European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer

On August 18, 2022 Celltrion Healthcare reported that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer (Press release, Celltrion, AUG 18, 2022, View Source [SID1234618492]).

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"The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price," said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. "With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year."

The EC approval of Vegzelma follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.

Today’s approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.2

Vegzelma (CT-P16) is Celltrion’s third oncology biosimilar approved for use in the EU, following the approval of Truxima (biosimilar rituximab) and Herzuma (biosimilar trastuzumab). Vegzelma was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA) in September 2021. Approval is expected during the third quarter of 2022.

Navidea Biopharmaceuticals Announces Extension of Subscription Period to August 24, 2022 and Updated Terms of its Previously Announced Rights Offering

On August 18, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it has extended the initial rights offering subscription period until 5:00 PM Eastern time on Wednesday, August 24, 2022 and has updated certain pricing information for its rights offering (Press release, Navidea Biopharmaceuticals, AUG 18, 2022, View Source [SID1234618489]). Each subscription right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one (1) share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.45 per share) and one (1) warrant to purchase 2,222 shares of Navidea’s common stock with an exercise price of $0.50 per share. The warrants will be exercisable for 5 years after the date of issuance.

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All record holders of rights that wish to participate in the rights offering must deliver a properly completed and signed subscription rights certificate, together with payment of the full subscription price for the units the holder wishes to purchase pursuant to both the basic subscription right and the over-subscription privilege to the Subscription Agent, to be received before 5:00 PM Eastern Time on August 24, 2022. The completed rights certificate and payment should be delivered to the Subscription Agent as follows:

Brentwood, NY 11717-0718

Edgewood, NY 11717

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the final prospectus and prospectus supplement, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

The Company’s registration statement on Form S-1 (Registration No. 333-262691) was declared effective by the Securities and Exchange Commission ("SEC") on August 3, 2022. The prospectus and prospectus supplement dated August 18, 2022 relating to and describing the terms of the rights offering have been filed with the SEC as a part of the registration statement and are available on the SEC’s web site at View Source Copies of the final prospectus and prospectus supplement for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will 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 registration or qualification under the securities laws of any such state or jurisdiction.

MOLECULAR PARTNERS HALF YEAR 2022 NEWS RELEASE AND INVESTOR CALL DETAILS

On August 18, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it will issue a press release summarizing its highlights and financial results for the first half-year of 2022, followed by an analyst & investor call the following day (Press release, Molecular Partners, AUG 18, 2022, View Source [SID1234618488]). Please see more details here:

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Release date and time

August 25, 2022, 4:30 pm ET (10:30 pm CET)
Call Details:

August 26, 2022, 8:00 am ET (2:00 pm CET)
The half year 2022 results presentation will be webcast live and will be made available on the Company’s website under the investor section. The replay will be available for 90 days following the presentation.

In order to register for the H1 2022 conference call on Friday, August 26, 2pm CET / 8am ET, please dial the following numbers approximately 10 minutes before the start of the presentation

Invitation to Scandion Oncology webcast and conference call August 25, 2022

On August 18, 2022 Scandion Oncology (Scandion) reported that it will publish its Q2 2022 interim report on Thursday, August 25, 2022 before 09:00 CET (Press release, Scandion Oncology, AUG 18, 2022, View Source;2022,c3615705 [SID1234618486]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Scandion’s Executive Management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

Access to the event can be obtained as follows:

LIVE access on Thursday August 25, 2022 at 10:00 CET

Entry into a Material Definitive Agreement

On August 18, 2022, Halozyme Therapeutics, Inc. (the "Company," "we," "us" or "our") completed its previously reported that sale of $720.0 million in aggregate principal amount of 1.00% Convertible Senior Notes due 2028 (the " Convertible Notes"), including $95.0 million in aggregate principal amount of 1.00% Convertible Senior Notes due 2028 purchased pursuant to the exercise by the initial purchasers of the Convertible Notes (the "Initial Purchasers") of the option (the "Notes Option") to purchase additional Securities in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, Halozyme, AUG 18, 2022, View Source [SID1234618483]). The Convertible Notes were issued under an indenture, dated as of August 18, 2022, (the "Indenture") between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee (the "Trustee"). The Company offered and sold the Convertible Notes in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act. The Initial Purchasers offered and sold the Convertible Notes to "qualified institutional buyers" pursuant to the exemption from registration provided by Rule 144A under the Securities Act. The offer and sale of the Convertible Notes and the shares of common stock issuable upon conversion of the Convertible Notes have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold absent registration or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements.

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The Company received net proceeds from the offering of approximately $701.4 million. The Company expects to use a portion of the net proceeds to repay all of the $250.0 million outstanding under its term loan facility due 2026. The Company used a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions consummated concurrently with or shortly after the offering (the "Note Repurchases"). In connection with the Note Repurchases, the Company paid approximately $77.6 million in cash, which includes accrued interest, and issued approximately 1.51 million shares of its common stock, to settle such exchanges. In addition, the Company used approximately $90.0 million of the net proceeds from the offering to repurchase shares of its common stock under its existing stock repurchase program (the "Share Repurchases") concurrently with the closing of the offering. The Company previously announced Share Repurchases for the remainder of the calendar year 2022 of up to $200.0 million, a $100.0 million increase from the previously announced amount, with such remaining additional repurchases to commence immediately following the closing of the offering.

The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company’s common stock from time to time under its existing stock repurchase program, working capital, capital expenditures, potential acquisitions and strategic transactions.

The Convertible Notes will pay interest semi-annually in arrears on February 15th and August 15th of each year at an annual rate of 1.00% and will be convertible into cash, and, if applicable, shares of the Company’s common stock, at the Company’s election, based on the applicable conversion rate at such time. The Convertible Notes are general unsecured obligations of the Company and will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the Convertible Notes, will rank equally in right of payment with all of the Company’s existing and future liabilities that are not so subordinated, will be effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness and will be structurally subordinated to all indebtedness and other liabilities (including trade payables) of the Company’s current or future subsidiaries.

Holders may convert their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on December 31, 2022, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, the "measurement period") in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on Company’s common stock, as described in the offering memorandum; (4) if we call such notes for redemption; and (5) at any time from, and including, February 15, 2028 until the close of business on the second scheduled trading day immediately before the maturity date.

The initial conversion rate for the Convertible Notes will be 17.8517 shares of common stock per $1,000 in principal amount of Convertible Notes, equivalent to a conversion price of approximately $56.02 per share of common stock. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

Subject to certain exceptions, holders may require the Company to repurchase, for cash, all or part of their Convertible Notes upon a "Fundamental Change" (as defined in the Indenture) at a price equal to 100% of the principal amount of the Convertible Notes being repurchased plus any accrued and unpaid interest, if any, up to, but excluding, the "Fundamental Change Repurchase Date" (as defined in the Indenture). In addition, upon a "Make-Whole Fundamental Change" (as defined in the Indenture) prior to the maturity date of the Convertible Notes, the Company will, in some cases, increase the conversion rate for a holder that elects to convert its Convertible Notes in connection with such Make-Whole Fundamental Change. The Company may not redeem the Convertible Notes prior to August 15, 2025 and on or before the 30th scheduled trading day immediately before the maturity date.

