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Blue Water Vaccines
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201 E. Fifth Street Cincinnati, OH 45202
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The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Onconetix

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition December 18, 2023

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Preliminary preclinical data supporting the use of its norovirus shell and protrusion (“S&P”) virus-like particle (“VLP”) platform to develop a novel monkeypox vaccine candidate.


Lead Product(s): VLP Vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 28, 2023

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Under the collaboration, Blue Water Biotech and IQVIA will market Blue Water’s commercial portfolio including, Entadfi, an FDA-approved, once daily pill that combines finasteride and tadalafil for benign prostatic hyperplasia and Zontivity (vorapaxar).


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: IQVIA

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 21, 2023

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Blue Water expands its commercial portfolio by purchasing six FDA-approved assets across multiple indications, including cardiology, otic infections, and pain management. The assets also include Conjupri (levamlodipine), a calcium channel blocker for the hypertension.


Lead Product(s): Levoamlodipine

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Conjupri

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: WraSer Pharmaceuticals

Deal Size: $8.5 million Upfront Cash: $8.5 million

Deal Type: Acquisition June 14, 2023

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The acquisition transforms the Company into a broader pharmaceutical company spanning multiple sectors by including ENTADFI (finasteride), an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Veru

Deal Size: $100.0 million Upfront Cash: $20.0 million

Deal Type: Agreement April 20, 2023

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Under the agreement, BWV will fund the NHP study to further evaluate the efficacy of BWV-401, a live attenuated, orally delivered Chlamydia vaccine, and provide additional support for development towards human clinical trials.


Lead Product(s): BWV-401

Therapeutic Area: Infections and Infectious Diseases Product Name: BWV-401

Highest Development Status: PreclinicalProduct Type: Vaccine

Partner/Sponsor/Collaborator: University of Texas Health Science Center

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 12, 2023

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Blue Water Vaccines and AbVacc will collaborate for the joint development of vaccine candidates targeting monkeypox and Marburg virus disease. Both candidate vaccines will utilize BWV’s norovirus shell and protrusion VLP platform.


Lead Product(s): Monkeypox Vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: DiscoveryProduct Type: Vaccine

Partner/Sponsor/Collaborator: AbVacc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration February 01, 2023

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Chlamydia vaccines have historically been challenging to produce, but the novel approach has demonstrated strong results in mouse models, which will translate into a human vaccine candidate.


Lead Product(s): Live Attenuated Chlamydia Vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Vaccine

Partner/Sponsor/Collaborator: University of Texas Health San Antonio

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement November 21, 2022

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New data, based on experiments at St. Jude Children’s Research Hospital, suggests that BWV-201 may also provide protection against pneumococcal pneumonia by limiting the ability of Streptococcus pneumoniae to infect the lungs.


Lead Product(s): BWV-201

Therapeutic Area: Infections and Infectious Diseases Product Name: BWV-201

Highest Development Status: IND EnablingProduct Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 11, 2022

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The Company intends to use the net proceeds from the private placement for the research and development of its pipeline as well as for working capital and other general corporate purposes.


Lead Product(s): BWV-101

Therapeutic Area: Infections and Infectious Diseases Product Name: BWV-101

Highest Development Status: PreclinicalProduct Type: Vaccine

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement August 11, 2022

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