On August 7, 2018 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the second quarter ending June 30, 2018 (Press release, PTC Therapeutics, AUG 7, 2018, View Source [SID1234528767]).

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"We have made significant progress towards delivering on our strategic plan this year," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "This includes furthering our underlying business as well as executing on two external transactions. We look forward to bringing value to both patients and shareholders with the acquisition of Agilis, the LATAM commercialization rights for Tegsedi and Waylivra and realizing additional growth in the second half of the year."

Second Quarter Financial Highlights:

Total revenues for the second quarter of 2018 were $68.7 million, compared to $48.0 million in the same period in 2017. The change in total revenue was a result of Emflaza, which launched in May 2017, and the expanded commercialization of Translarna.

Translarna net product revenues were $47.8 million for the second quarter of 2018, representing 4% growth over $45.8 million reported in the second quarter of 2017.

Emflaza net product revenues were $20.3 million for the second quarter of 2018, from $2.1 million reported in the second quarter of 2017.

GAAP R&D expenses were $32.6 million for the second quarter of 2018, compared to $30.8 million for the same period in 2017. Non-GAAP R&D expenses were $28.7 million for the second quarter of 2018, excluding $3.9 million in non-cash, stock-based compensation expense, compared to $26.9 million for the same period in 2017, excluding $3.9 million in non-cash, stock-based compensation expense. The increase in GAAP and non-GAAP R&D expense was primarily due to increased investment in research programs and advancement of the clinical pipeline.

GAAP SG&A expenses were $33.5 million for the second quarter of 2018, compared to $28.9 million for the same period in 2017. Non-GAAP SG&A expenses were $29.4 million for the second quarter of 2018, excluding $4.1 million in non-cash, stock-based

compensation expense, compared to $24.9 million for the same period in 2017, excluding $4.0 million in non-cash, stock-based compensation expense. The increase in GAAP and non-GAAP SG&A expense was primarily due to continued investment in commercial activities to support the Duchenne muscular dystrophy franchise.

Net loss for the second quarter of 2018 was $9.5 million, compared to a net loss of $17.5 million for the same period in 2017.

In April 2018, PTC completed a public offering of 4,600,000 shares of common stock, resulting in net offering proceeds of $117.9 million.

Cash, cash equivalents, and marketable securities totaled approximately $296.1 million at June 30, 2018, compared to approximately $191.2 million at December 31, 2017.

Shares issued and outstanding as of June 30, 2018 were 46.7 million.

2018 Guidance

Full year 2018 net product revenues are anticipated to be between $260 and $295 million. PTC anticipates Translarna net product revenue for the full year 2018 to be between $170 and $185 million. PTC projects a 5-year (December 31, 2022) compound annual growth rate of 15% for net product revenues, representing continued strong growth year-over-year by increasing penetration in current countries and pursuing opportunities for label expansion. PTC anticipates Emflaza net product revenue for the full year 2018 to be between $90 and $110 million.

GAAP R&D and SG&A expense for the full year 2018 is anticipated to be between $280 and $290 million.

Non-GAAP R&D and SG&A expense for the full year 2018 is anticipated to be between $250 and $260 million, excluding estimated non-cash, stock-based compensation expense of approximately $30 million.

Key Second Quarter and Other Corporate Highlights:

Agreement to acquire Agilis Biotherapeutics gene therapy platform and four CNS clinical assets diversify and strengthen PTC’s existing pipeline. Following successful completion of the transaction, PTC plans a smooth transition of operations and to rapidly accelerate the programs. PTC plans to submit a Biologics Licensing Application with FDA in 2019 for the lead program in AADC deficiency, based on compelling long-term clinical data. An IND submission to the U.S. FDA is expected in 2019 for the second lead program in Friedreich ataxia. The transaction is expected to close in the third quarter of 2018.

