On March 2, 2021 Purple Biotech Ltd. ("Purple Biotech") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective, and durable therapies by overcoming tumor immune evasion and drug resistance, reported financial results for the six and 12-months ended December 31, 2020 (Press release, Purple Biotech, MAR 2, 2021, View Source [SID1234575947]).

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"We have recently achieved substantial progress in multiple key aspects of our business," said Isaac Israel, Chief Executive Officer. "Most importantly, our promising anti-cancer product development pipeline continues to advance our Phase 1/2 clinical studies for NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3. We completed patient recruitment of the second dose level in the single agent dose-escalation phase, demonstrating the drug to be safe and well tolerated in the treated patients. We expect to begin imminently our Phase 1b/2 studies for CM24, our monoclonal antibody drug candidate blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Our robust clinical development activities are supported by a strong balance sheet, as we raised $68.5 million in 2020, ended the year with $60.8 million in cash, and we believe we are well-funded to support our currently planned corporate initiatives until 2024."

"As part of the completion of our transformation to a corporate mission dedicated to developing first-in-class oncology therapies, we were honored to ring the Nasdaq stock market opening bell on January 5, 2021 to commemorate the successful evolution of our business and the Company’s name change to Purple Biotech. We are firmly committed to improving the lives of cancer patients globally, and look forward to executing on the opportunities that lie ahead of us in 2021 and beyond," concluded Mr. Israel.

Recent Corporate Highlights

CM24:

Expanded the planned Phase 1b/2 clinical trial evaluating CM24 in combination with nivolumab in advanced non-small cell lung cancer (NSCLC) with a new cohort that will evaluate CM24 in combination with both nivolumab and nab-paclitaxel (Abraxane) in patients with pancreatic cancer under a clinical collaboration agreement with Bristol Myers Squibb.
Advanced preparations to initiate the Phase 1b/2 study, which is expected to begin imminently.
Received notifications from the U.S. Patent and Trademark Office, European Patent Office and the Chinese Patent Office to grant the patent application entitled "Humanized antibodies against CEACAM1," covering the humanized antibodies capable of specific binding to human CEACAM1 molecules, pharmaceutical compositions and methods of their use in treating and diagnosing cancer and other condition.
Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program positive results of a Phase 1 study consisting of a monotherapy dose escalating of CM24, as CM24 was found to be safe and well tolerated in all patients. In the study of efficacy evaluable patients (n=24), subjects were highly refractory to prior therapy, having received between two and eight prior therapies (with a median of four). Eight of the evaluable patients (33%) achieved stable disease, with most of these patients treated at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested that a higher dose level is required to achieve full saturation of CEACAM1 receptors.
NT-219:

Initiated and dosed the first patient in the Phase 1/2 clinical trial of NT219.
Presented new data supporting the mechanism of action of NT219 at the Epigenetics and Metabolism AACR (Free AACR Whitepaper) Special Virtual Conference by researchers at Tel-Aviv University.
Received notifications from the U.S. Patent and Trademark Office and the Chinese Patent Office to grant a patent application entitled "Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer," covering the various combinations of NT219 with multiple EGFR inhibitors, including cetuximab (Erbitux), which will be administrated in combination with NT219 for the treatment of recurrent or metastatic squamous cell carcinoma of the head as well as for neck cancer as part of our ongoing Phase 1/2 study, and osimertinib (TAGRISSO), a 3rd generation EGFR inhibitor approved in the U.S. for first-line treatment of EGFR-mutated non-small-cell lung carcinoma (NSCLC).

CONSENSI:

Growth of sales of Consensi in the U.S. has been slow primarily due to the COVID-19 environment, with minor sales of the drug in the second half of 2020. In addition, our distribution partner has not fulfilled all of its obligations as per the distribution agreement. We are currently evaluating a re-launch program that will be designed to boost sales and maximize the value of Consensi post-COVID-19. At this time, we are not able to provide revenue projections for the rest of 2021 and beyond.
Financial Results for the Six Months Ended December 31, 2020
Research and Development Expenses were $4.4 million, an increase of $3.4 million, or 342%, compared to $1.0 million in the same period of 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.

Selling, General and Administrative (SG&A) Expenses were $4.1 million, compared to $2.8 million in the same period of 2019, an increase of $1.3 million. The increase was due mainly to a $0.9 million increase in expenses related to stock options granted to directors and employees in the second and third quarters of 2020 and a $0.3 million increase in director and officer insurance expenses.

Operating Loss was $8.3 million, an increase of $4.7 million, or 131%, compared to $3.6 million in the same period of 2019.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $6.4 million, an increase of $3.6 million, compared to $2.8 million in the same period of 2019.

