TG Therapeutics to Participate in the Cantor Global Healthcare Conference

On August 28, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, reported it will participate in the Cantor Global Healthcare Conference, being held in New York, NY on September 3 – 5, 2025 (Press release, TG Therapeutics, AUG 28, 2025, View Source [SID1234655557]). The fireside chat is scheduled to take place on Wednesday, September 3, 2025, at 10:20am ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

TOLREMO therapeutics Receives Two FDA Fast Track Designations for TT125-802 in Pretreated, Advanced or Metastatic NSCLC With Either an EGFR or a KRAS-G12C Mutation

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.

Theralase® Releases 2Q2025 Financial Statements

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.

Cartesian Therapeutics to Participate in Upcoming Investor Conferences

On August 28, 2025 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, reported that its management expects to participate in the following investor conferences in September (Press release, Cartesian Therapeutics, AUG 28, 2025, View Source [SID1234655554]):

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A fireside chat at the Cantor Global Healthcare Conference 2025 at 11:30 a.m. ET on Thursday, September 4, 2025
A fireside chat at Morgan Stanley’s 23rd Annual Healthcare Conference at 4:05 p.m. ET on Tuesday, September 9, 2025
A presentation at the H.C. Wainwright 27th Annual Global Investment Conference at 8:30 a.m. ET on Wednesday, September 10, 2025
Live webcasts of the fireside chats and presentation are expected to be accessible in the Events section of the Company’s website at www.cartesiantherapeutics.com, where an archived replay of the events will also be available for a limited time.

Oncolytics Biotech® Announces Upcoming Investor Conferences in September

On August 28, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported it will participate in two investor conferences next month. CEO Jared Kelly will be meeting with institutional investors at the H.C. Wainwright 27th Annual Global Investment Conference and the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference (Press release, Oncolytics Biotech, AUG 28, 2025, View Source [SID1234655553]). Additional details for both of these events can be found below.

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Event: H.C. Wainwright 27th Annual Global Investment Conference
Date: Tuesday and Wednesday, September 9 & 10, 2025
Location: Lotte New York Palace Hotel, New York, NY

Event: Lake Street Capital Markets 9th Annual Best Ideas Growth Conference
Date: Thursday, September 11, 2025
Location: The Yale Club, New York, NY

Company management will be participating in one-on-one investor meetings at the conferences. To schedule a meeting, please submit a request on the conference website, contact your H.C. Wainwright or Lake Street Capital Markets representative, or email [email protected].