TScan Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
TScan Therapeutics (NASDAQ: TCRX) reported Q3 2024 financial results with revenue of $1.0 million, down from $3.9 million in Q3 2023. Net loss widened to $29.9 million from $23.0 million year-over-year. R&D expenses increased to $26.3 million, while G&A expenses rose to $7.4 million.
The company's ALLOHA Phase 1 trial showed promising results with no relapses in 16 treatment-arm patients, including five patients at one-year post-transplant. Cash position stands at $271.1 million, expected to fund operations into Q4 2026. TScan plans to present updated trial data at the upcoming ASH Annual Meeting and remains on track to dose its first patient with multiplex TCR-T therapy.
TScan Therapeutics (NASDAQ: TCRX) ha riportato i risultati finanziari del terzo trimestre 2024 con ricavi di 1,0 milioni di dollari, in calo rispetto ai 3,9 milioni di dollari nel terzo trimestre 2023. La perdita netta è aumentata a 29,9 milioni di dollari rispetto ai 23,0 milioni di dollari dell'anno precedente. Le spese per Ricerca e Sviluppo sono aumentate a 26,3 milioni di dollari, mentre le spese generali e amministrative sono cresciute a 7,4 milioni di dollari.
Il trial ALLOHA di fase 1 dell'azienda ha mostrato risultati promettenti con nessun relapse in 16 pazienti del braccio di trattamento, inclusi cinque pazienti a un anno dal trapianto. La posizione di liquidità è di 271,1 milioni di dollari, prevista per finanziare le operazioni fino al quarto trimestre del 2026. TScan prevede di presentare dati aggiornati sugli studi nel prossimo Congresso annuale ASH e rimane sulla buona strada per somministrare il primo trattamento con terapia multiplex TCR-T.
TScan Therapeutics (NASDAQ: TCRX) reportó los resultados financieros del tercer trimestre de 2024 con ingresos de 1.0 millones de dólares, disminuyendo de los 3.9 millones de dólares en el tercer trimestre de 2023. La pérdida neta se amplió a 29.9 millones de dólares desde los 23.0 millones de dólares en el año anterior. Los gastos de I+D aumentaron a 26.3 millones de dólares, mientras que los gastos generales y administrativos se elevaron a 7.4 millones de dólares.
El ensayo de Fase 1 ALLOHA de la compañía mostró resultados prometedores con ninguna recaída en 16 pacientes del grupo de tratamiento, incluidos cinco pacientes a un año después del trasplante. La posición de efectivo se sitúa en 271.1 millones de dólares, que se espera financie las operaciones hasta el cuarto trimestre de 2026. TScan planea presentar datos actualizados del ensayo en la próxima Reunión Anual de ASH y sigue en camino de tratar a su primer paciente con terapia TCR-T multiplex.
TScan Therapeutics (NASDAQ: TCRX)는 2024년 3분기 재무 결과를 발표하며 수익이 100만 달러로, 2023년 3분기의 390만 달러에서 감소했다고 전했습니다. 순손실은 전년 대비 2990만 달러로 확대되었습니다. 연구 개발(R&D) 비용은 2630만 달러로 증가하였고, 일반 및 관리(G&A) 비용은 740만 달러로 상승했습니다.
회사의 ALLOHA 1상 시험은 16명의 치료군 환자에서 재발 없이 유망한 결과를 보여주었으며, 이 중 5명은 이식 후 1년이 경과했습니다. 현금 보유고는 2억 7110만 달러로, 2026년 4분기까지 운영 자금으로 사용될 것으로 예상됩니다. TScan은 다가오는 ASH 연례 회의에서 업데이트된 시험 데이터를 발표할 계획이며, 다중 TCR-T 치료로 첫 환자를 투여할 준비를 하고 있습니다.
TScan Therapeutics (NASDAQ: TCRX) a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus de 1,0 million de dollars, en baisse par rapport à 3,9 millions de dollars au troisième trimestre 2023. La perte nette s'est creusée à 29,9 millions de dollars contre 23,0 millions de dollars l'année précédente. Les dépenses de R&D ont augmenté à 26,3 millions de dollars, tandis que les dépenses générales et administratives ont atteint 7,4 millions de dollars.
Le procès ALLOHA de phase 1 de l'entreprise a montré des résultats prometteurs, sans rechute chez 16 patients du groupe de traitement, y compris cinq patients un an après la greffe. La position de trésorerie s'élève à 271,1 millions de dollars, prévue pour financer les opérations jusqu'au quatrième trimestre 2026. TScan prévoit de présenter des données actualisées sur le procès lors de la prochaine réunion annuelle de l'ASH et reste sur la bonne voie pour traiter son premier patient avec la thérapie TCR-T multiplex.
TScan Therapeutics (NASDAQ: TCRX) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht, mit einem Umsatz von 1,0 Millionen Dollar, zurückgegangen von 3,9 Millionen Dollar im dritten Quartal 2023. Der Nettoverlust weitete sich auf 29,9 Millionen Dollar im Vergleich zu 23,0 Millionen Dollar im Vorjahr aus. Die Aufwendungen für Forschung und Entwicklung (F&E) erhöhten sich auf 26,3 Millionen Dollar, während die Verwaltungs- und Betriebskosten auf 7,4 Millionen Dollar anstiegen.
