Fresh Tracks Therapeutics(FRTX)
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Fresh Tracks Therapeutics(FRTX) - 2022 Q1 - Earnings Call Transcript
2022-05-12 22:35
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]
Fresh Tracks Therapeutics(FRTX) - 2022 Q1 - Earnings Call Presentation
2022-05-12 20:25
♡ 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 ...
Fresh Tracks Therapeutics(FRTX) - 2022 Q1 - Quarterly Report
2022-05-12 20:12
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 ...
Fresh Tracks Therapeutics(FRTX) - 2021 Q4 - Earnings Call Transcript
2022-03-15 18:39
Brickell Biotech, Inc. (BBI) Q4 2021 Earnings Conference Call March 15, 2022 8:30 AM ET Company Participants Garth Russell - IR, LifeSci Advisors Robert Brown - Chief Executive Officer Andrew Sklawer - Co-Founder & Chief Operating Officer Albert Marchio II - Chief Financial Officer Monica Luchi - Chief Medical Officer Deepak Chadha - Chief R&D Officer Conference Call Participants Tim Lugo - William Blair Mitchell Kapoor - H.C. Wainwright & Co. Leland Gershell - Oppenheimer & Co. Thomas Flaten - Lake Street ...
Fresh Tracks Therapeutics(FRTX) - 2021 Q4 - Annual Report
2022-03-15 11:43
☒ 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 ...
Fresh Tracks Therapeutics(FRTX) - 2021 Q3 - Earnings Call Transcript
2021-11-10 00:17
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 ...
Fresh Tracks Therapeutics(FRTX) - 2021 Q3 - Quarterly Report
2021-11-09 21:16
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 ...
Fresh Tracks Therapeutics(FRTX) - 2021 Q2 - Earnings Call Transcript
2021-08-12 22:51
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]
Fresh Tracks Therapeutics(FRTX) - 2021 Q2 - Quarterly Report
2021-08-12 20:16
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 ...
Brickell Biotech (BBI) Investor Presentation - Slideshow
2021-05-14 14:35
♡ 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 ...