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 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to the U.S. FDA under the 351(k) pathway (Press release, Coherus Biosciences, MAY 3, 2018, View Source [SID1234531702]).

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The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.

"The CHS-1701 BLA re-submission marks a significant milestone in our ongoing transition to a commercial company as we tightly focus on execution of our strategic plan," said Denny Lanfear, President and CEO of Coherus BioSciences. "Pegfilgrastim is the largest selling oncology product in the U.S., and CHS-1701 is the cornerstone of our oncology franchise. We believe we have a strong competitive position with this product, exemplified by our comprehensive clinical immunogenicity data as well as our excellent analytical biosimilarity data."

On May 3, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, Chief Executive Officer of OncoSec, will present at the Eighth Annual BioNJ BioPartnering Conference, developed in partnership with J.P. Morgan, being held Thursday, May 3, 2018 at the The Palace at Somerset Park in Somerset, NJ (Press release, OncoSec Medical, MAY 3, 2018, View Source [SID1234526023]).

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As part of his presentation, Mr. O’Connor will discuss OncoSec’s corporate growth strategy; provide a comprehensive overview of the Company’s ongoing and anticipated clinical programs involving ImmunoPulse IL-12 (or Intratumoral tavo-EP) in metastatic melanoma and triple-negative breast cancer (TNBC); and the potential of ImmunoPulse IL-12 as a monotherapy and in combination with anti-PD-1 antibody therapy in metastatic melanoma and triple-negative breast cancer (TNBC). In addition to the presentation, management will participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

BioNJ’s Eighth Annual BioPartnering Conference, developed in partnership with J.P. Morgan Chase, will bring together nearly 400 public and private company investors, life sciences professionals and academic partners from the Northeast to Mid-Atlantic states. Pharmaceutical sponsors for the conference include The Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and Pfizer.

On May 3, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the publication later today of a patient case study from the hematological arm of its THINK Phase I trial in the journal Haematologica1 (Press release, Celyad, MAY 3, 2018, View Source [SID1234526052]). The publication, entitled "NKG2D-based Chimeric Antigen Receptor Therapy Induced Remission in a Relapsed/Refractory Acute Myeloid Leukemia Patient" is authored by the trial investigators at the Moffitt Cancer Center and Research Institute in Tampa, Fla. and by Celyad’s scientific team.

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The publication details the first objective response to CAR-T in relapsed/refractory AML using CYAD-01, Celyad’s Natural Killer Group 2D (NKG2D) chimeric antigen receptor T-cell therapy, without pre-conditioning lymphodepletion. The patient received CYAD-01 infusions at the initial dose level of 3×108 cells every 2 weeks for 3 administrations, achieving a morphologic leukemia-free state (MLFS2) at 3-months which enabled the patient to benefit from an allo-hematopoietic stem cell transplant (allo-HSCT). The patient achieved a complete molecular remission and remains in remission 9 months post study enrollment. CYAD-01 was well tolerated with no significant toxicities. The demonstrated first objective response to any CAR-T in relapsed/refractory AML without preconditioning chemotherapy highlights the potential of CYAD-01 as a treatment for AML.

"Our results demonstrate the validity of NKG2D as a target, in particular in the context of refractory AML and without other intervening treatments nor preconditioning", commented Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad. "We look forward to continue our clinical development plan for our NKG2D CAR based platform and explore the various conditions within which this therapy could provide benefits to patients with end stage cancers."

Dr. David Sallman, Assistant Member in the Malignant Hematology Department of Moffitt Cancer Center, added: "The THINK study case report provides the first clinical validity of CYAD-01 as a tumor-specific antigen-receptor and AML as a disease sensitive to gene-engineered cell therapies. As antigen targeting offers significant challenges in AML, this outcome brings hope for the further use of gene-engineered T-cells for patients with AML that have run out of therapeutic options. It’s all the more striking that this outcome was observed without any prior lymphodepletion highlighting the potential of using a physiologic antigen-receptor."

On May 3, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the first quarter ended March 31, 2018 (Press release, Lpath, MAY 3, 2018, View Source [SID1234526078]).
First Quarter 2018 Highlights

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Total revenues increased 8% over the first quarter of 2017 to $15.7 million

Total Endo-bariatric product sales were $10.3 million, up 40% over the first quarter of 2017
Todd Newton, CEO of Apollo, said, "We are pleased with our first quarter results and 2018 is off to a great start for the Company. Our worldwide Endo-bariatric product sales increased 40% compared to the first quarter of 2017, with OverStitch sales more than doubling compared to the same quarter of last year. For Orbera, the launch of Orbera365 produced both higher selling prices and increased unit sales in our European markets and in the U.S. Orbera implant volume increased 27% compared to the fourth quarter of 2017 as we rebuild U.S. momentum."
First Quarter 2018 Results
Total revenues in the first quarter of 2018 were $15.7 million, compared to $14.5 million in the first quarter 2017, an increase of 8%.
Total Endo-bariatric product sales increased 40% to $10.3 million in the first quarter of 2018 compared to $7.3 million in the first quarter of 2017, primarily due to higher OverStitch product sales in all markets. Outside the U.S. ("OUS") Endo-bariatric product sales increased 61% or $2.4 million and U.S. Endo-bariatric product sales increased 18%, or $0.6 million in the first quarter of 2018 compared to the first quarter of 2017. Endo-bariatric product sales comprised 65% of total revenues in the first quarter of 2018 compared to 51% in the first quarter of 2017.
Total Surgical product sales decreased $1.8 million, or 26% in the first quarter 2018 compared to the first quarter of 2017 due to reductions in gastric banding procedures being performed.
Gross margin for the first quarter of 2018 was 58.4%, compared to 64.9% for the first quarter of 2017 as a result of a greater proportion of our overall product sales coming from our Endo-bariatric products. We have several gross margin improvement projects underway that are expected to be completed over the next couple of years with the goal to reduce the unit cost of our Endo-bariatric products.
Total operating expenses increased $0.6 million to $16.8 million in the first quarter of 2018, compared to the first quarter of 2017. Higher sales and marketing expenses and research and development expenses in the first quarter were partially offset by lower general and administrative expenses. The increase in sales and marketing expenses was primarily due to higher sales compensation costs while the increase in research and development expense was primarily the result of an increase in clinical study activity and associated costs. Lower general and administrative expenses in the quarter were due to non-recurring fees and costs we incurred in the first quarter of 2017 associated with new public company activities.
Interest expense for the first quarter of 2018 decreased $0.5 million when compared to the first quarter of 2017 due to lower interest charges as a result of a $7.0 million principal payment in March 2017.
Net loss for the first quarter 2018 was $8.1 million compared to $8.2 million for the first quarter of 2017.
Cash, cash equivalents and restricted cash were $23.3 million as of March 31, 2018. During the first quarter of 2018, we used $1.2 million of cash for capital expenditures associated with gross margin improvement projects, $1.2 million for inventory purchases required to maintain safety stock for Endo-bariatric product growth, and $1.2 million for interest and debt amendment fees related to our credit facility. The remaining $4.6 million change was due to cash outflows from our operating activities.
Conference Call

Apollo will host a conference call on May 3, 2018 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the first quarter ended March 31, 2018.
To participate in the conference call dial (888) 213-3934 for domestic callers and (323) 794-2557 for international callers. The conference ID number is 7312360. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.
A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, until Apollo releases its second quarter 2018 financial results. In addition, a telephonic replay of the call will be available until May 10, 2018. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. The replay conference ID number is 7312360.