{ "docId": "019de074-559c-76fa-9457-a7d91e9a06c5", "docSlug": "15199f0b497c4ef204a0760da27401b3", "documentTitle": "Dare Bioscience | Investor Presentation Deck | 54 slides", "authorId": "dare-bioscience", "authorName": "Daré Bioscience", "documentKindSlug": "pitchdeck", "documentKindLabel": "Pitch deck", "sourceTypeSlug": "investor_relations", "sourceTypeLabel": "Investor relations", "presentationDate": "2023-02-01 00:00:00", "orientation": "landscape", "aspectRatio": 1.2938006, "pageNumber": 41, "pageCount": 54, "prevPage": 40, "nextPage": 42, "slideType": "traction", "function": "show_traction", "density": "overcrowded", "nDataPoints": 4, "notes": "The slide highlights statistically significant improvements (p<0.01) across multiple clinical endpoints.", "elementsJson": null, "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019de074-559c-76fa-9457-a7d91e9a06c5/41", "deckHref": "/decks/019de074-559c-76fa-9457-a7d91e9a06c5", "deckJsonHref": "/decks/019de074-559c-76fa-9457-a7d91e9a06c5.json", "deckAnchorHref": "/decks/019de074-559c-76fa-9457-a7d91e9a06c5#slide-41", "components": [ { "bbox": { "h": 0.02, "w": 0.18, "x": 0.41, "y": 0.23 }, "kind": "paragraph", "text": "Completed Phase 1 STUDY", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "1940d208-0356-490a-b6d0-a2a2be16276d", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.28, "w": 0.86, "x": 0.07, "y": 0.59 }, "kind": "paragraph", "text": "The levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvement in VMS as well as the genitourinary symptoms of menopause, and vaginal pH and maturation index. Menopausal symptoms, including hot flashes and night sweats, were reduced compared with baseline in both DARE-HRT1 dose groups (p<0.01). Participants also showed significant improvement from baseline in all measures surveyed on The Menopausal Quality of Life Survey (MENQOL), which surveys not only parameters of VMS, but also physical, psychosocial and sexual symptoms (p<0.01 on all domains). With DARE-HRT1 use, vaginal pH significantly decreased compared to baseline (p<0.01) and cytologic tests of the vaginal epithelium (vaginal maturation index) showed significant normalization (all p values <0.01 for increases in superficial cells, increases in intermediate cells and decreases in parabasal cells from baseline) among all participants. Finally, the most common genitourinary symptom, vaginal dryness, which was reported by 70% of participants at baseline, showed significant improvement in both DARE-HRT1 groups (p<0.01) and this subset also experienced significant decreases in vaginal pain with DARE-HRT1 use (p<0.01).", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "24a345c0-f6f8-4af9-b9af-98c76429f3c9", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.07, "w": 0.86, "x": 0.07, "y": 0.34 }, "kind": "paragraph", "text": "The topline data from the study support DARE-HRT1's potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format to treat both VMS as well as vaginal symptoms of menopause.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "4f3eda48-616a-43ff-9780-87ba1ca3ec2c", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.07, "w": 0.86, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "Topline data from the study demonstrate that DARE-HRT1 successfully delivered estradiol and progesterone over the 12-week evaluation period. The levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "83f0f6d6-022d-43cf-b0bd-b0678754851f", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.2, "x": 0.4, "y": 0.41 }, "kind": "paragraph", "text": "Completed Phase 1 / 2 STUDY", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "bd143805-aae2-4ae7-8c8b-1f345bf7e185", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.05, "w": 0.86, "x": 0.07, "y": 0.45 }, "kind": "paragraph", "text": "The open-label study evaluated the PK of the two dose versions of DARE-HRT1 in approximately 20 healthy, post-menopausal women over approximately three consecutive months of use. The study also collected safety, usability, acceptability and symptom-relief data.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "e1eab717-6e19-44b0-907a-d8335f96c890", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.06, "w": 0.86, "x": 0.07, "y": 0.27 }, "kind": "paragraph", "text": "A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics (PK) and Safety of DARE-HRT1 (80 µg and 160 µg Estradiol/ 4 mg and 8 mg Progesterone Intravaginal Rings) in Healthy Post-Menopausal Women.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "f3951b0c-827d-451a-9817-6afe6215cbf3", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.1, "x": 0.02, "y": 0.84 }, "kind": "source-note", "text": "*505(b)(2) candidate³.", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d4177e93-b081-42f0-8126-7bcdd08bf635", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.06, "w": 0.82, "x": 0.09, "y": 0.14 }, "kind": "title", "text": "DARE-HRT1*", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "21c2e8dc-9ab3-4e87-8af4-98f61d81200d", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [ { "name": "SCQA Framework", "slug": "scqa-framework", "agent": "Architect", "layer": "slide", "matchId": "cf0d3d03-4c25-44e6-9284-e16f5a35bbc6", "evidence": "The levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvement in VMS as well as the genitourinary", "confidence": 0.7 } ], "frameworks": [], "arcBeats": [], "loops": [ { "to": 54, "from": 17, "name": "Cost Of Inaction", "slug": "27-cost-of-inaction", "bestFor": "Urgent budget requests, compliance, risk mitigation", "matchId": "2cf418f8-2568-4e9a-bf9d-f55bdd0bfb9e", "evidence": "The deck implies that inaction in women's health has significant consequences", "position": 0, "objective": "What is the cost of inaction in women's health?", "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point", "confidence": 0.6, "description": "Quantify what happens if the audience does nothing" } ], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }