RAPT Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights
RAPT (Nasdaq: RAPT) reported Q3 2025 results and program updates on Nov 6, 2025. Key clinical and financing highlights include FDA clearance of an IND to start a Phase 2b prestIgE trial of ozureprubart in food allergy and initiation of that randomized, placebo-controlled study evaluating Q8W and Q12W dosing.
RAPT and Shanghai Jeyou reported positive topline Phase 2 CSU data showing ozureprubart Q8W and Q12W had comparable efficacy and safety to omalizumab Q4W. The company completed an underwritten public offering raising $250.0M gross and expects cash to fund operations to mid-2028.
RAPT (Nasdaq: RAPT) ha riportato i risultati del terzo trimestre 2025 e aggiornamenti del programma il 6 novembre 2025. I principali aspetti clinici e finanziari includono l'autorizzazione FDA di un IND per avviare uno studio di fase 2b prestIgE di ozureprubart in allergia alimentare e l'inizio di quello studio randomizzato, controllato con placebo, che valuterà dosaggi Q8W e Q12W.
RAPT e Shanghai Jeyou hanno riportato dati positivi di fase 2 topline su CSU che mostrano che ozureprubart Q8W e Q12W hanno efficacia e sicurezza comparabili a omalizumab Q4W. L'azienda ha completato un'offerta pubblica sottoscritta che ha raccolto 250,0 milioni di dollari lorde e prevede di avere liquidità per finanziare le operazioni fino a metà 2028.
RAPT (Nasdaq: RAPT) informó resultados del tercer trimestre de 2025 y actualizaciones del programa el 6 de noviembre de 2025. Los aspectos clínicos y financieros clave incluyen la aprobación de la FDA de un IND para iniciar un ensayo de fase 2b prestIgE de ozureprubart en alergia a los alimentos y el inicio de ese estudio aleatorizado, doble ciego y controlado con placebo que evalúa las dos dosis Q8W y Q12W.
RAPT y Shanghai Jeyou reportaron datos positivos de fase 2 topline en CSU que muestran que ozureprubart Q8W y Q12W tienen eficacia y seguridad comparables a omalizumab Q4W. La empresa completó una oferta pública suscrita que recaudó 250,0 millones de dólares brutos y espera tener efectivo para financiar operaciones hasta mediados de 2028.
RAPT (나스닥: RAPT)가 2025년 11월 6일 발표한 2025년 3분기 실적 및 프로그램 업데이트에서 주요 임상 및 재무 하이라이트로 식품 알레르기에서 ozureprubart의 2b상 prestIgE 시험 시작을 위한 IND의 FDA 승인을 포함하고, 해당 무작위화된 위약 대조 연구에서 Q8W 및 Q12W 용량을 평가하는 시작을 포함합니다.
RAPT와 상하이 제요우는 CSU의 2상 topline 데이터에서 ozureprubart Q8W와 Q12W가 옴라지주맙(Q4W)과 비교해 동일한 효능과 안전성을 보였다고 발표했습니다. 회사는 2억 5천만 달러의 총모금 공모를 완료했으며 현금 흐름이 2028년 중반까지 운영 자금을 댈 것으로 예상합니다.
RAPT (Nasdaq : RAPT) a publié les résultats du troisième trimestre 2025 et des mises à jour du programme le 6 novembre 2025. Les principaux points cliniques et financiers incluent l'autorisation FDA d'IND pour lancer un essai de phase 2b prestIgE de ozureprubart dans l'allergie alimentaire et le démarrage de cet essai randomisé contrôlé par placebo évaluant les posologies Q8W et Q12W.
RAPT et Shanghai Jeyou ont rapporté des données positives de phase 2 topline sur CSU montrant que ozureprubart Q8W et Q12W présentent une efficacité et une sécurité comparables à celles de l'omalizumab Q4W. L'entreprise a mené une offre publique souscrite ayant levé 250,0 millions de dollars bruts et prévoit des liquidités pour financer ses opérations jusqu'à la mi-2028.
RAPT (Nasdaq: RAPT) meldete am 6. November 2025 Ergebnisse des dritten Quartals 2025 und Programmaktualisierungen. Wichtige klinische und finanzielle Highlights umfassen die FDA-Freigabe eines IND zum Start einer Phase-2b-Studie von ozureprubart bei Nahrungsmittelallergien und den Start dieser randomisierten, placebokontrollierten Studie, die Dosierungen Q8W und Q12W bewertet.
RAPT und Shanghai Jeyou meldeten positive Topline-Daten der Phase-2 CSU, die zeigen, dass ozureprubart Q8W und Q12W vergleichbare Wirksamkeit und Sicherheit wie Omalizumab Q4W aufweisen. Das Unternehmen hat eine unterzeichnete öffentliche Platzierung abgeschlossen, die Bruttoeinnahmen in Höhe von 250,0 Mio. USD einbrachte, und erwartet, dass die Liquidität bis Mitte 2028 ausreicht, um die Operationen zu finanzieren.
