Entry into a Material Definitive Agreement.

On July 15, 2021, Royalty Pharma plc (the "Issuer") reported that it entered into an underwriting agreement (the "Underwriting Agreement"), by and among the Issuer, Royalty Pharma Holdings Limited (the "Guarantor"), RP Management, LLC (the "Manager") and BofA Securities, Inc., Citigroup Global Markets Inc., Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, as representatives of the several underwriters listed on Schedule I thereto (the "Underwriters"), pursuant to which the Issuer has agreed to issue and sell to the Underwriters $600 million aggregate principal amount of its 2.150% Senior Notes due 2031 and $700 million aggregate principal amount of its 3.350% Senior Notes due 2051 (the "Notes") in a registered public offering pursuant to an effective shelf registration statement on Form S-3 (Registration File No. 333- 257883) (Filing, 8-K, Royalty Pharma , JUL 15, 2021, View Source [SID1234584917]). The Notes will be guaranteed on a senior unsecured basis by Royalty Pharma Holdings Ltd. The offering is expected to close on July 26, 2021, subject to the satisfaction of customary closing conditions. The description of the Underwriting Agreement contained herein is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is included as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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XOMA Acquires Royalty and Milestone Interest in Checkmate’s Vidutolimod (CMP-001) from Kuros Biosciences

On July 15, 2021 XOMA Corporation (NASDAQ: XOMA), reported it has acquired the royalty interest position Kuros Biosciences holds in Checkmate Pharmaceuticals’ vidutolimod (CMP-001), an advanced-generation Toll-like receptor 9 agonist packaged in a virus-like particle, for $7.0 million upfront plus sales milestones (Press release, Xoma, JUL 15, 2021, View Source [SID1234584885]). Vidutolimod is designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. The U.S. Food and Drug Administration has granted Fast Track designation to vidutolimod for the treatment of certain types of metastatic or unresectable melanoma and an Orphan Drug designation for Stages IIb – IV melanoma.

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"We were drawn to vidutolimod because of the breadth of Checkmate’s development activities," said Jim Neal, Chief Executive Officer at XOMA. "Checkmate currently is enrolling patients in a study with anti-PD-1 refractory advanced melanoma in combination with Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody, that is designed to serve as a registrational study. Checkmate also is pursuing a Phase 2/3 study in front line melanoma patients in combination with Opdivo and a study in patients with head and neck cancer and is planning a study in three indications in collaboration with Regeneron in non-melanoma skin cancers."

Under the terms of the agreement, XOMA has acquired all future potential royalties from commercial sales of vidutolimod, which are tiered from high-single to double digits. XOMA could receive up to $25 million in pre-commercial milestones associated with the Kuros/Checkmate license agreement. Kuros will be eligible to receive certain sales milestone payments from XOMA based on net sales of vidutolimod.

PTC Therapeutics to Host Conference Call to Discuss Second Quarter 2021 Financial Results

On July 15, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its second quarter 2021 financial results and provide an update on the company’s business and outlook on Thursday, July 29, 2021, at 4:30 p.m. (ET) after the closing of the market (Press release, PTC Therapeutics, JUL 15, 2021, https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-host-conference-call-discuss-second-quarter-6 [SID1234584869]).

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The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 7064479. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at View Source A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

IMV Inc. Announces Pricing of Public Offering

On July 15, 2021 IMV Inc. ("IMV" or the "Corporation") (NASDAQ: IMV; TSX: IMV), a clinical-stage immuno-oncology corporation, reported the pricing of its previously-announced underwritten public offering (the "Offering") of 14,285,714 units (the "Units") at a price to the public of US$1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately US$25 million, before deducting underwriting commissions and Offering expenses and excluding any proceeds the Corporation may receive from the exercise of the underlying warrants (Press release, IMV, JUL 15, 2021, View Source [SID1234584886]). Each Unit will be comprised of one common share and three-quarters of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant entitles the holder thereof to purchase one common share at a price of US$2.10 per common share, subject to adjustment in certain events, during a period of 60 months following the date of the closing of the Offering. All of the securities are being offered by the Corporation.

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The Corporation intends to use the net proceeds of the Offering to continue the clinical development of maveropepimut-S (DPX-Survivac) in diffuse large B cell lymphoma (DLBCL), breast cancer, ovarian cancer, bladder cancer and microsatellite instability high (MSI-H), start the clinical development of a new product, DPX-SurMAGE, in bladder cancer, continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes.

Wells Fargo Securities and Cantor are acting as joint book-running managers for the Offering. BTIG is acting as lead manager and iA Private Wealth is acting as co-manager.

The Offering is expected to close on or about July 20, 2021, subject to the satisfaction of customary closing conditions, including the listing of the common shares underlying the Units and the Warrants to be issued under the Offering on the TSX and Nasdaq and any required approvals of each exchange.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 16, 2020 (the "Registration Statement"), and the Corporation’s Canadian final short form base shelf prospectus dated June 26, 2020, as amended on October 15, 2020 (collectively, the "Base Prospectus"). A preliminary prospectus supplement dated July 14, 2021 relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States, and a final prospectus supplement relating to the Offering (the "Supplement") will be filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States. The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus, once available, can be found for free on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained, once available, in the United States from Wells Fargo Securities, Attn: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at [email protected] or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected], or in Canada from Wells Fargo Securities Canada, Ltd., 22 Adelaide Street West, Suite 2200, Toronto, ON, M5H 4E3, Attn: Akshay Pattni, email: [email protected] or from Cantor Fitzgerald Canada Corporation, Attn: Equity Capital Markets, 181 University Avenue, Suite 1500, Toronto, ON, M5H 3M7, email: [email protected]. Prospective investors should read the Supplement and accompanying Base Prospectus and the other documents the Corporation has filed before making an investment decision.

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

Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

On July 15, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer (Press release, Advaxis, JUL 15, 2021, View Source [SID1234584871]). The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. Mark Stein, M.D., associate professor of medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, is the study’s principal investigator.

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"Evaluating ADXS-504 in patients with biochemically recurrent prostate cancer is the first step in testing whether Lm-based immunotherapies may have a role in the adjuvant setting in cancer patients who have undergone radical therapy and who have no detectable primary tumor or metastatic disease at enrollment," said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. "This Phase 1 study will evaluate the safety, tolerability, immunogenicity and clinical activity of ADXS-504 in men who have undergone radical prostatectomy or radiotherapy and whose prostate specific antigen (PSA) levels in the blood are rising, which we believe are ideal patients to evaluate with this approach. Moreover, we believe our multi-neoantigen vector has the potential to drive T cell responses against both hormone-sensitive and hormone-resistant cancer cells, which could result in disease control and may delay the start of androgen blockade therapy and its associated long-term complications. This study will also examine our lowest dose of an Lm-based immunotherapy to date, which could enhance the risk/benefit ratio that we have previously observed in our ADXS-HOT program."

Kenneth A. Berlin, President and Chief Executive Officer of Advaxis stated, "We are pleased to be launching the first clinical evaluation of ADXS-504, expanding the reach of our off-the-shelf neoantigen immunotherapy program to a second potential indication. Our strong foundation of clinical data generated across both prostate cancer and non-small cell lung cancer suggest Lm-based immunotherapy may bring meaningful clinical benefit to patients and we look forward to continued momentum across the ADXS-HOT program."

The Phase 1 open-label dose escalation study will evaluate the safety and tolerability of two dose levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy, administered via infusion every four weeks for six total doses in 9-18 patients with biochemically recurrent prostate cancer (i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy). The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.

ADXS-504 is a novel Lm-based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control. Similar to Advaxis’s other Lm-based immunotherapies, ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment (TME) by reducing regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME.