On August 28, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in a fireside chat at the 2025 Wells Fargo Healthcare Conference on Wednesday, September 3, 2025, at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time in Boston, Massachusetts (Press release, Ascendis Pharma, AUG 28, 2025, View Source [SID1234655543]).

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A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On August 28, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 16,216,216 shares of common stock of the Company originally issued in June 2025 at an exercise price of $0.37 per share (Press release, Moleculin, AUG 28, 2025, View Source [SID1234655552]). The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to an effective registration statement on Form S-1 (File No. 333-287727). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.0 million, before deducting financial advisory fees.

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Roth Capital Partners is acting as the Company’s financial advisor for this transaction.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 64,864,864 shares of common stock, at an exercise price of $0.55 per share and will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.

The transaction is expected to close on or about August 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On August 28, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported that Dr. Steven Quay, Chairman and Chief Executive Officer, will participate in a fireside chat with biotech research analyst, Emily Bodnar, at the H.C. Wainwright (HCW) 27th Annual Global Investment Conference on Monday, September 8, 2025, at 3:00 p.m. ET, at the Lotte New York Palace Hotel in New York City (Press release, Atossa Therapeutics, AUG 28, 2025, https://www.prnewswire.com/news-releases/atossa-therapeutics-ceo-to-discuss-clinical-progress-and-upcoming-milestones-at-27th-annual-hc-wainwright-global-investment-conference-302540635.html [SID1234655567]).

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Dr. Quay will provide an update on Atossa’s lead program, (Z)-endoxifen, a highly potent Selective Estrogen Receptor Modulator (SERM) with dual mechanisms of action that may offer a differentiated solution for women in both prevention and treatment settings of breast cancer. This includes progress across multiple clinical studies and encouraging feedback recently received by regulatory advisors that could accelerate the Company’s path forward.

The live presentation will be webcast, with a replay available for approximately 90 days on the Company’s investor website: View Source

In addition, a 60-second video message from Dr. Quay previewing the presentation is now available here, offering a personal invitation to learn more of Atossa’s vision and upcoming catalysts.

Investors interested in scheduling meetings with Atossa management may do so through the HCW conference portal, via their HCW representative, or directly by contacting a Company representative.

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."

On August 28, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported financial results and clinical updates for H1, 2025 (Press release, Can-Fite BioPharma, AUG 28, 2025, View Source [SID1234655544]).

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Clinical & Development Milestones Achieved

Namodenoson Drug Candidate –

Pancreatic Cancer Phase 2a Study with Can-Fite’s Namodenoson Achieved Over 50% Enrollment Milestone

The Phase 2a study (NCT06387342) is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages (View Source).

Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients

Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.

Piclidenoson Drug Candidate –

Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia

The study headed by Dr. S. Thomas Carmichael, M.D., Ph.D., Professor and Chair Frances Stark Chair, Department of Neurology, Geffen School of Medicine at UCLA, utilized a vascular dementia mouse model with focal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model.

Vascular dementia is the second most common cause of dementia after Alzheimer’s disease, and caused by impaired blood flow to the brain, often due to stroke or chronic small vessel disease. There are no U.S. FDA approved therapies for this condition. Drugs that are used off-label, including donepezil or memantine, are used symptomatically or to address co-morbidities. Additionally, antihypertensives, antiplatelets, and statins are used to prevent further vascular damage, but none of these medications are disease-modifying. Nevertheless, due to an aging population and increasing diagnosis, the global market for Vascular Dementia is estimated at $6 billion as of 2025, with an expected CAGR of 5% through 2035.

Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile in hundreds of patients with Psoriasis and demonstrated anti-inflammatory activity in Phase 2 and Phase 3 clinical studies.

Financial Results

Revenues for the six months ended June 30, 2025 were $0.20 million, a decrease of $0.11 million, or 36.07%, compared to $0.31 million for the six months ended June 30, 2024. The decrease in revenues was mainly due to the recognition a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the six months ended June 30, 2025 were $3.03 million, an increase of $0.15 million, or 5.16%, compared to $2.88 million for the six months ended June 30, 2024. Research and development expenses for the first half of 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both Namodenoson and Piclidenoson.

General and administrative expenses for the six months ended June 30, 2025 were $2.07 million an increase of $0.54 million, or 35.47%, compared to $1.52 million for the six months ended June 30, 2024. The increase is primarily due to the increase in investors relationship expenses following one time project occurred during the first half of 2025. We expect that general and administrative expenses will remain at the same level through 2025.

Financial income, net for the six months ended June 30, 2025 was $0.02 million compared to $0.13 million for the six months ended June 30, 2024. The decrease in financial income, net was mainly due to lower income on short term deposits.

Net loss for the six months ended June 30, 2025 was $4.87 million compared with a net loss of $3.95 million for the six months ended June 30, 2024. The increase in net loss for the six months ended June 30, 2025 was primarily attributable to an increase in research and development expenses and an increase in general and administrative expenses.

As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million as compared to $7.88 million at December 31, 2024. The decrease in cash during the six months ended June 30, 2025 is mainly due to ongoing operations of the Company. On July 28, 2025, the Company completed a public offering for aggregate gross proceeds of $5 million.

The Company’s consolidated financial results for the six months ended June 30, 2025 are presented in accordance with US GAAP Reporting Standards.