ONCO (Onconetix, Inc.) PDUFA Date | FDA Catalyst & Approval Status

Jul 7, 2026

Onconetix Highlights Realbotix Partnership with Bloom Services to Launch UK Pilot Using Humanoid Robots to Combat Elderly Social Isolation

Onconetix has highlighted a partnership between Realbotix and Bloom Services to launch a pilot program in Northeast England. The initiative will deploy humanoid robots designed to improve the wellbeing of elderly residents by providing companionship and cognitive stimulation. This program aims to supplement human caregivers and will assess its impact on loneliness and quality of life.

Onconetix Highlights Realbotix’s Launch of Humanoid Robot and AI Teachers Assistant Pilot Program in New York State School District

Onconetix, Inc. has highlighted Realbotix's launch of the Optio AI-powered teacher's assistant in a pilot program at Salamanca City Central School District. The initiative aims to enhance educational engagement for approximately 500 high school students by deploying both Optio and a Realbotix M-Series humanoid robot. Onconetix is also in the process of acquiring Realbotix LLC, with the transaction expected to close in the latter half of 2026.

Onconetix, Inc. Announces 1-for-10 Reverse Stock Split

Onconetix, Inc. has announced a 1-for-10 reverse stock split effective May 21, 2026, to comply with Nasdaq's minimum bid price requirement. The decision follows stockholder approval for a reverse split ratio between 1-for-2 and 1-for-10. This move will reduce outstanding shares significantly while maintaining the same ownership percentage for shareholders.

May 13, 2026

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Onconetix Reports Q1 2026 Progress at Proteomedix AG, Including Two New Peer-Reviewed Publications and Initiation of U.S. Validation Study

Onconetix, Inc. reported significant progress in Q1 2026 through its subsidiary Proteomedix AG. The company highlighted two peer-reviewed publications that validate the effectiveness of its Proclarix® test in reducing unnecessary prostate cancer biopsies. Additionally, the PRIME study has been initiated in collaboration with Labcorp to further assess Proclarix® in the U.S. market. The company is also expanding its commercial presence in Europe.

Onconetix Highlights Realbotix's Launch of Vinci AI Vision System with Delivery of First Vinci-Equipped Humanoid Robot to Ericsson

Onconetix, Inc. announced the delivery of the first Vinci-equipped humanoid robot by Realbotix to Ericsson. Vinci, an AI vision system, enables robots to recognize users and track engagement. Onconetix is in the process of acquiring Realbotix, which is expected to enhance its offerings in innovative oncology solutions. The acquisition is pending shareholder and regulatory approvals.

Apr 2, 2026

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Onconetix Highlights Realbotix AI Humanoid Robot Delivery Update

Onconetix has announced its acquisition of Realbotix LLC, which is set to deliver 19 AI humanoid robots between March and May 2026. This acquisition aims to enhance Onconetix's capabilities in innovative oncology solutions. The transaction is expected to close in the second half of 2026, pending shareholder and regulatory approvals.

Mar 31, 2026

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Onconetix Appoints David White as Chief Executive Officer and Sammy Dorf as Member of the Board of Directors

Onconetix, Inc. has appointed David White as its new CEO and Sammy Dorf to its Board of Directors as it advances its acquisition of Realbotix LLC. David White brings over 30 years of executive experience across various sectors, indicating a potential for strong leadership. Sammy Dorf's track record in building and scaling businesses suggests he will contribute significantly to Onconetix's growth strategy. Both appointments reflect the company's commitment to creating shareholder value amid a significant acquisition.

Mar 25, 2026

Onconetix Highlights Realbotix’s Role in Ericsson’s World-First 6G Trial Demonstration

Onconetix announced its pending acquisition of Realbotix, which recently showcased its humanoid robot in Ericsson's first 6G trial. The robot served as a live endpoint, demonstrating the potential of next-gen networks for AI-driven technologies. This acquisition is anticipated to enhance Onconetix's offerings in the biotechnology sector.

Mar 23, 2026

Onconetix, Inc. Announces 1-for-5 Reverse Stock Split

Onconetix, Inc. has announced a 1-for-5 reverse stock split effective March 25, 2026, following stockholder approval. This decision aims to ensure compliance with Nasdaq's minimum bid price requirement. The reverse split will reduce the number of outstanding shares from approximately 3.6 million to 0.7 million, while the company's stock will continue trading under the symbol 'ONCO'.

Feb 12, 2026

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Onconetix to Acquire Realbotix LLC, USA-based, AI-Powered Humanoid Robotics Company

Onconetix, Inc. has announced its acquisition of Realbotix LLC, a leader in AI-powered humanoid robotics, in an all-stock transaction. The deal, which has been unanimously approved by both companies' boards, aims to enhance Onconetix's strategic direction and shareholder value. Realbotix's technology allows its robots to operate autonomously in various public venues. The transaction is expected to close in the second half of 2026, pending regulatory approvals.

Onconetix Announces Financing Through a $12.9 Million Private Placement of Series D Preferred Stock and Warrants, Termination of Merger Agreement with Ocuvex, Inc. and Settlement of $8.8 Million Debt with Veru, Inc.

Onconetix, Inc. has successfully completed a private placement financing of approximately $12.9 million, which will be used to settle debts and cover operational costs. The company also terminated its merger agreement with Ocuvex, Inc. and settled an $8.8 million debt with Veru, Inc. The financing includes convertible preferred stock and warrants for future stock purchases.

