On May 11, 2026 Anaveon, a late-stage preclinical biotechnology company focused on reprogramming the immune system for the treatment of autoimmune and inflammatory diseases, reported that new clinical data from its legacy oncology asset ANV600 (sunekafusp alpha) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Following its strategic pivot to immunology, Anaveon is actively seeking global development and commercialization partners for its oncology portfolio to maximize the potential of these highly differentiated assets.

ANV600 is a first-in-class, non-blocking PD-1-targeted IL-2R-βγ agonist designed to selectively expand tumor-reactive PD-1+ CD8+ effector T cells while reducing the toxicities historically associated with IL-2 therapy. It is compatible with existing checkpoint inhibitors and is positioned for use in CPI-resistant and CPI-relapsed settings.

Key results from the EXPAND-1 Phase 1 study will be highlighted in the poster:

Manageable safety profile as monotherapy and in combination with pembrolizumab
Clear proof-of-mechanism: preferential proliferation of PD-1+ CD8+ T cells over regulatory T cells
Encouraging early clinical activity, including tumor shrinkage in a meaningful proportion of patients (including post-CPI and CPI-naïve), disease control, and durable benefit
Recommended Phase 2 dose established
ASCO Annual Meeting abstracts may be accessed online via View Source

Details of the poster presentations are as follows:

Presentation Details:

Title: EXPAND-1: A phase 1 dose escalation study of the novel PD-1 targeted IL-2R-βγ agonist Sunekafusp alpha (ANV600) as a single agent and in combination with Pembrolizumab in patients with advanced solid tumors

First Author: Markus Joerger

Abstract number: 2587

Session Title: Development Therapeutics-Immunotherapy

Poster board: 377

Location, Date and Time: Hall A, May 30, 2026, 1:30 to 3:00 pm, local time

"ANV600 has delivered compelling clinical proof-of-mechanism and a promising safety-efficacy profile in patients with advanced solid tumors," said Thaminda Ramanayake, Chief Executive Officer of Anaveon. "With strong interest from physicians at clinical sites for Phase 2 development, we believe this asset is ideally suited for a partner with the resources and expertise to bring it forward in CPI-resistant NSCLC and other immuno-oncology indications."

Anaveon’s oncology portfolio also includes ANV700, a preclinical proximity-activated PD-1-targeted IL-21 fusion protein with potential for synergistic effects when combined with IL-2-based approaches.

The company is now prioritizing its core immunology pipeline and is open to various partnering structures (license, co-development, or acquisition) for the oncology assets.

(Press release, Anaveon, MAY 11, 2026, View Source [SID1234665478])

On May 11, 2026 Kyntra Bio (Nasdaq: KYNB) reported financial results for the first quarter 2026 and provided an update on the company’s recent developments.

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"In the first quarter, we continued to make steady progress across our pipeline. We are encouraged by the pace of enrollment in our Phase 2 trial of FG-3246 in patients with mCRPC and are on track for the interim analysis in the fourth quarter of 2026. We remain confident in the potential of FG-3246 to deliver competitive progression free survival results in the Phase 2 monotherapy trial," commented Thane Wettig, Chief Executive Officer of Kyntra Bio. "In addition, following FDA feedback, we are finalizing the protocol for the pivotal Phase 3 trial of roxadustat for the treatment of lower-risk MDS, and anticipate trial initiation in the second half of 2026."

Key Highlights of First Quarter, Recent Developments, and Upcoming Milestones

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

•
Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the fourth quarter of 2026
•
Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO (Free ASCO Whitepaper) GU 2026
o
In biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, the combination of FG-3246 and enzalutamide led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, and a median rPFS of 10.1 months in patients who progressed on only one prior ARPI.
o
Higher tumor uptake of FG-3180 was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection.
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Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial.
o
Results further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients.
Roxadustat

•
Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA
•
Company continues to explore the opportunity to develop roxadustat internally or with a strategic partner, with the goal of initiating the Phase 3 trial in the second half of 2026

Financial

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Total revenue from continuing operations for the first quarter of 2026 was $3.7 million, as compared to $2.7 million for the first quarter of 2025.
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Net loss from continuing operations for the first quarter of 2026 was $15.1 million, or $3.74 net loss per basic and diluted share, compared to a net loss of $16.8 million, or $4.15 net loss per basic and diluted share, one year ago.
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As of March 31, 2026, Kyntra Bio reported $100.3 million in cash, cash equivalents, investments, and accounts receivable.
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The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028.

