bluebird bio Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

On August 2, 2024 bluebird bio, Inc. (Nasdaq: BLUE) reported that the Compensation Committee of the Company’s Board of Directors approved an inducement grant of stock options to purchase a total of 38,200 shares of common stock to its controller and vice president of accounting, Joe Ewer, with a grant date of August 1, 2024 (Press release, bluebird bio, AUG 2, 2024, View Source [SID1234645313]).

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The stock options approved under the Inducement Plan have an exercise price per share equal to $1.08, the fair market value of the Company’s common stock on the grant date. The stock options vest over four years, with 25% vesting on the one-year anniversary of the grant date and 1/36 of the remaining shares vesting monthly thereafter, subject to Mr. Ewer’s continued service with the Company on each such date. The stock options have a 10-year term and are subject to the terms and conditions of the stock option agreement.

The Company granted the stock options as inducement materials to Joe Ewer entering into employment with bluebird bio, Inc. in accordance with NASDAQ Listing Rule 5635(c)(4).

Agilent Receives FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for Use with Newly Approved TCR T-Cell Therapy

On August 2, 2024 Agilent Technologies Inc., (NYSE: A) reported that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy (Press release, Agilent, AUG 2, 2024, View Source [SID1234645311]).

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MAGE-A4 (melanoma-associated antigen A4) is a cancer-testis antigen overexpressed in various cancers, including synovial sarcoma. MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay used to detect MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue. MAGE-A4 positivity in synovial sarcoma is a biomarker of eligibility for treatment with TECELRA. MAGE-A4 IHC 1F9 pharmDx is the first IVD for MAGE-A4 available on the market.

"MAGE-A4 plays a significant role in cancer research and holds promise as a therapeutic target. The FDA’s approval of Agilent’s MAGE-A4 IHC 1F9 pharmDx will expand treatment options for individuals diagnosed with synovial sarcoma," stated Lou Welebob, vice president and general manager of Agilent’s Pathology Division. "This endorsement amplifies Agilent’s pioneering role in shaping companion diagnostics for groundbreaking cancer therapies."

TECELRA, is a prescription medicine approved for advanced MAGE-A4 positive synovial sarcoma in adults with certain HLA types who have received prior chemotherapy. TECELRA is the first FDA-approved engineered TCR T-Cell therapy for a solid tumor cancer.

bioAffinity Technologies Announces Pricing of Registered Direct Offering and Concurrent Private Placement and Warrant Inducement for Aggregate Gross Proceeds of $1.75 Million

On August 2, 2024 bioAffinity Technologies, Inc. (NASDAQ: BIAF and BIAFW) reported that it has entered into warrant exercise agreements with three existing accredited investors to exercise certain outstanding warrants to purchase an aggregate of 1,041,667 of the Company’s shares of common stock (the "Existing Warrants"). In consideration for the immediate exercise in full of the Existing Warrants for gross cash proceeds of approximately $1,302,083, the exercising holders received in a private placement new unregistered warrants (the "New Warrants") to purchase up to an aggregate of 1,302,083 shares of common stock (equal to 125% of the shares of common stock issued in connection with the exercise of the Existing Warrants) with an exercise price of $1.50 per share and are initially exercisable on the date that stockholder approval of the exercise of the New Warrants is obtained and will expire five years from the date of such approval (Press release, BioAffinity Technologies, AUG 2, 2024, View Source [SID1234645310]). In connection with the exercise of the Existing Warrants, the Company agreed to reduce the exercise price of the Existing Warrants from $1.64 to $1.25 per share. The exercise of the Existing Warrants and the issuance of the New Warrants are expected to occur on August 5, 2024.

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The Company also announced today it has entered into a securities purchase agreement with an institutional investor for the purchase and sale of 360,000 shares of common stock in a registered direct offering and, in a concurrent private placement, common warrants (the "Private Warrants") to purchase up to 450,000 shares of common stock (together with the registered direct offering) at a combined purchase price of $1.25. The Private Warrants will have an exercise price of $1.50 per share, are initially exercisable on the date that stockholder approval of the exercise of the warrants is obtained and will expire five years from the date of such approval.

The closing of the offering is expected to occur on or about August 5, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $450,000, excluding any proceeds that may be received upon the exercise of the Private Warrants and before deducting placement agent fees and other offering expenses payable by the Company.

WallachBeth Capital is acting as sole placement agent for the registered direct offering and private placement and financial advisor for the warrant inducement transaction.

The common stock will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-275608) previously filed with the U.S. Securities and Exchange Commission (SEC), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on Nov. 27, 2023. The Private Warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered pursuant to an exemption from the registration requirements of the Securities Act of under Section 4(a)(2) thereof and Regulation D promulgated thereunder and have not been registered under the Securities Act or applicable state securities laws. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and available on the SEC’s website located at View Source Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

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

About CyPath Lung

CyPath Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin, TCPP, that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage cancer can improve outcomes and increase patient survival.

Immunovia files US patent application to protect its next-generation test

On August 2, 2024 Immunovia (Nasdaq Stockholm: IMMNOV), the pancreatic cancer diagnostics company, reported the company has filed a US provisional patent application to protect the intellectual property embodied in its next-generation test to detect stage 1 and 2 pancreatic cancer (Press release, Immunovia, AUG 2, 2024, View Source [SID1234645308]).

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The patent application claims methods of diagnosing pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The company is seeking patent protection for the unique combination of five specific biomarkers used in its test, as well as the method for combining these biomarkers to generate a positive or negative test result.

Immunovia filed the provisional patent application with the Patent and Trademark Office (PTO) in the United States of America, the first market for commercializing the company’s new test. In coming months, the company expects to submit additional clinical data to the USPTO bolster the patent application.

Immunovia also plans to file a single PCT (Patent Cooperation Treaty) application within the next year, enabling the company to seek patent protection for its invention across dozens of countries at one time. Immunovia will later pursue patents in specific high-value commercial markets outside the US.

"Our scientists have invented a breakthrough approach to detecting pancreatic cancer and it’s vital we protect that invention," said Jeff Borcherding, CEO of Immunovia.

As previously announced, Immunovia has completed development of its next-generation test to detect stage 1 and 2 pancreatic cancer. Immunovia will conduct a large, independent clinical validation study in fourth quarter 2024 to confirm the accuracy of the Immunovia test. The company is on track to launch the new test in the US in 2025.

Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity’s 44th Annual Growth Conference

On August 2, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that Chief Medical Officer Dr. Thomas Heineman will participate in a fireside chat at Canaccord Genuity’s 44th Annual Growth Conference, which is taking place August 13-15, 2024 at the InterContinental Boston Hotel in Boston, MA (Press release, Oncolytics Biotech, AUG 2, 2024, View Source [SID1234645307]). Additional details on the fireside chat can be found below.

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Date: Tuesday, August 13, 2024
Time: 8:30 a.m. ET
Location: InterContinental Boston, Hutchinson Room
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Canaccord representative, or email [email protected].

A live webcast of the Company’s presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months.