Sep 26, 2025

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Joint Press Release: Onconetix and Ocuvex Announce Mutual Termination of Merger Agreement

Onconetix and Ocuvex have mutually terminated their merger agreement, deciding to pursue independent paths. This decision was made after careful consideration and reflects both companies' commitment to their missions. Ocuvex is preparing for the commercial launch of Omlonti, having received its New Jersey state pharmaceutical license. Both organizations expressed appreciation for the professionalism shown during the discussions.

Sep 22, 2025

Onconetix announces its subsidiary, Proteomedix, licenses manufacturing IP to Immunovia enabling them to independently produce key reagents for their pancreatic cancer test PancreaSureTM

Onconetix's subsidiary, Proteomedix, has entered into a licensing agreement with Immunovia to enable the independent production of key reagents for the PancreaSure pancreatic cancer test. Under the agreement, Immunovia will pay Proteomedix $700,000 and a 3% royalty on future sales. This collaboration aims to enhance the early detection of pancreatic cancer, offering hope for improved patient outcomes.

Jul 16, 2025

Onconetix and Ocuvex Therapeutics announce execution of definitive merger agreement

Onconetix and Ocuvex Therapeutics have announced a definitive merger agreement, with Onconetix acquiring all equity interests of Ocuvex. This merger aims to enhance Onconetix's portfolio with Ocuvex's ophthalmic assets and provide access to public capital markets. The transaction has been approved by both companies' boards and is expected to close in Q4 2025, pending regulatory and stockholder approvals.

Jul 16, 2025

JULY 16, 2025 Onconetix and Ocuvex Therapeutics announce execution of definitive merger agreement CINCINNATI

Onconetix, Inc. (ONCO) and Ocuvex Therapeutics, Inc. have executed a definitive merger agreement aimed at integrating Ocuvex's ophthalmic product pipeline with Onconetix's resources. The boards of both companies have approved the transaction, which will result in Ocuvex equity holders receiving 90% of the shares in the newly formed entity. However, the transaction hinges on various regulatory approvals, and there are no guarantees that it will finalize as envisioned. The deal is expected to close in the fourth quarter of 2025, subject to customary conditions and adjustments.

Jun 16, 2025

ONCOFDA Updates

Onconetix, Inc. Announces Positive Decision by Nasdaq Hearings Panel

Onconetix, Inc. has received a positive decision from the Nasdaq Hearings Panel, allowing it to continue its listing on the Nasdaq Stock Market. The company has demonstrated compliance with the Periodic Filing Listing Rule and completed a reverse stock split. Onconetix is expected to meet the Bid Price Listing Rule by the end of June 2025.

Jun 11, 2025

Onconetix, Inc. Announces 1-for-85 Reverse Stock Split and Results of the Special Meeting of Stockholders

Onconetix, Inc. announced a 1-for-85 reverse stock split approved by stockholders at a special meeting. This action aims to help the company comply with Nasdaq's minimum bid price requirement. The reverse split will reduce outstanding shares significantly while maintaining stockholder ownership percentages. The company continues its focus on innovative health solutions.

May 22, 2025

ONCOFDA Updates

Onconetix, Inc. Announces Receipt of Additional Notice from Nasdaq

Onconetix, Inc. has received a delisting notice from Nasdaq due to its failure to file required financial reports. The company is currently facing compliance issues related to its stock price and has requested a hearing to address these concerns. Onconetix aims to file its overdue reports promptly to regain compliance with Nasdaq listing requirements.

Apr 8, 2025

Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex Therapeutics, Inc.

Onconetix, Inc. has signed a Non-Binding Letter of Intent to explore a potential business combination with Ocuvex Therapeutics, Inc. This merger aims to expand Onconetix's portfolio beyond oncology by leveraging Ocuvex's ophthalmic assets. The transaction is contingent upon due diligence, financing, and regulatory approvals, with no assurance of completion.

Mar 24, 2025

ONCOPhases

Onconetix Announces Successful Clinical Validation of its Innovative Prostate Cancer Test Proclarix in a Danish cohort

Onconetix has announced the successful clinical validation of its prostate cancer test, Proclarix, presented at the 2025 EAU congress. The test demonstrated high sensitivity and specificity, outperforming traditional diagnostic methods and significantly reducing unnecessary biopsies. Proclarix is CE-certified and aims to enhance prostate cancer diagnosis, particularly in patients with elevated PSA levels.

Mar 19, 2025

Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress

Onconetix, Inc. has announced that an abstract demonstrating the clinical performance of its Proclarix test for prostate cancer has been accepted for presentation at the 2025 European Association of Urology congress in Madrid, Spain. This presentation will highlight how Proclarix effectively rules out clinically insignificant or absent prostate cancer in a cohort from Lillebaelt Hospital-Danish patients. The Proclarix test, CE-certified under In Vitro Diagnostic Regulation, is designed to minimize unnecessary biopsies while accurately identifying significant prostate cancer cases. It is expected to be marketed in the U.S. as a lab-developed test through a partnership with Labcorp.

Feb 28, 2025

Onconetix, Inc. Consulting Agreement This Consulting Agreement (the "Agreement"), shall be effective as of

Onconetix, Inc. has entered into a consulting agreement with James Sapirstein, who will serve as the Executive Chairman. The agreement is effective from February 28, 2025, for a duration of one year, with the possibility of renewal. Sapirstein will provide strategic guidance, oversee compliance, and engage with stakeholders. However, compensation is contingent upon the company securing sufficient capital, raising concerns about the financial stability of the arrangement.

