TScan Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
TScan Therapeutics (NASDAQ: TCRX) reported its Q4 and full-year 2024 financial results, highlighting progress in its cancer treatment pipeline. The company's ALLOHA™ Phase 1 heme trial showed promising results with only 2 of 26 patients relapsing compared to 4 of 12 in the control arm.
Key financial highlights include: Q4 2024 revenue of $0.7M (down from $7.2M in Q4 2023), full-year revenue of $2.8M (down from $21M in 2023), and a Q4 net loss of $35.8M. The company secured $30M through a registered direct offering at a 37% premium and refinanced its debt with a $52.5M term loan from SVB.
R&D expenses increased to $107.4M for 2024 (from $88.2M in 2023) due to expanded clinical trials. With $290.1M in cash and equivalents, TScan expects to fund operations into Q1 2027. The company plans to initiate a registration trial for TSC-101 in H2 2025 and anticipates presenting multiplex TCR-T therapy data in the second half of 2025.
TScan Therapeutics (NASDAQ: TCRX) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi nel suo pipeline di trattamenti per il cancro. Il trial di fase 1 ALLOHA™ ha mostrato risultati promettenti, con solo 2 dei 26 pazienti che hanno avuto una recidiva, rispetto ai 4 su 12 del gruppo di controllo.
I principali punti finanziari includono: ricavi del quarto trimestre 2024 pari a $0,7 milioni (in calo rispetto ai $7,2 milioni del quarto trimestre 2023), ricavi annuali di $2,8 milioni (in calo rispetto ai $21 milioni del 2023) e una perdita netta nel quarto trimestre di $35,8 milioni. L'azienda ha ottenuto $30 milioni tramite un'offerta diretta registrata con un premio del 37% e ha rifinanziato il suo debito con un prestito a termine di $52,5 milioni da SVB.
Le spese per ricerca e sviluppo sono aumentate a $107,4 milioni per il 2024 (rispetto ai $88,2 milioni del 2023) a causa dell'espansione dei trial clinici. Con $290,1 milioni in contante e equivalenti, TScan prevede di finanziare le operazioni fino al primo trimestre del 2027. L'azienda intende avviare un trial di registrazione per TSC-101 nella seconda metà del 2025 e prevede di presentare dati sulla terapia multiplex TCR-T nella seconda metà del 2025.
TScan Therapeutics (NASDAQ: TCRX) reportó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances en su pipeline de tratamientos contra el cáncer. El ensayo de fase 1 ALLOHA™ mostró resultados prometedores, con solo 2 de 26 pacientes que recaen, en comparación con 4 de 12 en el grupo de control.
Los puntos financieros clave incluyen: ingresos del cuarto trimestre 2024 de $0.7 millones (a la baja desde $7.2 millones en el cuarto trimestre 2023), ingresos anuales de $2.8 millones (a la baja desde $21 millones en 2023) y una pérdida neta en el cuarto trimestre de $35.8 millones. La empresa aseguró $30 millones a través de una oferta directa registrada con una prima del 37% y refinanció su deuda con un préstamo a plazo de $52.5 millones de SVB.
Los gastos de I+D aumentaron a $107.4 millones para 2024 (desde $88.2 millones en 2023) debido a la expansión de ensayos clínicos. Con $290.1 millones en efectivo y equivalentes, TScan espera financiar sus operaciones hasta el primer trimestre de 2027. La empresa planea iniciar un ensayo de registro para TSC-101 en la segunda mitad de 2025 y anticipa presentar datos de terapia multiplex TCR-T en la segunda mitad de 2025.
TScan Therapeutics (NASDAQ: TCRX)는 2024년 4분기 및 연간 재무 결과를 발표하며 암 치료 파이프라인의 진전을 강조했습니다. ALLOHA™ 1상 시험에서는 26명의 환자 중 2명만이 재발한 반면, 대조군에서는 12명 중 4명이 재발하는 유망한 결과를 보여주었습니다.
주요 재무 하이라이트는 다음과 같습니다: 2024년 4분기 수익은 $0.7M(2023년 4분기 $7.2M에서 감소), 연간 수익은 $2.8M(2023년 $21M에서 감소), 4분기 순손실은 $35.8M입니다. 이 회사는 37% 프리미엄으로 등록된 직접 판매를 통해 $30M을 확보하고, SVB로부터 $52.5M의 기한부 대출로 부채를 재융자했습니다.
