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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On July 15, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the pricing of its upsized initial public offering of 18,750,000 shares of common stock at an initial public offering price of $16.00 per share (Press release, Erasca, JUL 15, 2021, View Source [SID1234584916]). All of the shares are being offered by Erasca. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Erasca, are expected to be $300.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on July 16, 2021 under the ticker symbol "ERAS." The offering is expected to close on July 20, 2021, subject to the satisfaction of customary closing conditions. In addition, Erasca has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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J.P. Morgan, Morgan Stanley, BofA Securities, Evercore ISI and Guggenheim Securities are acting as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on July 15, 2021. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any 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 state or jurisdiction.

On July 15, 2021 Novocure (NASDAQ: NVCR) reported the recipients of the 3rd Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research program (Press release, NovoCure, JUL 15, 2021, View Source [SID1234584899]). The program represents a joint effort between Novocure and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields). The AACR (Free AACR Whitepaper) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer.

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Such collaborations help to deepen the understanding of TTFields’ mechanism of action and to identify its optimal use. Extensive preclinical and clinical evidence provides the foundation upon which Novocure executes its strategy to advance TTFields through additional clinical research studies across multiple solid tumor types.

Professor Maurizio D’Incalci, M.D., of Humanitas University in Italy is one of the grant recipients. He and his team’s hypothesis is that the sensitivity of malignant pleural mesothelioma (MPM) cells to TTFields is related to the modulation of genes and pathways involved in cell proliferation and survival. Their research will investigate the potential synergism of TTFields with selected anticancer drugs in MPM based on the mechanistic insights.

"While great progress has been made regarding the research and development of Tumor Treating Fields, there is still more to learn and understand to continue deepening the science," Professor D’Incalci said. "We are excited to have begun our research and look forward to sharing the results."

The program includes research grants and career development awards totaling more than $2 million over the next three years. The research grants include six AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants and two AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research. Recipients of the research grants will receive a total of $100,000 to $250,000 over one to two years. Recipients of the career development awards will receive a total of $225,000 over three years.

"We are so proud of this year’s recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research," said Asaf Danziger, Novocure’s Chief Executive Officer. "We are honored to collaborate with the AACR (Free AACR Whitepaper) as we continue to deepen our understanding of the mechanism of action of Tumor Treating Fields. We wish great success to the recipients as they conduct this important work."

2021 AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants

Spencer J. Collis, Ph.D.; University of Sheffield (United Kingdom); TTFields-based DDRi combinations to overcome spatiofunctional heterogeneity
Maurizio D’Incalci, M.D.; Humanitas University (Italy); TTFields in mesothelioma: mechanisms and novel rational drug combinations
Chang-Young Jang, Ph.D.; Sookmyung Women’s University (South Korea); Identification of new target of TTFs in mitosis for therapeutic application
Sara G.M. Piccirillo, Ph.D.; University of New Mexico; The impact of Tumor-Treating Fields on residual disease in glioblastoma
Claudio E. Tatsui, M.D.; University of Texas MD Anderson Cancer Center; Tumor Treating Fields in the therapy of spinal metastases
Suhe Wang, M.D., Ph.D.; University of Michigan; Natural electrical fields treatment to induce immune modulation in NSCLC
2021 AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research

Gerben Borst, M.D., Ph.D.; University of Manchester (United Kingdom); Unraveling the cell cycle effect of TTFields towards synergistic strategies
Jared A. Weis, Ph.D.; Wake Forest University; Characterizing effects of TTFields on cell-extracellular matrix biophysics
About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.

On July 15, 2021 Orexo reported "First commercial DTx contract signed with a large healthcare provider" (Press release, Orexo, JUL 15, 2021, View Source [SID1234584897])

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Summary

Total net revenues of SEK 142.8 m (179.1)
Net earnings of SEK -73.7 m (-32.5)
EBITDA of SEK -41.1 m (-9.0)
US Pharma segment (ZUBSOLV US) net revenues of SEK 126.0 m (172.5), in local currency USD 15.0 m (17.8), EBIT of SEK 61.6 m (88.8)
Cash flow from operating activities of SEK -20.9 m (-7.2), cash balance of SEK 679.7 m (677.2)
Two patents for ZUBSOLV, with protection until 2032, were issued by the US Patent and Trademark Office
First patient enrolled in pivotal study evaluating the efficacy of modia in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder
Commercial agreement for vorvida and deprexis signed with Trinity Health North Dakota
Important events after the period

Commercial partnership agreement signed with Sober Grid, the largest global social media network for people in addiction recovery, giving a large group of users access to vorvida and deprexis
SEK m, unless otherwise stated

"The second quarter of 2021 showed some positive operational highlights in both our Digital Therapeutics (DTx) business and US Pharma. In DTx, I’m pleased to announce we’ve among others reached a commercial agreement with Trinity Health North Dakota. As a result, vorvida and deprexis are now also available for patients at their healthcare centers and hospitals. This is a major milestone and is already now an inspiring model for other healthcare providers in the US. In our US Pharma business, it was confirmed that ZUBSOLV is available for patients within Medicaid in Kentucky since July 1, representing a growth opportunity for our lead pharma product."

For the full CEO Comments please view the PDF

For further information, please contact
Nikolaj Sørensen, President and CEO, Joseph DeFeo, EVP and CFO, or Lena Wange, IR & Communications Director
Tel: +46 18 780 88 00, +1 855 982 7658, E-mail: [email protected]

Presentation

At 3.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend a presentation where Nikolaj Sørensen, CEO and Joseph DeFeo, CFO, will present the report and host a Q&A.

Questions can also be sent in advance to [email protected], no later than 11.00 am CET.

Please view the instructions below on how to participate.

Internet: View Source

Telephone: SE + 46 8 50 55 83 50 UK + 44 33 33 00 92 70 US + 1 64 67 22 49 04

The presentation material will be available on Orexo´s website prior to the audiocast, view Investors/Reports, presentations and audicasts

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on July 15, 2021.

On July 15, 2021 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January – June, 2021 (Press release, Hansa Biopharma, JUL 15, 2021, View Source [SID1234584896]).

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Highlights for the second quarter 2021

Commercial launch activities for Idefirix in Europe are progressing as planned in early launch countries, such as the Nordics, Benelux, U.K. and Germany. Hansa continues to prioritize its Market Access efforts through close interactions with national reimbursement authorities and leading transplant clinics.
In late June 2021, the Swedish New Therapies Council recommended the use of Idefirix as desensitization treatment for highly sensitized kidney transplant patients. The recommendation provided by the New Therapies Council in Sweden represents the first national level decision by an EU member state.
Hansa hosted an Idefirix launch symposium on June 30, 2021 with attendance from more than 120 transplant physicians representing around 80 transplant centers from 13 European countries.
Following U.S. FDA interactions, the U.S. trial design for a randomized, controlled trial of imlifidase in highly sensitized kidney transplant patients was announced in late June 2021. The new study will target 64 patients with the highest unmet medical need in the U.S., with the first patient expected to be included in H2 2021 as previously guided.
Patient recruitment in the phase 2 clinical studies in active antibody mediated rejection (AMR) and Guillain-Barré Syndrome (GBS) continues under a risk-based, site-by-site approach due to the COVID-19 pandemic. In the AMR and GBS trials, 12 and 10 patients, respectively, out of a target of 30 patients in each of the studies have now been enrolled. The persistent presence of the COVID-19 pandemic in Europe, most recently the emergence of the Delta variant causing new waves in several European countries where important trial centers are located, negatively impacts enrollment rates. As remedial action, efforts are underway to initiate recruitment in new centers. While the increase in number of active trial centers is expected to also increase the enrollment rate in H2 2021 despite the continued impact of COVID-19, the volatility of the situation leads Hansa to expand its guidance for completion of enrollment to also include the first half of 2022. First data read-out in both studies is expected in the second half of 2022, as previously guided.
IND-enabling toxicology studies for the NiceR program were initiated in the second quarter as planned. GLP toxicology studies are expected to be completed in 2022. Upon successful completion of these studies, Hansa expects to advance the NiceR program into clinical studies.
Annual General Meeting held on May 12, 2021, all resolutions were approved by shareholders, including the appointment of Hilary Malone, Ph.D. to the Board of Directors. Dr. Malone is currently COO and EVP at Valo Health, Inc. (U.S.) and has previously held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others.
Handelsbanken Fonder reported ownership above 5% on April 6 2021.
Financial summary

Solid cash position of SEK 1,139m at the end of June 2021. Hansa expects its operations to be financed into 2023.
Investments in R&D in the second quarter amounted to SEK 55m (Q2’20: SEK 53m) and to SEK 102m for the first half-year (H1’20: SEK 106m). SG&A expenses amounted to SEK81m in Q2 2021 (Q2’20: SEK 49m) and to SEK 141m for the first half-year (H1’20: SEK 88m), in line with plans.
Cash flow from operating activities for the second quarter ended at SEK -113m (Q2’20: SEK -77m) and SEK -233m for the first half of 2021 (H1’20: -199m).

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa Biopharma’s transformation into a fully integrated, commercial-stage biopharmaceutical company has become a reality in 2021, and we continue to deliver on our strategic priorities to build tomorrow’s Hansa Biopharma by ensuring the successful commercialization of Idefirix in the first markets, advancing our platform in new indications and therapeutic areas, building our organizational capabilities and expanding our technology platform.

