Entry into a Material Definitive Agreement

On July 15, 2021, Generex Biotechnology Corporation (the "Company") reported that it closed on a funding transaction by entering into a Securities Purchase Agreement with an investor pursuant to which the Company agreed to sell and sold a secured convertible promissory note bearing interest at 8% per annum with a 12-month maturity date (the "Note") in the aggregate principal amount of $1,085,000 (Filing, 8-K, Generex, JUL 15, 2021, View Source [SID1234585012]). The purchase price of the Note was $1,000,000 with $70,000 of principal amount represented original issue discount, along with the issuance of 705,173 shares of the Company’s common stock, as inducement shares. Pursuant to the Securities Purchase Agreement, the Company also sold to the Investor warrants to purchase up to an aggregate 904,167 shares of common stock.

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Subject to certain ownership limitations, the Note will be convertible at the option of the holder six months from the issue date into shares of the Company’s common stock at an effective conversion price of the lower of (i) $0.60 and (ii) 75% of the lowest VWAP during the 30 consecutive trading days immediately preceding the delivery of the conversion. Subject to certain ownership limitations, the warrants will be exercisable after the six-month anniversary of the initial exercise date through the fifth anniversary of issuance at an exercise price of $0.60 per share of common stock.

The conversion price of the Note and the exercise of the warrants will be subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. If the Company defaults on a timely repayment, then the conversion price will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances.

The Company is required to file a registration statement with the SEC by July 26, 2021, and have the registration statement become effective within 90 days of closing.

The Company has the right to prepay the Note at a premium after issuance. If the Note is prepaid within 60 days, the Company will pay 105% of the principal amount; if the Note is prepaid after 60 days but prior to 90 days, the Company will pay 110% of the principal amount. If the Note is prepaid after 90, the Company will pay 120% of the principal amount.

The net cash proceeds to the Company from the sale of the Note, after deducting the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, is expected to be approximately $1,000,000.

The Note, warrants, and the shares of common stock underlying the warrants, were offered privately pursuant to Rule 506 of Regulation D under the Securities Act of 1933.

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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ERASCA ANNOUNCES PRICING OF UPSIZED INITIAL PUBLIC OFFERING

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.

Novocure Announces Recipients of 3rd Annual AACR-Novocure Grants for Tumor Treating Fields Research Program

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.

Orexo Q2 2021 Interim Report

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.