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Bicycle Therapeutics Reports Recent Business Progress and Third Quarter 2024 Financial Results

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Bicycle Therapeutics (NASDAQ: BCYC) reported Q3 2024 financial results and business updates. Key highlights include a 45% overall response rate for both zelenectide pevedotin and BT5528 in metastatic urothelial cancer trials. The company's cash position stands at $890.9 million as of September 30, 2024, with runway extending into 2H 2027. Q3 showed a net loss of $50.8 million, or $(0.74) per share. R&D expenses increased to $48.3 million, up from $39.9 million in Q3 2023, while G&A expenses rose to $18.3 million from $16.3 million year-over-year.

Bicycle Therapeutics (NASDAQ: BCYC) ha riportato i risultati finanziari e gli aggiornamenti aziendali per il terzo trimestre del 2024. I punti salienti includono un tasso di risposta complessivo del 45% sia per lo zelenectide pevedotin che per il BT5528 negli studi sul cancro uroteliale metastatico. La posizione monetaria dell'azienda è di $890,9 milioni al 30 settembre 2024, con una prospettiva di finanziamento fino al secondo semestre del 2027. Nel terzo trimestre è stato registrato una perdita netta di $50,8 milioni, cioè $(0,74) per azione. Le spese per ricerca e sviluppo sono aumentate a $48,3 milioni, rispetto a $39,9 milioni nel terzo trimestre del 2023, mentre le spese generali e amministrative sono salite a $18,3 milioni da $16,3 milioni rispetto all'anno precedente.

Bicycle Therapeutics (NASDAQ: BCYC) informó sobre los resultados financieros y las actualizaciones comerciales del tercer trimestre de 2024. Los puntos destacados incluyen una tasa de respuesta global del 45% tanto para el zelenectide pevedotin como para el BT5528 en ensayos de cáncer urotelial metastásico. La posición de efectivo de la compañía se sitúa en $890.9 millones a fecha del 30 de septiembre de 2024, con un horizonte de financiación que se extiende hasta el segundo semestre de 2027. El tercer trimestre mostró una pérdida neta de $50.8 millones, o $(0.74) por acción. Los gastos de I+D aumentaron a $48.3 millones, frente a $39.9 millones en el tercer trimestre de 2023, mientras que los gastos generales y administrativos subieron a $18.3 millones desde $16.3 millones en comparación con el año anterior.

바이시클 테라퓨틱스 (NASDAQ: BCYC)는 2024년 3분기 재무 결과 및 비즈니스 업데이트를 보고했습니다. 주요 내용으로는 전이성 요로상피암 연구에서 제제인 제네센타이드 페베도틴과 BT5528의 전체 응답률이 45%에 달했습니다. 회사의 현금 보유액은 2024년 9월 30일 기준 $890.9 백만이며, 2027년 하반기까지 자금 운용이 가능합니다. 3분기에는 순손실이 $50.8 백만으로 $(0.74) 주당 손실이 발생했습니다. 연구개발 비용은 $48.3 백만으로 증가했으며, 2023년 3분기의 $39.9 백만에서 상승했습니다. 또한, 일반 및 관리 비용은 지난해의 $16.3 백만에서 $18.3 백만으로 증가했습니다.

Bicycle Therapeutics (NASDAQ: BCYC) a rapporté les résultats financiers et les mises à jour commerciales pour le troisième trimestre 2024. Les faits marquants incluent un taux de réponse global de 45 % pour le zelenectide pevedotin et le BT5528 dans les essais de cancer urotélial métastatique. La position de liquidités de l'entreprise s'élève à $890,9 millions au 30 septembre 2024, avec une trésorerie prévue jusqu'au deuxième semestre 2027. Le troisième trimestre a montré une perte nette de $50,8 millions, soit $(0,74) par action. Les dépenses de R&D ont augmenté à $48,3 millions, contre $39,9 millions au troisième trimestre 2023, tandis que les dépenses générales et administratives ont augmenté à $18,3 millions contre $16,3 millions d'une année sur l'autre.

