On November 13, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that clinical data from the ongoing phase 1b/2a study of in fostroxacitabine bralpamide (fostrox) in combination with Lenvima (lenvatinib) in hepatocellular carcinoma (HCC), will be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco, USA (Press release, Medivir, NOV 13, 2023, View Source;lenvima-in-hcc-and-shares-positive-response-from-type-d-meeting-with-fda-301985850.html [SID1234637582]).

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The abstract, titled "First safety and efficacy data from phase Ib/IIa study of fostroxacitabine bralpamide (fostrox, MIV-818) in combination with lenvatinib in patients with hepatocellular carcinoma (HCC)" will be presented by Dr. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain. The presentation will include updated safety and independently reviewed efficacy data regarding the clinical benefit of fostrox in combination with Lenvima, a tyrosine kinase inhibitor.

Medivir furthermore announces that interactions with the FDA regarding fostrox’s clinical development plan have intensified with a first Type D meeting with a positive response regarding critical elements of the design for the planned phase 2b study. The finalization of the study design will take place in connection with an upcoming Type C meeting to enable study start in 2024. The goal of the upcoming study, as previously communicated, is to apply for accelerated approval.

– "In this phase 1b/2a study, the fostrox + Lenvima combination has shown a good safety profile and promising tumor control in second-line HCC, and we confidently look forward to presenting these data at ASCO (Free ASCO Whitepaper)-GI. Despite some success with first-line immunotherapy, patients with HCC have a poor prognosis and effective second-line treatment options are lacking. The data from this study, combined with the great medical need, opens the possibility of an accelerated approval path, which is why we are now planning for a pivotal, randomized phase 2b study. The FDA’s response at our Type D meeting was a positive step towards our ambition to give this vulnerable patient group access to fostrox as a new treatment option.", says Pia Baumann, CMO at Medivir.

On November 13, 2023 Intensity Therapeutics, Inc. (Nasdaq: INTS), a late-stage biotechnology company that applies novel engineered chemistry to discover and develop proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Intensity Therapeutics, NOV 13, 2023, View Source [SID1234637581]).

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"Metastatic soft tissue sarcoma continues to plague cancer patients who have poor survival outcomes and insufficient therapeutic options. The positive overall survival and disease control rate data from our Phase 1/2 clinical trial of INT230-6 positions our lead candidate as a potential much needed reprieve, keeping the drug inside the tumor while sparing the body of toxicity. We expect to file an IND for a Phase 3 study of INT230-6 in soft tissue sarcoma by the end of 2023 and look forward to progressing this study," said Lewis H. Bender, President and Chief Executive Officer of Intensity.

Mr. Bender added: "To continue the momentum built from our successful upsized IPO in July, we also look forward to reporting additional results from our Phase 2 INVINCIBLE study in presurgical breast cancer at a medical meeting and finalizing the study design and protocol for a Phase 2/3 program in presurgical breast cancer before year end. I am pleased with our pace of progress to advance the clinical development of INT230-6 and am strongly encouraged by data to date, which reinforces the potential of INT230-6 to shift the treatment paradigm of cancer."

Recent Company Highlights

Presented Positive INT230-6 Data in Patients with Refractory Soft Tissue Sarcoma at the Connective Tissue Oncology Society (CTOS). In November, the Company presented positive data from its ongoing Phase 1/2 clinical trial of INT230-6 at the CTOS annual meeting. The data presented demonstrated a strong disease control rate of 93% for subjects in the monotherapy arm while also extending survival in subjects by nearly 15 months when compared to a synthetic control group. INT230-6 was found to be generally safe and well tolerated with the majority of treatment-emergent adverse events being grade 1 or 2.
Received Orphan Drug Designation for Components of INT230-6 for the Treatment of Soft Tissue Sarcoma. In September, Intensity was granted orphan drug designation (ODD) by the US Food and Drug Administration for three active moieties comprising its lead candidate INT230-6: cisplatin, vinblastine sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl) amino)octanoate).
Completed Upsized Initial Public Offering (IPO) with Full Exercise of the Over-Allotment Option. In July, Intensity announced that it had closed its IPO with the full exercise of its over-allotment option. Intensity received a total of $20.2 million in net proceeds from the transaction, providing sufficient cash and cash equivalents to fund operations into the second half of 2025.
Anticipated Near-Term Milestones

