On August 13, 2026 Evotec reported Half-Year Interim Report 2026.

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(Presentation, Evotec, AUG 13, 2026, View Source [SID1234670282])

On August 13, 2026 Baylink Biosciences, Inc. ("Baylink"), a biotechnology company focused on developing next-generation antibody-drug conjugates (ADCs) for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BLB101, a novel CLDN6/CLDN9 dual-targeting ADC for the treatment of patients with advanced solid tumors.

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BLB101 is Baylink’s lead ADC program and is designed to selectively deliver the highly potent topoisomerase I inhibitor Exatecan to tumor cells expressing CLDN6 and/or CLDN9. The molecule incorporates Baylink’s proprietary BL001 hydrophilic cleavable linker. It uses cysteine-maleimide conjugation approach with a drug-to-antibody ratio (DAR) of 8.

"FDA clearance of the BLB101 IND is an important milestone for Baylink and validates the progress of our ADC development platform," said Alice Chen, CSO of Baylink Biosciences. "BLB101 represents our differentiated approach to ADC development, combining dual CLDN6/CLDN9 targeting, a TOP1 inhibitor payload that is insensitive to efflux pump, and our proprietary hydrophilic linker technology. We look forward to advancing BLB101 into clinical development and evaluating its potential to provide a new treatment option for patients with advanced solid tumors."

Designed for Broader Tumor Targeting

CLDN6 is a tight-junction protein with highly restricted expression in most normal adult tissues and aberrant expression in some solid tumors. CLDN9, a closely related Claudin family member, is also expressed in a range of solid tumors and may provide complementary tumor coverage.

BLB101 incorporates Baylink’s proprietary 2D5S antibody, which binds both CLDN6 and CLDN9. This dual-targeting strategy is designed to expand the potential patient population and address tumor heterogeneity associated with expression of individual tumor antigens.

Preclinical studies have demonstrated specific binding to CLDN6 and CLDN9, internalization of BLB101 into target-positive tumor cells, and potent cytotoxic activity in relevant tumor models.

Exatecan Payload and Proprietary BL001 Linker

BLB101 uses Exatecan, a highly potent Topoisomerase I inhibitor that is insensitive to efflux pump, as its cytotoxic payload. Following internalization and intracellular processing of the ADC, Exatecan is released and induces DNA damage through stabilization of the TOP1-DNA cleavage complex, ultimately leading to tumor cell death.

Baylink’s proprietary BL001 linker was designed to improve the overall physicochemical properties and stability of high-DAR ADCs while supporting efficient intracellular payload release. BL001 incorporates hydrophilic structural elements and a cleavable Val-Ala sequence and supports a high drug-to-antibody ratio of 8. BL001 linker was also designed to reduce non-specific internalization by non-cancer cells which is expected to further reduce side effects.

Advancing Toward Clinical Proof of Concept

Baylink has completed key preclinical, CMC, and IND-enabling activities for BLB101, including GLP toxicology studies, pharmacokinetic and toxicokinetic characterization, analytical development, drug substance and drug product manufacturing, formulation development, and stability studies.

The FDA clearance of the BLB101 IND enables Baylink to initiate clinical development of BLB101 in patients with advanced solid tumors.

"The IND clearance is the result of the tremendous effort of the Baylink team," said Patrick Zweider-McKay, MD/PhD, Baylink’s Clinical Advisor. "We are excited to bring this program into the clinic and generate clinical data that will help determine the therapeutic potential of CLDN6/CLDN9 dual targeting."

(Press release, Baylink Biosciences, AUG 13, 2026, View Source [SID1234670159])

On August 13, 2026 BioCytics, Inc., and LIDE Biotech reported the formation of a strategic alliance to develop advanced screening platforms and companion diagnostics for immune-based cancer cell therapies. This collaboration combines BioCytics’ specialized cell manufacturing capabilities with LIDE’s unique, patient-derived xenograft technologies (PDX, miniPDX, and IO-based PDX models) to streamline the development of immuno-oncology (IO) treatments.

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The initial project based on the companies’ recently-executed Memorandum of Understanding will involve the creation of murine PDX models using human biospecimens from ethically consented patients on an institutional review board (IRB)-approved BioCytics tumor and immune cells collection study (View Source) that opened in 2007 and is still ongoing. These tumor models can then be used to observe a number of critical responses, such as drug resistance or induced cell death, for cells being treated in in vivo validation studies. Further model studies will involve DNA and RNA sequencing for additional response research such as human anti-tumor immune cell function.

BioCytics’ COO, Dr. Brent Dixon, says that "working with LIDE Biotech enables real breakthroughs in personalized medicine for cancer patients. We are excited about exploring our developments for autologous adaptive immune cell therapy (AAICT) within this unique model. We expect to learn more about the molecular pathways and signatures based upon the applied analytical methodologies."

This sentiment is echoed by Dr. Danyi Wen, LIDE’s Founder and CEO, who states that "LIDE is excited for its first-ever partnership with an American-based company to further deliver on our goals to support translational research for new drug R&D as well as personalized oncology. We are looking forward to working with BioCytics and leveraging its expertise to make LIDE technologies available outside of China. BioCytics’ patient-first vision is inspiring and truly aligns with LIDE’s mission to empower more scientists, accelerate more breakthroughs, and help move promising treatments one step closer to patients in need."

