On August 19, 2025 Incyte (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of September (Press release, Incyte, AUG 19, 2025, View Source [SID1234655386]):

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Cantor Global Healthcare Conference on Wednesday, September 3, 2025 at 8:00 am (EDT)
Well Fargo Healthcare Conference on Thursday, September 4, 2025 at 8:45 am (EDT)
Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9, 2025 at 10:00 am (EDT)
The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

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.

On August 19, 2025 VantAI, the leader in generative AI for proximity drug discovery, and Halda Therapeutics, the pioneer of RIPTAC (Regulated Induced Proximity Targeting Chimeras) therapeutics, reported a strategic research collaboration worth over $1 billion in total potential value, inclusive of upfront and milestone payments across multiple targets (Press release, Halda Therapeutics, AUG 19, 2025, View Source [SID1234655387]). This landmark alliance combines two category-defining platforms to accelerate the discovery and development of selective proximity-based therapies across cancer and immunology indications. The agreement includes upfront payments, research support, success-based development and commercial milestones, and tiered royalties on net sales, with a path to expand the collaboration over time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Under the partnership, VantAI will leverage its Neo-1 foundation model and NeoLink high-throughput structural proteomics platform to rapidly identify and validate novel, context-specific target–effector pairs. These pairs—across both oncology and immunology—will feed directly into Halda’s proprietary RIPTAC development pipeline, which harnesses a distinctive "hold-and-kill" mechanism to achieve potent, cell-selective effects in disease-relevant tissues. By pairing Halda’s validated modality with VantAI’s AI-driven rational drug design engine, the partnership is poised to deliver the next generation of selective, proximity-based therapeutics tailored to disease-specific signatures.

"Induced proximity is poised to unlock a new and exciting chapter of medicine, including but also beyond protein degradation," said Zachary Carpenter, Co-Founder and CEO of VantAI. "Halda is leading this next wave, already demonstrating its potential in the clinic. Together, we’re advancing a new generation of RIPTACs—leveraging the unique properties of this modality to address previously inaccessible targets, with the potential to meaningfully impact patients underserved by current treatment options."

"VantAI’s proprietary platform enables the systematic rewiring of protein interactions with precision," said Christian Schade, President and CEO of Halda Therapeutics. "By pairing Halda’s novel RIPTAC modality with VantAI’s AI-driven rational drug design engine, the partnership will complement platform discovery efforts and will help deliver the next generation of selective, proximity-based therapeutics tailored to disease-specific signatures." Halda’s lead candidate, HLD-0915, is currently advancing through Phase 1/2 clinical trials in metastatic castration-resistant prostate cancer (mCRPC).

On August 19, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Tumor Treating Fields (TTFields) for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial (Press release, Zai Laboratory, AUG 19, 2025, View Source [SID1234655388]). The Innovative Medical Device Designation allows Zai Lab to take advantage of an expedited approval procedure for TTFields that offers opportunities for the NMPA to prioritize the allocation of review resources to expedite the regulatory review and approval process.

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"We are excited that TTFields has been granted the Innovative Medical Device Designation, a status that offers expedited registration and priority review by the NMPA. This designation also allows us to submit the application in China before approval in the country of origin," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. We are on track to submit for regulatory approval in China in the second half of 2025 and look forward to collaborating closely with the NMPA throughout the review process."

The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau and Taiwan, collectively).

In August 2019, the NMPA granted Innovative Medical Device Designation for Optune in China for the treatment of newly diagnosed and recurrent glioblastoma (GBM). Zai Lab subsequently submitted the regulatory application in September 2019 and received approval in May 2020. Optune is a registered trademark of Novocure GmbH, and Zai Lab markets Optune under license from Novocure GmbH.

About PANOVA-3

PANOVA-3 is an international prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of TTFields therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer in China

Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases and 131,203 cancer deaths in 2022, and it is the sixth leading cause of cancer mortality in China1. Pancreatic cancer has a 5-year survival rate of less than 10%, making it the malignancy with the lowest survival rate in China 2.

The patients with locally advanced, unresectable pancreatic cancer are no longer operable, so chemotherapy with or without radiation is the only treatment option, with a median overall survival only nine to twelve months.

1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590.

2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) is a cancer therapy that uses electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibitors, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effects on cancer cells, visit tumortreatingfields.com.

On August 19, 2025 BerGenBio ASA (OSE: BGBIO reported financial results for the first half 2025 (Press release, BerGenBio, AUG 19, 2025, View Source [SID1234655374]).

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Highlights, including post period:

In February, following a preliminary analysis of response data, BerGenBio decided to close its lead clinical study, BGBC016, in bemcentinib in combination with standard of care therapy in first line (1L) non-squamous Non-Small Cell Lung Cancer (NSCLC) patients with a mutation in the STK11 gene.
The company has implemented significant cost-containment and cash-conservation measures. The Board of Directors has also decided to halt all remaining development activities for bemcentinib.
In June, the company entered into a merger agreement with Oncoinvent ASA.
The transaction combines BerGenBio’s capital resources and listing with Oncoinvent’s late-stage oncology pipeline, strengthening the combined company’s ability to advance innovative radiopharmaceutical cancer therapies.
The merger was approved by an Extraordinary General Meeting 4 August 2025 and is expected to be completed by end of September.
In connection with the merger, the EGM approved a fully underwritten rights issue of NOK 130 million. The funding has been committed by existing investors in Oncoinvent ASA and external investors and is expected to be completed in October after completion of the merger. All shareholders in the combined company will receive equal rights to participate in the rights issue depending on their shareholdings.
At time of the completion of the merger the Board of Directors and management will change. The Board of Directors will exist of the current Board of Directors in Oncoinvent ASA with the addition of Olav Hellebø and the executive management will consist of the current Oncoinvent ASA management. The current Board of Directors and Executive management of BerGenBio will leave their position at the same time.
The EGM also approved changing the name of BerGenBio ASA to Oncoinvent ASA, effective upon completion of the merger and the rights issue.

Olav Hellebø, Chief Executive Officer of BerGenBio stated:

"The first half of 2025 has been one of the most defining periods in BerGenBio’s history. After the decision to discontinue the BGBC016 trial, we conducted a comprehensive strategic review to identify the best way forward for our shareholders. This resulted in the proposed merger with Oncoinvent, a company with an exciting trajectory in radiopharmaceutical cancer therapies, experienced leadership, and strong growth prospects."

"As part of the transaction approved after the end of the first half, a fully underwritten rights issue was also approved, open to all shareholders on equal terms and offering the opportunity to participate in this next stage. The proposed merger and rights issue marks the closure of an important chapter in BerGenBio’s journey and the beginning of a new phase for its shareholders."

"Biotechnology is a unique industry. It demands optimism, courage, and years of dedicated effort, yet ultimately everything depends on clinical results and patient benefit. I would like to sincerely thank our shareholders for their support over the years, and particularly those who have been with us for a long time. Your commitment has been essential in enabling BerGenBio to pursue bold scientific ambitions, even in the knowledge that success is never guaranteed."

First half 2025 Financial Highlights

The operating loss for the first half was NOK 54.6 million (first half 2024: NOK 90.5 million).
Net cash flow for the first half was negative by NOK 73.9 million (first half 2024: negative by NOK 89.3 million).
Cash and cash equivalents amounted to NOK 65.9 million as of 30 June 2025 (140.2 million as of 31 December 2024).

Financial Report

The H1 2025 Financial report is attached to this stock exchange announcement and will be available at the Company’s website: View Source