On June 22, 2022, Applied Therapeutics, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with SVB Securities LLC (the "Underwriter"), relating to the issuance and sale pursuant to an underwritten public offering (the "Offering") of 20,000,000 shares (the "Shares") of its common stock, par value $0.0001 per share (the "Common Stock"), 10,000,000 pre-funded warrants to purchase Common Stock in lieu of Shares (the "Pre-Funded Warrants") at an exercise price of $0.0001 per share, and accompanying warrants to purchase up to 30,000,000 shares of its Common Stock (the "Common Warrants" and together with the Pre-Funded Warrants, the "Warrants") at an exercise price of $1.00 per share (the Shares and Warrants together, the "Securities") (Filing, 8-K, Applied Therapeutics, JUN 22, 2022, View Source [SID1234616309]). Each share of Common Stock and accompanying Common Warrant was sold at a public offering price of $1.00, less underwriting discounts and commissions, and each Pre-Funded Warrant and accompanying Common Warrant was sold at a public offering price of $0.9999, less underwriting discounts and commissions, as described in the prospectus supplement, dated June 22, 2022, filed with the Securities and Exchange Commission on June 24, 2022. The Pre-Funded Warrants and the Common Warrants are immediately exercisable and will expire five years from the date of issuance. Holders may not exercise any Pre-Funded Warrants or Common Warrants that would cause the aggregate number of shares of Common Stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding Common Stock immediately after exercise. Holders of the Warrants (together with affiliates) who immediately prior to the issue date beneficially own more than 9.99% of outstanding Common Stock may not exercise any portion of their Pre-Funded Warrants or Common Warrants if the holder (together with affiliates) would beneficially own more than 19.99% of the Company’s outstanding Common Stock after exercise. The Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Warrants will be entitled to receive, upon exercise of the Warrants, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Warrants immediately prior to such transaction. The Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of Common Stock are entitled. The Company intends to use the net proceeds from this Offering for general corporate purposes. General corporate purposes may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the Company’s product candidates, expansion of the Company’s research and development capabilities, working capital and capital expenditures. Entities affiliated with Alexandria Venture Investments, LLC, which, as of March 31, 2022, owned 13.1% of the Company’s outstanding Common Stock, purchased 3,500,000 shares and 1,500,000 Pre-Funded Warrants in the Offering.

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The Offering closed on June 27, 2022.

On June 22, 2022 The Company reported that entered into a Securities Purchase Agreement (the "Blue Lake Purchase Agreement"), with Blue Lake Partners, LLC ("Blue Lake"), pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $335,000 (the ‘Blue Lake Note") (Filing, 8-K, Mateon Therapeutics, JUN 22, 2022, View Source [SID1234616285]). The Blue Lake Note is convertible into shares of the Company’s common stock, par value $0.01 per share ("Common Stock"). The Blue Lake Purchase Agreement and Blue Lake Note are part of a cumulative debt financing of $1 million through JH Darbie and Co., Inc. ("JH Darbie"), of which the Company raised $605,000 from Mast Hill Fund, LP ("Mast Hill") in May 2022.

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The Mast Hill and Blue Lake Purchase Agreements and the Mast Hill and Blue Lake Notes were entered into for aggregate gross proceeds to the Company of up to $1 million (the "Financing"), undertaken by the Company pursuant to a Finder’s Fee Agreement between the Company and JH Darbie, dated October 26, 2021 (the "Agreement"). Pursuant to the Agreement, JH Darbie will be entitled to a finder’s fee of: (a) 10% of the gross proceeds received by the Company in cash; and (b) warrants equal 10% warrant coverage of the amount raised, with a purchase price equal to the Conversion Price, with such warrants to expire five years from the date of issuance. For this Financing, JH Darbie has agreed to accept a lower cash finder’s fee of 4.5% of the gross proceeds and warrant coverage of 10%. The Blue Lake Purchase Agreement and the Blue Lake Note contain identical terms to the securities purchase agreements (and promissory notes issued thereunder), to the Mast Hill funding from May 27, 2022 (the "Prior Issuance"), except with reference to the name of the holders, the use of proceeds, which included repayment of certain debt, general corporate expenses and payroll, as applicable, and the law governing the terms of the Prior Issuance. The Prior Issuance was previously reported on our Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on June 3, 2022.

