Duyuru • Apr 03
Kaleido Biosciences, Inc. announced delayed annual 10-K filing On 04/01/2022, Kaleido Biosciences, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Duyuru • Jan 30
Kaleido Biosciences, Inc. Decides Halt Work on a Planned Phase 2 Chronic Obstructive Pulmonary Disease (COPD) Study Kaleido Biosciences, Inc. has decided to halt work on a planned Phase 2 chronic obstructive pulmonary disease (COPD) study and terminate its agreement with the COPD Foundation. These decisions were made in order to re-align resources and focus the company's efforts. Reported Earnings • Nov 03
Third quarter 2021 earnings released: US$0.54 loss per share (vs US$0.65 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$23.1m (flat on 3Q 2020). Price Target Changed • Nov 03
Price target increased to US$15.60 Up from US$14.33, the current price target is an average from 6 analysts. New target price is 231% above last closing price of US$4.71. Stock is down 26% over the past year. The company is forecast to post a net loss per share of US$2.25 next year compared to a net loss per share of US$2.44 last year. Price Target Changed • Oct 19
Price target decreased to US$14.33 Down from US$16.00, the current price target is an average from 6 analysts. New target price is 210% above last closing price of US$4.62. Stock is down 38% over the past year. The company is forecast to post a net loss per share of US$2.17 next year compared to a net loss per share of US$2.44 last year. Major Estimate Revision • Aug 20
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$2.30m to US$2.05m. EPS estimate increased from -US$2.22 to -US$2.17 per share. Pharmaceuticals industry in the US expected to see average net income growth of 15% next year. Consensus price target of US$15.57 unchanged from last update. Share price fell 5.0% to US$5.83 over the past week. Major Estimate Revision • Aug 12
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$2.11m to US$1.75m. EPS estimate increased from -US$2.25 to -US$2.22 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target down from US$16.44 to US$16.00. Share price rose 7.8% to US$6.23 over the past week. Executive Departure • Aug 10
Chairman of the Board Michael Bonney has left the company On the 9th of August, Michael Bonney's tenure as Chairman of the Board ended after 3.0 years in the role. We don't have any record of a personal shareholding under Michael's name. A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 1.75 years, which is considered inexperienced in the Simply Wall St Risk Model. Major Estimate Revision • Jun 19
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$2.53m to US$2.11m. EPS estimate unchanged at -US$2.25 per share. Pharmaceuticals industry in the US expected to see average net income growth of 13% next year. Consensus price target broadly unchanged at US$16.00. Share price was steady at US$6.73 over the past week. Price Target Changed • Jun 17
Price target increased to US$17.83 Up from US$16.14, the current price target is an average from 6 analysts. New target price is 177% above last closing price of US$6.43. Stock is down 13% over the past year. Major Estimate Revision • May 11
Consensus revenue estimates fall to US$547.0k The consensus outlook for revenues in 2021 has deteriorated. 2021 revenue forecast decreased from US$1.80m to US$547.0k. Forecast losses increased from -US$2.20 to -US$2.30 per share. Pharmaceuticals industry in the US expected to see average net income growth of 12% next year. Consensus price target broadly unchanged at US$16.43. Share price fell 8.6% to US$6.73 over the past week. Executive Departure • Apr 17
Consultant has left the company On the 15th of April, Katharine Knobil's tenure as Consultant ended after less than a year in the role. We don't have any record of a personal shareholding under Katharine's name. Katharine is the only executive to leave the company over the last 12 months. Analyst Estimate Surprise Post Earnings • Mar 04
Revenue and earnings miss expectations Revenue missed analyst estimates by 92%. Earnings per share (EPS) also missed analyst estimates by 3.9%. Over the next year, revenue is forecast to grow 618%, compared to a 27% growth forecast for the Pharmaceuticals industry in the US. Duyuru • Feb 04
Kaleido Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $60.375 million. Kaleido Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $60.375 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,250,000
Price\Range: $11.5 Is New 90 Day High Low • Jan 27
New 90-day high: US$14.21 The company is up 126% from its price of US$6.29 on 29 October 2020. The American market is up 21% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 19% over the same period. Duyuru • Jan 26
Kaleido Biosciences, Inc. Announces Resignation of Katharine Knobil as Chief Medical Officer and Head of Research and Development, Effective as of January 29, 2021 On January 20, 2021, Kaleido Biosciences, Inc. and Katharine Knobil, M.D. reached a mutual agreement that Dr. Knobil will resign from her position as Chief Medical Officer and Head of Research and Development of the Company, effective as of January 29, 2021. Dr. Knobil is leaving the Company in order to pursue other opportunities and her decision to resign was not the result of any disagreement with the Company on any matters relating to the Company’s operations, policies or practices. In connection with her departure, the Company and Dr. Knobil entered into a separation agreement and general release dated as of January 25, 2021. Duyuru • Jan 15
