On July 3, 2024 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, reported the closing of its rights offering and the final results thereof (Press release, Pulse Biosciences, JUL 3, 2024, View Source [SID1234644666]).

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The Company received basic subscriptions and over-subscriptions in excess of $83 million, equal to approximately 138% of the $60 million gross proceeds limit in the rights offering, and subscriptions from over 800 accounts, including those of the Company’s Executive Chairman, Robert Duggan. Available Units were allocated proportionately among those rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under its basic subscription rights, in accordance with the procedures described in the prospectus, as amended to date, relating to the rights offering. The remaining oversubscription amounts will be returned by Broadridge Corporate Issuer Solutions, LLC (the "Subscription Agent") to the investors.

The rights offering resulted in the sale of six million units (the "Units"), at a price of $10.00 per Unit. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and two warrants, each being a warrant to purchase one-half of one share of common stock. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. A total of 5,999,999 shares of common stock and warrants to acquire up to an additional approximately six million shares of common stock were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $60 million. If exercised, additional gross proceeds of up to $66 million may be received through the exercise of warrants issued in the rights offering. Each warrant will be exercisable for $11.00 per whole share, which equals 110% of the subscription price for the Units. Warrants are exercisable immediately and will expire on the fifth anniversary of the closing of the rights offering. Half of the warrants issued in the rights offering are redeemable by the Company if the Company’s stock trading price exceeds $16.50 for twenty consecutive trading days and the other half of the warrants issued in the rights offering are redeemable by the Company if its stock trading price exceeds $22.00 for twenty consecutive trading days.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Shares, warrants and any excess subscription payments are expected to be distributed by the Subscription Agent on or about July 5, 2024.

After giving effect to the issuance of 5,999,999 shares of common stock in the rights offering (but excluding up to approximately six million shares of common stock underlying the warrants issued in the rights offering), the Company has 61,228,332 shares of common stock issued and outstanding.

The Company plans to use proceeds from the offering principally to support further product and clinical development, future regulatory submissions and commercial readiness of its three leading CellFX nsPFA products, Percutaneous Electrode, Cardiac Clamp, and 360° Cardiac Catheter. Each device is designed to deliver significant clinical advantages compared to the current standards of care and have a potential profound positive impact on healthcare for both patients, providers and other stakeholders.

The rights offering was made pursuant to the Company’s registration statement on Form S-3, as modified by the post-effective amendment filed with the Securities and Exchange Commission ("SEC") on May 28, 2024, which was deemed effective by the SEC on May 31, 2024, including the prospectus contained therein, as further modified by the prospectus filed pursuant to Rule 424(b)(2) of the Securities Act of 1933, which contains the detailed terms of the rights offering and was filed with the SEC on June 4, 2024.

On July 3, 2024 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 details for an upcoming oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary session on July 11, 2024, featuring new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, and a webcast to discuss these clinical results (Press release, Immutep, JUL 3, 2024, View Source [SID1234644662]).

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ESMO Virtual Plenaries are monthly presentations of the latest, original scientific data, including "Phase II trials which demonstrate remarkable therapeutic benefit, scientific insight or progress in an area of unmet need". The oral presentation will announce the substantially improved overall response rate, as advised 27 June 2024, and additional data in patients with first line head and neck squamous cell carcinoma who have negative PD-L1 (Cohort B).

Details for the ESMO (Free ESMO Whitepaper) Plenary presentation

Title: Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma: Primary Results from Cohort B (CPS <1) of the TACTI-003 Study
Presenter: Dr. Robert Metcalf, The Christie NHS Foundation Trust, Manchester, U.K.
Format: Oral Presentation
Date/Time: 18:30-19:30 Central European Time (CEST), July 11, 2024
Webcast Details

Immutep will host a webcast to discuss the clinical data. A replay of the webcast will be available under the Events section of Immutep’s website after the event.

Date/Time: Friday, July 12, at 9am AEST (7pm ET July 11)
Register: Link to register for webcast
Questions: Investors are invited to submit questions in advance via [email protected]
About the TACTI-003 Trial

The TACTI-003 (KEYNOTE-PNC-34) trial is an ongoing Phase IIb study evaluating eftilagimod alfa (efti), Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with pembrolizumab as compared to pembrolizumab monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with pembrolizumab in patients with PD-L1 negative tumours.

The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).

About Eftilagimod Alfa (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-g 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 first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On July 3, 2024 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported it has entered into securities purchase agreements with health-care focused institutional investors for the purchase and sale of 1,425,000 shares of common stock in a registered direct offering and warrants to purchase up to 1,425,000 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $1.39 per share (Press release, CNS Pharmaceuticals, JUL 3, 2024, View Source [SID1234644661]). The warrants issued pursuant to the concurrent private placement will have an exercise price of $1.26 per share, will be exercisable immediately following the date of issuance and will expire 5 years from the initial exercise date.

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The closing of the Offering is expected to occur on or about July 5, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $1.98 million before deducting financial advisory fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The common stock will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-279285) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on May 17, 2024. The warrants will be issued in a concurrent private placement. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source

The private placement of the ordinary warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement 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 the solicitation of an offer to buy any of the securities described herein, 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 July 3, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer, will participate in a fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 6:45 a.m. PDT / 9:45 a.m. EDT (Press release, Atara Biotherapeutics, JUL 3, 2024, View Source [SID1234644660]).

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A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

On July 3, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that it has now recruited 26 patients in the Phase 2a stage of its clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (Press release, Amplia Therapeutics, JUL 3, 2024, View Source [SID1234644656]). The ACCENT trial explores the use of narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

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The Phase 1b stage of the trial, completed in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding regular chemotherapy infusion, as safe and well tolerated. This dosing regimen is being employed in the Phase 2a trial where drug efficacy is being assessed.

The Phase 2a trial is being conducted using the industry-standard Simon’s Two-Stage Trial design, wherein an interim analysis of efficacy is determined at a statistically defined number of patients. In the ACCENT trial this is 26 patients. An efficacy assessment showing six or more partial or complete responses out of the 26 patients will be sufficient to continue the trial, when an additional 24 patients will be enrolled, giving a total of 50 patients.

Amplia CEO and MD Dr Chris Burns commented: "The recruitment of our 26th patient is an important milestone for the Company. With 26 patients enrolled, and based on experience to date, we believe that the outcome from the interim analysis will be reported around the beginning of Q4 2024. Imaging data for the first patients from this cohort is now being collated and efficacy signals to date mirror the positive data previously reported from the Phase 1b stage of the trial."

The ACCENT trial is currently being conducted at 6 sites in Australia and 5 sites in South Korea. Dr Burns added:

"We are grateful for the dedicated work of our study clinicians and clinical trial sites to reach this recruitment milestone, and as always thank the patients and their loved ones for being involved in the trial."

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein overexpressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies.

About the ACCENT Trial

The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

This second stage (Phase 2a), of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed. More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.