On August 14, 2018 ProMIS Neurosciences, Inc. (TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and six months ended June 30, 2018 (Press release, ProMIS Neurosciences, AUG 14, 2018, View Source [SID1234528931]).

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"Over the first half of 2018, we focused on three key priorities to advance our business", stated ProMIS Executive Chairman, Eugene Williams. "First, to continue to push toward our goal of initiating the first clinical trial of PMN310 in the second half of 2019; second, to differentiate the oligomer selectivity of PMN310 as best in class profile for the treatment of Alzheimer’s disease (AD) versus other amyloid-beta directed therapies in development; and third, to expand our portfolio by developing therapeutic antibodies targeting toxic oligomers of alpha-synuclein for Parkinson’s disease (PD) and toxic aggregates of Tar-DNA binding protein (TDP43) for ALS. We are pleased to be on target to meet our objectives for the year and look forward to communicating our accomplishments."

Recent Corporate Highlights

On May 1, we announced completion of a private placement of 19,306,668 common share units at a price of $0.375 per unit, for gross proceeds of approximately $7,240,000. Each unit consisted of one common share and one-half of a common share purchase warrant. Each whole warrant is exercisable into one common share at a price of $0.48 per share for a 60-month exercise period, subject to earlier expiry on 30 days’ notice if, at any time after four months from closing, the 20-day volume-weighted average trading price of the Company’s common shares is greater than CDN$1.00. Net proceeds from the private placement will be used for working capital and general corporate purposes.
During the second quarter of 2018, we received proceeds of $1,550,204 related to the exercise of common stock warrants and stock options. The warrants were exercisable at $0.17, $0.20 and $0.30.
On April 10, we announced publication of a peer reviewed scientific paper describing a novel target on toxic oligomers of amyloid-beta in AD.
On June 12, we announced the initiation of producer cell line development for PMN310, our lead therapeutic antibody candidate for treatment of AD. Selexis, SA will carry out this critical first step in the manufacturing of antibody therapeutics using their proprietary Selexis SUREtechnology Platform.
On June 26, we announced that our unique discovery platform generated potential new antibody therapeutic candidates targeting toxic oligomers implicated in the development and progression of PD and ALS.
On June 28, we announced results of the Annual Meeting of Shareholders, whereby all of the resolutions announced in the Management Proxy Circular and placed before the Meeting were overwhelmingly approved by the shareholders.
Financial Results

Results of Operations – Three months ended June 30, 2018 and 2017

The net loss for the three months ended June 30, 2018 was $2,214,861, compared to a net loss of $1,903,396 for the three months ended June 30, 2017. The increased loss in the current period reflects the costs associated with operating the Company’s AD therapeutics program, increased contract research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Research and development expenses for the three months ended June 30, 2018 were $1,531,075, as compared to $1,132,258 in the three months ended June 30, 2017. Costs were higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the three months ended June 30, 2018 were $683,786, as compared to $768,696 in the three months ended June 30, 2017. The decreased in expenditures in the current period reflect reduced investor relations expenses and foreign exchange expense, offset by higher consultant salaries and associated costs, other professional fees, and stock-based compensation.

Results of Operations – Six months ended June 30, 2018 and 2017

The net loss for the six months ended June 30, 2018 was $3,771,733, compared to a net loss of $3,275,599 for the six months ended June 30, 2017. The increased loss in the current period reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Revenues for the six months ended June 30, 2018 and 2017 were nominal and relate to legacy technologies.

Research and development expenses for the six months ended June 30, 2018 were $2,229,082, as compared to $1,851,360 in the six months ended June 30, 2017. Costs are higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the six months ended June 30, 2018 were $1,542,656, as compared to $1,420,056 in the six months ended June 30, 2017. The increased expenditures in the current period reflect increased consultant salaries and associated costs and higher stock-based compensation, offset by foreign exchange gains.

Outlook

The Company plans to further advance its AD portfolio, with a focus on development of PMN310 for clinical trial initiation in the second half of 2019. Based on the highly selective binding of PMN310 to the toxic Aβ oligomers and lack of off-target binding to non-toxic forms of Aβ (monomer, plaque), the ProMIS AD program will continue to develop data further supporting potential best in class safety and efficacy versus other Aβ-directed therapies currently in development.

Finally, using its unique technology platform, we will advance work to identify and validate selective antibody therapies for the toxic oligomers of alpha synuclein in PD and TDP43 in ALS, with a view to partnering these assets.