Jan 15, 2025

SETTLEMENT AGREEMENT This Settlement Agreement (the " Settlement Agreement ") is entered into as of

Onconetix, formerly known as Blue Water Vaccines, has entered into a Settlement Agreement with IQVIA regarding a financial dispute. Onconetix acknowledges a total balance owed of approximately $1.1 million, which includes unpaid invoices and an early termination fee. The agreement allows Onconetix to pay a reduced settlement amount of $150,000 to resolve the claims without an admission of liability. Both parties have agreed to confidentiality regarding the terms of the settlement.

Dec 12, 2024

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

Onconetix, Inc. announced receiving a notice from Nasdaq regarding the late filing of its Quarterly Report on Form 10-Q for the period ended September 30, 2024. The notification indicates a violation of Nasdaq's continued listing requirements. On December 10, 2024, the company complied by filing the overdue Form 10-Q with the Securities and Exchange Commission. This action adheres to Nasdaq’s rules on prompt disclosure of deficiencies.

Oct 3, 2024

Onconetix Announces Financing Through a $2.0 Million Private Placement of Series C Preferred Stock and Warrants, Establishes a $25 Million Equity Line of Credit

Onconetix, Inc. has announced a successful $2.0 million private placement of Series C Convertible Preferred Stock and warrants to bolster its capital. Additionally, the company secured a $25 million equity line of credit, allowing it to sell newly issued shares to an institutional investor under certain conditions. The proceeds will be utilized for working capital and general corporate purposes. These moves are seen as a positive step for the company's financial health and operational growth.

Sep 20, 2024

Onconetix, Inc. Announces 1-for-40 Reverse Stock Split and Results of the Annual Meeting of Stockholders

Onconetix, Inc. announced the results of its 2024 annual meeting, where stockholders approved all proposals, including a 1-for-40 reverse stock split effective September 24, 2024. This measure aims to help the company maintain compliance with Nasdaq's minimum bid price requirement. Additionally, stockholders approved an increase in share availability under the company's equity incentive plan. The company is focused on innovative solutions for men's health and oncology, continuing its efforts to commercialize its products.

Sep 5, 2024

Onconetix, Inc. (formerly known as Blue Water Biotech, Inc. and Blue Water Vaccines Inc.) (the "Company" or "Onconetix") was formed on

Onconetix, Inc. has completed a Share Exchange Agreement to acquire Proteomedix AG, making it a wholly owned subsidiary. The agreement involves Onconetix issuing shares valued at approximately $75 million to acquire all equity interests in Proteomedix. Despite this significant development, Onconetix reported a net loss of $25 million in its latest financial results. Additionally, the agreement includes plans for a reverse stock split, raising concerns among investors.

Jul 15, 2024

Onconetix Announces Closing of Warrant Exercise for $1.11 Million Gross Proceeds

Onconetix, Inc. announced the successful closing of a warrant exercise, generating $1.11 million in gross proceeds. The company exercised existing warrants at a reduced price and plans to use the net proceeds for working capital. In addition, Onconetix issued new unregistered warrants pending stockholder approval, which could further enhance their funding. The company continues its focus on men's health and oncology, emphasizing its products like Proclarix and ENTADFI.

Jul 11, 2024

Onconetix Announces Exercise of Warrants for $1.11 Million Gross Proceeds

Onconetix, Inc. has announced the immediate exercise of existing warrants, generating approximately $1.11 million gross proceeds. The exercise price for 7,458,642 shares of common stock is set at $0.15 per share, significantly lower than previous prices. The company plans to use the proceeds for working capital and corporate purposes. New unregistered warrants will also be issued, pending stockholder approval, to fund further growth initiatives.

Jun 13, 2024

RELEASE OF CLAIMS As used in this Release of Claims (this " Release "), the term "claims" will include all claims, covenants, warranties, promises, undertakings, actions, suits, causes of action, obligations, debts, acco

Bruce Harmon has signed a Release of Claims as part of his severance from the company. This legal document absolves the company and its affiliates from any claims or liabilities related to his employment and its termination. As a condition of this release, Harmon will receive a severance payment of $66,152.61, contingent upon his adherence to the terms outlined, including not seeking re-employment with the company. This release reflects ongoing corporate dynamics and the challenges faced by employees in such situations.

Feb 27, 2024

Proteomedix AG Financial Statements and Independent Auditors' Report For the Years Ended

Proteomedix AG released their financial statements for the years ending December 31, 2022, and 2021, providing insight into their financial health. The company reported significant recurring losses and raised concerns about its ability to maintain operations going forward. Revenues did increase year-on-year, indicating some business activity, but overall financial stability remains a concern due to a substantial net loss and declining cash reserves. The independent auditors expressed their opinion on the financial statements, confirming they were prepared according to accepted accounting standards but highlighted uncertainty regarding the company's going concern status.

Feb 13, 2024

Onconetix Announces Appointment of Seasoned Biotech Executives Dr. Ajit Singh and Dr. Thomas Meier to Its Board of Directors

Onconetix, Inc. has announced the appointment of Dr. Ajit Singh and Dr. Thomas Meier to its Board of Directors. Both bring significant expertise from their experiences in the biotechnology industry, which is expected to guide Onconetix in its strategic direction. Dr. Singh is known for his work in clinical diagnostics and oncology, while Dr. Meier has extensive experience in fundraising and product approvals. This move signals Onconetix's commitment to advancing its oncology-focused therapeutics and diagnostics business.

