On May 21, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, May 30, 2026, 1:15 PM-2:45 PM CDT.

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"Silevertinib continues to demonstrate potential to become a practice changing frontline therapy for NSCLC patients with EGFR-NCMs, delivering robust preliminary mPFS that far exceeds historical data for currently available therapies" said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics. "Importantly, silevertinib prevented the development of de novo brain metastases in this patient population, where progression via CNS metastases frequently occurs. We look forward to meeting with the FDA later this year to discuss our pivotal development plan."

"Patients with EGFR non-classical mutations represent a meaningful and underserved subset of NSCLC, with historically poor progression-free survival on available frontline TKIs," added Dr. Rotow. "The activity we are seeing with silevertinib across the full NCM spectrum, combined with its CNS activity, is highly encouraging, and I look forward to sharing these data with the oncology community at ASCO (Free ASCO Whitepaper) next week."

Silevertinib 1L NSCLC Phase 2 Results Summary

Results as of an April 11, 2026 data cutoff date include:

43 patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib
Patients presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (PACC) mutations
19 patients with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions
11.2 months median follow-up

Durability
Preliminary median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE)
Median duration of response (DOR) had not been reached (95%CI: 7.0, NE)
23 of 43 patients (53%) remain on therapy, with longest at 23.5 months

CNS Activity
No patients developed de novo brain metastases
Previously disclosed CNS Objective Response Rate (ORR by RANO-BM) remained at 86%

ORR and DCR
Previously disclosed Objective Response Rate (ORR by RECIST 1.1) and Disease Control Rate (DCR) remained at 60% and 91%, respectively
Variant allele frequency (VAF) reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC

Safety
No new safety signals were observed
The rate of TRAEs > Grade 3 was reduced to 28% following dose reduction
Patients maintained or deepened clinical responses after dose reduction
Safety and efficacy data support 150 mg QD for pivotal development

ASCO Abstract: 8519
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations
Presenter: Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at the time of the presentation on the Black Diamond website)

Company Webcast Information
Black Diamond will hold a webcast for investors on Thursday, May 21, 2026 at 5:30 p.m. EDT. The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com.

About Silevertinib

Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR‑mutant NSCLC or EGFR‑altered GBM have been treated with silevertinib.

In addition to the ongoing Phase 2 trial of silevertinib in patients with EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, MAY 21, 2026, View Source [SID1234665920])

On May 21, 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 the presentation of initial data from the randomized Phase 2 trial (Duravelo-2) evaluating zelenectide pevedotin (zelenectide) in previously untreated patients with metastatic urothelial cancer (mUC), demonstrating encouraging response rates and a potentially differentiated safety profile both as a monotherapy and in combination with pembrolizumab. In addition, updated data from the Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC patients demonstrated encouraging median progression-free survival (PFS) comparable to published data for standard of care (SOC). The data announced today will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2 in Chicago.

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"Despite recent advances for the treatment of bladder cancer, there remains an urgent need for more tolerable therapies. For instance, published clinical data for the current SOC for mUC demonstrate a significant number of tolerability-related drug discontinuations, and high rates of neuropathy and skin toxicities. In contrast, the initial Duravelo-2 data shared today demonstrate that zelenectide in combination with pembrolizumab continues to show response rates comparable to published data for SOC for mUC, while potentially offering substantially lower toxicity and improved tolerability for patients. We have now tested zelenectide as a monotherapy or in combination with pembrolizumab in more than 600 patients and have consistently observed lower rates and severity of neuropathy and skin toxicities," said Bicycle CEO Kevin Lee, Ph.D. "We believe that the extensive data we have generated in patients continue to demonstrate the unique nature of Bicycle molecules as targeting agents that offer a potentially differentiated tolerability profile to antibody-based approaches. We are excited to continue to explore these advantages with novel targets and novel payloads in our mission to help patients not only live longer but live well. Meanwhile, the Duravelo-2 trial has been converted into a randomized Phase 2 trial and we look forward to sharing further results in the second half of 2026."

Initial Duravelo-2 Data Results

Zelenectide is a Bicycle Drug Conjugate (BDC) targeting Nectin-4, a well-validated tumor antigen. The 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 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 PFS was not mature, and the results at the optimal dose showed:

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).
Median duration of treatment (mDOT) was 6.3 months (0.7-10.6).
65% of patients remain on treatment.
Median relative dose intensity in patients receiving the optimal dose was 97%.
Low rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including peripheral neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%). There were no reported instances of zelenectide-related hyperglycemia.
No zelenectide-related severe skin reactions of any grade were reported.
The single Grade 3 zelenectide-related AE of clinical interest, peripheral neuropathy, resolved to Grade ≤1. There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.
Notably, only one patient at the optimal dose discontinued therapy due to a zelenectide-related AE at the time of the data cut in Cohort 1.
The Duravelo-2 trial also evaluated the 5mg dose and 6mg dose regimens of zelenectide as a monotherapy in mUC patients with one or more prior lines of systemic therapy (Cohort 2). Cohort 2 data were extracted for the interim analysis at Week 27, on June 14, 2025. At the time of the data cut, the median PFS was not mature, and the results at the optimal dose showed:

