UroGen Pharma to Host UGN-102 Data Event on July 27, 2023

On July 6, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that it will host a data event on Thursday, July 27th, 2023 at 10:00 a.m. Eastern Time (Press release, UroGen Pharma, JUL 6, 2023, View Source [SID1234633090]). The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and will highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials.

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For ENVISION, UroGen will provide complete response rate (the primary endpoint) from approximately 240 patients who completed the study; and for ATLAS, the predecessor to ENVISION, UroGen will provide disease free survival (the primary endpoint) as well as complete response, durability, and safety data from approximately 280 patients that completed the study. The program will also feature Key Opinion Leaders and a panel discussion on the treatment of LG-IR-NMIBC.

Please register for the webinar under the Events & Presentations section of the Company’s Investor Relations site (View Source).

Following the live audio webcast, a replay will be available on the Company’s website (View Source).

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

Shorla Oncology Announces Licensing Agreement and Strategic Partnership for Rights to Market Chemotherapy Drug, PIP-101, in the United States

On July 6, 2023 Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, reported that it has entered into a licensing agreement and strategic partnership with a U.K.-based innovative drug development and manufacturing company (Press release, Shorla Oncology, JUL 6, 2023, View Source [SID1234633088]). Under the terms of the agreement, Shorla will obtain an exclusive license from the developer to register and commercialize PIP-101, the first palatable oral solution of the related chemotherapeutic agent in the U.S.

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PIP-101 is an oral solution treatment that slows or stops the growth of certain forms of leukemia, such as acute lymphoblastic leukemia and chronic myeloid leukemia.

"We are excited to partner with and leverage the developer’s oral oncology liquid manufacturing expertise," said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. "This commercial partnership is a strong endorsement of our commitment to bring to market differentiated oncology treatments to address key areas of unmet needs for patients."

Under the terms of the agreement, the developer will continue to manufacture PIP-101. Once Shorla has obtained approval of its New Drug Application (NDA), the company will be responsible for the timely launch, commercialization and sales of PIP-101 in the U.S.

"We look forward to a long-term relationship with the developer with not only PIP-101, but other treatments that are in the pipeline," said Orlaith Ryan, CTO and co-founder of Shorla Oncology. "We expect this partnership will take both companies to new heights and provide much-needed oncology treatments to patients with cancer."

The U.S. Food and Drug Administration recently approved Shorla Oncology’s Nelarabine Injection for the treatment of T-cell Leukemia, an aggressive blood and bone marrow cancer. Shorla also has plans to have three products on market and three or more in development by end of year 2024.

NKGen Biotech Inc. and Graf Acquisition Corp. IV to Co-Host Investor Event

On July 6, 2023 NKGen Biotech Inc. ("NKGen"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapies, and Graf Acquisition Corp. IV (NYSE: GFOR, GFOR.U, GFOR WS) ("Graf") reported that it will co-host an investor event at the Lotte New York Palace Hotel on July 20, 2023 at 10:00 AM ET (Press release, NKMax America, JUL 6, 2023, View Source [SID1234633087]).

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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

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Presentation topics include NKGen’s differentiated intellectual property and approach to NK cell therapy for Alzheimer’s and Parkinson’s diseases, NKGen’s Phase 1 clinical trial data of SNK01 to treat patients with Alzheimer’s disease, preclinical compassionate use case studies, and the proposed business combination transaction between NKGen and Graf.

A live question and answer session will follow the formal presentation. Register to attend in-person or virtually through the link here.