Report additional results from the Phase 2 INVINCIBLE study in presurgical breast cancer at a medical meeting in 4Q 2023
File an Investigational New Drug (IND) application for a Phase 3 study of INT230-6 in soft tissue sarcoma in 4Q 2023
Finalize the study design for a Phase 2/3 program in presurgical breast cancer in 4Q 2023
Third Quarter 2023 Financial Highlights

Research and Development (R&D) Expenses were $1.4 million for the three months ended September 30, 2023, as compared to $1.2 million for the same period last year. The increase is due to ongoing Phase 3 IT-03 in sarcoma and phase 2/3 IT-04 in presurgical breast cancer, which will continue to incur planning, multiple regulatory filing, manufacturing, study initiation and trial preparation costs in 2023.

General and Administrative (G&A) Expenses were $1.1 million for the three months ended September 30, 2023, as compared to $0.6 million for the same period in 2022. The increase is primarily due to the costs of operating as a public company. The accounting services and legal costs related to the IPO in 2023 were charged directly to the equity section of the balance sheet as a reduction of additional paid in capital.

Interest Expense for the three months ended September 30, 2023, were $0 as compared to $15,123 for the three months ended September 30, 2022. The decrease is due to the convertible notes and accrued interest being converted to common stock at the time of the IPO.

Net Operating Loss for the third quarter ended September 30, 2023, was $2.3 million as compared to $1.8 million for the three months ended September 30, 2022.

Cash, Cash Equivalents and Marketable Securities as of September 30, 2023, were approximately $15.6 million. The Company expects to have sufficient cash to fund current operations into the second half of 2025.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.

On November 13, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) and Aitia, a leader in the application of Causal AI and Digital Twins, reported a strategic agreement that gives Aitia access to Logica, Charles River’s Artificial Intelligence (AI) powered drug solution platform, for the optimized discovery and early development of multiple therapeutic programs for neurodegenerative disease and oncology (Press release, Charles River Laboratories, NOV 13, 2023, View Source [SID1234637580]).

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Under the terms of the agreement, Aitia will deploy Logica across their portfolio of novel drug targets with the aim of creating and advancing drug candidates for neurological indications, including Alzheimer’s, Parkinson’s, and Huntington’s diseases and cancers, including prostate cancer and multiple myeloma. According to the World Health Organization (WHO), Alzheimer’s disease (AD), the most common form of dementia, affects 33 million people globally, while Parkinson’s disease (PD) impacts 8.5 million, and it is estimated that Huntington’s disease (HD) affects approximatively 1 in 10,000 people worldwide. There are currently no known cures for these diseases, and the prevalence of all three diseases rises year-over-year. In the field of oncology, there are approximately 1.4 million new cases of prostate cancer and 160,000 new cases of multiple myeloma reported globally each year. Each cancer presents unique challenges with acquired resistance to novel therapies and corresponding rates of overall survival.

"Unraveling the complex genetic and molecular circuitry of neurodegenerative disorders is critical to the discovery of treatments that significantly slow or reverse these devastating diseases," said Colin Hill, Chief Executive Officer and Co-founder of Aitia. "I do not believe we will get there without the insights from our Digital Twins, which now combined with the advantages of Logica, positions Aitia to rapidly translate our discoveries into novel drug candidates. We are excited to join forces with Charles River, leveraging their decades of industry expertise in research to fuel our R&D efforts."

