Financial Data and Key Metrics Changes - The company reported cash and cash equivalents of $17.3 million as of March 31, 2022, which includes a $3 million upfront payment from Botanix Pharmaceuticals [30] - Revenue for Q1 2022 was approximately $92,000, a significant increase from $17,000 in Q1 2021, both derived from royalty revenue from ECCLOCK or SB Gel 5% sales in Japan [31] - R&D expenses were $6 million for Q1 2022, slightly down from $6.1 million in Q1 2021, with a notable reduction in clinical costs related to the U.S. Phase 3 program for SB Gel 15% [32][34] - The net loss for Q1 2022 was $9.4 million, compared to a net loss of $9 million for the same period last year [34] Business Line Data and Key Metrics Changes - The company completed the sale of sofpironium bromide (SB) to Botanix Pharmaceuticals, receiving an upfront payment of $3 million and potential future payments totaling up to $168 million [7][8] - The focus has shifted to advancing the pipeline of novel drug candidates, including the lead DYRK1A inhibitor BBI-02 and the STING inhibitor BBI-10 [10][15] Market Data and Key Metrics Changes - The company acquired exclusive global rights to a portfolio of STING inhibitors from Carna Biosciences, indicating a strategic move into the immunotherapy market [22] - The STING inhibitors are aimed at addressing high unmet need diseases, including autoimmune and inflammatory disorders [23] Company Strategy and Development Direction - The company is committed to developing a pipeline of novel autoimmune and inflammatory therapy candidates, with a focus on first-in-class therapies [6][10] - The strategy includes investing proceeds from the SB sale into advancing clinical trials and preclinical studies for new drug candidates [10][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting several important near-term milestones that could create significant shareholder value [36] - The company acknowledged challenges in supply chains affecting timelines but remains focused on initiating clinical studies as planned [39][40] Other Important Information - The Phase 1 clinical trial for BBI-02 is set to start imminently, with top-line results expected by early 2023 [20][36] - The company is conducting research on next-generation kinase inhibitors, which could provide treatment options for various debilitating diseases [25] Q&A Session Summary Question: Change in Phase 1 readout timeline - Management clarified that the timeline was adjusted due to the study starting later than initially intended, primarily due to supply chain challenges [39][40] Question: R&D and SG&A expense expectations - Management anticipates a reduction in R&D expenses in the coming quarters, while SG&A expenses may not see as significant a decrease [44][45] Question: Evaluation of preliminary efficacy measures in Part 2 of the study - Management explained that while the primary focus is on safety, they will assess multiple measures of inflammation and clinical endpoints during the study [46][47]

♡ BrickellBio ©2021 Brickell Biotech, Inc. All rights reserved NASDAQ: BBI Company Overview Presentation Making Fresh Tracks in Medicine™ May 2022 Forward-Looking Statements • Any statements made in this presentation relating to future financial, business, and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, Brickell Biotech Inc.'s ("Brickell") strategy; future operations; future financial position; future liquidi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-21088 BRICKELL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 93-0948554 (State or other jurisdi ...

Financial Data and Key Metrics Changes - The company reported cash and cash equivalents of $26.9 million as of December 31, 2021, which is expected to support operations beyond the receipt of Phase 1 results for BBI-02 anticipated by year-end 2022 [19] - Revenue for Q4 2021 was approximately $140,000, an increase from $27,000 in Q4 2020, primarily from royalty revenue [20] - R&D expenses for Q4 2021 were $3.1 million, down from $4.6 million in Q4 2020, mainly due to a reduction in clinical costs related to SB gel [20] - The net loss for Q4 2021 was $6.1 million, compared to $7.4 million for Q4 2020 [21] - For the full year 2021, revenue was $0.4 million, down from $1.8 million in 2020, with the decrease attributed to a shift from collaboration revenue to royalty revenue [22] - R&D expenses for 2021 were $28.2 million, up from $11.2 million in 2020, driven by increased clinical costs for SB gel and development of STING inhibitors [23] - The net loss for 2021 was $39.5 million, compared to $20.9 million in 2020 [25] Business Line Data and Key Metrics Changes - The company is advancing its most advanced program, sofpironium bromide, which is NDA ready following positive Phase 3 clinical study results [9][10] - BBI-02, a DYRK1A inhibitor, is set to enter Phase 1 clinical trials in Canada in Q2 2022 [13] - The lead STING inhibitor, BBI-10, is in preclinical development, with significant reductions in pro-inflammatory cytokines observed [16] Market Data and Key Metrics Changes - The company has established a presence in immunology and inflammation through recent partnerships and pipeline expansions [7] - The STING inhibitor portfolio targets high unmet need diseases, with several established pharmaceutical companies investing in this area [15] Company Strategy and Development Direction - The company aims to broaden its strategic focus by expanding its pipeline in immunology and inflammation, with several near-term milestones expected in 2022 [26] - The company is evaluating options to maximize the commercial success of SB gel, including potential partnerships [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA submission for SB gel, with no additional clinical studies required following the pre-NDA meeting with the FDA [53] - The company is optimistic about the positive feedback from patients in Japan regarding the product, despite some market challenges due to COVID-19 [60] Other Important Information - The company has acquired exclusive global rights to a portfolio of novel STING inhibitors and is engaged in research to optimize these compounds [15][17] - The company has a library of nearly 1,000 assets for potential screening and development [48] Q&A Session Summary Question: Details on the Phase 1 study design for BBI-02 - The Phase 1A study will involve 56 patients, while the Phase 1B will have at least 33 patients across three cohorts, with 30 to 40 patients in Part 2 [30] Question: Status of sofpironium bromide partnering discussions - The company is exploring various alternatives for partnering and has had encouraging conversations with multiple players [35] Question: Context of BBI-10 in relation to other STING inhibitors - The company believes its STING inhibitor is differentiated by its mechanism, although it is still early in development compared to competitors [39] Question: Expected trends in R&D expenses for 2022 - R&D expenses are expected to decrease as the company focuses on development-stage programs, with a slight increase anticipated as Phase 1 studies progress [41] Question: NDA submission components and readiness - The NDA preparation is on track, with a complete package ready for submission by mid-2022, and no additional clinical studies required [53]

