On March 16, 2026 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported two "trial in progress" presentations at the 2026 European Association of Urology congress (EAU) in London, UK. These trials investigate different stages of the diagnostic pathway, addressing data gaps to improve individual patient care and outcomes.

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The EAU annual meeting is one of the largest international meetings in the global urology calendar, showcasing the latest and most relevant clinical and scientific advancements in this area of patient care.

Photocure participated with its Hexvix product, designed for better detection and resection of bladder tumors. As in past sessions and as a service to non-attending urologists, Photocure will make 2026 EAU bladder cancer session highlights available to healthcare professionals after the event, by means of video interviews with the presenters of these sessions at the Photocure booth. This successful initiative is once again supported by two of the leading names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy.

In addition to this educational activity, the EAU scientific program prominently featured Photocure’s Hexvix product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable bladder cancer "trial in progress" presentations from Monday, March 16, 2026 were:

A0648: VI-RADS & PDD-TURBT to avoid Second-look and Resection (Re-TURBT) in Non-Muscle Invasive Bladder Cancers: The CUT-less Randomized Clinical Trial

F. Del Giudice, Rome (IT)

The CUT-less trial investigates whether second-look TURB can be safely omitted by combining preoperative staging accuracy of Magnetic Resonance Imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) with enhanced cystoscopy using blue-light-TURB

The primary endpoint of this randomized, single-center, non-inferiority trial is short-term bladder cancer recurrence. Patients eligible for second-look resection who are randomized to BL-TURB and demonstrate a very-low to low likelihood of muscle-invasive disease on MRI will omit the second-look resection, whereas patients randomized to WL-TURB will undergo the standard second-look resection. Over 3 years, 327 patients with intermediate- or high-risk NMIBCs* who are candidates for second-look TURBT will be enrolled. Results will also include building a health economic lifetime model, looking at cost-utility per quality-adjusted life year gained using 2-year clinical outcomes.

The CUT-less trial aims to generate evidence supporting a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway across the European Union and potentially worldwide.

ClinicalTrial.gov identifier (ID): NCT05962541 Read more: View Source

A0649: Trial in progress: Evaluation of urinary minimal residual disease and outcomes in high-risk non-muscle invasive bladder cancer surveilled with blue light compared to white light cystoscopy

A.K. Smith, Bethesda (US)

Urinary comprehensive genomic profiling offers a non-invasive method to assess the presence or extent of bladder cancer. The urinary biomarker UroAmp (Convergent Genomics) detects minimal residual disease (MRD). By enhancing tumor margin visualization, Blue Light Cystoscopy (BLC) may improve TURBT (transurethral resection of bladder tumors) completeness. This randomized controlled trial (RCT) enrolls high-risk NMIBC patients receiving either standard of care white light or Blue Light Cystoscopy. UroAmp will be used to evaluate completeness of resection for each modality.

The study will enroll 200 subjects undergoing TURBT for suspected high risk NMIBC randomized 1:1 to WLC or BLC-enhanced cohorts. Urinary MRD analyses will be conducted at all major decision points during treatment. The primary endpoint is the post-TURBT difference in MRD scores between the BLC and WLC arms. Secondary clinical outcomes include recurrence-free survival at 12 and 24 months.

Clinical Trial Registry number is NCT06525571. Read more: View Source

"Photocure’s support for these trials underscores our commitment to the transformation toward more personalized, data-driven care in uro-oncology, enabling better clinical outcomes and supporting the shift toward precision medicine. Minimally invasive procedures are on the rise and these trials address data gaps in the care pathway and in the impact of complete TURBTs using BLC to reduce tumor burden on clinical outcomes for high-risk patients. At Photocure, we strongly believe that the clinical utility of different precision diagnostic techniques can be optimized by using them in combination and in sequence throughout the patient pathway to inform physician decision-making and provide value for patients and healthcare. The same is true for their use in clinical trials," said Anders Neijber, Chief Medical Officer of Photocure.

During the EAU Congress on March 13, 2026, Photocure, in collaboration with medac, hosted a well-attended scientific event titled "Optimising Care in Bladder Cancer." The session was moderated by Mr. John McGrath (Consultant Urological Surgeon North Bristol Trust). The program brought together leading clinicians to discuss current challenges and advances in bladder cancer management, with a focus on improving patient pathways, in particular outcomes for women. This collaboration between Photocure and medac reflects a shared commitment to advancing evidence-based practice and supporting healthcare professionals in delivering high-quality, patient-centered bladder cancer care.

