Onconetix announces its subsidiary, Proteomedix, licenses manufacturing IP to Immunovia enabling them to independently produce key reagents for their pancreatic cancer test PancreaSureTM
MWN-AI** Summary
Onconetix, Inc. (Nasdaq: ONCO), a biotechnology firm focused on men's health and oncology, has announced a significant licensing agreement through its subsidiary, Proteomedix AG, with Immunovia AB, a company specializing in pancreatic cancer diagnostics. The deal enables Immunovia to independently produce essential reagents for its PancreaSure™ test by obtaining master cells for three out of five biomarkers used in the test and a license for the corresponding manufacturing intellectual property. This strategic collaboration will enhance Immunovia's manufacturing capabilities, allowing it to procure reagents directly from Proteomedix.
Under the agreement’s financial terms, Immunovia will remit $700,000 to Proteomedix across 2025 and 2026, alongside a 3% royalty on net sales of the PancreaSure test and any other products developed using the licensed technology from 2026 to 2032. Beat Rheiner, CEO of Proteomedix, expressed pride in supporting the PancreaSure's development, emphasizing the test’s potential for earlier pancreatic cancer detection, which could lead to improved patient outcomes.
Onconetix is also prioritizing the market expansion of its own diagnostic test, Proclarix®, aimed at prostate cancer, which has been validated through several clinical studies and is CE-certified under the In Vitro Diagnostic Regulation in the EU.
However, the company remains aware of various risks related to the commercialization and market recognition of its products, as highlighted in their forward-looking statements. These include challenges in securing regulatory approvals, maintaining compliance with Nasdaq listing criteria, and managing third-party dependencies. Onconetix remains committed to navigating these factors as it advances its product offerings in the oncology space. For more information, visit www.onconetix.com.
MWN-AI** Analysis
Onconetix, Inc. (Nasdaq: ONCO) has recently made a strategic move by licensing its subsidiary, Proteomedix AG, with Immunovia AB to independently manufacture key reagents for the PancreaSure test, a significant diagnostic tool for pancreatic cancer. This partnership is expected to enhance Immunovia’s capabilities while generating revenue for Onconetix through upfront payments and ongoing royalties. The total of $700,000 in payments over the next two years, along with a 3% royalty on future sales, should bolster Onconetix's liquidity in the near term and provide a capital influx that can be redirected towards expanding its own product lines, particularly the prostate cancer test, Proclarix®.
From an investment standpoint, this development indicates a solid growth trajectory for Onconetix as it seeks to enhance its commercial offerings in the oncology market. The agreement not only strengthens its financial position but also positions it favorably within the competitive landscape of cancer diagnostics. Onconetix's ongoing commitment to Proclarix® further underscores its potential for revenue generation, as existing clinical studies validate its reliability in detecting clinically significant prostate cancer.
However, potential investors should be aware of associated risks, including regulatory hurdles, the need for capital to support commercialization efforts, and reliance on third-party suppliers for manufacturing. As stated in their forward-looking guidance, these factors could materially affect Onconetix's performance and market outlook. Given these considerations, investors should maintain a cautious but optimistic view. The current licensing deal could be a turning point for Onconetix, making it a compelling watch for those interested in the biotech sector, particularly if they can successfully leverage this partnership to enhance market penetration of Proclarix® and potentially bring additional diagnostic innovations to market.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
CINCINNATI, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) ("Onconetix" or the “Company”) a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology, today announced that its wholly owned subsidiary, Proteomedix AG (“Proteomedix”) has signed a licensing agreement, with Immunovia AB, a pancreatic cancer diagnostics company based in Lund, Sweden.
Under the terms of the agreement, Proteomedix will provide Immunovia with master cells required to produce antibodies related to three of the five biomarkers included in the PancreaSure test and a license for key intellectual property for the manufacturing of reagents used to measure these biomarkers, allowing Immunovia to purchase reagents directly from the supplier of Proteomedix.
In return, Immunovia will make payments totaling $700,000 to Proteomedix in 2025 and 2026, as well as pay a 3% royalty on net sales of PancreaSure and any other products incorporating the licensed intellectual property from 2026 to 2032.
“We are proud to have contributed to the development of PancreaSure and are excited to now support its manufacturing. Earlier detection of pancreatic cancer through PancreaSure gives patients real hope for better outcomes,” said Beat Rheiner, PhD, CEO of Proteomedix.” “At the same time, we remain focused on expanding the market penetration of our early prostate cancer detection test, Proclarix®.” said Karina Fedasz, Interim CEO of Onconetix.
About Onconetix, Inc .
Onconetix (Nasdaq: ONCO) is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the IVDR.
For more information, visit www.onconetix.com .
About Proclarix®
Proclarix ® is CE-certified under In Vitro Diagnostic Regulation (“IVDR”) and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix ® is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix ® risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix ® is included in both the European (EAU) and American (AUA) guidelines.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated results of or proceeds from the license to Immunovia) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on June 2, 2025 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Contact Information:
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101
Investor Contact Information:
Onconetix Investor Relations Email: investors@onconetix.com
FAQ**
What strategic benefits does Onconetix Inc. ONCO anticipate from the licensing agreement with Immunovia AB in relation to their commercial growth in oncology?
How does the partnership with Immunovia AB enhance Onconetix Inc. ONCO’s capability in developing and marketing the PancreaSure test?
Can Onconetix Inc. ONCO provide insight into their financial expectations from the $700,000 upfront payment and royalty structure under the licensing agreement with Immunovia AB?
What specific steps is Onconetix Inc. ONCO taking to expand the market for Proclarix® following this new licensing agreement with Immunovia AB?
**MWN-AI FAQ is based on asking OpenAI questions about Onconetix Inc. (NASDAQ: ONCO).
NASDAQ: ONCO
ONCO Trading
0.14% G/L:
$0.5077 Last:
141,046 Volume:
$0.47 Open:
