Onconetix, Inc. Announces Receipt of Additional Notice from Nasdaq

Rhea-AI Summary

Onconetix (Nasdaq: ONCO) has received a Staff delisting letter from Nasdaq on April 24, 2025, due to failing to file its Annual Report (Form 10-K) for the fiscal year ended December 30, 2024. This violation follows a previous delisting notice from April 18, 2025, regarding non-compliance with the minimum bid price requirement of $1.00 per share.

The company has until May 1, 2025, to request a suspension stay, though approval isn't guaranteed. Onconetix, a commercial-stage biotechnology firm, specializes in men's health and oncology solutions. Their key products include:

• Proclarix® - An EU-approved in vitro diagnostic test for prostate cancer
• ENTADFI - An FDA-approved daily treatment combining finasteride and tadalafil for benign prostatic hyperplasia (BPH)

Positive

• FDA-approved ENTADFI product for BPH treatment in portfolio
• Owns Proclarix, an EU-approved diagnostic test for prostate cancer

Negative

• Received Nasdaq delisting notice for failing to file 2024 Form 10-K
• Non-compliant with Nasdaq minimum bid price requirement of $1.00
• Stock price remained below $1.00 from Nov 2024 to Jan 2025
• Risk of immediate stock suspension if stay request not granted by May 1, 2025

Insights

Securities Regulation Analyst

Onconetix faces Nasdaq delisting for failing to file 10-K, compounding previous minimum bid price violation, significantly threatening its exchange status.

Onconetix has received a second delisting notice from Nasdaq, this time for failing to file its Annual Report (Form 10-K) for fiscal year ended December 30, 2024, violating Listing Rule 5250(c)(1). This compounds a previous delisting letter (reported April 18, 2025) for failing to maintain the $1.00 minimum bid price requirement under Rule 5550(a)(2).

The company now faces a tight timeline - only until May 1, 2025 to request a stay of suspension. While such a request would temporarily pause any action during the hearing process, the press release explicitly acknowledges there's "no assurance that the Panel will grant the Company's request."

Missing regulatory filing deadlines is particularly concerning as it prevents investors from accessing crucial information about the company's performance and financial position. The press release offers no explanation for the delay, only stating the company "intends to file the Form 10-K as promptly as possible."

If delisted, Onconetix would likely move to over-the-counter markets, typically resulting in reduced liquidity, diminished institutional investment eligibility, and more challenging capital-raising conditions. For biotechnology companies commercializing products like Proclarix (prostate diagnostic) and ENTADFI (BPH treatment), maintaining exchange listing status is particularly important for accessing the capital needed to fund ongoing operations and development.

Cincinnati, OH, April 30, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (the “Company”) announced that it received a Staff delisting letter from The Nasdaq Capital Market (“Nasdaq”) on April 24, 2025 indicating that the Company’s failure to file its Annual Report on Form 10-K for the fiscal year ended December 30, 2024 is in violation of Nasdaq’s continued listing requirements under Nasdaq Listing Rule 5250(c)(1) (the “Rule”).
   
This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification.

 As previously reported in the Current Report on Form 8-K filed with the Securities and Exchange Commission (the “Commission”) on April 18, 2025, the Company received a Staff delisting letter from the Nasdaq Listing Qualifications Staff indicating that, based upon the closing bid price of the Company’s common stock, par value $0.00001 per share (“Common Stock”), from November 25, 2024 to January 10, 2025, the Company was no longer in compliance with the requirement for continued listing on The Nasdaq Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). As the Company is already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company has seven calendar days from the date of the Notice, or until May 1, 2025, to request a stay of the suspension, which request will stay the suspension of the Company’s securities pending the Panel’s decision. However, there can be no assurance that the Panel will grant the Company’s request for a stay pending the hearing process or any further extension following the hearing. The Company intends to file the Form 10-K as promptly as possible in order to regain compliance with the Rule.

About Onconetix, Inc.:

Onconetix 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 In Vitro Diagnostic Regulation (“IVDR”). We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com.

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

Why did Onconetix (ONCO) receive a delisting notice from Nasdaq on April 24, 2025?

Onconetix received a delisting notice because it failed to file its Annual Report (Form 10-K) for the fiscal year ended December 30, 2024, violating Nasdaq's continued listing requirement Rule 5250(c)(1).

What is the minimum bid price requirement that Onconetix (ONCO) failed to meet on Nasdaq?

Onconetix failed to maintain the minimum bid price requirement of $1.00 per share on The Nasdaq Capital Market, as required by Nasdaq Listing Rule 5550(a)(2), based on closing bid prices from November 25, 2024 to January 10, 2025.

How long does Onconetix (ONCO) have to request a stay of suspension from Nasdaq?

Onconetix has seven calendar days from April 24, 2025, until May 1, 2025, to request a stay of suspension pending the Panel's decision.

What are Onconetix's (ONCO) main products in its portfolio?

Onconetix owns Proclarix, an EU-approved in vitro diagnostic test for prostate cancer, and ENTADFI, an FDA-approved daily pill combining finasteride and tadalafil for treating benign prostatic hyperplasia (BPH).

What steps is Onconetix (ONCO) taking to maintain Nasdaq listing compliance?

Onconetix intends to file the Form 10-K as promptly as possible to regain compliance with Nasdaq's listing requirements, though there's no assurance the Panel will grant an extension following the hearing.