On May 15, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported financial results for the first quarter ended March 31, 2026 and provided a corporate update.

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"With enrollment now surpassing the first interim analysis threshold in the MIRACLE trial, we are just weeks away from beginning what we believe will be the most transformative period in the Company’s history. The impressive preliminary blinded remission data trend we reported earlier this year continues with the 45 subject blinded data. This trend supports our belief in Annamycin’s potential to meaningfully improve outcomes for patients with relapsed or refractory AML," said Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

"We also believe Annamycin has the potential to redefine the anthracycline class by addressing one of the most significant limitations of these foundational therapies, cardiotoxicity, while potentially expanding access to treatment options for patients who otherwise may not be eligible for standard anthracycline-based therapy due to current life-time dose limits," Mr. Klemp added.

Recent Highlights

Achieved enrollment of the first 45 subjects in the pivotal MIRACLE Phase 2B/3 trial evaluating Annamycin in combination with cytarabine ("AnnAraC") for the treatment of relapsed/refractory acute myeloid leukemia (AML)
Continued to observe encouraging blinded efficacy trends in the MIRACLE trial, including a previously reported preliminary blinded composite complete remission (CRc) rate of 40% at the first 30 subjects treated mark and also at the 45th subject mark
Completed financing transactions during the first quarter of 2026 resulting in approximately $8.3 million in gross proceeds, strengthening the Company’s near-term operating runway
Continued expansion of clinical trial operations across the United States and Europe to support accelerated enrollment and future development activities
Bolstered global intellectual property strategy for Annamycin, now covering four continents
Clinical Development Update

Annamycin – MIRACLE Trial
Moleculin continues to advance the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) trial, a pivotal adaptive-design Phase 3 study evaluating AnnAraC in adult patients with relapsed or refractory AML.

Expected Milestones for Annamycin Development Program

Q2 2026: MIRACLE – Unblinding of data for 45 subjects
Q3 2026: MIRACLE – Part A 90 subjects recruited and unblinding thereafter
2H 2026: MIRACLE – Start of Part B
2H 2026: Atlantic Health pancreatic cancer clinical trial begins
2027: Begin recruitment of 3rd line AML subjects
2027: Begin pediatric AML clinical study
2028: End recruitment of Part B
2028: Primary efficacy data for MIRACLE 2nd line subjects
2028: Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
Additional Pipeline Programs

Moleculin continues to support externally funded and investigator-sponsored studies involving WP1066 and other pipeline candidates targeting difficult-to-treat cancers and viral diseases.

First Quarter 2026 Financial Results

Research and development expenses for the three months ended March 31, 2026 and 2025 were $5.4 million and $3.4 million, respectively. The increase of $2.0 million is mainly related to the MIRACLE clinical trials in Europe of $1.4 million, additional nonclinical studies of $0.3 million and other research costs during the current quarter as compared to the prior year quarter.

General and administrative expenses for the quarter ended March 31, 2026 were approximately $2.5 million, compared with $2.5 million for the same period in 2025.

As of March 31, 2026, the Company had cash and cash equivalents of approximately $10.3 million. Management believes current cash resources, together with recent financing proceeds, will support planned operations into the third quarter of 2026.

(Press release, Moleculin, MAY 15, 2026, View Source [SID1234665773])

On May 15, 2026 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.

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In the neoadjuvant setting, Enhertu followed by a taxane, trastuzumab, and pertuzumab (THP) has been approved for the treatment of adult patients with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, Enhertu has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment.

Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, said: "HER2-positive breast cancer is an aggressive disease, and our goal is to reduce the risk of recurrence for patients as early as possible to achieve the best long-term outcomes. The neoadjuvant setting offers the earliest opportunity to improve outcomes, while the adjuvant setting provides another important chance to prevent recurrence for patients with residual disease after surgery. These two new indications in HER2-positive early breast cancer will evolve how we treat patients in these settings and support trastuzumab deruxtecan as a potential new standard of care in early-stage disease."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "HER2-positive early disease is considered highly curable, however up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting. These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning Enhertu as a foundational treatment in early breast cancer."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. said: "Enhertu has redefined the treatment of HER2-expressing breast cancer with practice-changing data across six breast cancer indications in seven years. Enhertu is now approved in the US across both early and metastatic HER2-positive breast cancer, accomplishing what we set out to achieve a little over a decade ago for patients at the start of our comprehensive clinical development programme."

Victoria Smart, Senior Vice President, Mission, Susan G. Komen, said: "Providing patients with early breast cancer more options to help prevent progression to metastatic disease can lead to improved outcomes. Progression and recurrence remain among the most significant unmet needs for those diagnosed with early breast cancer, and continued advances in treatment bring new hope to patients and families facing this disease."

