This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.
The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.

Start Date03 Sep 2021

Sponsor / Collaborator

Rapt Therapeutics, Inc.

NCT04768686

/ CompletedPhase 2

A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined with Pembrolizumab in Patients with Advanced or Metastatic Gastric Cancer

This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below.
* Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer
* Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.

Start Date18 May 2021

Sponsor / Collaborator

Hanmi Pharmaceutical Co., Ltd.

[+1]

NCT03674567

/ CompletedPhase 1/2

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.
The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

Start Date25 Sep 2018

Sponsor / Collaborator

Rapt Therapeutics, Inc.

[+1]

100 Clinical Results associated with Tivumecirnon Besylate

100 Translational Medicine associated with Tivumecirnon Besylate

100 Patents (Medical) associated with Tivumecirnon Besylate

News (Medical) associated with Tivumecirnon Besylate

08 May 2025

·www.globenewswire.com

RAPT Therapeutics Reports First Quarter 2025 Financial Results

SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT) (“RAPT” or the “Company”), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today reported financial results for the first quarter ended March 31, 2025. “The year is off to a great start. We believe RPT904 has the potential to be a best-in-class option to treat patients with food allergy and are making good progress toward our planned initiation of a Phase 2b trial in the second half of 2025,” said Brian Wong, President and CEO of RAPT. “We are also excited about RPT904's potential as a treatment for patients with chronic spontaneous urticaria (“CSU”) and look forward to clinical data later this year from our partner Jemincare to guide our development strategy in CSU.” Financial Results for the First Quarter March 31, 2025 Net loss for the first quarter of 2025 was $17.2 million, compared to $30.5 million for the first quarter of 2024. Research and development expenses for the first quarter of 2025 were $12.0 million, compared to $24.8 million for the same period in 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in costs related to development of RPT904 and early-stage programs. General and administrative expenses for the first quarter of 2025 were $7.2 million, compared to $7.7 million for the same period in 2024. The decrease in general and administrative expenses was primarily due to decreases in expenses for personnel and professional services, partially offset by an increase in facilities costs. As of March 31, 2025, the Company had cash and cash equivalents and marketable securities of $179.3 million. About RAPT Therapeutics, Inc. RAPT is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases. Utilizing our deep and proprietary expertise in immunology, we develop novel therapies that are designed to modulate the critical immune responses underlying these diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimates,” “expects,” “look forward,” “plans,” “potential” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify 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 therapeutic potential of RPT904, the timing of the initiation of or data from clinical trials, expectations concerning our partnership with Jemincare, the market opportunity for RPT904, and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, our reliance on our partners and other third parties, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. 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 May 8, 2025 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, except as required by law. RAPT Media Contact:Aljanae Reynoldsareynolds@wheelhouselsa.com RAPT Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com RAPT THERAPEUTICS INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share per share data)(Unaudited) Three Months EndedMarch 31, Three Months EndedMarch 31, 2025 2024 Operating expenses: Research and development 12,042 24,781 General and administrative 7,223 7,737 Total operating expenses 19,265 32,518 Loss from operations (19,265) (32,518)Other income, net 2,100 1,997 Net loss $(17,165) $(30,521)Other comprehensive income (loss): Unrealized loss on marketable securities (15) (113)Total comprehensive loss $(17,180) $(30,634)Net loss per share, basic and diluted $(0.08) $(0.79)Weighted average number of shares used in computing net loss per share, basic and diluted 215,410,253 38,625,365 RAPT THERAPEUTICS, INC.BALANCE SHEETS(In thousands) March 31,2025 December 31,2024Assets (Unaudited) (1)Current assets: Cash and cash equivalents $60,257 $169,735 Marketable securities 119,019 61,320 Prepaid expenses and other current assets 3,920 4,181 Total current assets 183,196 235,236 Property and equipment, net 1,158 1,367 Operating lease right-of-use assets 2,827 3,333 Other assets 389 389 Total assets $187,570 $240,325 Liabilities and stockholders’ equity Current liabilities: Accounts payable $1,295 $1,275 Accrued expenses 4,928 9,597 License fees payable — 35,000 Operating lease liabilities, current 2,315 2,422 Other current liabilities 140 57 Total current liabilities 8,678 48,351 Operating lease liabilities, non-current 1,520 2,070 Total liabilities 10,198 50,421 Commitments Stockholders’ equity: Preferred stock — — Common stock 13 13 Additional paid-in capital 809,036 804,388 Accumulated other comprehensive income 35 50 Accumulated deficit (631,712) (614,547)Total stockholders’ equity 177,372 189,904 Total liabilities and stockholders’ equity $187,570 $240,325 (1)The balance sheet for December 31, 2024 has been derived from audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Financial StatementImmunotherapyPhase 2

08 May 2025

·investors.rapt.com

RAPT Therapeutics Reports First Quarter 2025 Financial Results

SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT) (“RAPT” or the “Company”), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today reported financial results for the first quarter ended March 31, 2025. “The year is off to a great start. We believe RPT904 has the potential to be a best-in-class option to treat patients with food allergy and are making good progress toward our planned initiation of a Phase 2b trial in the second half of 2025,” said Brian Wong, President and CEO of RAPT. “We are also excited about RPT904's potential as a treatment for patients with chronic spontaneous urticaria (“CSU”) and look forward to clinical data later this year from our partner Jemincare to guide our development strategy in CSU.” Financial Results for the First Quarter March 31, 2025 Net loss for the first quarter of 2025 was $17.2 million, compared to $30.5 million for the first quarter of 2024. Research and development expenses for the first quarter of 2025 were $12.0 million, compared to $24.8 million for the same period in 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in costs related to development of RPT904 and early-stage programs. General and administrative expenses for the first quarter of 2025 were $7.2 million, compared to $7.7 million for the same period in 2024. The decrease in general and administrative expenses was primarily due to decreases in expenses for personnel and professional services, partially offset by an increase in facilities costs. As of March 31, 2025, the Company had cash and cash equivalents and marketable securities of $179.3 million. About RAPT Therapeutics, Inc. RAPT is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases. Utilizing our deep and proprietary expertise in immunology, we develop novel therapies that are designed to modulate the critical immune responses underlying these diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimates,” “expects,” “look forward,” “plans,” “potential” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify 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 therapeutic potential of RPT904, the timing of the initiation of or data from clinical trials, expectations concerning our partnership with Jemincare, the market opportunity for RPT904, and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, our reliance on our partners and other third parties, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. 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 May 8, 2025 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, except as required by law. RAPT Media Contact: Aljanae Reynolds areynolds@wheelhouselsa.com RAPT Investor Contact: Sylvia Wheeler swheeler@wheelhouselsa.com

Financial StatementImmunotherapyPhase 2

06 Mar 2025

·investors.rapt.com

RAPT Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results

SOUTH SAN FRANCISCO, Calif., March 06, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT) (“RAPT” or the “Company”) is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today reported financial results for the fourth quarter and year ended December 31, 2024. “Our focus for 2025 will be on advancing development of RPT904, a novel, potential best-in-class option to treat the large and underserved population of patients suffering from food allergy and chronic spontaneous urticaria,” said Brian Wong, President and CEO of RAPT. “We believe RPT904 can be a differentiated product to treat these diseases by targeting IgE, an approach validated by omalizumab. We expect to initiate a Phase 2b clinical trial for RPT904 in food allergy in the second half of 2025 and await clinical data later this year from our partner Jemincare to guide our development strategy in CSU.” Financial Results for the Fourth Quarter and Year Ended December 31, 2024 Fourth Quarter Ended December 31, 2024 Net loss for the fourth quarter of 2024 was $53.2 million, compared to $30.9 million for the fourth quarter of 2023. Research and development expenses for the fourth quarter of 2024 were $46.5 million, compared to $26.8 million for the same period in 2023. The increase in research and development expenses was primarily due to the $35.0 million upfront license fee for RPT904, partially offset by lower development costs related to zelnecirnon, tivumecirnon and early-stage programs, as well as decreased expenses for personnel, professional services, non-cash stock-based compensation and lab supplies. General and administrative expenses for the fourth quarter of 2024 were $8.0 million, compared to $6.5 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increases in expenses for professional services, non-cash stock-based compensation, personnel and facilities. In December 2024, the Company entered into a license agreement with Shanghai Jemincare Pharmaceutical Co., Ltd. (“Jemincare”), a company incorporated in the People’s Republic of China, under which the Company obtained exclusive rights to RPT904 throughout the world, excluding mainland China, Hong Kong, Macau and Taiwan. As consideration for those rights, the Company paid a $35.0 million upfront license fee and could pay up to $672.5 million in additional milestone payments, as well as tiered royalty payments (at percentages ranging from high single-digit to low double-digit) on future net sales. Also in December 2024, the Company sold through a private placement to a select group of accredited investors 100,000,000 shares of common stock at a price of $0.85 per share and pre-funded warrants to purchase 76,452,000 shares of common stock at a purchase price of $0.8499 per pre-funded warrant, resulting in net proceeds of $143.0 million after deducting offering expenses. Year Ended December 31, 2024 Net loss for the year ended December 31, 2024 was $129.9 million, compared to $116.8 million for the same period in 2023. Research and development expenses for the year ended December 31, 2024 were $107.2 million, compared to $101.0 million for the same period in 2023. The increase in research and development expenses was primarily due to the $35.0 million upfront license fee for RPT904 and an increase in non-cash stock-based compensation expense, partially offset by lower development costs related to zelnecirnon, tivumecirnon and early-stage programs, as well as decreased expenses for personnel, professional services and lab supplies. General and administrative expenses for the year ended December 31, 2024 were $28.9 million, compared to $26.1 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increased expenses for non-cash stock-based compensation, consultants, personnel, and facilities, partially offset by decrease in expenses for insurance premiums. As of December 31, 2024, the Company had cash and cash equivalents and marketable securities of $231.1 million. About RAPT Therapeutics, Inc. RAPT Therapeutics, Inc. (“RAPT” or the “Company”) is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases. Utilizing our deep and proprietary expertise in immunology, we develop novel therapies that are designed to modulate the critical immune responses underlying these diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimates,” “expects,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify 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 therapeutic potential of RAPT’s product candidates, the timing of the initiation of or data from clinical trials, the market opportunity for RAPT’s product candidates, potential milestone and royalty payments and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, fluctuations in inflation and interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2025 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, except as required by law. RAPT Media Contact: Aljanae Reynolds areynolds@wheelhouselsa.com RAPT Investor Contact: Sylvia Wheeler swheeler@wheelhouselsa.com

License out/inFinancial Statement

100 Deals associated with Tivumecirnon Besylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15570

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 2	United States	Rapt Therapeutics, Inc.	03 Sep 2021
Metastatic Gastric Carcinoma	Phase 2	United States	Hanmi Pharmaceutical Co., Ltd.	18 May 2021
Advanced cancer	Phase 2	United States	Rapt Therapeutics, Inc.	25 Sep 2018
Advanced cancer	Phase 2	Australia	Rapt Therapeutics, Inc.	25 Sep 2018
Advanced cancer	Phase 2	Hong Kong	Rapt Therapeutics, Inc.	25 Sep 2018
Advanced cancer	Phase 2	Taiwan Province	Rapt Therapeutics, Inc.	25 Sep 2018
Advanced cancer	Phase 2	Thailand	Rapt Therapeutics, Inc.	25 Sep 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04768686 (-, ASCO_GI2025) Manual	Phase 2	Stomach Cancer	20	FLX475 100 mg PO QD + PembrolizumabPembrolizumab 200 mg IV Q3W (Cohort 1 (EBV (-) GC))	jctquqpouw(gfsklohnfj) = not reached iakbizpkky (rvzitzjmbn )	Positive	23 Jan 2025
NCT04768686 (-, ASCO_GI2025) Manual	Phase 2	Stomach Cancer	20	FLX475 100 mg PO QD + Pembrolizumab 200 mg IV Q3W (Cohort 2 (EBV (+) GC))		Positive	23 Jan 2025
NCT03674567 (FLX475-02, AACR2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck PD-L1	32	FLX475 100 mg + pembrolizumab	mfdjfwtixg(ugruevshcv) = qutudfdxma rtlnucsbgq (ejigookjdg, 6 - 32) View more	Positive	05 Apr 2024
NCT04894994 (CTgov)	Phase 2	Melanoma	6	ipilimumab+FLX475	mesblyyeeh = rihcwiqwqc jksofkrwtc (rqhudkzoze, shpjaqhbry - qzgykiofgk) View more	-	05 Dec 2023
NCT03674567 (FLX475-02, SITC2023)	Phase 2	Non-Small Cell Lung Cancer	35	FLX475 (tivumecirnon) plus pembrolizumab	jnlmkrtdge(coleuogvsv) = hyqpfkjjjg wvhoffvcvy (unvohvyjpz ) View more	Positive	31 Oct 2023
NCT04768686 (SITC2022) Manual	Phase 2	Metastatic Gastric Carcinoma	20	pembrolizumab+FLX475 (EBV negative)	cxazbsnfrx(csnicgckup) = wxuemgbwyf prmydwfrkr (dwyamxdtxf )	Positive	01 Nov 2022
NCT04768686 (SITC2022) Manual	Phase 2	Metastatic Gastric Carcinoma	20	pembrolizumab+FLX475 (EBV positive)	cxazbsnfrx(csnicgckup) = zcbflaftns prmydwfrkr (dwyamxdtxf )	Positive	01 Nov 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis