On November 14, 2017 GTx, Inc. (Nasdaq:GTXI) reported financial results for the third quarter of 2017 and highlighted recent accomplishments and upcoming milestones (Press release, GTx, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316925 [SID1234522065]).

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"During the quarter, we achieved a key milestone for the company when we reported positive results from our first clinical trial in stress urinary incontinence," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Remarkably, 18 out of 18 women who received enobosarm for 12 weeks responded. These responses also appear to be durable, lasting months after dosing. These exciting results provided the basis for our recently initiated, placebo-controlled clinical trial of enobosarm for the treatment of SUI."

"Recent data suggests 50 percent of women report SUI, for which there are no FDA-approved pharmaceutical therapies. An orally-available therapy would offer numerous advantages over existing treatments including surgery, and would provide a significant new option that many women would choose in order to address this medical condition," said Kenneth M. Peters, M.D., Chairman of Urology, Oakland University William Beaumont School of Medicine and the principal investigator in the trial.

Third Quarter 2017 Clinical Highlights and Anticipated Milestones

Stress Urinary Incontinence (SUI):

Enobosarm, a Selective Androgen Receptor Modulator (SARM), is being evaluated in Phase 2 clinical development for SUI, the Company’s lead indication. Recent important milestones are summarized as follows:

Reported positive results from the Phase 2 proof-of-concept (POC) clinical trial of enobosarm 3 mg administered orally in post-menopausal women with SUI. With the inclusion of the final patient completing treatment in the POC clinical trial, data from the 18 evaluable patients completing the required 12 weeks of daily treatment showed a clinically meaningful reduction (50 percent or greater) in stress leaks per day, compared to baseline. The mean decrease in stress leaks per day was 81 percent overall (5.17 mean leaks/day at baseline to 1.0 mean leaks/day at 12 weeks).
Patients are being followed for an additional 28 weeks post-treatment to assess the durability of treatment effect. Durability of response for patients who completed the 28-week observation phase has resulted in a 41 to 100 percent reduction in stress leaks/day from baseline (N=6). For those patients who have not completed the 28-week observation phase, the durability of response, measured beginning 4 weeks post dosing, continues to be sustained.
Highlighted the Phase 2 POC results at the International Continence Society (ICS) annual meeting in a poster entitled, "Kegels in a Bottle: Preliminary Results of a Selective Androgen Receptor Modulator (GTx-024) for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women", which subsequently was voted best poster for the conference.

Initiated a second clinical trial, Assessing Enobosarm for Stress Urinary Incontinence Disorder (ASTRID): a randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of two doses of enobosarm (1 mg and 3 mg) administered orally in post-menopausal woman with SUI compared to placebo. The primary endpoint of the trial is the percentage of patients with at least a 50 percent reduction in mean leaks/day, compared to baseline. This trial is expected to enroll approximately 400 patients across 70 clinical sites in the U.S. Top-line results are expected to be available by the end of 2018.
Breast Cancer:

Enobosarm is also being evaluated as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer in a Phase 2 clinical trial for this advanced breast cancer population. As reported earlier for the 9 mg cohort, the Phase 2 trial pre-specified threshold for success, clinical benefit response (CBR), was attained and therefore met the primary efficacy endpoint. In addition, the 18 mg cohort has also met the primary efficacy endpoint. The trial has now completed enrollment of the predefined number of evaluable patients in both dosage arms with at least 44 patients in each of two cohorts receiving 9 mg or 18 mg daily doses of enobosarm.

In the 9 mg cohort, following 24 weeks of treatment, a total of 14 patients achieved a CBR out of 49 evaluable patients confirmed as AR positive (28.6%), with two patients achieving a partial response and 12 reporting stable disease. Currently, four patients in this cohort remain on study. In the 18 mg cohort, with 48 evaluable patients, 12 patients achieved a CBR (25%) at 24 weeks with one patient demonstrating a partial response and 11 patients reporting stable disease. Three patients remain on study in the 18 mg cohort. Both doses of enobosarm appear to be safe and generally well tolerated. A complete summary of the study results will be submitted for presentation or publication in 2018.

Although both the 9 mg and 18 mg cohorts met the primary efficacy endpoint in the Phase 2 clinical trial, after evaluating the drug development environment for breast cancer, where treatment paradigms are shifting to immunotherapies and/or combination therapies, the Company has decided that the time and cost of conducting the necessary clinical trials for approval in this indication do not warrant further development of enobosarm in this indication at this time.

Duchenne Muscular Dystrophy (DMD):

SARMs have also been evaluated in preclinical models of DMD, in which GTx SARMs have increased lean muscle mass and physical function. The Company is pursuing a potential strategic collaboration with biopharma companies experienced in orphan drug development to continue the development of a SARM for the treatment of DMD.

Prostate Cancer:

The Company has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer (CRPC). The Company has ongoing mechanistic preclinical studies designed to select the most appropriate compound to advance into a first-in-human clinical trial.

Third Quarter 2017 Corporate Highlights and Financial Results

During the quarter, GTx raised net proceeds of $45.6 million in a private placement of its common stock and warrants to purchase its common stock. GTx sold 5,483,320 immediately separable units, comprised of an aggregate of 5,483,320 newly-issued shares of common stock and warrants to purchase up to 3,289,988 additional shares of common stock. Both the common stock and warrants have been registered for resale with the Securities and Exchange Commission.

As of September 30, 2017, cash and short-term investments were $53.6 million compared to $21.9 million at December 31, 2016.

Research and development expenses for the quarter ended September 30, 2017 were $5.9 million compared to $4.6 million for the same period of 2016.

General and administrative expenses for the quarter ended September 30, 2017 were $2.6 million compared to $2.3 million for the same period of 2016.

Net loss for the three months ended September 30, 2017 was $8.5 million compared to a net loss of $6.9 million for the same period in 2016.

Net loss for the nine months ended September 30, 2017 was $21.2 million compared to a net loss of $10.9 million for the same period in 2016. The nine months ended September 30, 2016 included a non-cash gain of $8.2 million due to the change in fair value of the Company’s warrant liability. During the first quarter of 2016, the Company modified its outstanding warrants with no further adjustment to the fair value of these warrants being required.
GTx had approximately 21.5 million shares of common stock outstanding as of September 30, 2017. Additionally, there are warrants outstanding to purchase approximately 6.4 million shares of GTx common stock at an exercise price of $8.50 per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.

On November 14, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the first commercial sale of DARZALEX (daratumumab) in Japan has taken place, triggering USD 25 million in milestone payments from Janssen Biotech, Inc. (Janssen). The milestone was mentioned at the time of the September 2017 announcement of the approval of DARZALEX for the treatment of adults with relapsed or refractory multiple myeloma in Japan (Press release, Genmab, NOV 14, 2017, View Source [SID1234522064]). As a result of this milestone, Genmab is updating its 2017 financial guidance.

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"We’re pleased that DARZALEX is now commercially available for patients with relapsed or refractory multiple myeloma who are living in Japan," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

OUTLOOK
MDKK Revised Guidance Previous Guidance
Revenue 2,110 — 2,310 1,950 — 2,150
Operating expenses (1,000) — 1,100) (1,000) — (1,100)
Operating income 1,060 — 1,260 900 — 1,100
Cash position at end of year* >4,900 >4,500
*Cash, cash equivalents, and marketable securities

Genmab is improving its 2017 financial guidance last published on November 8, 2017 due to the inclusion of the DARZALEX milestones totaling USD 25 million associated with first commercial sale of DARZALEX in Japan.

Operating Result
We expect our 2017 revenue to be in the range of DKK 2,110 — 2,310 million, an increase of DKK 160 million compared to the previous guidance. We have increased our projected daratumumab milestones to DKK 960 million (previously DKK 800 million) due to inclusion of USD 25 million in milestone payments triggered by the first commercial sale of DARZALEX in Japan. We expect DARZALEX royalties to remain in the range of DKK 930 — 1,100 million, which are based on an estimated USD 1,100 — 1,300 million of DARZALEX sales in 2017. The remainder of the revenue mainly consists of Arzerra royalties, DuoBody milestones, and non-cash amortization of deferred revenue.
We anticipate that our 2017 operating expenses will remain in the range of DKK 1,000 —1,100 million.
As a result of the increased revenue, we now expect the operating income for 2017 to be approximately DKK 1,060 — 1,260 million, compared to DKK 900 — 1,100 million in the previous guidance.

