Chi-Med to Announce 2020 Half-Year Financial Results

On June 26, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it will be announcing its interim results for the six months ended June 30, 2020 on Thursday, July 30, 2020 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)) (Press release, Hutchison China MediTech, JUN 26, 2020, https://www.chi-med.com/chi-med-to-announce-2020-half-year-financial-results/ [SID1234561495]).

Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by Chi-Med management.

The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Thursday, July 30, 2020 and will be webcast live via the company website at www.chi-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.

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Artiva Biotherapeutics Launches with $78 Million Series A Financing to Advance NK Cell Therapies to Treat Cancer

On June 26, 2020 Artiva Biotherapeutics, Inc., an oncology company focused on developing and commercializing allogeneic natural killer (NK) cell therapies, reported the launch of the company with the close of a $78 million Series A financing (Press release, Artiva Biotherapeutics, JUN 26, 2020, View Source [SID1234561489]). The financing was co-led by 5AM Ventures, venBio Partners, and RA Capital Management, and joined by Medivate Partners and seed investors and strategic partners GC LabCell (Green Cross LabCell Corporation) (KRX: 144510) and GC (Green Cross Holdings Corporation) (KRX: 005250). Artiva will use the proceeds of this financing to develop off-the-shelf universal NK cells for use in combination with monoclonal antibody therapy and tumor targeting CAR-NK cell therapies.

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"We have seen tremendous breakthroughs in redirecting immune cells against cancer, but patient access to these therapies has been limited by safety, scale, manufacturing, logistics, and cost issues," said Tom Farrell, President and CEO of Artiva. "Our goal at Artiva is to do more, leveraging GC LabCell’s foundational work on true off-the-shelf NK cells into a pipeline of product candidates that are accessible to any cancer patient who may benefit."

Artiva’s initial pipeline includes AB-101, a universal NK cell therapy for use in combination with monoclonal antibodies. The company plans to enter the clinic this year with AB-101 in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma. The company is also advancing AB-201, a novel HER2-specific CAR-NK cell therapy for the treatment of HER2+ solid tumors, and AB-202, a CD19-specific CAR-NK cell therapy for the treatment of CD19+ B-cell malignancies. In each case, a large scale of production along with effective cryopreservation enables high and repeat dosing.

Scaling NK Cell Therapy for Cancer

Artiva’s pipeline of universal and targeted NK cell therapies leverages the innate anti-tumor biology and safety features of NK cells. The therapies are optimized for enhanced efficacy through chimeric antigen receptors (CARs), therapeutic antibody combination therapy, and genetic engineering. The pipeline leverages a manufacturing platform that supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies and proprietary CAR-NK and NK-specific gene-editing technologies to augment therapeutic activity.

Artiva’s platform incorporates cell expansion, activation, and engineering technology developed and enhanced through mid-stage clinical trials by the company’s corporate partner, GC LabCell. Artiva has exclusive ex-Asia-Pacific license agreements with GC LabCell covering their core manufacturing and CAR technology and initial product candidates and an option to take exclusive ex-Asia-Pacific licenses to additional research candidates generated by GC LabCell, under the governance of a Joint Steering Committee.

"The inherent biology of natural killer cells holds enormous therapeutic potential for cancer therapy, but until Artiva, technological barriers held back their advancement," said 5AM Ventures partner Brian Daniels, M.D. "Artiva is systematically resolving the barriers to safe and effective NK cell therapies at a scale that enables broader access to potentially life-saving cancer treatments."

Leadership Team: Deep Cell Therapy and Oncology Experience

Artiva’s proven executive team brings deep, diverse cell therapy and oncology experience to research and advance a pipeline of NK and CAR-NK cell therapies to treat cancer.

ERC Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP

On June 26, 2020 ERC Belgium, a clinical-stage biopharmaceutical company developing immunotherapies for the treatment of cancer, reported that it has submitted to the EMA its Marketing Authorization Application (MAA) for conditional approval of its lead product SITOIGANAP (ERC1671) to treat recurrent glioblastoma (GBM) (Press release, ERC Belgium, JUN 26, 2020, View Source [SID1234561485]).

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The MAA contains observations suggesting safety and efficacy of SITOIGANAP demonstrated from the interim data of a randomized double-blind phase II trial. The data show that administration of SITOIGANAP/GM-CSF/Cyclophosphamide combined with bevacizumab results in a clinically meaningful survival benefit with minimal toxicity.

The SITOIGANAP regimen presents unique advantages in comparison to historical controls and it significantly increased overall survival and median survival compared to controls. Moreover, current clinical data supports the safety of this product, with no severe adverse events observed; related side effects were grade 1 and 2 headache and local skin reactions.

Approximately 10% of the patients that received SITOIGANAP experienced total recovery and survived longer than 3 years when treated following GBM recurrence and after receiving standard of care. In contrast, no spontaneous remissions were observed in the control group, and all patients showed tumor progression.

Apostolos Stathopoulos, MD, PhD, President and CEO of ERC Worldwide commented, "We are excited to see such strong results from SITOIGANAP, especially the high number of patients going into remission. The beneficial advantage that we are bringing to patients suffering from this orphan disease like GBM is groundbreaking, especially being able to help those patients who have advanced to a stage without alternative therapeutic options."

About SITOIGANAP

SITOIGANAP is an advanced immunotherapy based on freshly extracted tumor cells and lysates that stimulates the patient’s immune system to recognize and reject cancer cells. The immunotherapy contains a combination of autologous tumor cells, and allogeneic tumor cells, generated from the glioma tumor tissues of three different donor cancer patients, and the lysates of all of these cells. Upon injection, this mixture stimulates the patient’s immune system to mount an immune response against the tumor cells, which may lead to their destruction.