The Indenture contains certain events of default after which the Convertible Notes may be due and payable immediately. Such events of default include, without limitation, the following: (1) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any Convertible Note; (2) a default for 30 days in the payment when due of interest on any Convertible Note; (3) the Company’s failure to deliver, when required by the Indenture, a fundamental change notice or other notices pursuant to the Indenture; (4) a default in the Company’s obligation to convert a Convertible Note in accordance with the Indenture upon the exercise of the conversion right with respect thereto, if such default is not cured within two business days after its occurrence; (5) a default in the Company’s obligations described in the Indenture with respect to consolidation, merger and sale of assets of the Company; (6) a default in any of the Company’s obligations or agreements under the Indenture or the Convertible Notes (other than a default set forth in the preceding (1), (2), (3), (4) or (5)) where such default is not cured or waived within 60 days after notice to the Company by the Trustee, or to the Company and the Trustee by holders of at least 25% of the aggregate principal amount of Convertible Notes then outstanding, which notice must specify such default, demand that it be remedied and state that such notice is a "notice of default"; (7) a default by the Company or any of the Company’s subsidiaries with respect to any one or more mortgages, agreements or other instruments under which there is outstanding, or by which there is secured or evidenced, any indebtedness for money borrowed of at least $50.0 million (or its foreign currency equivalent) in the aggregate of the Company or any of the Company’s subsidiaries, whether such indebtedness exists as of the date the Company first issues the Convertible Notes or is thereafter created, where such default: (x) constitutes a failure to pay the principal of, or premium or interest on, any of such indebtedness when due and payable at its stated maturity, upon required repurchase, upon declaration of acceleration or otherwise, in each case after the expiration of any applicable grace period; or (y) results in such indebtedness becoming or being declared due and payable before its stated maturity, in each case where such default is not cured or waived within 30 days after notice to the Company by the Trustee or to the Company and the Trustee by holders of at least 25% of the aggregate principal amount of Convertible Notes then outstanding; and (8) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of the Company’s "significant subsidiaries", as defined in the Indenture.

The foregoing description of the Indenture and Convertible Notes is qualified in its entirety by reference to the text of the Indenture and the Form of Convertible Note, copies of which are attached as Exhibits 4.1 and 4.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

Capped Call Transactions

On August 15, 2022, in connection with the pricing of the Notes, the Company entered into capped call transactions (the "Base Capped Call Transactions") with each of Bank of America, N.A., Mizuho Markets Americas LLC, Bank of Montreal, Royal Bank of Canada and Wells Fargo Bank, National Association (collectively, the "Capped Call Counterparties"). On August 16, 2022, in connection with the Initial Purchasers’ exercise of the Notes Option, the Company entered into additional capped call transactions with the Capped Call Counterparties (together with the Base Capped Call Transactions, the "Capped Call Transactions"). The Capped Call Transactions are expected generally to reduce potential dilution to holders of our common stock on any conversion of the Convertible Notes or at our election (subject to certain conditions) offset any cash payments we are required to make in excess of the principal amount of such converted Convertible Notes, as the case may be, with such reduction or offset subject to a cap. The cap price of the Capped Call Transactions is initially $75.4075 per share of common stock, representing a premium of 75% above the last reported sale price of $43.09 per share of common stock on August 15, 2022, and is subject to certain adjustments under the terms of the Capped Call Transactions.

The Capped Call Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock or purchasing or selling our common stock in secondary market transactions following the pricing of the Convertible Notes and prior to the maturity of the Convertible Notes (and are likely to do so during the relevant valuation period under the capped call transactions or following any early conversion of the Convertible Notes or repurchase of the Convertible Notes by us on any fundamental change repurchase date, any redemption date or otherwise, in each case if the Company exercises our option to terminate the relevant portion of the Capped Call Transactions). This activity could also cause or avoid an increase or decrease in the market price of our common stock or the Convertible Notes, which could affect the holders’ ability to convert the Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the Convertible Notes, it could affect the amount and value of the consideration that the holder will receive on conversion of such Convertible Notes.

The Capped Call Transactions are separate transactions entered into by the Company with the Capped Call Counterparties, are not part of the terms of the Convertible Notes, and will not affect any holder’s rights under the Convertible Notes. Holders of the Convertible Notes will not have any rights with respect to the Capped Call Transactions.

The form of the Capped Call Transaction confirmation (the "Capped Call Confirmation") is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference. The foregoing description of the Capped Call Confirmation does not purport to be complete and is qualified in its entirety by reference to such exhibit.