On March 1, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the year ended December 31, 2017. Net loss for the fourth quarter and year ended December 31, 2017 was $26.1 million, or $0.34 per share, and $91.9 million, or $1.26 per share, respectively (Press release, Aduro Biotech, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335736 [SID1234524292]). This compared to net loss of $29.6 million, or $0.44 per share, and $91.1 million, or $1.40 per share, respectively, for the same periods in 2016.

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Cash, cash equivalents and marketable securities totaled $349.7 million at December 31, 2017, compared to $361.9 million at December 31, 2016.

"In 2017, we expanded clinical development activities of our STING agonist program with the initiation of a global combination trial of ADU-S100 with Novartis’ proprietary anti-PD-1 checkpoint inhibitor, PDR001. We also initiated clinical development of BION-1301, a novel anti-APRIL antibody, in multiple myeloma," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe we are well-positioned with the support of our collaboration partners and strong cash position to further advance our clinical programs, particularly in the activation of the STING pathway."

2017

Development Achievements

Continued to advance ADU-S100 in a Phase 1 dose escalation in solid tumors and lymphomas
Initiated a global combination trial of ADU-S100 and Novartis’ anti-PD-1, PDR001, for the treatment of solid tumors and lymphomas
Presented preclinical data demonstrating anti-APRIL antibody blocking of TACI in addition to BCMA results in inhibition of regulatory T cells
Initiated Phase 1/2 clinical trial of novel anti-APRIL antibody, BION-1301, for the treatment of multiple myeloma
Initiated Phase 1 clinical trial of neoantigen-based personalized immunotherapy (pLADD)
Financial Performance

Revenues were $3.8 million for the fourth quarter of 2017 and $17.2 million for the full year 2017, compared to $3.9 million and $50.7 million, respectively, for the same periods in 2016. The decrease in revenue for the fourth quarter of 2017 was primarily due to a decrease in grant revenue. The decrease in revenue for the full year 2017 was primarily due to the recognition of a $35.0 million milestone payment in 2016 for the clinical advancement of ADU-S100 under our agreement with Novartis, partially offset by the recognition of a $2.0 million milestone payment in 2017 for progress in our anti-CD27 antibody program licensed to Merck.

Research and development expenses were $22.9 million for the fourth quarter of 2017 and $89.4 million for the full year 2017, compared to $20.9 million and $87.7 million, respectively, for the same periods in 2016. The increase in research and development expenses for the fourth quarter of 2017 was primarily due to higher contract manufacturing costs for our B-select antibodies and a related contingent payment obligation. The increase in research and development expenses for the full year 2017 was primarily due to higher personnel and allocated facility costs, as well as higher contract manufacturing costs associated with our B-select antibodies, partially offset by decreased manufacturing costs for a discontinued pancreatic cancer program.

General and administrative expenses were $8.8 million for the fourth quarter of 2017 and $33.8 million for the full year 2017, compared to $8.0 million and $34.3 million, respectively, for the same periods in 2016. The increase in general and administrative expenses for the fourth quarter of 2017 was primarily due to higher stock-based compensation expense and outside professional services. The decrease in general and administrative expenses for the full year 2017 was primarily due to a decrease in professional services and consulting fees.

Income tax benefit was $1.0 million for the fourth quarter of 2017 and $11.4 million for the full year 2017, compared to provision for income taxes of $5.1 million and $21.5 million, respectively, for the same periods in 2016. The income tax benefit recorded for the fourth quarter and full year 2017 was due to the current benefit of income taxes paid in 2016

On March 1, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, reported that the Company will release its year end 2017 financial results on March 8, 2018 before the market opens (Press release, Onconova, MAR 1, 2018, View Source [SID1234524312]).

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The Company will host a conference call to discuss these results and provide an update on all rigosertib programs, including promising interim analysis for the INSPIRE trial, on March 8, 2018 at 9:00 a.m. Eastern Time.

Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID 2947108.

The call will also be webcast live. Please click here to access the webcast.

A replay will be available at that link until June 29, 2018.