Bicycle Therapeutics (NASDAQ: BCYC) hat die finanziellen Ergebnisse und Unternehmensupdates für das dritte Quartal 2024 bekannt gegeben. Zu den wichtigsten Punkten gehört eine allgemeine Rücklaufquote von 45 % sowohl für Zelenectide Pevedotin als auch für BT5528 in klinischen Studien zu metastasiertem urotelialem Krebs. Die Liquiditätslage des Unternehmens beträgt zum 30. September 2024 $890,9 Millionen, mit einer Finanzierungsdauer bis in die zweite Hälfte von 2027. Im dritten Quartal wurde ein Nettoverlust von $50,8 Millionen oder $(0,74) pro Aktie verzeichnet. Die F&E-Ausgaben stiegen auf $48,3 Millionen, gegenüber $39,9 Millionen im dritten Quartal 2023, während die allgemeinen und administrativen Ausgaben auf $18,3 Millionen von $16,3 Millionen im Jahresvergleich anstiegen.

Positive
  • Strong cash position of $890.9 million providing runway into 2H 2027
  • 45% overall response rate for zelenectide pevedotin in metastatic urothelial cancer
  • 45% overall response rate for BT5528 in metastatic urothelial cancer
  • Promising safety profile with low rates of peripheral neuropathy in clinical trials
Negative
  • Net loss increased to $50.8 million in Q3 2024
  • R&D expenses increased by $8.4 million year-over-year to $48.3 million
  • G&A expenses rose by $2.0 million compared to previous year

Insights

The Q3 results show both progress and increased spending for Bicycle Therapeutics. With $890.9M in cash and equivalents, plus an additional $31.7M R&D tax credit, the company has extended its runway into 2H 2027. This strong cash position provides significant operational flexibility.

R&D expenses increased by $8.4M to $48.3M, primarily driven by zelenectide pevedotin development and higher personnel costs. The net loss of $50.8M ($0.74 per share) remained relatively stable compared to last year's $49.9M loss, despite expanded clinical programs.

The 45% overall response rates for both zelenectide pevedotin and BT5528 in metastatic urothelial cancer are promising clinical indicators that could drive future value. The advancement into registrational trials suggests potential commercialization timeline acceleration.

The clinical data presents compelling evidence of efficacy and safety. The 45% ORR for zelenectide pevedotin with an 11.1-month median duration of response in metastatic urothelial cancer is particularly noteworthy. The differentiated safety profile, especially regarding peripheral neuropathy, could provide a competitive advantage over existing treatments.

The MT1-MMP imaging data validates this novel target, showing specific tumor uptake and favorable biodistribution. The advancement in radiopharmaceuticals, particularly the EphA2 targeting and partnership with Eckert & Ziegler, positions the company well in this emerging therapeutic space.

Presented updated clinical results across oncology pipeline, including a 45% overall response rate (ORR) for zelenectide pevedotin monotherapy and a 45% ORR for BT5528 6.5 mg/m2 every two weeks monotherapy, both in metastatic urothelial cancer

Progressed radiopharmaceuticals pipeline with first human imaging data validating the potential of MT1-MMP as a novel cancer target and outlined company strategy in this area

Cash and cash equivalents of $890.9 million as of September 30, 2024, excluding $31.7 million UK R&D tax credit received in October 2024; expected financial runway into 2H 2027

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)-- Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported recent business progress and financial results for the third quarter ended September 30, 2024.

“In the third quarter, we continued to make significant advancements across our business and pipeline. At ESMO, we reported updated data for our clinical-stage molecules, further supporting their promising monotherapy response rates and differentiated safety profiles. Additionally, last week we shared exciting first human imaging data for our first radiopharmaceuticals molecule, validating the potential of MT1-MMP as a novel cancer target and providing important information on the ability of our Bicycle molecules to deliver radioisotopes to the tumor,” said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. “Altogether, we believe these data demonstrate the power and broad capabilities of our Bicycle technology platform, and we look forward to providing additional updates later this year.”

Third Quarter 2024 and Recent Events

  • 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 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 non-small cell lung cancer, in the lung and lymph nodes confirmed by endobronchial ultrasound biopsy. Both scans revealed multiple lymph node metastases and bone metastases in the sternum. 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. Clear imaging contrast was also observed at early time points.

      • In an e-poster presented by Bicycle Therapeutics, preclinical data demonstrate 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. These data build on the body of preclinical data that the company has published in this area demonstrating the use of Bicycle molecules to effectively deliver various radioisotopes, such as lutetium and lead, to tumors.

