Bicycle Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2024 Financial Results
Bicycle Therapeutics (NASDAQ: BCYC) reported its Q4 and full-year 2024 financial results and recent business progress. Updated Phase 1 data for zelenectide pevedotin plus pembrolizumab in metastatic urothelial cancer showed a 65% overall response rate among 20 efficacy evaluable patients. Enhanced response was observed in NECTIN4 gene-amplified breast and lung cancers, leading to FDA Fast Track designations. Several Phase 1/2 trials are expected in 2025.
The company is advancing its radiopharmaceuticals pipeline with additional MT1-MMP human imaging data expected mid-2025 and first EphA2 human imaging data planned for 2H 2025. Cash and cash equivalents were $879.5 million as of December 31, 2024, providing financial runway into 2H 2027.
R&D expenses were $49.8 million for Q4 and $173.0 million for the year, while G&A expenses were $21.6 million for Q4 and $72.2 million for the year. Net loss was $51.9 million for Q4 and $169.0 million for the year, compared to $49.1 million and $180.7 million, respectively, in 2023.
Bicycle Therapeutics (NASDAQ: BCYC) ha riportato i suoi risultati finanziari per il quarto trimestre e per l'intero anno 2024 e i recenti progressi aziendali. I dati aggiornati della Fase 1 per zelenectide pevedotin più pembrolizumab nel cancro uroteliale metastatico hanno mostrato un tasso di risposta complessivo del 65% tra 20 pazienti valutabili per l'efficacia. È stata osservata una risposta migliorata nei tumori al seno e ai polmoni amplificati dal gene NECTIN4, portando a designazioni di Fast Track da parte della FDA. Sono previsti diversi studi di Fase 1/2 nel 2025.
L'azienda sta avanzando il suo portafoglio di radiomedicine con ulteriori dati di imaging umano MT1-MMP attesi per metà 2025 e i primi dati di imaging umano EphA2 pianificati per la seconda metà del 2025. Le disponibilità liquide e equivalenti ammontavano a 879,5 milioni di dollari al 31 dicembre 2024, garantendo una copertura finanziaria fino alla seconda metà del 2027.
Le spese per ricerca e sviluppo sono state di 49,8 milioni di dollari per il quarto trimestre e di 173,0 milioni di dollari per l'anno, mentre le spese generali e amministrative sono state di 21,6 milioni di dollari per il quarto trimestre e di 72,2 milioni di dollari per l'anno. La perdita netta è stata di 51,9 milioni di dollari per il quarto trimestre e di 169,0 milioni di dollari per l'anno, rispetto a 49,1 milioni e 180,7 milioni, rispettivamente, nel 2023.
Bicycle Therapeutics (NASDAQ: BCYC) informó sus resultados financieros para el cuarto trimestre y el año completo 2024 y los recientes avances comerciales. Los datos actualizados de la Fase 1 para zelenectide pevedotin más pembrolizumab en cáncer urotelial metastásico mostraron una tasa de respuesta general del 65% entre 20 pacientes evaluables por eficacia. Se observó una respuesta mejorada en los cánceres de mama y pulmón amplificados por el gen NECTIN4, lo que llevó a designaciones de Fast Track por parte de la FDA. Se esperan varios ensayos de Fase 1/2 en 2025.
La compañía está avanzando su cartera de radiotecnologías con datos adicionales de imagenología humana de MT1-MMP esperados para mediados de 2025 y los primeros datos de imagenología humana de EphA2 planeados para la segunda mitad de 2025. El efectivo y equivalentes de efectivo eran de 879.5 millones de dólares al 31 de diciembre de 2024, proporcionando un margen financiero hasta la segunda mitad de 2027.
Los gastos de I+D fueron de 49.8 millones de dólares para el cuarto trimestre y de 173.0 millones de dólares para el año, mientras que los gastos generales y administrativos fueron de 21.6 millones de dólares para el cuarto trimestre y de 72.2 millones de dólares para el año. La pérdida neta fue de 51.9 millones de dólares para el cuarto trimestre y de 169.0 millones de dólares para el año, en comparación con 49.1 millones y 180.7 millones, respectivamente, en 2023.