In DESTINY-Breast11, Enhertu followed by THP as a neoadjuvant treatment demonstrated a pathologic complete response (pCR) rate of 67.3% compared with 56.3% for dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP], an improvement of 11.2% (95% confidence interval [CI] 3.9-18.3; p=0.003). At the time of the pCR analysis, 29 patients (4.5%) had event-free survival (EFS) events, and 12 patients (1.9%) had overall survival (OS) events. The results were published in Annals of Oncology.1

In DESTINY-Breast05, Enhertu as an adjuvant treatment reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant therapy (hazard ratio [HR] 0.47; 95% CI 0.34-0.66; p<0.0001). At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease, compared with 83.7% of those in the T-DM1 arm, with 51 (6%) events in the Enhertu arm and 102 (12%) in the T-DM1 arm. The results were published in The New England Journal of Medicine.2

Data from both trials were presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Based on the DESTINY-Breast05 results, trastuzumab deruxtecan (Enhertu) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 recommended treatment in the adjuvant setting for patients with HER2-positive early breast cancer with residual disease and a high risk of recurrence following preoperative therapy. See NCCN Guidelines for detailed recommendations.

No new safety concerns were identified with Enhertu in the DESTINY-Breast11 or DESTINY-Breast05 trials.

In DESTINY-Breast11, Enhertu followed by THP showed similar rates of drug-related overall adverse events (AEs) and interstitial lung disease (ILD)/pneumonitis as ddAC-THP, and lower rates of Grade 3 or higher AEs, serious AEs, AEs leading to treatment interruptions, left ventricular dysfunction and haematological toxicities.

In DESTINY-Breast05, Enhertu and T-DM1 showed similar rates of overall drug-related AEs and Grade 3 or higher AEs. Adjudicated drug-related ILD/pneumonitis occurred in 9.6% of patients in the Enhertu arm and 1.6% of patients in the T-DM1 arm. The majority of ILD/pneumonitis events were low grade in both arms. There were seven Grade 3 events and two deaths (Grade 5) in the Enhertu arm.

The DESTINY-Breast11 and DESTINY-Breast05 US regulatory submissions were both reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Separate regulatory applications for both trials are also under review in other countries. DESTINY-Breast05 previously received Priority Review and Breakthrough Therapy Designation by the FDA.

Enhertu is already approved in more than 95 countries, including the US, as a treatment for patients with HER2-positive metastatic breast cancer.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Financial Considerations
Following these approvals in the US, an amount of $155 million is due from AstraZeneca to Daiichi Sankyo as milestone payments for both these indications. Sales of Enhertu in the US are recognised by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

Notes

HER2-positive early breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million breast cancer cases were diagnosed in 2022, with an estimated 665,000 deaths globally.3 In the US, more than 320,000 cases of breast cancer are diagnosed annually with over 42,000 deaths.4

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.5 An estimated one in five cases of breast cancer is considered HER2-positive.6 Approximately one in three patients with HER2-positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis, and up to one in four will experience disease recurrence.7,8

HER2‑positive early breast cancer is generally treated across two phases: the neoadjuvant (pre‑surgical) phase and the adjuvant or post-neoadjuvant (post‑surgical) phase.

In the neoadjuvant setting, the current standard of care in many regions of the world involves combination chemotherapy regimens.9 In the US, the current standard of care consists of a combination regimen of carboplatin, trastuzumab, pertuzumab and a taxane.9,10 For patients with HER2-positive early breast cancer, achieving pCR, defined as no evidence of invasive cancer cells in the removed breast tissue or lymph nodes following treatment with neoadjuvant treatment, is an early indicator of improved long-term survival.11 Approximately half of patients (39-66%) who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.12-16

In the adjuvant setting, despite receiving additional treatment with current standard of care for residual disease, some patients still experience invasive disease or death.17 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.18

DESTINY-Breast11
DESTINY-Breast11 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of neoadjuvant Enhertu (5.4mg/kg) monotherapy or Enhertu followed by THP compared to ddAC-THP in patients with high-risk HER2-positive early-stage breast cancer.

Patients were randomised 1:1:1 to receive either eight cycles of Enhertu monotherapy; four cycles of Enhertu followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.

The Enhertu monotherapy arm was closed early following a recommendation from the Independent Data Monitoring Committee.

The primary endpoint of DESTINY-Breast11 is rate of pCR – defined as no evidence of invasive cancer cells in the removed breast cancer tissue or lymph nodes following treatment. Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

Patients were randomised 1:1 to receive 14 cycles of Enhertu or T-DM1.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. Secondary endpoints include investigator-assessed DFS, overall survival, distant recurrence-free interval, brain metastasis-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4mg/kg) followed by THP is approved in the US and China as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, United Arab Emirates and Saudi Arabia as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4mg/kg) is approved in more than 15 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, MAY 15, 2026, View Source [SID1234665793])

On May 15, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported financial results for the second quarter of fiscal year 2026 ended March 31, 2026, and provided a corporate update.

