Horizon Therapeutics plc to Release First-Quarter 2022 Financial Results and Host Webcast on May 4, 2022

On April 14, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that it will release its first-quarter 2022 financial results on Wednesday, May 4, 2022 (Press release, Horizon Therapeutics, APR 14, 2022, View Source [SID1234612238]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

Oncolytics Biotech® Announces Publication of Preclinical Data Demonstrating the Synergistic Anti-Cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors in Science Translational Medicine

On April 14, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the publication of preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors (Press release, Oncolytics Biotech, APR 14, 2022, View Source [SID1234612235]). The paper, entitled "Oncolytic virus-mediated expansion of dual-specific CAR T cells improves efficacy against solid tumors in mice," was published in Science Translational Medicine in collaboration with researchers at several prestigious institutions, including the Mayo Clinic and Duke University. A link to the paper can be found by clicking here.

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Oncolytics Biotech Inc.
"Having these results published in such a high-impact journal provides important external validation of their significance," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "While CAR T cells have generated long-term cures in hematologic malignancies1, the immunosuppressive tumor microenvironments (TMEs) of solid organ cancers have thus far limited their efficacy in these indications. Pelareorep has repeatedly been shown to reverse immunosuppressive TMEs, and in the present publication pelareorep is shown to enable the effectiveness of CAR T cells in multiple murine solid tumor models. This is a powerful finding that, if translated to the clinic, could significantly improve the prognosis of patients with a variety of highly prevalent cancers by providing a novel and potentially durable treatment option. By demonstrating the ability to improve T cell perseverance, reduce antigen escape, and overcome challenging solid tumor TMEs, the inclusion of pelareorep addresses the three most challenging roadblocks to effective CAR T therapy."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "Despite revolutionizing the treatment of certain cancers and surpassing a billion dollars in sales last year, CAR T therapies currently only serve a small subset of patients suffering from hematologic malignancies. With these latest results, we now have strong preclinical evidence that pelareorep can fully unlock the value of CAR T therapies by expanding their commercial potential to the significantly larger market of cancer patients who are battling solid tumors."

Preclinical studies published in the paper evaluated the persistence and efficacy of pelareorep-loaded CAR T cells ("CAR/Pela therapy") in multiple murine solid tumor models. The effects of combining CAR/Pela therapy with a subsequent intravenous dose of pelareorep ("pelareorep boost") were also investigated. Key data and conclusions from the paper include:

The persistence and anti-cancer activity of CAR T cells improved drastically when loaded with pelareorep. Compared to either treatment alone, treatment with CAR/Pela therapy led to statistically significant survival benefits in murine skin and brain cancer models.
CAR/Pela therapy followed by a pelareorep boost led to enhanced efficacy in murine skin and brain cancer models and tumor cures in >80% of treated mice in each model.
Loading CAR T cells with pelareoep led to improved cancer cell targeting and prevented antigen escape in vivo by generating CAR T cells with dual specificity that target their designed antigen and the native T cell receptor antigen. These results indicate that CAR/Pela therapy may provide longer-lasting therapeutic benefits compared to treatment with CAR T cells alone.
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. and co-author of the paper commented, "These exciting results are an excellent example of how we are leveraging collaborations with key opinion leaders and premier research institutions to broaden pelareorep’s potential therapeutic impact. This allows us to remain primarily focused on our lead breast cancer program, which has shown how pelareorep’s ability to promote tumor T cell infiltration leads to synergy with checkpoint inhibitors in the clinic. These newly published preclinical findings show pelareorep’s synergistic benefits extend even beyond checkpoint inhibitors and highlight an opportunity to increase our addressable patient population. As we pursue this opportunity moving forward, we intend to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency."

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.2

About Science Translational Medicine

Science Translational Medicine is the leading weekly online journal publishing translational research at the intersection of science, engineering, and medicine. The goal of Science Translational Medicine is to promote human health by providing a forum for communicating the latest research advances from biomedical, translational, and clinical researchers from all established and emerging disciplines relevant to medicine. In addition to original research, Science Translational Medicine also publishes Reviews, Editorials, Focus articles, and Viewpoints.

