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Kaleido Biosciences (Nasdaq: KLDO) announced updates on its COVID-19 clinical development program, focusing on KB109 for outpatients with mild-to-moderate disease. The enrollment target for the K031 study has increased to 350 patients, with top-line data now expected in Q1 2021, delayed from Q4 2020. Meanwhile, results from the K032 study with about 50 patients are also anticipated in Q1 2021. The company is adapting protocols for virtual visits due to COVID-19 impacts. Other ongoing studies include KB295 for ulcerative colitis and KB195 for urea cycle disorder, with results expected in mid-2021 and H2 2021, respectively.
Kaleido Biosciences (Nasdaq: KLDO) appointed Daniel Menichella as President and CEO effective October 13, 2020, following Alison Lawton's resignation due to family health reasons. Menichella brings extensive experience in advancing product candidates and business development from his previous roles, including serving as CEO at CureVac. His leadership aims to enhance Kaleido's position in microbiome therapies, with key milestones expected by the end of 2021. Lawton will remain available for advisory support during the transition.
Kaleido Biosciences (Nasdaq: KLDO) announced the dosing of the first patient in its clinical study for the MMT candidate KB295, targeting mild-to-moderate ulcerative colitis (UC). The study aims to evaluate KB295's safety and tolerability, with top-line results expected in mid-2021. KB295 is designed to modify the gut microbiome to reduce inflammation, which is significant given the role of microbiome alterations in UC progression. The study will enroll about 30 patients for eight weeks of treatment, followed by a one-month follow-up.
Kaleido Biosciences has commenced dosing the first patient in its clinical study for KB295, a Microbiome Metabolic Therapy (MMT™) candidate aimed at treating patients with mild-to-moderate ulcerative colitis (UC). The study seeks to evaluate the safety and tolerability of KB295, with top-line results anticipated in mid-2021. KB295 has shown potential in reducing inflammatory bacteria and increasing beneficial metabolites in prior studies. This open-label study will enroll around 30 patients over an eight-week period, examining various clinical and microbiome-related endpoints.
Kaleido Biosciences (Nasdaq: KLDO) announced that Executive Chair Michael Bonney will participate in upcoming healthcare conferences. The events include the Morgan Stanley 18th Annual Global Healthcare Conference on Sept. 16, 2020, at 12:30 p.m. EDT, and the Cantor 2020 Virtual Global Healthcare Conference on Sept. 17, 2020, at 3:20 p.m. EDT. Live webcasts will be available on their website, and archived replays will follow each event. Kaleido focuses on developing Microbiome Metabolic Therapies aimed at treating various diseases.
Kaleido Biosciences, Inc. (Nasdaq: KLDO) announced its Q2 2020 financial results and corporate updates, highlighting significant advancements in its COVID-19 clinical development program. The company initiated two clinical studies for KB109, targeting mild-to-moderate COVID-19, with topline data expected in Q4 2020. Kaleido completed a $35.6 million stock offering and reported a net loss of $18.9 million for the quarter, improving from $24.6 million in Q2 2019. The company holds $71.0 million in cash, ensuring operations into H2 2021.
Kaleido Biosciences (Nasdaq: KLDO) announced the initiation of a controlled clinical study (K032) in partnership with Massachusetts General Hospital, aimed at evaluating its Microbiome Metabolic Therapy (MMT) candidate KB109 for outpatients with mild-to-moderate COVID-19. This study follows a previous trial and addresses a patient population making up about 80% of symptomatic cases. The trial will assess safety, physiological effects, and microbiota changes over two weeks, with top-line results expected in early 2021. The study aims to understand how KB109 may mitigate inflammatory responses related to COVID-19.
Alison Lawton has stepped down as President and CEO of Kaleido Biosciences (KLDO) due to a family health matter. She'll continue as a director and special advisor during the transition. The Board has formed an Office of the CEO, led by Mike Bonney, to manage the company and maintain strategic direction. Lawton noted her pride in leading Kaleido's evolution into a public company and expressed confidence in its future, especially regarding upcoming clinical results targeting COVID-19 and other diseases.
Kaleido Biosciences (KLDO) announced its 2020 Annual Meeting of Stockholders will be held virtually on June 17, 2020, at 9:00 a.m. EDT due to COVID-19. This change ensures compliance with public health guidelines to safeguard participants' health. Stockholders can still vote online, and those wishing to attend must register by June 15, 2020. They are encouraged to vote in advance using the existing proxy cards. The meeting will address previously announced agenda items without alterations.
Kaleido Biosciences, a clinical-stage healthcare company focused on the microbiome, announced that CEO Alison Lawton will speak at the Goldman Sachs 41st Annual Global Healthcare Conference on June 11, 2020, at 11:20 a.m. ET. Interested parties can access a live webcast through the Investors & Media section on Kaleido's website. The event will also have an archived replay available for 90 days. Kaleido is advancing its pipeline of Microbiome Metabolic Therapies, targeting diseases with significant unmet needs.
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