37% (10/27) ORR regardless of confirmation and 30% confirmed ORR (8/27) was achieved among efficacy-evaluable patients. Of the confirmed responses, 3 (11%) were complete responses (CRs) and 5 (19%) were partial responses (PRs).
mDOT was 4.8 months (1.3-10.1).
31% of patients remain on treatment.
Median relative dose intensity in patients receiving the optimal dose was 86%.
Low rates of zelenectide-related AEs of clinical interest were observed, including peripheral neuropathy (38%); skin reactions (28%); eye disorders (10%); and hyperglycemia (3%).
There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.
Notably, no zelenectide-related severe skin reactions of any grade were reported, and no treatment discontinuations occurred at the optimal dose.
The company plans to share additional Duravelo-2 data from the randomized Phase 2 trial in the second half of 2026.

Updated Duravelo-1 Data Results

The company also announced the presentation of updated Phase 1 Duravelo-1 data evaluating zelenectide in mUC, including monotherapy data in enfortumab vedotin (EV)-naïve patients and in combination with 200mg of pembrolizumab once every three weeks in previously untreated cisplatin-ineligible patients. Both cohorts evaluated zelenectide at the 5mg dose.

Updated results as of the August 1, 2025 data cutoff evaluating zelenectide 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:

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 CRs and 6 (27%) were PRs.
Median PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of the data cutoff.
Updated results as of the August 1, 2025 data cutoff evaluating zelenectide as a monotherapy in EV-naïve recurrent, unresectable mUC patients who had prior anti-programmed death-1/programmed death ligand-1 (PD-1/PD-L1), had disease progression after or were ineligible for platinum-based chemotherapy showed:

38% (20/53) ORR regardless of confirmation, 32% confirmed ORR (17/53) and a DCR of 66%. Of the confirmed responses, 2 (4%) were CRs and 15 (28%) were PRs.
Median PFS was 5.4 months and mDOR was 10.0 months (5.3-16.6) among patients with confirmed responses.
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.

The presentations will be made available in the Publications sections of the Bicycle Therapeutics website following each presentation.

(Press release, Bicycle Therapeutics, MAY 21, 2026, View Source [SID1234665917])

On May 21, 2026 Aulos Bioscience, a clinical-stage immuno-oncology company developing an immune-activating antibody therapeutic designed by leveraging an AI platform, reported positive Phase 2 data from its ongoing Phase 1/2 study of imneskibart in patients with doublet checkpoint inhibitor (CPI)-refractory metastatic melanoma. The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, Illinois.

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The Phase 2 data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. Patients received either imneskibart plus low-dose, subcutaneous aldesleukin or the triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab. Across the study, imneskibart treatment was associated with sustained regulatory T cell (Treg) reduction, increased CD8/Treg ratios and evidence of durable anti-tumor activity, supporting its differentiated IL-2 mechanism.

"Imneskibart’s triplet regimen produced a 33% objective response rate and 67% disease control rate in metastatic melanoma patients whose disease progressed following earlier treatment with potent checkpoint inhibitor doublets," said Aron Knickerbocker, Aulos Bioscience’s President and Chief Executive Officer. "These patients urgently need safe, life-extending treatment options, particularly those who are not eligible for or do not receive TIL therapy. While lifileucel TIL therapy is the only FDA-approved product specifically indicated in the post-PD-1 setting, a substantial treatment gap remains. In addition to durable efficacy consistent with anti-tumor immune memory formation, imneskibart continues to demonstrate a differentiated, potentially best-in-class safety profile. These findings strongly support imneskibart’s mechanism and its ability to make a meaningful difference for patients."

As of the April 6, 2026 data cutoff, data were available from 83 patients across the Phase 1/2 study, including 12 patients in the Phase 2 melanoma triplet cohort evaluable for response:

Clinically meaningful activity observed with imneskibart triplet in doublet CPI-refractory melanoma

33% objective response rate (ORR) in confirmed doublet CPI-refractory cutaneous melanoma patients following prior anti-PD-1/CTLA-4 or anti-PD-1/LAG-3 therapy.
Four of 12 patients achieved partial responses, with target tumor reductions of 52%, 65%, 74% and 77%.
Four of 12 patients achieved stable disease, resulting in a 67% disease control rate.
Responses are ongoing and deepening, consistent with the potential generation of de novo anti-tumor immunity and immune memory formation; progression-free survival (PFS) and overall survival (OS) data continue to mature.
Strong signal of anti-tumor activity in imneskibart doublet regimen, with ongoing deep and durable tumor reductions in patients who progressed after receiving doublet CPI therapy (prior anti-PD-1 and anti-CTLA-4 and/or anti-PD-1 and anti-LAG-3)

