AgeX Therapeutics CEO Dr. Michael D. West to Present at Three Conferences in March 2018

On March 1, 2018 – AgeX Therapeutics, Inc., a subsidiary of BioTime, Inc. (NYSE American: BTX) reported that the company’s Chief Executive Officer Michael D. West, Ph.D. will participate at three upcoming conferences: the Mauldin Economics Strategic Investment Conference, March 6-9 in San Diego; Undoing Aging, March 15-17 in Berlin, Germany; and the 10th World Congress and Expo on Cell & Stem Cell Research, March 19-21 in New York City (Press release, BioTime, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335597 [SID1234524296]).

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Further details follow:

The Mauldin Economics Strategic Investment Conference
March 6-9 in San Diego, California
AgeX session: Wednesday, March 7, 1:50pm PST
Dr. West and AgeX’s VP of New Technology Discovery Aubrey de Grey, Ph.D. will participate on the Biotech panel, along with Eric Verdin, M.D., President and CEO of the Buck Institute for Research on Aging.

Undoing Aging
March 15-17 in Berlin, Germany
AgeX presentation: Friday, March 16 at 11:30am CET
Dr. West will discuss the prospect of using stem cell-derived cells for the treatment of age-related degenerative conditions.
The conference is being organized in part by Dr. de Grey in his capacity as Chief Science Officer of the SENS Research Foundation, which is co-sponsoring the event.

The 10th World Congress and Expo on Cell & Stem Cell Research
March 19-21 in New York City
AgeX presentation: Tuesday, March 20 at 9:00am EDT
Dr. West will deliver a presentation titled, "Induced tissue regeneration (iTR): Leveraging the unique regenerative potential of pluripotent stem cell-derived therapeutics."

A copy of Dr. West’s presentations will be available on the AgeX website.

Audentes Therapeutics to Release Fourth Quarter and Full Year 2017 Financial Results and Provide Corporate Update on Thursday, March 8, 2018

On March 1, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that it will host a conference call to report its fourth quarter and full year 2017 financial results and provide a corporate update on Thursday, March 8, 2018 (Press release, Audentes Therapeutics, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335596 [SID1234524295]).

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The conference call will be held at 4:30 p.m. ET, after the market closes. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investor + Media section of the Audentes website at www.audentestx.com. Alternatively, please call 1-833-659-8620 (U.S.) or 1-409-767-9247 (international) and dial the conference ID 5890848 to access the call.

A replay of the live webcast will be available on the Audentes website for approximately 30 days.

Argenx reports fourth quarter business update and full year 2017 financial results

On March 1, 2018 Argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported its fourth quarter business update and full year results for 2017 (Press release, argenx, MAR 1, 2018, View Source [SID1234524294]).

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The full year results will be discussed during a conference call and webcast presentation today at 3 pm CET/ 9 am EST. To participate in the conference call, please select your dial in number from the list included below, and use the confirmation code 6683242. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

"2017 was a year of tremendous momentum for argenx as we made progress on our pipeline and increased value for our shareholders. As a result of this focused execution, we believe we are well-positioned to advance our pipeline through several key clinical milestones in the year ahead," commented Tim Van Hauwermeiren, CEO of argenx. "In December, we announced positive clinical data from our Phase 2 trial of ARGX-113 for the treatment of generalized myasthenia gravis and plan to advance ARGX-113 to Phase 3 in this indication. This also marked the first dataset from our Phase 2 program aimed at evaluating the role of ARGX-113 in indications where the reduction of pathogenic autoantibodies may mediate disease. We continue to evaluate the asset in two additional Phase 2 indications, immune thrombocytopenia and pemphigus vulgaris, and expect to report data from both in the second half of 2018. We also advanced our lead oncology asset and reported interim data from our Phase 1/2 trial of ARGX-110 in acute myeloid leukemia, which we expect to transition into a Phase 2 trial this year. We feel that our achievements in 2017 have further validated our disciplined and differentiated approach to antibody development and look forward to providing updates on several important catalysts from our wholly-owned pipeline and strategic collaborations in 2018."

FOURTH QUARTER 2017 AND RECENT HIGHLIGHTS

· Reported positive topline results from Phase 2 proof-of-concept trial of ARGX-113 (efgartigimod) in generalized myasthenia gravis (MG) showing a strong clinical improvement over placebo throughout the entire duration of the trial as well as a favorable tolerability profile consistent with Phase 1 data.