Jan 12, 2024

RELEASE OF CLAIMS I, Dr. Neil J. Campbell, understand, and of my own free will, enter into this Release of Claims (" Release ") with Onconetix, Inc. (the " Company "), its parent(s) and any of its affiliates, subsidiarie

Dr. Neil J. Campbell has entered into a Release of Claims with Onconetix, Inc. This agreement includes a severance payment of $158,333.33 and releases the company from various employment-related legal claims. The release expressly covers potential claims for wrongful termination and discrimination, which could imply tensions surrounding his departure. Additionally, Campbell's obligations include refraining from disparaging the company and forfeiting any unvested stock options or equity compensation.

Dec 19, 2023

Onconetix™ Chief Executive Officer Dr. Neil J. Campbell Issues Letter to Shareholders

Onconetix, Inc. has issued a letter from CEO Dr. Neil J. Campbell highlighting the company's recent achievements and rebranding efforts aimed at oncology. The upcoming launch of Entadfi, combined with the strategic acquisition of Proteomedix, positions Onconetix for growth in therapeutic and diagnostic markets. The company’s shift from preclinical vaccine programs towards oncology suggests focused resource allocation, although it may pose certain risks. Dr. Campbell emphasizes the commitment to delivering innovative oncology solutions to improve shareholder value.

Dec 18, 2023

Blue Water Biotech Acquires Proteomedix as Part of Transformation to Commercial Stage Oncology Company; Announces Name Change to Onconetix Transaction strengthens commercial business with addition of diagnostics product

Blue Water Biotech has announced its acquisition of Proteomedix AG, transitioning into a commercial-stage oncology company and rebranding as Onconetix Inc. This strategic move enhances its portfolio with a focus on prostate cancer diagnostics and therapies. The acquisition grants Proteomedix shareholders a 19.9% stake in the new entity and establishes a European headquarters in Zurich. The company aims to leverage its newly acquired diagnostic technologies alongside its existing FDA-approved treatment for benign prostatic hyperplasia, Entadfi.

Nov 2, 2023

Blue Water Biotech Signs Non-Binding Term Sheet to Acquire a Commercial Stage Oncology Company Transaction will Advance Company's Shift in Business Strategy Aligned with Life Sciences Industry Expertise of New Leadership

Blue Water Biotech has signed a non-binding term sheet to acquire a private commercial stage oncology company, aligning with its new business strategy in oncology. This move is spearheaded by the leadership of Dr. Neil J. Campbell, who aims to capitalize on significant unmet medical needs in cancer care. The outcome of this acquisition is contingent upon shareholder approval and the completion of due diligence, as well as various other factors, which introduces uncertainty regarding its execution. Further details are expected upon finalizing a definitive agreement.

Oct 30, 2023

Blue Water Biotech Issues Letter to Shareholders Blue Water Biotech Issues Letter to Shareholders

Blue Water Biotech announced a strategic shift in focus towards oncology in a shareholder letter from CEO Dr. Neil Campbell. The company has regained compliance with Nasdaq listing rules and plans to enhance shareholder value through the launch of its first oncology therapeutic, Entadfi. Additionally, Blue Water Biotech is discontinuing its previous initiatives related to non-oncology assets and de-prioritizing vaccine programs to streamline operations. This refocus aims to establish the company as a key player in the oncology sector, enhancing its product offerings and market position.

Oct 10, 2023

GENERAL RELEASE OF CLAIMS I, Jon Garfield, hereby grant this General Release of Claims (" Release ") to Blue Water Biotech, Inc. (the " Company) " and each of its direct and indirect subsidiaries and affiliates (collecti

Jon Garfield has officially granted a General Release of Claims to Blue Water Biotech, Inc. This release pertains to his employment termination and prevents him from asserting any claims against the company, including those related to discrimination or wrongful termination. In exchange, Garfield will receive a severance payment of $72,500. The terms highlight an effort to mitigate future liabilities for the company amid potential legal exposure.

Aug 28, 2023

Blue Water Biotech, Inc. ANNOUNCES Notification From Nasdaq Related To Delayed QUARTERLY Report on Form 10-Q CINCINNATI, OH

Blue Water Biotech, Inc. announced a notification from Nasdaq regarding its failure to file its Quarterly Report on Form 10-Q on time. The company received a delinquency notification and has 60 days to submit a compliance plan to Nasdaq. If accepted, Blue Water may have an extended period to meet the filing requirements. The company is currently reviewing financial statements, which has contributed to the delay.

Aug 10, 2023

Blue Water Biotech and Copay Consultants Collaborate to Build Copay Assistance Programs for Blue Water's Commercial Products CINCINNATI, OH

Blue Water Biotech has entered an agreement with Copay Consultants to establish copay assistance programs for its commercial products, including ENTADFI and the upcoming ZONTIVITY. This collaboration is intended to help patients manage out-of-pocket expenses associated with these treatments. The programs are part of a broader strategy to ensure affordability and accessibility for patients. The official launch of these products is anticipated in the coming months, particularly following the acquisition of ENTADFI and the expected acquisition of ZONTIVITY.

Aug 3, 2023

Blue Water Biotech Announces Closing of Warrant Exercise and Issuance of New Warrants in A Private Placement For $2.7 Million Gross Proceeds

Blue Water Biotech announced the closure of a warrant exercise, leading to gross proceeds of $2.7 million. This funding is intended for working capital and supporting the launch of its commercial portfolio. The company issued new unregistered warrants for additional shares, which are exercisable for five years at a price of $1.09 each. Despite the successful transaction, Blue Water faces challenges related to market conditions and regulatory requirements.