바이시클 테라퓨틱스 (NASDAQ: BCYC)는 2024년 4분기 및 연간 재무 결과와 최근 사업 진행 상황을 보고했습니다. 전이성 요로상피암에서 젤레넥타이드 페베도틴과 펨브롤리주맙의 1상 데이터 업데이트는 20명의 효능 평가 가능 환자 중 65%의 전체 반응률을 보였습니다. NECTIN4 유전자 증폭 유방암 및 폐암에서 향상된 반응이 관찰되어 FDA의 패스트 트랙 지정을 받았습니다. 2025년에 여러 개의 1/2상 임상 시험이 예정되어 있습니다.
회사는 MT1-MMP 인간 이미징 데이터의 추가 진행을 통해 방사선 의약품 파이프라인을 발전시키고 있으며, 2025년 중반에 기대되고 있으며, EphA2 인간 이미징 데이터는 2025년 하반기에 계획되어 있습니다. 2024년 12월 31일 기준으로 현금 및 현금성 자산은 8억 7950만 달러였으며, 2027년 하반기까지 재정적 여유를 제공합니다.
연구개발 비용은 4분기에 4980만 달러, 연간 1억 7300만 달러였으며, 일반 관리 비용은 4분기에 2160만 달러, 연간 7220만 달러였습니다. 순손실은 4분기에 5190만 달러, 연간 1억 6900만 달러였으며, 2023년에는 각각 4910만 달러와 1억 8070만 달러였습니다.
Bicycle Therapeutics (NASDAQ: BCYC) a annoncé ses résultats financiers pour le quatrième trimestre et l'année 2024 ainsi que les progrès récents de l'entreprise. Les données actualisées de la phase 1 pour zelenectide pevedotin en association avec le pembrolizumab dans le cancer urotélial métastatique ont montré un taux de réponse global de 65 % parmi 20 patients évaluables pour l'efficacité. Une réponse améliorée a été observée dans les cancers du sein et du poumon amplifiés par le gène NECTIN4, ce qui a conduit à des désignations Fast Track de la FDA. Plusieurs essais de phase 1/2 sont attendus en 2025.
L'entreprise fait progresser son portefeuille de radiopharmaceutiques avec des données d'imagerie humaine MT1-MMP supplémentaires attendues pour la mi-2025 et les premières données d'imagerie humaine EphA2 prévues pour le second semestre 2025. Les liquidités et équivalents de liquidités s'élevaient à 879,5 millions de dollars au 31 décembre 2024, offrant une marge financière jusqu'au second semestre 2027.
Les dépenses de R&D se sont élevées à 49,8 millions de dollars pour le quatrième trimestre et à 173,0 millions de dollars pour l'année, tandis que les dépenses générales et administratives étaient de 21,6 millions de dollars pour le quatrième trimestre et de 72,2 millions de dollars pour l'année. La perte nette s'élevait à 51,9 millions de dollars pour le quatrième trimestre et à 169,0 millions de dollars pour l'année, contre 49,1 millions et 180,7 millions, respectivement, en 2023.
Bicycle Therapeutics (NASDAQ: BCYC) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 sowie aktuelle Geschäftsentwicklungen bekannt gegeben. Die aktualisierten Phase-1-Daten für Zelenectide Pevedotin in Kombination mit Pembrolizumab bei metastasiertem Urothelkarzinom zeigten eine Gesamtansprechrate von 65 % bei 20 auswertbaren Patienten. Eine verbesserte Reaktion wurde bei NECTIN4-gen-amplifizierten Brust- und Lungenkrebsarten beobachtet, was zu Fast-Track-Zulassungen durch die FDA führte. Mehrere Phase-1/2-Studien werden für 2025 erwartet.
