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California-Based Biotech Receives COVID-19 Trial Clearance
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The timeline and next steps for Equillium's proposed Phase 3 clinical study are outlined in an H.C. Wainwright & Co. report.

In a Sept. 21 research note, H.C. Wainwright analyst Ram Selvaraju reported that Equillium Inc. (EQ:NASDAQ) received approval from the U.S. Food and Drug Administration (FDA) to advance its COVID-19 clinical trial.

Selvaraju relayed what is now known about the program. Equillium intends to launch a global Phase 3 trial evaluating itolizumab (EQ001) as a treatment for patients with the coronavirus and admitted to the hospital.

The California-based biotech intends for the study to start in Q4/20, but it must first finalize the study protocol and submit an investigational new drug (IND) application to the FDA. Equillium expects to complete the latter in October 2020 and, also, apply to various government agencies for study funding.

In Equillium's pre-IND meeting, as part of the Coronavirus Treatment Acceleration Program, the FDA noted that if the primary and key secondary endpoints are met in the trial then itolizumab may qualify for a biologic license application. Details have yet to be announced other than the trial will be randomized, double blind, placebo controlled and conducted in the U.S. and other, as yet to be determined, countries.

Selvaraju indicated that H.C. Wainwright expects a fast timeline for clinical development of itolizumab in COVID-19-related respiratory conditions. This is due to the urgency surrounding development of a COVID-19 vaccine, the ease in finding study participants in the U.S. and the likely small number of enrollees required.

"We have modeled future sales of itolizumab in treatment of COVID-19-infected individuals who manifest breathing difficulties and must be given supplemental oxygen or mechanical ventilation," Selvaraju noted.

H.C. Wainwright estimates more than 12 million people will become infected with the SARS-CoV-2 virus in 2021 and the number will increase to close to 19 million in 2022 and then drop off.

"We thus believe that itolizumab could be developed rapidly for treatment of COVID-19-related respiratory complications and might be launched late next year pursuant to an emergency use authorization certification from the FDA," commented Selvaraju.

The analyst also reported that Equillium presented data at the virtual European Respiratory Society International Congress 2020 that indicate the CD6-ALCAM pathway may contribute to asthma and, therefore, is a potential viable target for therapy in patients with an uncontrolled form of the condition. Data also showed that elevated levels of soluble ALCAM were seen in the sputum of patients with severe asthma and high eosinophil levels in the sputum. As such, studies are being done to pursue this as a possible biomarker.

H.C. Wainwright has a Buy rating and a $22 per share target price on Equillium. The stock is now trading at about $6.04 per share.


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Disclosures from H.C. Wainwright & Co., Equillium, Inc., Company Update, September 21, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Equillium, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of August 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Equillium, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Equillium, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from Equillium, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Equillium, Inc. during the past 12 months.

The Firm does not make a market in Equillium, Inc. as of the date of this research report.

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