8-K
Equillium, Inc. (EQ)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENTREPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (date of earliest event reported): November 30, 2020
EQUILLIUM, INC.
(Exactname of registrant as specified in its charter)
| Delaware | 001-38692 | 82-1554746 |
|---|---|---|
| (State or other jurisdiction<br><br><br>of incorporation) | (Commission<br><br><br>File Number) | (IRS Employer<br><br><br>Identification No.) |
| 2223 Avenida de la Playa, Suite 105, La Jolla, CA | 92037 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (858)412-5302
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17<br>CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br><br><br>Symbol(s) | Name of each exchange<br><br><br>on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | EQ | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
|---|
On November 30, 2020, Equillium, Inc. issued a press release announcing that it will host a virtual Investor and Analyst Day on December 4, 2020, from 9:30 a.m. to 12:00 p.m. ET (the “Press Release”). A copy of the Press Release is furnished hereto as Exhibit 99.1 and is incorporated by reference herein.
In accordance with General Instruction B.2 of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. | |
|---|---|---|
| (d) | Exhibit<br><br><br>Number | Description. |
| --- | --- | --- |
| 99.1 | Press release, dated November 30, 2020, issued by Equillium, Inc. |
SIGNATURE
Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| EQUILLIUM, INC. | |
|---|---|
| Date: November 30, 2020 | By: /s/ Bruce D.Steel |
| Bruce D. Steel | |
| President and Chief Executive Officer |
EX-99.1
Exhibit 99.1
Equillium to Host Virtual Investor and Analyst Day on December 4, 2020
Review positive interim data from the study of itolizumab for the treatment of acute GVHD and pipeline programs in lupus / lupus nephritisand uncontrolled asthma
Featured guest speaker: John Koreth, M.D., D.Phil. of Dana-Farber Cancer Institute
LA JOLLA, Calif, November 30, 2020 — Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that it will host a virtual Investor and Analyst Day on December 4, 2020, from 9:30 a.m. to 12:00 p.m. ET. The event will include a review of the company’s lead clinical drug candidate, itolizumab, a first-in-class monoclonal antibody, which is being investigated in ongoing trials in acute graft-versus-host disease (aGVHD), lupus / lupus nephritis and uncontrolled asthma.
Presenters include:
| • | John Koreth, M.D., D.Phil. of Dana-Farber Cancer Institute |
|---|---|
| • | Providing a physician’s perspective on itolizumab in GVHD |
| --- | --- |
| • | Bruce Steel, Chief Executive Officer |
| --- | --- |
| • | Steve Connelly, Ph.D., Chief Scientific Officer |
| --- | --- |
| • | Krishna Polu, M.D., Chief Medical Officer |
| --- | --- |
| • | Joel Rothman, SVP Development Operations |
| --- | --- |
| • | Jason Keyes, Chief Financial Officer |
| --- | --- |
The presentations will be followed by Q&A with management and Dr. Koreth.
A live webcast of the event will be available for 30 days on the Events & Presentations page of the Investor Relations section of the Company’s website at https://ir.equilliumbio.com/events-and-presentations.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including aGVHD, lupus / lupus nephritis and uncontrolled asthma.
For more information, visit www.equilliumbio.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential benefit of treating patients with aGVHD, lupus / lupus nephritis or uncontrolled asthma with itolizumab, Equillium’s business strategy, Equillium’s plans and expected timing for developing itolizumab, including the expected timing of initiating, completing and announcing further results from the EQUATE, EQUIP and EQUALISE studies, the potential benefits of itolizumab, the potential for any of Equillium’s ongoing or planned clinical trials to show safety or efficacy, and the impact of the COVID-19 pandemic. Risks that contribute to the uncertain nature of the forward-looking statements include: the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that studies will not be completed as planned; uncertainties related to Equillium’s capital requirements; Equillium’s plans and product development, including the initiation, restarting and completion of clinical trials; uncertainties related to the actual impacts and length of such impacts caused by the COVID-19 pandemic; uncertainties caused by the recent restarting of the EQUIP and EQUALISE clinical trials after a pause; whether the results from clinical trials will validate and support the safety and efficacy of itolizumab; changes in the competitive landscape, and uncertainties having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact
Michael Moore,
Vice President, Investor Relations & Corporate Communications
+1-619-302-4431
ir@equilliumbio.com
MediaContact
Katherine Carlyle Smith
Senior Account Associate
Canale Communications
+1-805-907-2497
katherine.smith@canalecomm.com