Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need
Corporate Presentation
January 24, 2022
FORWARD-LOOKING STATEMENTS
This presentation contains forward-looking statements about Spruce Biosciences, Inc. ("we," "Spruce" or the "Company"). All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our strategy, our expectations regarding the timing and achievement of our product candidate's development activities and ongoing and planned clinical trials, and plans and expectations for future operations.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the effects of the evolving and ongoing COVID-19 pandemic; our limited operating history; net losses; our expectation that we will incur net losses for the foreseeable future, and that we may never be profitable; our need for additional funding and related risks for our business, product development programs and future commercialization activities; the timing and success of clinical trials we conduct; the ability to obtain and maintain regulatory approval of our product candidate; the ability to commercialize our product candidate; our ability to compete in the marketplace; risks regarding our license agreement; our ability to obtain and maintain intellectual property protection for our product candidate; and our ability to manage our growth. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations.
Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and Spruce's own internal estimates and research. While Spruce believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of Spruce's internal estimates or research and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research.
This presentation discusses a product candidate that is under clinical study and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of this product candidate for the use for which it is being studied.
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SPRUCE AT-A-GLANCE
Tildacerfont poised to transform treatment paradigm in classic CAH
Multiple expansion opportunities
Significant commercial opportunity
Strong IP protection
Highly experienced leadership team
Two late-stage clinical studies initiated; Data expected in 2H-2023(CAHmelia-203)and 2H-2024(CAHmelia-204).
Phase 2 programs in pediatric classic CAH (6 to 17 years of age) and polycystic ovary syndrome (FAH-PCOS) initiated
~$3B+ worldwide market opportunity in classic CAH
Comprehensive IP portfolio based on issued patents provides exclusivity to 2038 in U.S. combined with Orphan Drug Designation in U.S. and Europe
Management has contributed to development and commercial launch of endocrine and rare disease products
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Classic CAH Overview
CLASSIC CAH DISEASE OVERVIEW
Classic CAH is a chronic and potentially life-threatening rare disease
Classic CAH is an autosomal | Due to the severity and high | We estimate the total classic |
recessive disease characterized | incidence of the disease, most | CAH population to be |
by an inability to produce | developed countries have | approximately 20,000-30,000 |
cortisol, leading to a chronic | established newborn screening | people in the U.S., 50,000 |
imbalance of key hormones and | programs to test for classic | people in the EU, and at least |
an overproduction of adrenal | CAH at birth. | 145,000 people in China. |
androgens. |
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Spruce Biosciences Inc. published this content on 24 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 January 2022 13:03:07 UTC.