Daily Archives: May 3, 2017

Taconic Biosciences Announces Expansion of Key Alzheimer Animal Model

HUDSON, N.Y., May 03, 2017 (GLOBE NEWSWIRE) — Taconic Biosciences, a global leader in genetically engineered mouse models and associated services, announced it will expand the offering of a key Alzheimer’s Disease (AD) mouse model, APPSWE – Model 1349, to include aged animals.

Taconic will now offer off-the-shelf Model 1349 animals aged up to 42 weeks, saving months off the typical timeline to access Alzheimer’s models.  This program addresses customers’ need to have critical disease models immediately available, as opposed to placing an order and waiting for the animals to age and express the desired phenotype.

Dr. Michael Seiler, Taconic Biosciences’ portfolio director for genetically engineered models, commented, “The addition of aged APPSWE animals demonstrates Taconic’s commitment to help researchers reduce discovery timelines. These reductions save both time and money, ultimately making it easier to progress towards life-changing therapeutics.”

APPSWE mice express a mutated form of the human gene for amyloid precursor protein (APP) known as the Swedish mutation (APPSWE). The mutated gene encodes a double amino acid substitution and is associated with an inheritable increased susceptibility to Alzheimer’s Disease. Resulting phenotypic manifestations in APPSWE mice include a progressive accumulation of beta amyloid (Aβ) in the brain, analogous to classic “senile plaques” of human AD, and correlated cognitive deficits. Mice that overexpress an Alzheimer’s-associated isoform of the human amyloid precursor protein provide a model for human Alzheimer’s Disease and an experimental tool for a diversity of cellular mechanisms.

Alzheimer’s Disease and other dementias is expected to cost the United States $259 billion dollars in 2017 (www.alz.org), representing a major market and focus for pharmaceutical research.

Taconic also offers unaged Model 1349 animals, as well as a comprehensive neuroscience rodent model portfolio. To learn more about Taconic’s neuroscience portfolio, please contact Taconic Biosciences at 1-888-TACONIC (888-822-6642) in the US, +45 70 23 04 05 in Europe or at [email protected]

About Taconic Biosciences, Inc.
Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic helps biotechnology companies and institutions acquire, custom generate, breed, precondition, test, and distribute valuable research models worldwide.  Specialists in genetically engineered mouse and rat models, precision research mouse models, and integrated model design and breeding services, Taconic operates three service laboratories and six breeding facilities in the U.S. and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world.

Media Contact:
Kelly Owen Grover
Director of Marketing Communications
(518) 697-3824
[email protected]

RedHill Biopharma Reports 2017 First Quarter Financial Results

  • RedHill maintains a debt-free balance sheet with a $61 million cash balance1 at the end of the first quarter of 2017, allowing the Company to continue to diligently execute its development and U.S. commercialization plans

Select recent milestones include:

  • Exclusive U.S. co-promotion agreement for commercial GI drug Donnatal®2
  • Exclusive license agreement for commercial GI product EnteraGam®3
  • Completion of patient enrollment and treatment in the Phase III GUARD study with BEKINDA® (RHB-102) 24 mg for acute gastroenteritis and gastritis
  • Completion of patient enrollment in the Phase II study with BEKINDA® 12 mg for IBS-D
  • Initiation of an open-label extension study to the Phase III MAP US study with RHB-104 for Crohn’s disease
  • FDA QIDP Fast-Track designation granted to RHB-104 for nontuberculous mycobacteria (NTM) infections
  • Orphan Drug designation granted to YELIVA® (ABC294640) for the treatment of cholangiocarcinoma

Select potential milestones expected in the coming months:

  • Top-line results from the BEKINDA® 24 mg Phase III GUARD study for gastroenteritis and gastritis (the GUARD study) expected in Q2/2017
  • Top-line results from the BEKINDA® 12 mg Phase II study for IBS-D expected in Q3/2017
  • Initiation of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection expected in Q2/2017
  • Second independent DSMB meeting for the MAP US Phase III study with RHB-104 for Crohn’s disease, including an interim efficacy analysis and evaluation of an option for early stop for success for overwhelming efficacy, expected mid-year
  • Initiation of U.S. promotional activities for Donnatal® and EnteraGam® expected in Q2/2017
  • Initiation of additional Phase I/II studies with YELIVA® for cholangiocarcinoma, prevention of mucositis in head and neck cancer and ulcerative colitis expected in H2/2017
  • Initiation of a Phase I/II study with MESUPRON in pancreatic cancer expected in H2/2017

TEL-AVIV, Israel, May 03, 2017 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported its financial results for the quarter ended March 31, 2017.

The Company will host a conference call on Wednesday, May 3, 2017, at 9:00 am EDT to review the financial results and business highlights. Dial-in details are included below.

Financial highlights for the quarter ended March 31, 20174

Research and Development Expenses for the first quarter of 2017 were $8.1 million, up 74% compared to the first quarter of 2016 and up 9% compared to the fourth quarter of 2016. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA® (RHB-102)5 for gastroenteritis and diarrhea-predominant irritable bowel syndrome (IBS-D), respectively, the ongoing Phase III study with RHB-104 for Crohn’s disease, ongoing studies with YELIVA® (ABC294640)6 for multiple indications and preparations for the upcoming confirmatory Phase III study with RHB-105 for H. pylori infection.

Selling, Marketing and Business Development Expenses for the first quarter of 2017 were $0.6 million, up 94% compared to the first quarter of 2016. The increase was mainly due to activities related to the Company’s U.S. commercial operations.

General and Administrative Expenses for the first quarter of 2017 were $1.3 million, up 44% compared to the first quarter of 2016 and up 12% compared to the fourth quarter of 2016. The increase was mainly due to expanded operations.

Operating Loss for the first quarter of 2017 was $10.1 million, up 71% compared to the first quarter of 2016 and up 12% compared to the fourth quarter of 2016. The increase was mainly due to an increase in Research and Development Expenses, as detailed above.

Financial Income, net for the first quarter of 2017 was $1.5 million, compared to $379 thousand in the first quarter of 2016. The increase was mainly due to a fair value gain on derivative financial instruments related to investors’ warrants from the December 2016 financing.

Net Cash Used in Operating Activities for the first quarter of 2017 was $10.3 million, up 107% compared to the first quarter of 2016 and up 1% compared to the fourth quarter of 2016. The increase was mainly due to the increase in Operating Loss, as detailed above.

Net Cash Used in Investment Activities for the first quarter of 2017 was $18.6 million, compared to $4.6 million in the first quarter of 2016. The increase was mainly due to investments of the cash in bank deposits and purchase of marketable securities.

Net Cash Provided by Financing Activities for the first quarter of 2017 was $4.5 million compared to an immaterial amount for the first quarter of 2016. The increase was mainly due to proceeds from the exercise of warrants and options into ordinary shares.

Cash Balance as of March 31, 2017 was $61 million, a decrease of $5 million, compared to $66 million as of December 31, 2016. The decrease was a result of cash used in operating activities and investment activities, offset by cash provided by financing activities, as described above.

Micha Ben Chorin, RedHill’s CFO, said: “We are pleased with the achievements in the first quarter of 2017, which included securing rights for two commercial GI products in the U.S. as part of RedHill’s strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. and setting the stage for our late clinical-stage pipeline drugs, if approved. Our cash position of $61 million at the end of the first quarter should allow us to continue to execute our strategic plans for 2017 and diligently advance our late-stage clinical programs. We look forward to important events expected in the coming months, including top-line results from the Phase III GUARD study with BEKINDA® for gastroenteritis, initiation of the confirmatory Phase III study with RHB-105 for H. pylori infection, a second independent DSMB meeting for the ongoing Phase III MAP US study with RHB-104 for Crohn’s disease and the initiation of promotional activities in the U.S. with Donnatal® and EnteraGam®.”

Conference Call and Webcast Information:

The Company will host a conference call on Wednesday, May 3, 2017, at 9:00 am EDT to review the financial results and business highlights.

To participate in the conference call, please dial the following numbers 15 minutes prior to the start of the call: United States: +1-877-280-2342; International: +1-212-444-0896; and Israel: +972-3-763-0147. The access code for the call is 1922788.

The conference call will be broadcasted live and available for replay on the Company’s website, http://ir.redhillbio.com/events.cfm, for 30 days. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

Recent operational highlights:

  1. On January 3, 2017, RedHill announced the signing of an exclusive co-promotion agreement with a subsidiary7 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR) (“Concordia”), granting RedHill certain U.S. promotion rights for Donnatal®8, a prescription oral drug used with other drugs for the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal® by RedHill, based on an agreed upon split.
  2. On January 5, 2017, RedHill announced the signing of a new collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University for the evaluation of RedHill’s Phase II-stage oncology drug candidate, MESUPRON (upamostat). The new research collaboration follows previous non-clinical studies conducted with Denmark’s Aarhus University and is designed to identify additional high affinity molecular targets of MESUPRON. A Phase I/II study with MESUPRON in pancreatic cancer is planned to be initiated in the second half of 2017.
  3. On January 10, 2017, RedHill announced first dosing in a three-way crossover pharmacokinetic (PK) study with RHB-105 in 18 subjects (healthy volunteers), intended to evaluate the bioavailability of RHB-105 actives versus the comparator in the planned confirmatory Phase III study (dual therapy of amoxicillin and omeprazole) and a food-effect study with RHB-105. The confirmatory Phase III study with RHB-105 for H. pylori infection is planned to be initiated in the second quarter of 2017. Subject to a successful outcome, the confirmatory Phase III study and the supportive PK program are expected to complete the package required for a U.S. NDA for RHB-105.
  4. On January 11, 2017, RedHill announced that RHB-104 had been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of nontuberculous mycobacteria (NTM) infections. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. Under the FDA’s GAIN Act, QIDP designation allows for Fast-Track status and Priority Review, potentially leading to a shorter NDA review time by the FDA, and, if approved, an additional five years of U.S. market exclusivity on top of the standard exclusivity period. RedHill plans to consult with the FDA regarding the RHB-104 development program for NTM infections.
  5. On February 21, 2017, RedHill announced that the last patient enrolled in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA® 24 mg in the U.S. for the treatment of acute gastroenteritis and gastritis (the GUARD study) had completed the treatment course and observation period for the primary endpoint evaluation. The GUARD study treated 321 adults and children over the age of 12 in 29 U.S. clinical sites. Top-line results are expected in the second quarter of 2017. Furthermore, on April 18, 2017, RedHill announced that it had received notices of allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA®. Once granted, the patents are expected to be valid until at least 2034.
  6. On March 21, 2017, RedHill announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s disease (the MAP US study). The open-label extension study (the MAP US2 study) is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US study and remain with active Crohn’s disease (CDAI>150); these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label extension study.
  7. On April 4, 2017, RedHill announced that the FDA had granted YELIVA® (ABC294640) Orphan Drug designation for the treatment of cholangiocarcinoma. Orphan Drug designation allows RedHill to benefit from a seven-year marketing exclusivity period for the indication, if approved for marketing, as well as other development incentives to develop YELIVA® for cholangiocarcinoma. A Phase IIa clinical study with YELIVA® in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma is planned to be initiated in the third quarter of 2017.
  8. On April 5, 2017, RedHill announced the signing of an exclusive license agreement with Entera Health Inc. (“Entera Health”), granting RedHill the exclusive U.S. rights to EnteraGam®9, a commercially-available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. Under the terms of the agreement, RedHill will pay Entera Health royalties based on net sales generated from the sale of EnteraGam® by RedHill.
  9. On April 13, 2017, RedHill, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), announced that the Ministry of Health of Luxembourg had granted national marketing authorization for RIZAPORT® (5 mg and 10 mg). The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member State. The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT® under the European DCP.
  10. On April, 24, 2017, RedHill announced enrollment of the last patient in the Phase II study with BEKINDA® 12 mg for the treatment of IBS-D. The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in 127 U.S. patients with IBS-D. Top-line results are expected in the third quarter of 2017.

About Donnatal®:
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast-acting liquid.

Important Safety Information about Donnatal®:
Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.

Further information, including prescribing information, can be found on www.donnatal.com.

