On August 5, 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 second quarter ended June 30, 2026, and reported on recent and upcoming business highlights.

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"During the second quarter, we advanced our pipeline and reported interim Phase 1a data from CTIM-76 in a limited number of heavily pretreated patients with platinum-resistant ovarian cancer ("PROC") receiving weekly dosing," said Martin Lehr, Chief Executive Officer of Context. "These data demonstrated encouraging interim efficacy and safety findings. We intend to evaluate CTIM-76 with every-three-week ("Q3W") dosing in less heavily pretreated PROC patients in the second half of 2026, aiming to further characterize its clinical profile in a larger and more commercially relevant dataset."

Mr. Lehr added, "We also expect to dose the first patient in our Phase 1 clinical trial evaluating CT-202 in patients with Nectin-4-positive urothelial, colorectal, and triple-negative breast cancers in the third quarter of 2026, marking an important step in the clinical advancement of our Nectin-4 x CD3 TCE program."

Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs:

CTIM-76: CLDN6 x CD3 TCE

Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with PROC.

Recent Progress:

April 2026: The U.S. Food and Drug Administration granted Fast Track Designation for the treatment of PROC in patients that have received all standard of care therapies
June 2026: Presented interim Phase 1a safety, tolerability and efficacy data with weekly dosing in PROC patients
Upcoming Expected Milestones:

Q1 2027: Initiation of Phase 1b dose expansion trial
Q2 2027: Phase 1a initial safety, tolerability and efficacy data with Q3W dosing in PROC patients
CT-202: Nectin-4 x CD3 TCE

Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal, and triple-negative breast cancers.

Recent Progress:

April 2026: Human Research Ethics Committee approval and Clinical Trial Notification acknowledgement by the Australian Therapeutic Goods Administration to initiate a first-in-human Phase 1 clinical trial
May 2026: Entered into a License Agreement Amendment with BioAtla, Inc. removing all future milestones and royalty obligations owed
Upcoming Expected Milestones:

3Q 2026: First patient dosed in Phase 1 trial
2H 2027: Phase 1a initial topline safety, tolerability and early efficacy data
CT-95: MSLN x CD3 TCE

As part of a portfolio prioritization and capital allocation strategy, Context is discontinuing the development of CT-95 and will focus its development efforts on CTIM-76 and CT-202.

Second Quarter 2026 Financial Results

Cash and cash equivalents were $43.0 million at June 30, 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 the fourth quarter of 2027.
Research and development ("R&D") expenses were $12.5 million for the second quarter of 2026, as compared to $7.8 million for the second quarter of 2025. The increase in R&D expenses compared to the second quarter was primarily driven by higher CT-202 expense of $4.4 million and higher CTIM-76 expense of $0.8 million. The increase in CT-202 expense was primarily a result of a higher in-process research and development charge of $6.5 million related to consideration paid to amend the BioAtla license agreement for CT-202, offset by lower contract manufacturing and preclinical expenses. These increases were partially offset by lower personnel-related costs of $0.5 million.
General and administrative expenses were $2.4 million for the second quarter of 2026, as compared to $1.9 million for the second quarter of 2025. The increase was primarily driven by higher professional fees of $0.3 million and an increase of $0.2 million in salaries and personnel-related costs, including share-based compensation as compared to the same period in 2025.
Other income was $0.4 million for the second quarter of 2026, as compared to $0.9 million for the second quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances.
Context reported a net loss of $14.6 million for the second quarter of 2026, as compared to $8.8 million for the second quarter of 2025.

(Press release, Context Therapeutics, AUG 5, 2026, View Source [SID1234669758])

On August 5, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported an update on the expanding base of institutions ordering LYMPHIR (denileukin diftitox-cxdl) through wholesalers, continued formulary progress at priority U.S. treatment centers, and other key indicators supporting the product’s commercial launch.

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"Our commercial progress is reflected in two closely connected measures: growth in the number of institutions ordering LYMPHIR and continued expansion of the formulary approvals that enable additional institutions to begin ordering the product and treating patients," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "I am pleased to report that the number of new institutions ordering LYMPHIR rose, total institutional vial orders increased, formulary reviews and approvals grew, and wholesalers are reordering LYMPHIR to reflect this growth. Formulary inclusion is a key gateway to institutional ordering and patient access. The success of our targeted launch, so far, was accomplished by a small yet focused internal launch team. Together with our recently expanded commercial and medical affairs teams, we believe Citius Oncology is well positioned to broaden engagement with over 250 priority treatment centers, support continued adoption, and accelerate topline growth through the balance of the year."

