RAPT RAPT Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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FLX475
Advanced Cancer
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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RPT193
Atopic dermatitis
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Phase 1b
Phase 1b
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Phase 1b top-line data released June 14, 2021 - 42.9% of patients treated with RPT193 achieved a 50% improvement in EASI score (EASI-50) compared with 10.0% in the placebo group. Phase 1b top-line data displayed at Day 29 clear benefit over placebo with EASI-50, vIGA 0/1 (clear or almost clear skin), body surface area (BSA), and pruritis NRS-3 and 4 (3 and 4 point reduction on the numerical rating scale for itch). By Day 43, continued improvement in the EASI, EASI-50, EASI-75, EASI-90, vIGA 0/1, and BSA was displayed. No serious adverse events were reported, noted September 30, 2021. Additional clinical efficacy data presented at the 4th Inflammatory Skin Disease Summit November 3, 2021.
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Latest News
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SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (NASDAQ:RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the third quarter and nine months ended September 30, 2021.
"This has been an important year for RAPT as we advance the development of RPT193 in atopic dermatitis and FLX475 in cancer," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "In the third quarter, we presented additional incremental data for RPT193 at two separate dermatology meetings, allowing us to share our early positive data in atopic dermatitis with key members of the medical community. We are well positioned to advance RPT193 into Phase 2 clinical trials in atopic dermatitis and asthma in 2022. In addition, we have begun to focus development of FLX475 in key indications showing early promise, including EBV+ lymphoma, nasopharyngeal cancer and head and neck cancer. Our goal is to report data from ongoing cohorts in the Phase 1/2 trial for FLX475 at a medical meeting in 2022."
Financial Results for the Third Quarter Ended September 30, 2021Third Quarter ended September 30, 2021
Net loss for the third quarter of 2021 was $18.7 million, compared to $14.6 million for the third quarter of 2020.
Research and development expenses for the third quarter of 2021 were $15.7 million, compared to $12.9 million for the same period in 2020. This increase was primarily due to increased clinical trial costs for FLX475 and RPT193 and increases in stock-based compensation, personnel costs and facilities costs.
General and administrative expenses for the third quarter of 2021 were $3.8 million, compared to $3.2 million for the same period of 2020. The increase was primarily due to increases in stock-based compensation expense, insurance expense, personnel costs and facilities costs.
Nine Months Ended September 30, 2021
Net loss for the nine months ended September 30, 2021 was $51.3 million, compared to $40.2 million for the same period in 2020.
Research and development expenses for the nine months ended September 30, 2021 were $42.7 million, compared to $34.6 million for the same period in 2020. The increase was primarily due to increases in costs related to the clinical trials of FLX475 and RPT193, as well as increases in stock-based compensation, personnel expenses, facilities costs and laboratory supplies spend.
General and administrative expenses for the nine months ended September 30, 2021 were $11.5 million, compared to $9.3 million for the same period of 2020. The increase in general and administrative expenses was primarily due to increases in stock-based compensation expense, insurance expense and personnel costs.
As of September 30, 2021, the Company had cash and cash equivalents and marketable securities of $210.8 million.