Please see the following website for complete important safety information about Donnatal®:
http://www.donnatal.com/professionals/important-safety-information/

About EnteraGam®:
EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision. EnteraGam® binds microbial components10, such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders11 12.

Safety Information about EnteraGam®:
EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product.  EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers.  The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey.  EnteraGam® is gluten-free, dye-free and soy-free.

Please see full Product Information.

To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, as well as an exclusive license agreement with Entera Health for EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) RHB-105 an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON – a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) – an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP). More information about the Company is available at: www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal® and EnteraGam®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

1 Including cash and short-term investments.

2 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.

3 EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.

4 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.

5 BEKINDA® is an investigational new drug, not available for commercial distribution.

6 YELIVA® is an investigational new drug, not available for commercial distribution.

7 Concordia Pharmaceuticals Inc.

8 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.

9 EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.

10 Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to pathogen-associated molecular patterns. Poster presented at: Federation of American Societies for Experimental Biology; April 26-30, 2014; San Diego, CA.

11 Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.

12 Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.

REDHILL BIOPHARMA LTD.
CONSOLIDATED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
    Three months ended  
    March 31,   
  2017 2016
  U.S. dollars in thousands  
RESEARCH AND DEVELOPMENT EXPENSES, net  8,137  4,676
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES  605  *312
GENERAL AND ADMINISTRATIVE EXPENSES  1,315  *915
OTHER EXPENSES  45  —
OPERATING LOSS  10,102  5,903
FINANCIAL INCOME  1,556  380
FINANCIAL EXPENSES  50  1
FINANCIAL INCOME, net  1,506  379
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD  8,596  5,524
LOSS PER ORDINARY SHARE, basic and diluted  (U.S. dollars)  0.05  0.04
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)  170,072  127,129
*Reclassified
REDHILL BIOPHARMA LTD.
CONSOLIDATED CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
  March 31,  December 31, 
  2017 2016
  U.S. dollars in thousands
CURRENT ASSETS:
Cash and cash equivalents  29,624  53,786
Bank deposits  15,609  55
Financial assets at fair value through profit or loss  15,351  12,313
Prepaid expenses and receivables  2,675  1,661
   63,259  67,815
NON-CURRENT ASSETS:
Bank deposits  145  137
Fixed assets  151  165
Intangible assets  6,050  6,095
 6,346  6,397
TOTAL ASSETS  69,605  74,212
 
CURRENT LIABILITIES:         
Accounts payable and accrued expenses  3,786  3,356
Payable in respect of intangible asset purchase  2,000  2,000
 5,786  5,356
NON-CURRENT LIABILITIES:
Derivative financial instruments  4,873  6,155
TOTAL LIABILITIES  10,659  11,511
 
EQUITY:          
Ordinary shares  455  441
Additional paid-in capital  156,415  150,838
Warrants  —  1,057
Accumulated deficit  (97,924 )  (89,635 )
TOTAL EQUITY  58,946  62,701
 
TOTAL LIABILITIES AND EQUITY  69,605  74,212
REDHILL BIOPHARMA LTD.
CONSOLIDATED CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
Three months ended  
March 31,   
2017 2016  
U.S. dollars in thousands  
OPERATING ACTIVITIES:
Comprehensive loss  (8,596 )  (5,524 )
Adjustments in respect of income and expenses not involving cash flow:
Share-based compensation to employees and service providers  307  374
Depreciation  14  10
Write-off of intangible assets  45  —
Unrealized gains on derivative financial instruments  (1,262 )  (201 )
Fair value loses (gains) on financial assets at fair value through profit or loss  15  (8 )
Revaluation of bank deposits  (18 )  (58 )
Exchange differences in respect of cash and cash equivalents  (242 )  (82 )
 (1,141 )  35
Changes in assets and liability items:
Decrease (increase) in prepaid expenses and receivables  (1,014 )  440
Increase in accounts payable and accrued expenses  430  68
 (584 )  543
Net cash used in operating activities  (10,321 )  (4,981 )
INVESTING ACTIVITIES:
Purchase of fixed assets  —  (29 )
Change in investment in current bank deposits  (15,544 )  2,000
Purchase of non-current bank deposit  —  —
Purchase of financial assets at fair value through profit or loss  (3,453 )  (6,572 )
Proceeds from sale of financial assets at fair value through profit or loss  400  —
Net cash used in investing activities  (18,597 )  (4,601 )
FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares, net of expenses  1,282  —
Exercise of warrants and options into ordinary shares  3,232  10
Net cash provided by financing activities  4,514  10
DECREASE IN CASH AND CASH EQUIVALENTS  (24,404 )  (9,572 )
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS  242  82
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  53,786  21,516
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD  29,624  12,026
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH  71  94
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
[email protected]

IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
[email protected]

Confounding Expectations, Media Access More Difficult Under Myanmar’s Civilian Government

Media access to officials and information in Myanmar has become more difficult under the year-old civilian government of de facto national leader Aung San Suu Kyi, despite indications the situation would get better, the chairman of a press organization said Tuesday.

As everybody in the media world knows, media access has gotten harder under the new civilian government, said Thiha Saw, chairman of the Myanmar Press Council, an independent media adjudication body that investigates and settles press disputes, promotes journalism ethics, and protects journalists.

He made the comments at a ceremony organized by UNESCO and Sweden in the commercial capital Yangon to commemorate World Press Freedom Day, held annually on May 3 to raise awareness about freedom of the press and to remind governments of their duty to uphold the right to freedom of expression under Article 19 of the Universal Declaration of Human Rights.

Despite the criticism, Information Minister Pe Myint said in his opening speech at the event that his ministry has held 16 press conferences within the last year under the National League for Democracy (NLD) government and has been doing its best to ensure press freedom.

The Information Ministry is also providing media awareness training for spokespersons in all other ministries, he said.

Reporters can run into difficulties depending on where they are covering news, Pe Myint said. They have to be careful about covering news in some sensitive locations. They can learn how to be careful when they receive media training.

Sometimes, particular organizations or individuals feel that they are being disturbed when they are interviewed or written about, [but] we can’t say we don’t have press freedom because of it, he said.

But Zaw Thet Htwe, of the Myanmar Journalists Union, said the new government has failed to get rid of laws that restrict the freedom of the press, especially Article 66(d) of the Telecommunications Law, which prohibits use of the telecom network to extort, threaten, obstruct, defame, disturb, inappropriately influence or intimidate people and carries a jail sentence of up to three years and a fine for those who violate it.

Press freedom has declined in the previous year because of Article 66(d), he said. It is a shame to see that the article is still active under the NLD government, which has always asked for media freedom.

As the former editor of a popular sports magazine, Zaw Thet Htwe was sentenced to death in November 2003 for exposing irregularities by Myanmar sports officials, but his term was later reduced to three years’ imprisonment. A military junta, which ruled the country for five decades, had accused him of being involved in a conspiracy against the government and charged him with high treason.

The number of defamation suits filed under Article 66 (d), enacted in 2013 by the previous government, have soared under Aung San Suu Kyi’s administration, with 56 people charged for social media posts deemed inappropriate�12 of whom were journalists.

During the previous military-backed government of former president Thein Sein, only seven people were charged under Article 66(d), five of whom received prison sentences.

Fears of ‘bad luck’

Kyaw Zwa Moe editor of the English edition of the online journal The Irrawaddy, wrote in an editorial for World Press Freedom Day that the country must be free from Article 66(d), state- and military-owned media, and joint-venture media concerns between the state and its businessmen cronies.

The government is responsible for creating an atmosphere where independent media can thrive professionally, ethically, and commercially with laws guaranteeing the right to information, he said, adding that these aspirations have yet to be realized.

We journalists wake up every morning fearing that bad ‘luck’ will strike us�if influential players in the government or military or other powerful institutions have assumed that our stories published the day before ‘defamed’ them, he wrote.

He went on to say that powerful people have misused Article 66(d) to attack the media, instead of making use of more standard defamation charges described in penal codes.

Last November, Than Htut Aung, chief executive officer of Eleven Media Group, and Wai Phyo, chief editor of the Daily Eleven newspaper, were jailed for violating Article 66(d) after publishing an editorial that accused Phyo Min Thein, Yangon’s chief minister, of being involved in bribery.