Die ALLOHA Phase 1-Studie des Unternehmens zeigte vielversprechende Ergebnisse, da es bei 16 Patienten in der Behandlungsgruppe zu keinen Rückfällen kam, darunter fünf Patienten nach einem Jahr post-Transplantation. Die Liquiditätslage beträgt 271,1 Millionen Dollar, was voraussichtlich die Operationen bis ins vierte Quartal 2026 finanzieren wird. TScan plant, aktualisierte Studiendaten auf dem bevorstehenden ASH-Jahrestreffen zu präsentieren und ist auf Kurs, seinen ersten Patienten mit multiplex TCR-T-Therapie zu behandeln.
- Strong cash position of $271.1 million funding operations into Q4 2026
- Promising ALLOHA Phase 1 trial results with zero relapses in all 16 treatment-arm patients
- All treatment-arm patients achieved MRD-negative status
- Revenue declined 74% to $1.0 million from $3.9 million in Q3 2023
- Net loss increased 30% to $29.9 million from $23.0 million YoY
- R&D expenses increased by $3.5 million to $26.3 million
- G&A expenses rose by $1.5 million to $7.4 million
Insights
The Q3 2024 financials reveal significant operational expansion with key metrics to note: Revenue dropped to
Most notably, the company maintains a strong cash position of
The ALLOHA trial data shows promising early results with zero relapses in all 16 treatment-arm patients compared to 3 relapses (including 2 deaths) in the 11-patient control arm. All treated patients achieved MRD-negative status with no dose-limiting toxicities, suggesting a favorable safety profile.
The company's dual-program strategy is advancing well: the heme program is progressing toward expansion cohorts and potential registration trials, while the solid tumor program is implementing an innovative multiplex approach targeting multiple cancer antigens simultaneously. The manufacturing capacity expansion and CDMO partnership indicate preparation for potential commercialization.
Upcoming oral presentation for the ALLOHATM Phase 1 heme trial at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10th at 8:00 a.m. ET to discuss clinical updates from the ALLOHA Phase 1 trial and heme development strategy
On track to dose first patient with multiplex TCR-T therapy and will provide an update on our Phase 1 study by the end of the year
Cash, cash equivalents, and marketable securities continue to fund operations into the fourth quarter of 2026
WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.
“As we approach the end of the year, we remain committed to advancing our clinical-stage pipeline across both heme and solid tumor malignancies and providing an update on the ALLOHA Phase 1 trial following ASH. We are encouraged to see that none of the 16 patients on the treatment arm relapsed, including five patients at least one-year post-transplant as of the July 8th abstract cutoff date. We look forward to sharing updated data, including several additional patients, at ASH,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “During the third quarter we continued to prioritize screening, enrolling, and dosing patients in the solid tumor program and remain on track to dose our first patient with multiplex therapy and provide an update on our Phase 1 study by the end of the year.”
Recent Corporate Highlights
- The Company recently announced an upcoming oral presentation at the 66th ASH Annual Meeting. The data in the abstract included 16 treatment-arm patients and 11 control-arm patients with a data cutoff of July 8, 2024. No dose limiting toxicities were observed across all treatment-arm patients and the safety profile was generally consistent with hematopoietic cell transplantation (HCT). All treatment-arm patients (16 of 16) were relapse-free and minimal residual disease (MRD)-negative as of the data cutoff, whereas three control-arm patients (3 of 11) relapsed, two of whom died from their disease. These data support both the safety and potential of TSC-100 and TSC-101 to reduce relapses and increase relapse-free survival in patients receiving reduced intensity conditioning HCT. Updated data will be presented at the annual meeting.
- The Company will host a virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10th, at 8:00 a.m. ET to discuss the data presented at the ASH Annual Meeting. The Company will also discuss its clinical development strategy for the heme program. Dr. Reshef is the Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center. Additional details around the call will be provided closer to the event. Registration for the event can be found here.
- The Company recently increased its internal manufacturing capacity as well as identified a global contract development and manufacturing organization (CDMO) with commercial capabilities to support both the heme and solid tumor programs. The Company is on track to transfer the commercial heme manufacturing process to the CDMO in 2025.
- The Company recently presented three posters at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting held in Houston, TX and virtually:
- Discovery of a MAGE-A4-specific TCR-T Therapy Candidate for Multiplex Treatment of Solid Tumors
- Preclinical Models for T-Plex, a Customized Multiplexed TCR-T Cell Therapy Addressing Intra-Tumor Antigen and HLA Heterogeneity
- Development of a Target Agnostic Platform to Assess the Reactivity of T Cell Receptor (TCR)-Engineered T Cell (TCR-T) Therapies to Primary Human Tissues
- Discovery of a MAGE-A4-specific TCR-T Therapy Candidate for Multiplex Treatment of Solid Tumors
Copies of the presentation materials can be found under the “Publications” section of the Company’s website at tscan.com.
