On September 3, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, reported maturity of a $13 million convertible note from its previously announced strategic transaction with Imugene Limited (ASX: IMU) for azercabtagene zapreleucel (azer-cel) in oncology (Press release, Precision Biosciences, SEP 3, 2024, View Source [SID1234646306]). The proceeds to Precision BioSciences include $9.75 million in cash and $3.25 million in Imugene ordinary shares.

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"We are pleased that Imugene continues to advance azer-cel toward a pivotal trial in LBCL for patients with significant unmet need," said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. "This marks one year since our strategic decision to focus our in-house programs exclusively on in vivo gene editing and further bolsters our balance sheet, enabling us to generate Phase 1 clinical data across multiple in vivo gene editing programs starting in the first half of 2025. In the near term, we are focused on progressing our pipeline towards the clinic and remain on track to file applications with multiple global regulatory bodies for PBGENE-HBV for chronic hepatitis B later this year."

In August 2023, Precision announced a strategic transaction with Imugene. Under the agreement, Imugene assumed global rights to azer-cel for cancer, the ongoing clinical execution for azer-cel in large B-cell lymphoma (LBCL) patients who have relapsed following autologous CAR T treatment as well as Precision BioSciences’ CAR T capability, including manufacturing. In exchange, Precision received upfront economics valued at $21 million (all figures in USD) consisting of $8 million in cash and a $13 million convertible note. The convertible note matured on August 30, 2024 and resulted in payment to Precision of $9.75 million in cash and $3.25 million in Imugene stock. Precision is also eligible for additional payments based on azer-cel clinical milestones as well as milestones for other future nominated cancer research programs.

As of June 30, 2024, Precision had approximately $123.6 million in cash and cash equivalents, prior to receipt of the payment from Imugene. Existing cash and cash equivalents, upfront and potential near-term cash from CAR T transactions, along with expected operational receipts, continued fiscal and operating discipline, availability of Precision’s at-the-market (ATM) facility, and marketable securities are expected to extend Precision’s cash runway into the second half of 2026.

On September 3, 2024 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), reported that Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY (Press release, Outlook Therapeutics, SEP 3, 2024, View Source [SID1234646303]).

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In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 9, 2024, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

On September 3, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported that Paul Y. Song, MD, Chairman and CEO of NKGen, will participate in a virtual presentation and one-on-one meetings at the H.C. Wainwright 26th Annual Global Investment Conference, on September 9-11, 2024 (Press release, NKMax America, SEP 3, 2024, https://nkgenbiotech.com/nkgen-biotech-to-present-at-the-h-c-wainwright-26th-annual-global-investment-conference/ [SID1234646302]).

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The virtual presentation will be available on-demand for registered participants through the H.C. Wainwright conference portal starting at 7:00 AM Eastern Time on Monday, September 9, 2024. Registered participants can submit their questions to NKGen after the presentation has become available. Dr. Song will also be available for virtual one-on-one investor meetings during the conference.

For more information about the conference and to register for a one-on-one meeting, please visit the conference website at View Source

A webcast of the pre-recorded presentation can be accessed under the Events and Presentations page in the Investors section of the Company’s website at www.nkgenbiotech.com. An archived replay of the webcast will be available for 90 days following the presentation.

On September 3, 2024 Nkarta, Inc., a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conference (Press release, Nkarta, SEP 3, 2024, View Source [SID1234646301]):

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H.C. Wainwright 26th Annual Global Investment Conference
September 10, 2024
12:30 p.m. ET – fireside chat

A simultaneous webcast of each event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On September 3, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, reported that the Data Safety and Monitoring Board (DSMB) has validated the continuation of the Phase II trial, NANOBRAINMETS, managed by the Dana Farber Cancer Institute, following the futility analysis scheduled after the enrollment and follow up of 50% of patients in the study (Press release, NH TherAguix, SEP 3, 2024, View Source [SID1234646300]).

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Ongoing evaluation of the study has revealed no serious adverse events related to the administration of AGuIX, highlighting the very favorable safety profile of this drug candidate. Developed by NH TherAguix, AGuIX is designed to improve tumor targeting and increase radiobiological damage to tumor tissue locally, thanks to its radiation signal amplification capabilities.

96 patients have been randomized up to date on the 134 scheduled in the study’s protocol.

NANOBRAINMETS is a randomized, double-blind Phase II trial evaluating AGuIX in combination with stereotactic radiotherapy in patients with brain metastases, compared with a control arm using stereotactic radiotherapy alone. Next interim analysis is currently expected by the end of this year to assess the clinical efficacy of AGuIX.

Dr. Ayal Aizer, MD, MHS, Director of the Central Nervous System Radiation Oncology Division at the Brigham and Women’s Hospital / Dana-Farber Cancer Institute, principal investigator of the NANOBRAINMETS study said: "We are very pleased to continue this cutting-edge clinical trial, which evaluates a promising new treatment for patients suffering from brain metastases. This study could lead to the development of a new standard of treatment for these devastating cancers, addressing a significant medical need today."

Dr. Olivier de Beaumont, CMO of NH TherAguix said: "We sincerely thank Dr. Aizer and the teams at the Dana-Farber Cancer Institute for constant and fruitful collaboration of more than 10 years of research with NHT team".

Vincent Carrère, CEO of NH TherAguix, added: "This first positive step paves the way for the major next inflexion point expected in the second half of the year regarding the interim efficacy analysis of AGuIX. The Phase II final results expected by Q2-Q3 2026 will be decisive for the further clinical development of AGuIX and its commercial approval for treating these cancers with high medical need."