Conference Call and Webcast Presentation

Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website.

About FG-3246 and FG-3180

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracer. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, Kyntra Bio, MAY 11, 2026, View Source [SID1234665440])

On May 11, 2026 AbCellera (Nasdaq: ABCL) reported financial results for the first quarter of 2026 and positive interim results from the Phase 1 portion of its ongoing Phase 1/2 clinical trial of ABCL635. ABCL635 is a potential first-in-class antibody targeting the neurokinin 3 receptor (NK3R) for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We are excited to share interim Phase 1 data that show ABCL635 achieved robust NK3R target engagement at doses that were well-tolerated in healthy volunteers and a pharmacokinetic profile that may support a once monthly dosing regimen. We look forward to the efficacy readout from the Phase 2 data in Q3, which we believe will be highly de-risking for the program," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Through 2026 we are focused on delivering data readouts for our clinical programs, advancing ABCL688 and ABCL386 into IND-enabling studies, and selecting at least one additional development candidate. We continue to maintain our strong cash position, ending the quarter with approximately $655 million dollars in available liquidity to execute on our strategy."

Q1 2026 Business Summary and Program Updates

ABCL635 and ABCL575 continued to progress through clinical trials.
ABCL386 and ABCL688 are progressing through IND-enabling activities.
Generated a net loss of $43.2 million, compared to a net loss of $45.6 million in Q1 2025.
Ended the quarter with approximately $655 million in total available liquidity to execute on our strategy.
Clinical Update: ABCL635 Interim Phase 1 Data

Study Design

The Phase 1 trial of ABCL635 (NCT07118891) is a randomized, double-blind, placebo-controlled study designed to evaluate single and multiple doses of ABCL635 in healthy volunteers. A total of 40 healthy men and postmenopausal women were enrolled in the single ascending dose (SAD) part and treated with single doses ranging from 30 mg to 900 mg. The multiple ascending dose (MAD) part enrolled a total of 16 postmenopausal women who received multiple once monthly doses ranging from 300 mg to 600 mg.

Study Results

The interim Phase 1 data supported advancing ABCL635 into Phase 2. Data from the MAD part remain blinded, with safety follow-up visits ongoing. The unblinded interim data from the SAD part demonstrated the following:

A favorable tolerability profile: ABCL635 was well-tolerated across all doses, with no serious adverse events or elevations in liver enzymes. Treatment-emergent adverse events were generally mild and transient.
A pharmacokinetic profile that supports monthly dosing: ABCL635 exhibited an estimated half-life of ~24 days, supporting the potential for a once monthly subcutaneous dose.
Strong suppression of biomarkers of target engagement: To confirm target engagement of NK3R on kisspeptin, neurokinin B, and dynorphin (KNDy) neurons in the infundibular nucleus of the hypothalamus, testosterone, a clinically validated surrogate biomarker of NK3R antagonism, was measured in male volunteers. ABCL635 demonstrated sustained and dose-dependent suppression of testosterone over a four-week period.
Based on these data, AbCellera advanced ABCL635 into a Phase 2 study, as announced earlier this year. The Phase 2 is a multicenter, randomized, double-blind, placebo-controlled trial with approximately 80 postmenopausal women designed to evaluate the efficacy of ABCL635 in reducing the frequency and severity of moderate-to-severe VMS.

