On August 28, 2025 CorMedix Inc. ("CorMedix") (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that senior management will be presenting and participating in investor meetings at upcoming investor conferences taking place in September (Press release, CorMedix, AUG 28, 2025, View Source [SID1234655545]).

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Cantor Global Healthcare Conference
Date: September 5, 2025
Time: 8:35am Eastern
Format: Fireside Chat
Webcast: Link to webcast

Morgan Stanley 23rd Annual Global Healthcare Conference
Date: September 10, 2025
Time: 10:45am Eastern
Format: Fireside Chat
Webcast: Link to webcast

On August 28, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses reported it has released the Company’s unaudited condensed consolidated interim 2Q2025 financial statements ("Financial Statements") (Press release, Theralase, AUG 28, 2025, View Source [SID1234655555]).

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Theralase will be hosting a conference call on Wednesday, September 3rd at 11:00 am ET, which will include a presentation of the financial and operational results for the fiscal quarter ending June 30th, 2025. Questions are welcome. To ensure we have time to review and properly address them during the call, please send them in advance to [email protected].

Zoom Meeting Link: View Source
Webinar ID: 872 0348 0163
Conference Call in: 1-647-558-0588 (Canada) / 1-646-558-8656 (US) – not required for those attending by Zoom
An archived version will be available on the website following the conference call.

Financial Highlights

For the six-month period ended June 30, 2025 versus June 30, 2024:

Total revenue increased 12% to $310,933 from $276,401
Cost of sales decreased 4% to $178,966 (58% of revenue) from $186,324 (67% of revenue)
Gross margin increased 47% to $131,967 (42% of revenue) from $90,077 (33% of revenue)
Selling expenses decreased 5% to $139,011 from $145,915
Administrative expenses increased 10% to $995,333 from $907,378, driven primarily by increases in general and administrative expenses, administrative salaries and stock-based compensation
Research and development expenses increased 1% to $1,460,447 from $1,450,086, reflecting increased activity to support Study II progress
Net loss for the period increased 1% to $2,423,235 from $2,400,461. This included $471,174 in non-cash charges such as amortization and stock-based compensation.
Operational Highlights

Private Placements:

On April 14, 2025, the Company completed a non-brokered private placement, issuing 1,995,829 units at $0.21 per unit for gross proceeds of $419,124. Each unit included one common share and one non-transferable common share purchase warrant exercisable at $0.32 for five years.
On June 17, 2025, the Company completed a non-brokered private placement, issuing 2,855,000 units at $0.20 per unit for gross proceeds of $571,000. Each unit included one common share and one non-transferable common share purchase warrant exercisable at $0.30 for five years.
On July 28, 2025, the Company completed a non-brokered private placement, issuing 3,363,134 units at $0.20 per unit for gross proceeds of $672,627. Each unit included one common share and one non-transferable common share purchase warrant exercisable at $0.30 for five years.
Warrant Extension:

On June 26, 2025, the Company extended the expiry date of 4,800,000 warrants, all of which are exercisable at $0.35 per share. The warrants were issued on June 30, 2023, pursuant to a private placement involving the issuance of 4,800,000 units of the Company. The new expiry date of the warrants is June 30, 2028.

The Company continues to explore additional equity and non-dilutive funding opportunities to support its clinical and commercial milestones.

Study II Update:

As of August 26, 2025:

86 patients have been treated with the primary Study Procedure, representing approximately 96% of the total targeted enrollment of 90 patients.
70 patients have completed the clinical study being assessed at all assessment visits or have been prematurely removed from the clinical study by the principal investigator for lack of response
16 additional patients are pending study completion.
Interim clinical results indicate:

61.4% (43/70) patients achieved a Complete Response ("CR") at any point in time
70% (49/70) achieved a Total Response (CR + Indeterminate Response ("IR")) (IR = negative cystoscopy with positive urine cytology, without a confirmatory bladder biopsy)
At the 450-day assessment, 39.5% (17/43) of patients maintained a CR, indicating strong durability of treatment effect.
Theralase remains on track to complete enrollment in 3Q2025, with data lock targeted for 4Q2026 and regulatory submissions expected in 4Q2026.

For additional information, please refer to the Company’s Management’s Discussion and Analysis ("MD&A") available at www.sedarplus.ca.

About Ruvidar:
Ruvidar (TLD-1433) is a small molecule, able to be activated by light, radiation, sound and other drugs, intended for the safe and effective destruction of cancer, bacteria and viruses.

On August 28, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the activation of the NRG Oncology trial, ARCHER (NRG-GU015), a randomized, phase III study in muscle-invasive bladder cancer (MIBC) (Press release, Natera, AUG 28, 2025, View Source [SID1234655571]). The study is evaluating whether a shorter course of radiation can achieve outcomes comparable to the current standard of care. It prospectively incorporates Signatera, Natera’s personalized, tumor-informed molecular residual disease (MRD) test, as a pre-specified secondary endpoint.

