On August 13, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Altimmune, AUG 13, 2019, View Source [SID1234538730]).

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"2019 continues to be a transformative year for Altimmune, as we have met important strategic milestones through the acquisition of our NASH drug candidate, ALT-801, by successfully completing a pre-IND meeting with the FDA on HepTcell, and by obtaining encouraging data on NasoShield," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "These milestones solidify our value proposition as a biotech company with a diversified product pipeline poised to address large unmet medical needs. We are keenly focused on advancing the development of our product candidates to achieve meaningful inflection points in the near future."

Recent Highlights

Acquisition of Spitfire Pharma, Inc. with NASH Candidate ALT-801
The Company acquired Spitfire Pharma, Inc. including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile. ALT-801 is designed to treat the underlying metabolic dysfunction that leads to NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD), by acting upstream to block disease progression. The Company is preparing for an IND submission in 2020, with data readouts from a Phase 1 clinical trial anticipated during 2021.
HepTcell Successful Pre-IND Meeting with FDA
The Company successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA provided no objection to the planned study design and patient populations, or plans for manufacturing and product testing, and did not recommend any additional studies for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea where clear evidence of anti-HBV T cell activation in the highly immune-tolerized study population was noted. Altimmune intends to conduct a Phase 2 study in the United States in 2020 and the pre-IND meeting was held to obtain feedback from the FDA on the Company’s intended development path.
NasoShield Investigation Results Point Toward Improved Clinical Performance
An investigation into the lower than expected Phase 1 immunogenicity of NasoShield has provided compelling data that may resolve the disparate results obtained from the previous preclinical and clinical studies with the intranasal anthrax vaccine. The key finding was that induction of rapid and robust immunity was significantly impacted by the dosing position. In the investigation, nearly 80% of the vaccinated animals survived a lethal challenge when dosed in the standard supine position, compared to 0% survival following dose administration in a sitting position similar to the dosing position used in the Phase 1 study. Based on these results, the Company believes that a simple adjustment to the dosing position in humans will result in significantly higher immunogenicity similar to what was observed during the preclinical development of NasoShield. The Company is in discussions with Biomedical Advanced Research and Development Authority ("BARDA") about next steps for the program. NasoShield is funded through a contract with BARDA (HHSO100201600008C) with a total potential value of $130 million if all options in the contact are exercised.
ALT-702 Preclinical Development Update
During Q2, the Company received a Notice of Allowance from the United States Patent and Trademark Office for patent application No. 15/968,839, entitled "Immunogenic Compound" related to its immunostimulant product candidate, ALT-702, which, when granted, will be the second issued patent for this product. This candidate is based on a new synthetic peptide conjugate technology platform and represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company is currently conducting experiments on ALT-702 in murine tumor models and expects to provide an update on the results of these experiments later this year.
Financial Results for the Second Quarter Ended June 30, 2019

The Company had cash, restricted cash and cash equivalents of $41.7 million at June 30, 2019. Subsequent to quarter end, the Company collected $1.5 million in accounts receivable from U.S. government contracts representing payment on outstanding invoices from Q2.

Revenue in the second quarter was $1.6 million compared to $2.4 million in the prior year period. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials.

Research and development expenses in the second quarter were $2.9 million compared to $4.9 million in the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on its programs offset by transaction costs recognized related to the acquisition of Spitfire Pharma, Inc.

General and administrative expenses in the second quarter were $2.2 million compared to $2.9 million in the prior year period. The decrease was due primarily to a reduction in labor, legal and professional costs.

Net loss attributed to common stockholders for the second quarter was $3.4 million, or ($0.26) per share, compared to $9.8 million, or ($10.29) per share in the same period of 2018. The lower net loss is attributable to a $5.2 million charge related to the warrant liability in 2018, in addition to the changes in revenue, research and development expense, and general and administrative expense described above.
Conference Call Details
Date: Wednesday, August 14, 2019
Time: 8:30am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13692577
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay for 30 days on the Investor Relations page of the Company’s website at www.altimmune.com.

On August 13, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, VBL Therapeutics, AUG 13, 2019, View Source [SID1234538642]).