LYMPHIR is now available in 42 institutions including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions and community infusion centers. During the quarter ended June 30, 2026, the number of new institutions increased 78% compared with the prior quarter. Vials ordered by institutions from wholesalers rose 31% during the quarter. Subsequent to the quarter ended June 30, 2026, following an increase in both the number of ordering institutions and vial demand, orders from wholesalers have begun to reflect this incremental demand. Citius revenue is recognized when wholesale orders for LYMPHIR are placed and filled.

LYMPHIR’s growing institutional footprint consists of leading academic and cancer treatment centers with recognized CTCL expertise. Formulary inclusion is an important step in the commercial adoption process. Once approved, an institution can order the product through a nationwide wholesaler network and make the therapy available for prescribing to eligible adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Review times vary by institution and may range from several weeks to several months. Based on Company experience to date, institutions that add LYMPHIR to formulary have generally placed their first patient order within approximately two to six weeks. Citius Oncology anticipates more than 20 additional institutions during the current quarter, and is targeting formulary inclusion with 100 priority institutions by year-end.

The Company continues to engage leading CTCL experts through scientific exchange and educational initiatives designed to increase understanding of LYMPHIR’s clinical profile and support institutional evaluation of the therapy. At the Sixth World Congress of Cutaneous Lymphomas in Montreal, the Company met with many U.S. and international CTCL key opinion leaders. The expanded medical affairs team is expected to increase the frequency and breadth of the Company’s scientific engagement with the CTCL community.

According to Company tracking, LYMPHIR has secured near-universal payer coverage. Formulary inclusion and payer coverage address complementary requirements for market access. Together, these indicators reflect continued progress in building LYMPHIR’s commercial foundation.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Pharmaceuticals, AUG 5, 2026, View Source [SID1234669721])

On August 5, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"The second quarter was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet," said Rick Fair, Chief Executive Officer of Enliven. "The updated Phase 1 data support ELVN-001’s potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy."

ELVN-001 Program Highlights
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with chronic myeloid leukemia (CML).

In June 2026, the Company announced positive data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377). The data were presented in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Highlights include:
61% overall major molecular response (MMR) and 48% MMR achievement by 24 weeks in the 80 mg once daily (QD) Phase 1b cohort.
Response rates were higher in earlier-line patients, with 67% overall MMR and 55% achieving MMR by 24 weeks among patients with only one or two prior unique tyrosine kinase inhibitors (TKIs).
Patients previously treated with asciminib achieved response rates comparable to the overall efficacy-evaluable population.
Favorable safety and tolerability profile with 161 patients enrolled and a median treatment duration of 35 weeks, as of the March 10, 2026 cutoff.
Key outcomes from the End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA):
80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.
ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician’s choice of an ATP-competitive TKI.
Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
FDA granted Fast Track Designation to ELVN-001.
Collectively, these data and regulatory milestones continue to support advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, which the Company expects to initiate in the second half of 2026.
Second Quarter 2026 Financial Results

Cash position: As of June 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $895.2 million, which is expected to provide cash runway into 2030.
Research and development (R&D) expenses: R&D expenses were $29.0 million for the second quarter of 2026, compared to $21.5 million for the second quarter of 2025.
General and administrative (G&A) expenses: G&A expenses were $8.2 million for the second quarter of 2026, compared to $7.1 million for the second quarter of 2025.
Net loss: Enliven reported a net loss of $32.5 million for the second quarter of 2026, compared to a net loss of $25.3 million for the second quarter of 2025.

(Press release, Enliven Therapeutics, AUG 5, 2026, View Source [SID1234669744])

On August 5, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported that ACR-2316 has advanced into the randomized dose expansion portion of its ongoing Phase 1/2 study. The advancement is supported by the differentiated favorable safety profile and clinical activity observed during dose escalation, including tumor shrinkage and partial responses (PRs) with durable clinical benefit in multiple subjects. Acrivon has selected 120 mg and 160 mg administered orally once daily (QD) on a 3d on/4d off weekly schedule for further dose optimization and final dose selection.

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"Advancing ACR-2316 into dose expansion is an important milestone for Acrivon, and the exciting initial clinical activity observed represents further clinical validation of our AP3 platform," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "We rationally designed ACR-2316 using AP3 to overcome the resistance mechanisms that limit efficacy of single-target WEE1 and PKMYT1 inhibition, hence enabling potent tumor cell death. We are highly encouraged by the durable single-agent activity, including tumor shrinkage and PRs, and clinical benefit observed for more than a year in multiple heavily pretreated subjects with lung cancer. These data support our belief that ACR-2316 has the potential to become an important therapy across multiple high unmet need patient populations."

"ACR-2316 has demonstrated a favorable safety profile in dose escalation, with adverse events limited primarily to transient, mechanism-based hematological events, mainly neutropenia, and a notable absence of non-hematological adverse events," said Mansoor Raza Mirza, M.D., chief medical officer of Acrivon. "This promising differentiated safety profile and initial clinical activity support its rapid advancement into a randomized expansion phase, to establish the dose with the optimal benefit-risk profile to carry into subsequent development."