Entry into a Material Definitive Agreement

On June 30, 2023 (the "Closing Date"), Myriad Genetics, Inc. (the "Company") reported to have entered into a Credit Agreement (the "Credit Agreement") with the lenders from time to time party thereto ("Lenders"), certain of the Company’s domestic subsidiaries party thereto (the "Guarantors"), and JP Morgan Chase Bank, N.A., as Administrative Agent (in such capacity, "Administrative Agent") and as Issuing Bank, consisting of a revolving credit facility in an initial maximum principal amount of $90,000,000, with an option to increase the maximum principal amount by up to $25,000,000 (the "Credit Facility") (Filing, 8-K, Myriad Genetics, JUL 6, 2023, View Source [SID1234633085]). Availability under the Credit Facility is subject to a borrowing base, which is the lesser of (a) 85% of the Company’s and the Guarantors’ eligible accounts receivable plus certain cash maintained with the Administrative Agent in an amount up to $20,000,000 minus any reserves established by the Administrative Agent in accordance with the Credit Agreement and (b) the aggregate amount of cash collections from eligible accounts of the Company and the Guarantors for the 60 consecutive days most recently ended. The proceeds of the Credit Facility were or will be used for the working capital needs and general corporate purposes of the Company and its subsidiaries, including, without limitation, consummating permitted acquisitions and refinancing existing indebtedness.

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The Credit Facility matures on June 30, 2026. Loans outstanding under the Credit Facility will bear interest at a rate per annum equal to, at the option of the Company, either (a) the greater of (i) the daily Prime Rate, (ii) the daily NYFRB Rate plus 0.50%, and (iii) the monthly Adjusted Term SOFR Rate plus 1.00% (the "ABR") plus an applicable margin ranging from 1.00% to 1.50% depending on the aggregate average unused availability under the Credit Facility during the prior quarter or (b) term SOFR for a tenor of one, three or six months (at the Company’s election) plus 0.10% (the "Adjusted Term SOFR Rate") plus an applicable margin ranging from 2.00% to 2.50% depending on the average unused availability under the Credit Facility during the prior quarter, with an ABR floor of 1.00% and an Adjusted Term SOFR Rate floor of 0.00%.

The Company may elect to prepay all or any portion of the amounts owed prior to the Maturity Date without premium or penalty. The Credit Facility is also subject to customary mandatory prepayments with the proceeds of unpermitted indebtedness and upon the occurrence of an over-advance. Voluntary and mandatory prepayments and all other payments of the Credit Facility must be accompanied by payment of accrued interest on the principal amount repaid or prepaid.

Pursuant to the Credit Agreement, the obligations of the Company are guaranteed by the Guarantors. The obligations of the Company and the Guarantors under the Credit Agreement and under bank products and swap obligations owing by them to any Lender or its affiliates are secured by substantially all of the assets of the Company and its subsidiaries under a Pledge and Security Agreement entered into with the Administrative Agent (the "Security Agreement").

The Credit Agreement requires the Company and the Guarantors, on a consolidated basis, to comply with a minimum liquidity and minimum availability test at all times before achieving a fixed charge coverage ratio of 1.0 to 1.0 and thereafter, to maintain a fixed charge coverage ratio of 1.0 to 1.0 until achieving availability under the Credit Facility of greater than the greater of (a) $10,625,000 and (b) 12.5% of the lesser of the maximum commitment amount and the borrowing base for a period of 30 consecutive days. In addition, the Credit Agreement contains customary representations and warranties and affirmative and negative covenants, including covenants that limit or restrict the Company and its subsidiaries’ ability to incur liens, incur indebtedness, dispose of assets, make investments, make certain restricted payments, merge or consolidate and enter into certain speculative hedging arrangements. The Credit Agreement includes a number of customary events of default, including, among other things, nonpayment defaults, covenant defaults, cross-defaults to other material indebtedness, bankruptcy and insolvency defaults, material judgment defaults and the occurrence of a change of control. If any event of default occurs (subject, in certain instances, to specified grace periods), the principal, premium, if any, interest and any other monetary obligations on all the then outstanding amounts under the Credit Facility may become due and payable immediately.

The foregoing description of the Credit Agreement and the Security Agreement is qualified in its entirety by reference to the complete terms and conditions of the Credit Agreement and the Security Agreement, which are filed as Exhibit 10.1 and 10.2, respectively, to this Current Report on Form 8-K.

Moleculin to Participate in the Virtual Investor Summer Spotlight Series

On July 6, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that Walter Klemp, President and Chief Executive Officer and Jon Foster, Executive VP & Chief Financial Officer of Moleculin, will participate in the Virtual Investor Summer Spotlight Series on Wednesday, July 12, 2023 at 3:00 PM ET (Press release, Moleculin, JUL 6, 2023, View Source [SID1234633084]).

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A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.