On July 19, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the "Company"), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenue for the second quarter of 2019 (Press release, Nanobiotix, JUL 19, 2019, View Source [SID1234537632]).

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Income statement (unaudited) €K Q2 2019 Q2 2018 Revenues 31.9 73.3 Of which: License Services-31.9-73.3 A quarter marked by a significant achievement: First European market approval for Hensify (NBTXR3) for locally advanced Soft Tissue Sarcoma

Revenue for the second quarter of 2019 amounted to €31.9K, generated by the cross-charge to our partners related to shared contract research organization costs pursuant to our license and collaboration agreement. The company’s cash availability as of June 30, 2019 amounted to €54.9M.

In early April, the Company announced that first-in-class radioenhancer NBTXR3 obtained, under the brand name Hensify, first European market approval in the form of a CE marking for the treatment of locally advanced Soft Tissue Sarcoma (STS) of the extremity and chest wall. The CE marking enables Nanobiotix to potentially commercialize Hensify in 27 European Union countries. After positive phase II/III clinical trial results in STS, this approval represents a significant step forward in establishing NBTXR3 as a major oncology treatment.

Following the announcement, in order to accelerate its development, the Company raised approximately €29.5M in April in a placement of new shares to a specific class of investors.

The proceeds of this recent offering will primarily be used to prepare the launch of the expected phase II/III clinical trial in head and neck cancers for registration in the United-States. As a result of this latest transaction, the company’s cash visibility now extends through the end of 2020.

In addition, later in April, CEO Laurent Levy also subscribed new shares through the exercise of founders’ warrants (Bon de Souscription de Parts de Créateur d’Entreprise or BSPCE) for an amount of EUR 960,000. Post-transactions, the capital breakdown as of April 30, 2019 is as follows: Institutional investors (47%), Individual shareholders (45%), Management and employees (4%), Family office (4%), based on 22,360,039 shares. 2

Additionally, Nanobiotix recently announced organizational changes as the company enters its next stage after first European market approval. The changes aim to reinforce necessary competencies as strategic priorities evolve, and to help accelerate the company’s longstanding mission to significantly improve outcomes for patients.

On July 19, 2019, CASI Pharmaceuticals, Inc. ("CASI" or "Company"), reported that it has entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC ("Jefferies") (Filing, 8-K, CASI Pharmaceuticals, JUL 19, 2019, View Source [SID1234537631]). Pursuant to the terms of the Sales Agreement, the Company may elect to sell from time to time, at its option, up to $30 million shares of the Company’s common stock, par value $0.01 per share (the "Shares"), through Jefferies, as sales agent.

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Any sales of Shares pursuant to the Sales Agreement will be made under the Company’s effective "shelf" registration statement (the "Registration Statement") on Form S-3 (File No. 333-222046) which was declared effective on December 22, 2017 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the "SEC") on July 19, 2019.

Under the terms of the Sales Agreement, the Company may elect to sell shares of its common stock through Jefferies by any method permitted that is deemed an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"). Based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose) Jefferies will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Company’s common stock from time to time. Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any shares pursuant to the Sales Agreement. The Company will pay a commission rate of up to 3.0% of the gross sales price per share sold and agreed to reimburse Jefferies for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $90,000. The Company has also agreed pursuant to the Sales Agreement to provide Jefferies with customary indemnification and contribution rights.

The Company or Jefferies upon notice to the other, may suspend the offering of the Shares under the Sales Agreement at any time. The offering of the Shares pursuant to the Sales Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $30 million, or sooner if either the Company or Jefferies terminate the Sales Agreement pursuant to its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Sales Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Arnold & Porter Kaye Scholer LLP relating to the legality of the shares of Common Stock issuable under the Sales Agreement, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

The above disclosure shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The representations, warranties and covenants contained in the Sales Agreement were made solely for the benefit of the parties to the Sales Agreement. In addition, such representations, warranties and covenants (i) are intended as a way of allocating the risk between the parties to the Sales Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Sales Agreement, which subsequent information may or may not be fully reflected in public disclosures.

On July 19, 2019 Allergan plc (NYSE: AGN) reported that its Board of Directors has declared a cash dividend of $0.74 per ordinary share for the third quarter of 2019 (Press release, Allergan, JUL 19, 2019, View Source [SID1234537630]). The dividend will be paid on September 13, 2019 to shareholders of record at the close of business on August 13, 2019.

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On July 19, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Janssen-Cilag International NV (Janssen) has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX (daratumumab) for patients with multiple myeloma (Press release, Halozyme, JUL 19, 2019, View Source [SID1234537628]).

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"We are pleased that Janssen’s filing follows quickly after its filing last week of a Biologics License Application (BLA) with the U.S. Food and Drug Administration," said Dr. Helen Torley, President and CEO. "We are particularly excited that, pending approval by the EMA, a greater number of patients with multiple myeloma may soon have a new therapeutic option that offers the potential of DARZALEX with a shorter administration time."

Janssen’s submission follows the announcement of positive results from its Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX in comparison to intravenous DARZALEX in patients with relapsed and refractory multiple myeloma. Subcutaneous DARZALEX, using ENHANZE drug delivery technology, was found to be non-inferior to intravenous DARZALEX with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On July 19, 2019 Genmab A/S (CSE: GEN, Nasdaq: GMAB) reported the exercise in full by the underwriters of their over-allotment option in connection with its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the listing of the ADSs on the Nasdaq Global Select Market (Press release, Genmab, JUL 19, 2019, View Source [SID1234537616]). On July 18, 2019, BofA Merrill Lynch, Morgan Stanley and Jefferies, on behalf of the underwriters, notified Genmab of the underwriters’ exercise in full of their previously announced option to purchase up to 4,275,000 additional ADSs, representing 427,500 ordinary shares, to cover any over-allotments (the "Option") at a price of $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per underlying ordinary share at an exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of 10 to 1.

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The exercise of the Option will increase the total gross proceeds of the Offering to $581,756,250 (DKK 3,873.3 million) and will result in a total issuance of 32,775,000 ADSs, representing 3,277,500 ordinary shares.

The 427,500 additional shares will be delivered by Genmab in the form of new shares with a nominal value of DKK 1 each (the "New Shares").

Following the registration of the New Shares with the Danish Business Authority, which is expected to take place on July 23, 2019 or early thereafter (and presuming that the 2,850,000 new ordinary shares of a nominal value of DKK 1 that were offered during the Offering will be registered with the Danish Business Authority on July 22, 2019) Genmab’s share capital will amount to DKK 64,967,643 divided into 64,967,643 shares with a nominal value of DKK 1 each.

The New Shares will rank pari passu with Genmab’s existing shares and carry the same dividend and other rights.

The New Shares are expected to be issued and registered with the Danish Business Authority on July 23, 2019 (or early thereafter) and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 24, 2019 (or early thereafter), with the permanent ISIN code DK0010272202.

BofA Merrill Lynch, Morgan Stanley and Jefferies are acting as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets are acting as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen are acting as co-managers for the Offering. A copy of the preliminary prospectus and, when available, the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the preliminary prospectus and, when available, the final prospectus related to the Offering are also available, or will be available, at www.sec.gov. No Danish prospectus will be issued or offered.
This Company Announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.