Das Unternehmen entwickelt seine Radiopharmazeutika-Pipeline weiter, wobei zusätzliche MT1-MMP-Menschendaten für Mitte 2025 und erste EphA2-Menschendaten für die zweite Hälfte von 2025 geplant sind. Zum 31. Dezember 2024 betrugen die liquiden Mittel und Äquivalente 879,5 Millionen Dollar, was eine finanzielle Basis bis zur zweiten Hälfte von 2027 bietet.
Die F&E-Ausgaben betrugen 49,8 Millionen Dollar im vierten Quartal und 173,0 Millionen Dollar im Jahr, während die allgemeinen und administrativen Ausgaben im vierten Quartal 21,6 Millionen Dollar und im Jahr 72,2 Millionen Dollar betrugen. Der Nettoverlust betrug 51,9 Millionen Dollar im vierten Quartal und 169,0 Millionen Dollar im Jahr, verglichen mit 49,1 Millionen Dollar und 180,7 Millionen Dollar im Jahr 2023.
- Cash and cash equivalents of $879.5 million as of December 31, 2024
- Financial runway expected into 2H 2027
- FDA Fast Track designations for TNBC and NSCLC
- 65% overall response rate in Phase 1 zelenectide pevedotin trial
- Net loss of $51.9 million for Q4 2024
- Net loss of $169.0 million for full-year 2024
- Increased R&D expenses to $173.0 million for 2024
- Increased G&A expenses to $72.2 million for 2024
Insights
Bicycle Therapeutics' Q4 and full-year 2024 results showcase a company with strengthening clinical validation and a substantially improved financial position that significantly de-risks its development pathway. The $879.5 million cash position (up from $526.4 million YoY) provides an extended runway into 2H 2027, covering multiple value-creating clinical milestones across its pipeline.
The updated zelenectide pevedotin plus pembrolizumab data in first-line metastatic urothelial cancer represents a potential breakthrough. The 65% overall response rate and 50% confirmed response rate in cisplatin-ineligible patients significantly outperform the historical 20-30% response rates seen with pembrolizumab monotherapy. Importantly, the safety profile appears manageable with primarily low-grade adverse events, positioning this combination as potentially best-in-class compared to other antibody-drug conjugates (ADCs) that often face dose-limiting toxicities.
The company's NECTIN4 gene amplification biomarker strategy represents a sophisticated precision medicine approach that could dramatically expand zelenectide pevedotin's market opportunity beyond urothelial cancer. The 62.5% response rate in NECTIN4-amplified breast cancer and 40% in NECTIN4-amplified NSCLC patients demonstrates the potential for tumor-agnostic applications. Particularly noteworthy is the activity observed in patients previously treated with sacituzumab govitecan, suggesting zelenectide pevedotin's potential in overcoming resistance to established therapies.
The radiopharmaceuticals pipeline, while earlier stage, represents a strategic diversification that leverages Bicycle's platform technology. The MT1-MMP imaging data validates both the target and the BRC approach, with the favorable biodistribution profile (high tumor uptake with rapid renal clearance) potentially addressing key limitations of current radiopharmaceuticals.
Financially, while R&D expenses increased 10.5% to $173 million and G&A rose 19.5% to $72.2 million, the net loss decreased from $180.7 million to $169 million year-over-year. This improving financial efficiency, combined with the substantial cash position, gives management considerable operational flexibility to advance multiple programs simultaneously.
For investors, the multiple planned Phase 1/2 trials in 2025 (Duravelo-3, 4, and 5) targeting NECTIN4-amplified tumors, along with the Duravelo-2 dose selection data expected in 2H 2025, provide numerous potential catalysts. The Fast Track designations for TNBC and NSCLC further validate the regulatory pathway and could accelerate approval timelines.
With a differentiated technology platform, encouraging clinical data, biomarker-driven precision medicine strategy, and robust financial position, Bicycle Therapeutics appears well-positioned to progress toward commercialization of potentially transformative cancer therapies.
