On July 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 second quarter ended June 30, 2026, and provided recent corporate updates.

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"We are pleased with the progress we made during the second quarter. Our financial discipline with refined focus on nuzefatide pevedotin and our next-generation Bicycle conjugate pipeline, including Bicycle Radioconjugates (BRC), leaves us well capitalized to pursue our mission to help patients to not only live longer, but also live well," said Bicycle CEO Kevin Lee, Ph.D. "The encouraging data we presented during the quarter continue to deepen our belief in the potential of our technology to deliver oncology therapeutics with a superior benefit/risk profile against high-value targets like EphA2 and Nectin-4, the former being historically considered undruggable using antibody-based approaches. We believe this profile provides a strong rationale for developing nuzefatide in recurrent pancreatic cancer, where we successfully dosed our first patient in the ongoing Phase 2 trial in April. We remain on track to begin the Phase 1 trial for BT1702, our MT1-MMP targeting BRC, in 2027, backed by compelling human imaging data validating the targeting precision and translatability of our Bicycle technology."

Dr Lee added: "It is an honor to welcome world-renowned oncologist Professor Thomas Powles to our Clinical Advisory Board. His deep clinical insights and distinguished leadership in urothelial cancers will be instrumental as we accelerate our efforts to deliver precision-targeted therapies for patients."

Second Quarter 2026 and Recent Events

· Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 highlights significant opportunities for nuzefatide pevedotin (nuzefatide), a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), in EphA2 expressing cancers.

o 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 metastatic urothelial cancer (mUC) who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed a differentiated safety profile as well as promising anti-tumor activity.

o 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.

o Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing cell-line-derived xenograft models of head and neck squamous cell carcinoma.

Altogether, Bicycle Therapeutics believes that these data underscore the therapeutic potential for nuzefatide in EphA2-expressing cancers, including pancreatic cancer.

Bicycle Therapeutics is actively enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC. The first patient was successfully dosed in April 2026 at the 8mg/m2 Q2W 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) in seven patients with histologically confirmed PDAC. 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.

Bicycle Therapeutics continues to advance its emerging radioligand pipeline, with the initiation of the first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP targeting BRC, expected in 2027.

· Initial Duravelo-2 data presented at 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrates encouraging response rates comparable to published data for standard of care (SOC) and a potentially differentiated safety profile in previously untreated patients with mUC. Zelenectide pevedotin (zelenectide) is a BDC targeting Nectin-4, a well-validated tumor antigen. The dose optimization stage of the randomized Phase 2 Duravelo-2 trial evaluated two doses of zelenectide – 5mg/m2 weekly (5mg dose) and 6mg/m2 (6mg dose) two weeks on, one week off – in combination with 200mg of pembrolizumab once every three weeks in previously untreated patients with mUC (Cohort 1). Bicycle Therapeutics reached regulatory alignment on the zelenectide 6mg dose as optimal both in combination with pembrolizumab and as a monotherapy. Cohort 1 data were extracted for the interim analysis at Week 27, on July 23, 2025. At the time of the data cut, the median progression-free survival (PFS) was not mature, and the results at the optimal dose showed:

o 65% (17/26) overall response rate (ORR) regardless of confirmation and blinded independent central review (BICR) confirmed ORR of 58% (15/26) at the 27-week cutoff. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62% (16/26).

o Low rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including peripheral neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%).

o There were no reported instances of zelenectide-related hyperglycemia and no zelenectide-related severe skin reactions of any grade.

· Updated Duravelo-1 data presented at 2026 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrates encouraging median PFS comparable to published data for SOC in previously untreated, cisplatin-ineligible mUC patients. Updated Phase 1 Duravelo-1 results as of the August 1, 2025 data cutoff evaluating zelenectide at the 5mg dose in combination with pembrolizumab in previously untreated cisplatin-ineligible patients, 45% of whom were classified as Eastern Cooperative Oncology Group (ECOG) performance status of 2, showed:

o 59% (13/22) ORR regardless of confirmation, 50% confirmed ORR (11/22), and a disease control rate (DCR) of 82%. Of the confirmed responses, 5 (23%) were complete responses and 6 (27%) were partial responses.

o Median PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of the data cutoff.

Across all patients, the safety and tolerability profile was consistent with other zelenectide data to date. No new safety signals were observed and there were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest reported.

· Expanded Clinical Advisory Board with the addition of Thomas Powles, MBBS, MRCP, M.D. Dr. Powles is a Professor of Genitourinary Oncology and Director of Barts Cancer Centre at St Bartholomew’s Hospital, and Lead for Solid Tumor Research at Barts Cancer Institute, London. Dr. Powles is an international leader in the treatment of urothelial cancers, with a research focus spanning from Phase 1 to randomized Phase 3 clinical trials, particularly in translational Phase 2 studies investigating novel targeted and immune therapies. He has played a critical role in leading over twenty randomized clinical trials, resulting in multiple U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals.