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MIBC accounts for approximately one-quarter of all bladder cancer cases in the United States and typically requires aggressive treatment.1 Bladder-sparing treatment options are increasing in patient care, and there is a high interest in identifying therapeutic approaches that can achieve promising clinical outcomes while maximizing patient quality of life.2

The ARCHER trial is sponsored by NRG Oncology through the National Cancer Institute’s National Clinical Trials Network. It is expected to have enrollment from more than 100 sites across the U.S. and Canada. Signatera will be collected and reported to investigators during treatment and follow-up at defined timepoints. The test will enable investigators to evaluate real-time circulating-tumor DNA (ctDNA) clearance patterns in each treatment arm as a predictive marker of treatment response and recurrence. Natera will also assess urine tumor DNA as an exploratory endpoint. Signatera has been clinically validated in MIBC to detect recurrence months before standard imaging and to independently predict recurrence risk following curative-intent therapy.3

"With Signatera as a key assessment in the ARCHER trial, we aim to evaluate ctDNA dynamics to detect early molecular signs of disease recurrence in real time and refine our clinical surveillance toolbox beyond imaging and cystoscopy," said Catherine Spina, M.D., Ph.D., co-chair of translational science for the study. "By utilizing ctDNA to monitor treatment response and recurrence, we hope to improve clinical outcomes for patients with MIBC."

"By exploring whether we can safely reduce the intensity and duration of therapy without compromising outcomes, ARCHER has the potential to ease patient burden and improve quality of life," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "The use of serial Signatera testing in ARCHER represents an important step forward in determining how MRD insights can guide more precise patient management."

The launch of ARCHER will expand Natera’s breadth of MIBC clinical evidence, where data has proven how ctDNA testing can benefit patients. That includes the recent read-out of positive topline results from the randomized phase III IMVigor011 trial, which demonstrated Signatera’s ability to predict adjuvant immunotherapy benefit in patients post-cystectomy.

On August 28, 2025 CorMedix Inc. ("CorMedix") (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that senior management will be presenting and participating in investor meetings at upcoming investor conferences taking place in September (Press release, CorMedix, AUG 28, 2025, View Source [SID1234655545]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cantor Global Healthcare Conference
Date: September 5, 2025
Time: 8:35am Eastern
Format: Fireside Chat
Webcast: Link to webcast

Morgan Stanley 23rd Annual Global Healthcare Conference
Date: September 10, 2025
Time: 10:45am Eastern
Format: Fireside Chat
Webcast: Link to webcast

On August 28, 2025 TOLREMO therapeutics AG (TOLREMO), reported that their lead candidate, TT125-802, received two Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC) (Press release, TOLREMO, AUG 28, 2025, View Source [SID1234655556]). One Fast Track designation was granted for the treatment of patients with locally advanced or metastatic NSCLC with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation, with disease progression on at least one line of prior therapy including an EGFR inhibitor. The second Fast Track designation was granted for the treatment of patients with locally advanced or metastatic kirstin rat sarcoma viral oncogene homolog (KRAS)-G12C mutated NSCLC, with disease progression on at least one line of prior therapy including a KRAS G12C inhibitor.

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TT125-802 is an orally available small-molecule inhibitor of CBP/p300, a fundamental driver of cancer cell survival and treatment resistance that functions in parallel to primary oncogenic pathways. Encouraging initial efficacy and safety data from the first-in-human Phase 1 clinical trial, presented at ASCO (Free ASCO Whitepaper) 2025, demonstrated impressive clinical monotherapy activity in solid tumors without causing thrombocytopenia.

"NSCLC is a major cause of cancer-related death. While oncogene-targeting drugs such as EGFR and KRAS inhibitors improve overall survival, a significant number of patients eventually experience disease progression, representing a high unmet medical need," said Stefanie Flückiger-Mangual, PhD, Chief Executive Officer at TOLREMO. "TT125-802 has the potential to address this challenge by blocking transcriptional pathways that drive tumor growth and treatment evasion in parallel to the driving oncogene. This is supported by our clinical data to date, demonstrating deep and durable responses to TT125-802 as a single agent in patients with drug- resistant KRAS-G12C- or EGFR-mutant NSCLC. The Fast Track designations in these indications provide us with an accelerated path on our mission to deliver our differentiated treatment approach to patients who urgently need it."

"TT125-802’s highly selective mechanism of action and favorable safety profile without thrombocytopenia differentiate it from other agents in the class," added Alan Sandler, MD, Scientific Advisory Board member at TOLREMO. "The two Fast Track designations highlight TT125-802’s broad potential to provide a new approach for tackling drug resistance and tumor survival in solid tumors, including EGFR- and KRAS-G12C mutant NSCLC. We are looking forward to working closely with the FDA to advance the clinical evaluation of TT125-802 as an innovative backbone therapy."

FDA Fast Track status is designed to facilitate the development and expedite the review of new therapies that are intended to treat serious conditions with unmet medical need. Programs granted Fast Track designation have access to more frequent interactions with the FDA during clinical development and may be eligible for accelerated approval and/or priority review if certain criteria are met.

TOLREMO is assessing TT125-802 in a first-in-human, multicenter Phase 1 trial (NCT06403436) to evaluate the safety, tolerability, pharmacokinetics, and efficacy in patients with advanced solid tumors. The Fast Track designations will support the company’s clinical development strategy to advance TT125-802 in combination with an oncogene-targeting drug in KRAS- and EGFR-mutated NSCLC.