Theralase(R) Completes Enrollment in Bladder Cancer Clinical Study

On February 2, 2026 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that it has successfully completed its targeted milestone of enrolling and treating 90 patients in a multi-center Phase II clinical study for bladder cancer.

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The Phase II clinical study has a primary endpoint of efficacy, a secondary endpoint of duration of response and a tertiary endpoint of safety, in evaluating light-activated Ruvidar in the treatment of patients diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) ("Study II").

The enrollment and treatment of 90 patients achieves the Company’s statistical analysis plan and represents a significant step forward in evaluating a statistically and clinically significant dataset in support of a Health Canada and FDA regulatory approval. In accordance with the clinical protocol, Theralase will enroll and treat any additional patients, who are in or pending screening.

Pending Health Canada and FDA regulatory approval, light-activated Ruvidar represents a potentially transformative, bladder-sparing treatment option for patients with limited alternatives, addressing a significant unmet need in high-risk NMIBC.

Clinical data generated to date continues to demonstrate a strong efficacy, duration of response and favorable safety profile, with a majority of patients achieving durable responses with a single treatment.

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase, stated, "I am pleased that Theralase has completed enrollment of 90 patients in its Phase II registrational clinical study for bladder cancer. This accomplishment allows the Company to complete this study in 2026 and prepare for Health Canada and FDA regulatory approval submissions."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase, added,
"Enrolling and treating 90 patients in our Phase II registration clinical study represents a significant milestone for the Company. With the targeted enrollment now completed, we can focus on compilation of the clinical data for Health Canada and FDA regulatory approval. 2026 will be a pivotal year for the Company as we complete our bladder cancer study, embark on a combinational clinical study for bladder cancer and launch numerous Phase I/II adaptive clinical studies for brain, lung, muscle invasive bladder, pancreatic and colorectal cancers."

About Study II:
Study II utilizes the therapeutic dose of the small molecule Ruvidar, which has been light-activated by the TLC-3200 Medical Laser System. Study II will enroll and treat 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.

About NMIBC
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.1 In the United States, bladder cancer is the sixth most common cancer,2 fourth among men,3 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.3 Historically, 75% of bladder cancer presents as NMIBC.4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.5 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).6

About Ruvidar:
Ruvidar is a small molecule activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of cancer, bacteria and viruses.

(Press release, Theralase, FEB 2, 2026, View Source [SID1234662400])

Quest Diagnostics Launches Novel Flow Cytometry MRD Blood Test for Myeloma, Enabling Ultrasensitive Detection of Residual Disease

On February 2, 2026 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported the launch of a novel blood test that uses advanced flow cytometry methods to assess measurable residual disease (MRD) in patients with the blood cancer myeloma (also called multiple myeloma). Called Quest Flow Cytometry MRD for Myeloma, the new test provides comparable sensitivity as next-generation sequencing methods in detecting residual myeloma*, but at a fraction of the cost, supporting better care and outcomes.

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"Our Flow Cytometry MRD for Myeloma test harnesses cutting-edge science and technology to deliver ultrasensitive insights from a noninvasive blood test, thereby improving care and value for patients and the healthcare system," said board-certified oncologist and hematologist Yuri Fesko, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. "This new test merges this elite performance with improved access, given Quest’s approximately 7,000 phlebotomy sites across the United States, helping to illuminate a path to better health for more patients."

Advancing disease detection for a prevalent blood cancer

Myeloma is a cancer of plasma cells, a type of white blood cell, in which dysregulated growth leads to the creation of abnormal antibodies affecting the blood and bones. About 36,000 new cases of myeloma are diagnosed every year in the United States, and nearly 11,000 patients die of the disease annually, according to the American Cancer Society, making it one of the most common types of plasma cell cancers. While incurable, myeloma can often be treated as a chronic condition using chemotherapy and other personalized treatments and guided by MRD monitoring during and after treatment. Physicians typically assess MRD using flow cytometry methods that detect abnormal cells in bone marrow aspirates, a type of biopsy. In recent years, next-generation sequencing has been deployed on both blood and bone marrow aspirate specimens, improving sensitivity tenfold compared to conventional flow cytometry, but at a higher price point.