Aug 1, 2023

Blue Water Biotech Announces Exercise of Warrants and Issuance of New Warrants in A Private Placement For $2.7 Million Gross Proceeds

Blue Water Biotech has announced a definitive agreement for the exercise of existing warrants, allowing it to raise approximately $2.7 million in gross proceeds. The company plans to utilize these funds for working capital and to support its commercial portfolio launch activities. This transaction is expected to close around August 2, 2023. In conjunction with this, Blue Water will issue new warrants that are contingent upon stockholder approval. The new warrants could further strengthen the company’s financial position in the coming years.

Jul 31, 2023

Blue Water Biotech and Knipper Health Join Forces to Distribute Samples for ENTADFI and ZONTIVITY to Physicians CINCINNATI, OH

Blue Water Biotech has announced an agreement with Knipper Health to manage the distribution of product samples for its therapies ENTADFI and ZONTIVITY. This collaboration aims to expedite treatment initiation for physicians, leveraging Knipper's extensive experience in healthcare distribution. Blue Water is advancing its launch plans for these FDA-approved products, with a focus on increasing market access and familiarity among healthcare providers. Both ENTADFI and ZONTIVITY are positioned to provide effective treatment solutions for patients with BPH and cardiovascular complications respectively.

Jul 25, 2023

Blue Water Biotech Teams with UpScriptHealth to Launch Telemedicine Platform for Benign Prostatic Hyperplasia Asset

Blue Water Biotech announced a partnership with UpScriptHealth to launch a telemedicine platform aimed at distributing its benign prostatic hyperplasia (BPH) treatment, ENTADFI. This platform will facilitate online consultations and allow eligible patients to receive their prescriptions via mail, potentially improving therapy access for approximately 55 million affected men in the U.S. The initiative aligns with Blue Water's strategic goals to enhance its commercial portfolio, with the launch of ENTADFI expected in the coming months. However, the company must navigate challenges related to acquisitions and FDA compliance to realize these plans.

Jul 17, 2023

Blue Water Biotech Issues CEO Shareholder Letter Providing Update on Commercial Launch Activities CINCINNATI, OH

Blue Water Biotech has announced significant advancements as it transitions from a preclinical vaccine development company to a commercial stage pharmaceutical entity. In its recent shareholder letter, the company detailed the acquisition of several FDA approved assets, including ENTADFI, a treatment for benign prostatic hyperplasia (BPH). The company has also established a dedicated management team focused on commercial strategy and is securing necessary licenses for distribution. Furthermore, Blue Water emphasizes its commitment to improving patient access and raising product awareness through strategic marketing initiatives.

Jul 11, 2023

Blue Water Biotech Teams with Advantage Point Solutions to Provide Healthcare Payer Coverage Support Pharmaceutical consulting firm to provide Blue Water with access to healthcare payers and PBMs CINCINNATI, OH

Blue Water Biotech, Inc. has signed an agreement with Advantage Point Solutions to support its market access strategy for its pharmaceutical portfolio. The collaboration aims to enhance coverage and reimbursement for their products, particularly ENTADFI. With recent agreements and licenses, Blue Water is preparing to commercially launch its recently acquired therapies. Despite positive developments, the company is aware of potential risks related to product launches, access to capital, and regulatory hurdles.

Jul 6, 2023

Blue Water Biotech Secures License from Ohio State Board of Pharmacy to Operate as Pharmaceutical Wholesaler for its FDA Approved Products First state license is a key achievement as Blue Water continues to expand its bu

Blue Water Biotech has secured a pharmaceutical wholesaler license from the Ohio State Board of Pharmacy, marking a significant milestone as it expands its commercialization efforts. This license enables the company to conduct business in Ohio and supports its strategy to make FDA-approved products more accessible. Blue Water has also recently acquired multiple FDA-approved therapeutic assets and is focusing on building a sales team and collaborating with commercial partners to enhance product availability. The company aims to secure additional state licenses to foster nationwide access.

Jul 6, 2023

Blue Water Biotech Teams with BFW Advertising to Market and Advertise Commercial Product Portfolio CINCINNATI, OH

Blue Water Biotech has announced a collaboration with BFW Advertising to enhance the marketing and advertising of its commercial product portfolio. This partnership aims to create effective marketing materials targeting patients, healthcare providers, and payors. Blue Water is positioning itself for a successful commercial launch by leveraging BFW's extensive experience in the life sciences sector. With recent acquisitions, Blue Water is expanding its operations and product offerings in areas such as urology and cardiology.

Jun 28, 2023

ONCOPhases

Blue Water Biotech Announces Preclinical Data Supporting Immunogenicity of Novel Monkeypox Vaccine Utilizing Norovirus Virus-Like Particle Platform CINCINNATI, OH

Blue Water Biotech has announced promising preclinical data for a novel monkeypox vaccine utilizing its norovirus virus-like particle platform. Preliminary results demonstrate that immunized mice produced an effective immune response, including the generation of neutralizing antibodies against the vaccinia virus, closely related to monkeypox. The company aims to leverage this data to further develop the vaccine candidate and ultimately bring it through clinical trials. Additionally, the executives highlighted the importance of this vaccine within the context of rising monkeypox cases in the U.S. and globally.

