On March 17, 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 that the results from the Co-PSMA (NCT06907641)1 IIT were presented by Prof Louise Emmett (St Vincent’s Hospital Sydney) in an oral session at EAU Congress 2026, Europe’s largest urological conference, on the 16th March in London, UK2. The study data has also been accepted for publication in European Urology, the official journal of EAU with an impressive impact factor of 25.2.

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Co-PSMA (Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) was a Phase II IIT evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA (0.2 – 0.75 ng/mL) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT (at 1 hour and 24 hours post-injection, same-day and next-day imaging, respectively) on the same digital PET camera.1,3

The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number. Using a paired means test, a sample size of 50 provided power of 90% to detect a minimum alternative mean difference greater than zero of 0.432. Secondary endpoints included management impact questionnaires between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 and accuracy of the PET findings determined using a comprehensive reference standard, including biopsy, response to targeted treatment without androgen deprivation therapy (ADT), PSA rise without treatment or corroborative imaging.

Overall, 64Cu-SAR-bisPSMA PET/CT (24-hour imaging) was found to identify a higher number of disease recurrences than 68Ga-PSMA-11 PET/CT with substantial management impact and a high true positive rate in men with BCR post-radical prostatectomy.

Participants enrolled had a median PSA of 0.43 (IQR: 0.31 – 0.63) and 74% had an International Society of Urological Pathologists (ISUP) grade of 3 or higher. The mean per-patient lesion for 64Cu-SAR-bisPSMA (24–hour imaging) was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 24-hour 64Cu-SAR-bisPSMA imaging detected 63 lesions (representative image in Figure 1). The increase in the number of lesions identified by 64Cu-SAR-bisPSMA was noted in the prostatic bed region (local recurrence), pelvic/extra-pelvic lymph nodes and bone .

On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on 64Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the 64Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable standard of truth (SOT), the true positive rate was 71% for 24-hour 64Cu-SAR-bisPSMA (24/34) compared to 29% (10/34) for 68Ga-PSMA-11. The false negative rate was 21% for 24-hour 64Cu-SAR-bisPSMA (7/34) vs. 65% for 68Ga-PSMA-11 (22/34).

These results from the Co-PSMA IIT further build on the growing body of evidence demonstrating that 64Cu-SAR-bisPSMA improves the detection of prostate cancer compared to the current SOC PSMA PET agents which have lower sensitivity in patients with low PSA levels4,5. In the Phase II COBRA trial, 64Cu-SAR-bisPSMA was evaluated in patients with BCR who had a negative or equivocal scan at study entry. Among participants with a follow-up SOC PSMA PET, 90% were positive on 24-hour 64Cu-SAR-bisPSMA PET compared with only 60% on SOC PSMA PET. Overall, next-day imaging with 64Cu-SAR-bisPSMA identified more than 2.6 times lesions than SOC PSMA PET6. The COBRA data, combined with the Co-PSMA IIT results, will complement the anticipated findings from the Phase III registrational trial, AMPLIFY, which recently reached its target number of participants7. Together, they are intended to be submitted to the US FDA for a market authorisation of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer.

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "Head-to-head trials are very important in helping clinicians determine the most appropriate products for their patients. The Co-PSMA study shows that a novel PSMA-targeted PET agent like 64Cu-SAR-bisPSMA can deliver improved imaging performance compared to other SOC PSMA agents. In Co-PSMA, 64Cu-SAR-bisPSMA at 24 hours identified more sites of recurrence and directly informed personalised treatment decisions, highlighting its potential to improve outcomes in prostate cancer patients with BCR."

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Science underpins the entirety of our biotechnology sector, and as a science-driven organisation, nothing makes us more proud than to see our products progress from the Australian benchtop to now generating excellent results in the clinic and having this substantiated and quantified to the highest standard through the scientific method. We applaud the independent work of Prof Louise Emmett and her team at St Vincent’s Hospital in Sydney who chose to progress this trial in such detail, leading to the acceptance of the data in European Urology, a top-tier journal with a high impact factor of 25.2.