Net Loss for the second half of 2020 was $0.3 million, or $0.48 per diluted share, compared to a net loss of $3.3 million, or $1.70 per diluted share, in the second half of 2019. The decrease in net loss was due to $7.5 million in income from a change in the fair value of derivatives, partially offset by an increase of $4.5 million in operating expenses.

Financial Results for the Full Year Ended December 31, 2020
Revenues were $1.0 million for the year ended December 31, 2020, unchanged from the $1.0 million reported for the year ended December 31, 2019.

Research and Development Expenses were $7.5 million, an increase of $4.8 million, or 180%, compared to $2.7 million for the year ended December 31, 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.

SG&A Expenses were $6.3 million, compared to $6.1 million for the year ended December 31, 2019.

Operating Loss was $12.6 million, an increase of $5.5 million, or 76%, compared to $7.2 million for the year ended December 31, 2019.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $10.0 million, compared to $5.9 million, an increase of $4.1 million, for the year ended December 31, 2019.

Net Loss for the year ended December 31, 2020, was $28.1 million, or $2.44 per diluted share, compared to a net loss of $5.9 million, or $3.00 per diluted share, in the same period of 2019. The increase was due to $17.1 million increase in expenses on account of warrants mainly from a change in the fair value of derivatives and an increase of $4.8 million in R&D expenses.

As of December 31, 2020, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $60.8 million, compared to $4.4 million at December 31, 2019. Purple Biotech believes that its cash position will provide sufficient resources for its currently anticipated ongoing needs until fiscal year 2024.

On March 2, 2021 Aileron Therapeutics, Inc. (Nasdaq: ALRN) reported that it has expanded the enrollment target for its upcoming Phase 1b clinical trial of ALRN-6924 in patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy (Press release, Aileron Therapeutics, MAR 2, 2021, View Source [SID1234575946]). Aileron plans to enroll 60 patients, increased from the original target of 40 patients, with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed (with or without immune checkpoint inhibitors). The company anticipates beginning to enroll patients in the trial in the second quarter of 2021. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s attack on cancer cells, a novel concept known as chemoprotection.

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"Last month, the field of chemoprotection took a giant step forward with the approval of the industry’s first chemoprotection agent, which is approved to decrease the incidence of chemotherapy-induced myelosuppression in patients with extensive small-cell lung cancer1. With this milestone, the regulatory path for chemoprotective agents like ALRN-6924 has now been clarified. ALRN-6924 is the first and only reported chemoprotective agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. This strategy is designed to selectively protect healthy cells in the body from chemotherapy while ensuring we do not protect cancer cells. As a result, healthy cells are spared from chemotherapeutic destruction while chemotherapy continues to kill cancer cells. Given the high prevalence of p53-mutated cancers, we believe ALRN-6924 could potentially benefit millions of patients worldwide," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron.

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1 On February 12, 2021, the U.S. Food & Drug Administration approved G1 Therapeutics, Inc.’s COSELA (trilaciclib). COSELA is intended to help protect bone marrow in patients with extensive-stage small cell lung cancer when administered prior to chemotherapy.

Dr. Aivado continued, "Our recent equity fundraises in January of this year enabled us to enrich our ALRN-6924 clinical development planning, including a 50% increase in the planned enrollment target for our upcoming Phase 1b clinical trial of ALRN-6924 in patients with advanced p53-mutated NSCLC. We believe this enrollment expansion will enable a more robust exploration of ALRN-6924 as a novel chemoprotective agent to prevent toxicities in the NSCLC patient population and potentially better positions us to more rapidly reach late-stage clinical development."

In the planned Phase 1b NSCLC trial, patients will be randomized 1:1 to receive either carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or carboplatin/pemetrexed plus placebo for at least four 21-day treatment cycles. Evaluations will include the proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life. Aileron anticipates initial data from the trial late in the fourth quarter of 2021 and full results mid-2022.

The planned Phase 1b NSCLC trial follows Aileron’s presentation in October 2020 of clinical data from its ongoing Phase 1b clinical trial of ALRN-6924 in small cell lung cancer (SCLC) demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan.

About ALRN-6924

Aileron is developing ALRN-6924, a novel chemoprotective medicine, to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy preferentially acts on cells that are cycling, i.e. undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy preferentially targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, can lead to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients’ healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that mutated p53 has lost its function in those cells. Therefore, p53-mutated cancer cells continue to cycle uninterrupted and remain fully susceptible to being killed by chemotherapy.

On March 2, 2021 Seres Therapeutics, Inc., (Nasdaq: MCRB), a leading microbiome therapeutics company, reported fourth quarter and full year 2020 financial results and provided business updates (Press release, Seres Therapeutics, MAR 2, 2021, View Source [SID1234575945]).

