On September 29, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the oral presentation of the final readout on primary objectives from Study 102 Dose Expansion—the expansion part of a Phase 1 dose escalation and dose expansion study evaluating potential first-in-class radioenhancer NBTXR3 for elderly patients with locally advanced head and neck cancer—at the 65th Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Nanobiotix, SEP 29, 2023, View Source [SID1234635544]). These data have also been selected for inclusion in two scientific highlight sessions for review and discussion during the congress.

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Oral Presentation Highlights

ABSTRACT #55260: Novel Radioenhancer NBTXR3 Activated by Radiotherapy in Cisplatin-ineligible Locally Advanced HNSCC Patients: Final Results of a Phase 1 Trial

· Date/Time: Wednesday, October 4, 2023, 3:00 PM EDT / 9:00 PM CEST
· Session: Head and Neck – Augmenting the Potential of Radiation Therapy with Novel Therapeutics and Imaging
· Presenter: Dr. Christophe Le Tourneau, Institut Curie, Paris, France
· Location: Room 1, San Diego Convention Center, San Diego, California

This oral presentation at ASTRO will be followed by a conference call on Thursday, October 5, 2023, at 8:00 AM EDT / 2:00 PM CEST. During the call, Laurent Levy, chief executive officer, will review the Study 102 final data before taking questions from participants.

Details for the call are as follows:
Live (US): 1-877-423-9813
Live France: 0 800 912 848
Live (international): 1-201-689-8573
Call me: click here

Participants can use guest dial-in numbers above and be answered by an operator or they can click the Call me link for instant telephone access to the event (dial-out). The Call me link will be made active 15 minutes prior to scheduled start time. A live webcast of the call may be accessed by visiting the investors section of the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior the event start. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.

Participants are invited to email their questions in advance to [email protected].

On September 29, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that data from an ongoing Phase II study (PNOC022, NCT05009992) of paxalisib, an investigational drug for the treatment of diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC), has been awarded a late breaking oral presentation at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting (Filing, 6-K, Kazia Therapeutics, SEP 29, 2023, View Source [SID1234635541]).

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SNO exists to advance multi-disciplinary brain tumour research, education, and collaboration to drive discovery and improve patient care. The 28th Annual Meeting of the Society for Neuro-Oncology will take place from November 15 – 19, 2023 in Vancouver, Canada.

In line with conference publication guidelines, Late-Breaking Abstracts, for which no more than six will be selected, will be made public at 7:00 AM (EST) on the first day of the scientific meeting, Friday, November 17, 2023 and at View Source

Kazia Chief Executive Officer, Dr John Friend commented, "The Society for Neuro-Oncology conference is a high-profile meeting where many of the best ideas are discussed in brain tumour research. We are very excited that the abstract from the PNOC022 study has been selected for oral presentation in this forum and look forward to sharing data with our shareholders and the market in due course."

About the PNOC phase II study

The PNOC022 Phase II study is sponsored by PNOC, an international consortium focused on the development of novel combination therapies. It is an adaptive platform study that is examining paxalisib in combination with ONC201, an experimental dopamine receptor D2 (DRD2) antagonist developed by Chimerix, Inc. (Durham, NC). PNOC022 is enrolling children and young adults with diffuse midline gliomas, a category of brain tumours that includes DIPG. The study includes separate cohorts comprising newly diagnosed patients, patients who have completed initial radiotherapy, and patients who have experienced disease progression after treatment. The primary endpoint will be the proportion of patients who are progression-free at six months (PFS6) for newly diagnosed patients, and overall survival (OS) for recurrent patients.

On September 29, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported two poster presentations reporting positive data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting, taking place November 1-5, 2023, in San Diego, CA (Press release, In8bio, SEP 29, 2023, View Source [SID1234635540]). The presentations will showcase biological correlative data from the ongoing Phase 1 clinical trial of INB-200, targeting newly diagnosed glioblastoma multiforme (GBM) and pre-clinical insights on IN8bio’s induced pluripotent stem cell (iPSC) gamma-delta T cell platform.

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Details of the presentations at SITC (Free SITC Whitepaper) 2023 are as follows:

Title: INB-200: Phase I study of gene modified autologous gamma-delta (γδ) T cells in newly diagnosed glioblastoma (GBM) patients receiving maintenance temozolomide (TMZ): immunobiologic correlative data
Abstract #: 637
Location: Exhibit Halls A and B1 – San Diego Convention Center
Data and Time: Friday November 3, 2023, 9:00 AM – 8:30 PM PDT

Title: The Development of "Off-the-Shelf" manufacturing strategies of iPSC-based Gamma-Delta T Cells
Abstract #: 418
Location: Exhibit Halls A and B1 – San Diego Convention Center
Data and Time: Saturday November 4, 2023, 9:00 AM – 8:30 PM PDT

About the INB-200 Phase 1 Trial
INB-200 is a genetically modified autologous drug resistant immunotherapy (DRI) product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.

INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM.

On September 29, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on artificial intelligence assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that it has entered into a securities purchase agreement with a healthcare-focused institutional investor for the purchase and sale of 980,393 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $5.10 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Hepion Pharmaceuticals, SEP 29, 2023, View Source [SID1234635539]). In addition, in a concurrent private placement, Hepion will issue to the investor unregistered Series A Warrants to purchase up to an aggregate of 980,393 shares of common stock and Series B Warrants to purchase up to an aggregate of 980,393 shares of common stock. The Series A and Series B Warrants will have an exercise price of $4.85 per share, will be exercisable immediately following the date of issuance and will expire in five years and one and a half years, respectively. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The gross proceeds to Hepion from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by Hepion. Hepion intends to use the net proceeds from the offering for clinical development and working capital.

