On August 2, 2022 MDxHealth SA (NASDAQ/Euronext: MDXH) ("mdxhealth" or the "Company"), a commercial-stage precision diagnostics company, reported it has entered into an asset purchase agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation ("Exact Sciences"), to acquire the Oncotype DX GPS (Genomic Prostate Score) test from Exact Sciences along with most of its team of urology sales and marketing professionals (Press release, Genomic Health, AUG 2, 2022, View Source [SID1234617371]). This addition further solidifies the Company’s leadership in the precision diagnostics urology market. Additionally, the Company reported strong preliminary financial results for the half year ended June 30, 2022 and raised its current full year 2022 revenue guidance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michael McGarrity, CEO of mdxhealth, commented: "We are excited to announce this transformational acquisition of Oncotype DX GPS, a broadly commercialized and clinically validated test available today across the urology community, expanding mdxhealth’s current menu of tests targeted into urology and prostate cancer and reflecting our strategy to generate sustainable growth. After discussions with the Exact Sciences team, it became clear to both companies the substantial value we could unlock by adding the Oncotype DX GPS test to mdxhealth’s molecular test menu of Select mdx and Confirm mdx as well as our newly launched advanced molecular test for urinary tract infections (UTIs). We look forward to welcoming Exact Sciences’ Oncotype DX GPS prostate commercial team to mdxhealth, increasing our commercial footprint and providing this newly expanded sales team with a broader, highly complementary offering of precision diagnostic tests to better serve our combined customers in urology.

"We also believe this acquisition positions mdxhealth as one of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics. Our expanded menu provides clear and clinically actionably results to guide both patients and clinicians through the complex and often confounding prostate cancer diagnostic pathway."

Kevin Conroy, Chairman and CEO of Exact Sciences commented: "We believe the mdxhealth team is well positioned to serve patients and customers in the urology space. Adding the Oncotype DX GPS test and technology to their comprehensive urology test menu will provide an enhanced experience and more information to help patients and health care providers navigate a prostate cancer diagnosis."

Transaction Details

Acquisition of the Oncotype DX GPS Prostate Cancer Business

Under the terms of the asset purchase agreement, mdxhealth acquired the Oncotype DX GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $100 million, of which an amount of $25 million was paid in cash and an amount of $5 million will be settled through the delivery of 691,171 American Depositary Shares ("ADSs") of the Company, at a price per ADS of $7.23. Following the closing, which took place today, an additional aggregate earn-out amount of up to $70 million is to be paid by mdxhealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025, with the maximum earn-out payable in relation to 2023 and 2024 not to exceed $30 million and $40 million, respectively. At the option of mdxhealth, the earn-out amounts can be settled in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading price of the Company’s shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares representing the ADSs held by Exact Sciences shall not exceed more than 5% of the outstanding shares of mdxhealth.

Debt Financing of the Acquisition

Mdxhealth has financed the acquisition in part through a $35 million loan and security agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus"), which loan also replaces the Company’s existing EUR 9 million debt facility with Kreos Capital. Furthermore, at the option of the Company, an additional $35 million can be drawn from Innovatus, consisting of a $20 million term B loan and a $15 million term C loan, that can be drawn in 2024 and 2025 respectively, subject to certain conditions. The loans are secured by assets of the Company, including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund general business requirements.

The loans accrue interest at a floating per annum rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the "Money Rates" section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. At the election of the Company, a portion of the interest may be payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027. The lenders shall have the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans into ADSs of the Company at a price per ADS equal to $11.21, reflecting a substantial premium to the trading price prior to the announcement of the acquisition. Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan. Notable fees payable to Innovatus consist of a facility fee equal to 1% of the total loan commitment, due on the funding date of the relevant loans, and an end-of-loan fee equal to 5% of the amount drawn, payable upon final repayment of the relevant loans. As part of the new funding, the Company’s debt facility with Kreos for an outstanding principal amount of EUR 9 million will be repaid in cash, except that the Company also agreed that the outstanding amount of the Kreos discretionary convertible debt (being EUR 382,500, which is part of the EUR 9 million loan) will be converted into new shares of the Company or repaid in cash.

