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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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.

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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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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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.

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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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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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.

On July 6, 2023 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that on July 3, 2023, an authorized sub-committee of the Board of Directors of Mersana granted inducement awards, consisting of stock options to purchase an aggregate of 38,775 shares of its common stock and restricted stock unit awards (RSUs) to acquire an aggregate of 82,260 shares of its common stock, to 5 new employees whose employment commenced in June 2023 (Press release, Mersana Therapeutics, JUL 6, 2023, View Source [SID1234633083]). The awards were granted pursuant to terms and conditions fixed by the Compensation Committee and as an inducement material to each new employee entering employment with Mersana in accordance with Nasdaq Listing Rule 5635(c)(4).

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The option awards have an exercise price of $3.42 per share, which is equal to the closing price of Mersana’s common stock on July 3, 2023. Each option has a 10-year term and will vest over a period of four years, with 25% of the shares vesting on the one-year anniversary of the commencement of the employee’s employment and the remainder vesting in equal quarterly installments over the following three years, subject to the applicable employee’s continued service with Mersana on each such vesting date. The options are subject to the terms and conditions of Mersana’s 2022 Inducement Stock Incentive Plan and the terms and conditions of a stock option agreement covering each grant.

The RSUs will vest in equal annual installments on the first four anniversaries of May 15, 2023, subject to the applicable employee’s continued service with Mersana on each such vesting date. The RSUs are subject to the terms and conditions of Mersana’s 2022 Inducement Stock Incentive Plan and the terms and conditions of an RSU agreement covering each grant.

On July 6, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that its lead program, paxalisib, has been awarded Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy (Press release, Kazia Therapeutics, JUL 6, 2023, View Source [SID1234633082]).

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The FDA’s decision to grant FTD was based on promising clinical data from an interim analysis of an ongoing Phase 1 clinical trial in which patients with brain metastases from a primary tumour are receiving paxalisib in combination with radiotherapy (NCT04192981). These clinical data were presented at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases, jointly organized by the Society for Neuro-Oncology (SNO) and the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper), by Dr. Jonathan Yang, lead investigator in the clinical trial. All nine evaluable patients in the trial (100%) responded to the combination of paxalisib with radiotherapy. Published benchmarks suggest a typical response rate for radiotherapy alone to be around 20-40%.

Key Points

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FTD is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.

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FTD provides Kazia with enhanced access to FDA, including opportunities for face-to-face meetings and written consultation throughout the remaining development of paxalisib. Drugs granted FTD may also be eligible for Accelerated Approval and Priority Review, which may result in faster product approval.

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Paxalisib was previously granted FTD for glioblastoma in August 2020, giving paxalisib now two largely independent opportunities to access the benefits of this designation.

"Brain metastases are rapidly emerging as a key pillar of paxalisib’s clinical development," said Dr. John Friend, Chief Executive Officer of Kazia. "We have seen a high level of interest from clinicians in the emerging data from this patient population, and it is exciting to now have that interest complemented by FDA’s award of Fast Track Designation. With important data read-outs expected in adult and childhood brain cancer during CY2023, we will be working with investigators and advisors to drive forward our research in brain metastases also."

Brain Metastases

Brain metastases are a common complication of many tumours, but are particularly common in breast cancer, lung cancer, and melanoma. Brain metastases are typically highly resistant to treatment and survival rates are generally low. More than 250,000 patients are diagnosed with brain metastases each year in the United States alone.

Radiotherapy is a common treatment modality for brain metastases. Despite some efficacy, patients typically become resistant over time, and repeat courses of radiotherapy can be associated with significant neurological toxicity.

Expansion of Paxalisib Brain Metastases Study

The Phase I study (NCT04192981)is evaluating the safety and efficacy of paxalisib in combination with whole brain radiotherapy (WBRT) in patients with brain metastases and leptomeningeal metastases from any primary tumour (cancer that has spread to the brain from elsewhere in the body). The study was designed and initiated by Dr. Jonathan Yang, when he was at Memorial Sloan Kettering Cancer Center in New York, NY.

The study was designed in two stages. The first stage aimed to recruit 12 patients and was intended to establish the maximum tolerated dose (MTD) for paxalisib in conjunction with WBRT. Subject to positive results in the first stage, the study includes a second stage to assess initial efficacy signals and establish whether further development is warranted.

The results of the first stage of the study were reported at the SNO / ASCO (Free ASCO Whitepaper) 2022 Annual Conference on CNS Trials and Brain Metastases in August 2022. The combination was reported to be generally well-tolerated, with all nine evaluable patients showing evidence of clinical response.

Recruitment of the second stage commenced in 2H CY2022. The study is now open at two additional clinical sites: Miami Cancer Institute in Miami, FL, and the Fred Hutchinson Cancer Center in Seattle, WA, where Dr. Yang is now based.

Fast Track Designation

Introduced under the FDA Modernization Act (1997), FTD may be awarded by FDA to investigational drugs which are intended to treat a serious or life-threatening condition, and which fill an unmet medical need. FTD must be requested by the sponsor company and must be accompanied by a detailed review of both preclinical and clinical data. To be awarded FTD, drugs must generally be able to show some potential advantage over existing therapies, either in terms of safety or efficacy.

The key benefits of FTD comprise enhanced access to FDA, with regular and more frequent opportunities for consultation and discussion. In addition, drugs with FTD may be eligible for Accelerated Approval, in which a new medicine is approved based on a surrogate endpoint, and Priority Review, in which the standard 12-month review process may be reduced to eight months. Drugs with FTD may also receive a ‘rolling review’ of their NDA submission, in which sections are submitted for review as they become available, potentially expediting the approval process.

Next Steps

Further data from the ongoing Phase 1 study is expected in 1Q CY2024. Kazia continues to hold discussions with clinicians and advisors regarding the potential design of a registrational study in this indication.

Paxalisib is also the subject of nine other ongoing clinical trials, including the pivotal GBM AGILE study in glioblastoma, which is expected to provide final data in 2H CY2023, and a phase II study in pediatric patients with diffuse midline gliomas, which is expected to provide initial data in 3Q CY2023.