On August 14, 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 pipeline updates and operating results for the second quarter ended June 30, 2018 (Press release, Eleven Biotherapeutics, AUG 14, 2018, View Source [SID1234528923]).

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"The first half of 2018 was full of successful milestones for Sesen Bio, and I am excited to have joined the company at such an important time in its evolution," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio, who was recently appointed on August 7, 2018. "The three-month data from the Phase 3 VISTA Trial demonstrate a strong complete response rate and favorable safety with Vicinium for high-grade non-muscle invasive bladder cancer, and we look forward to assessing twelve-month efficacy data in less than a year’s time. Now, with Fast Track designation for Vicinium, we are focused on advancing our engagement with the FDA, kicking off critical manufacturing readiness activities, initiating pre-commercial efforts and preparing for our very first BLA submission for Vicinium for this highly deserving patient population. I am very confident in what the future holds for Sesen Bio and look forward to delivering on the important milestones we have ahead."

Business Update

In June 2018, Sesen Bio completed an underwritten public offering of its common stock raising gross proceeds of approximately $46 million. The company believes this financing extends the company’s cash runway into 2020 based on its current operating plan.
Vicinium Program Updates

In August 2018, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vicinium for the treatment of BCG-unresponsive, high-grade non-muscle invasive bladder cancer (NMIBC). Fast Track designation is intended to expedite the development and review process of therapeutics that address unmet medical needs, including opportunities for more frequent interactions with the FDA.
In June 2018, the National Cancer Institute (NCI) initiated patient dosing in the Phase 1 trial of Vicinium in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, Imfinzi (durvalumab). The NCI is evaluating the combination under a Cooperative Research and Development Agreement, which was executed in June 2017.
In May 2018, Sesen Bio presented positive, three-month data from its ongoing Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG), during a plenary session at the American Urological Association Annual Meeting.
In the cohort of patients with carcinoma in situ (CIS) with or without papillary disease whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 39 percent. In evaluable patients in the cohort of patients with CIS with or without papillary disease whose cancer recurred after six months, but before 11 months, after their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 80 percent. This translates into a 42 percent complete response rate for the combined cohorts of CIS patients who were BCG-unresponsive within 12 months of their last BCG treatment.
In patients with papillary disease without CIS whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.
To date, Vicinium has been well-tolerated by patients in the VISTA Trial. Sesen Bio anticipates reporting twelve-month data from its Phase 3 VISTA Trial in mid-2019.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $62.9 million as of June 30, 2018, compared to $15.8 for the same period in 2017.
R&D Expenses: Research and development expenses were $2.8 million for the quarter ended June 30, 2018, compared to $2.9 million for the same period in 2017. This decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $2.4 million for the quarter ended June 30, 2018, compared to $2.2 million for the same period in 2017. This increase was due primarily to an increase in professional fees.
Net Loss: Net loss was $9.0 million, or $0.16 per share, for the quarter ended June 30, 2018, compared to net loss of $7.3 million, or $0.30 per share, for the same period in 2017.
Financial Guidance: Following the company’s public offering in June 2018, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.
About the VISTA Clinical Trial
The VISTA Trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium in patients with high-grade non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS), which is cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) and/or papillary, which is cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue, who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease. Patients in the trial receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. Twelve-month data are anticipated in mid-2019. To learn more about the Phase 3 VISTA Trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

About Vicinium
Vicinium, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Twelve-month data from the trial are anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On August 14, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in upcoming investor conferences, including the Wedbush PacGrow Healthcare Conference, the H.C. Wainwright 20th Annual Global Investment Conference, and the Citi’s 13th Annual Biotech Conference (Press release, CymaBay Therapeutics, AUG 14, 2018, View Source [SID1234528922]).

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Wedbush PacGrow Healthcare Conference
Date: Wednesday, August 15
Time: 2:30pm Eastern Time
Location: Parker New York, New York, NY
Webcast: View Source

H.C. Wainwright 20th Annual Global Investment Conference
Date: Wednesday, September 5
Time: 9:10am Eastern Time
Location: St. Regis Hotel, New York, NY
Webcast: View Source

Citi’s 13th Annual Biotech Conference
Date: Thursday, September 6
Time: 1-on-1 meetings only
Location: Four Seasons Hotel, Boston, MA

On August 14, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, reported financial results for the second quarter and six months ended June 30, 2018 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, AUG 14, 2018, View Source [SID1234528921]).