On March 1, 2018 Rubius Therapeutics, a biotechnology company pioneering the creation of a new class of extraordinarily active, ready-to-use and life-changing cellular therapies, reported the successful completion of an oversubscribed $100 million crossover financing (Press release, Rubius Therapeutics, MAR 1, 2018, View Source [SID1234524362]). In just under nine months, the Company has now raised over $220 million.

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Rubius has developed the technology to grow, genetically engineer and mature long-circulating Red-Cell Therapeutics (RCT) products, which have the potential to provide transformational clinical benefits to a wide range of patients across multiple therapeutic areas. These allogeneic, off-the-shelf products offer the additional advantage of extended stability and storage to allow for rapid, universal access by the medical community. Proceeds from the financing will be used to accelerate the development of the Company’s portfolio of RCTs towards clinical proof-of-concept, and to enhance its manufacturing capacity and capabilities.

"The addition of this funding further strengthens our foundation and enables us to accelerate the development of our first wave of RCT products that are targeting treatment of enzyme deficiencies, cancer and autoimmune disease," said Torben Straight Nissen, Ph.D., President of Rubius Therapeutics. "We have assembled an extremely talented team of investors, leadership and advisors, which all share the long-term vision of bringing novel cellular therapies to patients."

"We are pleased with the quality of the investor group participating in this financing, and would like to thank our new and existing investors," said David Epstein, Executive Chairman of Rubius and Executive Partner of Flagship Pioneering. "Their strong support further validates the potential of RCT products and the opportunity that we have to make a meaningful impact in the lives of patients."

"Rubius has become one of the most exciting members of the Flagship family of companies; applying scientifically disruptive insights against unsolved problems to create groundbreaking new therapies," said Noubar Afeyan, CEO of Flagship Pioneering and Co-Founder of Rubius. "We are excited to further support Rubius in this crossover round as the company continues to advance the next generation of cellular therapies."

Omeros has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Omeros, 2018, MAR 1, 2018, View Source [SID1234524288]).

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On March 1, 2018 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the fourth quarter of 2017 and provided a corporate update on its near-term priorities (Press release, Apricus Biosciences, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335731 [SID1234524293]).

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"Since the end of the third quarter of 2017, we have been focused on supporting the Vitaros NDA resubmission and strengthening our balance sheet. While we were successful achieving the latter, we were extremely disappointed with the FDA’s recent decision regarding the approval of Vitaros. As such, we will submit a request to the FDA for an end-of-review meeting in the coming weeks with a meeting expected to be scheduled in April per FDA guidelines. Our objective for this meeting is to determine the specific requirements needed to address the deficiencies noted in the Complete Response," stated Richard W. Pascoe, Chief Executive Officer. "In parallel, we will focus our efforts on identifying and evaluating opportunities or business combinations to maximize shareholder value, as we look reduce our expenses and extend our cash runway."

Fourth Quarter and Full Year Financial Results

Net loss during the quarter ended December 31, 2017 was $2.4 million, or loss per share of $0.16, compared to a net loss of $0.3 million, or loss per share of $0.04, during the fourth quarter of 2016. Net income during the year ended December 31, 2017 was $0.3 million, or income per share of $0.02, compared to a net loss of $7.4 million, or loss per share of $1.15, during the year ended December 31, 2016.

Net income during the year ended December 31, 2017 was primarily due to the $12.3 million gain recorded upon the sale of our ex-U.S. Vitaros rights and assets to Ferring, offset by the $1.5 million regulatory milestone payment made to Allergan upon the FDA’s acknowledgment of our Vitaros NDA resubmission, Vitaros commercial preparation activities, as well as other general and administrative expenses.

For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations. As of December 31, 2017, the Company’s cash totaled $6.3 million, compared to $2.1 million as of December 31, 2016. As of February 26, 2018, the Company’s cash totaled $6.3 million, which is expected to fund operations through the end of 2018.

Conference Call Details

Apricus will host a live conference call and webcast today at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a corporate update. To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 3687726. The live and archived audio webcast can be accessed through the Investors Relations’ section of the Company’s website at www.apricusbio.com. Please log in approximately five to ten minutes before the event to ensure a timely connection. The archived webcast will be available for 30 days following the live call.