August 11, 2016 – IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") today reported its second quarter 2016 financial results for the three-month and six-month periods ended June 30, 2016 ((Press release, IntelGenx, AUG 11, 2016, View Source [SID:1234514524]). All amounts are in U.S. Dollars unless otherwise stated. The Company will host a conference call today at 4:30 p.m. ET to provide a corporate update.

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2016 Second Quarter Financial Highlights:

• Revenues reached $672 thousand, an increase of 15% over the same period last year

• Net comprehensive loss was ($806 thousand), compared to a net comprehensive loss of ($220 thousand) over the same period last year

• Adjusted EBITDA loss was ($665 thousand), compared to adjusted EBITDA loss of ($186 thousand) over the same period last year

• Cash and cash equivalents totaled $1.1 million as at June 30, 2016. Subsequent to quarter end, the Company monetized its royalty on future sales of Forfivo XL to SWK Holdings Corporation for $6 million (CAD$8 million)

Recent Highlights:

• Signed the first definitive agreement for RizaportTM with Grupo Juste for Spain and additional potential territories

• Continued late-stage discussions with global pharmaceutical companies for multiple products with the potential goal of concluding a definitive agreement to be finalized in the third quarter of 2016

• Initiated a phase 1 study of Montelukast for the treatment of degenerative diseases of the brain, such as: mild cognitive impairment and Alzheimers disease, the most prominent form of dementia. IntelGenx expects results from the phase 1 trial to be available in September 2016.

• Appointed Mark Nawacki as a new Director of the Board

"IntelGenx has made considerable progress this past quarter," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We successfully completed our first agreement for Rizaport in Spain with Grupo Juste, which we believe is significant as it will open new markets to build upon going forward. The initiation of our phase 1 study of Montelukast is an important step forward in what is our most important and promising drug repurposing opportunity. We are most excited about the future prospects for IntelGenx as we continue to advance the company forward into a global leader in pharmaceutical oral film development and manufacturing."

Financial Results:

Total revenues for the three-month period ended June 30, 2016 amounted to $672 thousand, representing an increase of $87 thousand or 15% compared to $585 thousand for the three-month period ended June 30, 2015. The increase for the three-month period ended June 30, 2016 compared to the last year’s corresponding period is mainly attributable to an increase in royalties of $480 thousand due to the Company’s recording of both Q1 and Q2 royalty amounts in the present quarter. Edgemont Pharmaceuticals reported the Q2 royalties to the Company shortly after the end of the quarter which allowed the Company to record the revenues in the second quarter. The increase was offset by a decrease in deferred revenues recognized of $393 thousand.

Operating costs and expenses were $1.5 million for the three-month period ended June 30, 2016 compared to $846 thousand for the corresponding period of 2015. The increase for the three-month period ended June 30, 2016 is mainly attributable to an increase in Research and Development expenses of $174 thousand and Selling, General and Administrative of $315 thousand.

For the second quarter of 2016, the Company generated an operating loss of ($794 thousand) compared to an operating loss of ($261 thousand) for the comparable period of 2015.

Net comprehensive loss was ($806 thousand) or ($0.01) on a basic and diluted per share basis for the second quarter of 2016 compared to a net comprehensive loss of ($220 thousand) or ($0.00) on a basic and diluted per share basis for the comparable period of 2015.

"IntelGenx recently strengthened its balance sheet with the largest influx of capital in the history of the company with the monetization of its royalty on future sales of Forvivo XL for $6 million," said Andre Godin, Executive Vice-President and CFO of IntelGenx. "We continue to focus on maintaining a strong financial discipline in managing our expenses throughout the organization. Finally, we have made a concerted effort to bring greater visibility of the corporation in the marketplace with an aggressive outreach campaign to take place in the near future."

Cash on hand as at June 30, 2016 was $1.1 million, representing a decrease of $1.8 million compared with the balance of $2.9 million as at December 31, 2015. The decrease in cash relates to the investment in leasehold improvement as well as the comprehensive loss incurred in the second quarter. Subsequent to quarter end, the Company monetized its royalty on future sales of Forfivo XL to SWK Holdings Corporation for $6 million (CAD$8 million).