(Press release, BioCytics, AUG 13, 2026, View Source [SID1234670098])

On August 13, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the second quarter ended June 30, 2026 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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"NuCana continues to build momentum as we advance NUC-7738 closer to several important clinical and regulatory milestones," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We are pleased to announce that recruitment is now complete in our Phase 2 NuTide:701 expansion study evaluating NUC-7738 in combination with Keytruda (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma. Based on the data presented to date, we remain confident in the benefit NUC-7738 may offer these patients, and we remain on track to present final data from this study later this year. Following the Investigational New Drug application ("IND") clearance from the U.S. Food and Drug Administration (the "FDA") earlier this year, we look forward to continuing our dialogue with the FDA to determine the optimal path toward a potential registrational strategy for NUC-7738 in melanoma."

Mr. Griffith continued, "We believe NUC-7738’s ability to disrupt RNA polyadenylation and act on multiple aspects of the tumor microenvironment could make an impact across a broad range of tumor types. The Company continues to assess potential additional indications, subject to emerging data and portfolio prioritization."

Mr. Griffith concluded, "None of this progress would be possible without a strong financial foundation. With cash resources anticipated to fund our operations into 2029, we have the flexibility to keep advancing our pipeline, including evaluating additional indications and combination strategies for NUC-7738 and NUC-3373. We look forward to delivering on our milestones over the remainder of 2026."

2026 Anticipated Milestones

NUC-7738

Complete patient recruitment in the Phase 2 expansion study (NuTide:701) evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Announce final data from the Phase 2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Obtain regulatory guidance from the FDA regarding a potential registrational strategy for NUC-7738 in melanoma; and
Advance evaluation of additional indications and combination strategies.
NUC-3373

Complete evaluation of optimal combinations and indications to inform potential future clinical studies of NUC-3373.
Second Quarter 2026 Financial Highlights and Cash Position

As at June 30, 2026, NuCana had cash and cash equivalents of £19.5 million compared to £21.5 million at March 31, 2026 and £24.3 million at December 31, 2025. NuCana anticipates its cash and cash equivalents at June 30, 2026 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £3.1 million for the quarter ended June 30, 2026, as compared to a net loss of £24.1 million for the quarter ended June 30, 2025. Basic and diluted loss per ordinary share was £0.00 for the quarter ended June 30, 2026, as compared to a loss per ordinary share of £0.00 for the comparable quarter ended June 30, 2025.

NuCana reported a net loss of £6.9 million for the six months ended June 30, 2026, as compared to a net loss of £26.6 million for the six months ended June 30, 2025. The net loss for the six months ended June 30, 2026 and for the comparable period included the following non-cash or non-recurring items:

Share-based payment expenses of £2.8 million (2025: £8.2 million);
Professional fees of £nil (2025: £1.4 million) related to the issue of warrants; and
Finance expense of £nil (2025: £12.6 million) relating to the non-cash loss on fair value revaluation of the warrants issued in the May 2025 financing.
Basic and diluted loss per ordinary share was £0.00 for the six months ended June 30, 2026, as compared to a loss per ordinary share of £0.01 for the comparable six months ended June 30, 2025.

(Press release, Nucana, AUG 13, 2026, View Source [SID1234670097])

On August 13, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer, reported a business and clinical programs update and announced financial results for the quarter ended June 30, 2026.

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Clinical and Corporate Update

Announced publication of positive clinical and immunological biomarker data from Stage 1 of the NCI-led metastatic colorectal cancer (mCRC) Phase 2, open-label, single-center, non-randomized clinical trial evaluating PDS0301 (formerly PDS01ADC), the Company’s tumor-targeted IL-12 immunocytokine. The clinical trial results, published in the March 2026 issue of the Journal of Clinical Oncology (JCO) Oncology Advances, included:

Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS0301, the ORR was 35% (7/20)
24-month survival rate approximately 80%; in the parallel trial without PDS0301, the 24-month survival rate was approximately 35%
Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS0301, the PFS was 8.1 months

On August 11, 2026, the Company issued a shareholder letter outlining its strategic refocus to prioritize PDS0301, its tumor-targeted IL-12 immunocytokine, as its lead development program. As part of this strategy, the Company will cease further internal investment in PDS0101, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intends to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. The Company believes that concentrating its capital and development resources on PDS0301, while maintaining financial discipline and preserving the potential value of PDS0101 through partnerships, may provide the strongest path toward creating long-term value for patients and shareholders.

Second Quarter 2026 Financial Results

Reported net loss was $9.8 million, or $0.18 per basic and diluted share, for the three months ended June 30, 2026, compared to $9.4 million, or $0.21 per basic and diluted share, for the three months ended June 30, 2025.

Research and development expenses were $3.3 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower clinical trial costs, manufacturing costs and personnel costs, partially offset by higher stock-based compensation expense.

General and administrative expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.4 million for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees.

Total operating expenses were $6.5 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025.

Net interest expenses were $3.3 million for the three months ended June 30, 2026, compared to $1.8 million for the three months ended June 30, 2025. The increase was primarily due to a non-cash charge for loss on retirement of debt, partially offset by lower cash interest payments.

The Company’s cash balance as of June 30, 2026, was $5.6 million.

(Press release, PDS Biotechnology, AUG 13, 2026, View Source [SID1234670096])