Spruce Biosciences, Inc. · NASDAQ:SPRB
Spruce Biosciences — Baird 2021 Global Healthcare Conference
17 slides from Spruce Biosciences's conference presentation, Sep 15, 2021
Slide 1: Baird 2021 Global Healthcare Conference
Baird 2021 Global Healthcare Conference Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Spruce BIOSCIENCES Exhibit 99.1
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS 2 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
Slide 3: Spruce At-A-Glance: Key Investor Highlights
SPRUCE AT-A-GLANCE 3 KEY INVESTOR HIGHLIGHTS Tildacerfont poised to transform treatment paradigm in classic CAH Strong IP protection Multiple expansion opportunities Significant commercial opportunity Highly experienced leadership team Two late-stage clinical studies initiated; Enriched patient popu
Slide 4: Classic CAH Disease Overview
4 CLASSIC CAH DISEASE OVERVIEW Classic CAH is a chronic and potentially life-threatening rare disease Classic CAH is an autosomal recessive disease characterized by an inability to produce cortisol, leading to a chronic imbalance of key hormones and an overproduction of adrenal androgens. Due to the
Slide 5: HPA Axis Function in Classic CAH Patients
HPA AXIS FUNCTION IN CLASSIC CAH PATIENTS 5 Lack of cortisol leads to overproduction of ACTH and precursor steroid molecules, resulting in excessive adrenal androgens The dysregulation of the HPA axis in classic CAH.
Slide 6: Current Challenges in Treating Classic CAH
SHORT STATURE CARDIOVASCULAR DISEASE INSULIN RESISTANCE SHORT STATURE ABNORMAL AND/OR EARLY PUBERTY INFERTILITY PSYCHOLOGICAL EFFECTS HIRSUTISM, AMENORRHEA ACNE Excess GCs Excess Androgens OSTEOPOROSIS OBESITY CURRENT CHALLENGES IN TREATING CLASSIC CAH 6 CAH, congenital adrenal hyperplasia; GC, gluc
Slide 7: Tildacerfont Is a Novel CRF1 Receptor Antagonist
Tildacerfont is an oral, second generation CRF1 receptor antagonist1 Tildacerfont binds to CRF1 receptors in the pituitary gland, blocking receptor stimulation by the hypothalamus1 TILDACERFONT IS A NOVEL CRF1 RECEPTOR ANTAGONIST 7 ACTH, adrenocorticotropic hormone; CRF, corticotropin-releasing fact
Slide 8: Key Findings from Phase 2 Studies: Summary
8 KEY FINDINGS FROM PHASE 1 AND 2 STUDIES: SUMMARY ACTH, adrenocorticotropic hormone; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CAH, congenital adrenal hyperplasia; QD, once daily; SAE, serious adverse event; TART, testicular adrenal rest tumor. Liver icon by Edwin PM, Noun Pro
Slide 9: SPR001-202: Robust Reduction in ACTH in Poorly Controlled Disease
9 SPR001-202: ROBUST REDUCTION IN ACTH IN POORLY CONTROLLED DISEASE *One subject at week 2 prior to discontinuation from the trial and two patient during month 3. ACTH, adrenocorticotropic hormone; QD, once daily. Sarafoglou K, et al. J Clin Endocrinol Metab. 2021:dgab438. DOI: https://doi.org/10.12
Slide 10: SPR001-202: Sustained Reduction in A4 in Poorly Controlled Disease
10 SPR001-202: SUSTAINED REDUCTION IN A4 IN POORLY CONTROLLED DISEASE A4, androstenedione; QD, once daily. Sarafoglou K, et al. J Clin Endocrinol Metab. 2021:dgab438. DOI: https://doi.org/10.1210/clinem/dgab438 [Epub ahead of print]. In poor disease control group, an initial drop in A4 was seen at w
Slide 11: CAHmelia-203: Adrenal Androgen Reduction Study
11 CAHmelia-203: ADRENAL ANDROGEN REDUCTION STUDY Study schema is not drawn to scale. SINGLE-BLIND RUN-IN (6 weeks on placebo) SAFETY FOLLOW-UP (30 days) PART B (12 weeks) PART A (12 weeks) PART C (46 weeks) RANDOMIZED PERIOD OPEN-LABEL EXTENSION Tildacerfont 200 mg QD Tildacerfont 100 mg QD Tildace
Slide 12: CAHmelia-204: GC Reduction Study
12 CAHmelia-204: GC REDUCTION STUDY A randomized, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of tildacerfont in reducing supraphysiologic GC use in adult patients with classic CAH Study schema is not drawn to scale. GC CONVERSION (6 or 12 weeks) (24 weeks) (5
Slide 13: Phase 2 Study in Pediatric CAH
13 PHASE 2 STUDY IN PEDIATRIC CAH Study schema is not drawn to scale. *Weight-based dosing at adult/effective dose equivalents. 17-OHP, 17-hydroxyprogesterone; A4, androstenedione; ACTH, adrenocorticotropic hormone; B, baseline; CAH, congenital adrenal hyperplasia; DSMB, Data Safety and Monitoring B
Slide 14: Polycystic Ovary Syndrome Overview
POLYCYSTIC OVARY SYNDROME OVERVIEW Polycystic ovary syndrome (PCOS) is a complex condition characterized by elevated androgen levels, menstrual irregularities, and/or small cysts on one or both ovaries. 5% to 10% of females 18 to 44 years of age are affected by PCOS (~5 million women in the U.S.), m
Slide 15: Phase 2 POC Study in Polycystic Ovary Syndrome
PHASE 2 POC STUDY IN POLYCYSTIC OVARY SYNDROME 15 Placebo Period 1: 50 mg Period 2: 50 mg Period 3: 50 mg (total duration: 16 weeks) Follow up Period 2: 100 mg Period 3: 100 mg (total duration: 12 weeks) Period 3: 200 mg (total duration: 8 weeks) Follow up Follow up Day 1 BL W2 W4 overnight W6 W8 ov
Slide 16: Key Anticipated Milestones
KEY ANTICIPATED MILESTONES 16 Initiate Phase 2 trial in pediatric classic CAH Initiate Phase 2 proof-of-concept (POC) trial in PCOS Topline results in adult classic CAH (CAHmelia-204)* Topline results in adu lt classic CAH (CAHmelia-203)* Phase 2 results in pediatric classic CAH and PCOS* 1H2023 * C
Slide 17: Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet
Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Spruce BIOSCIENCES
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