8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 13, 2021

Equillium, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-38692	82-1554746
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
2223 Avenida de la Playa Suite 105
La Jolla, California		92037
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 858 412-5302

(Former Name or Former Address, if Changed Since Last Report)

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:

☐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 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 Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	EQ	NASDAQ Global Select 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 2.02 Results of Operations and Financial Conditions.

On May 13, 2021, Equillium, Inc. (“Equillium”) issued a press release announcing its financial results for the first quarter ended March 31, 2021 and providing a business update (the “Press Release”). A copy of the Press Release is furnished hereto as Exhibit 99.1 and is incorporated by reference herein.

The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by Equillium whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release dated May 13, 2021
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Equillium, Inc.
Date: May 13, 2021	By:	/s/ Bruce D. Steel
		Bruce D. Steel
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

Equillium Reports First Quarter 2021 Financial Results and Provides Clinical Development Update 

Announced favorable data from Phase 1b EQUALISE study in patients with systemic lupus erythematosus 

Cash runway into the second half of 2023 

Multiple data and regulatory catalysts through the remainder of 2021 

LA JOLLA, California, May 13, 2021 - Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced financial results for the first quarter 2021, and provided an update on its clinical development programs.   

“During the quarter, we announced the first of multiple data catalysts across three indications expected in 2021 for itolizumab, highlighting its potential broad therapeutic utility,” said Bruce Steel, chief executive officer at Equillium. “Data from the Type A group of patients in the Phase 1b EQUALISE study, our first from subcutaneous delivery, showed favorable safety and tolerability results in systemic lupus erythematosus patients. It also demonstrated a dose-dependent reduction in the pharmacodynamic marker of CD6 expression on effector T cells, and that these results were consistent with the promising data generated from intravenous dosing of itolizumab in the EQUATE study in acute graft-versus-host disease (aGVHD).  We now look ahead to the EQUATE study where we expect to announce topline data before the end of this quarter, followed by regulatory feedback on our proposed pivotal study in first-line treatment of aGVHD in mid-2021.  In the second half of the year we expect to announce data from the Type B group of patients with lupus nephritis in the EQUALISE study along with data from the EQUIP study in uncontrolled asthma.”

2021 Year-to-Date Corporate & Clinical Highlights: 

Announced favorable data from the Type A group of patients with systemic lupus erythematosus in the EQUALISE study, where itolizumab: 

oWas found to be safe and well tolerated 

oDemonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action 

oDemonstrated changes in pharmacodynamic markers observed with subcutaneous dosing were consistent with intravenous dosing of itolizumab 

Presented positive interim data from the EQUATE study in patients with acute graft-versus-host disease at the following conferences: 

o2021 Transplantation and Cellular Therapy Meetings Digital Experience 

oEuropean Society for Blood and Marrow Transplantation 

Completed a registered direct offering with Decheng Capital on February 5, 2021, which raised $29.9 million in net proceeds, strengthening Equillium’s balance sheet and extending its expected cash runway into the second half of 2023 

Strengthened the company's leadership, including the following additions since the beginning of this year: 

oDolca Thomas, M.D., appointed as executive vice president of research and development and chief medical officer 

oY. Katherine Xu, Ph.D., partner at Decheng Capital, appointed to Equillium’s board of directors 

Upcoming Catalysts: 

EQUATE Phase 1b study: topline data in first-line aGVHD, 1H 2021 

Regulatory feedback on proposed pivotal study in first-line aGVHD, mid-2021

Initiate pivotal study in first-line aGVHD, 2H 2021* 

EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis), 2H 2021 

EQUIP Phase 1b study: topline data in uncontrolled asthma, 2H 2021 

*Proposed protocol & timeline for site initiation contingent on regulatory review 

First Quarter 2021 Financial Results 

Research and development (R&D) expensesfor the first quarter of 2021 were $5.9 million, compared with $4.7 million for the same period in 2020. The increase in the first quarter of 2021 compared to the same period in 2020 was driven by an increase in clinical development expenses, primarily related to the EQUATE and EQUALISE studies as well as purchases of drug product from Equillium's collaboration partner, Biocon, for Equillium's ongoing clinical trials, greater headcount expenses, and greater research and translational science expenses. Those increases were partially offset by a reduction in overhead costs, primarily travel, and lower consulting expenses.  

General and administrative (G&A) expensesfor the first quarter of 2021 were $2.8 million, compared with $2.7 million for the same period in 2020. The increase in the first quarter of 2021 compared to the same period in 2020 was driven by greater headcount expenses partially offset by lower consulting expenses, legal fees, and travel expenses.   

Net loss for the first quarter of 2021 was $9.0 million, or $(0.33) per basic and diluted share, compared with a net loss of $7.8 million, or $(0.45) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to increased research and development expenses.

Cash used in operations for the first quarter of 2021 was $7.9 million compared to $8.3 million in the fourth quarter of 2020.

Cash, cash equivalents and short-term investments totaled $104.1 million as of March 31, 2021, compared to $82.2 million as of December 31, 2020. The increase was due to the registered direct offering with Decheng Capital in February 2021, which raised $29.9 million in net proceeds. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into the second half of 2023.

About Itolizumab 

Itolizumab is a clinical-stage, first-in-class anti-CD6 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 acute graft-versus-host-disease (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, uncontrolled asthma, or lupus/lupus nephritis with itolizumab, 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 for any of Equillium’s ongoing or planned clinical studies to show safety or efficacy, statements regarding the impact of new leadership team members, Equillium’s anticipated timing of regulatory review and feedback, Equillium’s cash runway, and Equillium’s plans and expected timing for developing itolizumab and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of new leadership team members to integrate and perform as expected; Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that interim results of a clinical study 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 studies and the reporting of data therefrom; the risk that studies will not be completed as planned; Equillium’s plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; whether the results from clinical studies will validate and support the safety and efficacy of itolizumab; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; and 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 SEC. 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

Media Contacts

Aljanae Reynolds 

Wheelhouse Life Science Advisors 

areynolds@wheelhouselsa.com

Equillium, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

(unaudited)

	March 31,		December 31,
	2021		2020
Cash, cash equivalents and short-term investments	$	104,079	$	82,163
Prepaid expenses and other assets		2,759		3,265
Total assets	$	106,838	$	85,428
Current liabilities		7,417		7,245
Long-term notes payable		7,506		8,275
Other non-current liabilities		35		54
Total stockholders' equity		91,880		69,854
Total liabilities and stockholders' equity	$	106,838	$	85,428

Equillium, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(unaudited)

	Three Months Ended  March 31,
	2021			2020
Operating expenses:
Research and development	$	5,880		$	4,706
General and administrative		2,815			2,746
Total operating expenses		8,695			7,452
Loss from operations		(8,695	)		(7,452	)
Other expense, net		(296	)		(385	)
Net loss	$	(8,991	)	$	(7,837	)
Net loss per common share, basic and diluted	$	(0.33	)	$	(0.45	)
Weighted-average number of common shares    outstanding, basic and diluted		27,325,372			17,562,551

XML

Document And Entity Information	May 13, 2021
Cover [Abstract]
Document Type	8-K
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Document Period End Date	May 13, 2021
Entity Registrant Name	Equillium, Inc.
Entity Central Index Key	0001746466
Entity Emerging Growth Company	true
Entity File Number	001-38692
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-1554746
Entity Address, Address Line One	2223 Avenida de la Playa
Entity Address, Address Line Two	Suite 105
Entity Address, City or Town	La Jolla
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92037
City Area Code	858
Local Phone Number	412-5302
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	EQ
Security Exchange Name	NASDAQ