Apellis Pharmaceuticals Announces Pricing of Public Offering of Common Stock

On March 7, 2019 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, reported the pricing of its underwritten public offering of 6,000,000 shares of its common stock at a public offering price of $17.00 per share, for total gross proceeds of $102 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, MAR 7, 2019, View Source [SID1234534062]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 900,000 additional shares of its common stock at the public offering price, less the underwriting discount and commissions. The offering is expected to close on March 11, 2019, subject to customary closing conditions.

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Citigroup, J.P. Morgan and Cowen are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. is acting as lead manager for the offering.

The shares are being offered by Apellis pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC") on December 28, 2018 and amended on February 26, 2019. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (631) 274-2806.

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

ATARA BIOTHERAPEUTICS TO PARTICIPATE IN UPCOMING CONFERENCES

On March 7, 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 members of the Company’s management team will participate at several upcoming conferences (Press release, Atara Biotherapeutics, MAR 7, 2019, View Source [SID1234534078]):

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Cowen and Company 39th Annual Health Care Conference

Isaac Ciechanover, M.D., the Company’s President and Chief Executive Officer, will give a presentation on Tuesday, March 12, 2019 at 10:00 a.m. EDT. The conference will be held at the Boston Marriott Copley Place in Boston, MA.
Memorial Sloan Kettering 3rd Annual Clinical Application of CAR T Cells Conference

Chris Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in the Industry Session on Thursday, March 14, 2019 at 4:35 p.m. EDT. The conference will be held at the Zuckerman Research Center in New York, NY.
William Blair 9th Annual Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper)

Chris Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will present on Wednesday, March 20, 2019 at 11:00 a.m. EDT. The conference will be held at the Apella Event Space Alexandria Center in New York, NY.
Alliance for Regenerative Medicine 7th Annual Cell & Gene Therapy Investor Day

Chris Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in a panel titled "Cell Therapy for Solid Tumors" on Thursday, March 21, 2019 at 1:30 p.m. EDT. The Conference will be held at the Metropolitan Club in New York, NY.
Jefferies 6th Annual IO Cell Therapy Summit

Dietmar Berger, M.D., Ph.D., the Company’s Global Head of Research and Development, will present on Friday, April 5, 2019. The conference will be held at the Boston Harbor Hotel in Boston, MA and the time of the presentation will be available on Atara’s investor events webpage by March 29.
Live audio webcasts of the presentations at the Cowen and Company 39th Annual Health Care Conference and Alliance for Regenerative Medicine 7th Annual Cell & Gene Therapy Investor Day will be available by visiting the Investor Events and Presentations section of the Atara website. An archived replay of each webcast will be available on the Company’s website for 14 days following the conclusion of each presentation.

Aurinia Pharmaceuticals to Release Fourth Quarter and Full Year 2018 Financial Results on March 19, 2019

On March 7, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that it will release its fourth quarter and full year 2018 financial results on Tuesday, March 19, 2019, after the market closes (Press release, Aurinia Pharmaceuticals, MAR 7, 2019, View Source [SID1234534124]). Aurinia’s management team will host a conference call to discuss the company’s financial results for the fourth quarter and full year 2018 and to provide a general business update.

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The conference call and webcast is scheduled for March 19, 2019 at 4:30pm ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

Amgen To Present At The Cowen and Company 39th Annual Healthcare Conference

On March 7, 2019 Amgen (NASDAQ:AMGN) reported that will present at the Cowen and Company 39th Annual Healthcare Conference at 9:20 a.m. ET on Tuesday, March 12, 2019, in Boston (Press release, Amgen, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390558 [SID1234534168]). David W. Meline, executive vice president and chief financial officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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NuCana Reports Fourth Quarter and Year-End 2018 Financial Results and Provides Business Update

On March 7, 2019 NuCana plc (NASDAQ: NCNA) reported financial results for the fourth quarter and year ended December 31, 2018 and provided an update on its extensive clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAR 7, 2019, View Source [SID1234534063]).

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As of December 31, 2018, NuCana had cash and cash equivalents of £77.0 million compared to £78.4 million as of September 30, 2018 and £86.7 million as of December 31, 2017. NuCana reported a loss of £3.6 million for the quarter ended December 31, 2018, compared to £5.0 million for the quarter ended December 31, 2017 as the Company continued to advance its various clinical programs. Net loss for the year ended December 31, 2018 was £13.8 million, compared to a net loss of £23.1 million for the year ended December 31, 2017. Basic and diluted loss per share was £0.11 for the quarter and £0.43 for the year ended December 31, 2018, compared to £0.16 per share for the comparable quarter and £0.89 on a year-over-year basis in 2017.

NuCana believes its current cash and cash equivalents will be sufficient to fund operations into 2021. In addition to continuing or completing the ongoing clinical studies, NuCana’s current cash and cash equivalents will enable the following:

Open a Phase III study of Acelarin in combination with cisplatin in patients with advanced or metastatic biliary tract cancer;

Initiate a Phase II/III study of Acelarin in combination with a platinum agent for patients with ovarian cancer; and

Initiate a Phase II/III clinical study of NUC-3373 in combination with other agents for patients with colorectal cancer.

"2018 has been another very productive year for NuCana highlighted by several encouraging clinical data presentations for Acelarin and NUC-3373," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We began the year by announcing interim data at ASCO (Free ASCO Whitepaper)-GI from the ongoing Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer, which showed a 50% response rate, approximately doubling the response rate seen with the standard of care, gemcitabine plus cisplatin, in this patient population. At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October, we announced that the second cohort from this study maintained a 50% response rate. In addition, results showed the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time."

Mr. Griffith continued: "Additionally, in October we announced at ESMO (Free ESMO Whitepaper) interim data from an ongoing Phase I study of our second ProTide, NUC-3373, a transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), in patients with advanced solid tumors who had exhausted all current standards of care. Notably, three patients achieved stable disease lasting more than nine months at the time of data cutoff and, importantly, no patients developed hand-foot syndrome, which is a debilitating side effect associated with fluoropyrimidine therapy."

Mr. Griffith added: "In addition to the clinical successes of our first two ProTides, we expect to enroll the first patients with advanced solid tumors in the Phase I clinical study of our third ProTide, NUC-7738, which is based on a novel nucleoside analog, 3’-deoxyadenosine, and which has shown potent anti-cancer activity in preclinical studies."

Mr Griffith concluded: "We are very pleased with the progress NuCana made in 2018. We have continued to validate our ProTide technology’s ability to transform some of the most widely prescribed chemotherapy agents into more efficacious and safer treatments. With plans to open a Phase III study of Acelarin plus cisplatin in patients with advanced biliary tract cancer and additional data from the two ongoing studies with NUC-3373, as a single agent in patients with advanced solid tumors as well as in combination with other agents typically combined with 5-FU in patients with advanced colorectal cancer, we anticipate 2019 being another important year for NuCana."

Anticipated Milestones

Acelarin is NuCana’s ProTide transformation of gemcitabine. In 2019, NuCana expects to:

Open a Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.

Contingent on regulatory guidance and other factors, evaluate the initiation of a Phase II/III study of Acelarin in combination with a platinum agent for patients with ovarian cancer.

Report interim data from the ongoing Phase II study (PRO-105) of single-agent Acelarin for patients with platinum-resistant ovarian cancer.

Continue enrollment in the Phase III study (Acelarate) of Acelarin as a first-line treatment compared to gemcitabine for patients with metastatic pancreatic cancer.

NUC-3373 is NuCana’s second ProTide in clinical development, a transformation of the active anti-cancer metabolite of 5-FU. In 2019, NuCana expects to:

Report interim data from the ongoing Phase Ib study (NuTide:302) of NUC-3373 in patients with advanced colorectal cancer in combination with other agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan.

Report additional data from the ongoing Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.

Contingent on regulatory guidance and other factors, initiate a Phase II/III study of NUC-3373 in combination with other agents for patients with advanced colorectal cancer.

NUC-7738 is NuCana’s ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine . In 2019, NuCana expects to:

Report interim data from the Phase I study (NuTide:701).