Advisors

Jefferies LLC acted as sole financial advisor and Foley Hoag acted as lead legal counsel to mdxhealth for the acquisition; Baker McKenzie acted as lead legal counsel to mdxhealth for the debt facility.

First Half 2022 Preliminary Financial Results and FY 2022 Guidance

"Our focus on execution and growth as well as operating discipline, coupled with the early stages of patient flow returning from the impact of the pandemic, generated revenue of $13.0 million for the first half of 2022, an increase of 21% as compared to the first half of 2021." concluded Mr. McGarrity.

For Q2-2022, the Company generated revenue of $6.9 million representing an increase of 22% over Q2-2021, and H1-2022 revenue of $13.0 million representing 21% growth over H1-2021
The Company is increasing its revenue guidance for existing mdxhealth business to $27-29 million for FY 2022, up from previous revenue guidance of $25-27 million for FY 2022, representing anticipated growth of 21%-30% over full year 2021 revenue of $22.2 million
The Company is increasing its total FY 2022 revenue guidance to $40-42 million, up approximately 80%-89% above full year 2021 revenues, inclusive of $13 million in expected revenue for the acquired Oncotype DX GPS business over the August to December 2022 period
The Company ended the second quarter dated June 30, 2022, with a cash and cash equivalents balance of $40.0 million
The Company will report full first half results as scheduled on August 25, 2022
Conference Call

Michael K. McGarrity, Chief Executive Officer, and Ron Kalfus, Chief Financial Officer, will host a conference call and Q&A session today at 4:30PM ET / 10:30PM CET. The call will be conducted in English and a replay will be available for 30 days.

To participate in the conference call, please select your phone number below and use the Conference ID: 8001522.

On August 2, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard-to-treat cancers, and VolitionRx Limited (NYSE AMERICAN:VNRX) ("Volition"), a multi-national epigenetics company, reported a research and development collaboration to develop Neutrophil Extracellular Traps ("NETs") targeted, adoptive cell therapies for the treatment of cancer (Press release, Xenetic Biosciences, AUG 2, 2022, View Source [SID1234617250]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q NETs Test and Xenetic’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid cancers.

Under the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds from commercialization or licensing of any products arising from the collaboration.

"Since we in-licensed the DNase-based oncology platform in April of this year, our team is intently focused on driving the technologies forward with the goal of improving outcomes of existing therapeutic agents in multiple solid tumor indications. We are pleased to enter into our first industry research and development collaboration just a few short months after acquiring the technology platform. We have gotten to know the Volition team and are impressed by their technical expertise and creativity. We are therefore very excited to advance the development of this exciting new technology with an aligned strategic partner with the capabilities of Volition," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

Epigenetically modified nucleosomes are present on tumor cell surfaces and within the tumor microenvironment of multiple types of solid cancers, and thus these nucleosomes may represent generalizable tumor antigens that are not limited to a single cancer type. Volition’s Nu.Q technology can specifically recognize and target epigenetically modified nucleosomes, while Xenetic’s DNase-Armored CAR T platform is designed to enhance the function of CAR T cells within solid tumor microenvironments.

Jake Micallef, Volition’s Chief Scientific Officer, added, "Elevated levels of NETs are associated with poor patient outcomes in a range of diseases, such as COVID-19, sepsis and cancer. NETs are specifically implicated in metastatic cancer and removing them has been shown to prevent the spread of disease. Consequently, there’s an urgent need to develop treatments aimed at reducing the production of NETs or removing them from the body. Our CE marked Nu.Q NETs test is the only analytically validated test for the detection and evaluation of NETs. We are delighted to be working with Xenetic, employing our Nucleosomics technology to measure the level of NETs and help monitor the efficacy of their pioneering cancer therapies. It’s an exciting time ahead!"

On August 2, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in a fireside chat at the 2022 Wedbush Pacgrow Healthcare Conference (Press release, Karyopharm, AUG 2, 2022, View Source [SID1234617271]). The conference is being conducted in a virtual format and the fireside chat will take place on Tuesday, August 9, 2022 at 4:05 p.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay for 90 days following the event.