Bicycle Therapeutics' latest clinical results demonstrate compelling progress for zelenectide pevedotin, a novel Bicycle Toxin Conjugate (BTC) that fundamentally differs from traditional antibody-drug conjugates (ADCs). Unlike bulky antibodies (~150 kDa), Bicycles are small (~2 kDa) synthetic peptides that offer potentially superior tumor penetration, more homogeneous drug delivery, and rapid systemic clearance - addressing key limitations of current ADC approaches.
The updated zelenectide pevedotin plus pembrolizumab data in first-line cisplatin-ineligible metastatic urothelial cancer is particularly striking. The 65% ORR (50% confirmed) substantially outperforms the historical 29% ORR for pembrolizumab monotherapy in this population. Notably, this efficacy comes with a differentiated safety profile compared to enfortumab vedotin (Padcev), the approved NECTIN4-targeting ADC that carries a black box warning for serious skin reactions and neuropathy. Zelenectide pevedotin's primarily low-grade adverse events suggest a potentially improved therapeutic window that could enable more durable treatment and better quality of life.
The NECTIN4 gene amplification biomarker strategy represents a sophisticated precision medicine approach with substantial implications. NECTIN4 amplification occurs in approximately 10-15% of breast cancers, 15-20% of TNBCs, and 10-12% of NSCLCs - representing significant addressable patient populations. The dramatic response rate differences between amplified and non-amplified tumors (62.5% vs. 14.3% in breast cancer; 40% vs. 8.8% in NSCLC) validate this approach and could streamline clinical development by enriching for likely responders.
Particularly intriguing is the activity in patients previously treated with sacituzumab govitecan (Trodelvy), suggesting zelenectide pevedotin may overcome resistance mechanisms to traditional ADCs. This positions it as a potential sequential therapy in treatment paradigms for TNBC and other solid tumors.
The radiopharmaceutical program leverages Bicycle's platform technology to address emerging targets like MT1-MMP (highly expressed in aggressive cancers) and EphA2. The favorable biodistribution profile shown in first human imaging - with high tumor uptake and rapid renal clearance - addresses a critical limitation of current radiopharmaceuticals: off-target toxicity in organs of clearance. This could potentially expand the therapeutic window for targeted radionuclide therapy.
The planned expansion into multiple NECTIN4-amplified tumor types through the Duravelo trial series represents a tumor-agnostic development strategy similar to tissue-agnostic approvals for biomarker-driven therapies like pembrolizumab for MSI-high tumors. With Fast Track designations already secured and the potential for breakthrough therapy designations based on emerging data, zelenectide pevedotin could see accelerated approval pathways in multiple indications.
With $879.5 million providing runway through multiple clinical readouts, Bicycle is well-positioned to establish zelenectide pevedotin as a potential best-in-class precision therapy across multiple NECTIN4-driven cancers while advancing its innovative radiopharmaceutical pipeline.
Bicycle Therapeutics' latest results reveal a company with increasingly validated technology and a remarkably strong financial position that appears disconnected from its current valuation. With $879.5 million in cash against a ~$796 million market cap, investors are essentially assigning negative value to Bicycle's clinical pipeline and technology platform - an unusual disconnect that suggests significant potential upside if clinical programs continue to deliver.
Zelenectide pevedotin's performance in first-line metastatic urothelial cancer represents a potential best-in-class profile in a market dominated by Seagen/Astellas' Padcev (enfortumab vedotin). The 65% ORR in combination with pembrolizumab compares favorably to Padcev+pembrolizumab's 68% ORR in the EV-302 trial, but with a notably improved safety profile. While Padcev carries a black box warning for serious skin reactions and peripheral neuropathy, zelenectide pevedotin shows primarily low-grade adverse events - a critical differentiation in a therapy class where toxicity often limits treatment duration and effectiveness.
