Albumin-Bound Paclitaxel

CAMBRIDGE, Mass., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced that it has entered into a definitive securities purchase agreement for a private placement of securities to top-tier institutional and other accredited investors, that is expected to result in up front gross proceeds to the Company of approximately $25 million, before deducting fees and expenses. The closing of the private placement is subject to customary closing conditions and is expected to occur on or about August 26, 2025. “We are excited to announce updated Overall Survival (OS) and Progression-Free Survival (PFS) data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients, planned in the coming weeks. In June, we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our exceptional 6-month overall survival data in first-line pancreatic cancer patients generated strong interest from leading pharmaceutical companies and top-tier investors, including the visionary investors participating in today’s financing. We are developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, which we believe represent an important new way to keep cancer patients alive and help them thrive. The proceeds from this financing will help support our ongoing efforts to bring atebimetinib, our Deep Cyclic Inhibitor of MEK in the MAPK pathway, to as many cancer patients as possible as quickly as possible.” Under the securities purchase agreement, the investors agreed to purchase: (i) an aggregate of 6,329,113 unregistered shares of the company’s Class A common stock at a purchase price of $3.95 per share (or, for certain investors in lieu of Class A common stock, pre-funded warrants to purchase shares of Class A common stock), and (ii) accompanying purchase warrants to purchase an aggregate of 2,848,096 shares of Class A common stock, with each such warrant representing the right to purchase one share of the company’s Class A common stock at an exercise price of $5.50 per share. The pre-funded warrants were issued for a purchase price equating to $3.949 per pre-funded warrant share (which was the per share purchase price for the Class A common stock less the $0.001 per share unfunded exercise price for each pre-funded warrant). The $3.95 per share purchase price for the Company’s Class A common stock represents a premium of approximately 15% as compared to the Company’s last reported closing price on August 20, 2025. The investors will be granted registration rights as part of the transaction. The purchase warrants will be exercisable for a period of five years following the date on which the Class A common stock issued and issuable in the transaction are registered for resale. The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or other jurisdiction. About Immuneering Corporation Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents, including modified Gemcitabine/nab-paclitaxel (mGnP); the expected amount and use of proceeds from this financing; and the timing for release of additional results from the Phase 2a portion of the trial for atebimetinib. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Gina Nugent Gina.nugent.external@immuneering.com Investor Contact: Laurence Watts 619-916-7620 laurence@newstreetir.com

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 19, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced 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. 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. “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. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for developing and commercializing TTFields therapy, the potential benefits of TTFields therapy, and the potential treatment of pancreatic cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20250819525540/en/ For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited