UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(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:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
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 March 15, 2023, DICE Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 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 No. |
|
Description |
|
|
|
99.1 |
|
Press release issued by DICE Therapeutics, Inc. on March 15, 2023. |
|
|
|
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: |
March 15, 2023 |
By: |
/s/ Scott Robertson |
|
|
|
Scott Robertson |
Exhibit 99.1
DICE Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, CA, March 15, 2023 – DICE Therapeutics, Inc. (Nasdaq: DICE) (DICE or the Company), a biopharmaceutical company leveraging its proprietary DELSCAPE technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology, today reported financial results for the fourth quarter and full year ended December 31, 2022 and highlighted recent corporate achievements.
“We have entered 2023 with strong momentum and continue to make excellent progress advancing our oral IL-17 programs, including our lead product candidate DC-806 and fast follower DC-853,” said Kevin Judice, Ph.D., CEO of DICE Therapeutics. “Following the recent U.S. Food and Drug Administration (FDA) clearance of our investigational new drug (IND) application for DC-806, we remain on track to initiate a global Phase 2b clinical trial in the first half of 2023. In addition, we began dosing healthy volunteers in our Phase 1 trial with DC-853 and expect topline data in the second half of 2023. We are also continuing to utilize our DELSCAPE platform to advance our earlier stage research and development (R&D) programs, expanding our pipeline to other validated targets in immunology.”
Recent Highlights
1
Fourth Quarter and Full Year 2022 Financial Highlights
About the DICE Oral IL-17 Franchise
DICE is developing orally-available, small molecule antagonists of the pro-inflammatory signaling molecule IL-17, an immune cell-derived cytokine. Blockade of this pathway has proven to be an effective therapy in a number of auto-immune diseases. The anti-IL-17 injectable biologics have been approved for the treatment of psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
2
The DICE oral IL-17 franchise includes the lead therapeutic candidate, DC-806, the differentiated fast-follower candidate, DC-853, and the novel scaffold program. DICE is developing its lead therapeutic candidate, DC-806, for the treatment of psoriasis and plans to expand development to additional indications in which the marketed anti-IL-17 injectable biologics have proven to be effective.
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 the integrin α4ß7 for the treatment of inflammatory bowel disease.
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, the planned timing of the Company’s clinical trials, data results and further development of DC-806 and DC-853, and expectations regarding an oral development candidate targeting α4β7. 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 annual report on Form 10-K filed on March 15, 2023, and its other SEC filings. Accordingly, readers are cautioned not to place undue 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.
3
DICE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share amounts)
|
|
Three Months Ended |
|
|
Year Ended |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Collaboration revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,125 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
20,089 |
|
|
|
12,214 |
|
|
|
62,559 |
|
|
|
36,506 |
|
General and administrative |
|
|
6,361 |
|
|
|
3,996 |
|
|
|
25,662 |
|
|
|
12,222 |
|
Total operating expenses |
|
|
26,450 |
|
|
|
16,210 |
|
|
|
88,221 |
|
|
|
48,728 |
|
Loss from operations |
|
|
(26,450 |
) |
|
|
(16,210 |
) |
|
|
(88,221 |
) |
|
|
(47,603 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
3,697 |
|
|
|
75 |
|
|
|
5,213 |
|
|
|
136 |
|
Interest and other expense |
|
|
(471 |
) |
|
|
(60 |
) |
|
|
(679 |
) |
|
|
(174 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(200 |
) |
|
|
— |
|
Change in fair value of warrant liability |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,318 |
) |
Net loss |
|
$ |
(23,224 |
) |
|
$ |
(16,195 |
) |
|
$ |
(83,887 |
) |
|
$ |
(48,959 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.44 |
) |
|
$ |
(2.13 |
) |
|
$ |
(3.95 |
) |
Weighted-average shares used in computing net loss per share, basic and diluted |
|
|
45,431,180 |
|
|
|
37,157,057 |
|
|
|
39,401,106 |
|
|
|
12,384,015 |
|
4
DICE THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(unaudited)
(In thousands)
|
|
December 31, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Cash, cash equivalents, and marketable securities |
|
$ |
574,225 |
|
|
$ |
319,321 |
|
Total assets |
|
|
593,978 |
|
|
|
325,754 |
|
Total liabilities |
|
|
26,990 |
|
|
|
12,805 |
|
Accumulated deficit |
|
|
(187,594 |
) |
|
|
(103,707 |
) |
Total stockholders' equity |
|
|
566,988 |
|
|
|
312,949 |
|
Contacts:
Media:
Katie Engleman, 1AB
katie@1abmedia.com
Investors:
investors@dicetx.com
5