    • Bicycle Therapeutics’ strategy in radiopharmaceuticals focuses on pursuing novel targets with first-in-class potential and selecting the isotope that best aligns with the target biology and indication. In line with this strategy, the company selected EphA2, a novel tumor antigen that is widely expressed in many cancers, as its second BRC target and signed a letter of intent with leading isotope technology company Eckert & Ziegler to put in place an agreement to supply a range of radioisotopes and develop and manufacture BRC molecules.

  • Presented updated clinical results across oncology pipeline at the European Society for Medical Oncology Congress 2024.

    • Zelenectide pevedotin (formerly BT8009) is a Bicycle Toxin Conjugate (BTC®) molecule targeting Nectin-4, a well-validated tumor antigen. Updated results from the ongoing Phase 1/2 Duravelo-1 trial evaluating 5 mg/m2 weekly of zelenectide pevedotin monotherapy in patients with metastatic urothelial cancer (mUC) who had not previously been treated with enfortumab vedotin showed a 45% overall response rate (ORR) in efficacy-evaluable patients (n=38), with a median duration of response of 11.1 months among patients with confirmed responses (n=14). Zelenectide pevedotin continued to demonstrate an emerging differentiated safety profile, particularly around adverse events of interest such as peripheral neuropathy, skin reactions and eye disorders.

      The global Phase 2/3 Duravelo-2 registrational trial of zelenectide pevedotin in patients with mUC is currently enrolling. Additional data updates for zelenectide pevedotin monotherapy in other tumor types and in combination with pembrolizumab in first-line mUC are planned by year end.

    • BT5528 is a BTC molecule targeting tumor antigen EphA2, which has historically been difficult to target using other drug conjugate approaches. Updated results from the ongoing Phase 1/2 trial evaluating 6.5 mg/m2 every two weeks and 5 mg/m2 weekly of BT5528 monotherapy in patients with advanced solid tumors showed an emerging differentiated safety profile and antitumor activity, including a 45% ORR in mUC patients enrolled in the dose expansion cohort (n=11) receiving 6.5 mg/m2 every two weeks.

      Bicycle Therapeutics is currently assessing BT5528 at 6.5 mg/m2 every two weeks in combination with nivolumab, with results expected in 2025.

    • An analysis of BTC clinical data showed that treatment-related peripheral neuropathy (TRPN) in patients receiving either zelenectide pevedotin or BT5528 occurred at low rates and were primarily low grade. In 223 patients from ongoing Phase 1/2 studies, TRPN occurred in 28% of zelenectide pevedotin-treated patients and in 19% of BT5528-treated patients, nearly all of which were low grade (Grade 1-2). One Grade 3 event (neuralgia) was reported in a patient treated with zelenectide pevedotin following prior therapy with enfortumab vedotin, while no Grade 3-4 events were observed for BT5528.

      These data showing low rates of TRPN at primarily low severity with BTC molecules support the hypothesis that the antibody-drug construct may be a primary driver of peripheral neuropathy rather than monomethyl auristatin E (MMAE) toxicity as was previously believed.

    • BT7480 is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Initial data from the Phase 1/2 dose escalation trial evaluating BT7480 in patients with advanced solid tumors showed an emerging differentiated safety and tolerability profile, with low rates of severe adverse events among 39 patients assigned to receive one of 10 different doses (0.002-3.5 mg/kg weekly). Preliminary biomarker analyses support BT7480 dual targeting of CD137 and Nectin-4 as demonstrated by enhanced immune cell activation, aligned with the proposed mechanism of action of BT7480.

      As the maximum tolerated dose for BT7480 has not yet been reached, Bicycle Therapeutics is continuing dose exploration in combination studies, starting with nivolumab.

  • Promoted Zafar Qadir to Chief Legal Officer and General Counsel. Since joining Bicycle Therapeutics in April 2020, Mr. Qadir has managed critical responsibilities to support the company’s growth by leading the legal, compliance and intellectual property functions. Over the course of his career, Mr. Qadir has more than a decade of corporate, legal, intellectual property, regulatory and compliance experience and has played a pivotal role in Bicycle Therapeutics’ key partnerships and transactions.

Third Quarter 2024 Financial Results

  • Cash and cash equivalents were $890.9 million as of September 30, 2024, compared to $526.4 million as of December 31, 2023. The increase in cash and cash equivalents is primarily due to net proceeds from our PIPE financing in May 2024 and share option exercises, offset by the repayment of our debt facility with Hercules Capital, Inc. in July 2024 and cash used in operating activities.