· Launched Phase 1 trial with subcutaneous formulation of ARGX-113 evaluating pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability.

· Presented updates on Phase 1/2 clinical trials of ARGX-110 in acute myeloid leukemia (AML) and cutaneous T-cell lymphoma (CTCL) during American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

· Raised approximately $266 million in gross proceeds in an upsized U.S. public offering.

FINANCIAL HIGHLIGHTS (as of December 31, 2017) (compared to financial highlights as of December 31, 2016)

· Operating income of €41.3 million (December 31, 2016: €17.2 million).

· Net loss of €28.1 million (December 31, 2016: €21.4 million).

· Cash position of €359.8 million (cash, cash equivalents and current financial assets) allowing us to pursue development of our pipeline as planned.

DETAILS OF OPERATIONAL RESULTS

Products in Clinical Development:

ARGX-113 (efgartigimod)

· Reported positive topline results from Phase 2 proof-of-concept trial of ARGX-113 in generalized MG. ARGX-113 treatment resulted in a strong clinical improvement over placebo as measured by all four predefined clinical efficacy scales throughout the entire duration of the study. Among ARGX-113 treated patients, 75% had a clinically meaningful and statistically significant improvement for a period of at least six consecutive study weeks versus 25% of patients on placebo. Primary endpoint analysis revealed ARGX-113 to be well-tolerated in all patients and consistent with Phase 1 data.

· Nearing complete enrollment in the Phase 2 clinical trial of ARGX-113 in immune thrombocytopenia (ITP). Amended ITP trial protocol to extend the follow-up period from eight weeks to 21 weeks. In addition, a one-year open label extension study was added as a second amendment to allow (re)treatment of the ITP patients from the first study (dosed at 10 mg/kg).

· Launched Phase 1 trial to evaluate the PK, PD, safety and tolerability of a subcutaneously administered formulation of ARGX-113 in healthy volunteers.

ARGX-110

· Provided updates on Phase 1/2 clinical trials of ARGX-110 in AML and CTCL during ASH (Free ASH Whitepaper) Annual Meeting.

· Data from the Phase 1/2 clinical trial of ARGX-110 in combination with azacitidine in six newly diagnosed AML patients unfit for intensive chemotherapy showed signs of clinical activity, including complete remission (3/6 patients), complete remission with incomplete blood count recovery (1/6 patients) and partial response (2/6 patients). One of the patients that achieved a complete remission bridged to allogeneic stem cell transplant after five cycles. The preliminary data from the first set of patients suggest ARGX-110 is active both at the circulating and bone marrow blast levels and at the leukemic stem cell level. The data showed a favorable tolerability profile with no exacerbation of azacitidine toxicity.

· Amended Phase 1/2 AML trial protocol to add a 20mg/kg dose cohort to the dose escalation to best inform the recommended dose for a Phase 2 study.

· Data from the Phase 1/2 clinical trial of ARGX-110 in relapsed/refractory CTCL patients. Of the 22 CTCL patients under analysis, we observed one complete response, two partial responses and 10 patients with stable disease. ARGX-110 was observed to have a favorable tolerability profile in these CTCL patients.

Collaborations

· Bird Rock Bio, Inc. (BRB) and argenx have mutually agreed to terminate BRB’s license agreement to develop and commercialize ARGX-109 (gerilimzumab). Genor, a sublicensee of Bird Rock Bio, will continue to develop ARGX-109 for the Chinese market.

Corporate

· Intellectual property portfolio now includes 80 granted and 109 pending patents as of December 31, 2017.

· Company expanded to 95 employees and consultants in support of the growth of the business.

· Established argenx US, Inc., a subsidiary located in Boston, MA.

· Nominated James Michael Daly as a new member of the Board of Directors, subject to approval by the shareholders at the annual general meeting.

OUTLOOK 2018

argenx continues to implement its business plan through advancing its deep pipeline of differentiated antibody-based therapies, including ARGX-113, ARGX-110, ARGX-115 and ARGX-112, the forging of collaborations with pharmaceutical companies and leading academic labs under its Innovative Access Program and the strengthening of its shareholder base.