In Europe, we continue to roll out our commercial launch activities in the early launch countries as planned and are pleased with the progress we have made so far. As part of this effort, Hansa hosted a very productive Idefirix launch symposium on June 30, 2021 with attendance from more than 120 transplant physicians representing 80 transplant centers from 13 European countries. The symposium focused on Idefirix as the potential new standard of care for highly sensitized kidney transplant patients needing desensitization treatment and included multiple sessions where expert speakers discussed specific patient cases to address topics around patient selection, AMR management and patient care.

Hansa also continues to maintain close interactions with national reimbursement authorities and leading transplant clinics. A first national level market access decision was announced on June 28, 2021 by Sweden’s New Therapies Council, who recommends use of Idefirix as a desensitization treatment for highly sensitized kidney transplant patients in Sweden.

We are very pleased with this decision, which is an important step for transplant clinics across Sweden who would like to introduce Idefirix as a desensitization treatment to enable highly sensitized patients to qualify for potentially lifesaving and life-altering kidney transplant from a deceased donor. The recommendation follows an earlier health-economic assessment by the Swedish Dental and Pharmaceutical Benefits Agency (TLV), which concluded that Idefirix treatment would be cost effective or even cost saving for the society. Moving forward, we expect additional decisions and agreements around reimbursement, funding and market access to be reached in other early launch countries beginning in the second half of 2021 and onwards.

In the U.S., Hansa announced the study design for a randomized, controlled trial of imlifidase in highly sensitized kidney transplant patients. In the study, 64 highly sensitized kidney patients with a cPRA score of ≥99.9% will be enrolled, representing a subset of very highly sensitized patients that continue to be disadvantaged despite prioritization under the U.S. Kidney Allocation System.

We are pleased to move forward with this study that we believe could support a BLA in the U.S. under the accelerated approval pathway in the first half of 2024. Preparatory work has been initiated and we expect to engage with 12-15 leading U.S. transplantation centers to conduct the study. Among the new centers are Northwestern Memorial Hospital in Chicago and University of Alabama (UAB) Hospital in Birmingham. Robert A. Montgomery, M.D. Professor of Surgery and Director, NYU Langone Transplant Institute, New York City has been appointed t Principal Investigatorand we expect study initiation over the summer with the first patient enrolled in the second half of 2021.

In our ongoing phase 2 programs for GBS and AMR, we see patient enrollment progressing again following a temporary halt in the recruitment process during large parts of 2020 due to the COVID-19 pandemic. At the end of 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach.

As of July 15, 2021, 12 out of a target of 30 patients have now been enrolled in the AMR study, while 10 out of a target of 30 patients have been enrolled in the GBS study. To increase the rate of enrollment of patients in both studies, we plan to open additional centers this summer, reaching a total of 14 centers in the AMR study and 10 centers in the GBS trial compared to the 7 centers currently enrolling in each of the two studies. The persistent presence of the COVID-19 pandemic in Europe, most recently the emergence of the Delta variant, which has caused new waves in several European countries where important trial centers are located, continues to negatively impact enrollment rates. Given the volatility of the situation, we expand our guidance for completion of enrollment to also include the first half of 2022.

We are also pleased to have now initiated IND enabling toxicology studies with the lead candidate from our next generation of antibody cleaving enzymes, also known as "NiceR". NiceR is a new set of enzymes developed for repeat dosing scenarios that may potentially open up a broad array of new indications to pursue, including reoccuring AMR, relapsing autoimmune diseases and oncology.

Lastly, I also want to highlight how we continue to build a high-performance organization while adding new competences. At the end of June, Hansa had 113 employees, which represents close to a threefold increase in less than 3 years. Our international team is a diverse, talented and highly experienced group of professionals driven by a passion to make a difference for patients with rare immunologicdiseases.

I look forward to keeping you updated on the progress of Hansa Biopharma’s journey as we take the next steps towards building a global leader in rare diseases across multiple broad therapeutic areas through the development of new, transformative medicines for patients suffering from rare immunologic diseases."

Upcoming milestones and news flow

H2 2021 Kidney transplantation US: First patient dosed

H2 2021 Anti-GBM: Clarity around the regulatory path forward

H2’21/H1’22 AMR Phase 2 study: Complete enrollment

H2’21/H1’22 GBS Phase 2 study: Complete enrollment

2022 NiceR: Completion of GLP tox studies

H2 2022 Kidney transplantation US: Complete enrollment

H2 2022 AMR Phase 2 study: First data read out

H2 2022 GBS Phase 2 study: First data read out

H2 2023 Kidney transplantation US: 12 months follow-up completed

H1 2024 Kidney transplantation US: BLA submission

Conference call details

Hansa Biopharma will host a telephone conference today Thursday July 15 14:00 CET / 8:00am EST.

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentation" and will also be made available online after the call.

To participate in the telephone conference, please use the dial-in details provided below: