Atara Biotherapeutics Announces Proposed Offering of Common Stock

On July 18, 2019 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it has commenced an underwritten public offering of $125,000,000 of shares of its common stock (Press release, Atara Biotherapeutics, JUL 18, 2019, View Source [SID1234537613]). In connection with the proposed offering, Atara Biotherapeutics expects to grant the underwriters a 30-day option to purchase up to an additional $18,750,000 of shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the proposed offering will be sold by Atara Biotherapeutics. The proposed offering is subject to market and other conditions, and there can be no assurances as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Citigroup, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the proposed offering. Mizuho Securities and Canaccord Genuity are acting as co-managers.

The shares described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Goldman Sachs & Co. LLC, by mail at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at [email protected]; or Cowen, by mail at Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at 1-631-592-5973, or by email at [email protected]. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

Iovance Biotherapeutics Appoints Friedrich Graf Finckenstein, M.D., as Chief Medical Officer

On July 18, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the appointment of Friedrich Graf Finckenstein, M.D., as chief medical officer (Press release, Iovance Biotherapeutics, JUL 18, 2019, View Source [SID1234537598]). Dr. Graf Finckenstein brings over 19 years of experience in clinical development and translational research to the company.

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"We are very pleased to have Dr. Finckenstein join Iovance as we move forward with pivotal studies for lifileucel in metastatic melanoma and LN-145 in metastatic cervical cancer," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "Dr. Finckenstein’s experience with prior approval of checkpoint therapy as well as his breadth of involvement with translational medicine will be of great value to Iovance while we progress our late-stage development programs toward commercialization and expand the utility of TIL in new indications."

"I am very pleased to be part of a dedicated team working on bringing a novel cell therapy to patients with very limited approved therapeutic options," commented Friedrich Graf Finckenstein, M.D. "I’m excited to be able to contribute to development of TIL therapy as we work on the important next steps involved in preparing for regulatory submission."

Dr. Graf Finckenstein is a physician-scientist with decades of experience in clinical medicine, laboratory cancer research, and drug development in the biopharmaceutical industry. Prior to joining Iovance he was Global Head of Oncology Translational Medicine at Roche Pharma Research and Early Development (pRED) in Basel, Switzerland, where he led all clinical development aspects in the Oncology Discovery and Translational Area, including the design and conduct of clinical trials, exploratory development studies and translational medicine, biomarker and personalized healthcare strategy. Prior to that, Dr. Graf Finckenstein held multiple clinical leadership roles at Bristol-Meyers Squibb Company, where he worked on an array of products from early clinical development to late stage, including key contributions to the approval of Opdivo in lung cancer. Dr. Graf Finckenstein has a medical degree from the University of Hamburg in Germany. He holds a German medical license, a pediatric board certification, and has conducted basic cancer research at the Ludwig Institute, San Diego Branch, the Children’s Hospital Los Angeles and the University of Hamburg.

Genmab Prices its Initial Public Offering of American Depositary Shares (ADSs) in the United States

On July 18, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported the pricing of 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 under the symbol "GMAB (Press release, Genmab, JUL 18, 2019, View Source [SID1234537583])." The offering will produce gross proceeds of $505,875,000 from the sale of 2,850,000 ordinary shares of Genmab in the form of 28,500,000 ADSs at a price of $17.75 per ADS. Each ADS will represent one-tenth of one ordinary share of Genmab. In addition, Genmab has granted the underwriters an option to purchase up to 4,275,000 additional ADSs, representing 427,500 ordinary shares to cover any over-allotments (the "Option"). The Option can be exercised during the 30-day period commencing July 17, 2019.

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In connection with the anticipated listing of our ADSs on the Nasdaq Global Select Market, we have requested that Nasdaq Copenhagen change the symbol for our ordinary shares from "GEN" to "GMAB" to become effective in connection with the admission to trading of the ordinary shares underlying the ADSs on Nasdaq Copenhagen, expected to occur on July 23, 2019.

Summary of the Offering:

The Offering will consist of an offering of a total of 28,500,000 ADSs, corresponding to 2,850,000 underlying ordinary shares of Genmab (the "New Shares"), which in their entirety are expected to be subscribed for by BofA Merrill Lynch, Morgan Stanley and Jefferies (the "Joint Book-Running Managers"), as representatives of the several underwriters, with an instruction to deliver such new shares to Deutsche Bank Trust Company Americas acting as depositary for the underlying New Shares in the Offering;
The public offering price is $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;
The Joint Book-Running Managers, as representatives of the several underwriters, have been granted an Option to acquire an additional 4,275,000 ADSs, exercisable in whole or in part through August 16, 2019 to cover over-allotments.
The New Shares underlying the ADSs will correspond to 4.4% of Genmab’s entire share capital assuming no exercise of the Option and 5.0% of Genmab’s entire share capital assuming full exercise of the Option;
Gross proceeds from the Offering will amount to $505.9 million (DKK 3,368.1 million) assuming no exercise of the Option and $581.8 million (DKK 3,873.3 million) assuming full exercise of the Option;
Allocation of the ADSs has been determined by the board of directors in consultation with the Joint Book-Running Managers; and
A timetable of expected future principal events can be seen below:
Event Expected date
The ADSs start trading on the Nasdaq Global Select Market… July 18, 2019
Filing in the United States of the final prospectus …………….. July 18, 2019
Closing of the Offering …………………………………………… July 22, 2019
Registration of the New Shares underlying the ADSs
with the Danish Business Authority ……………………………..

July 22, 2019
Admission for listing of the New Shares underlying the
ADSs on Nasdaq Copenhagen ……………………………………..

July 23, 2019
In addition, Genmab announced that the board of directors of Genmab has today determined (i) to increase the size of the Offering from up to 27,800,000 ADSs to a total of 28,500,000 ADSs, and to issue a total of 28,500,000 ADSs (excluding any ADSs that may be sold or issued as part of the Option (as defined below)) and 2,850,000 underlying new Genmab shares, and (ii) that the public offering price for the ADSs issued as part of the Offering is $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per underlying share issued at an exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019. In connection with the pricing of the Offering the board of directors of Genmab has today decided to repeal the decision of July 9, 2019 to exercise its authorization to increase the share capital by up to 3,197,000 new shares underlying the ADSs and simultaneously in accordance with article 4A of Genmab’s articles of association exercised an authorization granted by Genmab’s annual general meeting held on April 10, 2018, to increase Genmab’s share capital by issue of up to 3,277,500 new shares underlying the ADSs, of which 2,850,000 cover the shares being issued in connection with the Offering and 427,500 will cover shares in case the Option is exercised.

The registration statement on Form F-1 relating to the ADSs, including the preliminary prospectus forming a part thereof, has been declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering of the ADSs is being made only by means of such prospectus.

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.

Transgene Receives MHRA Approval for a Clinical Trial of TG6002, a Next-generation Oncolytic Virus, Administered by Intrahepatic Artery Infusion in Patients with Colorectal Cancer with Liver Metastases

On July 18, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported it has received the approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with a Phase 1/2a clinical trial of TG6002 administered by intrahepatic artery (IHA) infusion in colorectal cancer patients with unresectable liver metastases (CRLM) (Press release, Transgene, JUL 18, 2019, View Source [SID1234537599]).

TG6002 is a next-generation oncolytic virus (OV), which has multiple mechanisms of action. It has been engineered to combine the killing of cancer cells (oncolysis), the production of 5-FU, a widely used chemotherapeutic agent, in the tumor site, and the eliciting of an immune response against tumor cells. TG6002 expresses the proprietary FCU1 gene in the cancer cells it has infected, leading to local conversion of the pro-drug 5-FC (administered orally) into 5-FU. This is particularly important as most gastrointestinal tumors are 5-FU sensitive. TG6002 has been shown to induce both response in the primary tumor and an immune-mediated regression of distant metastases in preclinical experiments1.

"Current systemic therapies prolong survival of CRLM patients at the cost of significant side effects. We believe that TG6002 therapy administered via an IHA infusion potentially offers an additional effective and well tolerated treatment modality for these difficult to treat patients. By administering it via the intrahepatic artery, we believe we can conveniently deliver more concentrated doses of TG6002 to the tumor, to achieve better outcomes for unresectable colorectal cancer, whilst limiting systemic exposure. In parallel, Transgene is conducting a Phase 1/2 trial to investigate TG6002 in colorectal cancer patients when given intravenously," said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

Dr. Adel Samson, MB ChB PhD, Medical Oncologist at St. James’ University Hospital, is the Chief Investigator of the trial.
This trial is a single-arm open-label Phase 1/2a trial evaluating the safety, pharmacokinetics and efficacy of repeated and ascending doses of TG6002 administered by IHA route in combination with oral 5-FC, a non-cytotoxic pro-drug that can be converted in 5-FU. The study is expected to start in Q4 2019 and could enroll up to 75 patients.

— End–

About TG6002
TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and allow the local production of chemotherapy (5-FU) in the tumor. TG6002 is a modified Vaccinia virus, with double gene deletion (TK-RR-), and expressing the proprietary FCU1 gene in the cancer cells it has infected, leading to the local conversion of the non-cytotoxic pro-drug, flucytosine (5-FC), into 5-FU, a widely used cancer chemotherapy. The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models. Transgene believes that TG6002 may represent a new therapeutic option in recurrent cancer patients.
Another Phase 1/2 trial using TG6002 administered intravenously is ongoing in Europe in patients with advanced gastrointestinal tumors.

About Colorectal cancer
Colorectal cancer (CRC) is the second most commonly diagnosed cancer in Europe and a leading cause of death both in Europe and worldwide. In 2012, there were 447,000 new cases of CRC in Europe with 215,000 deaths and worldwide, there were 1.4 million new cases with 694,000 deaths (Ferlay J. et al., 2013, Ferlay J. et al., 2015). Approximately half of all CRC patients develop liver metastases, only a small proportion of whom being suitable for potentially curative hepatic resection (Leporrier J, 2006). Over the last decade, the clinical outcome for patients with metastatic CRC (mCRC) has improved. Today, the median overall survival (OS) for patients with mCRC is ∼30 months.

Kronos Bio Completes $105 Million Series A Financing

On July 18, 2019 Kronos Bio, Inc. (Kronos), a Two River portfolio company, reported it has closed a $105 million Series A Preferred Stock financing (Press release, Kronos Bio, JUL 18, 2019, View Source [SID1234537600]). The financing was led by Vida Ventures, LLC and Omega Funds and included participation from Nextech, GV (formerly Google Ventures), Perceptive Advisors, Invus and Polaris Partners. This Series A round also included significant participation from Kronos’ President and Chief Executive Officer, Norbert Bischofberger, Ph.D. as well as members of the Board of Directors including Arie Belldegrun, M.D., FACS and John Martin, Ph.D. In conjunction with this financing, Jakob Loven, Ph.D., Partner at Nextech, will join the Board of Directors of Kronos Bio.

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Kronos’ Small Molecule Microarray platform (SMM) was built on more than a decade of research by its scientific founder, Angela Koehler, Ph.D., Associate Professor of Biological Engineering at the Massachusetts Institute of Technology. SMM is ideally suited for the rapid discovery of novel modulators or degraders of historically undruggable targets, such as transcription factors. Kronos has demonstrated SMM’s potential to identify compounds that bind to target proteins directly or interfere at nanomolar potency with protein activity. SMM enables discovery of hits that act through a variety of mechanisms, including disruption of protein-protein or protein-DNA interactions, or indirect modulation of target protein activity by binding to co-factors or other protein complex members.

"We are excited to have the continued support of high caliber investors who recognize the potential of Kronos’ technology and its team. This financing will help us advance two preclinical programs built upon hits identified from SMM screens, accelerate our research, and further expand the Kronos team in the Boston and San Francisco areas," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "We seek to challenge the historic belief that certain targets cannot be pursued. Our goal is to unlock new therapeutic approaches and bring treatments to areas with high unmet need."

Existing therapies target only a minority of the body’s proteins, which are well-structured and accessible to traditional small molecule approaches. The majority of proteins, however, are disordered or lack obvious binding pockets and have historically been considered undruggable. Kronos’ platform enables high-throughput screens of chemical libraries against such target proteins in a more physiologically relevant context to identify biologically active small molecules.

"When we founded Kronos at Two River, we identified early on the need for support by investors who embrace cutting edge innovation," said Joshua Kazam, a Kronos Board Member and a Director at Vida Ventures. "With this Series A round, we have expanded support with investors equally as passionate about funding scientific breakthroughs to impact how we treat some of the most challenging diseases we face today."

"Since our initial investment, we have been very excited about the opportunity to identify novel therapies provided by the Kronos platform: we believe this is a huge opportunity not just for investors but more importantly, for addressing unmet needs in hard-to-treat diseases," said Otello Stampacchia, Ph.D., a Kronos Board Member and Founder and Managing Director of Omega Funds. "We are delighted to co-lead this milestone Series A financing and to be a part of the Kronos Bio team in this journey."