Genocea to Host First Quarter 2018 Financial Results Conference Call & Webcast on May 10, 2018 at 9 a.m. ET

On May 4, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported that it will host a conference call and live audio webcast on Thursday, May 10, 2018 at 9:00 a.m. ET to discuss financial results for the first quarter of 2018 (Press release, Genocea Biosciences, MAY 4, 2018, View Source [SID1234526120]). Genocea management will also provide an update on the Company’s recent progress and upcoming milestones.

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Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and refer to conference ID number 3866939. To join the live webcast, please visit the investor relations section of the Genocea website at View Source

A webcast replay will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days

IMMUTEP TO PRESENT AT 2018 ASCO ANNUAL MEETING

On May 4, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company) reported that it will present posters during the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held 1-5, June 2018 in Chicago, Illinois (Press release, Immutep, MAY 4, 2018, View Source [SID1234526167]).

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Details of the poster presentations in relation to Immutep’s lead product candidate, eftilagimod alpha (also known as IMP321) are as follows:

Abstract Number and Title: 1050, "Combination of paclitaxel and a LAG-3 fusion protein (eftilagimod alpha), as a first-line chemoimmunotherapy in patients with metastatic breast carcinoma (MBC): Final results from the run-in phase of a placebo-controlled randomized phase II."

Poster Session: Breast Cancer—Metastatic

Session Data and Time: Saturday, Jun 2, 8:00 – 11:30 a.m. CDT

Location: Hall A, Poster Board Number: #131

Abstract Number and Title: TPS1109, "AIPAC (Active Immunotherapy PAClitaxel): A randomized, double blind, placebo controlled, multinational phase IIb trial evaluating the efficacy of eftilagimod alpha (a soluble LAG-3 fusion protein) in combination with paclitaxel in hormone receptor positive metastatic breast cancer."

Poster Session: Breast Cancer—Metastatic

Session Data and Time: Saturday, Jun 2, 8:00 – 11:30 a.m. CDT

Location: Hall A, Poster Number: #185b

Abstract Number and Title: TPS3129, "The "INSIGHT" trial: An explorative, open-labeled phase I study to evaluate the feasibility and safety of intra-tumoral, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumor entities."

Poster Session: Developmental Therapeutics—Immunotherapy

Session Data and Time: Monday, Jun 4, 8:00 – 11:30 a.m. CDT

Location: Hall A, Poster Board Number: #329a

About the AIPAC clinical trial

The ongoing AIPAC (Active Immunotherapy PAClitaxel) Phase IIb clinical trial is a European multi-centre study evaluating eftilagimod alpha ("efti" or "IMP321") in combination with paclitaxel in metastatic breast cancer (clinicaltrials.gov identifier NCT 02614833). To date, 33 out of a planned 34 clinical sites across Belgium, the Netherlands, Poland, Hungary, United Kingdom, France and Germany are now actively recruiting and treating patients. The study is expected to be to be fully recruited with 226 patients in third quarter of calendar 2018; first Progression Free Survival data are expected in calendar 2019.

About the INSIGHT clinical trial

The on-going INSIGHT Phase I clinical trial is an investigator initiated, explorative, single centre, open-label, study evaluating the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections of efti for advanced stage solid tumour entities (clinicaltrials.gov identifier NCT03252938. The Lead Investigator of this clinical trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF.

OncoSec to Present at Eighth Annual BioNJ BioPartnering Conference

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.

Haematologica publishes Celyad THINK Study

Case Report of CYAD-01 Induced Complete

Remission in Relapsed/Refractory AML Patient

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."

APOLLO ENDOSURGERY, INC. REPORTS FIRST QUARTER 2018 RESULTS

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.