(Press release, PhotoCure, MAR 16, 2026, View Source [SID1234663581])

On March 16, 2026 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported it will host an investor webinar on Wednesday, March 18th at 3:30pm ET to discuss follow-up data from its first-in-human study of its Targeted Hyperthermia Therapy ("THT") (the "Study") that resulted the generation of immune responses in 8/10 treated and biopsied tumors, with complete responses seen in 6/10. Interested parties can register for this webinar via the following link: View Source

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Joining on the webinar will be the study’s principal investigator, Dr. Carlos Rojas, executive director of the Centro de Investigacion Clinica, Bradford Hill, along with Sona’s CEO, David Regan, and CMO, Dr. Carman Giacomantonio. Data to be presented will include patient follow-up assessments, including evidence that THT treatments generated a clinical response in secondary, untreated tumors, known as an abscopal effect, in a Study patient. This study of ten, late-stage melanoma patients who had failed on standard-of-care immunotherapy protocols, was undertaken to assess the safety, tolerability and efficacy of THT in humans.

David Regan, Sona’s CEO, commented, "We are excited to be able to share our perspectives on some follow-up data from our first-in-human study from the Principal Investigator. While the Study was intended to assess THT’s safety, tolerability and ability to prime tumors for further treatment, THT given as a monotherapy treatment demonstrated in an astounding 80% clinical response rate ("CRR"), with 60% of treated, biopsied tumors cleared in only two weeks. In particular, evidence of an abscopal effect will be discussed with an opportunity for participants to question the study’s Principal Investigator."

A recording of the webinar will be made available following the webinar in the Investor Information section of the Company’s website.

(Press release, Sona Nanotech, MAR 16, 2026, View Source [SID1234663576])

On March 16, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported data from the Phase 1/2 ReDiscover trial of zovegalisib (RLY-2608) + fulvestrant at the recommended Phase 3 dose of 400mg twice daily (BID) taken with food (fed) in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. The data are being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026 in Paris, France.

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"As supported by the data presented, the 400mg BID fed regimen maintains robust efficacy with a safety profile consistent with mutant-selective PI3Kα inhibition," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "These results further support our decision to advance this regimen into the ongoing Phase 3 ReDiscover-2 trial and reinforce our confidence in selectively targeting PI3Kα mutations as a potentially differentiated approach for CDK4/6-experienced patients."

Phase 1/2 ReDiscover Trial – Zovegalisib 400mg Fed Cohort Data Consistent with 600mg Fasted Data

Zovegalisib is currently being evaluated in ReDiscover, an ongoing first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of zovegalisib in combination with fulvestrant and in combination with fulvestrant and CDK inhibitors in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.

As of the January 13, 2026 data cut-off date, 60 patients had received the 400mg BID fed regimen. The efficacy population consisted of 57 patients who did not have a PTEN or AKT co-mutation, consistent with the planned pivotal population. All patients had previously received a CDK4/6 inhibitor and at least one prior endocrine therapy in the advanced setting.

Pharmacokinetics of Both Doses are Similar

Pharmacokinetic analyses demonstrate that the 400mg BID fed regimen achieves exposures comparable to the previously evaluated 600mg BID fasted dose, with mean concentrations approaching IC90 in majority of patients and nearly all patients maintaining exposure above the IC80 throughout the dosing interval.

Efficacy Consistent with 600mg BID Fasted

As of the January 13, 2026 data cut-off date, among the 57 efficacy-evaluable patients at the 400mg BID fed dose, which is the recommended Phase 3 dose (RP3D):

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Median follow-up was 12.0 months
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Median progression-free survival (PFS) was 11.1 months (95% CI: 7.3–13.0)
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Median PFS was 11.2 months in patients with kinase mutations (n=33) and 11.0 months in patients with non-kinase mutations (n=24)
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Among 35 patients with measurable disease, confirmed objective response rate (ORR) was 43% (15/35) and in second line only patients the ORR was 52% (11/21)

Maintained Favorable and Differentiated Tolerability Profile

Zovegalisib + fulvestrant at the 400mg BID fed dose was generally well tolerated in the 60 treated patients as of the January 13, 2026 data cut-off. The overall tolerability profile consisted primarily of low-grade, manageable and reversible treatment-related adverse events (TRAEs).

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Safety profile consistent with previously disclosed 600mg BID fasted data
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Majority of hyperglycemia events were Grade 1; no Grade 4-5 hyperglycemia observed
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In the limited cases of Grade 2/3 hyperglycemia, the vast majority occurred in patients that were pre-diabetic at baseline
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Only four patients discontinued due to TRAEs

The data presentation from the ESMO (Free ESMO Whitepaper) TAT Congress 2026 is available on the Relay Therapeutics website in the "Publications/Presentations" section through the following link: View Source

ReDiscover-2 – Ongoing Phase 3 Trial

The Phase 3 ReDiscover-2 trial (NCT06982521) is evaluating zovegalisib 400mg BID administered in combination with fulvestrant versus capivasertib + fulvestrant in patients with PI3Kα-mutated, HR+/HER2- advanced breast cancer who have progressed on prior CDK4/6 inhibitor therapy. The study initiated in mid-2025 and is enrolling globally.