ACR-2316 Dose Escalation Data and Observations To Date

Two weekly (3d on / 4d off QD and 2d on / 5d off QD) oral dosing regimens have been established, while a bi-weekly (3d on / 11d off QD) oral dosing regimen was evaluated, but deprioritized.
A total of 35 subjects received ACR-2316 across 6 dose levels ranging from 30 to 240 mg QD in the two weekly oral dosing schedules.
Amongst the subjects treated with ACR-2316 at ≥120 mg QD in the weekly schedules, tumor shrinkage with long-lasting clinical benefit were observed across multiple tumor types, including PRs in lung cancer and endometrial cancer.
In the 7 efficacy-evaluable subjects (median 3 prior lines of systemic therapy) with SCLC, sqNSCLC, and adNSCLC, AP3-predicted tumor types not previously shown to be sensitive to clinical single agent WEE1 or PKMYT1 inhibitors, a disease control rate of 86% (2 PRs, 4 SD, and 1 PD) was observed.
Ongoing durable clinical benefit observed in 3 heavily pretreated lung cancer subjects remaining on treatment for over one year.
In the selected 3d on / 4d off dosing regimen, the 120 mg QD and 160 mg QD doses were well tolerated, with a favorable, differentiated safety profile; no grade ≥4 treatment-related adverse events (TRAEs) were reported, and grade 3 TRAEs were limited to primarily transient, mechanism-based hematologic events, predominantly neutropenia.
These observations support further evaluation of ACR-2316 in the selected 3d on / 4d off QD regimen in a randomized dose expansion study of AP3-informed tumor types.

The dose expansion will evaluate ACR-2316 in subjects with SCLC, sqNSCLC and adNSCLC, as well as endometrial cancer, cervical cancer, and esophago-gastric junction carcinoma, all with AP3-identified biomarker signatures associated with pathway vulnerability, including loss or mutation of TP53 or FBXW7, or overexpression or amplification of CCNE1 or CCNB1, or HPV+ in the case of cervical cancer. The expansion utilizes a 3d on / 4d off weekly administration schedule and will include stratification by lung cancer versus non-lung cancer tumor types, with 1:1 randomization within each group to the 120 mg QD or 160 mg QD dose level. The two selected doses are candidate doses for final recommended phase 2 dose selection.

The ACR-2316 dose escalation and expansion study adheres to the principles of the FDA’s Project Optimus, which emphasize dose selection based on the totality of efficacy, safety, tolerability, pharmacokinetic and pharmacodynamic data, and specifically stipulate randomized evaluation of multiple doses rather than routine selection of the maximum tolerated dose. Acrivon expects to provide further updates as the study progresses.

(Press release, Acrivon Therapeutics, AUG 5, 2026, View Source [SID1234669759])

On August 5, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported a number of updates on the SECuRE trial.

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Preliminary assessment of the 8 GBq 67Cu-SAR-bisPSMA dose cohorts
Patient population
The SECuRE trial is currently recruiting in the Cohort Expansion phase at the 8 GBq 67Cu-SAR-bisPSMA dose level (up to 6 doses). This preliminary efficacy and safety assessment includes all trial participants who received 8 GBq treatment cycles, comprising 16 participants from the ongoing Cohort Expansion phase and 3 participants from cohort 2 of the Dose Escalation phase (19 participants in total), by the data cut-off of 20 July 2026.

Most participants had bone metastases (63%) and had received multiple lines of therapy prior to being enrolled in the trial (79% received 5 or more previous anti-cancer regimens). Previous standard treatments included androgen deprivation therapy (ADT), radiation, first- and/or second-generation androgen receptor pathway inhibitor (ARPI), with some participants having received taxane-based therapy for metastatic hormone-sensitive disease. Some participants were exposed to an experimental prostate-specific membrane antigen (PSMA) T-Cell Engager prior to their enrolment into the SECuRE study. The median number of treatment cycles of 67Cu-SAR-bisPSMA across participants was two (range: 1-4, mean 2.1±1.0 [SD]). Three of these participants from the Cohort Expansion phase were treated with concomitant enzalutamide.

PSA and radiographic assessments
A substantial reduction in PSA was observed, with 74% (n=14) of participants achieving a PSA25 response (i.e. reductions of ≥25% in PSA), 63% (n=12) PSA50, 53% (n=10) PSA75, and 26% (n=5) PSA90 (Figure 1).

A total of 81% (n=13) of the participants who were evaluable for radiographic assessment (n=16) achieved disease control. This includes 50% (n=8) with stable disease and 31% (n=5) with complete response/undetectable disease (as assessed by RECIST and/or bone scan.