Second Quarter 2026 Financial Results

· Cash and cash equivalents were $510.1 million as of June 30, 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.

· Research and development (R&D) expenses were $41.2 million for the three months ended June 30, 2026, compared to $71.0 million for the three months ended June 30, 2025. The decrease in expense of $29.8 million was primarily due to decreased clinical program expenses for zelenectide, decreased personnel-related costs and share-based compensation due to our recent workforce reduction announced in March 2026, as well as decreased discovery, platform and other expenses, offset by lower U.K. R&D tax credits period over period.

· General and administrative (G&A) expenses were $14.0 million for the three months ended June 30, 2026, compared to $18.5 million for the three months ended June 30, 2025. The decrease in expense of $4.5 million was primarily due to decreased professional and consulting fees and decreased personnel-related costs and share-based compensation due to our recent workforce reduction announced in March 2026.

· Net loss was $50.3 million, or $(0.72) basic and diluted net loss per share, for the three months ended June 30, 2026, compared to net loss of $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025.

(Press release, Bicycle Therapeutics, JUL 30, 2026, View Source [SID1234669526])

On July 30, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the second quarter ended June 30, 2026.

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"Our second-quarter performance reflects continued execution across the key priorities that will drive sustainable growth for Agios: strong commercial momentum, pipeline diversification, and strategic portfolio discipline," said Brian Goff, Chief Executive Officer, Agios. "We are encouraged by the ongoing U.S. commercial launch of AQVESME in thalassemia, which continues to see robust engagement from both physicians and patients. We also progressed mitapivat toward a potential new indication in sickle cell disease, highlighted by the FDA granting Priority Review for our sNDA. Beyond these milestones, we strengthened our hematology pipeline with the licensing of cevidoplenib and advancement of AG-236 into Phase 2/3 development, while maintaining disciplined capital allocation. Together, these achievements underscore our ability to deliver meaningful innovation for patients and long-term shareholder value."

Second Quarter 2026 and Recent Corporate Highlights
•Mitapivat (PYRUKYND and AQVESME) Commercial Performance and Update –
o$40.9 million in U.S. net revenue and $3.8 million in ex-U.S. net revenue in the second quarter of 2026.
▪U.S. net revenue was driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026.
▪Ex-U.S. net revenue reflected anticipated demand for PYRUKYND (mitapivat) in Europe following approval for thalassemia in May 2026, as well as continued, consistent early demand in Gulf Cooperation Council (GCC) countries.
oAs of June 30, 2026, 442 cumulative AQVESME prescriptions for thalassemia have been written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians.

•Business Development –
oAgios announced an agreement with Oscotec to license the exclusive global rights to cevidoplenib, a highly-selective, next-generation, oral spleen tyrosine kinase (SYK) inhibitor for immune thrombocytopenia (ITP). The addition of cevidoplenib diversifies Agios’ rare hematology portfolio and represents an opportunity to unlock up to $1.0 billion in peak U.S. sales potential in this indication.
oAgios expects to advance cevidoplenib into Phase 3 development for ITP in the first half of 2028, following completion of additional chemistry, manufacturing, and controls (CMC) development work.

Research and Development (R&D) Highlights
•Mitapivat (pyruvate kinase [PK] activator)
oThalassemia –
▪The European Commission (EC) granted marketing authorization for PYRUKYND in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia, with an orphan medicinal product designation. With this decision, PYRUKYND is the only medicine approved in all European Union (EU) member states for this broad patient population.
▪Mitapivat is now approved for adults with thalassemia in the U.S., Saudi Arabia, United Arab Emirates, and EU.

oSickle Cell Disease –
▪The U.S. Food and Drug Administration (FDA) accepted Agios’ supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease with a Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.
▪Additionally, Agios dosed the first patient in the REIGNITE Phase 3 trial, the confirmatory clinical trial required to be conducted under the accelerated approval pathway. This global trial is designed to demonstrate the clinical benefit of mitapivat on reducing transfusion burden in patients with sickle cell disease aged 12 years or older.
▪Agios also filed for regulatory approval of mitapivat for sickle cell disease in Saudi Arabia.

•AG-236 (siRNA targeting TMPRSS6)
oPolycythemia Vera –
▪Results from Agios’ Phase 1 trial of AG-236 in healthy volunteers demonstrated sustained hepcidin control and effects on iron regulation biomarkers without the need for titration, supporting iron pathway modulation that can potentially address excess red blood cell production in polycythemia vera.
▪The data also indicate the potential for an up to every-six-month dosing schedule.
▪Based on these results, Agios will advance AG-236 into a Phase 2/3 development program in polycythemia vera, with initiation of the Phase 2 portion expected in the second half of 2026.