The NECTIN4 gene amplification biomarker strategy represents a sophisticated approach to expanding market opportunity while potentially accelerating regulatory pathways. By identifying patients most likely to respond (62.5% ORR in NECTIN4-amplified breast cancer vs. 14.3% overall), Bicycle could pursue tumor-agnostic approvals similar to pembrolizumab's MSI-high indication. This precision medicine approach also addresses the growing payer preference for biomarker-driven therapies with clear efficacy signals.
The current cash position provides runway through multiple value-inflection points: Duravelo-2 dose selection data (2H 2025), readouts from multiple Phase 1/2 trials in NECTIN4-amplified cancers (2025-2026), and advancement of the radiopharmaceutical pipeline toward clinical proof-of-concept (2025-2026). At the current quarterly burn rate of ~$42 million, Bicycle has approximately 20 quarters of runway - extraordinary for a clinical-stage biotech and providing significant negotiating leverage for any potential partnerships.
The radiopharmaceuticals program represents a strategic diversification into a rapidly growing market projected to reach $12-15 billion by 2030. Bicycle's approach offers potential advantages over antibody-based radiopharmaceuticals, including superior tumor penetration, more favorable biodistribution, and reduced off-target effects - addressing key limitations of current therapies like Pluvicto and Lutathera.
From a strategic perspective, Bicycle's combination of validated technology, promising clinical data, and strong financial position makes it an increasingly attractive partnership or acquisition candidate. Large pharmaceutical companies seeking differentiated oncology assets - particularly those with precision medicine approaches and potential for tumor-agnostic development - may view Bicycle as an appealing opportunity, especially given the current valuation disconnect.
The key risks include potential clinical setbacks in the Duravelo trial series, competitive advances from other NECTIN4-targeting therapies, and execution challenges in managing multiple parallel development programs. However, the strong cash position significantly mitigates financing risk and provides flexibility to navigate potential challenges.
With multiple catalysts approaching, a differentiated technology platform gaining clinical validation, and a financial position that provides exceptional operational flexibility, Bicycle represents an intriguing opportunity at current valuation levels.
Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line metastatic urothelial cancer; Duravelo-2 dose selection data expected in 2H 2025
Enhanced response to zelenectide pevedotin seen in NECTIN4 gene-amplified late-line breast cancer and non-small cell lung cancer (NSCLC), resulting in
Advancing radiopharmaceuticals pipeline, with additional MT1-MMP human imaging data expected in mid-2025 and first EphA2 human imaging data planned for 2H 2025
Cash and cash equivalents of
“In 2024, the significant progress across our pipeline and business continued to validate our approach to developing next-generation precision-guided therapeutics. We believe that zelenectide pevedotin’s promising anti-tumor activity and differentiated safety profile could transform the treatment landscape not only for patients with metastatic urothelial cancer but also NECTIN4 gene-amplified solid tumors. Additionally, our encouraging first human imaging data for MT1-MMP demonstrates the potential of our technology platform to produce radiopharmaceutical medicines to novel targets,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “With a clear strategy to build on this foundation and financial runway into the second half of 2027, we are strongly positioned for another year of execution across our research and development pipeline of oncology, radiopharmaceuticals and partnered programs as we work to bring innovative therapies to cancer patients.”
Fourth Quarter 2024 and Recent Events
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Announced updated topline combination data for zelenectide pevedotin plus pembrolizumab in first-line metastatic urothelial cancer (mUC). As of Jan. 3, 2025, updated topline results from the ongoing Phase 1 Duravelo-1 trial evaluating zelenectide pevedotin 5 mg/m2 weekly plus pembrolizumab 200 mg once every 3 weeks in 22 first-line cisplatin-ineligible patients with mUC continued to show promising anti-tumor activity and a differentiated safety profile.
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Among 20 efficacy evaluable patients, a
65% overall response rate (ORR) (13/20) was achieved, and a50% ORR (10/20) was reached among patients with confirmed responses. Of the 3 unconfirmed responses, 1 patient remained on treatment at the time of the reported clinical results. - Median duration of response (mDOR) is not yet mature, with 12 patients still on treatment at the time of the reported clinical results.