Jun 21, 2023

Blue Water Biotech Collaborates with IQVIA to Build Medical Sales Representative Team to Market Commercial Product Portfolio CINCINNATI, OH

Blue Water Biotech has announced a collaboration with IQVIA to establish a medical sales representative team aimed at marketing its commercial product portfolio, which includes ENTADFI and ZONTIVITY. The partnership focuses on optimizing sales efforts in key therapeutic areas such as urology and cardiology. This collaboration is seen as a strategic move to ensure effective outreach and education for healthcare providers regarding Blue Water's products. Blue Water is also working to integrate recently acquired FDA-approved assets into its commercial operations to expand its market presence.

Jun 14, 2023

Blue Water Biotech Expands Commercial Portfolio by Acquiring Six FDA-Approved Drugs Across Various Treatment Areas CINCINNATI, OH

Blue Water Biotech announced the acquisition of six FDA-approved drugs from WraSer, enhancing its portfolio across multiple treatment areas including cardiology and pain management. The total purchase price is $8.5 million, along with restricted stock. This acquisition aligns Blue Water's strategy to transition into a commercial-stage biopharmaceutical company. The company aims to leverage these assets to improve financial stability and patient access to critical therapies, further supported by a robust vaccine pipeline in development.

May 15, 2023

Corporate Overview & ENTADFI Opportunity May 2023 NASDAQ: BWV Forward Looking Statements 2 The Presentation (the "Presentation") has been prepared by Blue Water Biotech, Inc. (the "Company"). Certain information containe

Blue Water Biotech, Inc. (NASDAQ: BWV) provided an overview highlighting the upcoming commercial launch of its product ENTADFI, anticipated in Q3 2023. ENTADFI is the first FDA-approved combination therapy aimed at addressing benign prostatic hyperplasia (BPH) symptoms and erectile dysfunction. The company boasts a robust vaccine pipeline targeting various diseases alongside the commercialization of its products. The management team is composed of experienced professionals committed to driving innovation in the biopharmaceutical space.

May 12, 2023

Blue Water Biotech Reports First Quarter 2023 Financial Results and Recent Business Highlights CINCINNATI, OH

Blue Water Biotech reported its financial results for Q1 2023, highlighting its recent acquisition of ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia. The company is transitioning into a commercial-stage biotechnology firm and is progressing with various preclinical vaccine candidates. Despite a reported loss from operations, Blue Water remains optimistic about the future potential of its products and pipeline.

May 10, 2023

Blue Water Biotech to Present Corporate Overview and ENTADFI Launch Plan at the JMP Securities Life Sciences Conference in New York

Blue Water Biotech announced its participation at the JMP Securities Life Sciences Conference, where it will present a corporate overview and its launch plan for ENTADFI. This FDA-approved treatment for benign prostatic hyperplasia aims to reduce negative sexual side effects commonly associated with alternative therapies. The event is scheduled for May 15, 2023, in New York City, marking a significant opportunity for the company to share its vision with investors. Additionally, ENTADFI has demonstrated better efficacy compared to existing treatments, highlighting its potential in the market.

Apr 25, 2023

Blue Water Biotech to Participate in the American Urological Association Annual Meeting 2023 to Promote Benign Prostatic Hyperplasia Treatment

Blue Water Biotech, Inc. will participate in the American Urological Association Annual Meeting 2023 to promote ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia (BPH). The company's executives will discuss launch strategies and the product's benefits over traditional BPH therapies. ENTADFI addresses significant urinary and sexual dysfunction symptoms faced by millions of men. The product offers a once-daily treatment option that reduces adverse sexual side effects commonly associated with other therapies.

Apr 24, 2023

Moderator (00:00): Hello, and thank you for standing by. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Blue Water Vaccines Conference call. All lin

Blue Water Vaccines has announced its acquisition of Entadfi, a treatment for benign prostate hyperplasia (BPH), for $100 million in total consideration. The purchase, which includes an upfront payment and additional milestone payments, aims to expand Blue Water's commercial capabilities and patient base beyond vaccines. Entadfi's unique formulation combines finasteride and tadalafil, helping to alleviate BPH symptoms without the side effects of traditional medications. The acquisition is anticipated to support Blue Water's growth and ongoing vaccine development efforts.

Apr 20, 2023

Blue Water Announces Acquisition of ENTADFI , an FDA-Approved Benign Prostatic Hyperplasia Asset Acquisition Transforms the Company into a Broader Pharmaceutical Company Spanning Multiple Sectors Company Announces Corpor

Blue Water Vaccines Inc. (ticker: BWV) announced the acquisition of ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia, from Veru Inc. for $100 million. The agreement signifies Blue Water's strategic transition into a broader pharmaceutical company, reflecting its expanding portfolio. ENTADFI combines finasteride and tadalafil into a single treatment pill, aiming to minimize sexual side effects associated with traditional therapies. The company plans to optimize sales and marketing strategies post-acquisition to enhance patient access and revenue support for its vaccine pipeline.

Apr 12, 2023

ONCOPhases

Blue Water Vaccines Announces Signing of Sponsored Research Agreement with The University of Texas Health Science Center at San Antonio to Initiate Non-Human Primate Study for Live Attenuated, Orally Delivered Chlamydia

Blue Water Vaccines announced a Sponsored Research Agreement with The University of Texas Health Science Center at San Antonio to conduct a non-human primate study for its live attenuated orally delivered Chlamydia vaccine, BWV-401. This vaccine aims to prevent Chlamydia infections and addresses a significant global health need, as no vaccine currently exists. The upcoming study is expected to evaluate the efficacy and immune response in a model that closely mimics human conditions. If successful, BWV-401 could progress toward clinical trials, contributing to the prevention of this prevalent sexually transmitted infection.

