Nicox Announces 2018 Financial Results and 2019 Milestones

On March 6, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial and operating results for Nicox and its subsidiaries (the "Nicox Group") for the year ended December 31, 2018, as approved by the Board of Directors on March 5, 2019, and provided upcoming 2019 milestones (Press release, NicOx, MAR 6, 2019, View Source [SID1234533991]).

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2018 Financial Summary
In 2018, the Loss before tax of the Nicox Group was €18.3 million compared to €19.1 million in 2017. This reduction was achieved despite the significant investments in research and development made in 2018.

Net revenue for the 12 months to December 2018 was €4.0 million, which consists of the upfront payment from Ocumension Therapeutics for the license of NCX 470 for the Chinese market and net royalties on sales of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% by global partner Bausch + Lomb. This compares to a Net revenue for the 12 months to December 2017 of €2.3 million.

Operating expenses for the period 2018 increased to €26.5 million from €20.8 million for the 12 months to December 31, 2017 mainly due to investments in the development of our wholly-owned programs, NCX 470 and NCX 4251.

As of December 31, 2018, the Nicox Group had cash and cash equivalents of €22.0 million as compared with €41.4 million at December 31, 2017.

Event after the Reporting Period
On January 25, 2019, Nicox entered into a bond financing for up to €20 million from Kreos Capital, which together with cash on hand and anticipated royalties potentially extends the Company’s cash runway into 2021. The financing is structured as three tranches of which only the first tranche of €8 million has been drawn down. The exercise of the two other tranches is at Nicox’s sole discretion.

Upcoming 2019 Milestones
NCX 470: Top-line results from the Phase 2 clinical study for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension expected in Q4 2019.
NCX 4251: Phase 2 clinical study in patients with acute exacerbations of blepharitis to start shortly, with top-line results expected in Q4 2019.
ZERVIATETM U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. by our U.S. partner Eyevance Pharmaceuticals expected in summer 2019.
ZERVIATE ex-US partnering: Potential new licensing agreements, with multiple discussions ongoing.
Presentations on Nicox’s ophthalmology programs at key scientific conferences including the American Glaucoma Society (AGS), the Association for Research in Vision and Ophthalmology (ARVO).

Stemline Therapeutics to Present at the Cowen and Company 39th Annual Health Care Conference

On March 6, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the Cowen and Company 39th Annual Health Care Conference on Monday, March 11, 2019 at 4:50 PM ET at the Marriott Copley Place in Boston, MA (Press release, Stemline Therapeutics, MAR 6, 2019, https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-present-cowen-and-company-39th-annual [SID1234534013]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, and other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to, and validated by, the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

Savara To Report Q4/Year-End 2018 Financial Results And Business Update On March 13, 2019

On March 6, 2019 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported it will release its fourth quarter and year-end 2018 financial results on Wednesday, March 13, 2019 (Press release, Savara, MAR 6, 2019, View Source [SID1234534029]). Savara management will also host a conference call for investors at 5:30 p.m. ET/2:30 p.m. PT on Wednesday, March 13, 2019 to discuss its fourth quarter and year-end 2018 financial results and provide a business update.

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Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through March 20, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10128884.

Constellation Pharmaceuticals to Present at Upcoming Investor Conference

On March 6, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that Jigar Raythatha, CEO, will present at the Oppenheimer & Co. Inc. Healthcare Conference in New York at 10:55 AM EDT on Wednesday, March 20 (Press release, Constellation Pharmaceuticals, MAR 6, 2019, View Source [SID1234534049]). Live audio webcasts of these presentations and archives for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replays will be available for 90 days following the live presentation.

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Portola Pharmaceuticals to Webcast Presentation at Cowen and Company’s 39th Annual Health Care Conference

On March 6, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that Scott Garland, Portola’s president and chief executive officer, will present a corporate overview at Cowen and Company’s 39th Annual Health Care Conference in Boston on Tuesday, March 12, 2019 at 8:40 a.m. ET (5:40 a.m. PT) (Press release, Portola Pharmaceuticals, MAR 6, 2019, View Source;p=RssLanding&cat=news&id=2390398 [SID1234534069]).

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Webcast Details
To access the live investor webcast on Tuesday, March 12, at 8:40 a.m. ET (5:40 a.m. PT), go to the investor section of the company’s website at View Source A replay will be available for 30 days.