On April 19, 2023, the Company reported to have entered into an Asset Purchase Agreement (the "Purchase Agreement") with Blue Water Vaccines Inc. (the "Purchaser"). Pursuant to, and subject to the terms and conditions of, the Purchase Agreement, the Purchaser purchased substantially all of the assets related to the Company’s ENTADFI business (Filing, Veru, APR 19, 2023, View Source [SID1234630360]). The transaction closed on April 19, 2023. The purchase price for the transaction was $20.0 million, consisting of $6.0 million paid at closing, an additional $4.0 million the Purchaser is obligated to pay the Company in the Company’s fiscal year 2023 and an additional $10 million the Purchaser is obligated to pay the Company in installments in the Company’s fiscal year 2024, plus up to an additional $80 million based on the Purchaser’s net sales from ENTADFI business after closing (the "Milestone Payments "). The Milestone Payments are payable as follows: (1) $10 million is payable if annual net sales from the ENTADFI business are $100 million or more, (2) $20 million is payable if annual net sales from the ENTADFI business are $200 million or more and (3) $50 million is payable if annual net sales from the ENTADFI business are $500 million or more. No more than one Milestone Payment shall be made for the achievement of each net sales milestone. There can be no assurance that the net sales milestones for payment of any of the Milestone Payments will be reached.

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Furthermore, in connection with the transaction, the Purchaser assumed royalty and milestone obligations from the Company under an asset purchase agreement relating to the Company’s acquisition of the tadalafil-finasteride combination, which include a 6% royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million.

The Company and the Purchaser made customary representations and warranties, and agreed to certain customary covenants, in the Purchase Agreement. Subject to certain exceptions and limitations, each party has agreed to indemnify the other for breaches of representations, warranties and covenants and for certain other matters.

The description of the Purchase Agreement set forth herein is qualified in its entirety by reference to the full text of the Purchase Agreement, a copy of which is attached as Exhibit 10.1 hereto and incorporated by reference herein.

On April 20, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the first quarter of 2023 after market close on Tuesday, May 9, 2023 (Press release, Guardant Health, APR 19, 2023, View Source [SID1234630351]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On April 20, 2023 Evotec-partner Tubulis and Bristol Myers Squibb (NYSE: BMY) reported that they have entered into a strategic license agreement to develop differentiated antibody-drug conjugates ("ADCs") (Press release, Evotec, APR 19, 2023, View Source [SID1234630348]).

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Through the license agreement, Bristol Myers Squibb will gain exclusive rights to access Tubulis’ Tubutecan payloads in combination with Tubulis’ proprietary P5 conjugation platform for the development of a selected number of highly differentiated ADCs to treat solid tumors. The terms of the agreement include an upfront payment of $22.75 million to Tubulis in addition to the potential for over $1 billion in development, regulatory, and commercial milestone payments plus royalty payments on resulting marketed products.

Evotec made a strategic equity investment in Tubulis GmbH by participating in the company’s Series B financing round in May 2022.

On April 19, 2023 Dxcover Limited, a clinical-stage diagnostics company developing spectroscopic liquid biopsy technology for early detection of multiple cancers, reorted new data in a presentation titled "Early Detection and Molecular Markers of Prevention" on the detection of colorectal cancer (CRC) using the company’s liquid biopsy platform at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, Florida from April 14-19 (Press release, Dxcover, APR 19, 2023, View Source [SID1234630338]).

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Co-founder and CTO Matthew Baker, PhD, outlined data from a preclinical study evaluating the Dxcover Cancer Liquid Biopsy platform’s capabilities to detect advanced adenomas and early cases of colorectal cancer. CRC is the third most common cancer among both men and women, which would greatly benefit from earlier detection due to decreased survival rates as the cancer progresses. On average, the survival rate after diagnosis for CRC decreases from 91% in early-stage CRC to as low as 15% for stage IV.

Dxcover analyzed a retrospective cohort of 296 samples comprised of 100 CRC, 99 advanced adenomas (AA) removed by surgical resection and 97 colonoscopy screening controls. The classifier from the discovery reported the ability to detect 59% of advanced adenomas and 83% of Stage 1 CRC at a specificity of 90% which surpasses the targets set by the Centers for Medicare and Medicaid Services (CMS) for coverage of CRC tests.

"Early detection, and the detection of pre-cancerous adenomas, is critical to advancing lifespan for those impacted by potentially devastating diseases like colorectal cancer. This data shows that Dxcover’s unique approach at detecting biomarkers beyond tumor DNA allows our technology to detect sooner, faster and with precision to ensure patients receive the treatment they need, when it has the most potential to impact outcomes," said Prof. Baker.

The Dxcover Cancer Liquid Biopsy test uses Fourier transform infrared (FTIR) spectroscopy and machine learning algorithms to build a classifier of the resultant spectral profiles to detect cancer and can be fine-tuned to maximize either sensitivity or specificity depending on the requirements of specific international healthcare systems.

On April 19, 2023 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported the presentation of additional results from its completed Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer, among a subgroup of patients who had undergone primary treatment with radiation therapy only (Press release, Blue Earth Diagnostics, APR 19, 2023, View Source [SID1234630337]). The results will be presented at the upcoming American Urological Association’s 2023 Annual Meeting (AUA2023), being held in Chicago, Ill., from April 28 to May 1, 2023. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Currently, 18F-rhPSMA-7.3 is investigational and has not received regulatory approval.

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Details of the presentation are listed below.

Date:

Saturday, April 29, 2023

Presentation:

18F-rhPSMA-7.3 Detection Rates in Patients with Recurrence of Prostate Cancer Following Primary Treatment with Radiation Therapy: Results from the SPOTLIGHT study.

Presenter:

Brian T. Helfand, MD, Chief of Division of Urology, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group

Session Title:

Prostate Cancer: Detection and Screening 1

Type:

Moderated Poster MP40

Session Times:

1:00 – 3:00 PM CT

Abstract ID:

23-6028

Location:

McCormick Place South Building, Room S405ab

Blue Earth Diagnostics invites participants at AUA2023 to attend the presentation above and to learn more about the Company at Booth 645. For full session details and scientific presentation listings, please see the AUA online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. The radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics GmbH in 2018, followed by acquisition of exclusive rights to therapeutic applications in 2020. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease, and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. rhPSMA compounds are investigational and have not received regulatory approval.