On May 6, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported its financial results for the first quarter ended March 31, 2026, and reported on recent and upcoming business highlights.

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"We continue to execute across our pipeline and believe we are making meaningful scientific and operational progress," said Martin Lehr, Chief Executive Officer of Context Therapeutics. "We remain on track to report Phase 1a interim clinical data from our lead program, CTIM-76, in June 2026. This update is expected to include preliminary safety, efficacy, and other correlative results. In addition, we continue to anticipate reporting Phase 1a clinical data from our CT-95 program in September 2026."

Mr. Lehr added, "In April, we received approval in Australia to advance the development of CT-202, marking an important milestone as we prepare to initiate a first-in-human clinical study later this year. We look forward to evaluating CT-202 in the clinic, and we believe this program further supports our strategy of advancing differentiated T cell engaging therapeutics for patients with significant unmet medical needs."

Recent and Upcoming Business Highlights

Pipeline Highlights

In April 2026, Context announced that the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 TCE bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies.
In April 2026, Context presented preclinical data for CT-202, a Nectin-4 x CD3 TCE bispecific antibody, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.
In April 2026, Context received Human Research Ethics Committee ("HREC") approval and Clinical Trial Notification ("CTN") acknowledgement by the Australian Therapeutic Goods Administration ("TGA") to initiate a first-in-human Phase 1 clinical trial of CT-202.

Corporate Highlights

In March 2026, Context presented at the TD Cowen 46th Annual Health Care Conference, the Citizens Life Sciences Conference and the Leerink Partners Global Healthcare Conference.
In February 2026, Context presented at the Guggenheim Emerging Outlook Conference.

First Quarter 2026 Financial Results

Cash and cash equivalents were $54.5 million at March 31, 2026, compared to $66.0 million at December 31, 2025. The Company expects its cash and cash equivalents will be sufficient to fund its operations into mid-2027.
Research and development ("R&D") expenses were $7.0 million for the first quarter of 2026, as compared to $3.5 million for the first quarter of 2025. The increase in R&D expenses was primarily driven by higher CTIM-76 expense of $1.2 million, higher CT-202 expense of $0.9 million, higher personnel-related costs of $0.8 million, and higher CT-95 expense of $0.6 million.
General and administrative expenses were $2.3 million for the first quarter of 2026, as compared to $2.1 million for the first quarter of 2025. The increase was primarily driven by increases in salaries and personnel-related costs, including share-based compensation. Professional fees also increased by approximately $0.1 million as compared to the same period in 2025.
Other income was $0.7 million for the first quarter of 2026, as compared to $1.0 million for the first quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances.
Context reported a net loss of $8.7 million for the first quarter of 2026, as compared to $4.6 million for the first quarter of 2025.

(Press release, Context Therapeutics, MAY 6, 2026, View Source [SID1234665237])

On May 6, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported that the first clinical site in the ZIMA-101 Phase 1 trial has now been activated.

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This marks the transition of the study from clinical preparation to active trial execution of the ZIMA-101 study.

The first activated clinical site is The Christie NHS Foundation Trust in the United Kingdom, where Professor Fiona Thistlethwaite serves as Chief Investigator for the study.

ZIMA-101 is a first-in-human Phase 1 trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

On 20 February 2026, Zelluna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) had approved the Company’s Clinical Trial Application (CTA) for ZIMA-101 in the UK.

Activation of the second clinical site, The Royal Marsden, is expected in the near term.

"This is an important milestone for Zelluna. With the first clinical site now activated, we are entering the execution phase of the ZIMA-101 study. Our focus is now on advancing clinical execution, including patient screening and progression toward first patient dosing" says CEO Namir Hassan.

Zelluna has previously communicated that initial clinical data from the ZIMA-101 study are expected to emerge from mid-2026.

(Press release, Zelluna Immunotherapy, MAY 6, 2026, View Source [SID1234665236])

On May 6, 2026 InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a clinical trial of its novel CDH17 targeted ADC, ICP-B208.

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CDH17 is a calcium-dependent cell adhesion protein that plays a key role in tumor cell proliferation, migration, and metastasis. Its tumor-restricted expression and functional role in cancer biology make CDH17 an attractive and differentiated target for ADC therapy, which can be developed for the treatment of gastrointestinal cancers, including colorectal, gastric, pancreatic ductal adenocarcinoma, and biliary tract cancer. Currently, there are no approved CDH17 targeted ADCs globally.

ICP-B208 is a novel ADC comprising a humanized anti-CDH17 monoclonal antibody conjugated to a potent, in-house developed payload via a protease-cleavable linker. This design enables significantly enhanced tumor-killing effects with improved stability and safety. Preclinical studies show that ICP-B208 demonstrates good anti-tumor activity even in CDH17-low tumors, and improved cell killing activity compared to similar drugs.