"The high quality of these data now adds to the substantial body of evidence supporting our product, the optimised SAR-bisPSMA. The discovery and pre-clinical work has been previously circulated in numerous journals, including publications by our long-term collaborator, Prof Paul Donnelly, sharing his seminal work on the sarcophagine (SAR) chelator as well as on the SARTATE, SAR-Bombesin and the optimised SAR-bisPSMA agents in 2023 in Chemical Reviews8, one of the highest impact factor journals in chemistry with a 5-year impact factor of 67.5.

"The extraordinary quality of the academic research is coupled with the feverish pace of commercialisation where our registrational Phase III trials, AMPLIFY and CLARIFY, are nearing completion. We have recently shared that AMPLIFY reached its target number of participants with rising or detectable PSA after initial definitive treatment at clinical sites across the US and Australia in just 9 months since imaging the first patient7, and we look forward to collecting and analysing the final study data. Combined with results from the Co-PSMA and COBRA trials, we believe it will constitute a compelling application for approval of 64Cu-SAR-bisPSMA by regulatory authorities for the BCR indication. Armed with three Fast Track Designations for the one SAR-bisPSMA agent, we are ready to work closely with the US FDA to get it to patients in need as soon as possible, and we look forward to more positive interactions with the Agency on this journey. As always, we will continue updating the market on the progress of our bisPSMA program, including significant milestones in the AMPLIFY, CLARIFY and SECuRE trials, as well as on the supply chain and regulatory developments as we enter the market with our first product."

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.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide9. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, MAR 17, 2026, View Source [SID1234663610])

On March 17, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that the Israeli Patent Office has allowed its patent application No. 284463, titled "An A3 Adenosine Receptor Ligand for Use for Achieving a Fat Loss Effect." The allowed patent covers the use of A3 adenosine receptor (A3AR) agonists, including the Company’s lead drug candidate Namodenoson, for inducing fat loss and treating obesity and related metabolic disorders.

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This allowance represents a key addition to Can-Fite’s expanding global intellectual property portfolio around Namodenoson’s anti-obesity activity and follows similar patent advancements in other major jurisdictions including the US, Canada and Australia, strengthening the Company’s worldwide protection strategy. Recently the technology granted scientific recognition upon coming up with a breakthrough publication of peer-reviewed study in the International Journal of Obesity, demonstrating the anti-obesity effect of namodenoson (View Source ).

The global obesity therapeutics market is experiencing rapid growth, driven by increasing prevalence and the success of GLP-1 receptor agonists. However, current treatments are often associated with limitations including gastrointestinal side effects and high cost. Namodenoson, a highly selective A3AR agonist, offers a differentiated mechanism of action, targeting key pathways involved in adipogenesis, inflammation, and metabolic regulation. Preclinical and clinical studies have demonstrated its potential to reduce fat accumulation and improve metabolic profiles, positioning it as a promising candidate in the expanding obesity treatment landscape.

"With the allowance of this patent in Israel, we continue to build and strengthen our intellectual property portfolio around Namodenoson’s anti-obesity activity," said Dr. Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. "Given the significant unmet need and rapid growth of the obesity market, we believe Namodenoson’s unique mechanism and established safety profile position it as an attractive candidate for development and potential partnering opportunities."

The global obesity treatment market is projected to reach $60.5 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 22%, driven by increasing disease prevalence and demand for safe, effective oral therapies.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

(Press release, Can-Fite BioPharma, MAR 17, 2026, View Source [SID1234663609])

On March 17, 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 financial results for the fourth quarter and full year ended December 31, 2025, and provided recent corporate updates.

