iBio Announces Pricing of $50 Million Public Offering

On August 19, 2025 iBio, Inc. (Nasdaq: IBIO), an AI-driven innovator of precision antibody therapies, reported the pricing of an underwritten public offering (the "offering") of (i) pre-funded warrants to purchase 71,540,000 shares of iBio’s common stock (the "pre-funded warrants"), and (ii) accompanying Series G warrants representing the right to purchase (the "Series G warrants") (a) 35,770,000 shares of iBio’s common stock, or pre-funded warrants in lieu thereof, and (b) Series H warrants representing the right to purchase 35,770,000 shares of iBio’s common stock, or pre-funded warrants in lieu thereof (the "Series H warrants") (Press release, iBioPharma, AUG 19, 2025, View Source [SID1234655372]). The combined public offering price of one pre-funded warrant and one Series G warrant to purchase (1) one-half of a share of common stock, or a pre-funded warrant in lieu thereof, and (2) one Series H warrant to purchase one-half of a share of our common stock, or a pre-funded warrant in lieu thereof, which are being sold together but are immediately separable, is $0.699. The offering is expected to close on or about August 22, 2025, subject to satisfaction of customary closing conditions. All of the securities are being offered by iBio.

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The pre-funded warrants will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. The Series G warrants and Series H warrants will each be exercisable from their date of issuance and will have an exercise price equal to $0.70 per share of iBio’s common stock (or $0.699 per pre-funded warrant) and in the case of the Series G warrants, the accompanying Series H warrant. The Series G warrants will expire on the date that is the earlier of (i) 30 trading days following iBio’s public announcement, via a press release on a nationally recognized news wire or the filing of a Current Report on Form 8-K with the Securities and Exchange Commission (the "SEC"), that an Investigational New Drug Application ("IND") filed with the U.S. Food and Drug Administration, a Clinical Trial Notification filed with the applicable foreign governmental body in Australia, a Clinical Trial Application filed with the European Medicines Agency, or an equivalent submission filed with a foreign governmental body to initiate a clinical trial in any other foreign jurisdiction has been accepted or has otherwise gone into effect, as applicable (such public filing or announcement, the "Trial Initiation Milestone") and (ii) five years from the date of issuance. In addition, each Series G warrant will immediately expire in proportion to the extent that the corresponding pre-funded warrant held by a holder is exercised prior to the occurrence of the Trial Initiation Milestone (solely to the extent the proportion of the unexercised portion of the Series G warrant relative to the originally issued Series G warrant is greater than the proportion of the unexercised portion of the pre-funded warrant relative to the originally issued pre-funded warrant). When issued upon exercise of the Series G warrants, the Series H warrants will expire on the four-year anniversary of the closing date of this offering.

The estimated gross proceeds from the offering are expected to be approximately $50 million before deducting underwriting discounts and commissions and offering expenses. The pre-funded warrants and Series G warrants (and the Series H warrants upon exercise of the Series G warrants) may be exercised for cash or, in certain circumstances at the holder’s discretion, on a net exercise or "cashless" basis. If all of the Series G warrants sold in this offering and all of the Series H warrants underlying the Series G warrants were to be exercised in cash at their exercise price, we would receive additional gross proceeds of approximately $50 million, before deducting expenses and fees.

iBio intends to use the net proceeds received from the offering to advance its preclinical cardiometabolic programs, including IBIO-610, the myostatin and activin A bispecific, and IBIO-600 programs, through key development milestones, as well as to continue to progress its other preclinical pipeline assets, and the balance, if any, to fund iBio’s working capital requirements and for other general corporate purposes.

Leerink Partners acted as the lead bookrunner for the offering. LifeSci Capital and Oppenheimer & Co. acted as bookrunning managers. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as a financial advisor to iBio.

The offering is being made by iBio pursuant to a shelf registration statement on Form S-3 (File No. 333- 280680), as amended (the "registration statement"), initially filed with the SEC on July 3, 2024 and, which became effective on August 6, 2024. The offering is being made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may be obtained by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

Exact Sciences to Participate in September Investor Conferences

On August 19, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, AUG 19, 2025, View Source [SID1234655370]).

