Onconetix Stock Price, News & Analysis

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)

Onconetix (NASDAQ: ONCO) has signed a non-binding Letter of Intent for a potential business combination with Ocuvex Therapeutics, a private biopharmaceutical company specializing in ophthalmic therapeutics. The proposed transaction would result in Ocuvex shareholders owning approximately 90% of Onconetix's equity interests.

Ocuvex brings an FDA-approved product, Omlonti®, for ocular hypertension and open-angle glaucoma, along with late-stage clinical assets. Onconetix currently owns Proclarix®, an in vitro diagnostic test for prostate cancer approved in the EU, and ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia.

The transaction completion is subject to due diligence, definitive agreement execution, adequate financing, and regulatory and stockholder approvals. There is no guarantee the transaction will be completed as proposed.

Onconetix (NASDAQ: ONCO) has announced successful clinical validation results for its prostate cancer test Proclarix® in a Danish cohort, presented at the 2025 European Association of Urology congress. The study, involving 808 patients with suspected prostate cancer, demonstrated Proclarix's superior performance compared to traditional diagnostic methods.

In a subgroup of 371 patients with enlarged prostates, Proclarix® showed significantly better results than existing tools, with only 5% probability of missing clinically significant cancer, compared to 14% for %fPSA and 20% for the ERSPC risk calculator. The test reduced unnecessary biopsies by 22% while missing only 3 out of 101 significant cancers.

In the broader study group of 654 patients with PSA levels of 2-20 ng/ml, Proclarix® achieved 96% sensitivity and significantly higher specificity compared to current diagnostic tools.

Onconetix (NASDAQ: ONCO) has announced that new clinical data for its prostate cancer test Proclarix will be presented at the 2025 European Association of Urology (EAU) congress in Madrid, Spain, from March 21-24, 2025.

The presentation, titled 'Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,' will showcase results from a study involving over 800 patients from Lillebaelt Hospital - University Hospital of Southern Denmark.

According to Ralph Schiess, PhD, CEO of Proteomedix (a wholly-owned subsidiary of Onconetix), Proclarix has demonstrated in multiple studies its ability to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer, while maintaining minimal risk of missing clinically significant cases compared to standard care.

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.

Onconetix, Inc. (Nasdaq: ONCO) has announced a $2.0 million private placement of Series C Convertible Preferred Stock and Warrants, along with establishing a $25 million equity line of credit. The private placement includes 3,499 shares of Series C Preferred Stock and warrants to acquire up to 591,856 additional common shares. The Series C Preferred Stock is initially convertible into 776,590 common shares. Warrants have an exercise price of $4.38 per share, exercisable after six months and expiring three years later.

The company will seek stockholder approval for the issuance of shares related to this transaction. Proceeds will be used for working capital and general corporate purposes. Tungsten Advisors served as financial advisor. The equity line of credit allows Onconetix to sell up to $25 million of newly issued common stock to an institutional investor, subject to certain conditions.

Onconetix, Inc. (NASDAQ: ONCO) announced the approval of all proposals at its 2024 Annual Meeting of Stockholders held on September 5, 2024. The company's Board of Directors approved a 1-for-40 reverse stock split of its outstanding common shares, effective September 24, 2024. Key approvals include:

1) Election of two Class III directors
2) Increase in shares under the 2022 Equity Incentive Plan
3) Authorization for reverse stock split
4) Approval of share issuances related to Series A and B Preferred Stock conversions, private placement financing, and Proteomedix AG stock option assumption
5) Approval of share issuances for inducement preferred investment options and placement agent warrants
6) Ratification of EisnerAmper LLP as independent auditor

The reverse split aims to regain compliance with Nasdaq's minimum bid price requirement. It will reduce the number of outstanding shares from approximately 30.2 million to 755,000.

Onconetix (Nasdaq: ONCO) has closed the previously announced exercise of existing warrants, raising $1.11 million in gross proceeds. The company issued 7,458,642 shares of common stock at a reduced exercise price of $0.15 per share. In exchange, Onconetix issued new unregistered warrants to purchase up to 22,375,926 shares of common stock in a private placement.

The new warrants have an exercise price of $0.15 per share and are subject to stockholder approval. One-third of the warrants have a 5-year term, while two-thirds have a 24-month term from the date of stockholder approval. H.C. Wainwright acted as the exclusive placement agent for this transaction.

Onconetix announced the exercise of existing warrants, leading to gross proceeds of $1.11 million. The company agreed to lower the exercise price of warrants issued in August 2022 and 2023 from $1.09-$2.546 per share to $0.15 per share. This transaction, handled by H.C. Wainwright & Co., is anticipated to close by July 12, 2024. Proceeds will be used for working capital and corporate purposes. In return, Onconetix will issue new unregistered warrants for 22,375,926 shares at $0.15 per share, pending stockholder approval within 90 days. The new warrants will have varying exercise terms of 24 months and five years.