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.

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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 Ablaze Pharma and Wenjiang District Government of Chengdu reported that jointly signed the strategic agreement during the Conference of Major Advanced Manufacturing Projects by Foreign Direct Investment (Press release, Ablaze Pharmaceuticals, AUG 2, 2022, View Source [SID1234617367]). About 26,000㎡ of industrial land is selected in the Chengdu Medical City, with an initial investment of 100 million USD to build-up an innovative R&D and manufacturing center for targeted radiation therapies, where five anti-tumor varieties are under research at present, varying from Ac-225 to Lu-177. Ablaze Pharma intends to introduce the world-class innovative targeted radiopharmaceutical therapies (TRT) product designs and clinical experiences into Wenjiang District and jointly building-up the industrial chains of innovative radioactive targeted drug together with the industrial advantages of Wenjiang District.

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"We are deeply impressed by the strong support and recognition to the newly emerging targeted radiopharmaceutical enterprises from the Wenjiang District Government in the city of Chengdu," said Dr. Alex Qiao, President and CEO of Ablaze Pharmaceuticals, "Ablaze hopes to work with other companies in the park to build an ecosystem of targeted radiopharmaceuticals from early discovery to commercialization with the help of the resource advantages in nuclear science and technologies in Sichuan Province, and to promote the future development and progress of radiopharmaceutical drugs in China."

"Welcome and congratulations to Ablaze Pharma for the deployment of the R&D and manufacturing center in Chengdu Medical City. In next step, Chengdu Medical City will strengthen the investments and talent attractions to optimize the business environment for synergies to Ablaze Pharma and more industrials so as to build-up the leading highland of the domestic radiopharmaceutical industry." Li Zhang, Deputy Head Of The Management Committee Of Chengdu Medical City, Head Of The Investment Promotion Bureau said.

News Link by Chengdu Medical City： View Source

About Chengdu Medical City

Sichuan Province is an important base of nuclear industries of China, with national and provincial radioisotope and drug industry-academia platforms such as the National Engineering Research Center for isotopes and drugs, the Radioisotope And Drug R&D Center, and the Provincial Radioisotope Engineering Technology Research Center. These platforms form a collaborative and shared development with the layout of the pharmaceutical track in Chengdu Medical City, which can also enhance the synergies and collaborations of the academic and industrial chains between upstream and downstream. Chengdu Medical City has proactively made precise efforts to its radiopharmaceutical layouts, integrating the advantages of nuclide supplies, drug deliveries and R&D services, so as to accelerate the development of radiopharmaceutical industry in high efficiency and to gradually develop into the upland for radiopharmaceutical industrial hubs of integrated R&Ds, productions and applications.

On August 2, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended June 30, 2022 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, AUG 2, 2022, View Source [SID1234617327]).

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"We received acceptance last week of our New Drug Application (NDA) for sotagliflozin for the treatment of heart failure with a standard review assigned by the FDA and a PDUFA action date anticipated in May 2023," said Lonnel Coats, Lexicon’s chief executive officer. "As we mentioned in the announcement of the acceptance, we are seeking a broad heart failure label in the NDA, informed by our regulatory discussions, that encompasses heart failure patients with and without diabetes. We believe that the results of SOLOIST-WHF in patients admitted for recent worsening heart failure will be an important element distinguishing our proposed label."

"In another major accomplishment this quarter, we announced positive top-line results from our Phase 2 RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy at the end of June, achieving proof-of-concept for LX9211 with its novel mechanism of action in a historically difficult to treat indication," Mr. Coats continued. "We expect to report top-line results in the fourth quarter of this year from a second proof-of-concept study of LX9211 in post-herpetic neuralgia. We believe that our recent achievements for both sotagliflozin and LX9211 have the potential to be transformative for our organization, our stakeholders, and most importantly, patients."

Second Quarter Highlights

Sotagliflozin

A poster was presented at the 6th Annual HEART IN DIABETES Conference evaluating the effect of sotagliflozin on major adverse cardiovascular events (MACE: cardiovascular [CV] death, non-fatal myocardial infarction [MI] and non-fatal stroke) across the sotagliflozin clinical program of over 20,000 patients with type 1 or type 2 diabetes. The results showed that treatment with sotagliflozin was associated with a statistically significant and clinically meaningful reduction in MACE in patients with T1D and T2D.
A new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin was presented at the 82nd Scientific Sessions of the American Diabetes Association. The analysis showed that treatment with sotagliflozin significantly reduced HbA1c overall and across prespecified subgroups, including those with stage 4 chronic kidney disease with a severe decrease in glomerular filtration rate (eGFR <30mL/min/1.73m2), possibly reflecting the dual SGLT-1/2 mechanism of action of sotagliflozin.
LX9211

Positive top-line results for the Phase 2 proof-of-concept study of LX9211 for the treatment of painful diabetic neuropathy (RELIEF-DPN-1) were achieved at the end of the second quarter of 2022. Full results from the complete RELIEF-DPN-1 study are expected to be presented at a medical meeting in the fourth quarter of 2022.
Patient enrollment continued in the Phase 2 proof-of-concept study of LX9211 for the treatment of post-herpetic neuralgia (RELIEF-PHN-1), from which top-line results are expected in the fourth quarter of 2022.
Second Quarter 2022 Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2022 increased to $13.4 million from $10.3 million for the corresponding period in 2021, primarily due to increases in salaries and benefits and higher professional and consulting costs related to the resubmission of our NDA for sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2022 increased to $10.7 million from $7.9 million for the corresponding period in 2021, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of sotagliflozin.

Net Loss: Net loss for the second quarter of 2022 was $24.6 million, or $0.16 per share, as compared to a net loss of $18.1 million, or $0.13 per share, in the corresponding period in 2021. For the second quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.8 million for both quarters.

Cash and Investments: As of June 30, 2022, Lexicon had $62.0 million in cash and investments, as compared to $86.7 million as of December 31, 2021. This amount does not include $82.2 million in approximate net proceeds received from the company’s July 27, 2022 public offering and concurrent private placement of its common stock.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 78319165. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

On August 2, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the U.S. Patent and Trademark Office (USPTO) has granted the patent (Patent No. US 11,401,329) of its anti-CD47 antibodies (Press release, Phanes Therapeutics, AUG 2, 2022, View Source [SID1234617318]). The patent relates to the invention of anti-CD47 monoclonal antibodies and bispecific antibodies comprising an anti-CD47 arm, including PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for gastric and pancreatic cancers, and PT217, an anti-DLL3/anti-CD47 bispecific antibody being developed for the treatment of small cell lung cancer.

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Phanes has received clearance from the US FDA to commence Phase I studies with PT886 in June 2022 and expect to file IND with PT217 this year. Both PT886 and PT217 have been granted orphan drug designation from the FDA in June this year.

"This is the sixth Phanes patent granted this year." said Dr. Ming Wang, PhD, MBA, Founder and CEO of Phanes Therapeutics. "As Phanes expands from a research to a clinical development stage organization, we expect to have additional patent applications issued, further strengthening the intellectual property portfolio and competitiveness of our pipeline."

On August 2, 2022 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that it will release its financial results for the second quarter of 2022 on Wednesday, August 31, 2022 (Press release, Evogene, AUG 2, 2022, View Source [SID1234617317]).

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On the day of the announcement, Company management will host a conference call to discuss the results at 9:00 AM Eastern time, 4:00 PM Israel time.

To access the conference call, please dial +1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately two hours following the completion of the call. To access the replay, please dial +1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through September 2, 2022, and an archive of the webcast will be available on the webcast link for the following twelve months.