"Combining Aitia’s Digital Twins with Logica’s next-generation solution stands to transform the discovery and development of novel therapeutics for neurological diseases and oncology," said Professor Julie Frearson, Ph.D., Corporate Senior Vice President and Chief Scientific Officer, Charles River. "The research landscape for Alzheimer’s, Parkinson’s, and Huntington’s has moved slowly in recent years, and we are excited for the impact that this combined AI solution can deliver to patients."

Digital Twins: Increasing Translation Through Data
Additionally, Charles River and Aitia have signed a strategic partnership agreement, focused on the development of a patient-derived xenograft (PDX) Digital Twin to predict the best tumor models for in vivo oncology research. The partnership will combine Charles River’s robust, fully-characterized, disease-relevant PDX data and expertise with Aitia’s industry-leading Digital Twin technology to develop PDX Digital Twins in several cancer types. As part of the partnership, Charles River has made an equity investment in Aitia.

In drug discovery, Digital Twins enable the accurate simulation of gene and protein knockdowns at the individual patient level across patient cohorts to discover and genetically validate novel drug targets. This concept can be applied in a similar way to individual tumor types to design more targeted preclinical studies for oncology research. Digital Twins enable the simulation of disease progression and drug response for existing drug candidates to discover biomarkers to better select existing therapies and effective combination therapies.

The Strength of Logica, an Integrated AI Program
In 2022, Charles River and Valo Health launched Logica, leveraging the AI-powered Valo Opal Computational Platform and Charles River’s leading preclinical expertise, providing clients with transformed drug discovery with a single integrated offering seamlessly translating targets to candidate nomination. Logica is offered as a fully managed, risk-sharing model, with most of the client’s cost tied to success.

"Logica has optimized drug discovery," said Emilio Cordova, Executive Director, Logica. "Combining laboratory infrastructure, expert drug hunters, and large-scale compute capabilities, Logica eliminates whitespace and rapidly delivers results."

Logica utilizes industry-leading predictive models, chemical design, and synthesis capabilities, DNA-encoded libraries, in silico high throughput screening from Valo’s Opal Computational Platform as well as Charles River’s leading capabilities in all aspects of discovery optimization including high throughput screening, medicinal chemistry, ADME, biology, pharmacology, and ultimately safety testing and IND submission, joining together for the first time to create a computation-powered, unified target-to-candidate offering.

Last year, Charles River and Flagship’s Pioneering Medicines announced an agreement to deploy Logica across a portfolio of targets with the aim of creating optimized small molecules that lead to novel therapies for unmet medical needs. More recently, Charles River and Related Sciences announced a multi-program collaboration to apply Logica across several previously undrugged targets.

On November 13, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has signed a conditional Term Sheet to acquire QSAM Biosciences, Inc. (QSAM) and its lead asset, CycloSam (Samarium-153-DOTMP) (Press release, Telix Pharmaceuticals, NOV 13, 2023, View Source [SID1234637579]). QSAM is a United States (U.S.) based clinical stage company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

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CycloSam is highly synergistic with Telix’s existing therapeutic development activity in both prostate cancer and sarcoma. The proposed acquisition, subject to customary completion terms, will further enhance and differentiate Telix’s innovation position to provide a continuum of care to patients from diagnosis and staging, systemic treatment of metastatic disease, to palliative care.

With the broad success of immunotherapies and the more recent clinical impact of radiopharmaceutical therapies in diseases like prostate cancer, there is an unmet need to cost-effectively and safely manage pain from bone metastases in very late-stage patients. This unmet need is further exacerbated by the quality-of-life issues associated with metastatic pain management, particularly opioid administration. In the U.S. alone, there are an estimated 400,000 patients up-staged with malignant bone metastasis primarily from prostate, breast and lung cancer.[1]

In addition to near-term opportunities in metastatic disease management, the proposed acquisition may also broaden the Company’s pipeline depth in osteosarcoma, a disease that mostly affects children and young adults, where QSAM has received Orphan Drug[2] and Rare Pediatric[3] Disease Designations (RPDD) from the FDA. The RPDD designation may enable CycloSam to be brought to market more rapidly through additional incentives, including eligibility for a Priority Review Voucher (PRV) under which the FDA may reduce the review period for a drug candidate to six months.