Cash Position
As a result of the above and proceeds from the exercise of warrants during the year, we are now projecting a cash position at the end of 2017 of greater than DKK 4,900 million.

Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX and Arzerra sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2017 that could materially affect the results.

On November 14, 2017 ERYTECH Pharma (Nasdaq and Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Gil Beyen, Chairman and Chief Executive Officer, will present at the Jefferies Global Healthcare on November 15th, 2017 at the Waldorf Hilton Hotel (Aldwych) in London, UK (Press release, ERYtech Pharma, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316895 [SID1234522063]).

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Conference Details:

Conference: Jefferies Global Healthcare Conference
Date: November 15, 2017
Presentation Time: 2:00 PM GMT/ 9:00 AM ET

A live webcast of the Jefferies Global Healthcare presentation will be available online from the investor relations page of the company’s corporate website at www.erytech.com/webcast.com. After the live webcast, an archive of the presentation will be available on the company website for 30 days.

On November 14, 2017 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company pioneering the field of regenerative medicine, reported financial and operational results for the quarter ended September 30, 2017, as well as recent corporate progress (Press release, Asterias Biotherapeutics, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316950 [SID1234522062]).

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"We have continued to advance our spinal cord injury clinical trial while improving our financial profile in advance of the next phase of our AST-OPC1 program," said Mike Mulroy, President and Chief Executive Officer of Asterias. "Recent 12-month data from our SCiStar study showed subjects administered 10 million cells of AST-OPC1 observed meaningful and durable recovery of arm, hand and finger function that was more than double the rates of recovery seen at 12 months in both matched historical controls and published data. Based on this early encouraging result in the clinic, combined with our extensive pre-clinical work, our safety study in thoracic spinal cord injury, and MRI data suggesting durable engraftment of our OPC1 cells, we look forward to investing in a larger randomized controlled trial in the future. Our next data readout is expected in early 2018, and that data should help provide further clarity surrounding the design of that trial. Separately, in our cancer immunotherapy program, we received regulatory clearance during the third quarter to initiate the first-in-human clinical trial of AST-VAC2 in non-small cell lung cancer in the United Kingdom."

"On the financial front, the company has strengthened its cash position and improved its cost structure," said Ryan Chavez, Chief Financial Officer. "These steps, which include both our recent capital raise and a more focused allocation of capital into investments that can deliver value in the short and medium term, have strengthened the company’s financial outlook so that it may continue to advance its programs in the clinic and achieve additional important clinical milestones in 2018."

Third Quarter 2017 and Recent Key Achievements

AST-OPC1:

Reported 12-month data from the AIS-A 10 million cell cohort (Cohort 2) in the SCiStar study that showed additional motor level improvement was seen at 12 months. Specifically, 67% (4/6) of subjects have recovered two or more motor levels over baseline on at least one side through 12 months, which compares favorably to the rates of recovery at 9 months (50%) and at 3 months and 6 months (33%). Furthermore, the rate of recovery at 12 months is more than double the rates of recovery seen in both matched historical controls (29%) and published data in a similar population (26%).
Reported new 12-month MRI data from the SCiStar study that indicated no sign of lesion cavities in any subject. The MRI results are consistent with formation of a tissue matrix at the injury site, which is supportive evidence showing that AST-OPC1 cells have durably engrafted to help prevent lesion cavity formation, possibly reducing spinal cord tissue deterioration after spinal cord injury.
Reported continued positive safety profile for AST-OPC1 based on trial results to date. In September, an independent Data Monitoring Committee (DMC) recommended the SCiStar study continue as planned after it completed a regularly scheduled review of the accumulated safety data to date from the study.
Obtained U.S. Food and Drug Administration (FDA) designation as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act. The RMAT designation is intended to facilitate expedited development, review and approval for important new regenerative medicine therapies for which preliminary clinical evidence indicates the potential to address a serious or life-threatening disease or condition. In addition to providing an avenue for increased and earlier interactions with the FDA, RMAT-designated products may be eligible for priority review and accelerated approval.
Published new efficacy and safety data from preclinical studies of AST-OPC1 in the peer-reviewed journal "Stem Cells Translational Medicine." The preclinical studies described in this paper were among those submitted in Asterias’ 2014 Investigational New Drug Amendment in support of the SCiStar trial.
AST-VAC2:

Received regulatory clearance in the United Kingdom to initiate the clinical trial of Asterias’ cancer immunotherapy product AST-VAC2 in subjects with early and late stage non-small cell lung cancer (NSCLC). This First-In-Human (FIH) trial, which is being sponsored and managed by Cancer Research UK, will examine the safety, tolerability, immunogenicity and activity of AST-VAC2 in subjects with NSCLC.
Corporate:

In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds.
Asterias expanded its operating expense reduction efforts and reduced staffing allocated to non-clinical activities as a part of a broader effort to more closely align operating expenses with the company’s primary goal of continuing to generate clinical data in its key clinical stage programs. The company anticipates a one-time severance-related pre-tax restructuring charge of approximately $0.6 million in the fourth quarter of 2017 associated with the operating expense reductions. As a result of the operating cost saving initiatives implemented year to date, the company expects to reduce its operating costs by approximately 40% to start 2018.
Financial Results

As of September 30, 2017, the combined total of cash, cash equivalents, and available-for-sale securities totaled $20.7 million. In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds. As of October 31, 2017, Asterias had a combined total of cash, cash equivalents, and available-for-sale securities of approximately $27.3 million.

Total revenues were $1.7 million for the third quarter. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $6.6 million in the third quarter, with the primary driver being expenses associated with the company’s AST-OPC1 program. General and administrative expenses were $2.0 million in the third quarter.

Net loss was $6.8 million, or $0.14 per share, for the third quarter. For the quarter ended September 30, 2017, net cash used in operating activities was $4.5 million and net cash provided from financing activities was $1.1 million.

Conference Call and Webcast Details

Asterias will host a conference call and webcast today, November 14, 2017, at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the results and corporate developments. For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 877-830-2645 (U.S./Canada) or 785-424-1791 (international) five minutes prior to the start of the call and providing the Conference ID 8579194. To access the live webcast, go to View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by dialing 888-203-1112 (U.S./Canada) or 719-457-0820 (international) and providing the Conference ID 8579194. Additionally, the archived webcast will be available at View Source

On November 14, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported financial results for the quarter ended September 30, 2017, and provided an update on the Clinical Validation Study of DetermaVu, the Company’s liquid biopsy lung cancer diagnostic test (Press release, Oncocyte, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316948 [SID1234522061]).

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"We continued to make important progress during the third quarter, including the successful completion of the Analytical Validation Study of DetermaVu and certification of our CLIA laboratory," said William Annett, President and Chief Executive Officer. "The consistent and significantly positive data that we have demonstrated and the numerous presentations highlighting the results are raising awareness of the potential benefits of DetermaVu in the early diagnosis of lung cancer."

Recent Developments

Successfully completed the Analytical Validation and CLIA Lab Validation studies of OncoCyte’s liquid biopsy lung cancer diagnostic test, confirming data that was reported in May at the American Thoracic Society 2017 International Conference (ATS), which demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92,

Received Clinical Laboratory Improvements Amendments (CLIA) certification of registration from the Centers for Medicare and Medicaid Services (CMS),

Dr. Anil Vachani, an Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Philadelphia Veteran’s Administration Medical Center, reported data on DetermaVu at the CHEST Annual Meeting 2017 in Toronto, Ontario, Canada, and

Data from the Company’s most recent breast cancer diagnostic study has been selected for presentation in a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS), being held from December 5-9, 2017.
Clinical Validation Study Update and Commercial Launch Plans

The Clinical Validation Study for DetermaVu is the final development step prior to commercial launch. This step involves assaying approximately 300 blinded prospectively collected samples to assess the performance of the full diagnostic system against clinically confirmed diagnoses.

