DICE Therapeutics, Inc. (NASDAQ:DICE) is a clinical-stage biopharmaceutical company leveraging its proprietary DELSCAPE platform to develop novel oral therapeutic candidates for the treatment of chronic diseases in immunology and other therapeutic areas. The company's lead therapeutic candidate, DC-806, is currently in a global, dose-ranging Phase 2b clinical trial for the treatment of psoriasis, with positive topline data from a Phase 1 trial announced in October 2022.
DICE's financial performance has been marked by significant investments in research and development as the company advances its pipeline. For the fiscal year ended December 31, 2022, the company reported a net loss of $81.7 million, with no revenue generated. The company's annual operating cash flow was -$64.3 million, and its annual free cash flow was -$66.6 million, reflecting the capital-intensive nature of the company's drug development activities.
In the first half of 2023, DICE continued to make progress on its clinical programs. For the three months ended June 30, 2023, the company reported a net loss of $34.8 million, with no revenue generated. Research and development expenses were $28.2 million, up from $14.3 million in the same period of the prior year, driven by increased activities for the company's IL-17 franchise and other research programs. General and administrative expenses were $11.3 million, up from $7.4 million in the prior-year period, primarily due to increased insurance, legal, and accounting fees, as well as higher personnel-related expenses.
DICE's cash position remains strong, with $528.4 million in cash, cash equivalents, and marketable securities as of June 30, 2023. The company believes this cash runway provides sufficient capital resources to continue its operations for at least the next 12 months. However, the company will require additional funding to advance its pipeline and achieve its long-term goals.
Business Overview
DICE was founded in 2015 with the goal of developing novel oral therapeutic candidates that can modulate protein-protein interactions (PPIs) as effectively as systemic biologics. The company's DELSCAPE platform is designed to discover selective oral small molecules that can disrupt PPIs, a challenging but potentially high-impact approach to treating chronic diseases.The company's lead therapeutic candidate, DC-806, is being developed for the treatment of psoriasis, a chronic inflammatory skin condition. In October 2022, DICE announced positive topline data from a Phase 1 clinical trial of DC-806, which demonstrated favorable safety and pharmacokinetic profiles. Based on these results, the company initiated a global, dose-ranging Phase 2b clinical trial for DC-806 in the first quarter of 2023.
In addition to DC-806, DICE has a portfolio of earlier-stage therapeutic candidates targeting various indications within immunology and other therapeutic areas. The company's fast follower therapeutic candidate, DC-853, is also being developed for the treatment of psoriasis and is expected to enter clinical trials in the near future.
DICE's research and development efforts are focused on leveraging its DELSCAPE platform to identify and develop novel oral small molecules that can modulate PPIs. The company believes this approach has the potential to offer therapeutic benefits comparable to those of systemic biologics, but with the convenience and accessibility of an oral formulation.
Risks and Challenges
As a clinical-stage biopharmaceutical company, DICE faces a number of risks and challenges that are common to the industry. These include the inherent uncertainty of the drug development process, the potential for regulatory delays or setbacks, competition from other therapies, and the need to secure additional funding to support the company's ongoing operations and pipeline development.One of the key risks facing DICE is the successful completion of its ongoing and future clinical trials. The company's ability to obtain regulatory approval and commercialize its therapeutic candidates is heavily dependent on the outcomes of these trials. Any delays or failures in the clinical development process could have a significant impact on the company's financial performance and future prospects.
Additionally, DICE operates in a highly competitive environment, with numerous other biopharmaceutical companies developing therapies for the same or similar indications. The company's success will depend on its ability to differentiate its products, demonstrate superior efficacy and safety profiles, and effectively navigate the regulatory landscape.
Liquidity
As a clinical-stage biopharmaceutical company, DICE's financial ratios and liquidity position are reflective of its focus on research and development activities. As of June 30, 2023, the company had a current ratio of 25.88 and a quick ratio of 25.69, indicating a strong liquidity position.However, the company's profitability ratios, such as gross profit margin, operating profit margin, and net profit margin, are not meaningful at this stage, as the company has not yet generated any revenue from product sales. Instead, the company's financial performance is primarily driven by its research and development expenses, which accounted for $51.9 million, or 73% of total operating expenses, in the first half of 2023.
DICE's cash, cash equivalents, and marketable securities totaled $528.4 million as of June 30, 2023, providing the company with a strong liquidity position to fund its ongoing operations and pipeline development. The company's cash runway is expected to extend for at least the next 12 months, based on its current operating plan.
Outlook and Guidance
DICE has not provided any formal financial guidance for the full year 2023. However, the company has highlighted the continued advancement of its clinical programs as a key focus for the year. In particular, the company is prioritizing the successful completion of the ongoing Phase 2b trial for DC-806 in psoriasis, as well as the initiation of clinical trials for its fast follower candidate, DC-853, also in psoriasis.Additionally, the company is actively exploring opportunities to expand its pipeline through internal research and development efforts, as well as potential collaborations or strategic partnerships. DICE's management has emphasized the importance of maintaining a strong financial position to support the company's long-term growth and development.
Conclusion
DICE Therapeutics is a promising biopharmaceutical company that is leveraging its proprietary DELSCAPE platform to develop novel oral therapeutic candidates for the treatment of chronic diseases. The company's lead candidate, DC-806, has demonstrated positive results in early-stage clinical trials, and the ongoing Phase 2b trial will be a critical milestone in the company's development.While DICE has yet to generate any revenue from product sales, the company's strong cash position and continued investment in research and development suggest that it is well-positioned to advance its pipeline and potentially bring new therapies to market in the future. However, the company faces significant risks and challenges, including the inherent uncertainty of the drug development process and the highly competitive nature of the biopharmaceutical industry.
Overall, DICE Therapeutics represents an intriguing opportunity for investors interested in the company's innovative approach to targeting protein-protein interactions and its potential to address unmet medical needs in immunology and other therapeutic areas.