, and has limited safe and effective treatment options for the control and prevention of acute exacerbations.
"We are excited to embark on this partnership with the COPD Foundation to work towards our shared mission to bring about innovative therapies for people suffering from COPD," said Dan Menichella, President and Chief Executive Officer of Kaleido. "The previous KB109 COVID-19 trial demonstrated activity against the pathologies associated with respiratory viral infections by modulating the gut microbiome and host immune system. We believe this result warrants clinical investigation of KB109 in COPD patients, and we look forward to initiating a Phase 2a trial early in 2022."
COPD Foundation's President and Chief Scientific Officer Ruth Tal-Singer, PhD added, "At the Foundation, we were excited when we saw the KB109 COVID-19 data because of its potential to improve recovery from viral infections for patients with comorbidities. The COPD burden is projected to increase in the coming decades because of continued exposure to risk factors and the aging population. COPD patients would benefit from an oral therapy that could reduce exacerbations and improve quality of life. We are proud to partner with Kaleido in our continued efforts to find a treatment intervention that is affordable and potentially more efficacious for patients."
Patients with severe Acute Exacerbations in COPD (AECOPDs) often require hospitalization and have an increased mortality risk. COPD is not curable, but treatment can relieve symptoms, improve quality of life and reduce the risk of death. The majority of AECOPDs are triggered by respiratory tract viral or bacterial infections which result in lung microbiome dysbiosis, host immunity dysregulation, and pro-inflammatory cascades. With this collaboration, Kaleido and the COPD Foundation intend to further capitalize on KB109's potential to correct dysbiosis and prevent significant disease burden related to respiratory infections in people with COPD.
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/.
About the COPD Foundation
The COPD Foundation is a not-for-profit organization that was established to improve the lives of people with COPD, bronchiectasis, and nontuberculous mycobacterial (NTM) lung disease through initiatives that expand services and speed innovations that will make treatment more effective and affordable. The Foundation does this through scientific research, education, advocacy, and awareness with the goal of disease prevention, slowed progression, and ultimately a cure. The COPD Foundation leadership and Medical and Scientific advisory committee include representatives of the lung community, clinical science, genetics, and the social sciences (bioethics, economics, and/or law). To learn more, visit the COPD Foundation website or follow the Foundation on LinkedIn and Twitter.
About COPD360Net
COPD360Net's mission is to support the development and adoption of novel digital health tools, medical devices, and therapeutics that treat COPD, bronchiectasis, and NTM lung disease. This network consists of the core COPD Foundation accredited care centers; experts in COPD and related lung diseases; relevant subject matter experts, including primary care physicians; clinical trial designers; health economists and psychosocial experts, all working together to devise creative ways to support patients and their families in every aspect of their lives. COPD360Net is governed by a steering committee that includes clinical lead experts from participating centers, key content specialists and both patient and caregiver representatives.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing of initiation, completion and reporting of results of clinical studies, and our anticipated regulatory filings, strategy, business plans and focus. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in our stock price, changes in market conditions and satisfaction of customary closing conditions related to the public offering and those risks more fully discussed in the section entitled "Risk Factors" in Kaleido's annual report on Form 10-K for the fiscal year ended December 31, 2020, which is available at www.sec.gov, as well as discussions of potential risks, uncertainties, and other important factors in Kaleido's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Kaleido's views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Kaleido undertakes no duty to update this information unless required by law.Contacts:
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
william.duke@kaleido.comInvestors and Media
Kotaro Yoshida
Argot Partners
212-600-1902
kaleido@argotpartners.comCOPD Foundation Contact
Carol Johnson
Media Relations
COPD Foundation
786-749-7104
mediarelations@copdfoundation.org
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LEXINGTON, Mass., Aug. 06, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (NASDAQ:KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, today announced that CFO William Duke will participate in a fireside chat at the Canaccord Genuity Growth Conference at 2:30PM ET on Thursday, August 12.