Mar 9, 2023

Blue Water Vaccines Reports Year 2022 Financial Results and Recent Business Highlights

Blue Water Vaccines Inc. announced its financial results for 2022, highlighting a significant increase in net loss to approximately $13.4 million. The company has made notable advancements in its vaccine candidates, particularly those targeting Streptococcus pneumoniae, and successfully raised capital through public and private offerings. Appointments to strengthen the board and favorable analyses from healthcare-focused banks were also reported. However, the increased operating expenses and reliance on further financing raise concerns about the company's financial stability as it continues its developmental efforts.

Jan 17, 2023

Blue Water Vaccines Announces Appointment of Seasoned Public Market and Private Equity Investment Leader Timothy Ramdeen to Board of Directors CINCINNATI, OH

Blue Water Vaccines Inc. has appointed Timothy Ramdeen to its board of directors, enhancing its leadership team. Ramdeen brings nearly a decade of experience in private equity, capital markets, and life sciences. His previous roles include co-founder of Sixth Borough Capital Management and advisor for various early-stage companies. The appointment is anticipated to support the company's growth as it develops innovative vaccines to address significant health challenges globally.

Jan 9, 2023

Blue Water Vaccines to Present at Biotech Showcase 2023 During the 41 st Annual J.P. Morgan Healthcare Conference Week in San Francisco CINCINNATI, OH

Blue Water Vaccines announced that its management will present at the Biotech Showcase 2023 during the J.P. Morgan Healthcare Conference in San Francisco. The presentation will include a corporate overview, recent milestones, and developments regarding the company's vaccine pipeline. CEO Joseph Hernandez expressed enthusiasm about sharing their progress at this notable event. The company focuses on developing innovative vaccines to tackle significant global health challenges, including flu, norovirus, and pneumococcus-related infections.

Jan 6, 2023

January 2023 NASDAQ: BWV The Presentation (the "Presentation") has been prepared by Blue Water Vaccines, Inc. (the "Company"). Certain information contained herein has been derived from sources prepared by third parties.

Blue Water Vaccines, Inc. has prepared a presentation detailing its pipeline of vaccine candidates focusing on key infectious diseases. The company highlights a team with extensive industry experience and collaborations with respected research institutions. However, it acknowledges the inherent risks associated with vaccine development, including regulatory approval challenges and financial needs. The presentation also notes ongoing research and potential developments in response to high-burden diseases.

Dec 12, 2022

Blue Water Vaccines Announces Institutional Research Coverage by Two Notable Healthcare-Focused Wall Street Banks, Receives "Buy" Rating From Both CINCINNATI, OH

Blue Water Vaccines Announces Institutional Research Coverage by Two Notable Healthcare-Focused Wall Street Banks, Receives "Buy" Rating From Both CINCINNATI, OH, December 12, 2022 -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), a biopharmaceutic

Dec 7, 2022

Mucosal Vaccines to Protect Against Mucosal Infections May Be The Right Answer to Address Major Unmet Medical Needs NASDAQ: BWV Ali Fattom and Jason Rosch* Bluewater Vaccines Inc.

Mucosal Vaccines to Protect Against Mucosal Infections May Be The Right Answer to Address Major Unmet Medical Needs NASDAQ: BWV Ali Fattom and Jason Rosch* Bluewater Vaccines Inc. December 7, 2022 *Department of Infectious Diseases St. Jude Children's Research Hospital, Memphis,

Dec 1, 2022

Blue Water Vaccines to Present Update on Novel, Live Attenuated, Intranasally Delivered Streptococcus pneumoniae Vaccine to Prevent Acute Otitis Media, Pneumococcal Pneumonia, and Invasive Pneumococcal Disease at the Wor

Blue Water Vaccines to Present Update on Novel, Live Attenuated, Intranasally Delivered Streptococcus pneumoniae Vaccine to Prevent Acute Otitis Media, Pneumococcal Pneumonia, and Invasive Pneumococcal Disease at the World Vaccine & Immunotherapy Congress West Coast 2022 CINCI

Nov 21, 2022

Blue Water Vaccines Announces Exclusive, Global License Agreement for Chlamydia Vaccine Candidate Development from The University of Texas Health San Antonio CINCINNATI, OH

Vaccines Announces Exclusive, Global License Agreement for Chlamydia Vaccine Candidate Development from The University of Texas Health OH, November 21, 2022 -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company") a biopharmaceutical company developing tra

Nov 10, 2022

Blue Water Vaccines Reports Third Quarter 2022 Financial Results and Recent Business Highlights; Announces 5 Million Share Repurchase Program Closed private placement in August 2022, with net proceeds of approximately $8

Blue Water Vaccines Reports Third Quarter 2022 Financial Results and Recent Business Highlights; Announces 5 Million Share Repurchase Program CINCINNATI, OH, November 14, 2022 - Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), today announced its fin

Nov 8, 2022

Blue Water Vaccines Announces Appointment of Vuk Jeremi , Previous Chair of the Council of Europe's Committee of Ministers and Previous President of the United Nations General Assembly, to Its Board of Directors CINCINNA

Blue Water Vaccines Announces Appointment of Vuk Jeremi , Previous Chair of the Council of Europe's Committee of Ministers and Previous President of the United Nations General Assembly, to Its Board of Directors CINCINNATI, OH, November 8, 2022 -- Blue Water Vaccines Inc. ("B

Oct 13, 2022

Intranasal Live Attenuated Pneumococcus Vaccine to Protect Against Pneumonia & AOM and Potential Platform for Combination Vaccines NASDAQ: BWV