Business Metrics

December 31, 2025

March 31, 2026

Partner-led programs with downstreams

44

40

In the clinic

5

5

In discovery or preclinical development

39

35

Molecules in the clinic with downstreams

14

14

Beginning in Q1 2026, AbCellera is reporting new business metrics to focus on programs and molecules with downstream participation which are believed to be progressing. At the end of Q1 2026, partners led 40 programs which AbCellera believes to be progressing and where AbCellera holds a downstream stake (down from 44 on December 31, 2025). In total, AbCellera held downstream stakes in 14 molecules in the clinic understood to be progressing on March 31, 2026.

Discussion of Q1 2026 Financial Results

Revenue – Total revenue was $8.3 million, compared to $4.2 million in Q1 2025.
Research & Development (R&D) Expenses – R&D expenses were $46.7 million, compared to $42.5 million in Q1 2025.
Sales, General, & Administrative (SG&A) Expenses – SG&A expenses were $12.3 million, compared to $19.1 million in Q1 2025.
Net Loss – Net loss of $43.2 million, or $(0.14) per share on a basic and diluted basis, compared to net loss of $45.6 million, or $(0.15) per share on a basic and diluted basis, in Q1 2025.
Liquidity – $531 million of total cash, cash equivalents, and marketable securities and approximately $124 million in available non-dilutive government funding, bringing total available liquidity to approximately $655 million to execute on AbCellera’s strategy.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

About ABCL635

ABCL635 is a potential first-in-class antibody drug for the non-hormonal treatment of moderate-to-severe VMS, commonly known as hot flashes, associated with menopause. ABCL635 specifically targets NK3R, a clinically validated G protein-coupled receptor (GPCR) expressed on KNDy neurons in the infundibular nucleus of the hypothalamus. ABCL635 is the first program from AbCellera’s GPCR and ion channel platform to advance into the pipeline, entering the clinic in July 2025. Additional details are available at www.abcellera.com/pipeline.

(Press release, AbCellera, MAY 11, 2026, View Source [SID1234665463])

On May 11, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the first quarter ended March 31, 2026, and highlighted recent Company progress.

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"Our two ongoing pivotal firmonertinib trials in uncommon EGFR-mutant non-small cell lung cancer (NSCLC) continue to advance, with topline monotherapy data for frontline EGFR exon 20 insertion mutations expected in mid-2026 and our global Phase 3 pivotal ALPACCA study continuing to enroll patients globally," said Bing Yao, CEO of ArriVent. "At American Association for Cancer Research (AACR) (Free AACR Whitepaper), we presented preclinical data highlighting the unique structural features of firmonertinib that improve binding and enhance activity against EGFR mutant proteins, further strengthening confidence in the broad activity of firmonertinib in EGFR-mutant NSCLC."

Dr. Yao continued, "We also presented preclinical data for our antibody-drug conjugate (ADC), ARR-002 at AACR (Free AACR Whitepaper). This novel MUC16/NaPi2b dual-targeting tetravalent ADC demonstrated synergistic anti-tumor activity compared to single-target and bivalent ADCs, along with a favorable tolerability profile, supporting its best-in-class potential. Following the recent clearance of our Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), we plan to initially advance ARR-002 into the clinic for ovarian and endometrial cancers. Our balance sheet continues to be strong with projected cash runway into the fourth quarter of 2027, and we are focused on continued execution across our key registrational catalysts."

First Quarter 2026 and Recent Highlights

Firmonertinib

New preclinical data for firmonertinib presented at AACR (Free AACR Whitepaper). Preclinical findings for EGFR inhibitor firmonertinib showcased high resolution crystal structure data supporting the ongoing pivotal Phase 3 study in frontline EGFR exon 20 insertion mutant NSCLC at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Received National Medical Products Administration (NMPA) accelerated approval in China in second-line EGFR exon 20 insertion mutations. In February 2026, our partner Shanghai Allist Pharmaceutical Technology Co., Ltd., received NMPA accelerated approval for firmonertinib for adults with locally advanced or metastatic NSCLC who have progressed on or after prior platinum-based chemotherapy or who are intolerant to platinum-based chemotherapy and who have been tested for the presence of EGFR exon 20 insertion mutations.