•AG-181 (phenylalanine hydroxylase [PAH] stabilizer)
oPhenylketonuria (PKU) –
▪Agios dosed the first patient in the Phase 1b trial evaluating the safety and tolerability of AG-181 in adults with PKU. Data from this trial are expected in the second half of 2026.
•Tebapivat (PK activator)
oLower-Risk Myelodysplastic Syndromes (LR-MDS) –
▪Agios announced that it will not advance tebapivat in LR-MDS following results from the company’s Phase 2b trial. While tebapivat demonstrated evidence of biological activity, it did not demonstrate clinical benefit in a sufficient proportion of patients or any patient subgroup to meet the company’s predefined threshold for advancement in LR-MDS.

oSickle Cell Disease –
▪Agios announced that it will not advance tebapivat in sickle cell disease following results from the company’s Phase 2 trial. The data further reinforced PK activation as a clinically validated mechanism in sickle cell disease; however, they did not demonstrate a sufficiently differentiated profile relative to other PK activators to justify continued development of tebapivat in this indication.

Second Quarter 2026 Financial Results
For the quarter ended June 30, 2026, net loss was $100.7 million, compared to net loss of $112.0 million for the quarter ended June 30, 2025.
•Net product revenue from U.S. sales of mitapivat (PYRUKYND and AQVESME) for the second quarter of 2026 was $40.9 million, compared to $12.2 million for the second quarter of 2025.

•Net product revenue from ex-U.S. sales of mitapivat (PYRUKYND) for the second quarter of 2026 was $3.8 million, compared to $0.3 million for the second quarter of 2025.
•Cost of sales for the second quarter of 2026 was $3.0 million.

•Research and Development (R&D) expenses were $100.8 million for the second quarter of 2026, compared to $91.9 million for the second quarter of 2025, driven primarily by the $25.0 million up-front payment associated with the agreement with Oscotec to license cevidoplenib.

•Selling, General and Administrative (SG&A) expenses were $51.5 million for the second quarter of 2026, compared to $45.9 million for the second quarter of 2025, due to an increase in activities related to the U.S. commercial launch of AQVESME in thalassemia.

•Cash, cash equivalents and marketable securities were $964.8 million as of June 30, 2026, compared to $1.2 billion as of December 31, 2025. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to execute the U.S. commercial launch of AQVESME in thalassemia, prepare for the potential U.S. commercial launch of mitapivat in sickle cell disease, advance the company’s existing clinical programs, and opportunistically expand its pipeline through both internally- and externally-discovered assets.

Second Quarter 2026 Conference Call Information
Agios will host a conference call and live webcast today, July 30, 2026, at 8:00 a.m. ET to discuss the company’s second quarter 2026 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, JUL 30, 2026, View Source [SID1234669525])

On July 29, 2026, Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported to have entered into a $4.9 million convertible Promissory Note financing with YA II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP ("Yorkville"). The term of the Note is 12 months. No payments by the Company are due until maturity. The Note carries an Original Issue Discount of five percent but no interest. Repayment of all outstanding amounts is due at maturity. The Note includes customary default provisions. During the term of the Note, it is convertible at the option of the holder, at a small discount to the then prevailing market price. The Company plans to use the proceeds for general corporate purposes, including both its lead product and its in-licensed portfolios.

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The Company and Yorkville also entered into a standby equity subscription agreement (the "Subscription Agreement") which the Company may use after the Note is repaid or converted. The prior standby equity subscription agreement was cancelled. Under this Subscription Agreement, NW Bio has the option, in its discretion, to require Yorkville to subscribe for up to $50 million of common shares in the Company at any time during the 24-month term of the Subscription Agreement at a small discount to the then prevailing market price, after the Note is repaid or converted. The Company has no obligation to make any such use of this arrangement, and the Company can cancel the arrangement at any time after the Note is repaid or converted. The Company has no current plans to draw upon this standby facility; however, the Company believes it will be useful to have this facility available for special funding needs in connection with certain key potential upcoming milestones.

Yorkville also acquired a warrant to purchase up to $2 million of shares at $0.205 per share pursuant to the above transaction.

(Filing, Northwest Biotherapeutics, JUL 29, 2026, View Source [SID1234669577])

On July 29, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported an update on its core patent portfolio. During the first half of 2026, first patent applications were filed to cover the Company’s new generation of technologies including its T cell engager (BiTAC-TCE) and antibody-drug-conjugate (BiTAC-ADC) platforms and therapeutic programs derived from them. Additionally, previously granted patents covering auxiliary technology modules have now cleared the opposition period. Overall, VERAXA now has a portfolio of more than 50 granted owned or exclusively licensed patents in 14 countries, which are spread across 26 patent families. Once the recently filed patent applications are granted, they are expected to protect VERAXA’s core technology suite through at least 2047.

