On September 11, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will attend the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sep. 13-17 (Press release, MEDIAN Technologies, SEP 11, 2024, View Source [SID1234646522]). Median iCRO and eyonis teams will be present to welcome interested parties at Booth #525, Hall 3, from September 13-16 (exhibition dates). The Company will share the most recent advances for iCRO AI-powered clinical trial imaging services as well as latest developments for eyonis Lung Cancer Screening (LCS) Software as Medical Device (SaMD).

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Median eyonis team will present a peer-reviewed poster presentation of the full positive results of the independent verification study for Median proprietary SaMD eyonis Lung Cancer Screening (LCS). Preliminary results of the study were communicated on January 17, 2024. This independent verification study is part of a process in medical device development required by regulators; it ensures devices meet stringent regulatory standards and defined product requirements. The independent verification study was completed prior to the pivotal independent standalone validation study, REALITY, for which highly positive results were communicated on August 29, 2024.

Poster presentation: #1192P: Optimizing Lung Cancer Screening: Independent Verification of an AI/ML Computer-Aided Detection and Characterization Software as Medical Device

Authors: S. BODARD1, C. M VOYTON2, P. BAUDOT2, E. GEREMIA2, P. SIOT2, G. DE BIE2, V. LE2, D. FRANCIS2, B. RENOUST2, B. HUET2 – [1] Université de Paris Cité, AP-HP, Paris, France, [2] Median Technologies, Valbonne, France.

Onsite display date: Sep 15, 2024

Poster Session: New Diagnostic Tools

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered computer aided diagnostic device that uses machine learning (ML) to help analyze imaging data generated with low-dose computed tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed – Clinicaltrials.gov identifier: NCT0657623) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit, to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

About ESMO (Free ESMO Whitepaper): The annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress is one of the most widely attended and highly regarded global oncology conferences. It attracts clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world for presentations and discussions on the latest cutting-edge research from academia and industry. For more information about the ESMO (Free ESMO Whitepaper) Congress 2024, visit View Source

On September 11, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that it has closed the third tranche (the "Third Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 6,100,000 units (the "Units") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $305,000.00 (Press release, BioVaxys Technology, SEP 11, 2024, View Source [SID1234646521]).

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Each Unit consists of one common share in the capital of the Company (each, a "Share") and one whole common share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until September 11, 2026, being the date that is 24 months from the date of issue.

The Company intends to use the proceeds of the Private Placement for general working capital purposes, including enabling the Company to fund and advance its business plans in regard to its successful recent acquisition of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., which was purchased from IMV USA ("IMV") on February 16, 2024.

No finder’s fees were paid in connection with the Third Tranche of the Private Placement. All securities issued pursuant to the Third Tranche are subject to a statutory hold period under applicable Canadian securities laws expiring January 12, 2025, being the date that is four months and one day from the date of closing of the Third Tranche.

James Passin, Chief Executive Officer and Director of the Company, participated in the Third Tranche of the Private Placement by purchasing 6,000,000 Units for $300,000. The participation by Mr. Passin, as an insider of the Company, constitutes a "related party transaction" as defined under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company is relying on the exemptions from the valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as neither the fair market value of the Units purchased by Mr. Passin, nor the consideration for the Units paid by Mr. Passin, exceeded 25% of the Company’s market capitalization. The Company did not file a material change report in respect of the related party transaction at least 21 days before the closing of the Third Tranche of the Private Placement, which the Company deems reasonable in the circumstances in order to complete the Third Tranche in an expeditious manner.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom. This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States.

On September 11, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported its participation at the 2024 Cantor Global Healthcare Conference (Press release, Tyra Biosciences, SEP 11, 2024, View Source [SID1234646520]).

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Todd Harris, CEO of TYRA, will participate in a fireside chat on Tuesday, September 17, 2024, at 9:45 am ET. TYRA management will also participate in one-on-one meetings with investors during the conference.

A live and archived webcast of the fireside chat will be available via the For Investors page on the Investor section of the TYRA website.

On September 11, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported positive overall survival data of its Phase 2 clinical study of Bria-IMT in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer (Press release, BriaCell Therapeutics, SEP 11, 2024, View Source [SID1234646519]).

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Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT formulation currently being used in BriaCell’s ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed.

This represents a substantial improvement over BriaCell’s 13.4 months median overall survival previously reported in December 2023.

"Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor," stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. "The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints."

"We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature," stated Dr. William V. Williams, BriaCell’s President and CEO. "The nearly two-fold overall survival benefit we are seeing with the Bria-IMT regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT with the goal of establishing it as a new standard of care for patients with metastatic breast cancer."

"The Bria-IMT regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "These survival and clinical benefit data support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer."

The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023.

On September 11, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the pricing of a best-efforts offering of 12,325,000 common shares (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof), priced at-the-market under Nasdaq rules (Press release, BriaCell Therapeutics, SEP 11, 2024, View Source [SID1234646518]). Each common share (or Pre-Funded Warrant) is being sold at an offering price of $0.69 per share (inclusive of the Pre-Funded Warrant exercise price). All of the common shares and Pre-Funded Warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $8.5 million. The offering is expected to close on September 12, 2024, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity is acting as sole placement agent for the offering.

The securities described above are being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering is being made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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