On August 15, 2022, Radius reported connection with the Merger, Parent, Purchaser, as the initial borrower immediately prior to the Merger, and the Company, as borrower after giving effect to the Merger, entered into a credit agreement (the "Credit Agreement") with OrbiMed Royalty & Credit Opportunities III, LP and OrbiMed Royalty & Credit Opportunities IV, LP, as lenders, and Wilmington Trust, National Association, as administrative agent, providing for a $350.0 million senior secured term facility (the "Term Loan") (Filing, 8-K, Radius, AUG 15, 2022, View Source [SID1234618343]). The proceeds of the Term Loan were used on the closing date under the Credit Agreement to finance the transactions contemplated by the Merger Agreement, to refinance certain existing indebtedness of the Company and to pay related fees and expenses.

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The Term Loan will mature on August 15, 2028. The Term Loan will start amortizing on the 37-month anniversary of the closing date, with equal monthly installments of principal due through the maturity date.

Borrowings under the Term Loan bear interest at a rate per annum equal to the greater of (a) 30-day average SOFR and (b) one-half percent (0.50%) per annum, in either case, plus the applicable margin of eight percent (8.00%) per annum ("Interest"). For the first twelve (12) months after the closing date, the Company will have the option to accrue up to one-half percent (0.50%) of the Interest as a payable in kind.

The Credit Agreement contains representations and warranties, covenants and events of default customary for agreements of this type.

Supplemental Indenture for Convertible Notes

In connection with the consummation of the Merger, the Company and Wilmington Trust, National Association, as trustee (the "Trustee"), entered into a Second Supplemental Indenture, dated as of August 15, 2022, which amends and supplements the Base Indenture, dated as of August 14, 2017, by and between the Company and the Trustee (the "Base Indenture"), as supplemented by the First Supplemental Indenture, dated as of August 14, 2017, by and between the Company and the Trustee (the "First Supplemental Indenture"), governing the Company’s 3.00% Convertible Senior Notes due 2024 (the "Notes") in the aggregate outstanding principal amount of approximately $193,000,000. The Second Supplemental Indenture was entered into to provide for a change in the conversion right of the Notes resulting from the Merger.

The Second Supplemental Indenture provides that, from and after the effective time of the Merger (the "Effective Time"), the right to convert each $1,000 principal amount of the Notes based on a number of Shares equal to the Conversion Rate (as defined in the First Supplemental Indenture) in effect immediately prior to the Merger will be changed into a right to convert such principal amount of Notes based on a number of units of reference property equal to the Conversion Rate consisting of (i) prior to the Milestone Payment Date (as defined in the CVR Agreement), $10.00 in cash and one (1) CVR, and (ii) after the occurrence of the Milestone Payment Date, $10.00 in cash plus the Milestone Payment Amount (as defined in the CVR Agreement) in cash.

The Second Supplemental Indenture also provides that the Company irrevocably elects to eliminate Cash Settlement and Combination Settlement (each as defined in the First Supplemental Indenture) and that its obligations to convert the Notes will be satisfied solely by Physical Settlement (as defined in the First Supplemental Indenture).

The foregoing description of the Base Indenture, the First Supplemental Indenture and the Second Supplemental Indenture does not purport to be complete and is subject to, and qualified in its entirety, by the full text of the Base Indenture and the First Supplemental Indenture, which were included as Exhibits 4.1 and 4.2, respectively, to the Company’s Current Report on Form 8-K, filed with the SEC on August 14, 2017, and is incorporated into this Item 1.01 of this Current Report on Form 8-K by reference, and the full text of the Second Supplemental Indenture, which is included as Exhibit 10.1 hereto, is incorporated herein by reference.

On August 15, 2022 Boston Scientific Corporation (NYSE: BSX) reported the acquisition of Obsidio, Inc., a privately-held company that has developed the Gel Embolic Material (GEM) technology used for embolization of blood vessels in the peripheral vasculature (Press release, Boston Scientific, AUG 15, 2022, View Source,-Inc [SID1234618342]).

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Embolization is a minimally invasive procedure intended to obstruct or reduce blood flow to an abnormality or tumor to stop hemorrhaging, reduce the size of malignant and benign tumors, and stabilize venous and arterial malformations.