The new test from Quest is unique for using next-generation flow cytometry techniques with a level of detection comparable to next-generation sequencing but on noninvasive blood specimens instead of bone marrow aspirates. In addition, the test can be used in situations where a baseline aspirate sample is not available, unlike NGS methods, which require a pre-treatment baseline sample to provide a reference for ongoing monitoring. The test also features five-day specimen stability, compared to three or fewer days by conventional flow cytometry, supporting access when specimen transport to the lab takes several days.

"The enthusiastic response received at the recent American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition upon educating the medical community about the Quest Flow Cytometry MRD for Myeloma test made it clear to me that this assay has the potential to greatly improve the treatment paradigm," said Timothy Looney, PhD, Senior Director, Immuno-Oncology, Quest Diagnostics. "The sensitivity, cost, and sample stability that we can now offer to patients and their care team will help those suffering from this potentially devastating condition."

In addition to supporting clinical care, the Quest Flow Cytometry MRD for Myeloma test is expected to have utility as a response monitoring tool in clinical trials. In January 2026, the FDA provided draft guidance on using MRD as a primary endpoint in trials evaluating drug and biological products to treat patients with multiple myeloma to support accelerated approval.

Quest is a leading provider of oncology testing services, including the Haystack MRD test for assessing MRD in solid tumor cancers. This new offering complements Quest’s comprehensive portfolio of hematopathology and advanced molecular oncology testing and services aiding care and outcomes for patients with cancer.

(Press release, Quest Diagnostics, FEB 2, 2026, View Source,-Enabling-Ultrasensitive-Detection-of-Residual-Disease [SID1234662399])

Molecular Partners Announces Presentation of First Imaging and Dosimetry Data of DLL3-Targeting Radiotherapy MP0712 in Patients at TWC 2026

On February 2, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of first patient imaging and dosimetry data of MP0712, its DLL3-targeted Radio-DARPin candidate co-developed with strategic partner Orano Med, at the 8th Theranostics World Congress (TWC), taking place in Cape Town, South Africa on January 29-February 1.

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The data, presented in two posters and an oral presentation, are highly supportive of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb for patients with small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers. The data from five evaluable patients were generated with MP0712 carrying the diagnostic isotope 203Pb under the leadership of Dr. Mike Sathekge as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa (also referred to as Section 21 of the Medicines and Related Substances Act).

"I am highly encouraged by the data generated in my group suggesting a favorable distribution profile of MP0712, a DLL3-targeted radiopharmaceutical for patients with SCLC and NEC cancers," said Dr. Mike Sathekge, Professor and Head of Nuclear Medicine at the University of Pretoria and Steve Biko Academic Hospital, and President and CEO of the Nuclear Medicine Research Infrastructure (NuMeRI). During the imaging step with 203Pb, we observed in our patients a promising tumor uptake, paired with a clean profile in healthy organs indicating a therapeutic potential for MP0712. I look forward to seeing this confirmed in the upcoming Phase 1 study."

The images show specific uptake as well as robust accumulation of MP0712 in tumor lesions, with limited uptake in healthy tissues, as intended. MP0712 is half-life engineered to promote tumor uptake over time via the DLL3 internalization and replenishment mechanism. Biodistribution of MP0712 in patients with various DLL3-expressing cancers, including small cell lung, urothelial, and other neuroendocrine cancers, provides a strong rationale for broad clinical development of MP0712 in SCLC and neuroendocrine cancers. The dosimetry extrapolations support the Phase 1/2a study design of MP0712 with 212Pb as therapeutic radioactive payload.

"The clinical data presented at TWC 2026 validate our assumptions and support the ongoing U.S. Phase 1/2a study, enabling us to initiate dosing of MP0712 within a potentially therapeutic range," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "These encouraging results reinforce our ambition to become a leader in alpha‑targeted therapies for patients with small cell lung cancer and other neuroendocrine malignancies. We thank the NuMeRi team for the strong collaboration and look forward to continuing our work together across our emerging pipeline. The biodistribution and dosimetry data demonstrate exactly what we aim to achieve with Radio‑DARPins — strong tumor accumulation with rapid clearance from healthy tissues. We look forward to sharing initial Phase 1 safety and activity data in 2026 as we advance our Radio-DARPin platform to deliver potent alpha‑emitting radioisotopes to solid tumors across multiple indications."

