On May 3, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported a poster presentation highlighting scientific data for NCX 667, a novel nitric oxide (NO) donating compound, at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting, one of the key scientific events in the ophthalmology calendar, being held on April 29 – May 3, 2018 in Honolulu, Hawaii, United States.

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Synthesized and characterized by Nicox, NCX 667 is a lead molecule among the Company’s future generation of stand-alone NO-donors which are designed to optimize NO dosing and can be used alone or in combination with existing standard-of-care drugs, as either ophthalmic solutions or extended release formulations, to enable robust intraocular pressure (IOP)-lowering in patients with open-angle glaucoma or ocular hypertension.

The ARVO 2018 abstract by Francesco Impagnatiello, Ph.D., et al. describes results following single dose administration of various doses (0.1%, 0.3% and 1.0% solution) of NCX 667 in several ocular normotensive and ocular hypertensive animal models. These results demonstrate that NCX 667 lowers IOP in a dose-dependent manner. Furthermore, an in vitro bioengineered human trabecular meshwork/Schlemm’s canal (TM/SC) system was used to study the effects of NCX 667 on the conventional outflow facility. These data support the hypothesis that the IOP-lowering effects of NCX 667 are likely due to an increase in outflow facility via the TM/SC outflow pathway.

Michael Bergamini, Ph.D., Executive Vice President, Chief Scientific Officer of Nicox, commented: "The results presented at ARVO this year show a clear, dose-dependent, and meaningful lowering of IOP in both ocular normotensive and hypertensive models. These results, combined with the in vitro data, continue to build upon the growing body of scientific evidence supporting the development of NCX 667, a lead molecule among our future generation of stand-alone NO-donors. We are continuing to generate new compounds in this class and are testing multiple leads using topical and sustained release dosing."

An estimated 3.5% of the worldwide population between 40 and 80 years of age are affected by the most common forms of glaucoma1.

The ARVO 2018 abstracts have been published in the meeting website located at View Source and details for the poster presentation are as follows:

Title: NCX 667, a novel nitric oxide (NO) donor lowers intraocular pressure (IOP) via stimulation of trabecular meshwork/Schlemm’s canal outflow facility

Date and time: Wednesday, May 2, 2018 from 11:15 am to 1:00 pm HAST

Presenter: Francesco Impagnatiello, Ph.D. , Nicox Research Institute

Session n° 448, Title: Glaucoma – Trabecular Meshwork

Abstract n°: 4707 / Poster n°: B0131

Location: Hawaii Convention Center, Exhibit Hall

On May 3, 2018 The NEOMED Institute reported that it has entered into a development collaboration with McGill University (Press release, NEOMED, MAY 3, 2018, View Source [SID1234527387]). Kemal Payza, Senior Project Director at NEOMED Institute will collaborate with Professor Alain Nepveu, Professor at the Goodman Cancer Research Centre and Departments of Oncology, Biochemistry and Medicine at McGill University, to discover new therapeutic small molecules to inhibit the protein target, Cut-Like Homeobox 1 (CUX1).

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"I am delighted that we have added this new drug discovery project into NEOMED’s pipeline and I look forward to working with Dr. Nepveu on this very exciting target. Dr. Nepveu is a renowned expert on the DNA repair function of CUX1, a mechanism upon which RAS-driven cancer cells are acutely dependent for their survival. This is very important, because currently there is no treatment that targets RAS-driven tumours," explains Payza.

"This academic/industrial collaboration that we have entered into with the NEOMED Institute will permit us to rapidly leverage our biological understanding of this important target to develop small molecule drug candidates. A drug capable of interfering with the ability of CUX1 to participate in DNA repair would target many types of cancers in which reactive oxygen species are produced as a consequence of mutation in a RAS gene or any oncogene that activates the RAS pathway; such activation is seen in 59% of pancreatic cancers and some 30% of human cancers overall," adds Professor Nepveu.

"This collaboration exemplifies, once again, the ability of NEOMED to deliver on its mission to help advance academic innovation and excellence by leveraging our industrial drug development experience and expertise. We look forward to collaborating with world-leading experts, like Professor Nepveu and Zubaidah Ramdzan, to translate their science into therapeutic options for patients within the Canadian ecosystem," concludes Donald Olds, President & CEO of NEOMED Institute.