Recently cleared by the U.S. Food and Drug Administration (FDA), the GEM technology is a semi-solid, proprietary material packaged in a ready-to-use form, thus reducing the preparation time required for many embolization procedures. Physicians deliver the GEM agent through a catheter, and its gel-like composition enables controlled placement within patient anatomy. Unlike solid and liquid embolics that can take time to form an obstruction to blood flow, once placed, the GEM technology conforms to the targeted vasculature, immediately creating a barrier.

"The GEM technology combines benefits of currently available embolics, such as precise control of a solid and malleability of a liquid, to create a unique technology that offers procedural efficiency and a more personalized therapy for patients," said Peter Pattison, president, interventional oncology and embolization, Peripheral Interventions, Boston Scientific. "This acquisition strengthens our interventional oncology and embolization portfolio with a differentiated solution for physicians and their patients suffering from hemorrhages, cancer and other debilitating conditions."

The transaction is expected to be immaterial to Boston Scientific’s GAAP and adjusted earnings per share in 2022. Specific terms of the transaction have not been disclosed.

On August 15, 2022 Sigyn Therapeutics, Inc. (OTCQB: SIGY), a development-stage company focused on the creation of therapeutic solutions that address unmet needs in global health, reported its financial results for the second quarter ended June 30, 2022 and provides an update on recent corporate developments (Press release, Sigyn Therapeutics, AUG 15, 2022, View Source [SID1234618341]).

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"We continue to take meaningful steps toward our goal to advance Sigyn Therapy into human clinical studies," commented Jim Joyce, co-founder and CEO of Sigyn Therapeutics. "Of particular note was our successful completion of in vivo animal studies, which followed a series of in vitro studies that demonstrated the ability of Sigyn Therapy to isolate and extract pathogen sources of life-threatening inflammation in concert with the broad-spectrum depletion of proinflammatory cytokines from human blood plasma. The data from these studies is being incorporated into an Investigational Device Exemption that we are drafting for submission to the U.S. Food and Drug Administration to support potential human studies of Sigyn Therapy in the United States."

Sigyn Therapy is multi-function blood purification technology designed to treat life-threatening infections and inflammatory disorders that are not addressed with approved drugs. In vitro study validations of pathogen sources of life-threatening inflammation include endotoxin (a gram-negative bacterial toxin), peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins), and viral pathogens, including COVID-19. In vitro study validations of inflammatory cytokines include interleukin-1 beta (IL-1b), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-a).
Based on these capabilities, the Company believes that Sigyn Therapy is a candidate to treat pathogen-associated sepsis (leading cause of hospital deaths), community acquired pneumonia (a leading cause of death among infectious diseases), emerging pandemic threats, and hyperinflammation & endotoxemia that commonly occurs in end-stage renal disease patients.

Recent 2022 Developments

Reported the successful completion of in vivo animal studies conducted at the University of Michigan.
Appointed accomplished financial executive, Jeremy Ferrell, CPA, MBA as Chief Financial Officer.
Established a Scientific Advisory Board comprised of recognized clinician researchers and thought leaders from the fields of nephrology, neurology, hepatology, and liver transplantation.
On August 3, 2022, announced that its securities had graduated from trading on the OTC Pink Market to the OTCQB Venture Exchange, and confirmed the Company continues to pursue the listing of its securities on a major exchange.
Summary Second Quarter 2022 Financial Results
For the quarter ended June 30, 2022, the Company had a loss from operations of approximately $533,000, compared to an operating loss of approximately $442,000 for the comparable period of 2021. The Company’s net loss for the 2022 second quarter was approximately $666,000, or approximately $0.02 per share, compared to a net loss of approximately $650,000, or approximately $0.02 per share, for the comparable period in 2021. Second quarter 2022 net cash used in operating activities was approximately $395,000.

For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, and on the Company’s website at www.SigynTherapeutics.com under "Financial Info" in the Investors section.

On August 15, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") relating to an At-the-Market offering (the "ATM Program") (Press release, Valneva, AUG 15, 2022, View Source [SID1234618340]). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $75.0 million of American Depositary Shares ("ADS"), each ADS representing two of the Company’s ordinary shares, from time to time in sales deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, and pursuant to the terms of an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), acting as sales agent, subject to French regulatory limits. The timing of any sales will depend on a variety of factors and the Company is not under any obligation to utilize the ATM Program in a specified amount or at all.

