DICE Therapeutics Reports Third Quarter 2021 Financial Results and Recent Highlights
- Dosed first healthy volunteers in Phase 1 clinical trial of oral IL-17 antagonist S011806
- Successfully completed
$234.6 millionupsized initial public offering
“The third quarter represented a pivotal time for DICE both clinically and operationally as we transitioned into a clinical-stage, public company,” said
- Dosed first volunteers in Phase 1 clinical trial of S011806. S011806 is an orally-available, small molecule antagonist of the pro-inflammatory cytokine, interleukin-17 (IL-17), which is a validated drug target for the treatment of a variety of immunological diseases. The Phase 1 trial is designed to generate safety and pharmacokinetic data, as well as provide early clinical proof-of-concept in psoriasis patients. The trial will be conducted in three cohorts: Phase 1a and 1b in healthy volunteers, and Phase 1c in psoriasis patients.
$234.6 millioninitial public offering. DICE closed its initial public offering of 13,800,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,800,000 additional shares of common stock at the public offering price of $17.00per share. The aggregate gross proceeds were approximately $234.6 millionbefore deducting underwriting discounts and other offering expenses, bringing total cash, cash equivalents and marketable securities to $335.7 millionat the end of September 30, 2021.
Third Quarter 2021 Financial Results
- Cash Position: Cash and cash equivalents and marketable securities totaled
$335.7 millionat September 30, 2021. The company expects its current cash position to fund operations through the end of 2023 and through key clinical milestones.
- R&D Expenses: Research and development expenses were
$11.7 millionfor the third quarter of 2021, compared to $4.5 millionfor the third quarter of 2020. The increase of $7.2 millionwas primarily due to an increase of $4.5 millionrelated to the preclinical advancement of our IL-17 franchise and an increase in research and development expenses of $0.6 millionrelated to our other preclinical programs. Personnel-related expenses also increased by $2.0 milliondue to an increase in headcount and stock-based compensation.
- G&A Expenses: General and administrative expenses were
$4.4 millionfor the third quarter of 2021, compared to $1.7 millionfor the third quarter of 2020. The increase of $2.7 millionwas primarily due to a $2.1 million increase in personnel related costs related to an increase in headcount and stock-based compensation, and a $0.6 million increase in professional service fees primarily associated with becoming a public company.
- Net Loss: Net loss totaled
$17.3 millionand $6.0 millionfor the third quarters of 2021 and 2020, respectively, with non-cash stock-based compensation expense of $3.2 millionand $0.1 millionfor the third quarters of 2021 and 2020, respectively.
- DICE management plans to participate at the following upcoming investor conferences:
- 4th Annual
Evercore ISI HealthCONx Conference2021, being held from November 30 to December 2.
- Piper Sandler 33rd Annual Healthcare Conference, being held from
November 29 to December 2.
- 4th Annual
About S011806 and Psoriasis
S011806 is an orally-available, small molecule antagonist 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 over-react 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 psoriasis, a skin disease that occurs in the absence of an obvious infectious event. 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 the
S011806 is being developed initially for the treatment of psoriasis, with the objective of achieving therapeutic benefit similar to that of the
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 cash position and financial results, and the planned timing of the Company’s dosing and further clinical development of S011806. 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 we believe the expectations reflected in such forward-looking statements are reasonable, we 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 our forward-looking statements due to a variety of factors, including risks and uncertainties related to our ability to advance S011806 and our other therapeutic candidates, obtain regulatory approval of and ultimately commercialize our therapeutic candidates, the timing and results of preclinical and clinical trials, our ability to fund development activities and achieve development goals, the impact of the COVID-19 pandemic on our business, our ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in our final prospectus filed with the Securities and Exchange Commission (SEC) pursuant to Rule 424(b)(4) on September 16, 2021, and our 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.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Three Months Ended
|Research and development||11,689||4,457|
|General and administrative||4,444||1,750|
|Total operating expenses||16,133||6,207|
|Loss from operations||(16,133||)||(5,982||)|
|Other income (expense):|
|Interest and other income, net||20||7|
|Change in fair value of warrant liability||(1,162||)||(38||)|
|Other comprehensive income (loss):|
|Unrealized loss on marketable securities||(2||)||(2||)|
|Net loss per share, basic and diluted||$||(2.30||)||$||(2.68||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||7,551,128||2,248,687|
Selected Consolidated Balance Sheet Data
|Cash, cash equivalents, and marketable securities||$||335,662||$||59,687|
|Convertible preferred units||—||107,374|
|Total stockholders' equity /members' (deficit)||327,520||(53,145||)|
1) The selected consolidated balance sheet data as of
Source: DICE Therapeutics, Inc.