Tidewave Bio Completes FDA INTERACT Meeting for TBC-1, a Universal Cell Therapy Platform in Solid Tumors

On August 28, 2025 Tidewave Bio, a biotechnology company developing a universal, off-the-shelf, gene-enhanced antigen-presenting cell therapy platform, reported the successful completion of its FDA INTERACT meeting (Press release, Tidewave Bio, AUG 28, 2025, https://www.globenewswire.com/news-release/2025/08/28/3140757/0/en/Tidewave-Bio-Completes-FDA-INTERACT-Meeting-for-TBC-1-a-Universal-Cell-Therapy-Platform-in-Solid-Tumors.html?utm_source=chatgpt.com [SID1234656369]). This milestone provides critical regulatory feedback as the company advances its lead program, TBC-1, toward IND-enabling studies.

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Tidewave Bio’s platform is designed to address one of the greatest challenges in oncology: effective and accessible treatment for solid tumors. Unlike current therapies that target limited antigens or require patient-specific manufacturing, Tidewave’s universal cell therapy is tumor type–agnostic, cost-reducing, and available in real time. By delivering a broad repertoire of tumor antigens, the platform is designed to activate robust and durable immune responses across a wide range of cancers.

"We are proactively engaging with the FDA as an external validation of our risk-mitigation strategy during product development," said Francois Binette, PhD, Chief Executive Officer and Co-Founder. "The feedback from our INTERACT meeting provides clarity and confidence as we progress toward IND-enabling activities. Our mission is to expand access to advanced therapies for all solid tumor patients, and today we are one step closer to that goal."

Tidewave Bio will integrate FDA feedback into its development program and pursue a pre-IND meeting to further shape its regulatory strategy. The company intends to work closely with regulatory agencies in the U.S. and abroad throughout product development to progressively de-risk its innovative program toward successful IND/CTA submissions.

Crescent Biopharma to Present at September Investor Conferences

On August 28, 2025 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that management is scheduled to present at the following investor conferences in September (Press release, Crescent Biopharma, AUG 28, 2025, View Source [SID1234655981]):

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– Cantor Global Healthcare Conference 2025, fireside chat on Thursday, September 4, 2025, at 1:00 p.m. ET in New York.

– Morgan Stanley 23rd Annual Global Healthcare Conference, fireside chat on Monday, September 8, 2025, at 5:35 p.m. ET in New York.

A live webcast of each presentation will be available in the Investors section of the Company’s website at View Source, and a replay will be accessible for 90 days.

Milestone Payment of $5 Million Received for IMM2510 and IMM27M Collaboration between ImmuneOnco and Instil Bio

On August 28, 2025, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as "ImmuneOnco," with the stock code 01541.HK on the Hong Kong Stock Exchange) reported that, in accordance with the collaboration development plan, it has received the third clinical development milestone payment of $5 million from Instil Bio, Inc (Nasdaq: TIL, "Instil") as scheduled, in relation to the licensing and collaboration on IMM2510 and IMM27M (Press release, ImmuneOnco Biopharma, AUG 28, 2025, View Source [SID1234655713]).

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The receipt of this $5 million payment marks significant progress in the clinical development of the collaboration project. It not only reflects ImmuneOnco’s strength in innovative drug research and development but also demonstrates the efficient cooperation between the two parties, providing strong financial support for the further advancement of the project. With the arrival of this milestone payment, the total amount received from the collaboration project has reached as high as $35 million, indicating the rapid progress of the collaboration and the positive and sincere attitude of both parties in their cooperation.

Key Terms of the Licensing Agreement
On August 1, 2024, ImmuneOnco entered into a business development (BD) collaboration worth over $2 billion with Axion Bio, Inc., a wholly-owned subsidiary of Instil Bio, Inc. (formerly known as SynBioTx). Axion Bio, Inc. obtained the rights to develop and commercialize two products, IMM2510 and IMM27M, from ImmuneOnco’s pipeline outside the Greater China region. In addition to retaining the rights to these two products within the Greater China region, ImmuneOnco received an upfront payment and recent payments totaling $50 million, as well as over $2 billion in subsequent development, registration, and commercial milestone payments, and single-digit to low double-digit sales royalties outside the Greater China region.

Clinical Trial Updates
The Phase I clinical study of IMM2510 in Chinese patients with solid tumors has shown positive efficacy signals and good safety, especially in patients with squamous non-small cell lung cancer (SQ-NSCLC) who had previously failed treatment with PD-1 or PD-L1 inhibitors. These results will be presented at the 2025 World Conference on Lung Cancer (WCLC).

The Phase II clinical trial of IMM2510 in combination with chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC) is recruiting patients smoothly in China. As of July 1, 2025, the overall best objective response rate (ORR) in the evaluable population was 62%, with an ORR of 80% in patients with squamous NSCLC. The safety of this therapy is tolerable and controllable, supporting further clinical development. Plans are underway to initiate a Phase III clinical trial. More relevant research results will be published at future international academic conferences.

A Phase I clinical trial of IMM2510 monotherapy for recurrent/refractory solid tumors is scheduled to be launched in the United States in the second half of 2025.

(The above Phase II clinical data for IMM2510 in combination with chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC) has been previously disclosed by the company.)

Statement from ImmuneOnco’s Founder, Chairman, CEO, and CSO

Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated: "We are very pleased that our collaboration with Instil Bio has achieved another clinical development milestone. This not only recognizes our strength in innovative drug research and development but also reflects the close cooperation and efficient progress between the two parties. We will continue to work closely with Instil Bio to accelerate the global development of IMM2510 and IMM27M, striving to bring new treatment hopes to cancer patients worldwide as soon as possible. At the same time, ImmuneOnco will continue to be committed to the research and development of innovative drugs, providing more high-quality treatment options for patients globally."

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.