- The safety and tolerability profile continues to be broadly consistent with other Phase 1 zelenectide pevedotin monotherapy and combination cohorts. Adverse events of clinical interest such as peripheral neuropathy, skin reactions and eye disorders were primarily low grade. All cases of Grade 3 treatment-related adverse events (TRAEs) of clinical interest were reversible, and there were no Grade 4 or Grade 5 TRAEs of clinical interest.
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Among 20 efficacy evaluable patients, a
Bicycle Therapeutics is currently conducting the Phase 2/3 Duravelo-2 registrational trial evaluating zelenectide pevedotin plus pembrolizumab versus chemotherapy in first-line mUC (Cohort 1), and zelenectide pevedotin monotherapy and in combination with pembrolizumab in late-line mUC (Cohort 2). In each cohort, two doses of zelenectide pevedotin – 5 mg/m2 weekly and 6 mg/m2 two weeks on, one week off – are being assessed before a planned final dose selection in 2H 2025.
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Announced development strategy leveraging NECTIN4 gene amplification for zelenectide pevedotin in breast cancer, lung cancer and multiple tumor types. During the 2024 San Antonio Breast Conference Symposium, Bicycle Therapeutics presented data from post-hoc analyses of late-line breast cancer and lung cancer patients enrolled in the Phase 1/2 Duravelo-1 trial evaluating zelenectide pevedotin 5 mg/m2 weekly. Results showed enhanced anti-tumor activity of zelenectide pevedotin monotherapy in patients with NECTIN4 gene amplification and/or polysomy.
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Among 38 breast cancer patients enrolled, 35 patients were efficacy evaluable. Additionally, 23 breast cancer patient samples were available for NECTIN4 testing, of which 8 demonstrated NECTIN4 gene amplification or harbored NECTIN4 polysomy. Results showed a
62.5% ORR (5/8) in patients with NECTIN4 gene amplification and/or polysomy versus14.3% ORR (5/35) in efficacy-evaluable patients. All responses were seen in patients with NECTIN4 gene amplification and/or polysomy. -
Among 32 triple-negative breast cancer (TNBC) patients enrolled, 30 patients were efficacy evaluable. Additionally, 19 TNBC patient samples were available for NECTIN4 testing, of which 7 demonstrated NECTIN4 gene amplification or harbored a NECTIN4 polysomy. Results showed a
57.1% ORR (4/7) in patients with NECTIN4 gene amplification and/or polysomy versus13.3% ORR (4/30) in efficacy-evaluable patients. All responses were seen in patients with NECTIN4 gene amplification and/or polysomy. Notably, all 3 patients with NECTIN4 gene amplification who responded to zelenectide pevedotin had prior treatment with sacituzumab govitecan. -
Among 40 non-small cell lung cancer (NSCLC) patients enrolled, 34 patients were efficacy evaluable. Additionally, 19 NSCLC patient samples were available for NECTIN4 testing, of which 6 demonstrated NECTIN4 gene amplification. Five out of 6 patients with NECTIN4 gene amplification were efficacy evaluable. Results showed a
40.0% ORR (2/5) in patients with NECTIN4 gene amplification versus8.8% ORR (3/34) among efficacy-evaluable patients. Of the 3 partial responses, 2 were confirmed and 1 was unconfirmed. Two out of 3 responses were seen in patients with NECTIN4 gene amplification.
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Among 38 breast cancer patients enrolled, 35 patients were efficacy evaluable. Additionally, 23 breast cancer patient samples were available for NECTIN4 testing, of which 8 demonstrated NECTIN4 gene amplification or harbored NECTIN4 polysomy. Results showed a
Zelenectide pevedotin was generally well tolerated, demonstrating a safety and tolerability profile consistent with data from other Duravelo-1 cohorts, and TRAEs were primarily low grade, further supporting the potential for NECTIN4 gene amplification to serve as a biomarker for therapy stratification. Based on these data, the
Bicycle Therapeutics has continued to build a robust patent estate related to the use of NECTIN4 gene amplification as a biomarker for patient selection. The company plans to initiate several additional Phase 1/2 trials evaluating zelenectide pevedotin in NECTIN4 gene-amplified cancer, including breast cancer (Duravelo-3) in 1H 2025 and lung cancer (Duravelo-4) and multi-tumor (Duravelo-5) in 2H 2025.