Appointment of New Director:

Subsequent to quarter end, the Corporation announced the appointment of Mr. Mark Nawacki as a new member of the Board of Directors. Mr. Nawacki is currently the President and CEO of Searchlight Pharma Inc., a Canadian-based specialty pharmaceutical company focused on the acquisition and commercialization of innovative and unique healthcare and pharmaceutical products. Prior to joining Searchlight Pharma, Mr. Nawacki spent over 11 years building out the commercial and geographic footprint of Paladin Labs, having served until September 2014 as Executive Vice President, Business and Corporate Development. Over the course of his 11-year tenure at Paladin, Mr. Nawacki helped shape the therapeutic focus of Paladin’s Canadian business via licensing and acquisitions, and built Paladin’s international expansion and emerging markets strategy. From his arrival at Paladin in 2003, consolidated revenues grew from $20 million to almost $270 million annually, and the company’s value increased from $75 million to over $3 billion when it was acquired by Endo International in 2014.

"We are very pleased that Mr. Nawacki has agreed to join our board," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "As IntelGenx is now completely focused on becoming a global leader in pharmaceutical oral films, Mark’s strong pharmaceutical background, knowledge and extensive network will support the Company in the execution of its business plan."

On August 11, 2016 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported an update on select research and development potential milestones and estimated timelines (Press release, RedHill Biopharma, AUG 11, 2016, View Source [SID:1234514510]).

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"RedHill continues to pursue its multiple-shots-on-goal strategy with a focus on advancing its three ongoing gastroenterology Phase III programs in the U.S., RHB-105 for H. pylori infection, RHB-104 for Crohn’s disease and BEKINDA for gastroenteritis, as well as additional Phase II programs, supported by a strong and debt-free balance sheet," stated Mr. Dror Ben-Asher, RedHill’s Chief Executive Officer. "We continue to further enhance the overall robustness of our flagship Phase III programs and increase data collection in support of future potential new drug applications, while maintaining a substantially consistent cash burn through the end of 2017." Mr. Ben-Asher added, "In light of strong recruitment rates in the ongoing Phase II study with BEKINDA for IBS-D, we are pleased to provide guidance, for the first time, on the estimated timing for top-line results, which are anticipated in mid-2017. RedHill is well-positioned for continued solid growth and we look forward to several Phase III and Phase II data points and other important milestones and potential catalysts expected in the coming months."

RHB-105 – H. pylori bacterial infection (confirmatory Phase III)

Following the positive FDA meeting in April 2016, and in light of guidance received on the potential path for marketing approval, preparations continue for the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study is planned to be initiated in the fourth quarter of 2016 or in the first quarter of 2017, following completion of a supportive pharmacokinetic (PK) program. The study is planned to enroll approximately 440 patients in up to 50 clinical sites in the U.S.

The planned confirmatory Phase III study, along with the results from the successfully completed first Phase III study (the ERADICATE Hp study) and data to be obtained from a supportive PK program, are expected to support a U.S. New Drug Application (NDA) for RHB-105. The first Phase III clinical study with RHB-105 successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The Phase III ERADICATE Hp study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Notably, subsequent open-label treatment with SoC therapies of patients in the placebo arm of the Phase III ERADICATE Hp study demonstrated only 63% eradication rate, further supporting the potential superior efficacy of RHB-105 over SoC.
RHB-104 – Crohn’s disease (Phase III) and multiple sclerosis (Phase IIa)

Crohn’s disease – first Phase III study ongoing

Approximately 200 subjects out of the planned total of 270 have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study with RHB-104 for Crohn’s disease (the MAP US study).

Interim data and safety monitoring board (DSMB) analysis is on track to take place in the fourth quarter of 2016 and RedHill remains blinded to the interim and ongoing results.