Pipeline

Clinical advancement of ADC lead ARR-217 (MRG007). ArriVent received FDA IND clearance for ARR-217 and dosed its first patient in March 2026 and continues to advance the ongoing Phase 1 dose escalation for ARR-217, a CDH17 targeted ADC, in gastrointestinal malignancies in partnership with Lepu Biopharma Co., Ltd.
IND clearance for ARR-002 in endometrial and ovarian cancer. In May 2026, ArriVent received IND clearance from the FDA for ARR-002, a novel dual-target MUC16/NaPi2b tetravalent ADC, for ovarian and endometrial cancers. The Company plans to advance ARR-002 into the clinic through a first-in-human study evaluating safety, dosing, and early signals of efficacy.
New preclinical data for ARR-002 presented at AACR (Free AACR Whitepaper). ArriVent presented preclinical data on ARR-002, also known as AV-P138-ADC, characterizing its superior ADC potential in ovarian and endometrial cancers and planned advancement towards clinical evaluation. The data was presented with Aarvik Therapeutics, Inc., who also presented data for ARR-002 as part of an oral presentation at the Clinical Research Mini Symposium at AACR (Free AACR Whitepaper).

Upcoming Milestones

Firmonertinib pivotal EGFR exon 20 insertion data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is projected to be in mid-2026.
Initiate Phase 1 dose optimization for ARR-217. Complete Phase 1 dose escalation and initiate dose optimization for ARR-217, a CDH17 targeting ADC program, in the second half of 2026.
Dosing of first patient with ARR-002. Dosing of first patient with ARR-002 in a Phase 1 trial expected in the second half of 2026.

2026 Financial Results

As of March 31, 2026, the Company had cash and investments of $326.4 million, which is expected to fund operations into 4Q 2027.
Net cash used in operations was $41.9 million and $68.0 million for the three months ended March 31, 2026 and 2025, respectively.
Research and development expenses were $37.6 million and $61.3 million for the three months ended March 31, 2026 and 2025, respectively.
General and administrative expenses were $8.5 million and $5.5 million for the three months ended March 31, 2026 and 2025, respectively.
Net loss was $43.3 million and $64.4 million for the three months ended March 31, 2026 and 2025, respectively.

(Press release, ArriVent Biopharma, MAY 11, 2026, View Source [SID1234665479])

On May 11, 2026 PharmaMar (MSE:PHM) reported that it has completed patient recruitment objective for the Phase III SaLuDo clinical trial (Sarcoma Patients treated with Lurbinectedin and Doxorubicin), which is evaluating lurbinectedin in combination with doxorubicin as a first-line treatment for patients with metastatic leiomyosarcoma (LMS).

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SaLuDo is a global, open-label, multicenter, randomized Phase III clinical trial in metastatic leiomyosarcoma (LMS). The primary endpoint of the study is progression-free survival (PFS), with overall survival (OS) as the key secondary endpoint. The trial includes three treatment arms: two arms evaluating different dose combinations of lurbinectedin and doxorubicin, and a control arm evaluating doxorubicin as a single agent. A total of 450 patients have been enrolled across more than 90 centers in the United States and several European countries.

Leiomyosarcoma is a subtype of soft tissue sarcoma that accounts for approximately 10–20% of all cases within this group of tumors. Soft tissue sarcoma represents around 1% of all cancers in the adult population, so leiomyosarcoma is considered a rare tumor. This type of cancer originates in smooth muscle tissue, which is found in organs such as the retroperitoneum, the gastrointestinal tract, blood vessels, and, in women, the uterus[1].

PharmaMar expects the results of the trial to be available during the first half of 2027, following completion of patient follow-up and data analysis.

(Press release, PharmaMar, MAY 11, 2026, View Source [SID1234665441])