The webcast of the presentation will be made available in the Investors & Media section of Kaleido's website at https://investors.kaleido.com/events-presentations. An archived replay will be available 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/.Contacts:
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
william.duke@kaleido.comInvestors
Argot Partners
Kotaro Yoshida
212-600-1902
kaleido@argotpartners.com -
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New Board Members Will Help Advance ‘Gene Writing' Platform and Mission to Cure Disease by Writing in the Code of Life
Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of Elliott Sigal, M.D., Ph.D. and Mary Rozenman, Ph.D. to the company's Board of Directors. This announcement represents the latest key development for Tessera, following the March appointments of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations, and a $230 million Series B fundraising round in January.
"Elliott and Mary bring phenomenal leadership, experience, and creativity to Tessera's Board of Directors," said Geoffrey von Maltzahn, Ph.D., CEO and Co-Founder of Tessera. "Elliott has overseen more than a dozen new medications on their way to market, and Mary has guided major strategic, fundraising, and partnership efforts. Together, they offer decades of experience that will help us rapidly grow Tessera and to fulfill our mission of curing diseases by writing in the code of life."
"The next frontier in medicine will be therapeutics that cure and provide enduring protection against disease. I am excited to welcome Elliott and Mary to the team at Tessera and look forward to working closely with them as we advance Tessera's Gene Writing platform and pioneer the future of genetic medicine," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board, Tessera and CEO of Flagship Pioneering.
Dr. Sigal brings decades of clinical experience in drug discovery, drug development, and corporate strategy to Tessera's Board of Directors. He currently serves as a senior advisor to the healthcare team of New Enterprise Associates and is a member of the Board of Directors for Adaptimmune Therapeutics, Surface Oncology, Vir Therapeutics, and Affinia. He co-chairs the Scientific Advisory Board for Amgen and is a member of the Scientific Steering Committee for the Sean Parker Institute for Cancer Immunology. He previously served on the Board of Directors for the gene therapy company, Spark Therapeutics. Dr. Sigal is a former Executive Vice President and Director of Bristol-Myers Squibb, and served as the company's Chief Scientific Officer and President of R&D from 2004 until 2013. Under his leadership, fourteen new medicines came to market in multiple therapeutic areas including virology, oncology, immunology, psychiatry, metabolic diseases and cardiovascular disease. During his tenure, Dr. Sigal was named the best R&D chief in the pharmaceutical industry by Scrip Intelligence. Dr. Sigal received his M.D. from the University of Chicago and trained in Internal Medicine and Pulmonary Medicine at UCSF. Prior to medical school, he received his B.S., M.S., and Ph.D. in Industrial Engineering from Purdue University.
"Tessera's Gene Writing technology represents a major breakthrough in the field with potential to fundamentally change the future of medicine across many therapeutic areas," said Dr. Elliott Sigal. "I am honored to join the Board and look forward to helping guide the company through continued growth and innovation."
Dr. Rozenman brings more than 15 years of scientific expertise, company building, and transactions leadership in the biotech industry to Tessera's Board of Directors. She serves as the CFO and CBO of insitro, leading strategic and operational finance and accounting strategy, business development, investor relations, corporate communications, as well as project and portfolio management. Prior to insitro, Dr. Rozenman served as the Senior Vice President of Corporate Development and Strategy at Aimmune Therapeutics, where she oversaw business development and partnerships with companies including Regeneron/Sanofi and Nestle Health Science and supported the company's strategic finance and investor relations efforts. Across her time at both insitro and Aimmune, Dr. Rozenman has raised more than $1 billion in capital through a range of public and private transactions, including leadership of Aimmune's IPO in 2015. She received her Ph.D. in Organic Chemistry and Chemical Biology from Harvard University and her B.A. in Biochemistry and Russian Literature from Columbia University.
"Tessera is pioneering Gene Writing at a pivotal moment for drug discovery, as we rapidly expand our understanding of the genetic drivers of disease. Tessera's work to write into the genome may open opportunities to cure and prevent a broad range of diseases. I am thrilled to join the Board during such an exciting time in the company's growth and look forward to partnering with Geoff and the world class Tessera team," said Dr. Mary Rozenman.
For more information on Tessera, including how Gene Writing works, partnership opportunities, and job openings, visit www.tesseratherapeutics.com.
About Tessera Therapeutics
Tessera Therapeutics is an early-stage life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $90 billion in aggregate value. To date, Flagship has deployed over $2.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).
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