On August 2, 2022 Amplia Therapeutics Limited (ASX: ATX) (Amplia or the Company) reported to advise that the first patient has been dosed in the Company’s Phase 1b/2a ACCENT clinical trial of focal adhesion kinase inhibitor AMP945 (Press release, Amplia Therapeutics, AUG 2, 2022, View Source;[email protected] [SID1234617287]). AMP945 targets focal adhesion kinase (FAK) and its use in the ACCENT trial is intended to enhance the efficacy of gemcitabine/nab-paclitaxel chemotherapy for people with advanced pancreatic cancer undergoing first-line treatment. Patients in the trial will receive AMP945 in addition to a standard treatment regimen with gemcitabine/nab-paclitaxel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In a prior Phase 1 clinical trial of AMP945, conducted in healthy volunteers and completed in 2021, once daily oral doses of AMP945 showed excellent safety, tolerability and pharmacokinetic properties. AMP945 was also shown to inhibit FAK in skin samples provided by the healthy volunteers.

Dr John Lambert, Amplia’s CEO and Managing Director commented that "This is another exciting milestone marking the achievements and growth of our Company and we’re very proud of our team’s efforts in starting up the ACCENT trial. The work we have done to date with AMP945 both in the clinic and in preclinical models of pancreatic cancer tells us that AMP945 deserves to be clinically tested in this dangerous type of cancer. We are also grateful to our first patient and their family for consenting to join the trial. It is our sincere hope that addition of AMP945 to a standard of care in pancreatic cancer improves outcomes for all patients."

About the ACCENT Trial

The protocol for the ACCENT trial is entitled "A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients".

The trial is to be conducted in two stages. The first, Phase 1b stage of the trial, is a single-arm open-label study to select an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in combination with gemcitabine and nab-paclitaxel (Abraxane) in first-line patients with advanced pancreatic cancer. Approximately 12 patients will be recruited across 4-5 sites in Australia where ascending oral doses of AMP945 will be given together with a fixed dose combination of gemcitabine and nab-paclitaxel. It is expected that for each dose level of AMP945, three patients will be recruited. After each group of three patients has completed their first 28-day treatment cycle, the Company and an independent data monitoring committee will review the data before authorising progression to the next dose level of AMP945. The Company assumes that up to four dose levels of AMP945 will be assessed and that, assuming all four dose levels are required, the Phase 1b stage of the trial will take approximately 9 months to complete.

The second, Phase 2a, stage of the trial is also a single-arm open-label study and is designed to perform an assessment of the optimal dose of AMP945 (selected in the Phase 1b part of the trial) in combination with gemcitabine and nab-paclitaxel. The primary endpoint of the Phase 2a trial is the Objective Response Rate (ORR) of patients to treatment. Further endpoints will assess efficacy by other means as well as safety and tolerability. To determine whether addition of AMP945 to gemcitabine/nab-paclitaxel improves the ORR in this patient population, data from the ACCENT trial will be compared to a historical control of 23% ORR which was established in the original pivotal trial of gemcitabine/nab-paclitaxel. The Phase 2a trial uses a Simon 2-Stage design in which approximately 26 patients with advanced pancreatic cancer will be recruited across sites in Australia and South ABN 16 165 160 841 Level 17, 350 Queen Street, Melbourne VIC 3000 Email [email protected] www.ampliatx.com Korea before an interim efficacy analysis is performed. Assuming the interim analysis concludes that adding AMP945 to gemcitabine/nab paclitaxel may be beneficial, the trial will continue to recruit a further 24 patients across Australian, South Korean and US sites.

More information about the ACCENT trial, including a list of participating sites, can be found at ClinicalTrials.gov NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On August 2, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant Reveal molecular residual disease (MRD) test (Press release, Guardant Health, AUG 2, 2022, View Source [SID1234617303]). Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after surgery to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy. It is the first blood-only liquid biopsy test available for MRD testing in patients with colorectal cancer (CRC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The decision means Guardant Reveal is covered for fee-for-service Medicare patients in the United States with stage II or III CRC whose testing is initiated within three months following curative intent therapy. "We are pleased that Medicare has taken this important step to make MRD testing more widely available and help oncologists make more informed treatment decisions for their patients with colorectal cancer," said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for cancer patients. In December 2019, Palmetto GBA expanded local coverage determination (LCD) of the Guardant360 assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors. In March 2022, Palmetto GBA also conveyed coverage for Guardant360 TissueNext, the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.