On April 30, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the first quarter ended March 31, 2026, and provided recent corporate updates.

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"The data we reported in the first quarter continues to provide further validation of the potential of our Bicycle technology to deliver oncology therapeutics with improved benefit/risk profiles compared to existing modalities," said Bicycle CEO Kevin Lee, Ph.D. "We are excited by the emerging profile of our EphA2 drug conjugate, nuzefatide pevedotin, which we have now tested in over 150 patients to date, both as a monotherapy and in combination with a checkpoint inhibitor. Nuzefatide has been shown to be generally well tolerated at clinically active doses, in contrast to previous attempts to drug this target with other modalities. We believe these data, together with those presented at AACR (Free AACR Whitepaper), provide a strong rationale for advancing the development of nuzefatide in pancreatic cancer, and we are pleased to have recently dosed our first patient in our Phase 2 trial. In addition to this, the preliminary data we have reported from our Duravelo-2 program demonstrate zelenectide pevedotin to also be clinically active with a differentiated safety profile, providing convincing evidence that Bicycle drug conjugates may exhibit a fundamentally different tolerability profile to that seen with antibody-based approaches, and support our mission of helping patients not only to live longer but also to live well."

Dr. Lee added: "Following a strategic reprioritization in the first quarter, we are converting the Duravelo-2 trial into a randomized Phase 2 trial, allowing us to focus our internal resources on our emerging pipeline of next-generation therapeutics, including nuzefatide and Bicycle-based radiotherapeutics and imaging agents. We look forward to presenting initial dose selection data from our Duravelo-2 trial at the upcoming 2026 ASCO (Free ASCO Whitepaper) Annual Meeting and will continue to evaluate the best path for this program as the data continues to mature."

First Quarter 2026 and Recent Events

Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 demonstrates significant opportunities for nuzefatide pevedotin (nuzefatide), formerly BT5528, a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), in EphA2 expressing cancers.
Nuzefatide Phase 1/2 data show a differentiated safety profile in combination with nivolumab in metastatic urothelial cancer (mUC) patients as well as promising anti-tumor activity. As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2 once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with mUC who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed:
40% confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumors and 100% confirmed ORR (3/3) among patients with EphA2+ tumors that were monomethyl auristatin E (MMAE)-naïve.
Patients who achieved a partial response (PR) or at least 16 weeks of stable disease (SD) were on treatment for a minimum of 56 weeks and most continued on treatment at the time of the data cut-off.
Nuzefatide in combination with nivolumab was generally well tolerated with no Grade ≥3 treatment-related adverse events (TRAEs) of clinical interest and no TRAEs of hemorrhage observed. Only one dose-limiting toxicity of Grade 3 fatigue that lasted for five days was reported and improved to Grade 1 without dose reduction.
Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of pancreatic ductal adenocarcinoma (PDAC). Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models were sensitive to nuzefatide, six of which showed high sensitivity.
Preclinical assessment of nuzefatide anti-tumor activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma (HNSCC). Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing CDX models of HNSCC.
Altogether, Bicycle Therapeutics believes that these data highlight significant opportunities for nuzefatide in EphA2 expressing cancers, including pancreatic cancer.

In March 2026, Bicycle Therapeutics began enrolling a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC, and the first patient was successfully dosed in April 2026. Bicycle Therapeutics has determined 8mg/m2 Q2W as the preferred dose for the trial.

Additional human imaging data of a Bicycle Imaging Agent (BIA) targeting EphA2 in patients with PDAC presented at AACR (Free AACR Whitepaper) Annual Meeting 2026. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA). Seven patients with histologically confirmed PDAC underwent PET/CT imaging up to three hours post injection of the EphA2 BIA. Data demonstrated rapid tumor uptake in six out of seven patients with excretion primarily via the kidneys. EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node, and peritoneal metastases.
These data are representative of the results seen in 15 out of 18 patients with PDAC who have undergone EphA2 BIA imaging to date. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle molecules for targeted radioligand therapies and radiopharmaceutical imaging.