In-licensed LATAM commercial rights to Tegsedi (inotersen) and Waylivra (volanesorsen) from Akcea Therapeutics. The collaboration leverages its global commercial infrastructure and adds to growing commercial pipeline. Tegsedi has received marketing authorization approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR amyloidosis). PTC estimates that there are approximately 6,000 patients in LATAM and that it is well positioned to file for registration in key countries in LATAM for Tegsedi. Tegsedi has a PDUFA date of October 6, 2018. Waylivra is under

regulatory review in the U.S., Europe and Canada for the treatment of people with familial chylomicronemia syndrome (FCS). Waylivra recently received a positive vote from the FDA’s Division of Metabolism and Endocrinology Products Advisory Committee and has a PDUFA date of August 30, 2018. Waylivra is also in clinical development for Familial Partial Lipodystrophy, or FPL.

Compelling data from FIREFISH study and advancement of SMA clinical programs. Data presented at the CureSMA conference demonstrated that at Day 182, over 90% of the babies in the FIREFISH study achieved a greater than 4-point increase in CHOP-INTEND score compared to baseline. The CHOP-INTEND data were further supported by video presented by the investigator in which babies demonstrated improved motor function including head control, rolling from supine, and sitting. Three babies were depicted sitting independently. Updated SMA data including additional sitting babies from part 1 of the FIREFISH study will be presented at the upcoming World Muscle Congress. Part 2 of the pivotal FIREFISH study is ongoing. SUNFISH, a pivotal trial in Type 2/3 SMA patients is also ongoing.

European Commission ratifies CHMP’s positive opinion for the label expansion of Translarna for children as young as 2 years of age. The authorization allows PTC to market Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged two years and older in the 28 countries that are Member States of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway.

Focus on intensifying the conversion of Emflaza bridge patients. There are currently hundreds of patients who have been prescribed Emflaza for whom commercial shipments were not yet made. PTC plans to intensify the efforts and programs to expedite the conversion of those prescriptions to commercial shipment in the second half of the year.

Publication of additional data demonstrating the clinically differentiated benefit of deflazacort. The results published in Muscle and Nerve demonstrated Duchenne muscular dystrophy patients treated with deflazacort had notably less decline from baseline in 6-minute walk distance at Week 48 than those treated with prednisone/prednisolone. The extrapolated time to loss of ambulation was 8.58 years for deflazacort and 4.74 years with prednisone/prednisolone. In addition to the time to delay of loss of ambulation, patients on deflazacort demonstrated a slowing of disease progression as measured by physical function endpoints.

Non-GAAP Financial Measures
In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude stock-based compensation expense. This non-GAAP financial measure is provided as a complement to financial measures reported in GAAP because management uses this non-GAAP financial measure when assessing and identifying operational trends. In management’s opinion, this non-GAAP financial measure is useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating

performance of PTC and the company’s future outlook. Quantitative reconciliations of non-GAAP financial measures to their closest equivalent GAAP financial measures are included in the tables below.

Today’s Conference Call and Webcast Reminder:
Today’s conference call will take place at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 8284468. A live, listen-only webcast of the conference call and corresponding slides can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks. PTC’s current Investor Presentation and R&D Day slides are available at the same website location.

On August 7, 2018 Synlogic(Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer, and chief medical officer, will present a corporate update at the 2018 Wedbush PacGrow Healthcare Conference at 3:05pm ET on Tuesday, August 14, 2018, in New York City (Press release, Synlogic, AUG 7, 2018, View Source [SID1234528792]).

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A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived webcast recording will be available on the Synlogic website for approximately 30 days after the event.

On August 7, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported key leadership transitions as part of its evolution into a commercial-stage oncology company (Press release, Eleven Biotherapeutics, AUG 7, 2018, View Source [SID1234528926]). Thomas Cannell, DVM has been appointed chief executive officer and a member of the board of directors, bringing with him a wealth of leadership experience in building and overseeing strategic operations and global pharmaceutical commercialization for life science companies. Stephen Hurly left his employment with Sesen Bio effective August 7, 2018.

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"Over the last two years, Sesen Bio has undergone a unique evolution as a company. Following the acquisition of Viventia and the resulting transition from an ophthalmology organization to an oncology company, we have been wholly focused on developing Vicinium for high-grade non-muscle invasive bladder cancer," said Wendy Dixon, Ph.D., chair of Sesen Bio’s board of directors. "We are grateful to Steve for his many significant contributions in advancing Sesen Bio to where it is today, and we wish him all the best in his future endeavors. As we transition further as a company, Tom will be an exceptional strategic leader bringing deep experience in drug development and commercialization to drive Vicinium, our pipeline and the company through this important next chapter."
Thomas Cannell most recently served as chief operating officer and president of global commercial products at Orexigen Therapeutics, Inc., where he led the successful commercialization and profitability of Contrave. Prior to Orexigen, Dr. Cannell spent 27 years with Merck & Co., Inc., where he held senior leadership positions in global commercialization, consumer marketing, and sales operations and management for both development-stage programs and approved marketed products. While with Merck, he served as president of Merck Canada and head of marketing and strategy for Merck Sharp & Dohme Corp., Japan, a subsidiary of Merck & Co., where he was responsible for setting up a long-standing strategic process and plan, managed a multi-billion-dollar product portfolio and oversaw thousands of employees. In addition, he designed and successfully piloted an innovative, customer-centric commercial model for Merck’s U.S. business. Dr. Cannell received his DVM degree from Washington State University.
"My enthusiasm for joining Sesen Bio is based on the novel mechanism of Vicinium, its potential as a monotherapy and combination agent, particularly with checkpoint inhibitors, and

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the range of therapeutic opportunities with our novel fusion proteins," stated Dr. Cannell. "Over the next several months, we will be focused on several strategic objectives across our pipeline. These include: completing the Phase 3 registration trial for Vicinium with 12-month data expected by mid-2019; engaging with regulatory authorities to prepare for our first BLA submission; initiating the appropriate pre-commercial activities to support a potential future product approval and launch; and exploring new therapeutic opportunities in additional indications. I am excited to join the company at this pivotal time and believe strongly in our ability to execute these strategic priorities to make a meaningful difference in the lives of patients."
Sesen Bio also announced today that Abbie Celniker, Ph.D. and Paul Chaney have stepped down from the company’s board of directors, effective August 7, 2018. Dr. Celniker, who served on the board of directors since the company’s founding by Third Rock Ventures in 2011, is focusing on her partner role at Third Rock Ventures and early-stage portfolio-building efforts. Mr. Chaney joined the company’s board in 2014 as a leader in developing innovative ophthalmic therapeutics and is leaving to continue his efforts in that area of drug development.
"I am very proud of the progress and many milestones that the Sesen Bio team has achieved, and it has been a pleasure to serve on the board with this outstanding group of industry leaders," said Dr. Celniker. "The company is uniquely positioned with a Phase 3 trial that is well underway, established clinical data, a lead product candidate with a pipeline of opportunities and a strong balance sheet to fund its growing organization. I look forward to watching Sesen Bio’s continued success as a supportive investor with Third Rock Ventures."
In connection with the appointment of Dr. Cannell, Sesen Bio entered into an employment agreement with Dr. Cannell that, among other things, provides for the grant of a non-statutory stock option outside of the company’s 2014 Stock Incentive Plan as an inducement material to Dr. Cannell’s entering into employment with Sesen Bio in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option to purchase 1,350,000 shares of the company’s common stock is being granted effective as of August 7, 2018. The stock option grant was approved by the independent compensation committee of the board of directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option will have an exercise price per share equal to the closing price per share of Sesen Bio’s common stock on The Nasdaq Global Market on August 7, 2018. The stock option will have a ten-year term and will vest over a four-year period, with 25 percent of the shares underlying the stock option award vesting on the first anniversary of the date of grant and an additional 6.25 percent of the shares underlying the stock option vesting at the end of each successive three-month period following the one-year anniversary of the date of grant of the stock option, subject to Dr. Cannell’s continued service with the company through the applicable vesting dates.

On August 6, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results for the second quarter ended June 30, 2018 and recent corporate updates (Press release, Arcus Biosciences, AUG 6, 2018, View Source [SID1234528461]).

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"We are pleased with the progress we have made in advancing our molecules into studies in patients with three product candidates now in clinical development," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "We continue to believe that AB928, our dual adenosine receptor antagonist, has the potential to significantly enhance the activity of anti-PD-1 antibodies as well as certain chemotherapies and have designed our clinical program for AB928 to demonstrate the potential of these combinations in multiple tumor types where the adenosine pathway is believed to play a critical role. The program will include extensive biomarker analysis to identify biomarkers that may be predictive of response and to demonstrate that changes in immune markers correlate with responses and are consistent with AB928’s mechanism. We look forward to reporting initial safety, biomarker and clinical data for our AB928 combinations in patients in the first half of 2019."