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"We have successfully completed the dose selection portion of the Duravelo-2 trial and received regulatory alignment that the 6mg dose and schedule is optimal for zelenectide in mUC based on strong anti-tumor activity and its differentiated safety profile. We look forward to sharing these data at an upcoming scientific conference. Based on the regulatory feedback we have received, the existing Duravelo-2 trial design is no longer considered acceptable as an approval path for zelenectide in mUC. Preliminary discussions with regulatory agencies have outlined several potential paths for zelenectide’s approval in mUC. While we believe the strength of these data and the clear medical need justify continued development of zelenectide, we have reached the difficult decision to deprioritize this program for internal development at this time. We have initiated a process to convert our ongoing Duravelo-2 trial to a randomized Phase 2 study. Once we have these randomized Phase 2 data in hand, we will determine the most appropriate path for zelenectide," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We believe these data provide further validation of the ability of our Bicycle technology to deliver oncology therapeutics with a potentially improved benefit/risk profile compared to existing modalities. In view of this, we have decided to conduct a strategic reprioritization, which includes a proposed workforce reduction, to best position the company to focus our resources on our promising pipeline of next-generation therapeutics."

Fourth Quarter 2025 and Recent Events

Promising Duravelo-2 data and multiple potential regulatory pathways provide a range of options for a Phase 3 trial and potential commercialization of zelenectide in mUC. Initial dose selection data from the Duravelo-2 trial demonstrate response rates comparable to those published for existing standards of care, with physician assessed overall response rate (ORR) of 65%, blinded independent central review (BICR) confirmed ORR of 58% at the 27-week cutoff and a differentiated safety profile. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62%. The 6mg dose demonstrated a differentiated safety profile with only one patient discontinuing therapy due to a treatment-related adverse event (TRAE) at the 27-week cutoff. Bicycle Therapeutics expects to present initial dose selection data from the Duravelo-2 trial at an upcoming scientific conference. While Bicycle Therapeutics evaluates preliminary regulatory feedback from the European Medicines Agency, U.S. Food and Drug Administration (FDA), and Medicines and Healthcare products Regulatory Agency, and the potential paths for this program, the company plans to convert the ongoing Duravelo-2 trial to a randomized Phase 2 trial and deprioritize this program for internal development at this time. Once available, data from the randomized Phase 2 trial will be shared with the scientific and medical community.

Strategic reprioritization focuses on promising pipeline of next-generation therapeutics. Bicycle Therapeutics has initiated a strategic reprioritization in order to focus its resources on its promising pipeline of next-generation therapeutics, including BT5528, a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), as well as its emerging bicycle conjugate pipeline, including BRCs. As part of the reprioritization, Bicycle Therapeutics will seek to discontinue the Phase 1/2 Duravelo-3 trial for zelenectide in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide in NECTIN4-amplified non-small cell lung cancer. Further enrollment for these trials will be closed, and patients already enrolled will complete their course of treatment. In addition, Bicycle Therapeutics is proposing to implement a workforce reduction pursuant to which it would reduce its workforce by approximately 30%. Anticipated annual operational savings related to the workforce reduction and strategic reprioritization are expected to reduce annual operating expenses by approximately 50% based on the company’s current plans. These actions are expected to extend Bicycle Therapeutics’ cash runway by approximately two years, into 2030.
Established multiple strategic partnerships to create end-to-end supply chain to support wholly owned radiopharmaceutical pipeline. Bicycle Therapeutics entered into a 15-year contract including an option to renew with the UK Nuclear Decommissioning Authority (NDA) for access to up to 400 tonnes of reprocessed uranium (RepU). RepU continually regenerates providing a potentially sustainable supply of 212Pb. In addition, Bicycle Therapeutics announced a collaboration with United Kingdom National Nuclear Laboratory (UKNNL), pursuant to which it plans to extract 228Th from the RepU obtained from NDA. The extracted 228Th will then be further processed into 224Ra and loaded into bespoke 212Pb generators being developed exclusively for Bicycle Therapeutics by SpectronRx. Collectively, this bespoke set of arrangements is designed to support the potential discovery, development, and commercial supply of a portfolio of BRCs containing 212Pb. These arrangements build on a previously announced agreement with Eckert & Ziegler to supply a range of radioisotopes for the manufacture and development of BRCs and Bicycle Imaging Agents (BIA), enabling an isotope agnostic strategy.