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Announced first human imaging data for a Bicycle® Radionuclide Conjugate (BRC®) targeting MT1-MMP and outlined strategy for leadership in next-generation radiopharmaceuticals. Data presented at the European Association of Nuclear Medicine 2024 Congress validate the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrate the translatability of BRC preclinical data and highlight the potential of Bicycle® molecules for targeted radionuclide therapy.
- In an oral presentation, the German Cancer Consortium (DKTK) shared results of fluorine-18-labelled FDG-PET/CT imaging and gallium-68-labelled BRC MT1-MMP PET/CT imaging in a 65-year-old male diagnosed with advanced pulmonary adenocarcinoma, the most common type of NSCLC, in the lung and lymph nodes. MT1-MMP imaging demonstrated tracer uptake in the primary tumor in the lung and lymph node and bone metastases, consistent with FDG imaging. Additionally, the MT1-MMP BRC tracer showed renal excretion, with all other organs showing only a negligible tracer uptake.
- Preclinical data presented by Bicycle Therapeutics demonstrated the suitability of Bicycle molecules to deliver indium to tumors in vivo due to their favorable properties, including specific tumor uptake, rapid tumor penetration and rapid renal elimination. Additionally, imaging showed how the biodistribution profile of BRCs can be optimized to maintain high tumor uptake and retention while significantly reducing kidney levels.
Bicycle Therapeutics continues to advance its emerging BRC pipeline, with additional MT1-MMP human imaging data anticipated in mid-2025 and initial EphA2 human imaging data expected in 2H 2025. The company is targeting clinical trials for its first radiotherapeutic program to begin in 2026.
- Expanded Clinical Advisory Board with the appointment of three distinguished oncology experts to further support the advancement of the company’s clinical programs. Bicycle Therapeutics welcomed Howard A. “Skip” Burris, III, M.D., president and chief medical officer of Sarah Cannon Research Institute; Markus Eckstein, M.D., a board-certified senior consultant pathologist at the University Hospital Erlangen (FAU Erlangen-Nürnberg); and Niklas Klümper, M.D., senior consultant for Urology & Genitourinary Oncology at the University Hospital Bonn.
Participation in Upcoming Investor Conferences
Bicycle Therapeutics management will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, at 9:50 a.m. ET. A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.
Fourth Quarter and Year End 2024 Financial Results
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Cash and cash equivalents were
$879.5 million $526.4 million -
Research and development (R&D) expenses were
$49.8 million $173.0 million $44.7 million $156.5 million $5.1 million $16.5 million $2.2 million $3.8 million U.K. R&D tax credits period over period. -
General and administrative expenses were
$21.6 million $72.2 million $14.9 million $60.4 million $6.7 million $11.8 million $0.3 million $1.8 million -
Net loss was
$51.9 million $(0.75) $169.0 million $(2.90) $49.1 million $(1.16) $180.7 million $(5.08)
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radionuclide Conjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential for zelenectide pevedotin to transform the treatment landscape for patients with mUC and NECTIN4 gene-amplified solid tumors; the potential for Bicycle Therapeutics’ technology to produce radiopharmaceutical medicines; the company’s ability to build on its foundation, including with respect to execution across its pipeline; the planned dose selection for Duravelo-2; the anticipated initiation of clinical trials of zelenectide pevedotin in breast cancer, lung cancer and multi-tumor types and of the company’s first radiotherapeutic program; the timing of announcement of human imaging data for MT1-MMP and EphA2 targeting BRCs; expectations