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): November 09, 2022

DICE THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-40794	47-2286244
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
400 East Jamie Court, Suite 300
South San Francisco, California		94080
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 650 566-1420

N/A

(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, $0.0001 Par Value Per Share	DICE	The NASDAQ Stock Market LLC

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 Condition.

On November 9, 2022, DICE Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2022. A copy of the press release is attached as Exhibit 99.1 to this report.

The information in this Item 2.02, including Exhibit 99.1 to this report, 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 liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press release issued by DICE Therapeutics, Inc. regarding its financial results for the quarter ended September 30, 2022, dated November 9, 2022.
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 thereunto duly authorized.

			DICE THERAPEUTICS, INC.
Date:	November 9, 2022	By:	/s/ Scott Robertson
			Scott Robertson Chief Business and Financial Officer

EX-99.1

Exhibit 99.1

 

DICE Therapeutics Reports Third Quarter 2022 Financial Results and Recent Highlights

•Reported positive Phase 1 proof-of-concept data supporting the further development of lead oral IL-17 antagonist, DC-806, as potential best-in-class oral agent for psoriasis

•Demonstrated direct inhibition of a cytokine with a small molecule in psoriasis patients, which we believe validates the DELSCAPE platform and DICE’s approach to identifying and advancing oral medicines against protein-protein interactions in immunology

•Completed $345 million upsized public offering providing funding into 2026

SOUTH SAN FRANCISCO, CA, November 9, 2022 – DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, today reported financial results and business highlights for the third quarter ended September 30, 2022.

“With clear clinical proof-of-concept achieved in our Phase 1 trial of DC-806 in psoriasis, we have attained a consequential milestone on our mission to advance transformative oral medicines for autoimmune and inflammatory diseases via our DELSCAPE platform,” said Kevin Judice, Ph.D., CEO of DICE Therapeutics. “Following the completion of our recent $345 million public offering, we believe we are extremely well positioned to advance this promising direct oral IL-17 antagonist into a Phase 2b clinical trial in the first half of 2023.”

Recent Highlights

•Reported positive Phase 1 proof-of-concept data supporting the further development of lead oral IL-17 antagonist, DC-806, as potential best-in-class oral agent for psoriasis.

oClinical proof-of-concept was achieved, with a mean percentage reduction in Psoriasis Area and Severity Index (PASI) from baseline of 43.7% in the high dose psoriasis group compared to 13.3% in the placebo group, with an exploratory p-value of 0.0008 following 4 weeks of treatment.

oBoth doses of DC-806 were shown to be biologically active via analysis of well-precedented biomarkers with dose-dependent IL-17 target engagement, rapid onset of action, and pharmacodynamic effects consistent with direct inhibition of IL-17 signaling.

oDC-806 showed a favorable pharmacokinetic (PK) profile with dose-proportional increases in serum concentrations throughout the study.

oDC-806 was well tolerated with an excellent safety profile across all dose groups in healthy volunteers and psoriasis patients.

oDICE plans to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first half of 2023 and advance DC-806 into a

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dose-ranging Phase 2b clinical trial in patients with moderate-to-severe psoriasis to further explore peak efficacy with a longer duration of treatment.

•Continued execution of stated oral IL-17 franchise strategy: Phase 1 data on second oral IL-17 antagonist, DC-853, anticipated in the second half of 2023.

oDICE’s strategy involves the advancement of multiple oral IL-17 compounds into clinical development, each with differentiated properties. Topline data from the Phase 1 clinical trial of DC-853 in healthy volunteers is expected in the second half of 2023.

Third Quarter 2022 Financial Highlights

•Cash Position: Cash, cash equivalents and marketable securities totaled $266.6 million at September 30, 2022. In addition, in October 2022, DICE announced the successful closing of an upsized public offering, raising gross proceeds of $345.0 million. The Company expects its current cash position to fund operations through expected key clinical milestones and into 2026.

•R&D Expenses: Research and development expenses were $14.7 million for the third quarter of 2022, compared to $11.7 million for the same period in 2021. The increase of $3.0 million was primarily due to an increase of $0.7 million related to the advancement of DICE’s IL-17 franchise and other research programs, and increases related to personnel expenses of $2.0 million due to an increase in headcount and stock-based compensation expense.

•G&A Expenses: General and administrative expenses were $6.4 million for the third quarter of 2022, compared to $4.4 million for the same period in 2021. The increase of $2.0 million was primarily due to a $0.7 million increase in personnel costs related to increased headcount and stock-based compensation and a $1.3 million increase in professional service fees and other costs primarily due to the additional expenses associated with operating as a publicly-traded company.

•Net Loss: Net loss totaled $20.6 million and $17.3 million for the third quarters of 2022 and 2021, respectively, with non-cash stock-based compensation expense of $3.5 million and $3.2 million for the third quarters of 2022 and 2021, respectively.