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Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, "Our financial results for the second quarter of 2018 are in line with our expectations. We have made tremendous progress since the start of 2018 and remain committed to working with the relevant regulatory authorities and our strategic partners in the U.S. and in China to provide high quality, life-saving medications to patients. We will continue to advance our current product portfolio while evaluating additional opportunities to add further medicines to our pipeline."

Second Quarter and Recent Business Highlights

China FDA (CFDA) import drug registration priority review of EVOMELA in progress – On April 26, 2018, the Center for Drug Evaluation (CDE) of the China FDA held a Clinical Advisory Committee (the "Advisory Committee") meeting to review the EVOMELA application. CASI has recently received a series of standard questions from the CFDA related to EVOMELA drug product production which usually reflect the final stage of CFDA assessment before approval based on the Import Drug Approval registration pathway. CASI is working with Spectrum Pharmaceuticals and its vendors from whom EVOMELA is in-licensed to address the questions and submit the requested documents.

Preparation continues for EVOMELA’s commercial launch in China – CASI is building an in-house marketing and sales team with key members in place. The team is led by Thomas Zhang who has a 20-year track record of commercialization of multiple anti-cancer drugs in China for companies such as Roche and Johnson & Johnson.

CFDA review in progress for MARQIBO and ZEVALIN – CASI continues to work with the CFDA on advancing MARQIBO’s import drug clinical trial application and anticipates that the regulatory agency will complete its review within the next four to six months. The import drug clinical trial application for ZEVALIN is also in process with CFDA. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the application require separate submissions of which both are currently under technical review by the CDE of CFDA and the quality confirmatory testing by National Institute for Food and Drug Control (NIFDC) of CFDA as part of the regulatory review process.

Company enters into strategic manufacturing agreement – In June 2018, CASI entered into a strategic and long-term contracting manufacturing agreement for the manufacturing of entecavir and cilostazol. The partnership will support CASI’s plan to market and sell both products in China, U.S. and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that were acquired from Sandoz in January 2018.

CASI added to Russell 2000, 3000 and Microcap Indexes – In July 2018, CASI announced that the company has been added to the Russell 2000, 3000 and Microcap Indexes.

Second Quarter and First Half 2018 Financial Results

Cash Position: As of June 30, 2018, CASI had cash and cash equivalents of $66.2 million compared to $49.9 million as of March 31, 2018. This increase primarily reflects the remaining gross proceeds of $20.7 million received in April 2018 related to CASI’s $50 million private placement announced in March 2018, partially offset by costs related to operating expenses during the quarter.

R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2018, were $1.7 million and $3.4 million, respectively, compared to $1.7 million and $2.8 million for the same periods in 2017. The increase in R&D expenses primarily reflects personnel costs associated with the technology transfer activities and regulatory support associated with the recently acquired ANDA portfolio, offset by a decrease in costs related to the timing of the CFDA regulatory process of CASI’s in-licensed U.S. FDA approved assets from Spectrum Pharmaceuticals.

G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2018, were $4.0 million and $5.3 million, respectively, compared to $0.7 million and $1.3 million for the same periods in 2017. The increase in G&A over the prior year is primarily attributed to non-cash stock-based compensation expense for the stock options issued to the Company’s Executive Chairman and an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with business development related to exploratory acquisition activities, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period. G&A expenses include non-cash stock-based compensation of $1.5 million and $1.6 million for the three and six months ended June 30, 2018, respectively, compared to $0.1 million and $0.2 million in the respective periods in 2017.

Net Loss: The Company reported a net loss attributable to common shareholders for the three and six months ended June 30, 2018 of ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12) per share, respectively, compared to ($2.4) million, or ($0.04) per share, and ($4.1) million, or ($0.07) per share for the same periods in 2017. The larger net loss is primarily due to the non-cash stock-based compensation expense for stock options issued to the Company’s Executive Chairman, costs associated with the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million in January 2018 due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development and investor relations activities, as well as other professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, can be found at www.casipharmaceuticals.com.

On August 14, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported financial and operating results for the second quarter ended June 30, 2018 as well as an update on its strategic direction and key organizational initiatives (Press release, Cancer Genetics, AUG 14, 2018, View Source [SID1234528920]).