Kaleido Biosciences, Inc. Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-To-Moderate COVID-19 Kaleido Biosciences, Inc. 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. KB109 demonstrated a favorable safety and tolerability profile with no unexpected treatment-related adverse events or discontinuations related to treatment. 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. Is New 90 Day High Low • Jan 08
New 90-day high: US$11.40 The company is up 1.0% from its price of US$11.33 on 09 October 2020. The American market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 5.0% over the same period. Duyuru • Jan 05
Kaleido Biosciences Announces Completion of Enrollment of 350 Subjects in Controlled Study of KB109 in the Treatment of Mild-to-Moderate COVID-19 Kaleido Biosciences, Inc. announced that completion of enrollment of 350 subjects in the controlled clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109 in the treatment of mild-to-moderate COVID-19. The multi-center, non-IND clinical study is designed to evaluate the effects of KB109 plus supportive self-care (SSC) compared to SSC alone for outpatients who are positive for SARs-Cov-2 and have symptoms. Study endpoints include safety and tolerability, biomarkers of the inflammatory response, and time to resolution of symptoms. The Kaleido KB109 development program involves two controlled, non-IND clinical studies including one study of 350 patients evaluating symptom resolution and one study of approximately 50 patients evaluating effects on microbiome composition and biomarkers of inflammatory response. Subjects are randomized to either receive SSC (the control group) or SSC plus KB109 for two weeks and then followed for a further three weeks. KB109 was selected for evaluation in COVID-19 studies based on its ability to increase microbiome production of short chain fatty acids, which act as modulators of the immune response. Price Target Changed • Dec 26
Price target raised to US$14.00 Up from US$12.60, the current price target is an average from 4 analysts. The new target price is 50% above the current share price of US$9.33. As of last close, the stock is up 69% over the past year. Major Estimate Revision • Nov 09
Analysts update estimates The 2020 consensus revenue estimate increased from US$14.1m to US$18.0m. Earning per share (EPS) estimate was further reduced from -US$2.37 to -US$2.50 for the same period. The Pharmaceuticals industry in the US is expected to see an average net income growth of 2.5% next year. The consensus price target was lowered from US$12.60 to US$11.60. Share price is up 17% to US$6.73 over the past week. Price Target Changed • Nov 05
Price target lowered to US$11.60 Down from US$12.60, the current price target is an average from 4 analysts. The new target price is 81% above the current share price of US$6.40. As of last close, the stock is up 1.7% over the past year. Analyst Estimate Surprise Post Earnings • Nov 03
Earnings beat expectations Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 19%. Over the next year, revenue is forecast to grow 1,101%, compared to a 32% growth forecast for the Pharmaceuticals industry in the US. Major Estimate Revision • Oct 23
Analysts update estimates The 2020 consensus revenue estimate was lowered from US$17.7m to US$14.1m. Earning per share (EPS) estimate was unchanged from the last update at -US$2.37. The Pharmaceuticals industry in the US is expected to see an average net income growth of 8.0% next year. The consensus price target of US$12.60 was unchanged from the last update. Share price is down by 21% to US$6.97 over the past week. Duyuru • Oct 14
Kaleido Biosciences, Inc. Announces Change of Role of Michael Bonney from Executive Chair of the Board to Chair of the Board Kaleido Biosciences, Inc. on October 9, 2020 changed Michael Bonney’s role from Executive Chair of the Board to Chair of the Board, effective as of October 13, 2020. The change in Bonney’s title was not the result of any disagreement with the Company on any matters relating to the Company’s operations, policies or practices. Duyuru • Oct 07
Kaleido Biosciences, Inc. Provides Update on KB109 Clinical Data Timeline Kaleido Biosciences, Inc. 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. 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. Duyuru • Sep 30
Kaleido Biosciences Announces First Patient Dosed in Clinical Study of Microbiome Metabolic Therapy KB295 in Patients with Mild-to-Moderate Ulcerative Colitis Kaleido Biosciences, Inc. announced that the first patient has been dosed in its clinical study evaluating Microbiome Metabolic Therapy (MMT) candidate KB295 in patients with mild-to-moderate ulcerative colitis (UC). UC is an inflammatory bowel disease that can cause debilitating symptoms, including abdominal pain, bowel urgency and diarrhea. Evidence suggests that a feature of UC is alteration of the gut microbiome, including an increase in inflammatory bacteria and decrease in commensal diversity which interfere with the normal immune response. In ex vivo studies, KB295 has demonstrated the ability to increase the production of short chain fatty acids and suppress the growth of inflammatory bacteria such as Enterobacteriaceae. This non-IND/non-CTA open label, single arm clinical study is expected to enroll approximately 30 patients with mild-to-moderate UC. Patients will receive KB295 for eight weeks titrated up to 40 g twice daily and then enter a one-month follow-up period. The study will evaluate the safety and tolerability of KB295 and other assessments including the Simple Clinical Colitis Activity Index (SCCAI) composite score, changes in microbiome composition and biomarkers of inflammation. Is New 90 Day High Low • Sep 24
New 90-day low: US$5.09 The company is down 35% from its price of US$7.79 on 26 June 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. 