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The ADSs intended to be sold under the Sales Agreement, if any, will be issued and sold pursuant to a shelf registration statement on Form F-3 (the "Registration Statement"), once declared effective by the SEC.

To the extent that ADSs are sold pursuant to the ATM Program, the Company currently intends to use the net proceeds (after deduction of fees and expenses), if any, of sales of ADSs issued under the ATM Program, together with its existing cash and cash equivalents, primarily for research and development of the Company’s product candidates, working capital and other general corporate purposes, at the Company’s discretion.

Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company to eligible investors requesting it, consistent with Jefferies’ normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.

The ADSs and the underlying ordinary shares will be issued through one or more share capital increases without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to and within the limits set forth in the 24th and 28th resolutions adopted by the combined shareholders’ general meeting dated June 23, 2022 (the "General Meeting") (or any substitute resolutions, adopted from time to time), i.e. a maximum number of 30,666,666 ordinary shares (being the maximum authorized by the shareholders for the 24th resolution), representing a maximum potential dilution of approximately 26.1% based on the existing share capital of the Company. In any event the number of underlying ordinary shares to be admitted on the regulated market of Euronext in Paris ("Euronext Paris") shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a French listing prospectus.

The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM Program may only be issued to the categories of investors defined in the 24th resolution adopted by the General Meeting (or any similar resolutions that may be substituted for it in the future), comprising (i) natural persons or legal entities, including companies, trusts, investment funds or other investment vehicles, regardless of their form, under French or foreign law, investing on a regular basis in the pharmaceutical, biotechnological or medical technology sector, and/or (ii) French or foreign companies, institutions or entities of any form, carrying out a significant portion of their business in the pharmaceutical, cosmetics or chemical sector or in the field of medical devices and/or technologies or research in these areas. The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Select Market ("Nasdaq").

On an illustrative basis, assuming the issuance of the full amount of $75.0 million (or €72.5 million (all convenience translations in this press release are based on an exchange rate of €1.00 = $1.0338, the exchange rate reported by the European Central Bank on August 11, 2022) of ADSs under the ATM Program at an assumed offering price of $20.83 per ADS (or €10.03 per ordinary share), the last reported sale price of the ADSs on Nasdaq on August 11, 2022, a holder of 1.0% of the outstanding Company’s share capital as of the date of this press release, would hold 0.99% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release), it being specified that, in any event, the number of underlying ordinary shares shall not exceed the limit set forth in the 24th resolution adopted by the General Meeting (or any substitute resolutions, adopted from time to time) and shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a listing prospectus.

During the term of the ATM Program, the Company will include information in the publication of its half-year and full-year financial reports about its use of the ATM Program during the preceding period and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM Program from time to time.

The Registration Statement (including a prospectus) relating to Valneva’s securities, including the ADSs, was filed with the SEC on August 12, 2022 but has not yet been declared effective. No offers or sales of ADSs under the ATM Program can be made until the Registration Statement is declared effective by the SEC. Before purchasing ADSs in an offering, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]. No prospectus will be subject to the approval of the French Financial Markets Authority (the Autorité des Marchés Financiers or the "AMF") pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the "Prospectus Regulation") since the contemplated share capital increase(s) (for the issuance of the ordinary shares underlying the ADSs) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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. In particular, no public offering of the ADSs will be made in Europe.

Information Available to the Public

Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in the Company’s Annual Report on Form 20-F (the "Annual Report"), filed with the SEC on March 24, 2022, as well as in the half-yearly financial report (containing an update of the main information on the Company, its development and its projects) (the "Half-Year Report"), and documents filed with the SEC from time to time (the "SEC Filings"). The Annual Report and SEC Filings are available on the SEC’s website (www.sec.gov). The Company’s Universal Registration Document filed with the AMF on March 23, 2022 under number D.22-0140 and the Company’s half year report published on its website on August 11, 2022 as well as other regulated information are available on the AMF website (www.amf-france.org). All of the foregoing documents are available on the Company’s website and are available free of charge on request at the Company’s registered office at 6 rue Alain Bombard, 44800 Saint-Herblain, France.

On August 15, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 15, 2022, View Source [SID1234618339]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from August 8, 2022 to August 12, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 482,983 shares as treasury shares, corresponding to 0.73% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.