Intranasal Live Attenuated Pneumococcus Vaccine to Protect Against Pneumonia & AOM and Potential Platform for Combination Vaccines NASDAQ: BWV October 13, 2022 Ali Fattom, Brian Price, Ron Cobb, and Jason Rosch* Bluewater Vaccines Inc. * St. Jude Children's Research Hospital, Mem

Oct 11, 2022

Blue Water Vaccines Announces Plans to Evaluate Efficacy of Streptococcus pneumoniae Vaccine Candidate Against Pneumococcal Pneumonia at the World Vaccine Congress in Barcelona CINCINNATI, OH

Blue Water Vaccines Announces Plans to Evaluate Efficacy of Streptococcus pneumoniae Vaccine Candidate Against Pneumococcal Pneumonia at the World Vaccine Congress in Barcelona CINCINNATI, OH, October 11, 2022 -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or the

Sep 12, 2022

September 2022 NASDAQ: BWV The Presentation (the "Presentation") has been prepared by Blue Water Vaccines, Inc. (the "Company"). Certain information con tai ned herein has been derived from sources prepared by third part

September 2022 NASDAQ: BWV The Presentation (the "Presentation") has been prepared by Blue Water Vaccines, Inc. (the "Company"). Certain information con tai ned herein has been derived from sources prepared by third parties. While such information is believed to be reliable for

Aug 22, 2022

Blue Water Vaccines Announces Appointment of Retired Deloitte Consulting Senior Managing Director Simon Tarsh to Board of Directors

Blue Water Vaccines Announces Appointment of Retired Deloitte Consulting Senior Managing Director Simon Tarsh to Board of Directors August 22, 2022 at 2:00 PM EDT Aug. 22, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company"), a b

Aug 9, 2022

Blue Water Vaccines Announces $10 Million Private Placement Priced At-the-Market under Nasdaq Rules

Blue Water Vaccines Announces $10 Million Private Placement Priced At-the-Market under Nasdaq Rules CINCINNATI, Ohio, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company"), a biopharmaceutical company developing transforma

Jul 20, 2022

Blue Water Vaccines Announces Signing of Sponsored Research Agreement with Cincinnati Children's Hospital Medical Center for S&P Vaccine Platform Development CINCINNATI

Blue Water Vaccines Announces Signing of Sponsored Research Agreement with Cincinnati Children's Hospital Medical Center for S&P Vaccine Platform Development CINCINNATI, July 20, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company"

May 31, 2022

Blue Water Vaccines Announces Sponsored Research Agreement Amendment to Continue Funding Universal Influenza Vaccine Development at The University of Oxford CINCINNATI, OH

Water Vaccines Announces Sponsored Research Agreement Amendment to Continue Funding Universal Influenza Vaccine Development at The University OH, May 31, 2022 -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company") a biopharmaceutical company developing tr

Apr 21, 2022

Blue Water Vaccines Presents New Data Supporting Universal Influenza Vaccine Candidate at the World Vaccine Congress 2022 in Washington

Water Vaccines Presents New Data Supporting Universal Influenza Vaccine Candidate at the World Vaccine Congress 2022 in Washington, DC CINCINNATI, OH, April 21, 2022 - Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company"), a biopharmaceutical company devel

Apr 20, 2022

Blue Water Vaccines Announces Closing of $8 Million Private Placement Priced At-the-Market Under Nasdaq Rules Proceeds To Fund Research and Development of BWV-101, BWV-102 and BWV-103 CINCINNATI

Blue Water Vaccines Announces Closing of $8 Million Private Placement Priced At-the-Market Under Nasdaq Rules Proceeds To Fund Research and Development of BWV-101, BWV-102 and BWV-103 CINCINNATI, April 20, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. ("BWV" or "Blue Wat

Apr 20, 2022

UNIVERSAL INFLUENZA VACCINE PROGRAM - BWV - 101 Developing a single vaccine to protect against all influenza strains using ground - breaking mathematical models and research Brian Price, Ph.D.

UNIVERSAL INFLUENZA VACCINE PROGRAM - BWV - 101 Developing a single vaccine to protect against all influenza strains using ground - breaking mathematical models and research Brian Price, Ph.D. April 20, 2022 | World Vaccine & Immunotherapy Congress 2022 Forward Looking Statement

Apr 18, 2022

Blue Water Vaccines Announces $8 Million Private Placement Priced At-the-Market Under Nasdaq Rules Proceeds To Fund Research and Development of BWV-101, BWV 102 and BWV-103. CINCINNATI, OH, April 13 , 2022 -- Blue Water

Blue Water Vaccines Announces $8 Million Private Placement Priced At-the-Market Under Nasdaq Rules Proceeds To Fund Research and Development of BWV-101, BWV 102 and BWV-103. OH, April 13, 2022 -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company"), a b

Mar 22, 2022

Blue Water Vaccines Announces Publication in Nano Research Supporting Novel S&P Vaccine Platform Versatility - Blue Water Vaccines has exclusive, global licensing rights to Cincinnati Children's Hospital Medical Center's

Water Vaccines Announces Publication in Nano Research Supporting Novel S&P Vaccine Platform Versatility OH, March 22, 2022 -- Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company") a biopharmaceutical company developing vaccines, today announced that their l

Feb 17, 2022

Blue Water Vaccines Announces Pricing of approximate $20M Initial Public Offering CINCINNATI

Water Vaccines Announces Pricing of approximate $20M Initial Public Offering Feb. 17, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines, Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), a biopharmaceutical company developing vaccines, today announced the pricing of its initia