Orion publishes Interim Report for January–March 2022 on Thursday 28 April 2022

On April 14, 2022 Orion reported that it will publish Interim Report for January–March 2022 on Thursday, 28 April 2022 at approximately 12.00 noon EEST (Press release, Orion , APR 14, 2022, View Source [SID1234612234]). The report and related presentation material will be available on the company’s website at www.orion.fi/en/investors after publishing.

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Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Thursday, 28 April 2022 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

Pulse Biosciences, Inc. Announces Rights Offering

On April 14, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported that the Company’s Board of Directors has approved a rights offering available to all holders of record of the Company’s common stock, par value $0.001 per share (the "Common Stock") as of the close of market on April 25, 2022 (the "Record Date") (Press release, Pulse Biosciences, APR 14, 2022, View Source [SID1234612229]). The offering is to commence on or about May 4, 2022.

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The Company intends to issue non-transferable subscription rights to its stockholders of record as of the Record Date to purchase up to $15,000,000 of units (the "Units," and each, a "Unit") at a subscription price per Unit equal to the lesser of (i) $3.72 per share, the closing price of the Common Stock on April 13, 2022 (the "Initial Price") and (ii) the volume weighted average price of the Common Stock for the five-trading day period through and including the subscription expiration date (the "Alternate Price"). Each Unit shall consist of one share of the Company’s Common Stock and a warrant to purchase one share of Common Stock at an exercise price that shall be equal to the subscription price for the Units. The Common Stock and the warrants comprising the Units will separate upon the closing of the rights offering and will be issued separately; however, they may only be purchased as a Unit and the Units will not trade as a separate security.

Following the Record Date, the Company intends to mail to stockholders of record on the Record Date a prospectus and related documents for use in exercising subscription rights. The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m., Eastern Time, on May 23, 2022 (the "Expiration Date").

Stockholders wishing to exercise subscription rights must timely pay the Initial Price for the full number Units they wish to acquire. If the Alternate Price on the Expiration Date is lower than the Initial Price, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional Units in the rights offering. The Company will not sell fractional Units. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional Units that are not purchased by other stockholders, on a pro rata basis and subject to availability.

The Company intends to register the rights offering with the Securities and Exchange Commission (the "SEC"). When available, a copy of the prospectus may be obtained at the SEC’s website at www.SEC.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The rights offering will be made pursuant to the Company’s shelf registration statement on Form S-3, which became effective on August 21, 2020, and a prospectus supplement containing the detailed terms of the rights offering to be filed with the SEC. Any offer will be made only by means of a prospectus forming part of the registration statement.

Moleculin Announces Corporate Rebranding and Launch of New Website

On April 14, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported the launch its new corporate branding and website www.moleculin.com (Press release, Moleculin, APR 14, 2022, View Source [SID1234612227]).

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"As we drive clinical development across our broad portfolio of drug candidates, expand our growing body of clinical data and build value among all stakeholders, we believed it was an important step to refresh our corporate branding identity and website to align with the true potential and vision we have for Moleculin. We are wholeheartedly committed to potentially solving some of the toughest challenges and importantly, bringing better treatments to patients where there remains unmet medical need. The work completed and data demonstrated to-date bolsters our confidence as we believe we can successfully execute on a number of key clinical and regulatory milestones that will be instrumental in establishing a clear path to approval and commercialization of Annamycin. I am excited for this evolution of Moleculin and to take another step forward towards the future of this exciting company," commented Walter Klemp, Chairman and CEO of Moleculin.

The Company’s lead product candidate, Annamycin, is a next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines, and may have the potential to treat a number of additional indications.

Additionally, Moleculin has a robust priority and follow on pipeline comprised of Immune/Transcription Modulators and a portfolio of antimetabolites in development for the treatment of a number of highly resistant tumors and viruses.

For more information about the Company’s portfolio of product candidates and ongoing clinical trials, please visit www.moleculin.com.