  • Research and Development (R&D) expenses were $48.3 million for the three months ended September 30, 2024, compared to $39.9 million for the three months ended September 30, 2023. The increase in expense of $8.4 million was primarily due to increased clinical program expenses for zelenectide pevedotin development and increased personnel-related expenses, including incremental share-based compensation of $1.1 million, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist® molecule development, lower discovery, platform and other expenses, and higher U.K. R&D tax credits period over period.

  • General and administrative expenses were $18.3 million for the three months ended September 30, 2024, compared to $16.3 million for the three months ended September 30, 2023. The increase of $2.0 million was primarily due to increased personnel-related expenses, including incremental share-based compensation expense of $0.7 million.

  • Net loss was $50.8 million, or $(0.74) basic and diluted net loss per share, for the three months ended September 30, 2024, compared to net loss of $49.9 million, or $(1.26) basic and diluted net loss per share, for three months ended September 30, 2023.

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 Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com.

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 Bicycle’s anticipated progress across its R&D pipeline and the advancement of its business and its product candidates, including zelenectide pevedotin, BT5528 and BT7480; the anticipated progression of Bicycle’s clinical trials and the timing of announcement of data from clinical trials and program updates for clinical candidates; the development of potential radiopharmaceutical product candidates; the use of Bicycle’s technology through various partnerships to develop potential therapies in diseases beyond oncology; and Bicycle’s expected financial runway. Bicycle 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’s product candidates; the risk that Bicycle may not realize the intended benefits of its technology or partnerships; timing of results from clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; the risk that Bicycle’s 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’s 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’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2024, as well as in other filings Bicycle 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 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

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

 

September 30,

 

 

2024

 

2023

 

2024

 

2023

Collaboration revenues

 

$

2,676

 

$

5,352

 

$

31,567

 

$

21,645

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

48,265

 

 

39,868

 

 

123,188

 

 

111,799

General and administrative

 

 

18,257

 

 

16,281

 

 

50,588

 

 

45,557

Total operating expenses

 

 

66,522

 

 

56,149

 

 

173,776

 

 

157,356

Loss from operations

 

 

(63,846)

 

 

(50,797)

 

 

(142,209)

 

 

(135,711)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income

 

 

10,583

 

 

3,985

 

 

23,981

 

 

7,726

Interest expense

 

 

(33)

 

 

(814)

 

 

(1,678)

 

 

(2,443)

Loss on extinguishment of debt

 

 

(954)

 

 

 

 

(954)

 

 

Total other income, net

 

 

9,596

 

 

3,171

 

 

21,349

 

 

5,283

Net loss before income tax provision

 

 

(54,250)

 

 

(47,626)

 

 

(120,860)

 

 

(130,428)

(Benefit from) provision for income taxes

 

 

(3,448)

 

 

2,272

 

 

(3,683)

 

 

1,137

Net loss

 

$

(50,802)

 

$

(49,898)

 

$

(117,177)

 

$

(131,565)

Net loss per share, basic and diluted

 

$

(0.74)

 

$

(1.26)

 

$

(2.15)

 

$

(3.95)

Weighted average ordinary shares outstanding, basic and diluted

 

 

68,988,858

 

 

39,576,467

 

 

54,566,490

 

 

33,291,701

 

Condensed Consolidated Balance Sheets Data

(In thousands)

(Unaudited)

 

September 30,

December 31,

 

2024

2023

Cash and cash equivalents

$

890,862

$

526,423

Working capital

909,789

492,331

Total assets

996,746

595,344

Total shareholders’ equity

831,032

370,932

 

Investors:

Stephanie Yao

SVP, Investor Relations and Corporate Communications

stephanie.yao@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 was Bicycle Therapeutics (BCYC) Q3 2024 net loss per share?

Bicycle Therapeutics reported a net loss of $(0.74) per share for Q3 2024.

What is the cash runway for Bicycle Therapeutics (BCYC)?

The company's current cash position of $890.9 million is expected to provide runway into the second half of 2027.

What was the response rate for zelenectide pevedotin in urothelial cancer trials?

Zelenectide pevedotin showed a 45% overall response rate in metastatic urothelial cancer patients.

How much did R&D expenses increase in Q3 2024 for BCYC?

R&D expenses increased by $8.4 million to $48.3 million compared to Q3 2023.

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