About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the progress of RAPT's inflammation and oncology programs and RAPT's intended plans for the clinical development of RPT193 and FLX475. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT's Form 10-Q filed with the Securities and Exchange Commission on November 10, 2021 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.RAPT Media Contact:
Aljanae Reynolds
[email protected]RAPT Investor Contact:
Sylvia Wheeler
[email protected]RAPT THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share per share data) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Revenue $ 966 $ 1,528 $ 3,057 $ 3,740 Operating expenses: Research and development 15,725 12,912 42,686 34,581 General and administrative 3,774 3,197 11,546 9,288 Total operating expenses 19,499 16,109 54,232 43,869 Loss from operations (18,533 ) (14,581 ) (51,175 ) (40,129 ) Other income (expense), net (118 ) 237 (100 ) 763 Net loss before taxes (18,651 ) (14,344 ) (51,275 ) (39,366 ) Provision for income taxes — 287 — 791 Net loss $ (18,651 ) $ (14,631 ) $ (51,275 ) $ (40,157 ) Other comprehensive income (loss): Foreign currency translation adjustment 173 (70 ) 281 (65 ) Unrealized gain (loss) on marketable securities 9 (33 ) (59 ) 119 Total comprehensive loss $ (18,469 ) $ (14,734 ) $ (51,053 ) $ (40,103 ) Net loss per share, basic and diluted $ (0.63 ) $ (0.60 ) $ (1.92 ) $ (1.67 ) Weighted average number of shares used in computing net loss per share, basic and diluted 29,491,857 24,449,115 26,663,209 23,989,926 RAPT THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) September 30, December 31, 2021 2020 Assets (Unaudited) (1) Current assets: Cash and cash equivalents $ 59,999 $ 24,918 Marketable securities 150,787 86,592 Prepaid expenses and other current assets 3,709 4,088 Total current assets 214,495 115,598 Property and equipment, net 2,578 2,982 Other assets 389 389 Total assets $ 217,462 $ 118,969 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 4,017 $ 2,383 Accrued expenses 6,845 4,935 Deferred revenue, current 1,538 4,096 Other current liabilities 295 328 Total current liabilities 12,695 11,742 Deferred rent, net of current portion 2,149 2,185 Deferred revenue, non-current 745 863 Total liabilities 15,589 14,790 Commitments Stockholders' equity: Preferred stock — — Common stock 3 2 Additional paid-in capital 467,942 319,196 Accumulated other comprehensive income (loss) 45 (177 ) Accumulated deficit (266,117 ) (214,842 ) Total stockholders' equity 201,873 104,179 Total liabilities and stockholders' equity $ 217,462 $ 118,969 (1) The condensed consolidated balance sheet for December 31, 2020 has been derived from audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 
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SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (NASDAQ:RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced the appointment of Lori Lyons-Williams, a 20-year industry veteran, to its Board of Directors.
"We are very excited to welcome Lori to RAPT's board of directors," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "Her strong track record of driving strategic and commercial success across both biotech and pharmaceutical products will be invaluable as we continue to advance our pipeline of promising inflammation and oncology product candidates."
Ms. Lyons-Williams is President and Chief Operating Officer at Neumora Therapeutics, a clinical-stage biotechnology company pioneering precision medicines for brain diseases. In her current role, Ms. Lyons-Williams is responsible for research and development, external affairs, CMC/manufacturing, program management and new product planning. Prior to Neumora, she served as Chief Commercial Officer of Dermira, a publicly traded biotech focused on medical dermatology including atopic dermatitis, until its acquisition. Previously, as Vice President of Sales and Marketing at Allergan, Lori built an emerging neurotoxin franchise, successfully launched multiple products and expanded the pipeline through external collaborations and strategic transactions. Lori currently serves as an independent director on the board of Pipeline Therapeutics, a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration. She was previously an independent director on the board of Five Prime Therapeutics, a clinical-stage biotech focused on the discovery and development of protein therapeutics in immuno-oncology, until its acquisition. Ms. Lyons-Williams holds an MBA from the Carlson School of Management at the University of Minnesota and a BA from Virginia Tech. She is a member of Executive Women in Bio's Boardroom Ready, an executive leadership program working to diversify life science corporate boards by championing women from the C-suite to the boardroom.
"I see the potential of RAPT's pipeline to meaningfully improve the lives of people living with inflammatory disease and cancer, and I am particularly encouraged by the broad opportunity for RPT193 in atopic dermatitis and allergic diseases given my prior experience in these therapeutic areas. As RPT193 and FLX475 continue to progress, I look forward to collaborating with the RAPT management team and board members as we work to advance the company and these novel candidates which have shown initial clinical promise."
