IntelGenx Reports Fourth Quarter and Full-Year 2017 Financial Results

On March 29, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2017 (Press release, IntelGenx, MAR 29, 2018, View Source [SID1234525061]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2017 Fourth Quarter Financial Highlights:

Revenue was $1.5 million, compared to $1.9 million in the fourth quarter of 2016
Adjusted EBITDA was ($600,000), compared to $640,000 in Q4-2016
Cash and short-term investments totalled $4.9 million as at December 31, 2017
2017 Full-Year Financial Highlights:

Revenue was $5.2 million, unchanged from $5.2 million in 2016
Net comprehensive loss was $2.7 million, compared to net comprehensive loss of $1.5 million over the same period last year
Adjusted EBITDA was ($1.4 million), compared to ($280,000) in 2016
Recent Operating Highlights:

Regained exclusive worldwide rights to develop and commercialize RIZAPORT
Received a Notice of Allowance from the United States Patent and Trademark Office for a formulation specific orange book eligible patent for Montelukast VersaFilm
Site obtained GMP compliant rating from Health Canada for manufacturing and packaging activities
Initiated Phase 2a proof of concept Montelukast VersaFilm clinical trial in Alzheimer’s patients
"2017 was an important year, as we continued down the path to clinical and commercial success," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have taken many important steps to support our efforts in pharmaceutical oral film development, manufacturing and commercialization, and remain on track for bringing our products to market. Moving forward, we believe that 2018 will represent a landmark period for IntelGenx, as we continue to advance our product pipeline, and begin clinical testing of our potentially groundbreaking Montelukast VersaFilm in Alzheimer’s patients."

Financial Results:

Total revenues for the three-month period ended December 31, 2017 amounted to $1.5 million, representing a decrease of $400,000 compared to $1.9 million for the three-month period ended December 31, 2016. The decrease is mainly attributable to upfront payments received in Q4-2016, partially offset by an increase in R&D revenues. Operating costs and expenses were $2.3 million for the fourth quarter of 2017, versus $1.5 million for the corresponding three-month period of 2016. For Q4-2017, the Company had an operating loss of $850,000, compared to operating income of $430,000 for the comparable period of 2016. Net comprehensive loss was $1.1 million, or $0.02 on a basic and diluted per share basis, for the fourth quarter of 2017, compared to net comprehensive loss of $22,000 or $0.00 on a basic and diluted per share basis, for the comparable period of 2016.

Total revenues for the twelve-month period ended December 31, 2017 amounted to $5.2 million, compared to $5.2 million for the twelve-month period ended December 31, 2016. Operating costs and expenses were $7.7 million for the full year 2017, versus $6.2 million for the corresponding 12-month period of 2016. For the twelve-month period of 2017, the Company had an operating loss of $2.5 million, compared to an operating loss of $980,000 for the comparable period of 2016. Net comprehensive loss was $2.7 million, or $0.04 on a basic and diluted per share basis, for the twelve-month period of 2017, compared to net comprehensive loss of $1.5 million, or $0.02 on a basic and diluted per share basis, for the comparable period of 2016.

As at December 31, 2017, the Company’s cash and short-term investments totalled $4.9 million, compared with $4.5 million as at December 31, 2016.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2017 as well as the 2018 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities March 29, 2018 at 4:00 p.m. EDT.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2017 fourth quarter and full year financial results March 29, 2018, at 4:30 p.m. EDT. The dial-in number for the conference call is (833) 211-3233 (Canada and United States) or (647) 689-3955 (International), conference ID 6786519. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.

Summary of Recent Published Research on Delcath’s PHP Therapy Presented at Society of Surgical Oncology Annual Symposia

On March 29, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that a comparative summary of recently published research on the Company’s PHP Therapy was presented at the 2018 Society of Surgical Oncology Annual Cancer Symposium (SSO), held in Chicago, IL March 21-24, 2018 (Press release, Delcath Systems, MAR 29, 2018, View Source;p=RssLanding&cat=news&id=2340305 [SID1234525454]).