Douglas Baum, QSAM CEO and Co-Founder said, "CycloSam is a novel, de-risked clinical asset that has the potential to deliver tangible improvements of prior bone-seeking agents with established efficacy, safety and commercial utility. By joining forces with Telix we are accessing a specialised commercial team, distribution network and development expertise, with the goal of realising the full potential of this asset."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix continued, "We are pleased to announce our intention to acquire QSAM. This acquisition will bring a validated therapeutic candidate with the potential to accelerate development under the Orphan Drug and Rare Pediatric Disease Designations, and a highly experienced team that has completed numerous FDA approvals.

With CycloSam we plan to leverage Telix’s extensive experience and success in distributing short-life radiopharmaceuticals using a cold kit product from a nuclear pharmacy. Given these factors, we see a strong pathway to commercialisation."

Deal terms and conditions
Upon signing of the Term Sheet, Telix has agreed to pay QSAM an upfront Collaboration and Option Fee of US$2 million (approximately AU$3.1 million)[4] to advance development efforts based on mutually agreed goals and to provide sixty days of exclusivity pending completion of diligence and execution of a definitive acquisition agreement (Purchase Agreement).

If the acquisition of QSAM proceeds, upon closing, Telix will pay a total purchase price of US$33.1 million in equity through the issue of fully paid ordinary Telix shares. Following closing, Telix will also pay up to US$90 million in contingent clinical and commercial milestone payments in cash or equity (at Telix’s election), subject to achievement and satisfactory completion of milestones, through a Contingent Value Rights structure. The Purchase Price constitutes approximately a 52% premium to QSAM’s fully diluted capitalisation for the 10 days prior to execution of the Term Sheet.

The execution of the Purchase Agreement and closing of the acquisition is subject to many conditions, including satisfactory completion of diligence by both parties and approval of QSAM shareholders. The material terms of the Term Sheet relating to the proposed acquisition of QSAM are subject to change.

If the proposed Acquisition of QSAM does not close, the Collaboration and Option Fee will be converted to QSAM common stock at US$6.70 per share.

About bone cancer
In the U.S., there are over 400,000 new patients diagnosed each year with metastatic bone cancer and 350,000 patient deaths.[5] The incidence of advanced malignant tumours with bone metastasis can be up to 70%, especially common in patients with advanced prostate and breast cancer.[6] Osteosarcoma and Ewing’s sarcoma are the most common malignancies of bone tissues in children. The current standard of care is aggressive and suboptimal, and has led to marginal success with significant side effects and poor long-term survival prognosis.

On November 13, 2023 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Theriva Biologics, NOV 13, 2023, View Source [SID1234637574]).

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"We are encouraged by the growing clinical data that underscores the promise of our systemically administered oncolytic adenovirus and lead program, VCN-01, in key indications and combinations," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Data from the ongoing study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) were recently presented at the annual ESMO (Free ESMO Whitepaper) Congress. Results showed enhanced patient survival, which correlated with VCN-01 mediated increases in the CPS (combined positive score for PD-L1 staining), a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies. Together with data presented at this year’s SITC (Free SITC Whitepaper) meeting, these data further validate the feasibility of combining VCN-01 with immunotherapies."

Mr. Shallcross continued, "We continue to advance VIRAGE, our Phase 2b trial of VCN-01 in newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), with patients dosed across sites in the U.S. and Spain. We have observed a consistent safety and tolerability profile and remain on track to complete enrollment for VIRAGE in the first half of 2024. As part of our commitment to transforming therapeutic approaches for devastating cancers, we will meet with the FDA before year-end to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. While our key area of focus is on advancing and maximizing the therapeutic potential of VCN-01, we continue to explore opportunities to bolster our pipeline with new oncolytic virus candidates from utilizing our Albumin Shield technology."