연구개발 비용은 2024년에 $107.4M으로 증가했으며(2023년 $88.2M에서 증가), 이는 확대된 임상 시험 때문입니다. TScan은 $290.1M의 현금 및 현금성 자산을 보유하고 있으며, 2027년 1분기까지 운영 자금을 지원할 것으로 예상하고 있습니다. 이 회사는 2025년 하반기에 TSC-101에 대한 등록 시험을 시작할 계획이며, 2025년 하반기에 다중 TCR-T 치료 데이터 발표를 예상하고 있습니다.
TScan Therapeutics (NASDAQ: TCRX) a publié ses résultats financiers du quatrième trimestre et de l'année entière 2024, mettant en avant les progrès de son pipeline de traitements contre le cancer. L'essai de phase 1 ALLOHA™ a montré des résultats prometteurs, avec seulement 2 des 26 patients ayant rechuté, contre 4 sur 12 dans le groupe de contrôle.
Les principaux points financiers incluent : des revenus de 0,7 million de dollars pour le quatrième trimestre 2024 (en baisse par rapport à 7,2 millions de dollars au quatrième trimestre 2023), des revenus annuels de 2,8 millions de dollars (en baisse par rapport à 21 millions de dollars en 2023) et une perte nette de 35,8 millions de dollars pour le quatrième trimestre. L'entreprise a sécurisé 30 millions de dollars par le biais d'une offre directe enregistrée avec une prime de 37 % et a refinancé sa dette avec un prêt à terme de 52,5 millions de dollars de SVB.
Les dépenses de R&D ont augmenté à 107,4 millions de dollars pour 2024 (contre 88,2 millions de dollars en 2023) en raison de l'expansion des essais cliniques. Avec 290,1 millions de dollars en liquidités et équivalents, TScan s'attend à financer ses opérations jusqu'au premier trimestre 2027. L'entreprise prévoit de lancer un essai d'enregistrement pour TSC-101 dans la deuxième moitié de 2025 et prévoit de présenter des données sur la thérapie multiplex TCR-T dans la seconde moitié de 2025.
TScan Therapeutics (NASDAQ: TCRX) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seiner Krebstherapie-Pipeline hervorgehoben. Die ALLOHA™ Phase-1-Studie zeigte vielversprechende Ergebnisse, da nur 2 von 26 Patienten einen Rückfall erlitten, verglichen mit 4 von 12 im Kontrollarm.
Wichtige finanzielle Höhepunkte sind: Einnahmen im vierten Quartal 2024 von 0,7 Millionen USD (ein Rückgang von 7,2 Millionen USD im vierten Quartal 2023), Gesamteinnahmen für das Jahr von 2,8 Millionen USD (ein Rückgang von 21 Millionen USD im Jahr 2023) und ein Nettoverlust im vierten Quartal von 35,8 Millionen USD. Das Unternehmen sicherte sich 30 Millionen USD durch ein registriertes Direktangebot mit einer Prämie von 37 % und refinanzierte seine Schulden mit einem Terminkredit von 52,5 Millionen USD von SVB.
Die F&E-Ausgaben stiegen im Jahr 2024 auf 107,4 Millionen USD (von 88,2 Millionen USD im Jahr 2023) aufgrund erweiterter klinischer Studien. Mit 290,1 Millionen USD an Bargeld und Äquivalenten erwartet TScan, die Betriebskosten bis ins erste Quartal 2027 zu finanzieren. Das Unternehmen plant, in der zweiten Hälfte des Jahres 2025 eine Registrierungstudie für TSC-101 zu starten und erwartet, in der zweiten Hälfte des Jahres 2025 Daten zur multiplexen TCR-T-Therapie zu präsentieren.
- Strong ALLOHA trial results with 8% relapse rate vs 33% in control arm
- Secured $30M financing at 37% premium
- Extended cash runway into Q1 2027 with $290.1M cash position
- Expanded clinical pipeline to seven FDA-cleared TCR-Ts
- Successfully refinanced debt with non-dilutive $52.5M term loan
- Revenue declined 87% to $2.8M in 2024 from $21M in 2023
- Net loss increased to $127.5M from $89.2M year-over-year
- R&D expenses increased 22% to $107.4M
- G&A expenses rose 15% to $30.3M
Insights
TScan's financial results reveal a well-capitalized clinical-stage biotech strategically positioned to advance its pipeline through multiple value-inflection points. The
The company demonstrated exceptional capital markets strength by completing a
While annual revenue decreased from
The debt refinancing with Silicon Valley Bank improved TScan's capital structure by replacing convertible debt with a term loan featuring deferred principal payments until September 2027. This strategic financing aligns debt obligations with anticipated clinical milestones while minimizing dilution risk.
The financial foundation appears sufficiently robust to support upcoming catalysts, including multiplex therapy data in H2 2025 and the planned registration trial for TSC-101, potentially positioning TScan for partnership opportunities or independent commercialization planning in the coming years.