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"Patentable innovations are at the heart of any biotechnology company, and we are very pleased to provide an update on recent developments. Our IP strategy mirrors the breadth of novel concepts and innovations we are pursuing with regard to our BiTAC-TCE and BiTAC-ADC platforms, novel payload strategies, and the conjugation technologies and click chemistry enabling such therapies," commented Christoph Antz, Ph.D., CEO and Co-Founder of VERAXA. "Overall, we are building toward a strong IP portfolio protecting our core technology platforms and product candidates."

VERAXA is reimagining key aspects of bispecific T cell engager (TCE) and antibody-drug-conjugate (ADC) biology through its BiTAC (Bi-targeted Tumor-Associated Cytotoxicity) strategy. This novel approach relies on a dual-component molecular architecture to enhance tumor selectivity and safety via a true "AND-gate" mechanism. For T cell engagers (BiTAC-TCEs), the platform uses two split antibody constructs. Each targets a distinct tumor-associated antigen and carries one half of the T cell binding motif. Only when both precursors bind to the same cancer cell do they form a functional molecule—a mechanism that restricts T cell activity to cells displaying both tumor markers, sparing healthy tissue. For antibody-drug conjugates (BiTAC-ADCs), the technology delivers a systemically inactive prodrug and a cell-impermeable proactivator through two separate antibodies, each targeting a defined tumor-associated antigen. The payload is only released inside the cancer cell through a rapid, highly efficient chemical reaction called ‘click-to-release’. VERAXA’s click chemistry leverages the ultra-fast reaction between trans-cyclooctenes (TCOs) and tetrazines—one of the fastest in nature. The reaction kinetics and other proprietary improvements enable VERAXA to avoid the premature payload release during systemic circulation, as seen with past ADC approaches, and unlock cost savings in BiTAC-ADC manufacturing. In addition, VERAXA applies proprietary conjugation, linker, and hydrophilic payload technologies across its BiTAC and non-BiTAC pipelines, further enhancing the safety, efficacy, and manufacturability of its next-generation therapies.

(Press release, Veraxa Biotech, JUL 29, 2026, https://www.globenewswire.com/news-release/2026/07/29/3335104/0/en/veraxa-biotech-strengthens-patent-portfolio-to-protect-core-technology-platforms-and-product-candidates.html [SID1234669516])

On July 29, 2026 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, reported that the first patient has been infused with TSC-101 in the pivotal Phase 3 ALLOHA-2 trial (NCT07702578). The patient, who was enrolled in June, has now received their first infusion of TSC-101 following successful stem cell engraftment. The trial is investigating the efficacy and safety of TSC-101 for the treatment of residual disease to prevent relapse following allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

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"Dosing our first patient in the ALLOHA-2 study is a significant milestone for TScan. Having been a part of TScan as we moved TSC-101 from an idea to Discovery, through Phase 1 clinical development, and now to a Phase 3 study, I want to acknowledge all the hard work that went into bringing TSC-101 to this integral step and congratulate all current and previous members of the TScan team," said Gavin MacBeath, Ph.D., Chief Executive Officer. "I would also like to thank the investigators, the patients, and their families for participating in our Phase 1 ALLOHA trial. In June, we reported initial data from Cohort C of that study, in which patients were treated with our commercial-ready manufacturing process. The strong clinical efficacy and positive safety profile observed in this cohort gives us added confidence in our Phase 3 trial and future clinical development plans."

"TSC-101 has demonstrated a safety profile and clinical results that continue to excite the transplant community," said Chrystal U. Louis, M.D., Chief Medical Officer. "The pace of Cohort C enrollment highlights the growing interest in TSC-101 as a potential therapeutic option for people with AML or MDS, and we look forward to working with our investigators to address residual disease and improve survival in patients after allo-HCT."

The Phase 3 ALLOHA-2 pivotal trial is a study evaluating TSC-101 administered after standard of care HCT vs HCT alone in patients with AML or MDS. Treatment is based on biological assignment (genetic randomization), with A*02:01-positive subjects with an appropriate donor assigned to the treatment arm, and A*02:01-negative subjects, or A*02:01-posititve subjects without an appropriate donor, assigned to the control arm. All subjects will receive HCT with reduced intensity conditioning. Subjects in the treatment arm will receive two infusions of TSC-101 following engraftment. The primary endpoint for the study is relapse-free survival, and key secondary endpoints include overall survival and event-free survival.

To learn more about the ALLOHA-2 clinical trial, visit clinicaltrials.gov (identifier: NCT07702578).

(Press release, TScan Therapeutics, JUL 29, 2026, View Source [SID1234669515])