On July 31, 2023 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) reported that it has entered into an agreement with Leede Jones Gable Inc. as underwriter and bookrunner (the "Underwriter"), pursuant to which the Underwriter has agreed to purchase, on a bought-deal basis, 6,667,000 units (the "Equity Units") for gross proceeds to the Company of US$15,000,750 (the "Offering") at a price of US$2.25 per Equity Unit (Press release, Oncolytics Biotech, JUL 31, 2023, View Source [SID1234633554]).

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Each Equity Unit will consist of one common share of the Company (a "Common Share") and one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of US$2.81 (the "Exercise Price") at any time up to 60 months following the Closing (as defined below).

The Company has granted the Underwriter an option (the "Over-Allotment Option"), exercisable in part or in whole at the Underwriter’s sole discretion, at any time beginning on the Closing until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.

The Equity Units will be offered by way of a prospectus supplement to the Company’s short form base shelf prospectus to be filed in all provinces of Canada except Quebec pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 – Shelf Distributions.

The Company intends to use the net proceeds from the Offering to continue its pelareorep clinical programs in metastatic breast cancer and pancreatic cancer and general corporate and working capital purposes.

The closing of the Offering is expected to occur on or about August 4, 2023 (the "Closing") and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Exchange.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

On July 31, 2023 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and POINT Biopharma Global Inc. (NASDAQ: PNT) ("POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the expansion of their global supply agreements signed in 2020 (Press release, ITM Isotopen Technologien Munchen, JUL 31, 2023, View Source [SID1234633553]). The expanded agreement broadens the supply of ITM’s non-carrier-added lutetium-177 (n.c.a. 177Lu) to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline. Financial details of the agreement were not disclosed.

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"Since POINT launched in late 2019, ITM has been a key partner to us as we have worked to establish a commercially scalable, reliable and redundant n.c.a. lutetium-177 supply chain," said Joe McCann, Ph.D., CEO of POINT Biopharma. "In building on this established trust and ITM’s position as the world’s leading manufacturer of n.c.a. lutetium-177, we value the ability to utilize ITM’s highly pure radioisotope across our growing pipeline of next-generation radioligands for precision oncology."

Steffen Schuster, CEO of ITM added, "It is our objective to make Targeted Radionuclide Therapy as broadly available as possible, not only by advancing our own pipeline, but also by supporting the whole industry with a stable and scalable isotope supply. We look forward to enriching our long-term collaboration with POINT by supplying our versatile n.c.a. lutetium-177 for the development and commercialization of various novel molecules."

ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta).

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About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.

On July 31, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that data from its TACTI-002 Phase II trial evaluating the chemo-free combination of eftilagimod alpha ("efti") and KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Rahway, NJ, USA) anti-PD-1 therapy, in 1st line non-small cell lung cancer (1L NSCLC) has been accepted for a Mini Oral presentation at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress that will be held in Madrid, Spain from 20-24 October 2023 (Press release, Immutep, JUL 31, 2023, View Source [SID1234633552]). The presentation will include more mature overall survival data, following on from the data announced on 17 May 2023.

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Additionally, data from INSIGHT-003, an investigator-initiated Phase I trial conducted by the Frankfurt Institute of Clinical Cancer Research IKF evaluating efti in conjunction with anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy (carboplatin/pemetrexed) in non-squamous 1L NSCLC, has been accepted for a poster presentation. Also, a Trial in Progress poster for the EFTISARC-NEO investigator-initiated Phase II trial evaluating efti with pembrolizumab and radiotherapy in soft tissue sarcoma will be presented.

Oral Presentation
Title: Combining the antigen-presenting cell activator eftilagimod alpha (soluble LAG-3) and pembrolizumab: overall survival data from the 1st line non-small cell lung carcinoma (NSCLC) cohort of TACTI-002 (Phase II)

Presenter: Dr. Enric Carcereny, Catalan Institute of Oncology, Badalona (ICO)
Date and Time: Saturday, October 21, 2023; 9:05 AM CEST
Session: Mini Oral session, 1312MO
Abstract ID: (#2174)
Poster Presentations
Title: INSIGHT 003 evaluating feasibility of eftilagimod alpha (soluble LAG-3) combined with 1st line chemo-immunotherapy in metastatic non-small cell lung cancer (NSCLC) adenocarcinomas

Presentation # 1042P

Title: Pembrolizumab in combination with eftilagimod alpha and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas – EFTISARC-NEO trial

Presentation # 1987TiP

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

On July 31, 2023 UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") and options ("Options") to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing employment with UroGen (Press release, UroGen Pharma, JUL 31, 2023, View Source [SID1234633550]).

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Up to 30,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs and up to 20,000 ordinary shares are issuable upon the vesting and exercise of the Options. The Options have an exercise price of $8.84 per share, which is the closing price of the ordinary shares on the date of grant as reported on The Nasdaq Stock Market. The RSUs and Options will vest over three years, with one third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs and Options are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU and Option grant notice and agreements thereunder. The RSUs and Options were granted as an inducement material to the employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

On July 31, 2023 UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") and options ("Options") to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing employment with UroGen (Press release, UroGen Pharma, JUL 31, 2023, View Source [SID1234633550]).

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Up to 30,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs and up to 20,000 ordinary shares are issuable upon the vesting and exercise of the Options. The Options have an exercise price of $8.84 per share, which is the closing price of the ordinary shares on the date of grant as reported on The Nasdaq Stock Market. The RSUs and Options will vest over three years, with one third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs and Options are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU and Option grant notice and agreements thereunder. The RSUs and Options were granted as an inducement material to the employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).