During the process of running initial samples for the Clinical Validation Study, inconsistent analytic results were observed by OncoCyte’s technical team. OncoCyte believes this was caused by a variance in a recently received lot of consumables used in the processing system that analyzes blood samples for the genetic markers that indicate whether lung nodules found in patients are benign or suspicious. To address this issue, OncoCyte has ordered and is waiting to receive new lots of consumables from the supplier. Once the new consumables are received, OncoCyte will conduct internal quality control procedures to ensure that they meet OncoCyte’s requirements. Upon confirming that the new consumables will allow the analytic devices to generate data with the consistency and precision required for DetermaVu, OncoCyte will initiate the Clinical Validation Study. Due to the time required for these steps, OncoCyte now anticipates that completion of the Clinical Validation Study necessary for the commercial launch of DetermaVu will be delayed into 2018, depending on the successful rectification of the causes of the inconsistent analytic results.

OncoCyte has only observed this issue in the recent lot of consumables. Earlier studies were conducted using different lots of consumables where this issue was not observed. Consequently, the previous studies were not impacted by this issue and the positive results reported to date have not changed.

Mr. Annett commented, "We remain confident in the positive results reported to date and believe that the clinical use of DetermaVu can make an important contribution to the management of lung cancer nodules and help to improve therapeutic outcomes for lung cancer patients."

Breast Cancer Diagnostic Update

Data from the Company’s most recent breast cancer diagnostic study has been selected for presentation in a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS), which is being held from December 5-9, 2017. The data to be presented are from the Company’s NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer follow-on study.

Third Quarter 2017 Financial Results

For the quarter ended September 30, 2017, OncoCyte incurred a net loss of $6.9 million, or ($0.22) per share, compared to a net loss of $2.6 million, or ($0.10) per share, in the third quarter of 2016.

Operating expenses for the three months ended September 30, 2017, were $6.8 million, as reported, and were $3.2 million, on an as adjusted basis.

Research and development expenses for the quarter ended September 30, 2017, were $1.8 million compared to $1.4 million for the same period in 2016. The increase in research and development expenses for the three months ended September 30, 2017, of $0.4 million compared to the three months ended September 30, 2016, is primarily attributable to increases in salaries and compensation related expenses, development expenses primarily for our lung cancer test and stock-based compensation expenses.

General and administrative expenses for the three months ended September 30, 2017, increased by $3.2 million in comparison to the comparable period in 2016. The increase is mainly attributable to $3.0 million in shareholder noncash expense for the issuance of warrants to certain investors to exercise warrants, $0.1 million in recruiting and hiring expenses and $0.1 million in stock based compensation expenses.

At September 30, 2017, OncoCyte had cash and cash equivalents of $11.0 million and available-for-sale securities valued at $1.0 million.

Nine Month 2017 Financial Results

The net loss for the nine months ended September 30, 2017, was $15.4 million, or ($0.52) per share, compared to $8.1 million, or ($0.31) per share, in the first nine months of 2016.

Total operating expenses for the nine months ended September 30, 2017, were $15.0 million, as reported, and were $9.3 million on an as adjusted basis.

Research and development expenses for the nine months ended September 30, 2017, were $5.7 million compared with $4.2 million for the nine months ended September 30, 2016. The increase in research and development expenses of $1.4 million is primarily attributable to increases in salaries and payroll related expenses, clinical trial expenses for OncoCyte’s lung cancer test, DetermaVu, stock based compensation expenses, charges to OncoCyte by BioTime for shared services expenses, which includes facilities, insurance and other indirect expense, and services and development expenses primarily for DetermaVu. The increases were offset by a decrease in outside services expenses and consulting fees.

General and administrative expenses for the nine months ended September 30, 2017, increased by $4.3 million in comparison to the comparable period in 2016. The increase is mainly attributable to $4.1 million in noncash expense for the issuance of warrants to certain investors who exercised warrants, and $0.2 million in insurance expense.

Conference Call

OncoCyte will host a conference call today, November 14, 2017, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.

The dial-in number in the U.S./Canada is 888-542-1102; for international participants, the number is 719-325-2356. For all callers, please refer to Conference ID 1817036. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 1817036. Additionally, the archived webcast will be available at View Source