Data for an early BIA targeting MT1-MMP presented at European Association of Nuclear Medicine (EANM) 2025 Congress. An e-poster presentation outlined the first clinical experience with an early BIA targeting MT1-MMP. An additional e-poster presented by the German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), highlighted preclinical BRC data demonstrating the potential of this approach for radiotheranostic use. Altogether, these data build on preclinical and first human imaging data previously disclosed at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and EANM 2024 Congress. Bicycle Therapeutics believes these data further support the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrate the translatability of BRC preclinical data and highlight the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging.

Bicycle Therapeutics continues to advance its emerging radioligand pipeline, with additional EphA2 human imaging data expected in the first half of 2026 and the initiation of the first company-sponsored radioligand clinical trial, for BT1702, an MT1-MMP targeting BRC, expected in 2027.

BT5528, a potential first-in-class EphA2 targeting BDC molecule. Bicycle Therapeutics announced nuzefatide pevedotin (nuzefatide) as the International Nonproprietary Name for BT5528. Phase 1 nuzefatide combination data with nivolumab in mUC patients will be presented at a scientific conference in the first half of 2026.
In March 2026, Bicycle Therapeutics began enrolling a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent pancreatic ductal adenocarcinoma (PDAC). Additional information regarding this indication will be presented at a scientific conference in the first half of 2026.

BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA), is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Phase 1 BT7480 combination data with nivolumab will be presented at a scientific conference in the first half of 2026. After reporting combination data, Bicycle Therapeutics will no longer develop BT7480 internally and intends to seek a potential partner for future development.

Evolving leadership team strengthens transition to next phase of innovation across oncology pipeline. Bicycle Therapeutics has appointed Jennifer Perry, Pharm.D. as chief operating officer (COO), and Alistair Milnes as chief corporate development officer (CCDO). In her role as COO, Jennifer will oversee portfolio and new product strategy, business development, commercial and medical affairs, while in his role as CCDO, Alistair will oversee government affairs, human resources and information technology. Bicycle Therapeutics also recently promoted Travis Thompson as chief financial officer, overseeing the finance, accounting and investor relations functions and Michael Method, M.D., MPH, MBA, to chief medical officer, overseeing all clinical development and the relationship with Bicycle Therapeutics’ Clinical Advisory Board. In addition, Michael Skynner, Ph.D., now serves as chief scientific officer, overseeing scientific discovery, early-stage pipeline development and the relationship with Bicycle Therapeutics’ Research and Innovation Advisory Board.

Fourth Quarter and Year End 2025 Financial Results

Cash and cash equivalents were $628.1 million as of December 31, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities.

Collaboration revenue was $48.0 million for the three months ended December 31, 2025 and $72.6 million for the year ended December 31, 2025, compared to $3.7 million for the three months ended December 31, 2024 and $35.3 million for the year ended December 31, 2024. The increases in collaboration revenue of $44.3 million and $37.3 million for the three months and year ended December 31, 2025, respectively, were primarily due to the recognition of all remaining revenue under Bicycle Therapeutics’ collaboration with Novartis Pharma AG upon a notice of termination of the collaboration agreement, as well as the recognition of revenue under Bicycle Therapeutics’ collaboration with Bayer Consumer Care AG upon a notice of termination of one of the target programs under the collaboration agreement.

R&D expenses were $51.8 million for the three months ended December 31, 2025, and $240.3 million for the year ended December 31, 2025, compared to $49.8 million for the three months ended December 31, 2024, and $173.0 million for the year ended December 31, 2024. The increase in expense of $2.0 million for the three months ended December 31, 2025 was primarily due to increased discovery, platform and other expenses and lower U.K. R&D tax credits period over period, offset by decreased clinical program expenses for zelenectide development and Bicycle TICA molecules. The increase in expense of $67.3 million for the year ended December 31, 2025 was primarily due to increased clinical program expenses for zelenectide development, discovery, platform and other expenses, higher personnel-related costs, including severance-related expenses of the workforce reduction completed in August 2025, and lower U.K. R&D tax credits period over period, offset by decreased clinical program expenses for Bicycle TICA molecules.