The shares of common stock (or common stock equivalents in lieu thereof) being offered in the registered direct offering (but not the warrants being in the concurrent private placement or the shares of common stock underlying such warrants) are being offered by Hepion pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254996) previously filed with the Securities and Exchange Commission (the "SEC") on April 2, 2021 and declared effective by the SEC on November 24, 2021. The offering of the shares of common stock (or common stock equivalents in lieu thereof) in the registered direct offering is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 29, 2023 Renovaro Biosciences Inc. (NASDAQ: RENB) (Renovaro), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy reported to have signed a definitive agreement to combine with GEDi Cube Intl Ltd., (GEDi Cube) an AI medical technology company, in which GEDi Cube will become a wholly-owned subsidiary of Renovaro in a stock-for-stock acquisition (the "Transaction") (Filing, 8-K, Enochian BioSciences, SEP 29, 2023, View Source [SID1234635537]).

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If completed, the Transaction will result in a combined company that will offer advanced early diagnosis and early identification of recurring cancer as well as potential therapies for several critical diseases such as pancreatic cancer and other solid tumors with poor life expectancy. It is expected that the combined company will have a unique advantage: Renovaro Biosciences’ pre-clinical and clinical trial data could be utilized to accelerate GEDi Cube’s AI capabilities that, in turn, could potentially help to accelerate Renovaro’s development of potential new therapies. AI will be used to advance the fields of diagnosis and treatment with the aim of redefining the future of medicine.

"We believe GEDi Cube’s AI technology will enhance and accelerate the development of treatments we are currently pursuing as well as power the discovery of new therapeutic approaches for cancer and other diseases," said Dr. Mark Dybul, CEO of Renovaro Biosciences. "The combined company will have independent operating divisions that will allow each technology to move as quickly as possible to commercialization while the collaboration between divisions will aim to drive new advances in both AI and medicine."

"I believe this is a unique opportunity to leverage the capabilities of our two companies, allowing us to accelerate our product development roadmap and our potential to improve diagnostics and treatments for many cancers," said Craig Rhodes, CEO of GEDi Cube. "We expect to begin offering commercial diagnostic products in 2024 that, in our view, will be comparable or superior to what is currently in the marketplace. We are looking forward to this exciting new venture."

GEDi Cube has been developing its innovative technologies over the last decade and has already validated early diagnosis of lung cancer in humans at a leading university hospital. The company has also validated technology to target 12 additional cancers, including pancreatic and breast cancer.

Renovaro Biosciences has developed advanced cell, gene and immunotherapy techniques designed to reignite the body’s natural tumor-fighting capabilities. The company expects to begin human Phase 1/2 clinical trials of its leading candidate for pancreatic cancer and other solid tumors with poor life expectancy by the second half of 2024.

About the Transaction

The Transaction is structured as a stock-for-stock acquisition whereby all of GEDi Cube’s outstanding equity interests will be exchanged for shares of Renovaro common stock. Following the closing of the Transaction, GEDi Cube equity holders are expected to own approximately 50% of the combined company, subject to certain adjustments provided for in the definitive agreement. The agreement was executed by a supermajority controlling interest of 78 percent of GEDi Cube shareholders; it is expected the remaining 22 percent will be included in the agreement prior to closing.

The boards of directors of both companies have unanimously approved the definitive agreement. The Transaction is expected to close late in the fourth quarter of 2023 or early 2024, subject to satisfying certain closing conditions, including the receipt of stockholder approval by Renovaro stockholders of the issuance of the shares of Renovaro common stock in the Transaction and an amendment to its certificate of incorporation to increase the number of authorized shares of common stock of Renovaro.

Important Additional Information and Where to Find It

In connection with the proposed Transaction, Renovaro intends to file a proxy statement (the "proxy statement"), and will file other documents regarding the proposed Transaction with the SEC. INVESTORS AND SECURITYHOLDERS OF RENOVARO ARE URGED TO CAREFULLY AND THOROUGHLY READ, WHEN THEY BECOME AVAILABLE, THE PROXY STATEMENT, AS MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND OTHER RELEVANT DOCUMENTS FILED BY RENOVARO WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT RENOVARO, GEDI CUBE AND THE PROPOSED TRANSACTION, THE RISKS RELATED THERETO AND RELATED MATTERS.

Once complete, a definitive proxy statement will be mailed to stockholders of Renovaro. Investors will be able to obtain free copies of the proxy statement, as may be amended from time to time, and other relevant documents filed by Renovaro with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. Copies of documents filed with the SEC by Renovaro, including the proxy statement (when it becomes available), will be available free of charge from Renovaro’s website at www.renovarobio.com under the "Financials" tab.

Participants in the Solicitation

Renovaro and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Renovaro in connection with the proposed Transaction. Information about Renovaro’s directors and executive officers is set forth in Renovaro’s definitive proxy statement for the 2023 annual meeting of stockholders filed with the SEC on May 16, 2023, and the proxy statement (when it becomes available). Other information regarding the interests of such individuals, as well as information regarding other persons who may be deemed participants in the proposed Transaction, will be set forth in the proxy statement and other relevant materials to be filed with the SEC when they become available. Stockholders of Renovaro, potential investors, and other readers should read the proxy statement carefully when it becomes available before making any voting or investment decisions.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval with respect to the proposed Transaction or otherwise. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, or otherwise in accordance with applicable law.