In 2018, argenx aims to execute its ambitious business plan as follows:

Report full data from the Phase 2 proof-of-concept trial for ARGX-113 in generalized MG at the American Academy of Neurology conference (April 21-27, 2018,Los Angeles, CA)

Report topline data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP and interim data of the Phase 2 proof-of-concept trial in pemphigus vulgaris in the second half of 2018. Report full data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP before the end of the year.

Progress ARGX-113 into Phase 3 clinical development in generalized MG before the end of the year.

Report the full data of the Phase 1 healthy volunteer trial with the subcutaneous formulation of ARGX-113 during the second quarter of the year.

Provide an update on the Phase 1/2 clinical trial in AML in the second half of the year.

Report the full data of the AML Phase 1/2 and CTCL Phase 2 clinical trials of ARGX-110 by the end of the year.

· Launch the Phase 2 proof-of-concept trial for ARGX-110 in AML before the end of the year.

DETAILS OF THE FINANCIAL RESULTS

Cash, cash equivalents and current financial assets totaled €359.8 million for the year ended on December 31, 2017, compared to €96.7 million on December 31, 2016. The increase in the year-end cash balance on December 31, 2017 resulted primarily from €304.7 million of net proceeds received from the initial and follow-on U.S. public offerings of American Depositary Shares on the Nasdaq Global Select Market completed respectively in May and December 2017.

Operating income increased by €24.1 million for the year ended December 31, 2017 to reach €41.3 million, compared to €17.2 million for the year ended December 31, 2016. The increase primarily related to a €11.0 million increase in the recognition of upfront payments and a €9.2 million increase in milestone payments from our collaboration partners.

Research and development expenses totaled €51.7 million and €31.6 million for the years ended December 31, 2017 and 2016, respectively. The increase is mainly the result of higher external research and development expenses, reflecting higher clinical trial costs and manufacturing expenses related to the development of our product candidate portfolio.

Selling, general and administrative expenses totaled €12.4 million and €7.0 million for the years ended December 31, 2017 and 2016, respectively. The increase of €5.4 million in selling, general and administrative expenses for the year ended December 31, 2017 primarily resulted from higher personnel expenses, office costs and consulting fees incurred to support our growth and prepare the company to become and operate as a Nasdaq-listed company.

For the year ended December 31, 2017, financial income amounted to €1.3 million compared to €0.1 million for the year ended December 31, 2016. The increase of €1.2 million relates to (i) a €0.9

million realized gain on the sale of a participation in FairJourney Biologics LDA in December 2017 and (ii) an increase in the interest received on our cash, cash equivalents and current financial assets.

Exchange losses totaled €5.8 million for the year ended December 31, 2017 compared to €0.03 million for the year ended December 31, 2016. The increase is mainly attributable to unrealized exchange rate losses on our cash and current financial assets position in U.S. dollars due to the unfavourable fluctuation of the EUR/USD exchange rate.

The total comprehensive loss for the year ended December 31, 2017 was €28.1 million compared to €21.4 million for the year ended December 31, 2016.

U.S. SEC and statutory financial reporting

argenx’s primary accounting standard for quarterly earnings releases and annual reports is International Financial Reporting Standars (IFRS) as issued by the International Accounting Standards Board (IASB). Quarterly summarized statements of profit and loss based on IFRS as issued by the IASB are available on www.argenx.com.

In addition to reporting financial figures in accordance with IFRS as issued by the IASB, argenx also reports financial figures in accordance with IFRS as adopted by the European Union (EU) for statutory purposes. The consolidated statement of financial position, the consolidated statements of profit and loss, the consolidated statements of cashflow, and the consolidated statement of changes in equity are not affected by any differences between IFRS as issued by the IASB and IFRS as adopted by the EU.

The consolidated statement of profit and loss data of argenx SE as of December 31, 2017 presented in this press release are unaudited.

Annual Report 2017

argenx expects to publish its 2017 Annual Report based on IFRS as issued by the IASB and its 2017 Annual Report for statutory purposes based on IFRS as adopted by the EU on March 26, 2018. These Annual Reports will be available on www.argenx.com.

Apricus Biosciences Provides Corporate Update, Fourth Quarter and Full Year 2017 Financial Results

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.

Aduro Biotech Announces Fourth Quarter and Full Year 2017 Financial Results

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