14 evaluable patients received the imneskibart doublet regimen.
Three patients with the deepest target tumor reductions continued treatment beyond one year: one patient with a 48% tumor reduction continued on treatment for 13 months; another patient with a 58% reduction in measurable non-target tumors continued on treatment for 18.5 months; and a third patient with a complete response (100% reduction) in the target lesions continues on treatment for more than 25 months.
Imneskibart and low-dose, subcutaneous aldesleukin, with or without nivolumab, exhibits unique pharmacodynamic (PD), biological and pharmacokinetic (PK) effects in the IL-2 class, with a higher peripheral blood CD8/Treg ratio correlating with increased survival

Durable increases in CD8+ T cells and CD8/Treg ratios were observed in patients, with a corresponding decrease in Tregs.
PD data support hypothesis of selective effector cell expansion, validating imneskibart’s mechanism of action of redirecting interleukin-2 (IL-2) away from trimeric IL-2 receptors (expressed on Tregs and vasculature) and toward dimeric IL-2 receptors (on CD8+ T effector and natural killer cells).
The data show that imneskibart demonstrates durable activity coupled with a persistent reduction in Tregs and a higher CD8/Treg ratio that is associated with longer OS, PFS and time on treatment for patients.
PK data demonstrate sustained, selective signaling with a half-life of greater than 19 days, enabling potent immune activation without Treg expansion or high-dose IL-2 toxicities such as vascular leak syndrome or pulmonary edema.
Well-tolerated triplet regimen, with no apparent increase in Grade 3/4 adverse events following addition of nivolumab

Most drug-related adverse events were Grade 1 or 2; no patient discontinued treatment due to a drug-related adverse event.
The emerging safety profile of the triplet regimen is consistent with the known safety profiles of nivolumab and imneskibart plus aldesleukin, with no new toxicity signals observed.
Enrollment is complete in the Phase 2 doublet cohort evaluating imneskibart plus a single loading dose of low-dose, subcutaneous aldesleukin in patients with unresectable locally advanced or metastatic cutaneous melanoma following confirmed progression on doublet CPI therapy. Enrollment continues in the Phase 2 triplet cohort evaluating imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab in approximately 20 evaluable second-line cutaneous melanoma patients, with plans advancing toward potential registrational development.

Two ongoing Phase 2 cohorts are evaluating imneskibart and low-dose, subcutaneous aldesleukin administered without and with avelumab (anti-PD-L1 with an active Fc domain and ADCC effector function) in patients with advanced PD-L1+ non-small cell lung cancer (NSCLC) that progressed on prior CPI therapy (with or without chemotherapy). Aulos anticipates presenting comprehensive clinical data from the NSCLC Phase 2 cohorts by year-end.

The poster, "Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study," (Abstract 9526) will be presented live in the poster session "Melanoma/Skin Cancers" in the Exhibit Hall at McCormick Place on Sunday, May 31, 2026, 9:00 a.m. to 12:00 p.m. CDT. The poster will also be accessible to meeting registrants as an electronic poster on the ASCO (Free ASCO Whitepaper) online meeting platform.

To learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

(Press release, Aulos Bioscience, MAY 21, 2026, View Source [SID1234665916])

On May 21, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, reported that Eric Easom, Co-Founder, Chairman, President and CEO will present at the 2026 Jefferies Global Healthcare Conference on June 4, 2026 at 12:50 PM ET, and members of management will be available for 1×1 meetings.

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A webcast can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

(Press release, AN2 Therapeutics, MAY 21, 2026, View Source [SID1234665915])

On May 21, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing modulator payload, reported the successful pricing of a private placement financing round. This transaction is expected to raise an aggregate of approximately $5.5 million in gross proceeds. With these funds the Company will focus on advancing its lead ADC program utilizing its unique RNA splicing modulator payload, AKTX-101, toward a first-in-human Phase 1 clinical trial.

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"This financing reflects deep conviction from our long-term strategic investors and positions Akari to build on our strong momentum to accelerate our lead ADC program towards clinical data, pursue strategic partnerships, and unlock the full potential of our novel ADC platform," stated, Abizer Gaslightwala, Akari’s CEO.

The Company entered into definitive purchase agreements with the investors for the issuance and sale of 1,470,588 unregistered American Depository Shares (ADSs), or prefunded warrants in lieu thereof, and unregistered Series H Warrants, Series I Warrants and Series J Warrants ("the Offering"). The ADSs were priced at $3.74 per ADS.

The gross cash proceeds from the Offering are expected to be approximately $5.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The issuance of the Series H, I and J Warrants is subject to the Company obtaining shareholder approval and will each be exercisable for 1,470,588 ADSs. The Series H Warrants will have an exercise price of $3.74 per ADS, have a term of 18 months, and will be immediately exercisable. The Series I Warrants will have an exercise price of $3.74 per ADS, have a term of 60 months, and will be immediately exercisable. The Series J Warrants will have an exercise price of $3.74 per ADS, have a term of 60 months, and will be immediately exercisable.

Paulson Investment Company LLC is acting as placement agent for the financing. The gross proceeds of the private placement will be funded in three separate tranches pursuant to three separate closings, expected to occur between May 27, 2026 and July 15, 2026.

The ADSs and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and have not been registered under the Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Akari Therapeutics, MAY 21, 2026, View Source [SID1234665914])