The Phase 1/2a study of MP0712 (ClinicalTrials.gov: NCT07278479) is a multi-center study in the U.S., with the objectives to assess safety and determine a recommended phase 2 dose for MP0712 carrying the potent therapeutic isotope 212Pb. The study, which contains an imaging and dosimetry step with 203Pb-labeled MP0712, is ongoing with initial clinical data expected in 2026.

Details of the presentations at TWC 2026

Two Poster Presentations:

Abstract 207: First-in-human evaluation of DLL3-Targeting 203Pb/212Pb DARPin MP0712 SPECT/CT in high-grade neuroendocrine malignancies: safety, biodistribution, and optimal imaging windows
Abstract 260: First-in-human dosimetry of the DLL3-targeting 203Pb/212Pb theranostic DARPin MP0712 in patients with small cell lung cancer and high-grade neuroendocrine tumours
Time & Presenters: Friday January 30, 2026, 17:30-18:30 SAST, by the NuMeRI team of Dr. Mike Sathekge.

Oral Presentation:
Title: From DARPins to Radio-DARPin Therapeutics – Progressing the first Radio-DARPin Therapeutic MP0712 (212Pb x DLL3) for SCLC into the clinic

Time: Saturday January 31, 2026; 10:30-12:00 SAST;
Session: "Antibody Drug Conjugates and Diversification of the Mechanisms of Action"
Presented by Molecular Partners

Webcast to be held on Monday February 2 at 8:00 ET (14:00 CET):
In addition to the presentations at TWC, Molecular Partners will host a webcast to discuss the new clinical data. Prof. Ken Herrmann, Chairman of the Scientific Advisory Board at Molecular Partners, will comment on the clinical data in the webcast.

Details as follows:
For Participants who want to listen and view slides: Please register here.

For Participants who may want to ask a question following the presentation: Please register here. These participants will be provided with additional dial-in instructions to join the live conference call and will have the ability to "raise their hand" and ask a verbal question during the Q&A.

(Press release, Molecular Partners, FEB 2, 2026, View Source [SID1234662397])

MAA Laboratories Completes Regulatory Engagement with Australia’s TGA for Dasatinib Nanoparticle Tablets

On February 2, 2026 MAA Laboratories, Inc. reported that it has completed early regulatory engagement with the Therapeutic Goods Administration (TGA) of Australia for its Dasatinib Nanoparticle Tablets, developed using the Company’s proprietary NanoCont platform technology.

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The engagement provides procedural clarity on the applicable regulatory pathway for the program in Australia. The product is being developed under a Category 1, Type F regulatory framework, consistent with global regulatory precedents for differentiated, suprabioavailable formulations of approved drug substances.

MAA’s Dasatinib Nanoparticle Tablets are designed to achieve equivalent systemic exposure at lower doses through enhanced bioavailability, enabling a development strategy centered on bioavailability and bioequivalence (BA/BE) studies. Under this pathway, regulatory evaluation is conducted at the time of submission.

Importantly, this approach is aligned with scientific advice previously received in Europe and Canada, as well as IND clearance by the U.S. Food and Drug Administration, where a BA/BE-based development strategy without additional clinical efficacy, safety, or toxicology studies was considered appropriate for this differentiated formulation.

"We view Australia as an important market for innovative, patient-focused therapies," said Dr. Anjani Jha, Founder and CEO of MAA Laboratories. "Our engagement with the TGA provides clarity on the appropriate regulatory framework and is consistent with the global development strategy we are executing across the U.S., Europe, and Canada."

MAA Laboratories’ NanoCont platform enables the development of differentiated, branded products that retain the regulatory efficiencies of established molecules while offering the potential benefits of improved bioavailability, optimized dosing, and enhanced tolerability. The Company continues to advance its dasatinib program and broader oncology pipeline toward global registration and commercialization.

(Press release, MAA Laboratories, FEB 2, 2026, View Source [SID1234662396])

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On February 2, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 1,799 restricted stock units (RSUs) to four newly-hired employees. These RSU awards were granted as of January 31, 2026 (the "Grant Date") pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each RSU award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the Grant Date. The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates.

(Press release, Karyopharm, FEB 2, 2026, View Source [SID1234662395])