Promising Duravelo-2 data and multiple potential regulatory pathways provide a range of options for a Phase 3 trial and potential commercialization of zelenectide pevedotin (zelenectide) in mUC. Initial dose selection data from the Duravelo-2 trial demonstrate response rates comparable to those published for existing standards of care, with physician assessed ORR of 65%, blinded independent central review (BICR) confirmed ORR of 58% at the 27-week cutoff and a differentiated safety profile. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62%. Zelenectide at 6mg/m2 two weeks on, one week off demonstrated a differentiated safety profile with only one patient discontinuing therapy due to a TRAE at the 27-week cutoff.
While Bicycle Therapeutics evaluates preliminary regulatory feedback from the European Medicines Agency, U.S. Food and Drug Administration (FDA), and Medicines and Healthcare products Regulatory Agency, and the potential paths for this program, the company is converting the ongoing Duravelo-2 trial to a randomized Phase 2 trial and deprioritized the program for internal development.

Bicycle Therapeutics will present initial Duravelo-2 dose selection data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago.

Strategic reprioritization focuses on promising pipeline of next-generation therapeutics. In March 2026, Bicycle Therapeutics initiated a strategic reprioritization in order to focus its resources on its promising pipeline of next-generation therapeutics, including nuzefatide, as well as its emerging Bicycle conjugate pipeline, including BRCs. As part of the reprioritization, Bicycle Therapeutics seeks to discontinue the Phase 1/2 Duravelo-3 trial for zelenectide in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide in NECTIN4-amplified non-small cell lung cancer. Enrollment for these trials is closed, and patients currently enrolled will complete their course of treatment. In addition, Bicycle Therapeutics announced a workforce reduction pursuant to which it expects to reduce its workforce by approximately 30%. Anticipated annual operational savings related to the workforce reduction and strategic reprioritization are expected to reduce annual operating expenses by approximately 50% based on the company’s current plans. These actions are expected to extend Bicycle Therapeutics’ cash runway by approximately two years, into 2030.
First Quarter 2026 Financial Results

Cash and cash equivalents were $559.5 million as of March 31, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily due to cash used in operations, including cash payments for clinical program activities.
Collaboration revenue was $0.9 million for the three months ended March 31, 2026, compared to $10.0 million for the three months ended March 31, 2025. The decrease in collaboration revenue of $9.1 million was primarily due to the termination of our collaboration programs with Genentech and Novartis.
Research and development (R&D) expenses were $48.9 million for the three months ended March 31, 2026, compared to $59.1 million for the three months ended March 31, 2025. The decrease in expense of $10.2 million was primarily due to decreased clinical program expenses for zelenectide and share-based compensation due to our workforce reduction, offset by lower U.K. R&D tax credits period over period.
General and administrative (G&A) expenses were $17.5 million for the three months ended March 31, 2026, compared to $21.1 million for the three months ended March 31, 2025. The decrease in expense of $3.6 million was primarily due to decreased professional and consulting fees and decreased share-based compensation due to our workforce reduction.
Net loss was $60.8 million, or $(0.87) basic and diluted net loss per share, for the three months ended March 31, 2026, compared to net loss of $60.8 million, or $(0.88) basic and diluted net loss per share, for the three months ended March 31, 2025.

(Press release, Bicycle Therapeutics, APR 30, 2026, View Source [SID1234664960])

On April 30, 2026 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported that the Company will be presenting on multiple programs at upcoming scientific conferences being held in May and June.

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Presentation details are outlined below.

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting
Poster Presentation

Title: Evaluation of KB409 and KB410, two HSV-1-based gene therapy vectors for the treatment of primary ciliary dyskinesia (PCD)
Presenter: Bruce Nmezi, PhD
Date and Time: May 12, 2026 from 5:00PM to 6:30PM ET

American Thoracic Society (ATS) International Conference 2026
Oral Presentation

Title: Interim results of the CORAL-1 trial of KB407 for the treatment of cystic fibrosis
Presenter: Jorge Lascano, MD, Professor of Medicine, Associate Director of the Adult Cystic Fibrosis Program, and Director of the Cystic Fibrosis Therapeutics Development Center at the University of Florida
Date and Time: May 20, 2026 at 10:03AM ET

2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Poster Presentation

Title: Inhaled delivery of KB707, a novel HSV-based immunotherapy, in combination with pembrolizumab in advanced non-small cell lung cancer: a phase 1/2 study
Presenter: Wen Wee Ma, MBBS, Enterprise Vice Chair for Research and Director of the Novel Cancer Therapeutics Center at Cleveland Clinic Cancer Institute
Date and Time: May 31, 2026 from 9:00AM to 12:00PM CT

Additional presentation details will be available to conference attendees. Following completion of each conference, presentation slides or posters, as applicable, will also be available to view online on the Investor section of the Company’s website.