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"Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer continues as planned," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The final results from the prior Phase 2 study (presented at ASCO (Free ASCO Whitepaper) in June) which show statistically significant prolongation of overall survival in platinum-resistant patients, strengthen our belief in the potential of VB-111. An important outcome from Phase 2 was the correlation between CA-125 response and survival benefit. Measurement of CA-125 will, therefore, be the focus of our interim analysis in OVAL, planned for year-end 2019."

Second Quarter and Recent Corporate Highlights:

●Two posters on VB-111, in platinum resistant ovarian cancer and in recurrent glioblastoma multiforme (rGBM), were featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, held in June 2019 in Chicago.
°Final data from the prior Phase 2 study in ovarian cancer demonstrated a statistically significant dose dependent increase in median overall survival in patients treated with therapeutic dose vs. low dose of VB-111 (498 days vs. 172.5 days, p=0.03).
°CA-125 biomarker response (GCIG) was reported in 58% of evaluable patients and was predictive of median overall survival (808 days vs. 351 days) in ovarian cancer, in patients treated with a therapeutic dose of VB-111.
Post treatment tumor infiltrating CD8 T-cells and apoptotic cancer cells indicated tumor transformation from immunologically ‘cold’ to ‘hot’, possibly contributing to the favorable clinical outcomes in ovarian cancer.
°Results were presented from a radiographic analysis conducted at the Brain Tumor Imaging Laboratory at UCLA of the Phase 2 and Phase 3 trials of VB-111 in rGBM. This analysis provides independent, quantitative data that priming with VB-111 results in clinically-meaningful activity in rGBM, which can be seen by MRI signature, demonstrates objective response to VB-111 and is correlated with a statistically significant survival advantage.
°VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, that was established to support the commercial supply of VB-111 for the first indication, was certified by a European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). This important approval is expected to support future commercialization of VB-111.
Second Quarter ended June 30, 2019 Financial Results:

●Cash Position: At June 30, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $45.1 million and working capital of $39.1 million. The Company expects that its cash, cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements for at least two years.
●Revenues: Revenues related to VBL’s collaborations were $0.1 million in the second quarter of 2019.
●R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended June 30, 2019, were approximately $3.7 million, compared to approximately $2.9 million in the same period in 2018.
●G&A Expenses: General and administrative expenses for the quarter ended June 30, 2019 were $1.2 million, as in the same period in 2018.
●Comprehensive Loss: VBL reported a net loss for the quarter ended June 30, 2019 of $4.7 million, or ($0.13) per share, compared to a net loss of $4.1 million, or ($0.13) per share, in the quarter ended June 30, 2018.
For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

Conference Call:

Tuesday, August 13th @ 8:30am Eastern Time

From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13692422
Webcast: Webcast

On August 13, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), consolidated financial results for the fiscal 2019 third quarter ended June 30, 2019 (Press release, Applied DNA Sciences, AUG 13, 2019, View Source [SID1234538658]). "Our fiscal third quarter performance reflects our continuing abilities to monetize our molecular taggant technology and our diagnostic and therapeutic platforms while also realigning our cost structure and reorienting our sales and business development efforts to support new opportunities," said Dr. James A. Hayward, chairman, president and CEO of Applied DNA. "Revenues increased over 100% this quarter over the same period last fiscal year and increased 164% quarter over quarter, supplemented by the receipt of a $1 million cash payment under the terms of our exclusive licensing agreement with TheraCann International Benchmark Corporation (TheraCann)."

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"After the close of the quarter we received a written delisting notice from Nasdaq regarding our non-compliance with the requirements for a $1.00 bid price and $35 million market value of listed securities. We are diligently working to comply with all applicable requirements for continued listing on Nasdaq and we intend to submit a plan to that effect to the NASDAQ Hearings Panel as part of the hearing process," continued Dr. Hayward. "As part of our plan, we secured a non-binding term sheet from TheraCann for the outstanding $4 million balance under our licensing agreement in the form of $4 million in convertible preferred stock as well as an incremental $1 million convertible note. We also raised $1.5 million through a convertible note offering, which increases our current convertible notes outstanding to approximately $3.7 million. If any portion of these notes were to convert into common stock, it would increase our equity as a further step towards facilitating Nasdaq compliance. We are engaged in Nasdaq’s appeal process, and I am pleased to report that we have secured a hearing for September 19, 2019 that allows us additional time to execute on the balance of our plan. However, we can not provide assurance that we will be successful in our NASDAQ appeal."