Pipeline Updates

AB928 (dual A 2a R/A 2b R antagonist)

Reported the unblinded safety results from the Phase 1 double-blinded, randomized, placebo-controlled trial for AB928 in healthy volunteers. AB928 was found to be safe and well tolerated at all doses evaluated, including the highest dose tested of 200 mg once daily (QD) (with food). At the AACR (Free AACR Whitepaper) Annual Meeting in April 2018, the Company presented pharmacodynamic data demonstrating that an AB928 dose between 75 mg and 150 mg QD should be sufficient to achieve greater than 90% inhibition of the adenosine 2a receptor (A2aR) pathway.
Initiated dosing of patients in dose-escalation trial to evaluate AB928 in combination with AB122. This trial is designed to identify the recommended dose of AB928 that can be combined with a fixed dose of AB122 for the AB928 + AB122 expansion cohorts in the AB928 Phase 1/1b program. Dosing began with 75 mg QD of AB928 and 240 mg of AB122 every two weeks (Q2W). Subsequent dose-escalation cohorts will evaluate doses of 150 mg and 200 mg QD of AB928, or intermediate doses, in combination with 240 mg Q2W of AB122.
Preparing to initiate Phase 1/1b trials to evaluate AB928 in combination with three different chemotherapy regimens. Each trial will evaluate AB928 in combination with a chemotherapy regimen that is considered a standard of care for each tumor type:
–AB928 in combination with Doxil in triple negative breast cancer (TNBC) and ovarian cancer
–AB928 in combination with mFOLFOX in colorectal and gastroesophageal cancers
–AB928 in combination with carboplatin/pemetrexed and pembrolizumab in non-small cell lung cancer (NSCLC)

Each of these chemotherapy regimens induces immunogenic cell death (a hallmark of which is the generation of significant amounts of adenosine), and therefore their anti-cancer activity is believed to be enhanced by A2aR antagonism. The trials will begin with a dose-escalation portion to identify the recommended dose of AB928 for each chemotherapy regimen, which will be followed by expansion cohorts. The dose-escalation portion will enroll patients with the same tumor types as the expansion cohorts. The Company also plans to evaluate other AB928 combinations, e.g. AB928 + AB122, in these trials.

Initiated development of an immunohistochemistry assay with a leading cancer diagnostic company to be used in Arcus’s clinical trials for AB928 and future clinical trials of AB680. This assay will test for expression of multiple proteins, including PD-L1 and CD73, as well as CD8+ T cells, in the Company’s Phase 1/1b program for AB928.
AB122 (anti-PD-1 antibody)

Continued dosing in the ongoing Phase 1 dose-escalation trial in cancer patients in Australia. The Company has identified 240 mg as the recommended dose for AB122 when administered every two weeks and is currently enrolling patients in additional cohorts to explore other dosing schedules.
Preparing to initiate an expansion cohort to evaluate AB122 as a monotherapy in NSCLC. The objective of this cohort is to confirm that the clinical activity of AB122 is similar to that of approved anti-PD-1 antibodies in NSCLC patients.
AB154 (anti-TIGIT antibody)

Received regulatory approval to initiate a Phase 1 trial to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AB154 as monotherapy and in combination with AB122 in Australia. The dose-escalation portion will first evaluate increasing doses of AB154 as a monotherapy and subsequently in combination with AB122. Once the recommended doses for AB154 as a monotherapy and in combination with AB122 have been identified, the Company plans to initiate expansion cohorts to evaluate AB154 as a monotherapy and in combination with AB122 in selected tumor types. In the future, the Company plans to explore AB154 in combination with some of its other product candidates. The Company also plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2018 to initiate clinical testing of AB154 in the U.S.
AB680 (small molecule CD73 inhibitor)

Initiated pre-clinical development of an oral formulation of AB680. IND-enabling studies of an oral formulation of AB680 are ongoing.
Corporate Updates