RAPT (ناسداك: RAPT) أبلغت عن نتائج الربع الثالث من 2025 وتحديثات البرنامج في 6 نوفمبر 2025. تشمل أبرز النقاط السريرية والمالية موافقة FDA على IND لبدء تجربة من الدرجة 2b prestIgE لـ ozureprubart في حساسية الغذاء وبداية تلك الدراسة العشوائية المحكومة بشكل مزدوج وتقييم جرعات Q8W وQ12W.
أبلغت RAPT وشركة Shanghai Jeyou عن بيانات مرحلية إيجابية من المرحلة 2 CSU تُظهر أن ozureprubart بجرعات Q8W وQ12W لها فاعلية وسلامة مماثلة ل omalizumab Q4W. أكملت الشركة عرضاً عاماً مكتتباً جمع 250.0 مليون دولار إجمالاً وتتوقع أن تكفي السيولة لتمويل عملياتها حتى منتصف 2028.
- FDA cleared IND for Phase 2b prestIgE food allergy trial
- Positive Phase 2 CSU topline showing comparable efficacy to omalizumab
- $250M public offering completed to strengthen cash position; proceeds ~ $234.4M net
- Company remains unprofitable with Q3 net loss of $17.6M
- R&D spend declined to $36.4M for nine months vs $60.8M year-ago (nine-month comparison)
Insights
Positive clinical momentum: IND cleared, Phase 2b started in food allergy and favorable Phase 2 CSU topline supports Phase 3 planning.
Ozureprubart shows programmatic progress with an FDA IND clearance and initiation of the prestIgE Phase 2b food allergy trial, and positive topline Phase 2 CSU data from a China study. The CSU data reportedly showed numerically greater improvement on UAS7 and higher rates of UAS7=0 at Weeks 8, 12 and 16 versus omalizumab Q4W, and the partners plan Phase 3 advancement.
Dependencies and risks include that the CSU study was not a formal non-inferiority trial and no statistical hypothesis testing was performed, which limits regulatory certainty. Planned meetings with the FDA and other regulators will be critical to define a registrational pathway in CSU and clarify required evidence.
Watch for topline results from Jeyou’s Phase 2 asthma trial and regulatory meeting outcomes; expect key readouts and agency feedback across the next 6–18 months, and potential Phase 3 trial designs thereafter.
Balance sheet strengthened by a large public offering and cash runway extended to support planned Phase 3 studies.
The company completed an underwritten offering of 8,333,334 shares at
Financials show narrowing net losses year-over-year and lower R&D spend driven by reductions in other programs, partly offset by increased costs for ozureprubart. This suggests reallocation of capital toward priority programs while preserving runway.
Key near-term items to monitor are the company cash balance updates, actual spend cadence on Phase 3 start, and outcomes of the planned FDA meetings within the next 6–12 months.
- Initiated prestIgE Phase 2b trial of ozureprubart in food allergy
- Announced positive topline data from Phase 2 trial in chronic spontaneous urticaria; results showed ozureprubart at both Q8W and Q12W dosing had comparable efficacy and safety to omalizumab at Q4W dosing
- Completed
SOUTH SAN FRANCISCO, Calif., Nov. 06, 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 third quarter and nine months ended September 30, 2025.
“We have considerable momentum heading into the end of the year. We see tremendous potential for ozureprubart in large IgE-driven indications such as food allergy and CSU, and our recent financing gives us additional capital to advance our programs,” said Brian Wong, President and CEO of RAPT. “Looking ahead, we plan to report topline results from Jeyou’s Phase 2 trial of ozureprubart in asthma and to provide additional details from the recently reported Phase 2 clinical trial in CSU at a medical meeting next year. We also plan to meet with the FDA and other regulatory agencies to discuss the registrational pathway in CSU.”
Recent Highlights
- In September, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of ozureprubart (RPT904) in food allergy. In October, the Company initiated the prestIgE Phase 2b trial, a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of ozureprubart dosed every 8 weeks (Q8W) and every 12 weeks (Q12W) as a treatment for food allergy.
In October, together with Shanghai Jeyou Pharmaceutical Co., Ltd. (Jeyou), announced positive topline data from Jeyou’s Phase 2 trial of ozureprubart as monotherapy in chronic spontaneous urticaria (CSU). Results from this study, which was conducted in China, indicate that ozureprubart dosed Q8W or Q12W has comparable efficacy and safety to omalizumab dosed Q4W, and the companies believe these results warrant advancing ozureprubart to Phase 3 development in CSU. Although the study was not a formal non-inferiority study and no statistical hypothesis was tested, the data from both the ozureprubart Q8W and Q12W treatment arms showed numerically greater improvement on the UAS7 endpoint and numerically higher proportion of patients with UAS7=0 at all timepoints (Weeks 8, 12 and 16) compared to omalizumab Q4W.
- In October, completed an underwritten public offering of 8,333,334 shares of common stock at a price of
$30.00 per share for gross proceeds of$250 million . The Company’s current cash balance is projected to fund operations to mid-2028, which includes the planned initiation of Phase 3 studies of ozureprubart in CSU.
Financial Results for the Third Quarter and Nine Months Ended September 30, 2025
All share and per share amounts in this press release have been adjusted to reflect the 1-for-8 reverse split of the Company's common stock effected on June 16, 2025.
Third Quarter Ended September 30, 2025
Net loss for the third quarter of 2025 was
Research and development expenses for the third quarter of 2025 were
General and administrative expenses for the third quarter of 2025 were
Nine Months Ended September 30, 2025
Net loss for the nine months ended September 30, 2025 was
Research and development expenses for the nine months ended September 30, 2025 were
General and administrative expenses for the nine months ended September 30, 2025 were
As of September 30, 2025, the Company had cash and cash equivalents and marketable securities of
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,” “believe,” “estimates,” “expects,” “look ahead,” “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 timing of the initiation of, or disclosure of data from, clinical trials, expectations concerning our partnership with Jeyou, the therapeutic and commercial potential of ozureprubart, the sufficiency of our capital to take our programs into late-stage clinical development, plans for regulatory interactions, the development of our pipeline 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 November 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
| RAPT THERAPEUTICS, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Three Months Ended September 30, | Nine Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 12,034 | $ | 13,340 | $ | 36,416 | $ | 60,761 | ||||||||
| General and administrative | 7,337 | 6,448 | 21,755 | 20,875 | ||||||||||||
| Total operating expenses | 19,371 | 19,788 | 58,171 | 81,636 | ||||||||||||
| Loss from operations | (19,371 | ) | (19,788 | ) | (58,171 | ) | (81,636 | ) | ||||||||
| Other income, net | 1,791 | 1,356 | 5,783 | 5,020 | ||||||||||||
| Net loss | $ | (17,580 | ) | $ | (18,432 | ) | $ | (52,388 | ) | $ | (76,616 | ) | ||||
| Other comprehensive income: | ||||||||||||||||
| Unrealized gain on marketable securities | 84 | 154 | 50 | 4 | ||||||||||||
| Total comprehensive loss | $ | (17,496 | ) | $ | (18,278 | ) | $ | (52,338 | ) | $ | (76,612 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.65 | ) | $ | (3.79 | ) | $ | (1.94 | ) | $ | (15.80 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 26,963,107 | 4,862,935 | 26,946,491 | 4,850,066 | ||||||||||||
| RAPT THERAPEUTICS, INC. BALANCE SHEETS (In thousands) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | (Unaudited) | (1) | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 37,930 | $ | 169,735 | ||||
| Marketable securities | 119,414 | 61,320 | ||||||
| Prepaid expenses and other current assets | 3,701 | 4,181 | ||||||
| Total current assets | 161,045 | 235,236 | ||||||
| Property and equipment, net | 765 | 1,367 | ||||||
| Operating lease right-of-use assets | 1,883 | 3,333 | ||||||
| Other assets | 2,046 | 389 | ||||||
| Total assets | $ | 165,739 | $ | 240,325 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,102 | $ | 1,275 | ||||
| Accrued expenses | 9,008 | 9,597 | ||||||
| License fees payable | — | 35,000 | ||||||
| Operating lease liabilities, current | 2,209 | 2,422 | ||||||
| Other current liabilities | 56 | 57 | ||||||
| Total current liabilities | 13,375 | 48,351 | ||||||
| Operating lease liabilities, non-current | 387 | 2,070 | ||||||
| Total liabilities | 13,762 | 50,421 | ||||||
| Commitments | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 2 | 13 | ||||||
| Additional paid-in capital | 818,810 | 804,388 | ||||||
| Accumulated other comprehensive income | 100 | 50 | ||||||
| Accumulated deficit | (666,935 | ) | (614,547 | ) | ||||
| Total stockholders’ equity | 151,977 | 189,904 | ||||||
| Total liabilities and stockholders’ equity | $ | 165,739 | $ | 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. |
FAQ
What did RAPT announce on Nov 6, 2025 about ozureprubart and IND status?
What were the topline results from the Phase 2 CSU trial of ozureprubart (RAPT) reported in Oct 2025?
How much did RAPT raise in its October 2025 public offering and what are net proceeds?
How long does RAPT expect its cash to fund operations after the offering?
What were RAPT's net loss and R&D trends in Q3 and nine months ended Sept 30, 2025?
When will RAPT disclose additional clinical details and regulatory plans for ozureprubart?