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Wells Fargo Healthcare Conference, Boston
Fireside chat on Wednesday, September 3, 2025 at 1:30 p.m. ET
Baird Global Healthcare Conference, New York
Fireside chat on Tuesday, September 9, 2025 at 10:50 a.m. ET
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Delcath Systems Announces First Patient Dosed in Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer

On August 19, 2025 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC) (Press release, Delcath Systems, AUG 19, 2025, View Source [SID1234655369]).

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The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will be conducted at more than 20 sites across the United States and Europe. Results from the trial’s primary endpoint, hepatic progression-free survival (hPFS), are anticipated by mid-2028, while overall survival (OS), a secondary endpoint, is expected in late 2028.

The company estimates that the total addressable market for liver-dominant mCRC receiving third-line treatment is between 6,000 and 10,000 patients annually in the United States. This market includes patients who present with significant liver disease burden, determined through radiological and clinical criteria. Delcath aims to provide a novel treatment option for this patient population with limited therapeutic alternatives.

"This milestone marks a significant advancement in our mission to address unmet needs in liver-dominant cancers," said Vojislav Vukovic, Chief Medical Officer of Delcath Systems, Inc. "Dosing the first patient in this Phase 2 trial is an exciting step toward exploring HEPZATO’s potential to provide a new treatment option for patients with metastatic colorectal cancer, building on its proven role in metastatic uveal melanoma."

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

On August 19, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the"Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors (Press release, ALX Oncology, AUG 19, 2025, View Source [SID1234655368]).

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"Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026."

The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial.

ALX2004: Optimized for Success Based on Rigorous Drug Design Process

Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload.

Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class

Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile.

LIXTE Biotechnology Holdings Provides Corporate Update

On August 18, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, reported an update on its recent activities (Press release, Lixte Biotechnology, AUG 18, 2025, View Source [SID1234655373]).

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"This has been a transformative period for our company," said Geordan Pursglove, who became LIXTE’s new Chairman and Chief Executive Officer in June. "Momentum has been energized on several fronts, including securing essential funding to support our ongoing clinical trials, and to pursue long-term growth opportunities to enhance shareholder value."

Added Bas van der Baan, President and Chief Scientific Officer, "We are especially proud of the recent publication in a leading medical journal, Nature, further validating the promise of our proprietary compound, LB-100, to treat ovarian and colorectal cancer. The recent formation of our medical advisory committee marks yet another strategic step toward our mission of developing and delivering effective solutions to patients battling cancer."

LIXTE’s clinical trials are underway for ovarian cancer at the M.D. Anderson Cancer Center and at Northwestern University, supported by GSK. The Company’s colorectal trial, supported by F. Hoffmann-La Roche, is being conducted at the Netherlands Cancer Institute.

Summary of Recent Corporate Activities:

● Completion of two financings: a private placement with accredited investors, raising aggregate gross proceeds to the Company of approximately $5 million, and a registered direct offering with accredited investors, raising aggregate gross proceeds to the Company of approximately $1.5 million. Proceeds will be used for general corporate purposes and working capital and allowed the Company to regain compliance for continued listing on the Nasdaq Capital Market.

● Management and Board changes: Geordan Pursglove was appointed Chairman and Chief Executive officer in June 2025, succeeding Bas van der Baan, who became President and Chief Scientific Officer. Jason Sawyer and Michael Holloway, MD, joined LIXTE’s Board as independent directors in July 2025, succeeding Stephen Forman, MD, and Yun Yen, MD, who were appointed to serve as members of a newly established Scientific Advisory Committee. Other committee members include Bas van der Baan and Board member René Bernards, PhD.

● Validation of LB-100: The medical journal Nature has published findings that validate LIXTE’s ongoing clinical trials with LB-100. A team led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, studied survival outcomes of patients treated with immune checkpoint blockade therapy. The study showed that patients having tumors with inactivating mutations in PPP2R1A – the major scaffold subunit of protein phosphatase 2A (PP2A) – had significantly better overall survival, compared with patients who did not have this mutation in their tumors. (View Source

● New Pre-Clinical trial: LIXTE has initiated a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LB-100. The study represents a new opportunity in cancer prevention.