with respect to Bicycle Therapeutics’ financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop potential therapies in diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its technology, partnerships or NECTIN4 gene-amplification strategy; the risk that Bicycle Therapeutics may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics’ projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle Therapeutics’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 31, 2024, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Bicycle Therapeutics plc |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share data) |
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(Unaudited) |
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2024 |
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2023 |
|
2024 |
|
2023 |
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Collaboration revenue |
|
$ |
3,708 |
|
|
$ |
5,331 |
|
|
$ |
35,275 |
|
|
$ |
26,976 |
|
Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
49,778 |
|
|
|
44,697 |
|
|
|
172,966 |
|
|
|
156,496 |
|
General and administrative |
|
|
21,593 |
|
|
|
14,869 |
|
|
|
72,181 |
|
|
|
60,426 |
|
Total operating expenses |
|
|
71,371 |
|
|
|
59,566 |
|
|
|
245,147 |
|
|
|
216,922 |
|
Loss from operations |
|
|
(67,663 |
) |
|
|
(54,235 |
) |
|
|
(209,872 |
) |
|
|
(189,946 |
) |
Other income (expense): |
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|
|
|
|
|
|
|
|
|
|
|
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Interest and other income |
|
|
10,303 |
|
|
|
6,276 |
|
|
|
34,284 |
|
|
|
14,002 |
|
Interest expense |
|
|
(52 |
) |
|
|
(820 |
) |
|
|
(1,730 |
) |
|
|
(3,263 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(954 |
) |
|
|
— |
|
Gain on extinguishment of research and development funding liability |
|
|
4,476 |
|
|
|
— |
|
|
|
4,476 |
|
|
|
— |
|
Total other income, net |
|
|
14,727 |
|
|
|
5,456 |
|
|
|
36,076 |
|
|
|
10,739 |
|
Net loss before income tax provision |
|
|
(52,936 |
) |
|
|
(48,779 |
) |
|
|
(173,796 |
) |
|
|
(179,207 |
) |
(Benefit from) provision for income taxes |
|
|
(1,082 |
) |
|
|
320 |
|
|
|
(4,765 |
) |
|
|
1,457 |
|
Net loss |
|
$ |
(51,854 |
) |
|
$ |
(49,099 |
) |
|
$ |
(169,031 |
) |
|
$ |
(180,664 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.75 |
) |
|
$ |
(1.16 |
) |
|
$ |
(2.90 |
) |
|
$ |
(5.08 |
) |
Weighted average ordinary shares outstanding, basic and diluted |
|
|
69,051,745 |
|
|
|
42,419,326 |
|
|
|
58,207,593 |
|
|
|
35,592,362 |
|
Balance Sheets Data |
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(In thousands) |
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(Unaudited) |
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|
December 31, |
|
December 31, |
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|
|
2024 |
|
2023 |
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Cash and cash equivalents |
|
$ |
879,520 |
|
$ |
526,423 |
Working capital |
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|
861,375 |
|
|
492,331 |
Total assets |
|
|
956,868 |
|
|
595,344 |
Total shareholders’ equity |
|
|
793,060 |
|
|
370,932 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250225808318/en/
Investors:
Stephanie Yao
SVP, Investor Relations and Corporate Communications
ir@bicycletx.com
857-523-8544
Matthew DeYoung
Argot Partners
ir@bicycletx.com
212-600-1902
Media:
Jim O’Connell
Weber Shandwick
media@bicycletx.com
312-988-2343
Source: Bicycle Therapeutics plc
FAQ
What were the financial results for Bicycle Therapeutics in Q4 2024?
How did zelenectide pevedotin perform in recent trials?
What is the financial outlook for Bicycle Therapeutics?
What are the upcoming trials for zelenectide pevedotin?
What are the expected milestones for Bicycle Therapeutics' radiopharmaceuticals pipeline?
What were the R&D expenses for Bicycle Therapeutics in 2024?
What Fast Track designations did zelenectide pevedotin receive?