Zovegalisib + fulvestrant has received FDA Breakthrough Therapy designation for the Phase 3 ReDiscover-2 trial population.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies. For more information on zovegalisib, please visit here.

(Press release, Relay Therapeutics, MAR 16, 2026, View Source [SID1234663574])

On March 16, 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 an amendment to its existing convertible note with Avondale Capital, LLC (the "Existing Note") and the issuance of a new non-convertible, unsecured note with Atlas Sciences, LLC (the "New Note").

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Under the amendment to the Existing Note, the maturity date of the Existing Note has been extended to December 31, 2026, with no other changes to the terms. The lender has confirmed that the Existing Note is not in default.

In addition, Outlook Therapeutics entered into the $18.4 million New Note. The Company expects to receive $17 million in net proceeds, after original issue discount. Proceeds from the New Note will be used to pay down a portion of the Existing Note, reducing the balance and leaving approximately $10.8 million of principal and interest remaining on the Existing Note.

The New Note bears interest at a rate equal to the Prime Rate plus 3%, subject to a minimum interest rate of 9.5% per annum, and matures on June 16, 2027.

(Press release, Outlook Therapeutics, MAR 16, 2026, View Source [SID1234663573])

On March 16, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the fourth quarter and full year ended December 31, 2025.

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"2025 was a year of strong execution across the business as we advanced palazestrant as a differentiated endocrine therapy across multiple regimens, highlighted by continued enrollment and strong investigator interest in our OPERA-01 and OPERA-02 trials," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our earlier-phase combination studies with palazestrant continue to advance and we are pleased to have initiated a Phase 1b/2 study with atirmociclib in collaboration with Pfizer, further demonstrating palazestrant’s potential as the combination endocrine therapy of choice in the metastatic setting."

Bohen continued, "In November, we strengthened our balance sheet through a public offering that generated gross proceeds of approximately $218.5 million, enabling us to fund operations through numerous expected value-creating events with palazestrant. With initial clinical results from OP-3136 anticipated in Q2 2026, top-line data from OPERA-01 expected in the fall of this year, and commercial launch preparations underway for a potential approval in late 2027, we are entering an exciting chapter in Olema’s history. We remain focused on transforming the metastatic breast cancer treatment paradigm and delivering meaningful new treatment options to patients living with breast cancer and beyond."

Recent Progress

Initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer in collaboration with Pfizer.
Presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2025.
Continued enrollment in the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.
Completed an underwritten public offering of an aggregate of 11,500,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of approximately $218.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.
Anticipated Upcoming Events

Report initial clinical results for OP-3136 in Q2 2026 at a major medical conference.
Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast cancer in the fall of 2026.
Fourth Quarter and Full Year 2025 Financial Results
Cash, cash equivalents, and marketable securities as of December 31, 2025, were $505.4 million.

Net loss for the quarter and year ended December 31, 2025 was $46.1 million and $162.5 million, respectively, as compared to $33.6 million and $129.5 million for the quarter and year ended December 31, 2024, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant and the advancement of OP-3136, partially offset by higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $43.2 million and $157.7 million for the quarter and year ended December 31, 2025, respectively, as compared to $32.3 million and $124.5 million for the quarter and year ended December 31, 2024. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and personnel-related costs, partially offset by a decrease in non-cash stock-based compensation expense.

Non-GAAP R&D expenses were $40.6 million and $145.5 million for the quarter and year ended December 31, 2025, respectively, excluding $2.6 million and $12.2 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $27.7 million and $108.0 million for the quarter and year ended December 31, 2024, respectively, excluding $4.6 million and $16.5 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $6.9 million and $21.0 million for the quarter and year ended December 31, 2025, respectively, as compared to $4.5 million and $17.7 million for the quarter and year ended December 31, 2024. The increase in G&A expenses was primarily due to increased spending on corporate-related costs.

Non-GAAP G&A expenses were $5.2 million and $15.6 million for the quarter and year ended December 31, 2025, respectively, excluding $1.7 million and $5.4 million non-cash stock-based compensation expense, respectively. Non-GAAP G&A expenses were $2.8 million and $11.7 million for the quarter and year ended December 31, 2024, excluding $1.7 million and $6.0 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, MAR 16, 2026, View Source [SID1234663572])