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.

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

Genprex Receives USAN Approval of Non-Proprietary Name for Lead Drug Candidate

On June 25, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that the United States Adopted Names (USAN) Council has approved the non-proprietary name quaratusugene ozeplasmid for GPX-001, formerly called Oncoprex immunogene therapy, the Company’s lead drug candidate for non-small cell lung cancer (NSCLC) (Press release, Genprex, JUN 25, 2020, View Source [SID1234561470]).

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The USAN Council is responsible for selecting simple, informative, and unique non-proprietary (generic) drug names. As a part of Genprex’s corporate communication strategy and drug nomenclature branding, the Company is also pursuing formal proprietary brand name approval for its lead drug candidate, GPX-001 (quaratusugene ozeplasmid). Obtaining regulatory approval of these adopted drug names is a necessary step in securing marketing approval.

In conjunction with the adoption of quaratusugene ozeplasmid as the Company’s non-proprietary name for GPX-001, Genprex has rebranded the naming of its unique, proprietary, non-viral nanoparticle delivery system, now referred to as its Oncoprex Nanoparticle Delivery Platform, which is the vehicle used to deliver its oncology platform technologies.

"The USAN’s adoption of our non-proprietary name is another step toward advancing our lead drug candidate, GPX-001 for non-small cell lung cancer, toward commercialization," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "We look forward to the adoption and rollout of a brand name for this drug as we continue to move along the development pathway. In the meantime, we’ve focused our branding efforts on our proprietary, non-viral nanoparticle delivery system with our recognized Oncoprex name. We believe this delivery system is a significant differentiator for GPX-001, as well as an important platform delivery system that could be used for additional drug candidates."

As a part of the rollout of its newly adopted nomenclature and to also include its gene therapy drug candidate for diabetes, referred to as GPX-002, the Company has completed an overhaul of its website, fact sheet and pipeline. For more information, please visit www.genprex.com.

Eureka Therapeutics to Present at Oppenheimer’s Private Life Sciences Company Call Series

On June 25, 2020 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, reported that Dr. Cheng Liu, President and Chief Executive Officer, is scheduled to participate at Oppenheimer’s Private Life Sciences Company Call Series on Monday, June 29, 2020 (Press release, Eureka Therapeutics, JUN 25, 2020, View Source [SID1234561488]).

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Dr. Liu will be presenting the use of Eureka’s novel antibody-TCR receptor (ARTEMIS T cell) that has been engineered with a proprietary human TCR-mimic antibody to target the alpha fetoprotein (AFP)-peptide/HLA-A2 complex on HCC cancer cells.

Presentation Details

Title:


ARTEMIS Antibody TCR T Cell Therapy for Solid Tumors

Speaker:


Dr. Cheng Liu, President and CEO

Date:


Monday, June 29, 2020

Time:


3:00 p.m. EST

Location:


View Source

Pfizer Declares Third-Quarter 2020 Dividend

On June 25, 2020 The board of directors of Pfizer Inc. (NYSE:PFE) reported a 38-cent third-quarter 2020 dividend on the company’s common stock, payable September 1, 2020, to holders of the Common Stock of record at the close of business on July 31, 2020 (Press release, Pfizer, JUN 25, 2020, View Source [SID1234561472]). The third-quarter 2020 cash dividend will be the 327th consecutive quarterly dividend paid by Pfizer.

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