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (720) 505-4755 Securities registered pursuant to Section 12(b) of the Act: or ☐ TRANSITION REPO ...

Brickell Biotech, Inc. (BBI) Q3 2021 Results Conference Call November 9, 2021 4:30 PM ET Company Participants Garth Russell - IR, LifeSci Advisors Rob Brown - CEO Bert Marchio - CFO Monica Luchi - Chief Medical Officer Deepak Chadha - Chief R&D Officer Andy Sklawer - COO Conference Call Participants Thomas Flaten - Lake Street Leland Gershell - Oppenheimer Operator Greetings. Welcome to Brickell Biotech, Inc. Q3 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-21088 BRICKELL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 93-0948554 (State or other jur ...

Financial Data and Key Metrics Changes - The company reported cash and cash equivalents of $24.4 million as of June 30, 2021, with a subsequent equity capital raise of approximately $8.1 million [22][9] - Revenue for Q2 2021 was approximately $151,000, up from $17,000 in Q1 2021, but down from $600,000 in Q2 2020 [24] - R&D expenses increased to $8.8 million in Q2 2021 from $2.7 million in Q2 2020, primarily due to clinical trial costs [25] - G&A expenses totaled $2.9 million in Q2 2021, slightly down from $3 million in the same period last year [26] - The net loss for Q2 2021 was $11.1 million, compared to $5.1 million in Q2 2020, driven by increased R&D expenses [27] Business Line Data and Key Metrics Changes - The company is advancing sofpironium bromide through pivotal Phase 3 studies for primary axillary hyperhidrosis, with enrollment completed in both studies [8] - The last patient in the Cardigan I study has completed all scheduled visits, and the last patient in Cardigan II is expected to complete their final visit soon [8] Market Data and Key Metrics Changes - Kaken is in the early stages of launching ECCLOCK (sofpironium bromide gel 5%) in Japan, which is the first topical prescription product approved for primary axillary hyperhidrosis in the country [10] - Brickell receives royalties based on a percentage of net sales of ECCLOCK in Japan and is entitled to sales-based milestone payments [11] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) for sofpironium bromide gel 15% to the U.S. FDA in mid-2022, pending Phase 3 results [9][23] - Brickell is exploring potential business development opportunities to expand its pipeline with transformative therapies [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Phase 3 readout and the potential advancement for the company and patients [28] - The company highlighted the resilience and resourcefulness of its team in achieving milestones during the pandemic [30] Other Important Information - The Phase 3 pivotal studies are expected to report top-line results in Q4 2021, which will inform the NDA submission process [17] Q&A Session Summary Question: Are there any significant items outstanding required for the NDA submission? - Management indicated that no additional clinical work is needed for the NDA submission, and they plan to meet with the FDA post-Phase 3 [34] Question: How does the company view indication expansion under Brickell? - Management expressed excitement about Kaken's Phase 1 study for palmoplantar hyperhidrosis and noted the unmet need in this area, indicating potential future opportunities [36]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from to Commission File Number: 000-21088 BRICKELL BIOTECH, INC. (Exact name of registrant as specified in its charter) Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 93-0948554 (State or other jurisdic ...

♡ BrickellBio ©2021 Brickell Biotech, Inc. All rights reserved 1 NASDAQ: BBI Company Overview Presentation Making Fresh Tracks in Dermatology® May 2021 Forward-Looking Statements Ø This presentation contains forward-looking statements that involve substantial risk and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation other than statements of historical fact, including, but not limited to, statements r ...