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John A. Roberts, Chief Executive Officer of Cancer Genetics said, "During the second quarter of 2018, we made significant advances in reorienting the company and are continuing to take the necessary steps to increase the efficiency of our overall business portfolio and accelerate our path to profitability.

"We are making good progress in consolidating the operations of our West Coast molecular profiling laboratory and moving these capabilities to our facilities in New Jersey and North Carolina. We believe that the consolidation of the Los Angeles facility will reduce our operating expenses, making a positive contribution towards our cost structure consistent with our growth and transformation strategy for 2018 and beyond."

Mr. Roberts added, "To supplement our efforts aimed at growing our biopharma business, we strengthened our management team with the appointment of Michael McCartney as the company’s Chief Commercial Officer. Michael will be responsible for overseeing our commercial strategy and leading the Company’s business development initiatives. To that end, I am particularly pleased with the recent developments in our biopharma channel strategy with an increased velocity of project work with our channel partner firms. We have a solid, collaborative foundation stemming from previous partnership agreements signed in 2016, and have recently begun expanding the scope of our work with these partners."

Mr. Roberts concluded, "On the financial front, we recently completed a convertible note financing and raised $2.5 million to support the execution of our 2018 transformation and strategic plan to reorganize our business and position the company for future growth. Further, our engagement with Raymond James as a financial advisor in evaluating strategic options continues to progress, as we have been engaged in discussions regarding several potential transactions and hope to make an announcement concerning these developments in the near future. Overall, we are committed to executing on our growth strategy and remain focused on making CGI a premier company in the precision oncology arena."

SECOND QUARTER 2018 AND RECENT OPERATIONAL HIGHLIGHTS

Strengthened leadership team with appointment of Michael McCartney as Chief Commercial Officer.
Completed sale of wholly-owned subsidiary BioServe Biotechnologies (India) Private Limited to REPROCELL for $1.9 million in April 2018.
Raised $2.5 million through a convertible note financing in July 2018.
Progressed the consolidation of the West Coast molecular profiling laboratory and relocation of most of these activities to New Jersey and North Carolina laboratories, as part of 2018 transformation strategy. The consolidation of this facility is currently expected to be complete by the end of the third quarter, and reduce operating expenses by over $4 million annually once completed.
SECOND QUARTER 2018 FINANCIAL RESULTS

The Company reported total revenue of $7.0 million for the second quarter of 2018 compared to revenue of $6.6 million in second quarter of 2017, an increase of 7% or $0.4million.

Biopharma services revenue totaled $3.6 million in the second quarter, compared to $3.3 million during the second quarter 2017. Biopharma projects are dependent on the timing, size and duration of our contracts with pharmaceutical and biotech companies and clinical research organizations, and can fluctuate in comparable periods. The Company increased the number of clinical studies and trials it is supporting to 342, up from 170 in Q2 2017. The Company’s booking-to-billing ratio for Q2 2018 was 2.5.

​Clinical Services revenue decreased by approximately $1 million in the second quarter of 2018 compared to the same period in 2017, from $3.1 million to $2.1 million.

The Company’s Discovery Services contributed $1.3 million in revenue for the second quarter of 2018 driven by our acquisition of vivoPharm in August of 2017. This represents an increase of approximately $1.0 million as compared to $0.3 million in revenue for the second quarter of 2017.

Gross profit margin was 31% or $2.2 million in Q2 2018, compared to 39% or $2.6 million in the second quarter 2017.

Total operating expenses for the second quarter of 2018 were approximately $7.4 million, an increase of 30% compared to $5.7 million during the second quarter of 2017, principally due to restructuring costs of $0.7 million, an increase in our professional fees of $0.5 million related to recent financing and M&A activities, an increase in our bad debt expense of $0.2 million, and an increase in our selling expenses of $0.1 million.

Net loss was $3.6 million or $0.13 per share for the second quarter of 2018, compared to a net loss of $2.8 million or $0.16 per share for the second quarter of 2017.

Cash and cash equivalents as of June 30, 2018 totaled $1.6 million, compared to $4.0 million as of March 31, 2018. In July 2018, the Company closed a convertible note financing generating net proceeds of approximately $2.5 million.

As announced previously, the Company engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership.

CONFERENCE CALL & WEBCAST
Tuesday, August 14, 2018, 8:30 a.m. Eastern Time
Domestic: 800-289-0438
International: 323-794-2423
Conference ID: 1766530
Webcast: View Source
Replay – Available through August 28, 2018
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 1766530