About CUX1
Activation of the RAS pathway in cancer cells leads to higher production of reactive oxygen species, which cause DNA damage by oxidation. In turn, sustained DNA damage triggers cellular senescence. Cancer cells can adapt to such oxidative DNA damage by increasing their expression of CUX1, which stimulates the activities of two enzymes that repair oxidized bases in DNA. Knocking down the CUX1 protein has been found to kill all cancer cells that have high levels of reactive oxygen species (ROS). Thus, small molecules that inhibit the ability of CUX1 to stimulate those critical DNA repair enzymes would be expected to provide therapeutic benefit to patients with RAS-driven cancers. While therapeutic approaches targeting various aspects of the DNA damage response are strategically important in cancer, direct inhibition of base excision repair enzymes can cause severe adverse effects on normal cells. In contrast, CUX1 is not essential to normal cells, but is absolutely required for survival in situations of severe genotoxic stress such as that caused by reactive oxygen species in RAS-driven cancer cells or by DNA-damaging cancer treatments. Thus, small molecules that inhibit the ability of CUX1 to stimulate base excision repair enzymes are expected to treat RAS-driven cancers with an improved therapeutic window.

On May 3, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported consolidated financial results for the first quarter ended March 31, 2018 (Press release, Pacira Pharmaceuticals, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346741 [SID1234526024]).

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"2018 is off to a terrific start with EXPAREL daily sales volumes accelerating from 6 percent in January to 15 percent in March, as well as a recently expanded label that now includes interscalene brachial plexus block," said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. "As the only long-acting, single-dose nerve block commercially available, EXPAREL has the potential to eliminate cumbersome delivery technologies, like catheters and pumps, and shift more procedures to the outpatient setting. We believe this expanded label along with our robust educational initiatives and strong coalition of like-minded collaborators, including Johnson & Johnson, will fuel positive sales trends as we continue to drive meaningful change toward eliminating the role of the operating room as a gateway to opioid use and abuse."

First Quarter 2018 Financial Results

EXPAREL net product sales were $74.0 million in the first quarter of 2018, a 9% increase over the $67.7 million reported for the first quarter of 2017.

Total operating expenses were $81.5 million in the first quarter of 2018, compared to $83.3 million in the first quarter of 2017.

GAAP net loss was $10.7 million, or $(0.26) per share (basic and diluted), in the first quarter of 2018, compared to a GAAP net loss of $19.9 million, or $(0.52) per share (basic and diluted), in the first quarter of 2017.

Non-GAAP net income was $0.9 million, or $0.02 per share (basic and diluted) in the first quarter of 2018, compared to a non-GAAP net loss of $7.3 million, or $(0.19) per share (basic and diluted) in the first quarter of 2017.

Pacira ended the first quarter of 2018 with cash, cash equivalents, short-term and long-term investments ("cash") of $361.5 million.

Pacira had 40.7 million basic weighted average shares of common stock outstanding in the first quarter of 2018.

For non-GAAP measures, Pacira had 41.6 million diluted weighted average shares of common stock outstanding in the first quarter of 2018.
2018 Outlook

Pacira reiterated its full year 2018 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $300 million to $310 million.

Non-GAAP gross margins of 70% to 72%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, May 3, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 6585169.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 6585169. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt and exit costs related to the discontinuation of DepoCyt(e) production.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2018 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2018 financial guidance for gross margins, R&D expense and SG&A expense.

On May 3, 2018 Cerus Corporation (Nasdaq: CERS) reported that Dr. Laurence M. Corash, co-founder and chief scientific officer, and Lainie Corten, vice president of global marketing, are scheduled to present a corporate update at the Deutsche Bank 43rd Annual Health Care Conference at the InterContinental Hotel Boston on Wednesday, May 9th at 1:30 pm ET (Press release, Cerus, MAY 3, 2018, View Source [SID1234526053]).

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A live webcast of the presentation will be available from the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the event.

On May 3, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has engaged Voisin Consulting Life Sciences ("VCLS"), as an additional regulatory consulting firm and contract research organization ("CRO") to prepare for expansion of its clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, MAY 3, 2018, View Source [SID1234526079]).

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Moleculin engaged Voisin Consulting Life Sciences, headquartered in Paris, France to evaluate additional countries for the potential expansion of its AML clinical trial. VCLS is a multinational regulatory consulting firm and contract research organization with 150 life science professionals. The Moleculin engagement is intended to evaluate Australia and selected Western European countries to provide additional clinical sites.

"Now that our AML trial is underway, we are focused on expanding the opportunity for AML patients to participate in the trial," commented Walter Klemp, Moleculin’s Chairman and CEO. "Our strategy is to choose countries with the best possible balance between an efficient clinical trial authorization process, solid AML clinical trial experience and a population of qualified AML patients."

About Voisin Consulting Life Sciences

From discovery to product launch and life cycle management

AT Voisin Consulting Life Sciences (VCLS), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 150 employees, VCLS serves a broad range of developers and their investors.

For more information, visit www.voisinconsulting.com