The Notes carry an interest rate of 12% per annum and matures on the earlier of (a) the one-year anniversary of the date of the Purchase Agreements, or (b) the acceleration of the maturity of the Notes by the applicable holder upon occurrence of an Event of Default (as defined below). The Notes contain a voluntary conversion mechanism whereby the applicable holder may convert the outstanding principal and accrued interest under the terms of the Notes into shares of Common Stock (the "Conversion Shares"), at a fixed price of $0.10 per share (the "Conversion Price"), subject to adjustments upon the occurrence of certain corporate events. The Company also issued 3,025,000 warrants to purchase shares of Common Stock of the Company at an exercise price of $0.20. Prepayment of the Notes may be made at any time upon three trading days’ prior written notice to the respective holder, by payment of the then outstanding principal amount plus accrued and unpaid interest and reimbursement of such holder’s administrative fees. The Notes contains customary events of default (each an "Event of Default"). If an Event of Default occurs, at the respective holder’s election, the outstanding principal amount of the Notes, plus accrued but unpaid interest, will become immediately due and payable in cash. The Purchase Agreements require the Company to use the proceeds for general working capital, and not for (i) the repayment of any indebtedness owed to officers, directors or employees of the Company or their affiliates, (iii) any loan to or investment in any other corporation, partnership, enterprise or other person (except in connection with the Company’s currently existing operations), (iv) any loan, credit, or advance to any officers, directors, employees, or affiliates of the Company, or (v) in violation or contravention of any applicable law, rule or regulation.

The issuance of the Notes are exempt from the registration requirements of the Securities Act of 1933, as amended ("Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act. The shares of Common Stock issuable upon conversion of the Notes have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

The foregoing descriptions of the Purchase Agreements and the Notes are qualified in their entirety by reference to the full text of the form of such agreements, copies of which are attached as Exhibit 10.1 and 10.2, respectively and each of which is incorporated herein in its entirety by reference.

On June 22, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the signing of a definitive agreement for the sale of revenues from U.S. and European royalty and milestone interests in Klisyri (tirbanibulin) to Sagard Healthcare Partners and funds managed by Oaktree Capital Management, L.P. ("Oaktree") for $85 million (Press release, Athenex, JUN 22, 2022, View Source [SID1234616235]). Approximately $80 million of the proceeds from the transaction will be used toward partially paying down existing debt and operating the business, with $5 million to be placed into escrow and paid to Athenex upon the satisfaction of certain conditions. The transaction is subject to customary closing conditions.

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"We are executing on our new strategy and will continue to deliver on the objectives that we laid out to extend our cash runway by over 18 months. We are pleased to enter into this agreement, as we believe it generates meaningful benefits for our stockholders as we continue to pay down debt and extend our cash runway," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "The sale of the revenues from the U.S. and European royalty and milestone interests in Klisyri represents another step in continuing to monetize non-core assets to focus on developing our potential best-in-class NKT cell platform."

Ladenburg Thalmann & Co. Inc. and Royalty/Revenue Interest Capital Advisors LLC served as financial advisors to Athenex and Cooley LLP served as legal counsel to Athenex. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to Sagard Holdings and Oaktree.

On June 22, 2022 Race Oncology Limited ("Race") reported to share further interim results from its preclinical melanoma research program (ASX announcement: 19 March 2021) (Press release, Race Oncology, JUN 22, 2022, View Source [SID1234616228]). The program’s objective was to explore the use of Zantrene (bisantrene dihydrochloride) in novel drug combinations for the treatment of drug and immunotherapy resistant melanomas using cell and animal models.