The clinical data from TScan's ALLOHA trial demonstrates encouraging efficacy signals with only 2 of 26 patients (8%) in the treatment arm experiencing relapse compared to 4 of 12 patients (33%) in the control arm. This translates to a hazard ratio of 0.30 for event-free survival, strongly favoring TCR-T therapy. While the sample size remains , this magnitude of difference suggests potential clinical benefit in preventing relapse in hematologic malignancies.
The company's strategic decision to advance only TSC-101 makes scientific sense, as this candidate enables treatment of approximately
TScan's solid tumor program now encompasses seven distinct TCR-T therapies targeting different cancer-associated antigens across multiple HLA types. This multiplex approach represents a sophisticated strategy to overcome the fundamental challenge of tumor heterogeneity and antigen escape that has efficacy of single-target cell therapies in solid tumors.
The TCR-T platform offers a mechanistic advantage over CAR-T approaches by recognizing intracellular antigens presented on HLA molecules, dramatically expanding the repertoire of targetable cancer antigens beyond surface proteins. The inclusion of MAGE-A4-targeted TSC-202-A0201 adds a well-validated cancer testis antigen to their portfolio.
The clean safety profile observed in the ALLOHA trial, with no dose-limiting toxicities, provides a solid foundation for potential combination approaches and outpatient administration, representing meaningful advantages over other cellular immunotherapies that frequently encounter serious toxicity limitations.
Presented updated data from ongoing ALLOHA™ Phase 1 heme trial at the 66th ASH Annual Meeting and Exposition
IND application cleared for seventh TCR in PLEXI-T™ Phase 1 solid tumor program; TSC-202-A0201 targeting MAGE-A4 on HLA-A*02:01
Closed
Cash, cash equivalents, and marketable securities continue to fund operations into the first quarter of 2027
WALTHAM, Mass., March 05, 2025 (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 three months and full year ended December 31, 2024, and provided a business update.
“The progress we achieved across our pipeline in 2024 has paved the way for a transformative year ahead. We are encouraged by the ALLOHA™ heme data presented at ASH with only 2 of 26 patients having relapsed compared to 4 of 12 control-arm subjects. We look forward to presenting additional data from the Phase 1 trial by the end of the year, including two-year relapse data on the initial patients,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “For the PLEXI-T™ solid tumor program, we continue to enroll patients investigating seven different TCR-Ts, including the recently added MAGE-A4 TCR-T (TSC-202-A0201). We look forward to treating our first patient with multiplex therapy in the first half of 2025 and sharing safety and response data for multiplex therapy in the second half of the year.”
Recent Corporate Highlights
- The Company recently presented updated results from the ongoing ALLOHA trial of TSC-100 and TSC-101 at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
- Infusions with TSC-100 and TSC-101 were well-tolerated with no dose limiting toxicities and adverse events were consistent with hematopoietic cell transplantation (HCT).
- TSC-100 and TSC-101 TCR-T cells have been detected >1 year post infusion and have a clear dose-persistence relationship.
- 2 of 26 (
8% ) treatment-arm subjects relapsed as compared to 4 of 12 (33% ) control-arm subjects.- Median time to relapse was not evaluable in TCR-T-treated subjects vs 160 days in the control arm.
- Event-free survival strongly favors the treatment arm (HR=0.30).
- Infusions with TSC-100 and TSC-101 were well-tolerated with no dose limiting toxicities and adverse events were consistent with hematopoietic cell transplantation (HCT).
- In December 2024, the Company refinanced its previous convertible debt facility maturing in 2026 with a non-dilutive term loan for up to
$52.5 million from Silicon Valley Bank (SVB), a division of First Citizens Bank, of which$32.5 million was drawn at closing. The SVB term loan allows for monthly interest-only payments through September 30, 2027, and matures on September 1, 2029. - In December 2024, the Company completed a
$30 million registered direct offering with Lynx1 Capital Management LP (Lynx1), a large existing shareholder of the Company, and an investment fund advised by Lynx1, for pre-funded warrants to purchase up to 7,500,000 shares of the Company’s voting common stock at a price of$4.00 per pre-funded warrant, representing a premium of37% to the previous closing price of TScan Therapeutics’ common stock. Net proceeds from the offering extended the Company’s cash runway into the first quarter of 2027. - The Company announced that it has been named one of the Top Places to Work in Massachusetts for the third consecutive year in the 17th annual, employee-based survey from The Boston Globe. The 2024 Top Places to Work issue can be found online at Globe.com/TopPlaces.
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 ALLOHA trial, NCT05473910).