(Press release, Krystal Biotech, APR 30, 2026, View Source [SID1234664979])

On April 30, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (the "Company"), reported its full year 2025 unaudited consolidated financial results, as approved by the Board of Directors on April 29, 2026. Audit procedures by the Company’s statutory auditors on the Company’s 2025 consolidated financial statements are still ongoing.

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Full Year 2025 Consolidated Financial Results (IFRS, unaudited)

In million euros 2024 2025
Revenues 69.9 2.6
Other income 13.6 0.1
Operating income 83.4 2.7
Research and development expenses (30.4) (33.9)
General and administrative expenses (6.5) (8.8)
Share-based payments non-cash expenses (2.7) (1.9)
Other operating items - 4.4
Operating profit (loss) 43.7 (37.5)
Financial income (loss) (3.9) 0.1
Net income (loss) 37.4 (37.7)
EPS (in € per share) 1.71 (1.69)
Net cash flows from operating activities 48.4 (34.0)
Net cash flows from investment activities (46.9) 41.4
Net cash flows from financing activities (3.5) (6.5)
Net cash flows (1.9) 0.8
Cash and cash equivalents at closing 16.7 17.6
Total Cash Position at closing (incl. long-term deposits) 64.2 22.7

Operating income in 2025 amounted to €2.7 million, primarily reflecting revenues generated by Tedopi’s supply of early access program in France for €1.4 million, and the deferred recognition of a portion of the $48 million upfront payment from the AbbVie licensing agreement on OSE-230 signed in April 2024 for €0.8 million. In comparison, operating income in 2024 totaled €83.4 million, mainly driven by the immediate booking of the majority of the AbbVie upfront payment for €42.2 million, €25.3 million from the amendment to the agreement with Boehringer Ingelheim on BI 765063 (OSE-172), and €13.5 million from the asset purchase by Boehringer Ingelheim related to the "cis-targeting" anti-PD1/cytokine platform.

Research and development expenses increased by 11.5% over the period, amounting to €33.9 million in 2025, compared to €30.4 million the prior year. This increase reflects our development programs moving forward, notably the ongoing Phase 3 pivotal trial of Tedopi – Artemia – actively recruiting, as well as a lower amount of Research Tax Credit (CIR) amounting to €4.6 million in 2025, compared to €5.3 million in 2024.

General and administrative expenses increased by 34.0% over the period, amounting to €8.8 million in 2025, compared to €6.5 million in 2024. This significant increase primarily reflects legal fees incurred in connection with the exceptional context surrounding the Annual General Meeting held on September 30, 2025, which led to a complete renewal of the Company’s governance, as well as legal proceedings initiated against certain minority shareholders. These non-recurring expenses were partially offset by a reduction in personnel costs, following the partial deferral of compensation from 2023 to 2024 for certain key executives. Excluding these non-recurring expenses, general and administrative expenses represented €7.8m, increasing by 19.5% year-on-year.

Share-based payments non-cash expenses amounted to €1.9 million in 2025, compared to €2.7 million a year earlier. These expenses are mainly comprised of calculated non-cash expenses in application of IFRS2, amounting to €1.5 million and €2.1 million in 2025 and 2024, respectively. The decrease in 2025 notably reflects a reversal of expenses due to the cancellation of 219,970 free shares granted in 2024 to former CEO Nicolas Poirier, following a negative vote by shareholders on the "Say-on-Pay" ex post provision at the Annual General Meeting held on September 30, 2025.

Other operating items amounted to €4.4 million in 2025, representing a partial waiver of debt related to conditional advances paid by Bpifrance for the EFFICLIN project after it was terminated by the Company.