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"We remain committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval. Our objective is clear: to bring the first FDA-approved ophthalmic formulation of bevacizumab to patients in the United States," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "In addition, we are encouraged by the continued momentum of our European commercial launch of LYTENAVA, highlighted by our expansion into new markets, as well as our recently announced partnership in Switzerland and growing physician adoption in our initial launch countries."

During the second quarter of fiscal year 2026, Outlook Therapeutics continued to advance the commercial rollout of LYTENAVA (bevacizumab gamma) in Europe. In anticipation of a potential launch in Switzerland, the Company entered into a Commercial Distribution Agreement with Mediconsult AG for the sale and distribution of LYTENAVA (bevacizumab gamma) in Switzerland. As part of the agreement, Mediconsult AG will be responsible for regulatory activities in Switzerland, including seeking and maintaining Marketing Authorization. The Company is targeting a 2027 launch of LYTENAVA in Switzerland in 2027, subject to receipt of Marketing Authorization in that country.

Building on the initial launch momentum, Outlook Therapeutics intends to expand into the Netherlands and Ireland later in 2026 and additional European markets and beyond in 2027. As Outlook Therapeutics continues to see increasing physician adoption and demand in the initial launch countries, the Company remains focused on executing its commercialization strategy to pursue additional launches and potential partnerships inside and outside of Europe and further establishing LYTENAVA as a new treatment option for wet AMD.

The Company also launched a real-world evidence study in Germany to further evaluate the performance of LYTENAVA in routine clinical practice following its approval in the European Union and the United Kingdom. These data are expected to support reimbursement and market access efforts in key European markets, inform potential regulatory interactions, and further strengthen the overall value proposition of LYTENAVA for physicians, patients, and stakeholders.

ONS-5010 U.S. Regulatory Update

Outlook Therapeutics continues to advance its regulatory efforts in the United States for ONS-5010/LYTENAVA (bevacizumab-vikg). The Company conducted its formal dispute resolution meeting with the U.S. Food and Drug Administration (FDA) in April 2026 and remains engaged in the process as it awaits the formal decision from the FDA. The Company has provided a comprehensive package of clinical, functional, pharmacodynamic, and safety data, including results from the NORSE TWO and NORSE EIGHT studies, which the Company believes support the efficacy and safety profile of ONS-5010/LYTENAVA for the treatment of wet AMD. Outlook Therapeutics remains committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval.

Outlook Therapeutics expects a formal decision from the FDA in May 2026.

Financial Highlights for the Second Fiscal Quarter Ended March 31, 2026

For the second fiscal quarter ended March 31, 2026, Outlook Therapeutics reported net loss attributable to common stockholders of $4.5 million, or $0.05 per basic and diluted share. This compares with net loss attributable to common stockholders of $46.4 million, or $1.50 per basic and diluted share for the same period last year.

For the fiscal quarter ended March 31, 2026, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $14.1 million, or $0.16 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $12.4 million, or $0.40 per basic and diluted share for the second fiscal quarter of 2025.

Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2026, excludes $2.5 million of gain from change in fair value of promissory notes, $0.3 million of gain on extinguishment of debt, and $6.8 million of gain from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2025, excludes $33.9 million of warrant inducement expenses, $2.1 million of gain from change in fair value of warrant liability, and $2.1 million of loss from change in fair value of promissory notes.

Net revenue in the fiscal quarter ended March 31, 2026, was offset by recurring fixed distribution costs during the quarter. Overall, unit sales of LYTENAVA in Europe for the second fiscal quarter of 2026 were down approximately 10% compared to the quarter ended December 31, 2025, but have trended upward early in the current quarter. Outlook Therapeutics has taken steps to reduce costs in Europe in an effort to improve margins in future quarters.

In March 2026, Outlook Therapeutics reported that it had restructured its outstanding convertible promissory note to extend the maturity until December 2026, as well as entered into a non-convertible promissory note that was used to reduce the outstanding balance of the convertible note. Additionally, the Company completed a public offering of common stock and accompanying warrants in March 2026, for approximately $4.0 million of net proceeds, after deducting placement agent fees and other offering expenses. In April 2026, the Company completed a registered direct offering of common stock and, in a concurrent private placement, accompanying warrants, for $4.2 million of net proceeds, after deducting placement agent fees and other offering expenses. As of March 31, 2026, Outlook Therapeutics had cash and cash equivalents of $7.7 million, which does not include the net proceeds of the April 2026 registered direct offering.