About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the progress of RAPT's oncology and inflammation programs. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT's Form 10-Q filed with the Securities and Exchange Commission on August 11, 2021 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.RAPT Media Contact:
Aljanae Reynolds
[email protected]RAPT Investor Contact:
Sylvia Wheeler
[email protected]
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SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (NASDAQ:RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced that Brian Wong, M.D., Ph.D., President and CEO, will present at the following investor conferences in November:
- Stifel 2021 Virtual Healthcare Conference – Company presentation on Monday, November 15, 2021, at 2:00 p.m. ET
- Piper Sandler 33rd Annual Virtual Healthcare Conference – Pre-recorded fireside chat available on-demand Monday, November 22, 2021, at 10:00 a.m. ET
To access the live webcast or subsequent archived recordings of the company presentations, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.
About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammatory diseases and cancer, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.RAPT Media Contact:
Aljanae Reynolds
[email protected]RAPT Investor Contact:
Sylvia Wheeler
[email protected]
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SOUTH SAN FRANCISCO, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (NASDAQ:RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced that it will present additional clinical efficacy data from its Phase 1b monotherapy trial of RPT193 in patients with moderate-to-severe atopic dermatitis at the 4th Inflammatory Skin Disease Summit to be held November 3-6, 2021 in New York, NY.
Presentation details as follows:
Title: RPT193, an oral CCR4 inhibitor: Efficacy results from a randomized, placebo-controlled Phase 1b monotherapy trial in patients with moderate-to-severe atopic dermatitis Date & Time: November 3, 2021, 5:00 – 5:30 p.m. EST Presenter: Robert Bissonnette, MD, FRCPC, Chief Executive Officer and Medical Director of Innovaderm Research Inc. About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the progress of RAPT's oncology and inflammation programs and the interpretation of topline results from the Phase 1b trial of RPT193. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT's Form 10-Q filed with the Securities and Exchange Commission on August 11, 2021 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.RAPT Media Contact:
Aljanae Reynolds
[email protected]RAPT Investor Contact:
Sylvia Wheeler
[email protected]
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- Benefit demonstrated in all key exploratory efficacy endpoints - EASI, EASI-50, EASI-75, EASI-90, vIGA, BSA and pruritus NRS-3 and 4 - with once-daily, oral treatment with RPT193
- Continued improvement observed 2 weeks after end of treatment on multiple endpoints
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (NASDAQ:RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced that positive topline results from its randomized placebo-controlled Phase 1b clinical trial of RPT193 as monotherapy in 31 patients with moderate-to-severe atopic dermatitis (AD) were presented at the European Academy of Dermatology and Venereology (EADV) Congress by Robert Bissonnette, M.D., FRCPC. Dr. Bissonnette is a board-certified dermatologist and currently serves as president of the board of directors of the International Eczema Council. He is also chief executive officer and medical director of Innovaderm Research Inc., a contract research organization that specializes in conducting clinical studies in dermatology.
"These Phase 1 results strongly support the potential of RPT193 as an effective once-daily, oral treatment for atopic dermatitis with a clean safety profile," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "RPT193 demonstrated impressive improvements in measures of disease severity, including vIGA and EASI-75, which are the approvable endpoints in the US and Europe. The magnitude and extended clinical benefits observed even after dosing cessation are especially intriguing and warrant further investigation. We look forward to initiating our Phase 2b clinical trial in atopic dermatitis and to expanding our exploration of RPT193 in a Phase 2a trial in asthma."
The Phase 1b trial results demonstrated that at Day 29 after end of treatment, clear benefit over placebo was observed on Eczema Area and Severity Index (EASI) score, EASI-50, vIGA 0/1 (clear or almost clear skin), body surface area (BSA), and pruritis NRS-3 and 4 (3 and 4 point reduction on the numerical rating scale for itch). By the end of study, including the two-week follow-up period (Day 43), RPT193 demonstrated continued improvement in the EASI, EASI-50, EASI-75, EASI-90, vIGA 0/1, and BSA. In a post-hoc statistical analysis comparing RPT193-treated patients to placebo-treated patients, statistically significant improvements in EASI, EASI-50 and BSA were observed at Day 43. RPT193 was well tolerated in the Phase 1b study. No serious adverse events were reported, and all adverse events reported were mild or moderate in intensity."These early-stage clinical results for RPT193 are very promising and demonstrate its potential as an attractive, differentiated treatment for atopic dermatitis," said Dr. Bissonnette. "Further improvement after cessation of dosing could be consistent with unique kinetics associated with the mechanism of action of RPT193 and its unique design in targeting Th2 cell migration and function."
