Onconetix, Inc. Announces Receipt of Notice from Nasdaq Regarding Late Filing of Quarterly Report on Form 10-Q and Subsequent Filing

Rhea-AI Summary

Onconetix (NASDAQ: ONCO) received a notice from Nasdaq on December 6, 2024, regarding its failure to file the Q3 2024 Form 10-Q, which violated Nasdaq's continued listing requirements. The company subsequently filed the required report on December 10, 2024.

Onconetix is a commercial-stage biotechnology company specializing in men's health and oncology. The company owns Proclarix®, an EU-approved in vitro diagnostic test for prostate cancer acquired through Proteomedix, and ENTADFI, an FDA-approved daily medication combining finasteride and tadalafil for benign prostatic hyperplasia (BPH) treatment.

Positive

• FDA-approved product ENTADFI in portfolio
• EU-approved Proclarix® diagnostic test for prostate cancer
• Prompt resolution of filing delay within 4 days

Negative

• Violation of Nasdaq listing requirements due to late Q3 2024 filing
• Risk of potential delisting if compliance issues persist

Insights

Financial Analyst

The late filing of Form 10-Q and subsequent Nasdaq notice raises significant governance concerns for this $4.5M market cap biotech company. While the company has now filed the required document, such delays often indicate internal control issues or potential financial challenges that warrant investor attention. For a commercial-stage company with EU-approved Proclarix® and FDA-approved ENTADFI in its portfolio, maintaining timely financial reporting is important for market confidence. The prompt resolution through filing suggests management's commitment to compliance, but investors should scrutinize the delayed 10-Q for any underlying issues that may have caused the late submission. The small market cap and reporting delay combination could impact investor confidence and liquidity in the near term.

Legal Expert

The Nasdaq notice under Rule 5250(c)(1) represents a serious compliance matter, though the company's swift filing of the Form 10-Q within days of receiving the notice demonstrates responsive remediation. The prompt disclosure of the deficiency notification complies with Nasdaq Listing Rule 5810(b), showing proper regulatory adherence. While the immediate compliance risk appears resolved, this incident could trigger increased regulatory scrutiny and potentially impact the company's relationship with Nasdaq. The quick resolution likely prevents more severe consequences such as potential delisting proceedings, but shareholders should monitor future filings for timeliness to ensure this doesn't become a pattern that could threaten the company's listing status.

Cincinnati, OH, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Onconetix, Inc. (NASDAQ: ONCO) (the “Company”) announced that it received a letter from The Nasdaq Capital Market (“Nasdaq”) on December 6, 2024 indicating that the Company’s failure to file its Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”) is in violation of Nasdaq’s continued listing requirements under Nasdaq Listing Rule 5250(c)(1) (the “Rule”).

On December 10, 2024, the Company filed the Form 10-Q with the Securities and Exchange Commission.  

This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification.  

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 recent 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

What caused Onconetix (ONCO) to receive a Nasdaq notice in December 2024?

Onconetix received a Nasdaq notice on December 6, 2024, due to failing to file its Q3 2024 Form 10-Q, violating Nasdaq Listing Rule 5250(c)(1).

When did Onconetix (ONCO) resolve its Nasdaq filing compliance issue?

Onconetix resolved the compliance issue by filing its Q3 2024 Form 10-Q on December 10, 2024, four days after receiving the Nasdaq notice.

What are the main products in Onconetix's (ONCO) portfolio as of December 2024?

Onconetix's main products include Proclarix®, an EU-approved prostate cancer diagnostic test, and ENTADFI, an FDA-approved medication for benign prostatic hyperplasia (BPH).

Is Proclarix® approved for use in the United States?

According to the press release, Proclarix® is only mentioned as being approved for sale in the European Union under the In Vitro Diagnostic Regulation (IVDR), with no mention of US approval.