Upcoming Anticipated Milestones
Heme Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) undergoing allogeneic HCT (the ALLOHATM trial, NCT05473910).
- Plans to open expansion cohorts at the proposed recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints by the end of 2024.
- One-year clinical and translational data on initial patients to be reported by the end of 2024.
- Initiate a registration trial, pending feedback from regulatory authorities, and plans to report two-year clinical and translational data in 2025.
Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of therapeutic TCR-Ts that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-Ts to overcome tumor heterogeneity and prevent resistance that may arise from either target or HLA loss (screening protocol: NCT05812027; treatment protocol: NCT05973487).
- Actively screening, enrolling, and dosing patients across the TCR-T therapy candidates.
- Update on solid tumor program expected by the end of 2024.
- Investigational new drug (IND) filing for TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) planned by the end of the year.
- Response data for multiplex therapy anticipated in 2025.
Third Quarter 2024 Financial Results
Revenue: Revenue for the third quarter of 2024 was
R&D Expenses: Research and development expenses for the third quarter of 2024 were
G&A Expenses: General and administrative expenses for the third quarter of 2024 were
Net Loss: Net loss was
Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2024, were
Share Count: As of September 30, 2024, the Company had issued and outstanding shares of 53,354,124, which consists of 49,077,536 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 65,587,945 shares of voting common stock at an exercise price of
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company is also developing TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s hematologic malignancies program, including clinical updates of the ALLOHA Phase 1 heme trial, presentation of data, opening of expansion cohorts, and initiation of registrational trials; the Company’s plans, progress, and timing relating to the Company’s solid tumor program, including, screening, enrolling, and dosing patients, presentation of data, and submission of additional INDs to expand the ImmunoBank; the progress of the hematologic malignancies and solid tumor programs being indicative or predictive of the success of each program; the engagement of CDMO being indicative of successful initiation or support of manufacturing activities or execution of definitive agreements; the Company’s current and future research and development plans or expectations; the structure, timing and success of the Company’s planned preclinical development, submission of INDs, and clinical trials; the potential benefits of any of the Company’s proprietary platforms, multiplexing, or current or future product candidates in treating patients; the Company’s ability to fund its operating plan with its existing cash, cash equivalents, and marketable securities; and the Company’s goals, strategy and anticipated financial performance. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s recently approved INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timeline; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.
Contacts
Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
hsavelle@tscan.com
Maghan Meyers
Argot Partners
212-600-1902
TScan@argotpartners.com
| TScan Therapeutics, Inc. | ||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||||||
| (unaudited, in thousands, except share amount) | ||||||||||||
| September 30, 2024 | December 31, 2023 | |||||||||||
| Assets | ||||||||||||
| Cash and cash equivalents | $ | 133,118 | $ | 133,359 | ||||||||
| Other assets | 214,909 | 138,790 | ||||||||||
| Total assets | $ | 348,027 | $ | 272,149 | ||||||||
| Liabilities and Stockholders' Equity | ||||||||||||
| Total liabilities | $ | 118,940 | $ | 121,282 | ||||||||
| Total stockholders' equity | 229,087 | 150,867 | ||||||||||
| Total liabilities and stockholders' deficit | $ | 348,027 | $ | 272,149 | ||||||||
| Common stock and pre-funded warrants outstanding (1) | 118,942,069 | 94,840,055 | ||||||||||
| (1) Both periods include outstanding pre-funded warrants to purchase shares of voting common stock at an exercise price of | ||||||||||||
| TScan Therapeutics, Inc. | |||||||||
| Condensed Consolidated Statements of Operations | |||||||||
| (unaudited, in thousands, except share and per share amounts) | |||||||||
| Three Months Ended September 30, | |||||||||
| 2024 | 2023 | ||||||||
| Revenue | |||||||||
| Collaboration and license revenue | $ | 1,049 | $ | 3,887 | |||||
| Operating expenses: | |||||||||
| Research and development | 26,262 | 22,741 | |||||||
| General and administrative | 7,409 | 5,894 | |||||||
| Total operating expenses | 33,671 | 28,635 | |||||||
| Loss from operations | (32,622 | ) | (24,748 | ) | |||||
| Interest and other income, net | 3,693 | 2,733 | |||||||
| Interest expense | (958 | ) | (982 | ) | |||||
| Net loss | $ | (29,887 | ) | $ | (22,997 | ) | |||
| Net loss per share, basic and diluted | $ | (0.25 | ) | $ | (0.24 | ) | |||
| Weighted average common shares outstanding—basic and diluted (2) | 118,700,362 | 94,829,844 | |||||||
| (2) For the three months ended September 30, 2024 and 2023, 65,587,945 and 47,010,526 shares of the Company's voting common stock issuable upon exercise of the pre-funded warrants are included as outstanding common stock in the calculation of basic and diluted net loss per share. | |||||||||
FAQ
What were TScan Therapeutics (TCRX) Q3 2024 financial results?
What were the ALLOHA Phase 1 trial results for TCRX's TSC-100 and TSC-101?
How long will TCRX's current cash position last?