About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and a Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA must receive pricing and reimbursement approval before it can be sold.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

(Press release, Outlook Therapeutics, MAY 15, 2026, View Source [SID1234665774])

On May 15, 2026 Accuray Incorporated (NASDAQ: ARAY) and the University of Wisconsin School of Medicine and Public Health (UW SMPH) reported a new 10‑year strategic collaboration to advance personalized cancer treatments using Accuray’s Stellar adaptive radiation therapy platform. This agreement builds on longstanding shared history of partnership between Accuray and the school to develop precision radiation therapy technologies using imaging to precisely deliver dose sculpting for cancer treatments. This newest collaboration will support clinical research, education and training, and the development of adaptive therapies that help empower medical care teams to continually raise the standard in cancer care.

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"Our success depends on collaboration, innovation, and the energy that comes from addressing meaningful clinical needs for patients," said Steve La Neve, President and CEO of Accuray. "This Master Research Agreement formalizes and expands our longstanding relationship with the University of Wisconsin–Madison and grounds our innovations in real-world clinical practice and impactful patient care. By leveraging our respective strengths, we aim to extend the curative power of radiotherapy so departments of all sizes around the world can benefit from advanced adaptive therapies."

In the late 1980s, University of Wisconsin-Madison Professor of Medical Physics, Human Oncology, and Engineering Thomas "Rock" Mackie and his team invented technology that would later be commercialized as Accuray’s first helical radiation delivery platform, the TomoTherapy System. This ushered in a new era in radiation medicine, enabling clinicians for the first time to integrate helical 3D image-guidance with intensity-modulated radiation therapy (IG-IMRT), increasing treatment precision and accuracy to help improve patients’ cancer care. Since its introduction, Accuray has continued to enhance the helical platform, introducing advances in image quality, speed, versatility, and workflow efficiency.

The new agreement between the UW School of Medicine and Public Health and Accuray will build on this shared history to advance the next generation of adaptive radiotherapy approaches, according to Zachary Morris, MD, PhD, professor and chair of human oncology. "At UW we have exceptionally talented innovators in radiation medicine across the spectrum from discovery science to translational and clinical research and we have a track-record of advancing discoveries to clinical practice. This agreement with Accuray is an exciting next step that will accelerate the process of translating research innovation into technologies that better serve patients, leveraging a robust academic-industry collaboration to advance personalized radiotherapy treatments," said Morris.

"This framework enables us to build on a long history of shared innovation with Accuray to deepen our collaboration, bring future innovations from bench to bedside, and create translational research and training opportunities that keep patients at the center of our work," said Nita Ahuja, MD, MBA, Dean of the UW School of Medicine and Public Health and Vice Chancellor for Medical Affairs at the University of Wisconsin–Madison.

(Press release, University of Wisconsin, MAY 15, 2026, View Source [SID1234665794])

On May 15, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, reported positive updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC). These results in Bacillus Calmette-Guérin (BCG)-Naïve NMIBC patients will be featured today during a poster session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.

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"Today’s presentation demonstrates TARA-002’s impressive 12-month durability data and excellent safety profile for patients with BCG-Naïve NMIBC," said Mark Tyson, M.D., Professor of Urology, Mayo Clinic Phoenix, and ADVANCED-2 study investigator. "The NMIBC patient community faces a critical unmet need for safe, effective and bladder-sparing treatment options for this devastating disease. These compelling data, coupled with a simple, streamlined administration for both physicians and patients, make TARA-002 a potentially important new treatment option for BCG-Naïve high risk NMIBC patients."

"These data continue to support our conviction that TARA-002 has the potential to make a meaningful difference in the lives of patients with BCG-Naïve NMIBC," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "Notably, the durable 12-month complete response (CR) rate observed in the BCG-Naïve cohort continues to perform competitively among approved treatments and investigational therapies in development. We look forward to completing enrollment in the registrational BCG-Unresponsive cohort of ADVANCED-2 and initiating ADVANCED-3, a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-Naïve and potentially BCG-Exposed patients in the second half of 2026."

Updated Data Results in BCG-Naïve Patients

Efficacy

The BCG-Naïve dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5, 2026 data cutoff.

The CR rate at any time in BCG-Naïve patients was 72.4% (21 of 29).
The CR rate in BCG-Naïve patients was 66.7% (18 of 27) at six months and 55.0% (11 of 20) at 12 months.
Among responders:
The Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4).
91.7% (11 of 12) maintained their CR from nine to 12 months.
66.7% (4 of 6) of re-induced patients converted to a CR at six months.
Safety

The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria.

About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve. Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months. Protara has completed enrollment of the BCG-Naïve cohort and expects to complete enrollment of the BCG-Unresponsive cohort in the second half of 2026.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

(Press release, Protara Therapeutics, MAY 15, 2026, View Source [SID1234665775])