SITOIGANAP is for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed. The response to SITOIGANAP is the same whether the MGMT promoter is methylated or unmethylated.

SITOIGANAP is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma multiforme and gliosarcoma.

New Study Demonstrates the Ability of myPath® Melanoma to Accurately Classify Lesions Ruled Indeterminate by Standard Pathological Assessment

On June 25, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, reported that a new study published in Future Medicine demonstrates the ability of myPath Melanoma to accurately classify skin lesions ruled indeterminate by standard pathological review (Press release, Myriad Genetics, JUN 25, 2020, View Source [SID1234561738]).

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"This validation study for myPath Melanoma demonstrates the ability of the test to accurately classify lesions which are ruled indeterminate by an expert dermatopathologist," said Nicole Lambert, president of Myriad International, Oncology and Women’s Health. "Importantly, this accuracy was linked to the gold standard endpoint of real world clinical outcomes demonstrating the accuracy of the myPath Melanoma test result for patients and physicians concerned about this deadly cancer."

The study evaluated 181 skin lesions of which 125 were ruled indeterminate by at least one of seven blinded dermatopathologists who reviewed the samples. The samples were linked to known real world outcomes with 43 percent of samples representing malignant melanomas. Importantly, myPath Melanoma demonstrated 90.4 percent sensitivity and 95.5 percent specificity in the indeterminate sample cohort and 93.8 percent sensitivity and 96.2 percent specificity when evaluating the entire sample cohort. This data is consistent with multiple other clinical validation studies for myPath Melanoma which have demonstrated the ability of the test to delineate melanoma from benign skin lesions with high diagnostic accuracy.

About Melanoma
According to the American Cancer Society, approximately 100,350 Americans are expected to be diagnosed with melanoma this year. Early and accurate diagnosis of melanoma is critical for long-term survival.

About Myriad myPath Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. The test measures the expression of 23 genes and accurately distinguishes melanoma from benign nevi. For more information visit: View Source

Entry into a Material Definitive Agreement

On June 24, 2020 (the "Closing Date"), HTG Molecular Diagnostics, Inc. (the "Company") reported that it entered into a Loan and Security Agreement (the "Loan Agreement"), by and among the Company and Silicon Valley Bank ("SVB"), as lender, which provides a secured term loan in the principal amount of $10.0 million (the "Term Loan") (Filing, HTG Molecular Diagnostics, JUN 25, 2020, View Source [SID1234561674]).

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The proceeds from the Term Loan were fully funded on the June 25, 2020. The proceeds from the Term Loan, together with cash on hand, were used to repay in full all outstanding amounts and fees due under the (i) Credit and Security Agreement (Term Loan), dated as of March 26, 2018, by and among the Company, as borrower, the lenders party thereto from time to time and MidCap Financial Trust, as agent (the "MidCap Term Loan"), in the aggregate amount of approximately $7.5 million, (ii) Credit and Security Agreement (Revolving Loan), dated as of March 26, 2018, by and among the Company, as borrower, the lenders party thereto from time to time and MidCap Funding IV Trust (together with MidCap Financial Trust, "MidCap"), as agent (the "MidCap Revolving Loan"), in the aggregate amount of approximately $22,000 and (iii) Subordinated Convertible Promissory Note, dated as of October 26, 2017, issued by the Company to Qiagen North American Holdings, in the aggregate amount of approximately $3.2 million.

The Term Loan bears interest at a floating rate equal to the greater of 2.50% above the Prime Rate (as defined in the Loan Agreement) and 5.75%. Interest on the Term Loan is due and payable monthly in arrears. The Term Loan has interest-only payments through June 30, 2021. The interest only period may be extended for six months upon the achievement of an equity milestone as more fully described in the Loan Agreement. The ultimate interest-only period will be followed by equal monthly payments of principal and interest through the maturity date of January 1, 2024.

Prepayments of the Term Loan, in whole or in part, will be subject to early termination fees in an amount equal to 3.0% of principal prepaid if prepayment occurs on or prior to the first anniversary of the Closing Date, 2.0% of principal prepaid in prepayment occurs after the first anniversary of the Closing Date but on or prior to the second anniversary of the Closing Date, and 1.0% of principal prepaid if prepayment occurs after the second anniversary of the Closing Date and prior to the maturity date.

Upon termination of the Loan Agreement, the Company is required to pay an exit fee equal to 8.00% of the principal amount of the Term Loan.

The Company’s obligations under the Loan Agreement are secured by a security interest in substantially all of its assets, excluding intellectual property (which is subject to a negative pledge). Additionally, the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the Loan Agreement.

The Loan Agreement contains customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries, if any, to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The Company must also comply with a financial covenant requiring the Company to maintain unrestricted cash at an account with SVB of not less than the greater of (i) $12.5 million and (ii) an amount equal to six (6) times the amount of Company’s average trailing three (3) month Cash Burn (as defined in the Loan Agreement), tested monthly as of the last day of each month.

The Loan Agreement also contains customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, delisting of the Company’s common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, SVB may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the agreement. During the existence of an event of default, interest on the obligations could be increased by 5.0%.

Warrant

In connection with the Loan Agreement, the Company granted to SVB a warrant to purchase up to 643,413 shares of the Company’s common stock at a purchase price of $0.7771 per share (the "Warrant"). The Warrant will

expire on June 24, 2030 and may be exercised for cash or at the election of the holder on a cashless, net exercise basis.

The foregoing is only a summary of the material terms of the Loan Agreement and the Warrant and does not purport to be complete and is qualified in its entirety by reference to the full text of the Loan Agreement and the Warrant, copies of which are filed as Exhibit 10.1 and Exhibit 4.1 to this report, respectively.