Rakovina Therapeutics Announces Three-Month Q2 ended June 30, 2025 Financial Results and Provides Corporate Update

On August 28, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through Al-powered drug discovery, reported its financial results for the three months ended June 30, 2025 ("Q2 2025"), and provided an update on recent corporate developments (Press release, Rakovina Therapeutics, AUG 28, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-three-month-q2-ended-june-30-2025-financial-results-and-provides-corporate-update [SID1234655586]).

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Q2 2025 Financial Highlights
Reported a net loss of $2,916,944.
Research and development (R&D) expenses were $1,611,985, reflecting continued advancement of Al-powered drug candidates.
General and administrative (G&A) expenses were $1,213,489 including investor & public relations and exchange-related fees.
Operating expense cash burn (non-IFRS measure) was approximately $2.65 million.
Cash and cash equivalents as at June 30, 2025 were $1.88 million.
Recent Corporate Highlights
Private Placement Financing: On June 6, 2025, the Company closed a non-brokered private placement of 7,110,300 equity units (71,103,000 pre-consolidation) for gross proceeds of approximately $3.56 million and a concurrent $1.35 million unsecured convertible debenture financing. Each unit consisted of one common share and one warrant exercisable at $1.00 postconsolidation ($0.10 pre-consolidation) for 24 months from the date of issuance.
Reverse Share Consolidation: Effective June 24, 2025, the Company implemented a 1-for-10
share consolidation. Following the consolidation, there were 21,148,039 common shares issued
and outstanding as at June 30, 2025.
Convertible Debentures: During Q2, the Company recorded accretion expense of $38,817 and
issued shares for accrued interest in accordance with the debenture terms.
Subsequent Events
On June 30, 2025, the Company announced its intention to amend certain outstanding warrants and unsecured convertible debentures with an aggregate principal amount of $1.45 million. Amendments remain subject to TSXV approval.
On July 24, 2025, the Company announced a warrant exercise incentive program to encourage early exercise of certain outstanding warrants.
On July 29, 2025, the Company granted 540,000 stock options post-consolidation to consultants, employees, officers, and directors, exercisable at $0.70 per share with a vesting period of six months over three years.
Selected Financial Results for Q2 2025:
June 30, 2025
$ Dec 31, 2024
$
Cash and Cash Equivalents 1,882,886 1,312,743
Working Capital 622,851 321,442
Intangible Assets 3,711,622 3,977,473
Total Assets 6,554,120 6,240,920
Total Liabilities 3,338,110 1,942,005
Deficit (20,076,327) (14,997,929)
Statement of Loss and Comprehensive Loss – Q2 Three months ended June 30
June 30, 2025
$ June 30, 2024
$
Research & Development 1,611,985 479,785
General and Administrative 1,213,489 276,183
Net loss and comprehensive loss (2,916,944) (820,720)
Basic and diluted loss per share (0.18) (0.12)
Operating expense cash burn* 2,653,997 584,535
Weighted average shares outstanding 15,909,657 (post) 7,070,929 (post)
"Operating expense cash burn" = R&D + G&A less non-cash items. This is a non-IFRS measure without a standardized meaning under IFRS.

Rakovina Therapeutics’ financial statements as filed with SEDAR can be accessed from the Company’s website at: View Source

Novocure Announces Upcoming Investor Events

On August 28, 2025 Novocure (NASDAQ: NVCR) reported that management will participate in three upcoming investor events (Press release, NovoCure, AUG 28, 2025, View Source [SID1234655574]).

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2025 Wells Fargo Healthcare Conference, September 4, 2025: Ashley Cordova, Chief Executive Officer, will take part in a fireside chat at 9:30 a.m. ET, as well as one-on-one meetings with investors throughout the event.
H.C. Wainwright 27th Annual Global Investment Conference, September 9, 2025: Ms. Cordova will take part in a fireside chat at 2:00 p.m. ET, and will be joined by Christoph Brackmann, Chief Financial Officer, for one-on-one meetings with investors.
Morgan Stanley 23rd Annual Global Healthcare Conference, September 10, 2025: Ms. Cordova will take part in a fireside chat at 3:20 p.m. ET, and will be joined by Mr. Brackmann for one-on-one meetings with investors.

Live audio webcasts of these presentations can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Primary Large B-Cell Lymphomas of Immune-Privileged Sites, including Primary Vitreoretinal Lymphoma

On August 28, 2025 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma (Press release, Aldeyra Therapeutics, AUG 28, 2025, View Source [SID1234655573]). There is currently no approved treatment for patients with primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer that affects approximately 100 to 200 people per year in the European Union.

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"Primary vitreoretinal lymphoma is a potentially fatal cancer that today is treated with off-label compounded formulations of methotrexate that are injected into the eye," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The receipt of Orphan Designation from the EMA, in conjunction with the previously announced Orphan Drug Designation from the U.S. Food and Drug Administration, is another important step forward for our retinal disease program, complementing our ongoing clinical development of ADX-2191, a novel, vitreous-compatible formulation of methotrexate that is specifically designed for intraocular injection."

A proposed clinical trial, which received Special Protocol Assessment agreement from the U.S. Food and Drug Administration, is designed to compare cancer cell clearance after 30 days of therapy in up to 20 patients following 1:1 randomization to receive either a single intraocular injection or eight intraocular injections of ADX-2191. The frequency of methotrexate injections has been linked to cancer cell clearance in patients with primary vitreoretinal lymphoma,1 and approximately five injections on average has been observed to achieve cancer cell clearance.2 The clinical trial is expected to begin in the second half of 2025 and conclude in 2026.

The EMA grants orphan designation to drugs and biologics intended for the treatment, diagnosis, or prevention of rare, life-threatening, or chronically debilitating diseases or conditions that affect fewer than five in 10,000 people in the European Union. Orphan designation allows companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants, and up to 10 years of market exclusivity in the European Union.

About ADX-2191

ADX-2191 (methotrexate intravitreal injection, USP) is a sterile, non-compounded intravitreal formulation of methotrexate for the potential treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma and retinitis pigmentosa. The ADX-2191 intravitreal formulation is preservative-free, is designed to be vitreous-compatible, and is optimized for excipient composition, viscosity, density, tonicity, pH, concentration, and volume of administration. ADX-2191 received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa, and EMA Orphan Designation for the treatment of inherited retinal dystrophies of the rod-dominant phenotype, including retinitis pigmentosa, and the treatment of primary large B-cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma.

About Primary Vitreoretinal Lymphoma

Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer that is diagnosed in approximately 200 to 600 patients in the United States and 100 to 200 patients in the European Union per year. The median survival for newly diagnosed patients is less than five years. No approved treatments are currently available, though intravitreal injection of compounded methotrexate represents the current standard of care.

Zai Lab Announces Participation in Investor Conferences in September 2025

On August 28, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that members of the Company’s senior management team will participate in the following investor conferences in September 2025 (Press release, Zai Laboratory, AUG 28, 2025, View Source [SID1234655572]):

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Cantor Global Healthcare Conference
Presentation: Thursday, September 4, 2025, 10:20 a.m. ET
Location: New York, NY

Morgan Stanley 23rd Annual Global Healthcare Conference
Fireside Chat: Tuesday, September 9, 2025, 2:35 p.m. ET
Location: New York, NY

Live webcasts will be available on the Investor Relations page of Zai Lab’s website at ir.zailaboratory.com/webcasts-presentations and archived replays will be available for up to 90 days following the completion of the events.

Signatera™ Test Selected for NRG-Sponsored Phase III ARCHER Trial in Bladder Cancer

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.