Recent Program Highlights and Anticipated Milestones:

VCN-01:

Dosing is underway and enrollment continues to progress for VIRAGE, the randomized, controlled, multicenter, open-label Phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients. Dosing at sites across the U.S. and Spain continues and VCN-01 has been well tolerated with a safety profile consistent with prior clinical trials. The trial is expected to enroll 92 patients and remains on track to complete enrollment in H1 2024.
The Institut Catala d’Oncologia (ICO) presented Phase 1 data from the investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with R/M HNSCC. Encouraging survival was observed in patients progressing to anti-PD(L)-1 agents after systemic VCN-01 in combination with durvalumab. These data were featured in a poster presentation at the ESMO (Free ESMO Whitepaper) Congress, held both virtually and in Madrid, Spain from October 20-24, 2023.
Theriva hosted a virtual KOL event featuring expert oncologist Ricard Mesia, M.D. (Institut Català d’Oncologia / Catalan Institute of Oncology). In addition to reviewing key takeaways from the ESMO (Free ESMO Whitepaper) poster presentation, Dr. Mesia discussed the unmet medical needs in head and neck cancer, current treatment limitations, and the therapeutic potential of VCN-01 to elicit an extended anti-tumor immune response.
The University of Pennsylvania presented initial data from a Phase 1 study evaluating VCN-01 in combination with mesothelin-directed lentiviral transduced human chimeric antigen receptor modified T cells (huCART-meso) in patients with pancreatic and serous epithelial ovarian cancer. Initial results highlight the feasibility of administering VCN-01 with huCART-meso cells to treat solid tumors. These data were featured in a poster presentation at the SITC (Free SITC Whitepaper) Annual Meeting, held both virtually and in San Diego, November 1-5, 2023.
Additional anticipated milestones:
The Company will meet with the FDA before year-end to discuss the clinical development and potential registration pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.
SYN-004 (ribaxamase):

Dosing is underway for the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). SYN-004 appeared to be well tolerated in HCT patients treated with IV meropenem and SYN-004 was not detected in blood samples from the majority of the evaluable patients. The trial is on track to complete enrollment in the second cohort in H1 2024.
Third Quarter Ended September 30, 2023 Financial Results

General and administrative expenses decreased to $212,000 for the three months ended September 30, 2023, from $2.4 million for the three months ended September 30, 2022. This decrease of 91% is primarily comprised of the decrease in the fair value of the contingent consideration of $1.6 million, along with lower salary and bonus costs, investor relations fees, audit fees, travel, and VCN administrative expenses not included in the prior year, offset by an increase in consulting fees. The charge related to stock-based compensation expense was $95,000 for the three months ended September 30, 2023, compared to $93,000 for the three months ended September 30, 2022.

Research and development expenses increased to $4.0 million for the three months ended September 30, 2023, from approximately $2.6 million for the three months ended September 30, 2022. This increase of 56% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, offset by decreased expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, Phase 1a clinical trial of SYN-020, and decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020. We anticipate research and development expenses to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $40,000 for the three months ended September 30, 2023, compared to $28,000 related to stock-based compensation expense for the three months ended September 30, 2022.

Other income was $388,000 for the three months ended September 30, 2023 compared to other income of $161,000 for the three months ended September 30, 2022. Other income for the three months ended September 30, 2023 is primarily comprised of interest income of $382,000 and an exchange gain of $6,000. Other income for the three months ended September 30, 2022 is primarily comprised of interest income of $170,000 offset by an exchange loss of $9,000.

Cash and cash equivalents totaled $31.2 million as of September 30, 2023, compared to $41.8 million as of December 31, 2022.

Conference Call

Theriva Biologics will host a conference call on Monday, November 13, 2023, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2023 and provide a corporate update. Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13741546. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "News & Media" section of the company’s website, View Source, under "Events" or by clicking here, up to 90 days after the call.