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Used at low concentrations, Zantrene was found to enhance cancer immunotherapy in three distinct and complementary ways: (1) direct killing of melanoma cells; (2) activation of immune cells targeting the tumour, and (3) reducing the expression of immune evasion genes in the tumour.

On June 22, 2022 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported the launch of a research test, codeveloped with Merck (known as MSD outside the United States and Canada) (Press release, Illumina, JUN 22, 2022, https://www.prnewswire.com/news-releases/illumina-launches-research-test-codeveloped-with-merck-to-unlock-deeper-insights-into-the-tumor-genome-301571457.html [SID1234616196]). The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology. The test adds assessment of a new genomic signature to the distributed, market leading TruSight Oncology 500 assay. It will be available globally, excluding the United States and Japan and will enable researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD).

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Illumina, Inc. reported the launch of a research test, codeveloped with Merck. The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
Illumina, Inc. reported the launch of a research test, codeveloped with Merck. The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
"HRD status has emerged as an important biomarker in tumors that harbor high levels of DNA damage, such as ovarian, breast, prostate, and pancreatic cancers," said Phil Febbo, MD, chief medical officer at Illumina. "With one sample and one test, TruSight Oncology 500 HRD assay provides labs with comprehensive, accurate, sensitive results that can greatly enhance our understanding of the genomic nature of a tumor."

The Research Use Only TruSight Oncology 500 HRD test is a next-generation sequencing (NGS)–based assay that harnesses the power of Illumina NGS technology and validated HRD technology from Myriad Genetics (NASDAQ: MYGN), enabling labs to accurately detect genomic instability and analyze more than 500 genes simultaneously, including those relevant to HRD status. HRD is a genomic signature used to describe when cells are unable to effectively repair double-stranded DNA breaks. When this occurs, cells rely on alternative, error-prone DNA repair mechanisms, which may lead to genomic instability and, eventually, tumor formation.

The Molecular Pathology Diagnostic Unit at the Technical University of Munich participated in the TSO 500 HRD early access program in order to compare the results of Illumina’s prototype TSO 500 HRD assay to a validated reference standard, from Myriad Genetics.

"Our institution is delighted by the release of TruSight Oncology 500 HRD and we are very happy with our results from the early access program," said Nicole Pfarr, head of the Molecular Pathology Diagnostic Unit, Technische Universität München. "We look forward to using this assay routinely in our lab for future projects. Combining HRD assessment with TruSight Oncology 500 in one workflow will unlock the most comprehensive view of the tumor genome, while maintaining efficiency in the lab."

Large-cohort studies show that comprehensive genomic profiling (CGP) has the potential to identify relevant genetic alterations in up to 90% of samples. A single, comprehensive assay to assess a wide range of biomarkers uses less sample and returns results more quickly compared to multiple, iterative tests. As a kitted, distributable solution, this test helps to remove barriers for internalization of CGP and HRD testing, so that labs of all sizes can offer this powerful test.

"We are pleased to reach this first milestone with Illumina to commercialize an assay for HRD assessment that will aid in advancing clinical research and broaden access to clinical trials," said Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

The research test is expected to begin shipping globally (excluding the US and Japan) in August. In addition, as part of the partnership announced in September 2021, work is ongoing to develop a new HRD companion diagnostic (CDx) test for the EU and the UK to aid in the identification of ovarian cancer patients with positive HRD status.

This partnership expands on Illumina’s broad portfolio of oncology partnerships with industry leaders, with the united goal of advancing cancer diagnostics and precision medicine.

About TruSight Oncology 500
TSO 500 is a Research Use Only pan-cancer assay that enables Comprehensive Genomic Profiling. Designed to identify known and emerging tumor biomarkers across 523 genes, TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. In addition, the assay assesses key immune-oncology biomarkers, such as Tumor Mutational Burden (TMB), Microsatellite Instability (MSI) and Homologous Recombination Deficiency (HRD). Due to its comprehensive biomarker content, labs can consolidate multiple single-gene or small-panel workflows into a single assay, saving biopsy specimen and time. Click here to learn more.