RedHill is currently reviewing a possible amendment to the Phase III MAP US study protocol intended to further enhance the overall robustness of the study, provide a more precise assessment of RHB-104’s treatment effect, collect additional endoscopic mucosal healing data, further evaluate the Crohn’s disease population enrolled and address retention and early terminations. No changes are planned to the primary endpoint of remission at week 26 or the study’s 90% power. Taking into account a potential protocol amendment, completion of recruitment is expected in 2017 with no anticipated material impact on the Company’s overall cash burn rate through the end of 2017. The Company expects to provide further details in the coming weeks, once plans are finalized.
Multiple sclerosis – Phase IIa study ongoing

Top-line final results from the Phase IIa CEASE-MS study with RHB-104 for relapsing-remitting multiple sclerosis (RRMS) are expected in the fourth quarter of 2016, following the recently announced last patient follow-up visit in the study. In the first 24 weeks, patients enrolled in the CEASE-MS study received treatment with RHB-104 as an add-on therapy to interferon beta-1a and were then evaluated for an additional 24-week follow-up period during which they were treated with interferon beta-1a alone. Top-line interim results announced in March 2016, after completion of the 24-week treatment period, demonstrated positive safety and efficacy signals, including an encouraging relapse-free rate, Expanded Disability Status Scale (EDSS) scores and MRI results, which support further clinical development.
BEKINDA (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)

Acute gastroenteritis and gastritis – Phase III study ongoing

RedHill has implemented a protocol amendment to the ongoing Phase III study with BEKINDA 24 mg for acute gastroenteritis (the GUARD study) to increase the safety data collected, so that the study results may support a potential NDA filing, as per FDA’s recommendation. The study protocol now requires patients to remain in the emergency room for a longer follow-up period and perform an ECG (electrocardiogram) at the end of follow-up and prior to discharge. In light of this amendment, completion of patient enrollment in the randomized, double-blind, placebo-controlled Phase III GUARD study is currently expected in early 2017.
IBS-D – Phase II study ongoing

Completion of patient enrollment in the ongoing randomized, double-blind, placebo-controlled Phase II study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) is expected in the first half of 2017, with top-line results expected mid-2017.
YELIVA – Phase I/II studies for multiple oncology and inflammatory indications

A Phase I/II study with YELIVA, a first-in-class SK2 selective inhibitor, for the treatment of refractory or relapsed multiple myeloma is planned to be initiated later this year at Duke University Medical Center. The study is supported by a $2 million grant from the National Cancer Institute (NCI) awarded to Apogee Biotechnology Corp. (Apogee) in conjunction with Duke University, with additional support from RedHill.

A Phase II study with YELIVA for the treatment of advanced hepatocellular carcinoma is planned to be initiated later this year. The study will be conducted at the Medical University of South Carolina (MUSC) Hollings Cancer Center and additional clinical centers in the U.S. It is supported by a $1.8 million grant from the NCI awarded to MUSC, intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, including the Phase II study with YELIVA, and will be further supported by additional funding from RedHill.

A Phase I/II clinical study to evaluate YELIVA as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy is planned to be initiated later this year.

A Phase I/II clinical study evaluating YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) was initiated at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans in June 2015 and was recently put on administrative hold, pending a protocol amendment aimed at improving overall recruitment prospects. The study is supported by a grant awarded to Apogee from the NCI, as well as additional support from RedHill.

Following the successful Phase I study with YELIVA in patients with advanced solid tumors, and in light of the drug’s novel mechanism of action, RedHill is evaluating potential clinical studies for additional oncology and inflammatory indications, as well as potential collaboration opportunities to evaluate YELIVA as an add-on therapy.
RHB-106 – encapsulated bowel preparation, exclusive worldwide rights licensed to Salix Pharmaceuticals (now Valeant Pharmaceuticals International)

The exclusive worldwide rights to RedHill’s RHB-106 encapsulated bowel cleanser, as well as additional related rights (RHB-106 Program), were licensed to Salix Pharmaceuticals Ltd. in 2014, which was acquired by Valeant Pharmaceuticals International Inc. (Valeant) in 2015. Valeant remains fully responsible for the development of the RHB-106 Program and for future potential commercialization. RedHill has recently been informed by Valeant that, as a result of Valeant’s greater focus on R&D investment, the development of the RHB-106 Program continues to be explored.

Earlier this week, Valeant highlighted their commitment to bolstering their R&D and commercial offering and enhance their gastrointestinal business with the acquisition of the North American rights to a powder for oral solution bowel cleanser (NER1006) from Norgine B.V.
Ebola virus disease therapy (RedHill’s proprietary experimental therapy) – NIH collaboration

Initiation of the research collaboration with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is expected in the fourth quarter of 2016. The new study is intended to evaluate RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease and follows encouraging results from preliminary non-clinical studies conducted in conjunction with NIAID. Top-line results from the study are expected in 2017.