Operating loss amounted to €(37.5) million in 2025, compared to a profit of €43.7 million a year earlier, essentially reflecting an exceptional income in 2024 related to the AbbVie licensing agreement on OSE-230 and the amendment on the BI 765063 (OSE-172) agreement as well as the asset purchase agreement from the "cis-targeting" anti-PD1/cytokine platform by Boehringer Ingelheim.

Financial income amounted to €0.1 million in 2025, compared to a loss of €(3.9) million a year earlier. This variation is mainly related to calculated non-cash expenses reflecting the change in fair value of the warrant passive derivative in the European Investment Bank (EIB) finance contract.

Net loss amounted to €(37.7) million in 2025, compared to a profit of €37.4 million a year earlier, essentially reflecting non-recurring income in 2024.

Net cash flows from operating activities amounted to €(34.0) million in 2025, reflecting our development programs moving forward, notably the ongoing Phase 3 trial of Tedopi – Artemia – actively recruiting, compared to €48.4 million a year earlier, essentially reflecting non-recurring income in 2024.

Net cash flows from investment activities amounted to €41.4 million in 2025, compared to €(46.9) million a year earlier, essentially reflecting cash management in various term deposit instruments.

Net cash flows from financing activities amounted to €(6.5) million in 2025, compared to €(3.5) million a year earlier. This variation mainly reflects an early repayment of the EIB loan for €3.0 million in January 2025.

Cash and cash equivalents totaled €17.6 million as of December 31, 2025, compared to €16.7 million a year earlier. Including fixed-term deposits classified as current and non-current financial assets, total cash position amounted to €22.7 million and €64.2 million as of December 31, 2025 and 2024, respectively.

Cash Runway and Financing

The Company’s cash and cash equivalents totaled €17.0 million as of March 31, 2026, compared to €22.7 million as of December 31, 2025.

Based on its current plans, assumptions and available financial resources, the Company estimates that its cash and cash equivalents will be sufficient to fund its operations until the beginning of fourth quarter 2026, as previously guided. This cash runway does not include any potential exercise of warrants issued to the benefit of Vester Finance, as the contract was fully terminated in April 2026, nor any potential future milestone payments from existing partnerships.

To extend its runway beyond the beginning of the fourth quarter of 2026, the Company continues to evaluate several complementary options, including a potential new strategic partnership involving one of its proprietary assets, equity financing, restructuring of its existing debt, and potential milestone payments from current partnerships.

Although the Company is confident in its ability to meet its short-term financing objectives, there is no guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions to finance all of its activities on a 12-month horizon.

Pending the potential completion of such above-mentioned transactions, the Company has deferred the publication of its audited consolidated financial statements and its Universal Registration Document for the fiscal year 2025 to May 28, 2026, at the latest. Certification of the 2025 consolidated financial statements by the Company’s auditors will take place before the filing of the Universal Registration Document with the French financial markets authority (Autorité des Marchés Financiers) (the "AMF"), no later than May 28, 2026. Should no sufficient financing transaction be completed in due time, the statutory auditors are expected to include a going concern qualification in their certification report.

(Press release, OSE Immunotherapeutics, APR 30, 2026, View Source [SID1234664994])

On April 30, 2026 Bristol Myers Squibb (NYSE: BMY) reported first quarter 2026 financial results.

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Visit the company’s Investor Relations website at View Source to view the detailed first quarter 2026 earnings press release and investor presentation.

The company will host a conference call and live audio webcast for analysts and investors at 8:00 a.m. ET today, April 30, 2026, which is accessible here. Company executives will review financial results with the investment community during the call.

A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

(Press release, Bristol-Myers Squibb, APR 30, 2026, View Source [SID1234664961])

On April 30, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review.

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The application, covering commercially significant European markets[2], has now moved into a 210-day active assessment phase[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.

In Europe, there is currently no generally available commercial product for PET[5] imaging of glioma with 18F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product [6]. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally[8] and is launching in multiple European countries.

Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making."

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101‑Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision‑making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted[9]."

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors[11]. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting4. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount6. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine) is Telix’s PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix’s IPAX-2[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi". Brand name and commercial launch are subject to final regulatory approval.

(Press release, Telix Pharmaceuticals, APR 30, 2026, View Source [SID1234664980])