ICP-B208 is the second novel ADC to enter into clinical development by the Company’s in-house developed ADC platform, following ICP-B794, a novel B7-H3 targeted ADC. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates.

Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, said, "The approval of the clinical trial of ICP-B208 marks another milestone in our solid tumor pipeline and validates the huge drug development potential of our ADC platform. We will continue to expand our portfolio with multiple ADC candidates and bring new hope to cancer patients worldwide."

(Press release, InnoCare Pharma, MAY 6, 2026, View Source [SID1234665235])

On May 6, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION, a tumor-activated oncology delivery platform, reported it will present two new developments at its Science Day 2026 event.

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The Company is presenting comparative analyses of pre|CISION payload delivery via one of its programs, AVA6103, compared with now two approved Antibody-Drug Conjugates (ADCs).It is also presenting updated in vivo studies of the dual payload delivery system in another program, AVA6207.

Christina Coughlin, CEO of Avacta, commented:

"These presentations further underline the potential of our unique pre|CISION technology to improve treatment options for cancer patients.

"Providing data analysis of two ADCs, including Enhertu, as part of the AVA6103 program, further demonstrates the alignment of the ADC mechanism and highlights the critical advantages of our pre|CISION delivery directly to the tumor with higher selectivity, regardless of the ADC target.

"The data with our pre|CISION technology to deliver dual payloads has now demonstrated for the first time an efficacy advantage over single payload ADCs in a FAP-low and HER2-positive patient-derived cancer model.

"We continue to build momentum and enhance our IP – at a pace that we are confident exceeds industry norms."

AVA6103: The new data analyses in the AVA6103 program comparing pre|CISION FAP-cleavable exatecan delivery with those of leading marketed ADCs have been extended to Datroway, an ADC targeting the TROP2 antigen, as well as Enhertu an ADC targeting the HER2 antigen.

Details of these studies:

All three of these drugs (AVA6103, Enhertu and Datroway) feature tumor-targeted delivery of topoisomase I inhibitors (exatecan or deruxtecan) and these comparisons are designed to address the differences in the payload delivery and control for the differences in cancer models
The delivery kinetics of exatecan (derived from AVA6103) and deruxtecan (derived from Enhertu or Datroway) demonstrate more rapid tumor penetration of released exatecan from AVA6103 (Tmax of minutes, AVA6103 versus Tmax >24 hours, Enhertu or Datroway) and higher maximal concentration (Cmax) of released payload in the tumor with differences observed of over 1-log
The tumor selectivity index (TSI) is a measure of the overall exposure (area under the curve, AUC) in the tumor vs. the bloodstream (TSI = AUC[tumor/plasma]) which is at least 3 times higher with released exatecan from AVA6103 than either released deruxtecan from Enhertu or Datroway
The Company is planning to publish these findings at an upcoming academic meeting and in a peer-reviewed journal
AVA6207: The in vivo data in the AVA6207 program show the dual payload delivery demonstrating prolonged deep complete responses despite tumor regrowth with the conventional cytotoxic drugs. Initial data was published at AACR (Free AACR Whitepaper) 2026 last month and has been updated.

Findings include:

Results indicate that deep and durable complete responses are observed in the FAP-high model, HEK-FAP where tumors regrow with conventional therapy.
In the FAP-low/HER2-positive patient derived xenograft model of gastric cancer, durable responses with AVA6207 are observed where tumor regrowth is observed with Enhertu. These results suggest optimal treatment with the combination is more effective in this model than the deruxtecan-based ADC.
The investor Science Day 2026 event is being held at the Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA, starting at 10.30am. Attendance capacity is limited, so attendance is limited to those who have received confirmation of registration previously. The presentations will be recorded and published on the Company website in due course.

Enhertu is a registered trademark of Daiichi Sankyo Company, Limited and AstraZeneca. Datroway is a registered trademark of Daiichi Sankyo Company, Limited.

(Press release, Avacta Life Sciences, MAY 6, 2026, View Source [SID1234665234])

On May 6, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to treat nodular basal cell carcinoma (BCC) of the skin, the most common type of skin cancer.

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These additional pre-specified analysis, build upon the previously reported positive topline results, provide expanded biological, histologic, and safety insights that further strengthen SkinJect’s therapeutic profile and future registrational discussions with the U.S. Food and Drug Administration (FDA). These additional findings are also consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025, reinforcing reproducibility across studies.