In April, a court in Yangon charged NLD researcher Myo Yan Naung Thein with defamation under Article 66(d) for defaming Senior General Min Aung Hlaing, the country’s commander-in-chief of the armed forces, in a Facebook post. He was sentenced to six months in jail but was released a week later as part of a prisoner amnesty.

We are likely to see more charges against individuals or journalists under Article 66(d) unless the NLD government or the NLD-dominated parliament repeals or amends this law for the sake of protecting freedom of expression, Kyaw Zwa Moe wrote.

No place for media freedom

Myanmar ranks 131 out of 180 countries on the 2017 World Press Freedom Index issued by Paris-based Reporters Without Borders (RSF), though it moved up 12 places from its 2016 ranking.

After the National League for Democracy’s election victory, Burmese journalists hoped that they would never again have to fear arrest or imprisonment for criticizing the government or the military, RSF said on its website about Myanmar’s latest ranking.

However, media freedom unfortunately does not have a place among the new government’s priorities, it said.

Thein Sein, who led the country for five years until the end of March 2015, lifted controls on the media early on in his administration and granted amnesty to journalists who were imprisoned.

But RSF charges that Myanmar’s media continues to engage in self-censorship because government officials and military officers continue to exert pressure on them and directly intervene in editorial policies.

Some rights groups believe that Aung San Suu Kyi, widely touted as a democracy icon in the West, has failed to live up to expectations for increased freedom of the press under the NLD administration.

In an interview with RFA’s Myanmar Service in December 2015, a month after her party swept national elections by a landslide, she said that government-owned media were not good for democracy in the Southeast Asian nation.

Myanmar has three state-owned newspapers whose objectives are to communicate the activities and policies of the government.

We will not abolish them immediately, but yet don’t want to delay doing it as well, Aung San Suu Kyi said at the time. It would be better if we did everything according to democratic principles as soon as possible.

There are government supported media in the United States and United Kingdom, such as the Voice of America and the British Broadcasting Corporation, but they have their freedom, she said. They are working with their own channels. It is important to work freely even though we have government supported media.

Copyright (copyright) 1998-2016, RFA. Used with the permission of Radio Free Asia, 2025 M St. NW, Suite 300, Washington DC 20036

Trump Administration Literally Trying to Erase Human Rights

Just days after marking Trump’s first 100 days in office by detailing 100 ways his administration has threatened human rights, Amnesty International again reacted to new actions by the Trump Administration that appear to push human rights to the sidelines.

Secretary of State Rex Tillerson told State Department staff today that the United States will no longer insist that other countries adopt values that respect human rights, saying values are separate from policies.

And Mother Jones today reported that a key position on the National Security Council has dropped human rights from its title.The special assistant to the president for multilateral affairs and human rights who helped craft policies related to human rights will now be known as special assistant to the president for multilateral affairs.

The Trump Administration is literally trying to erase human rights before our very eyes, said Margaret Huang, executive director of Amnesty International USA. His own actions and those of his staff show a dangerous disregard for freedom, justice and equality throughout the world. It is more critical than ever that we stand up and fight back against any effort to erode human rights at home or abroad.

Source: Amnesty International USA

Trump Administration Literally Trying to Erase Human Rights

Just days after marking Trump’s first 100 days in office by detailing 100 ways his administration has threatened human rights, Amnesty International again reacted to new actions by the Trump Administration that appear to push human rights to the sidelines.

Secretary of State Rex Tillerson told State Department staff today that the United States will no longer insist that other countries adopt values that respect human rights, saying values are separate from policies.

And Mother Jones today reported that a key position on the National Security Council has dropped human rights from its title.The special assistant to the president for multilateral affairs and human rights who helped craft policies related to human rights will now be known as special assistant to the president for multilateral affairs.

The Trump Administration is literally trying to erase human rights before our very eyes, said Margaret Huang, executive director of Amnesty International USA. His own actions and those of his staff show a dangerous disregard for freedom, justice and equality throughout the world. It is more critical than ever that we stand up and fight back against any effort to erode human rights at home or abroad.

Source: Amnesty International USA