General and administrative expenses were $20.9 million for the three months ended December 31, 2025, and $79.4 million for the year ended December 31, 2025, compared to $21.6 million for the three months ended December 31, 2024, and $72.2 million for the year ended December 31, 2024. The decrease in expense of $0.7 million for the three months ended December 31, 2025 was primarily due to decreased professional and consulting fees. The increase in expense of $7.2 million for the year ended December 31, 2025 was primarily due to increased personnel-related costs including share-based payments, offset by a favorable impact of foreign exchange rates.
Net loss was $20.2 million, or $(0.29) basic and diluted net loss per share, for the three months ended December 31, 2025, and net loss was $219.0 million, or $(3.16) basic and diluted net loss per share, for the year ended December 31, 2025, compared to net loss of $51.9 million, or $(0.75) basic and diluted net loss per share, for the three months ended December 31, 2024, and net loss was $169.0 million, or $(2.90) basic and diluted net loss per share, for the year ended December 31, 2024.

(Press release, Bicycle Therapeutics, MAR 17, 2026, View Source [SID1234663608])

On March 17, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported two poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in San Diego, California April 17-22.

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Preclinical findings for EGFR inhibitor firmonertinib will highlight high resolution crystal structure data supporting the ongoing pivotal Phase 3 study in frontline EGFR exon 20 insertion mutant non-small cell lung cancer (NSCLC). ArriVent in partnership with Aarvik Therapeutics, Inc. (Aarvik) will also present preclinical data on ARR-002, a novel dual-target MUC16/NaPi2b tetravalent antibody drug conjugate (ADC), characterizing its superior ADC potential in ovarian and endometrial cancers and planned advancement towards clinical evaluation. Data for ARR-002 will also be presented as part of an oral presentation by Aarvik at the Clinical Research Mini Symposium.

Abstract Highlights and Presentation Details

Discovery and Characterization of Firmonertinib, a Novel EGFR Inhibitor with Broad Activity Against both EGFR Classical and Exon 20 Insertion Mutations

Abstract Number: 2745

Time and Date: Tuesday April 21, 2026 from 2 – 5 PM PT

Session: Experimental and Molecular Therapeutics / Tyrosine Kinase, Phosphatase, & Other Inhibitors
Poster Location: Section 18, Board 9, Number 5871

Lung cancers with classical EGFR mutations respond to approved EGFR inhibitors, whereas those with EGFR exon 20 insertion (ex20ins) mutations have limited sensitivity and few treatment options. Firmonertinib is a novel, brain-penetrant irreversible EGFR inhibitor with early clinical evidence supporting activity against uncommon mutations, including ex20ins and PACC variants, and is approved in China for frontline classical and second line exon20ins EGFR mutant NSCLC. Preclinical characterization of firmonertinib demonstrated:

·

High potency inhibition of EGFR harboring classical and ex20ins mutations using a series of structural, biochemical, cell line and xenograft data

·

Strong anti-tumor activity and high brain penetrance reinforced across multiple in vitro and in vivo models

·

Findings support the structural mechanism of broad EGFR binding and inhibition by firmonertinib

AV-P138-ADC (ARR-002), a Novel MUC16/NaPi2b Dual-target Tetravalent ADC, for the Treatment of Ovarian and Endometrial Cancers

Abstract Number: 5757

Time and Date: Monday April 20, 2026 from 9 AM – 12 PM PT

Session: Clinical Research / Targeted Antigen Therapies and Immunity

Poster Location: Section 49, Board 12, Number 2660

Dual-target ADCs aim to overcome challenges underlying the high failure rate of single-target ADCs in the clinic including limited internalization, low payload delivery, and heterogeneous target expression in tumors. MUC16 and NaPi2b are highly expressed on ovarian and endometrial cancers with limited expression in normal tissues, making them ideal co-targets. ARR-002 utilizes a novel tetravalent format to fully target both MUC16 and NaPi2b. This dual targeting approach is designed to be more active and overcome tumor escape mechanisms that limit single target ADCs. Initial preclinical characterization of ARR-002 demonstrated:

·

Effective binding to individual targets, simultaneous engagement of both targets, and enhanced internalization vs. single-target antibody controls

·

Superior in vivo efficacy vs. single-target ADCs in the OVCAR-3 xenograft model

·

The potential for a wider therapeutic window based on a favorable tolerability profile in cynomolgus monkeys, consisting of reversible hematologic findings at a higher maximum tolerated single dose vs. other approaches in development

Mini Symposium Details

MUlti-epitope Targeting Tetravalent Antibody (MUTTA) Platform for Developing NextGen ADCs with an Improved Therapeutic Window

Abstract Number: 6758

Time and Date: Tuesday April 21, 2026 from 2:30 – 4:30 PM PT

Session: Clinical Research / Targeted Therapy: Data Driven Approaches and Novel Drugs

(Press release, ArriVent Biopharma, MAR 17, 2026, View Source [SID1234663607])

On March 17, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the fourth quarter and year ended December 31, 2025.

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"Our recent decision to advance oral epetraborole into a Phase 2 study for polycythemia vera highlights the growing opportunity across AN2’s boron chemistry pipeline and our commitment to addressing serious, underserved diseases. It also represents one of three proof-of-concept catalysts we believe we are well positioned to achieve in the next two years, including the Phase 2 investigator-initiated trial in M. abscessus complex lung disease and a Phase 2 proof-of-concept study in chronic Chagas disease planned for later this year, pending the outcome of our Phase 1 study," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. "Looking ahead, we remain on track to bring two boron-based oncology candidates into development in 2026, further demonstrating the versatility of our platform. I’m proud of the momentum we’re carrying into the year and the continued execution from our team as we work to deliver impactful therapies to patients with urgent unmet needs."

Fourth Quarter & Recent Business Updates:

Polycythemia Vera

Expanding development of oral epetraborole into Phase 2 trial for PV

In March 2026, the Company announced its plan to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, many patients experience uncontrolled hematocrit levels and persistent symptom burden, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S. AN2 is proceeding through the regulatory process and anticipates initiating the Phase 2 trial in India in the third quarter of 2026. The Company expects to provide periodic data readouts beginning as early as the fourth quarter of 2026 and throughout 2027, subject to regulatory clearance and enrollment progress.
M. abscessus Complex Lung Disease

Preparing to initiate enrollment for Phase 2 study of epetraborole in patients with M. abscessus complex lung disease

In December 2025, the U.S. Food and Drug Administration (FDA) cleared an investigational New Drug Application to proceed with a Phase 2 investigator-initiated study in collaboration with Oregon Health & Science University (OHSU) evaluating epetraborole for the treatment of M. abscessus lung disease. This multicenter, randomized, double-blind, placebo-controlled, prospective clinical study will be led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at OHSU, in conjunction with other investigators across an estimated 10-15 sites in the U.S. M. abscessus lung disease is a serious and difficult-to-treat non-tuberculous mycobacterial infection requiring prolonged therapy including with IV-only antibiotics, and characterized by limited treatment options and high rates of morbidity, and 5-year mortality. No FDA-approved drug currently exists for its treatment. The Company expects to initiate enrollment in the first quarter of 2026 and report topline results in late 2027.
Chagas Disease

Phase 1 first-in-human clinical trial of oral AN2-502998 approaching completion; Phase 2 proof-of-concept study planned for 2026 pending results of Phase 1 study

In August 2025, as part of AN2’s Chagas disease clinical development program, the Company commenced its Phase 1 first-in-human trial of oral AN2-502998 in healthy volunteers. Chagas disease (American trypanosomiasis) is an infectious disease caused by Trypanosoma cruzi, which affects an estimated 6-10 million people worldwide, including approximately 300,000 people in the U.S. and over 100,000 in Europe. Chagas disease can remain asymptomatic for years before progressing to chronic disease. In approximately 20-30% of infected individuals, chronic infection leads to serious cardiac and gastrointestinal complications, including cardiomyopathy, heart failure, arrhythmias, stroke, and megacolon or megaesophagus, which can result in significant morbidity and premature death. AN2-502998 is the only compound of which the Company is aware, to have demonstrated curative activity in preclinical studies across multiple species, including in nonhuman primates (NHPs) with long-term, naturally acquired chronic infections caused by diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, these efficacy data may be more predictive of efficacy in human clinical trials than other animal models. There are no FDA-approved treatments for adults with Chagas disease.