SKNJCT-003 Study Design Overview (NCT06608238)::

The SKNJCT-003 (NCT06608238) clinical study was designed as a randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma. It was a multi-center study designed to enroll 90 participants presenting with nodular type basal cell carcinoma. The participants were randomized 1:1:1 into three groups:

Device-controlled group receiving P-MNA
Low-dose group receiving 100µg of D-MNA
High-dose group receiving 200µg of D-MNA

Expanded central pathology reconciliation demonstrated that 69 participants met intended nodular BCC inclusion criteria, while 21 participants were identified as superficial or mixed subtype lesions.

The Results from Pre-specified Expanded Analysis of 69 participants are summarized below:

Dose # of patients(n) Day 29 post-treatment # of patients(n) Day 57 post-treatment
35 Clinical Clearance Histological Clearance (CR) 34 Clinical Clearance Histological Clearance (CR)
Device-only 12 42 % 25 % 14 29 % 29 %
100ug D-MNA 12 42 % 25 % 9 44 % 33 %
200ug D-MNA 11 46 % 27 % 11 64 % 55 %

The expanded analysis demonstrates a progressive and dose-dependent improvement, with the strongest separation emerging at Day 57.

"We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program" stated Dr. Raza Bokhari, Chairman and CEO of Medicus. "We are confident that this dataset moves us from Proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major un-met medical need".

From Positive Topline Dataset to Positive Dose-Response:

The Company previously reported topline results from the population of 90 randomized patients, which demonstrated a positive topline and decision-grade dataset. The 69-patient refined efficacy analysis further strengthens the regulatory alignment of the study as the Company advances toward End-of-Phase 2 (EOP2) discussions with the FDA.

The topline dataset showed that:

The 200µg cohort achieved the highest observed activity at Day 57
Clearance rates improved from Day 29 to Day 57, consistent with continued biological activity over time

The pre-specified expanded dataset analysis builds on this foundation by:

Revealing a clear and consistent dose-response relationship across endpoints
Demonstrating stronger separation between the 200µg cohort and control, particularly at Day 57
Strengthens differentiation between drug-driven efficacy and device-only biological activity

Importantly, this expanded central pathology verified dataset provides a more precise and clinically interpretable view of treatment effect, with the 200µg cohort at Day 57 emerging as the leading dose with the most robust and consistent efficacy signal.

These findings suggest that many treated lesions may in the future be able to avoid immediate surgical intervention, representing a potentially meaningful shift in the treatment paradigm for BCC. Given the short treatment and excision timeline evaluated, these results are particularly encouraging and may suggest clinically meaningful anti-tumor activity within a highly practical therapeutic window.

Collectively, this dataset may support future registration-intent or NDA-enabling development discussions, including optimized patient population, lesion subtype, dose regimen, and treatment-to-excision interval.

D-MNA continued to demonstrate a highly favorable safety and tolerability profile, was generally well tolerated with no drug-related serious adverse events, no evidence of systemic doxorubicin toxicity, and predominantly mild localized treatment-site reactions, supporting repeatable lesion-directed administration consistent with prior Phase 1 observations.

Reinforcing Drug-Driven Therapeutic Effect:

The device-only arm also demonstrated early biological activity consistent with microneedle-induced local immune response, but it did not show sustained or deepening efficacy over time. In contrast, the 200µg D-MNA cohort demonstrated progressive improvement from Day 29 to Day 57, resulting in clear separation across both clinical and histological endpoints. This pattern is consistent with drug-driven therapeutic effect, rather than a device-only response.

Independent Investigator Validation Supports Clinical and Regulatory Read-Through

These findings are further supported by independent investigator validation from a leading academic dermatologist and clinical investigator.

Dr. Babar K. Rao, MD, FAAD, Principal Investigator of the SKNJCT-003 study, is an internationally recognized academic dermatologist, dermatopathologist, and clinical investigator in skin oncology. He serves as Professor of Dermatology and Pathology at Rutgers Robert Wood Johnson Medical School and holds academic appointments at Weill Cornell Medical College.

Dr. Rao has evaluated the dataset and noted that he believes it demonstrates a clinically meaningful rapid onset efficacy, clear differentiation between drug and device effect and a profile that supports continued development and regulatory progress. Dr. Rao noted the consistency between visual, histologic, and central pathology findings is highly encouraging and provides growing confidence that SkinJect is producing meaningful biologic anti-tumor effects. Notably, clinically meaningful anti-tumor responses were observed within weeks, potentially differentiating D-MNA from many existing non-surgical therapies that often require substantially longer treatment durations. This analysis also improves the understanding of the patient populations and treatment parameters most likely to optimize future clinical outcomes.

The Company believes these findings further de-risk advancement of the 200µg regimen and informs the design of subsequent development studies, including assessment timing, lesion selection, and endpoint strategy.

(Press release, Skinject, MAY 6, 2026, View Source [SID1234665233])