RIZAPORT (RHB-103) – acute migraines (approved for marketing in Germany)

Re-submission of the RIZAPORT U.S. NDA to the FDA is expected in the first half of 2017. RIZAPORT was approved for marketing in Germany under the European Decentralized Procedure (DCP) in October 2015 and a first commercialization agreement was recently signed with Grupo JUSTE S.A.Q.F for Spain and additional potential territories.

RedHill continues discussions with additional potential commercialization partners for RIZAPORT in the U.S., Europe and other territories.
MESUPRON – First-in-class small molecule for oncology indications (Phase II-stage)

RedHill’s current development program for MESUPRON includes nonclinical studies as well as re-analysis of certain prior clinical data. MESUPRON is a first-in-class, orally-administered uPA inhibitor targeting gastrointestinal and other solid tumors. MESUPRON completed a total of ten Phase I and Phase II clinical studies, and the ongoing development program is intended to better define the molecular markers and patient population for future clinical studies. RedHill plans to initiate a Phase II development program with MESUPRON in 2017, subject to a successful outcome in the ongoing nonclinical studies.
RP101 – First-in-class small molecule for oncology indications (Phase II-stage)

RedHill has extended the term of the August 2014 exclusive option agreement with RESprotect GmbH for RP101, a first-in-class, orally-administered Hsp27 inhibitor, for an additional nine months period until May 2017. The Company intends to conduct additional nonclinical studies with RP101 before concluding whether to advance its development or terminate the option agreement with RESprotect GmbH.

On August 11, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the second quarter ended June 30, 2016 (Filing, Q2, BioLineRx, 2016, AUG 11, 2016, View Source [SID:1234514504]).

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Highlights and achievements during second quarter of 2016 and to date:

· Submission of regulatory filings to initiate Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA, under immuno-oncology collaboration with Merck announced earlier this year

· Signing of additional immuno-oncology collaboration, this time with MD Anderson Cancer Center, for second Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA

· Continued enrollment in large (n=194), randomized Phase 2b study for BL-8040 as consolidation treatment for AML patients following standard induction treatment

· Commercial launch of BL-5010 as OTC treatment for non-surgical removal of skin lesions by Omega Pharma (a division of Perrigo), following CE Mark approval in March

· In-licensing of liver fibrosis project under Novartis collaboration

· Philip A. Serlin appointed Chief Executive Officer, effective October 2016

Expected upcoming significant milestones for remainder of 2016:

· Initiation of Phase 2a study in pancreatic cancer, under immuno-oncology collaboration with Merck, following expected regulatory approval in Q3 2016

· Second Phase 2a immuno-oncology study in pancreatic cancer, under collaboration with MD Anderson Cancer Center, expected to commence by end of 2016

· Full set of data from Phase 2a study for BL-8040 in r/r AML to be presented at the Society of Hematologic Oncology (SOHO) annual meeting, September 7-10, 2016, in Houston, Texas

· Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by end of 2016

· Regulatory submission for BL-7010 clinical efficacy study, for marketing purposes as food supplement

· Expansion of commercial rollout of BL-5010 by Omega to additional countries and development of 2nd OTC indication for the product

Philip A. Serlin, Chief Financial and Operating Officer of BioLineRx, remarked, "The second quarter of 2016 highlighted the continued execution of our plans as we advance and expand our lead oncology platform, BL-8040; see the initial market penetration of BL-5010; continue the development of BL-7010 as a food supplement; and maintain active asset screening and in-licensing activities with Novartis."

"We are pleased to have entered into an immuno-oncology collaboration with MD Anderson for a second Phase 2a study of BL-8040 with Merck’s KEYTRUDA in pancreatic cancer, which provides additional validation of the potential of our lead oncology drug platform in the cancer immunotherapy space. We continue to examine other potential collaborations in this space. In addition, we are looking forward to announcing full results from our successful Phase 2a study for relapsed and refractory AML at the upcoming Society of Hematology Oncology Meeting in September and we continue to push forward in our Phase 2b trial in an earlier treatment line for AML as a consolidation treatment following standard induction treatment. We also look forward to initiating our Phase 2a study in pancreatic cancer under our collaboration with Merck, expected by the end of this quarter," added Mr. Serlin.

