It could be a big year as several biotech companies gear up for key microbiome therapies Regulatory and Clinical Benchmarks In 2022, Kaleido Biosciences will not be among them. The company is shutting down as a last resort after the company suffered setbacks and was unable to find the financial foundation to support its clinical-stage programs.
on a friday Regulatory filing, Kaleido said its board voted earlier in the day to immediately halt the company’s operations. The decision came after a strategic review failed to find a way forward.
“Unfortunately, this strategic process has not identified any viable transactions, and given its limited resources, the company is unable to continue operations and believes that an orderly closing process is the best option,” Kaleido said in the filing.
Kaleido’s approach to the microbiome is different from other biotechnologies. Instead of therapy consisting of live microorganisms added to the patient’s microbial environment, Kaleido develops Microbiome Metabolic Therapy (MMT), which describes it as a collection of molecules that influence the microbiome and drive the function and composition of a patient’s existing microbes. The company aims to treat diseases related to the microbiome; its product line spans immune-mediated diseases, respiratory diseases and immuno-oncology. The company has a research partnership with Johnson & Johnson subsidiary Janssen that focuses on other diseases such as allergies in children.
Kaleido was founded in 2015 by Flagship Pioneering, a venture capital firm whose other Microbiome portfolio companies include Seres Therapeutics and Evelo Bioscience. Flagship Startup Senda Biosciences, analyzing interactions between humans and bacteria But it doesn’t call itself a microbiome company.After hatching within a flagship, Kaleido emerged from stealth in 2017, then Listed in two years, raised $75 million by selling shares at $15 a share — well below the biotech’s planned range of $20 to $22 a share. Flagship was Kaleido’s largest shareholder with a 45.9 percent stake in the company as of the end of March, regulatory filings show.
Shares of Kaleido closed at 26 cents on Friday, down more than 81% from Thursday’s close. In Kaleido’s three years as a public company, its shares have mostly fallen from their IPO prices, except at the beginning of the year.At the time, there were few treatment options available for Covid-19, and Kaleido’s stock surged after the company’s encouraging report Interim Clinical Data For MMT, it is being tested as a potential treatment. Kaleido’s drug KB109 was originally developed to prevent multidrug-resistant infections. The company has said it could offer a non-antibiotic way to selectively boost the growth of beneficial gut bacteria at the expense of pathogens. For Covid, the company believes its experimental therapy can help limit the cascade of inflammation caused by the viral infection.
Early encouraging data from KB109 is the last positive sign for the therapeutic candidate and Kaleido. last August, FDA issues warning letter to company Raising concerns about a study evaluating microbiome therapy as a medical food rather than a drug. The FDA said Kaleido was testing KB109 in Covid-19 but did not meet the drug’s requirements for clinical trials.
Ahead of the FDA warning letter, red flags were waving around Kaleido. For more than a year, the biotech company’s financial statements have disclosed dwindling cash and doubts about the company’s ability to continue as a going concern.In its annual report In its filing in early April, Kaleido said it had only $38.5 million in cash at the end of 2021 — not enough to support the company for another year. The company added that it expects to raise additional capital through equity or debt financing, or through partnerships or licensing deals. None of these options are implemented.
Kaleido said in regulatory filings that it laid off all of its employees on Friday. The annual report shows that by the end of 2021, the company has a total of 76 employees; 58 of them are engaged in research and development. The company said it will file with the U.S. Securities and Exchange Commission about the delisting of its shares, which is expected to take effect around April 28.
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