Concluded, Dr. Hayward, "As we projected last quarter, our growth is coming from cannabis, textiles and biotherapeutics. Looking ahead, we remain focused on growth supported by these business verticals. TheraCann’s ETCH BioTrace solution powered by our tagging platform is attracting the attention of large cannabis players. We will soon launch our CertainT brand into the cotton apparel market. Initial product from our recently completed tagging program for Egyptian cotton is being used to build demand among brands and manufacturers. Our LineaRx subsidiary is increasingly being viewed within the biotech industry as a cleaner, higher-performing alternative to plasmid DNA production that is converting to increased order-flow. We have a burgeoning pipeline and growing scientific and intellectual property assets following the recent acquisition by LineaRx of the assets and IP of Vitatex, Inc. that further broaden our platform’s applicability in the potentially high-reward cancer diagnostic and therapeutic spaces. Just last week we submitted to the NIH our application for a 3-year, approximately $4 million SBIR Phase IIb grant to be matched with funding being sought from commercial 3rd parties, that, if granted, will fund the full commercialization of the Vitatex platform for early detection of non-hematologic cancers."

Fiscal Third Quarter 2019 Financial Results:

Revenues increased 102% for the third quarter of fiscal 2019 to $2.1 million, compared with $1.0 million reported in the second quarter of fiscal 2018, and increased 164% from the $778 thousand reported in the second fiscal quarter ended March 31, 2019. The increase in revenues was due primarily to an increase in revenue from a licensing agreement in the cannabis industry of $1 million.
Total operating expenses decreased to $3.2 million for the second fiscal quarter of 2019, compared with $3.6 million in the prior fiscal year’s second quarter. This decrease is primarily attributable to approximately a $409 thousand decrease in payroll, due to a realignment of the sales force and reductions in overall headcount. This decrease in payroll was offset by an increase in legal and professional fees.
Net loss for the quarter ended June 30, 2019 was $1.5 million, or $0.04 per share, compared with a net loss of $2.9 million, or $0.10 per share, for the quarter ended June 30, 2018 and a net loss of $2.7 million, or $0.08 per share, for the quarter ended March 31, 2018.
Excluding non-cash expenses, Adjusted EBITDA was negative $1.2 million and a negative $2.5 million for the quarters ended June 30, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.
Nine-Month Financial Highlights:

Revenues for the first nine months of fiscal 2019 totaled $3.7 million, an increase of 37% from $2.7 million from the same period in the prior fiscal year. The increase in revenues was due to an increase in service revenues of $1.4 million, or 92%, offset by a decrease in product revenues of $344 thousand, or 28%. The increase in service revenue was attributable to an increase in revenue of $1 million from the licensing agreement in the cannabis industry, as well as increases of $140 thousand for a pre-commercial feasibility project under the cooperation agreement with TheraCann entered into during 2018, $51 thousand for the government contract award and $143 thousand from pre-commercial pilots within the textile industry.
Effective October 1, 2018, the Company was required to adopt Accounting Standards Update (ASU; the "Update") No. 2014-09, Revenue from Contracts with Customers (Topic 606), utilizing the modified retrospective method. Had the Company not adopted the Update, the Company would have recognized additional revenue of approximately $851 thousand during the first nine months of fiscal 2019. This amount was primarily comprised of the recognition of $766 thousand during the nine months periods ended June 30, 2019, under a $1.15 million cotton order shipped in June 2018, with extended payment terms. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $494 thousand. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
Operating expenses for the nine months ended June 30, 2019 increased by $486 thousand or 5% for the same period last fiscal year. The increase is primarily attributable to an increase in stock-based compensation and legal and professional fees, offset by a decrease in payroll of $659 thousand.
Net loss for the nine months ended June 30, 2019 was $7.4 million or $0.21 per share, compared with a net loss of $8.2 million or $0.28 per share for the nine months ended June 30, 2018.
Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2019 was a negative $6.1 million as compared to a negative $7.6 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Fiscal Third Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2019 results on Tuesday, August 13, 2019 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

Participant Toll Free:1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through August 21, 2019):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10133063
Webcast replay: View Source
For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On August 13, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it intends to offer to sell common shares and warrants to purchase common shares in an underwritten public offering (the "Offering") (Press release, Oncolytics Biotech, AUG 13, 2019, View Source [SID1234538711]). The Company expects to grant the underwriter a 30-day option to purchase additional common shares and warrants to purchase common shares. The Offering is subject to market conditions, as well as NASDAQ and TSX approvals, and there can be no assurance as to whether or when the Offering may be completed, or the actual size or terms of the Offering.

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Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American:LTS), is acting as the sole book-running manager in connection with the Offering.

The Company intends to use the net proceeds of the Offering for research and development activities and working capital purposes.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on May 7, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated May 4, 2018. The preliminary prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the Alberta Securities Commission in Canada, and with the SEC in the United States. No common shares or warrants will be offered or sold to Canadian purchasers. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed with the SEC for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov. Alternatively, when available, copies of the preliminary prospectus supplement can also be obtained from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172 or by email at [email protected]

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 13, 2019 Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, reported results for the second quarter ended June 30, 2019 (Press release, Innovus Pharmaceuticals, AUG 13, 2019, View Source [SID1234538733]).

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Financial highlights for the second quarter ended June 30, 2019 included:

Revenues of approximately $6.8 million, an increase of $1.2 million or 27.7% compared to prior quarter;
Year to date revenue of approximately $12.2 million in 2019 compared to $11.9 million in 2018;
Increased focus on our highly profitable Canadian market representing 26% for the three months ended June 30, 2019 compared with 13% for the previous quarter;
Continued diversification of revenue streams with e-commerce business representing 23% of total revenues in the three months ended June 30, 2019 as compared to 7% of total revenues in the three months ended June 30, 2018;
Total operating loss of $1.2 million for the three months ended June 30, 2019 representing a 21% decrease from the previous first quarter 2019 results and from the three months ended June 30, 2018 results
Sales & marketing expense as a percentage of total revenue declined to 41.7% for the three months ended June 30, 2019 compared with 75.6% in comparable period in the prior year;
Quarterly product subscription and outbound concierge net revenue of $1.1 million compared to $0.7 million in the prior year or a 57.1% increase;
Cash used in operations of $0.8 million for the three months ended June 30, 2019 compared with $2.8 million in the comparable period in the prior year;
Reduced net loss per share to $0.66 for the three months ended June 30, 2019 compared with $0.94 for the comparable period in the prior year;
Company’s cash and merchant processor holdback position as of August 9, 2019 was $2.1 million; and
Expanded our FDA approved ANDA pipeline by three new OTC products.
2019 Second Quarter and Recent Corporate Progress

Established relationship with two large media publication organizations in Canada;
Announced supply relationship with a third party to supply Omeprazole 20mg tablets and Omeprazole 20mg 24 hour delayed release capsules approved by the FDA for the treatment of frequent heartburn;
Announced the CPNP notification number required to commercialize Diabasens in all 28 member countries of the European Union; and
Engaged with a third-party fulfillment company to support Canadian sales to reduce shipping costs by up to 45%.
"We continue to show improvements in our sales and marketing focused on achieving profitability as we spend on highly profitable sales channels and geographies, diversify our revenue streams and expand globally which has resulted in a reduction of our operating loss by 21% compared with the prior quarter. We continue to work on identifying cost efficiencies and profitable revenue streams to enhance our core business, increase our product revenues and work towards our goal of profitability," stated Bassam Damaj, President and Chief Executive Officer of Innovus Pharma.

The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT today to discuss the financial results and recent business developments. To participate in the call, please dial 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers and request to join the Innovus Pharmaceuticals conference call. A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Replay Access Code: 10134333. The replay will be available shortly after the end of the conference call.