Onconetix, Inc. - BWV STOCK NEWS

Blue Water Biotech announced the appointment of Dr. Jay Newmark as Chief Medical Officer on April 26, 2023. Dr. Newmark, a board-certified urologist with over 30 years of experience, will support the launch of ENTADFI®, an FDA-approved treatment for benign prostatic hyperplasia (BPH). This medication aims to counteract negative sexual side effects associated with alternative BPH therapies. Dr. Newmark previously served as CMO at Clarus Therapeutics and has significant experience in product development in Men's Health. His appointment is seen as pivotal for Blue Water's commercial strategy surrounding ENTADFI®, which combines finasteride and tadalafil, providing a preferred treatment option for BPH symptoms. The product has demonstrated superior effectiveness and a favorable safety profile in clinical trials.

Blue Water Biotech announced its participation in the American Urological Association Annual Meeting 2023 from April 28 to May 1 in Chicago. Management, including CEO Joseph Hernandez, will promote ENTADFI®, an FDA-approved treatment for benign prostatic hyperplasia (BPH). They will discuss the upcoming launch strategy and highlight ENTADFI®'s benefits over traditional therapies. Presently, approximately 50% of men over 50 and 90% of those over 85 experience BPH, with 70% facing erectile dysfunction. In 2022, around 44 million prescriptions related to BPH were issued. ENTADFI® is a once-daily oral treatment combining finasteride and tadalafil, aiming to alleviate BPH symptoms with a lower incidence of sexual side effects compared to finasteride alone. The company is transitioning to a commercial-stage biotechnology firm.

Blue Water Vaccines Inc. has announced a corporate name change to Blue Water Biotech following its acquisition of ENTADFI®, an FDA-approved treatment for benign prostatic hyperplasia (BPH). This transition marks the company’s evolution into a commercial-stage biotechnology firm. CEO Joseph Hernandez emphasized the potential of ENTADFI® in generating revenue within the BPH market while also highlighting the robustness of the management team, led by seasoned marketing executive Frank Jaeger. In addition to ENTADFI®, the company is advancing multiple vaccine candidates, including a Streptococcus pneumoniae vaccine targeting acute otitis media and a universal influenza vaccine. Blue Water's common stock continues trading under the ticker symbol BWV.

Blue Water Vaccines (BWV) has signed an Asset Purchase Agreement with Veru to acquire ENTADFI®, an FDA-approved treatment for benign prostatic hyperplasia (BPH). The total consideration for the purchase is $100 million, consisting of $20 million upfront and up to $80 million based on sales milestones. ENTADFI® combines finasteride and tadalafil, addressing BPH symptoms while minimizing sexual side effects. Blue Water aims to leverage its experienced management to optimize sales and marketing of ENTADFI® and expand its operations beyond vaccines, reflecting a broader pharmaceutical focus. The corporate name will change to Blue Water Biotech to align with this strategic shift. A conference call is scheduled for April 20, 2023, to discuss the acquisition and future strategies.

Blue Water Vaccines Inc. (BWV) announced a Sponsored Research Agreement with The University of Texas Health Science Center at San Antonio to fund a non-human primate study of BWV-401, a novel Chlamydia vaccine. This follows an exclusive licensing agreement with UT Health in November 2022. BWV-401, delivered orally, has shown promise in mouse models by preventing Chlamydia without disturbing gut microbiota. The upcoming NHP study aims to confirm its safety and efficacy, addressing a significant public health need, as Chlamydia remains the most reported bacterial STI in the U.S. and globally. The study’s success could lead to human clinical trials, bolstering BWV's position in the vaccine market.

Blue Water Vaccines (BWV) reported its financial results for the fiscal year ending December 31, 2022. The company had a cash position of $25.8 million, significantly up from $1.9 million in 2021, primarily due to a successful IPO and private placements that raised about $32.7 million. However, BWV reported a net loss of approximately $13.4 million, an increase from $3.4 million in 2021. Research and development expenses grew by $2.8 million largely due to preclinical activities. BWV expanded its vaccine candidates, including a Chlamydia vaccine and collaboration for monkeypox and Marburg virus vaccine development. The company aims to positively impact public health.

Blue Water Vaccines Inc. (BWV) has appointed Frank Jaeger as Senior Vice President of Marketing and Business Development, bringing over 25 years of biopharmaceutical experience. Jaeger has a strong track record from R&D to commercialization, having previously transformed Clarus Therapeutics into a commercial entity and contributed to launching its first asset in under five months. His leadership at AbbVie resulted in the successful launch of AndroGel, doubling its sales to $1.3 billion. BWV aims to leverage Jaeger’s expertise as it advances its vaccine pipeline, including candidates for flu, norovirus, and pneumococcus.

Blue Water Vaccines (BWV) announced a collaboration with AbVacc Inc. for vaccine development against monkeypox and Marburg virus disease (MVD). Both candidate vaccines will utilize BWV's virus-like particle platform, allowing for multiple antigens to be presented. The partnership aims to optimize vaccine designs and conduct preclinical studies. Notably, MVD has high fatality rates and no approved vaccines, highlighting the collaboration's significance. Additionally, there are about 30,000 reported cases of monkeypox in the U.S., and existing vaccines have limited availability, further emphasizing the need for new developments.

Blue Water Vaccines (BWV) announced the appointment of Timothy Ramdeen to its board of directors. Ramdeen brings nearly a decade of experience in private equity, capital markets, and company formation. He has held key positions at Dharma Capital Advisors and Sixth Borough Capital Management, focusing on both private and public equities. His background includes significant work in healthcare investments and company development. Chairman and CEO Joseph Hernandez expressed confidence that Ramdeen's expertise will enhance BWV's growth and presence in the biotechnology sector.