- Opened expansion cohorts at dose level 3 to further characterize safety and evaluate translational and efficacy endpoints.
- Plans to continue development of TSC-101 only, as TSC-101 enables treatment of ~
98% of patients with HLA type A*02:01. - Initiate a registration trial for TSC-101, pending further feedback from regulatory authorities, in the second half of 2025.
- Plans to present additional data from the Phase 1 trial by the end of the year, including two-year relapse data on the initial patients.
- Plans to file an investigational new drug (IND) application for TSC-102-A0301, a TCR-T targeting CD45 on HLA-A*03:01, in the second half of 2025.
Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of TCR-T therapy candidates that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial, NCT05973487).
- IND filing for TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) recently cleared by U.S. Food and Drug Administration (FDA).
- The Company now has seven TCR-Ts cleared for clinical development in its PLEXI-T Phase 1 trial.
- Progressing through initial dose levels across the TCR-T therapy candidates.
- Plans to dose first patient with multiplex TCR-T therapy in the first half of 2025.
- Safety and response data for multiplex TCR-T therapy anticipated in the second half of 2025.
Financial Results
Revenue: Revenue for the fourth quarter of 2024 was
R&D Expenses: Research and development (R&D) expenses for the fourth quarter of 2024 were
G&A Expenses: General and administrative (G&A) expenses for the fourth quarter of 2024 were
Net Loss: Net loss was
Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2024 were
Share Count: As of December 31, 2024, the Company had issued and outstanding shares of 56,590,627, which consists of 52,314,039 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 73,087,945 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 are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA™ Phase 1 heme trial). 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 (the PLEXI-T™ Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.
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, expectations, 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, filing of an IND for TSC-102-A0301, and initiation of registrational trials; the Company’s plans, progress, expectations and timing relating to the Company’s solid tumor program, including clinical updates of the PLEXI-T Phase 1 solid tumor trial, enrolling and dosing patients, and presentation of data; the progress of the hematologic malignancies and solid tumor programs being indicative or predictive of the success of each program; 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 into the first quarter of 2027 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 product candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s 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 product candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy product 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) | ||||||||||
December 31, 2024 | December 31, 2023 | |||||||||
Assets | ||||||||||
Cash and cash equivalents | $ | 178,689 | $ | 133,359 | ||||||
Other assets | 192,429 | 138,790 | ||||||||
Total assets | $ | 371,118 | $ | 272,149 | ||||||
Liabilities and Stockholders' Equity | ||||||||||
Total liabilities | $ | 130,148 | $ | 121,282 | ||||||
Total stockholders' equity | 240,970 | 150,867 | ||||||||
Total liabilities and stockholders' deficit | $ | 371,118 | $ | 272,149 | ||||||
Common stock and pre-funded warrants outstanding (1) | 129,678,572 | 94,840,055 | ||||||||
(1) Includes at December 31, 2024 and 2023, respectively, 73,087,945 and 47,010,526 issued and 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 December 31, | Twelve Months Ended December 31, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenue: | ||||||||||||||||
Collaboration and license revenue | $ | 665 | $ | 7,211 | $ | 2,816 | $ | 21,049 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 29,354 | 22,407 | 107,350 | 88,153 | ||||||||||||
General and administrative | 8,023 | 6,161 | 30,287 | 26,354 | ||||||||||||
Total operating expenses | 37,377 | 28,568 | 137,637 | 114,507 | ||||||||||||
Loss from operations | (36,712 | ) | (21,357 | ) | (134,821 | ) | (93,458 | ) | ||||||||
Interest and other income, net | 2,777 | 2,596 | 12,065 | 7,999 | ||||||||||||
Interest expense | (784 | ) | (852 | ) | (3,653 | ) | (3,759 | ) | ||||||||
Loss on extinguishment of debt | (1,090 | ) | - | (1,090 | ) | - | ||||||||||
Net loss | $ | (35,809 | ) | $ | (19,613 | ) | $ | (127,499 | ) | $ | (89,218 | ) | ||||
Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (0.21 | ) | $ | (1.14 | ) | $ | (1.36 | ) | ||||
Weighted average common shares outstanding—basic and diluted (2) | 120,789,625 | 94,835,735 | 111,990,417 | 65,599,858 | ||||||||||||
(2) The calculation of weighted average common shares outstanding-basic and diluted includes 73,087,945 shares of the Company's voting common stock issuable upon exercise of pre-funded warrants for the three and twelve months ended December 31, 2024, and includes 47,010,526 shares of the Company's voting common stock issuable upon exercise of pre-funded warrants for the three and twelve months ended December 31, 2023. |