In July, Arcus announced that Taiho Pharmaceutical Co., Ltd. exercised its option under the Option and License Agreement entered into in September 2017 to obtain an exclusive development and commercialization license to the Company’s adenosine receptor antagonist program, which includes AB928 and back-up compounds, in Japan and certain other territories in Asia (excluding China).
In June, Arcus and Infinity Pharmaceuticals announced a clinical collaboration to evaluate two triple combination therapies in TNBC and ovarian cancer. These cohorts will be incorporated into Arcus’s Phase 1/1b trial for AB928 in TNBC and ovarian cancer.
In June, Arcus announced the promotion of Jennifer Jarrett to Chief Operating Officer. Ms. Jarrett also continues to serve as the Company’s Chief Financial Officer.
Upcoming Milestones

In the second half of 2018, the Company expects to

Present the final data from the Phase 1 trial of AB928 in healthy volunteers at a medical conference in the fall.
Initiate a Phase 1 trial to evaluate the safety and pharmacokinetic profile of AB680 in healthy volunteers.
Present safety, pharmacokinetic, receptor occupancy and clinical activity data from the ongoing Phase 1 trial of AB122.
In the first half of 2019, the Company expects to

Present initial data from the dose-escalation trials of AB928 + AB122 and AB928 + chemotherapy, which will include data on safety, biomarker analysis and clinical activity for each of the combinations.
Initiate the expansion cohorts for the AB928 + AB122 and AB928 + chemotherapy combinations. Initial data from the expansion cohorts are expected in late 2019.
Report safety and pharmacokinetic data from the Phase 1 trial of AB680 in healthy volunteers.
Initiate clinical testing of AB680 in cancer patients.
Second Quarter and Year-to-Date 2018 Financial Results

Cash Position: At June 30, 2018, cash and investments (which include cash equivalents and both short- and long-term investments) were $277.5 million, compared to $175.7 million at December 31, 2017. The increase was primarily attributable to $124.7 million in net proceeds from the Company’s initial public offering in March.
Revenues: Collaboration and license revenues for the second quarter ended June 30, 2018 were $1.3 million, compared to no revenue for the same period in 2017. Collaboration and license revenues for the six months ended June 30, 2018 were $2.5 million, compared to no revenue for the same period in 2017. The increase in revenues for both periods was attributable to revenues recognized from the Option and License Agreement the Company entered into with Taiho in September 2017.
R&D Expenses: Research and development expenses for the second quarter ended June 30, 2018 were $13.7 million, compared to $7.8 million for the same period in 2017. The increase was primarily driven by the Company’s ongoing clinical studies of AB928 and AB122, pre-clinical and manufacturing costs to prepare two additional programs, AB154 and AB680, for clinical trials, an increase in R&D headcount to support the Company’s other programs and a milestone payable due to the regulatory filing for AB154. Research and development expenses for the six months ended June 30, 2018 were $25.4 million, compared to $13.6 million for the same period in 2017.
G&A Expenses: General and administrative expenses for the second quarter ended June 30, 2018 were $3.5 million, compared to $1.8 million for the same period in 2017. The increase was primarily due to higher legal and accounting fees and additional staff in key areas required to support a public company infrastructure, as well as increased facilities and office expenses related to our expanded facility in Hayward. General and administrative expenses for the six months ended June 30, 2018 were $6.4 million, compared to $3.3 million for the same period of 2017.
Net Loss: Net loss for the second quarter ended June 30, 2018 was $13.5 million, compared to $9.6 million for the same period in 2017. Net loss for the six months ended June 30, 2018 was $26.5 million, compared to $16.8 million for the same period in 2017. The increase in net loss was primarily attributable to the increase in operating expenses noted above.
Based on its current operating plan, the Company expects that its cash and investments as of June 30, 2018 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into at least the fourth quarter of 2020.

On August 6, 2018 BioLineRx Ltd. (NASDAQ, TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported it will release its unaudited financial results for the quarter ended June 30, 2018 on Monday, August 13, 2018, before the US markets open (Press release, BioLineRx, AUG 6, 2018, View Source;itemid=619 [SID1234528445]).

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The Company will host a conference call on Monday, August 13, 2018 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until August 16, 2018; please dial +1-877-456-0009 from the U.S. or +972-3-925-5937 internationally.