Figure 1. PSA responses of participants from cohort 2 (N=3) and Cohort Expansion (N=16) who received 1-4 doses of 8 GBq of 67Cu-SAR-bisPSMA as of 20 July 2026.

Safety profile
Participants who received 8 GBq cycles, including those in the Cohort Expansion Phase, generally developed a lower prevalence and severity of related AEs compared to the overall trial population. The most frequently reported related AEs were dry mouth and nausea, each occurring in 9 (47%) and 8 (42%) participants, respectively. Anaemia and decreased neutrophil count were each reported in 4 (21%) participants, while fatigue was reported in 5 (26%) participants. Most events were low grade (mild/moderate) and transient, with two Grade 3 events (lymphocyte and white blood cell count decreases) in 1 (5%) participant. No Grade ≥4 related events were reported.

Complete response/undetectable disease observed in seven participants in the 67Cu-SAR-bisPSMA program
Two new participants in the Cohort Expansion phase of the SECuRE trial who were evaluable at data cut-off achieved complete response as assessed by RECIST. Combined with the five previously announced cases2,3,4,5, this brings the total number of participants who achieved complete response or undetectable disease (assessed by RECIST, bone scan and/or PSA) across the 67Cu-SAR-bisPSMA program to seven. Five out of these seven participants received treatment at the 8 GBq 67Cu-SAR-bisPSMA dose level. This represents almost a third (31%) of all participants evaluable for radiographic assessment treated at the 8 GBq 67Cu-SAR-bisPSMA dose level.

The median baseline PSA among these seven participants was 90.3 ng/mL (range 3.3 – 490.3). They had received a median of 5 prior anti-cancer regimens (range 4-7). Bone metastases were present in four of seven participants (57%). Among the participants who had received 8 GBq doses, the median number of cycles was 3 (range 1-4, mean 2.8±0.8 [SD]). All seven participants had received prior second-generation ARPI.

These observations demonstrate considerable anti-tumour activity of 67Cu-SAR-bisPSMA following a small number of 8 GBq treatment cycles in metastatic castration-resistant prostate cancer (mCRPC) patients who have failed multiple lines of therapy.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The SAR-bisPSMA product continues to generate an impressive body of evidence in clinical trials and case studies, highlighting the strength of the evidence in both diagnostic and theranostic applications.

"Most impressively, despite the relatively small numbers of patients enrolled in the SECuRE trial to date, and most having received up to 2 treatment cycles at 8 GBq, we see a trend that is impossible to ignore. We continue seeing patients with mCRPC, who have gone through numerous lines of therapy prior to the SECuRE study enrolment, achieve undetectable disease and/or complete response following 67Cu-SAR-bisPSMA treatment. Seven participants have now achieved undetectable disease and/or complete response across all cohorts (assessed by RECIST, bone scan and/or PSA), and five of these are from the 8 GBq cohorts. This means that almost a third of all evaluable patients treated at this dose level have achieved a complete response and/or undetectable disease.

"The evidence of the depth and consistency of responses achievable with 67Cu-SAR-bisPSMA is further substantiated by the PSA responses across the SECuRE study in patients who received their 67Cu-SAR-bisPSMA treatments at the 8 GBq dose level. PSA reductions of ≥50% are currently at 63%, with over a quarter of patients reaching PSA90. Importantly, 67Cu-SAR-bisPSMA at the 8 GBq dose level shows a favourable safety profile, with AEs being mostly mild to moderate and transient. This highlights the potential of this therapy in earlier stages of disease, aiming to help improve treatment outcomes of a broader prostate cancer patient population.

"The SECuRE trial will continue enrolment into the Cohort Expansion Phase with Phase III registrational trial planning ongoing based on data that continues to be generated.

"The benefits we are seeing in the clinic, based on the treatment responses and favorable safety profile achieved with so few doses, are due to our unique combination of the optimised bivalent "bis" structure with the advantages offered by the beta emitter, copper-67, enabled by the proprietary sarcophagine (SAR) chelating technology. Time and time again we are seeing the benefits of this approach across both the diagnostic and therapeutic areas with this one molecule, from early detection in pre-prostatectomy patients to visualisation of biochemically recurrent prostate cancer and then to the treatment of mCRPC patients. Armed with the growing body of high-quality data, our team and collaborators continue to advance SAR-bisPSMA towards the paradigm shift it could bring to the prostate cancer space, aiming to improve the outcomes of so many patients with prostate cancer across multiple stages of their disease."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3. Recruitment is currently ongoing for the Cohort Expansion Phase which will include 24 participants (Figure 2). A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial6 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

(Press release, Clarity Pharmaceuticals, AUG 5, 2026, View Source [SID1234669722])