About the Phase 1a/1b Study of RPT193
The Phase 1b study reported today was part of RAPT's first-in-human Phase 1a/1b trial of RPT193. The Phase 1b portion of the trial was a randomized, double-blind, placebo-controlled study examining RPT193 as monotherapy in patients with moderate-to-severe AD. The study was conducted at multiple sites in the United States and enrolled 31 patients with moderate-to-severe AD who had an inadequate response to, or were intolerant of, topical corticosteroids. The primary endpoint of the Phase 1b study was safety. Secondary and exploratory endpoints included pharmacokinetics, biomarkers and clinical efficacy as evaluated by multiple measurements, including percent change in the Eczema Area and Severity Index (EASI) score, change in body surface area (BSA) affected by AD, the validated Investigator Global Assessment (vIGA) and pruritus Numerical Rating Scale (NRS). The Phase 1b trial was not powered to achieve statistical significance for any particular endpoint.The Phase 1a portion of the Phase 1a/1b trial was a standard single and multiple dose-escalation study in healthy volunteers. The data from the Phase 1a study demonstrated pharmacokinetics and pharmacodynamics that support once-daily oral dosing with RPT193, and blinded safety data supported initiation of the Phase 1b portion of the trial.
About RPT193
RPT193 is a small molecule oral therapy in development for the treatment of atopic dermatitis and other inflammatory diseases. RPT193 is designed to selectively inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4, a receptor highly expressed on Th2 cells. Preclinical data suggest that RPT193 also has the potential to modulate Th2 cell function by lowering the secretion of Th2 cytokines upon stimulation. In allergic inflammatory diseases such as AD, chemokines recruit Th2 cells via CCR4 into inflamed tissues, where the Th2 cells secrete proteins known to drive the inflammatory response. The role of Th2 cells has been clinically validated by injectable biologics targeting this pathway. Patients with atopic dermatitis express higher levels of CCR4 ligands compared with healthy humans; these ligands also correlate with the severity of disease. RAPT believes that by inhibiting CCR4, RPT193 has the potential to bring therapeutic benefit to patients across a broad spectrum of inflammatory diseases, including atopic dermatitis, asthma, chronic urticaria, allergic rhinitis, chronic rhinosinusitis and eosinophilic esophagitis.About Atopic Dermatitis
Atopic dermatitis is a highly prevalent chronic, inflammatory skin disease characterized by skin barrier disruption and immune dysregulation. Patients with AD have chronically inflamed skin lesions that can cause debilitating pruritus (itch), which can severely impair quality of life. While there is a marketed injectable product for the treatment of AD, RAPT believes RPT193, if approved, could fill an unmet medical need for the treatment of inflammatory disorders with the convenience of once-daily oral dosing. There are ~19M adults and ~10M children affected by AD in the US.About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, RAPT is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. RAPT is also pursuing a range of targets that are in the discovery stage of development.Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about interpretations of the topline results from the Phase 1b clinical trial of RPT193, clinical development progress including the anticipated advancement of RPT193 to a Phase 2b trial in atopic dermatitis as well as Phase 2 trials in other indications and the potential of RPT193 to treat atopic dermatitis or other inflammatory diseases. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2021, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.Investor Contact:
Sylvia Wheeler
[email protected]Media Contact:
Aljanae Reynolds
[email protected]
- Benefit demonstrated in all key exploratory efficacy endpoints - EASI, EASI-50, EASI-75, EASI-90, vIGA, BSA and pruritus NRS-3 and 4 - with once-daily, oral treatment with RPT193