About the DICE Oral IL-17 Franchise and Psoriasis

DICE is developing orally-available, small molecule antagonists of the pro-inflammatory signaling molecule IL-17, an immune cell-derived cytokine that is produced in response to infection by certain microorganisms. Upon binding to its receptor on various cell types found in tissues (e.g., keratinocytes, fibroblasts, and epithelial cells), IL-17 elicits downstream signals that orchestrate sustained tissue inflammation, with the aim of clearing the invading pathogen.

In autoimmune diseases, the immune system appears to overreact and mount strong immune responses in the absence of an obvious infectious event. Over the past two decades, research has shown that IL-17 is a powerful driver of the skin disease psoriasis. Psoriasis manifests as erythematous plaques with thick scaling that can occur anywhere on the body. Symptoms include itching, bleeding and pain; furthermore, the disease can lead to disfiguration and considerable psychological burden. According to

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the National Psoriasis Association, more than eight million Americans – and 125 million people worldwide – suffered from psoriasis in 2020. There is no cure for psoriasis.

The therapeutic candidates in DICE’s oral IL-17 franchise are being developed initially for the treatment of psoriasis, with the objective of achieving therapeutic benefit similar to that of the U.S. FDA-approved injectable biologics. DC-806 is the lead candidate in DICE’s oral IL-17 franchise.

About DICE Therapeutics, Inc.
DICE Therapeutics, Inc. is a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas. DICE is initially focused on developing oral therapeutics against well-validated targets in immunology, with the goal of achieving comparable potency to their systemic biologic counterparts, which have demonstrated the greatest therapeutic benefit to date in these disease areas. The Company’s DELSCAPE platform is designed to discover selective oral small molecules with the potential to modulate protein-protein interactions (PPIs) as effectively as systemic biologics. DICE’s lead therapeutic candidates are oral antagonists of the pro-inflammatory signaling molecule, IL-17, which is a validated drug target implicated in a variety of immunology indications. DICE is also developing oral therapeutic candidates targeting α4ß7 integrin and αVß1/αVß6 integrin for the treatment of inflammatory bowel disease and idiopathic pulmonary fibrosis, respectively.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and prospects, the Company’s anticipated runway, any expectations regarding the safety or efficacy of DC-806 and other candidates under development, the ability of DC-806 to treat psoriasis or related indications, and the planned timing of the Company’s clinical trials, data results and further development of DC-806 and DC-853. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the Company’s ability to advance DC-806, DC-853 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact of the COVID-19 pandemic on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described under the heading “Risk Factors” in the Company’s quarterly report on Form 10-Q filed on November 9, 2022, and its other SEC filings. Accordingly, readers are cautioned not to place undue

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reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein.

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DICE THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(unaudited)

(In thousands, except share and per share amounts)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Revenue:
Collaboration revenue	$	—		$	—		$	—		$	1,125
Operating expenses:
Research and development		14,730			11,689			42,470			24,292
General and administrative		6,439			4,444			19,301			8,226
Total operating expenses		21,169			16,133			61,771			32,518
Loss from operations		(21,169	)		(16,133	)		(61,771	)		(31,393	)
Other income (expense):
Interest and other income, net		702			20			1,516			61
Interest expense		(83	)		(60	)		(208	)		(114	)
Loss on extinguishment of debt		—			—			(200	)		—
Change in fair value of warrant liability		—			(1,162	)		—			(1,318	)
Net loss	$	(20,550	)	$	(17,335	)	$	(60,663	)	$	(32,764	)
Net loss per share, basic and diluted	$	(0.55	)	$	(2.30	)	$	(1.62	)	$	(8.12	)
Weighted-average shares used in computing net loss per share, basic and diluted		37,480,179			7,551,128			37,368,993			4,035,590

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DICE THERAPEUTICS, INC.

Selected Consolidated Balance Sheet Data

(unaudited)

(In thousands)

	September 30, 2022			December 31, 2021
Cash, cash equivalents, and marketable securities	$	266,614		$	319,321
Total assets		284,994			325,754
Total liabilities		23,880			12,805
Accumulated deficit		(164,370	)		(103,707	)
Total stockholders' equity		261,114			312,949

Contacts:

Media:
Katie Engleman, 1AB
katie@1abmedia.com

Investors:
investors@dicetx.com

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XML

Document And Entity Information	Nov. 09, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 09, 2022
Entity Registrant Name	DICE THERAPEUTICS, INC.
Entity Central Index Key	0001645569
Entity Emerging Growth Company	true
Securities Act File Number	001-40794
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-2286244
Entity Address, Address Line One	400 East Jamie Court, Suite 300
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	650
Local Phone Number	566-1420
Entity Information, Former Legal or Registered Name	N/A
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, $0.0001 Par Value Per Share
Trading Symbol	DICE
Security Exchange Name	NASDAQ