The Company’s Phase 1 first-in-human trial with oral AN2-502998 is nearing completion, with initial clinical data expected in the first quarter of 2026 and initiation of the proof-of-concept Phase 2 trial in patients with chronic Chagas disease in 2026, depending on the outcome and timing of completion of the Phase 1 study.

FDA approval of a treatment for Chagas disease, which is designated as a tropical disease under Section 524 of the Federal Food, Drug, and Cosmetic Act (FDCA), would qualify the Company to receive a priority review voucher intended to incentivize the development of therapies for neglected infectious diseases.
Boron Chemistry Pipeline

Advancing research programs in oncology

The Company is pursuing a number of oncology targets for which boron chemistry may offer a competitive advantage in terms of binding site differentiation, pharmacodynamics, drug-like properties, and intellectual property. AN2’s lead programs include PI3Kα and ENPP1. The Company plans to advance two oncology candidates into development in 2026 targeting PI3Kα and ENPP1.
Global Health

Research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting tuberculosis (TB); AN2 awarded third year funding from Gates Foundation

In November 2025, the Company announced a collaboration agreement with the global biopharma company GSK to develop new therapies for TB. As part of this effort, the Gates Foundation will provide a third year of funding to support AN2’s work within the collaboration. TB continues to pose a major global health challenge, affecting more than a quarter of the world’s population and causing over 1.25 million deaths annually. The Company’s global health programs also include melioidosis, a severe bacterial infection associated with high death rates in endemic regions.
Selected Fourth Quarter Financial Results

Research and Development (R&D) Expenses: R&D expenses for the full year 2025 were $24.8 million, compared to $40.5 million in the prior year. R&D expenses for the fourth quarter of 2025 were $6.9 million, compared to $5.4 million for the same period during 2024 due to increased personnel-related expenses, preclinical and research studies expenses, chemistry manufacturing and controls expenses, and allocated facilities expenses. These increases were partially offset by decreased clinical trial expenses due to termination of the EBO-301 study, partially offset by initiation of the Phase 1 trial in Chagas disease.
General and Administrative (G&A) Expenses: G&A expenses for the full year 2025 were $13.3 million, compared to $14.1 million in the prior year. G&A expenses for the fourth quarter of 2025 were $2.4 million, compared to $3.2 million for the same period during 2024 due to decreased professional and outside services expenses and personnel-related expenses.
Restructuring Charges: There were no restructuring charges in the full year or the fourth quarter of 2025. Restructuring charges for the full year and the fourth quarter of 2024 were $2.2 million and $0.9 million, respectively, due to severance payments and other employee termination-related expenses.
Interest Income: Interest income for the full year 2025 was $2.9 million, compared to $5.5 million for the same period in 2024. Interest income for the fourth quarter of 2025 was $0.6 million, compared to $1.1 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024.
Net Loss: Net loss for the full year 2025 was $35.2 million, compared to $51.3 million for the same period in 2024. Net loss for the fourth quarter of 2025 was $8.7 million, compared to $7.5 million for the same period during 2024.
Cash Position: The Company had cash, cash equivalents and investments of $60.0 million at December 31, 2025. On March 9, 2026, the Company announced that it had entered into a securities purchase agreement for a private placement with gross proceeds of approximately $40 million, before deducting placement agent fees and other expenses. The private placement included participation from Coastlands Capital, Commodore Capital, Vivo Capital and other new and existing institutional investors. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2029 under the current operating plan.

(Press release, AN2 Therapeutics, MAR 17, 2026, View Source [SID1234663605])