On December 8, 2020 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Delcath Systems, DEC 8, 2020, View Source [SID1234572443]). All of the shares of common stock to be sold in the offering will be offered by Delcath. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Delcath also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering.

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Delcath intends to use the net proceeds from this offering for (i) the completion of its FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the "Focus Trial"), a global registration clinical trial that is investigating the primary endpoint of objective response rate, as well as other secondary and exploratory endpoints, in metastatic ocular melanoma, or mOM; (ii) preparation of the federal regulatory application for the HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO, a drug/device combination product regulated as a drug, designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects; (iii) preparation for the commercial launch of HEPZATO; (iv) continued clinical development, including additional indications and expanded access trials in metastatic ocular melanoma; and (v) general corporate purposes, which may include capital expenditures and other operating expenses.

Canaccord Genuity and Roth Capital Partners are acting as joint book-running managers for the proposed offering.

A shelf registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on December 21, 2018. The offering is being made only by means of a preliminary prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement, which will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by email at [email protected] or Roth Capital Partners, LLC, 888 San Clemente, Newport Beach, CA 92660, Attention: Prospectus Department, or by telephone at (800) 678-9147.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.

On December 8, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $21.00 per share (Press release, Sutro Biopharma, DEC 8, 2020, View Source [SID1234572459]). The gross proceeds from this offering are expected to be $126.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. Sutro has also granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock in connection with the public offering. All of the shares of common stock are being offered by Sutro. The offering is expected to close on or about December 11, 2020, subject to the satisfaction of customary closing conditions.

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Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities are acting as co-managers in the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares are being offered by Sutro pursuant to registration statements filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, and when available, the final prospectus supplement, may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, 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.

On December 8, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported the closing of its previously announced private placement of equity (Press release, Regulus, DEC 8, 2020, View Source [SID1234572427]). The Company received gross proceeds of approximately $19.4 million from the sale of 24,341,607 shares of the Company’s common stock ("Common Stock") and accompanying warrants to purchase up to an aggregate of 18,256,204 shares of Common Stock at a purchase price of $0.622 per share of Common Stock and $0.125 for each share of Common Stock underlying such warrants. In addition, the Company sold 272,970 shares of non-voting Class A-3 convertible preferred stock, in lieu of shares of Common Stock, at a price of $6.22 per share, and accompanying warrants to purchase an aggregate of 2,047,276 shares of Common Stock at a price of $0.125 for each share of Common Stock underlying these warrants. Each share of non-voting Class A-3 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The Company expects to use the net proceeds from the transaction primarily to advance RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease and for general corporate purposes. H.C. Wainwright and Co. acted as exclusive placement agent for the financing.

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The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

Additional details regarding the private placement are included in the Form 8-K filed with the Securities and Exchange Commission on December 4, 2020.

On December 8, 2020 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has raised its full-year 2020 outlook for growth of net sales and adjusted earnings per share (EPS) and is looking forward to another strong performance in 2021 (Press release, Qiagen, DEC 8, 2020, View Source [SID1234572444]).

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These results are expected to be driven by QIAGEN’s focus on five pillars of growth that leverage differentiated testing solutions used in highly attractive, growing markets involving Life Sciences and Molecular Diagnostics customers.

"2020 has demonstrated QIAGEN employees worldwide stepping up to deal with demanding changes. We have responded to the demands of the COVID-19 pandemic by launching novel testing solutions and ramping up production capacity," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "As we finish 2020 with an improved outlook, we have confidence in our future and in the benefits of our unwavering focus on our five pillars of growth. We expect another strong performance in 2021, balancing investments in our portfolio to create new organic long-term growth opportunities with improved near-term earnings to deliver significant value creation."

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "QIAGEN has developed a solid foundation for continued financial success. This is reflected in our solid outlook for 2020 and 2021, along with expectations for double-digit CER net sales growth post-COVID from our non-COVID products. We have also reaffirmed our disciplined capital allocation strategy, anchored by our commitment to invest in our business and increase returns to shareholders."

Additionally, QIAGEN announced today that its Supervisory Board plans to expand the number of members from the current level of six. The Board intends to further diversify, complement and increase its already extensive expertise and experience in the Life Sciences and diagnostics.

QIAGEN is planning to hold a Virtual Deep Dive on Tuesday, December 8, from 16:30-19:00 CET / 10:30-13:00 EST. This webcast will feature top executives and be led by Thierry Bernard and Roland Sackers, who will provide a strategic and financial update. More details about the event are available via the Investor Relations section on www.qiagen.com.

Increased outlook for Q4 2020, full-year 2020 and full-year 2021 results

QIAGEN now expects net sales for the fourth quarter of 2020 to grow at least 32% at constant exchange rates (CER) from $413.5 million in the same period of 2019, and for adjusted EPS to increase to approximately $0.64-0.65 CER from $0.48 in the year-ago quarter.

QIAGEN also now expects full-year 2020 net sales to grow approximately 22% CER from $1.53 billion in 2019, and for adjusted EPS to increase to $2.13-2.14 CER from $1.43 in 2019.

These strong trends are expected to continue into 2021. QIAGEN now expects full-year 2021 net sales to grow 18-20% CER from the midpoint of the anticipated range for full-year 2020 net sales results. Adjusted EPS is now expected to be $2.42-2.46 CER. These results include significant investments planned for R&D and clinical trials to strengthen the competitive profile of QIAGEN’s five pillars of growth. In particular, these include initiatives to enlarge the test menu for the NeuMoDx and QIAstat-Dx systems in the U.S. and Europe.

QIAGEN plans to maintain or take a top leadership position in these areas identified as the five pillars of growth: (1) Sample technologies used to gain nucleic acids from biological samples; (2) QuantiFERON for immune response testing, especially tuberculosis (TB); (3) the integrated PCR system NeuMoDx; (4) the QIAstat-Dx syndromic testing solution; and (5) the QIAcuity digital PCR portfolio.

On December 8, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Antengene Corporation for the development of a systems pharmacology modeling in immuno-oncology (Press release, Applied BioMath, DEC 8, 2020, View Source [SID1234572460]). Applied BioMath will develop a systems pharmacology model for a PDL1/41BB bispecific antibody, ATG-101, in immuno-oncology indications. The model will be used to predict clinical starting and efficacious doses for first-in-human studies. "Antengene Corporation is dedicated to developing first-in-class and/or best-in-class therapies in oncology," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "We decided to collaborate with Applied BioMath in an effort to provide ourselves the highest likelihood possible of predicting accurate starting and efficacious doses which is a critical part of our first-in-human studies."

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Predicting starting and efficacious doses for first-in-human studies is non-trivial for complex therapeutics such as Antengene’s bispecific therapeutic," said Dr. John Burke, Ph.D., Co-Founder, President, and CEO of Applied BioMath. "We have developed algorithms and tools specifically for this purpose that have a proven track record of predicting such doses. We look forward to collaborating with Antengene to support them in this project."