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In a presentation entitled Percutaneous Hepatic Perfusion (PHP) in Hepatic Liver Metastases, Jonathan Zager, MD, FACS, Chair of Graduate Medical Education at Moffitt Cancer Center and Professor of Surgery at the University of South Florida School of Medicine, compared the results from the Company’s prior Phase 3 study, published by Hughes, et al (Annals of Surgical Oncology, 2015) with more recent results published by Karydis, et al (Journal of Surgical Oncology, 2017) and Abbott, et al (American Journal of Clinical Oncology, 2017). The Hughes study was conducted from 2005 to 2010, and used an earlier generation of the Melphalan/HDS system, whereas the Karydis and Abbott studies evaluated patients primarily treated with the Generation Two version of the Melphalan/HDS system along with other refinements to the peri- and post-procedure management of patients.

Dr. Zager highlighted that in all three studies results with PHP provided evidence of improved efficacy, with Hughes showing a 5x increase in hPFS over the study control arm (PHP 245 days vs BAC 49 days), and Abbott showing significantly longer hPFS for PHP than treatment with chemoembolization (CE) and Yttrium-90 beads (Y90) (PHP 310 days, CE 80 days, Y-90 54 days). Karydis showed an overall response rate with PHP of 47%, a >84% disease control rate and hPFS of 9.1 months.

Regarding safety, Dr. Zager compared select safety data in the Hughes study conducted with the generation one system with data from the Karydis study conducted primarily in patients treated with the generation two system. The Hughes study was characterized by high percentages of hematologic side effects ranging from 60%-86% (anemia, thrombocytopenia, neutropenia). In the Karydis study, Grade 3 and 4 hematologic side effects (anemia, neutropenia, thrombocytopenia) were seen in approximately 30% of patients treated with PHP. Dr. Zager attributed this improvement in the safety profile to improvements in filtration with the generation two system, improved peri- and post-procedure management of patients, and greater experience in the treating centers. Dr. Zager concluded that PHP Therapy can be administered safely in high-volume cancer centers.

"Dr. Zager’s presentation at SSO provided a very useful overview of the efficacy consistently seen with PHP Therapy in appropriately selected patients, both in our original Phase 3 trial and in the more recent research," said Jennifer K. Simpson Ph.D., MSN, CRNP President and CEO of Delcath. "Importantly, the improvement in the safety profile noted by Dr. Zager provides confidence that our current Phase 3 FOCUS Trial in ocular melanoma liver metastases can address safety concerns expressed by the FDA after our original Phase 3 trial data was submitted, and can meet its objective of supporting an application for FDA approval for this important therapy."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Deciphera Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Deciphera Pharmaceuticals, 2018, MAR 28, 2018, View Source [SID1234525029]).

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bluebird bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

On March 28, 2018 bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) reported that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States (Press release, bluebird bio, MAR 28, 2018, http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-and-celgene-corporation-enter-agreement-co-develop [SID1234525035]).

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This press release features multimedia. View the full release here: View Source

"Entering into this co-development and co-promotion partnership with Celgene is a significant step forward in building a fully integrated oncology franchise for bluebird and together, we are committed to rapidly advancing development of bb2121 for patients," said Joanne Smith-Farrell, Ph.D., oncology franchise leader and senior vice president, corporate development and strategy, bluebird bio. "The collaboration builds upon our extensive research and development capabilities in oncology and is a testament to the strong partnership that exists between our two companies."

The companies originally entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology, which included bb2121.

"We are extremely pleased to advance our collaboration with bluebird on bb2121 and we believe this therapy has the potential to significantly impact the treatment approach and outcomes for patients with multiple myeloma," said Nadim Ahmed, President, Hematology and Oncology for Celgene.

About the bluebird bio-Celgene Collaboration

bluebird bio and Celgene are collaborating to develop CAR T cell therapies targeting BCMA. The collaboration’s lead oncology program, bb2121, is currently being studied for the treatment of relapsed and refractory multiple myeloma. For bb2121, bluebird and Celgene have joint responsibility for development, manufacturing and commercialization in the United States. Celgene will assume sole responsibility for drug product manufacturing and commercialization outside the United States.

bluebird bio and Celgene are also working together on a second clinical-stage anti-BCMA CAR T program, bb21217.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Can-Fite BioPharma has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Can-Fite BioPharma, 2018, MAR 28, 2018, View Source [SID1234525030]).

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