"BL-5010, our first product in the market, is already being sold in a number of countries in Europe. Omega Pharma plans to continue to gradually launch the product in additional European countries over the next 6-9 months, and beyond that time frame, to additional territories. To date, we have not recorded material revenues from this collaboration, but we expect revenues to gradually increase as the first product launch expands and the second product launch commences. In addition, we have in-licensed a drug candidate for the treatment of liver fibrosis, specifically nonalcoholic steatohepatitis (NASH), under our strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates, and we expect to in-license additional promising projects to the collaboration in the next few months," continued Mr. Serlin.

"In closing, we ended the second quarter with $41.8 million of cash on our balance sheet. With our focus on achieving our expected milestones, we remain well positioned to carry out our strategic and operational plans," Mr. Serlin concluded.

2

Financial Results for Second Quarter Ended June 30, 2016

Research and development expenses for the three months ended June 30, 2016 were $2.7 million, a decrease of $0.2 million, or 5.2%, compared to $2.9 million for the comparable period in 2015. The small decrease resulted primarily from lower spending on BL-7010 in the 2016 period, partially offset by increased spending related to clinical trial preparations for BL-8040. Research and development expenses for the six months ended June 30, 2016 were $5.3 million, a decrease of $0.8 million, or 13.5%, compared to $6.1 million for the comparable period in 2015. The decrease resulted primarily from lower expenditures for BL-7010 during the 2016 period, as well as the conclusion of one of the clinical trials for BL-8040 in 2015.

Sales and marketing expenses for the three months ended June 30, 2016 were $0.3 million, similar to the comparable period in 2015. Sales and marketing expenses for the six months ended June 30, 2016 were $0.5 million, similar to the comparable period in 2015.

General and administrative expenses for the three months ended June 30, 2016 were $0.9 million, a decrease of $0.1 million, or 12.5%, compared to $1.0 million for the comparable period in 2015. The small decrease resulted primarily from a decrease in salary-related payments and depreciation. General and administrative expenses for the six months ended June 30, 2016 were $1.8 million, similar to the comparable period in 2015.

The Company’s operating loss for the three months ended June 30, 2016 amounted to $3.8 million, compared with an operating loss of $4.2 million for the corresponding 2015 period. The Company’s operating loss for the six months ended June 30, 2016 amounted to $7.6 million, compared with an operating loss of $8.5 million for the corresponding 2015 period.

Non-operating income (expenses) for the three and six months ended June 30, 2016 and 2015 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet. These fair-value adjustments, which were not material in the 2016 periods, are highly influenced by the Company’s share price at each period end (revaluation date).

Financial income (expenses), net for the three and six months ended June 30, 2016 and 2015 primarily relate to investment income earned on bank deposits, as well as banking fees. The decrease from 2015 to 2016 reflects a lower cash balance and a continued reduction in global investment yields.

The Company’s net loss for the three months ended June 30, 2016 amounted to $3.7 million, compared with a net loss of $4.8 million for the corresponding 2015 period. The Company’s net loss for the six months ended June 30, 2016 amounted to $7.2 million, compared with a net loss of $9.1 million for the corresponding 2015 period.

The Company held $41.8 million in cash, cash equivalents and short-term bank deposits as of June 30, 2016.

3
Net cash used in operating activities was $7.4 million for the six months ended June 30, 2016, compared with net cash used in operating activities of $7.1 million for the comparable period in 2015. The $0.3 million increase in net cash used was primarily the result of a decrease in trade payables and accruals.

Net cash provided by investing activities for the six months ended June 30, 2016 was $4.2 million, compared to net cash used in investing activities of $17.9 million for the comparable period in 2015. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the six months ended June 30, 2016 was $1.5 million, compared to net cash provided by financing activities of $28.6 million for the comparable period in 2015. The decrease in cash flows from financing activities reflects the underwritten public offering which was completed in March 2015.