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"Seres continues to make progress executing against our top corporate priorities. We are enrolling our open label study to support a Biologics License Application (BLA) for SER-109, a potential first-ever FDA approved microbiome therapeutic. We have also advanced our clinical pipeline and expanded our core microbiome therapeutic drug discovery and CMC capabilities," said Eric Shaff, President and Chief Executive Officer of Seres.

"We enter 2021 with a strong balance sheet, poised to continue leading the microbiome therapeutic field. Our pipeline spans infectious diseases, inflammatory diseases, and oncology, and we look forward to continued progress during the year, including our development stage pipeline candidates and earlier stage drug discovery efforts. We are pleased to have achieved target enrollment for the SER-287 ECO-RESET Phase 2b study and look forward to obtaining topline results mid-year, an acceleration compared to our prior projections. Our SER-287 program is another embodiment of our mission to develop product candidates with the potential to fundamentally transform patients’ lives by providing substantial clinical benefit over today’s standard of care," concluded Mr. Shaff.

Program and Corporate Updates

SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved a high rate of sustained clinical response in our Phase 3 clinical trial by repairing the disrupted microbiome in patients with recurrent C. difficile infection (CDI).

In August 2020, Seres announced positive topline interim results from the SER-109 Phase 3 study, ECOSPOR III. The Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) is a multicenter, randomized, placebo-controlled study that enrolled 182 patients with multiply recurrent CDI. Patients were randomized 1:1 to receive either SER-109 or placebo after standard of care antibiotic treatment. Final end-of-study 24-week results reiterated that ECOSPOR III achieved the study’s primary endpoint and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at 8 weeks post-treatment, which is a relative risk reduction of 69%. SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm and an adverse event profile comparable to placebo.

Following the topline Phase 3 study results, the FDA reaffirmed its prior position regarding the efficacy requirements to support an SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, as well as its prior position that the safety database should be at least 300 subjects. Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration.

In October 2020, Seres presented SER-109 Phase 3 topline results along with additional clinical data at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting. These new data demonstrated that the 12-week treatment difference between SER-109 and placebo remained consistent with the 8-week treatment difference. In addition, subsequent 24-week data demonstrate that the clinical effect of SER-109 is durable.

In January 2021, at the Keystone Symposium, Seres presented Phase 3 microbiome and metabolomic endpoint data that provide mechanistic support for the SER-109 efficacy observed. The study data demonstrate that SER-109 bacterial species rapidly engraft into the gastrointestinal tract; engraftment was observed as early as 1-week post-treatment and was durable through eight weeks, confirming the biological activity of SER-109. SER-109 administration also rapidly shifted the gastrointestinal metabolic landscape, including a significant decrease in primary bile acids and an increase in secondary bile acids, providing a mechanistic basis for inhibition of C. difficile spore germination and vegetative growth.

Seres is conducting an ongoing SER-109 open-label study in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183128), which also admits patients with a single recurrence of CDI, to expand the SER-109 safety database. The Company continues to make progress activating new clinical sites and enrolling subjects into the study at clinical sites across the U.S. and Canada. Additional information is available at serescdiffstudy.com.

SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287, an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicute spores, is designed to normalize the gastrointestinal microbiome of individuals with UC. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate ulcerative colitis. SER-287 targets restructuring the microbiome to reduce proinflammatory activity and modulate UC-relevant inflammatory pathways, potentially providing a much-needed non-immunosuppressive treatment option to patients suffering from ulcerative colitis. SER-287 has the potential to be used as both a monotherapy and potentially in combination with other approved agents.

The SER-287 Phase 2b ECO-RESET study is a randomized, placebo-controlled, three-arm induction trial designed to enroll 201 patients with active mild-to-moderate ulcerative colitis who have failed prior therapy. In arm A, patients receive a short course of vancomycin preconditioning followed by ten weeks of the same daily regimen used in the arm of the Phase 1b trial that showed the highest clinical remission rate. In arm B, patients receive vancomycin preconditioning followed by two weeks of the SER-287 daily regimen as in the first arm, followed by eight weeks of a lower dose of SER-287. In arm C, patients receive placebo.

The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis has achieved target enrollment. Topline study results are anticipated in mid-2021. The timing of anticipated study results represents an acceleration compared to the Company’s prior expectations.

Publication of SER-287 Phase 1b study results: The Phase 1b study results demonstrated that SER-287 administration was associated with high rates of clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile. The paper, titled "A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, For Active Mild-To-Moderate Ulcerative Colitis," was published as the highlighted cover article in the January 2021 print edition of the leading journal Gastroenterology.

SER-301 Phase 1b study in adults with mild-to-moderate ulcerative colitis: In November 2020, the Company dosed the first patient in its Phase 1b study for SER-301, an investigational oral, rationally-designed, cultivated microbiome therapeutic and study enrollment is ongoing. SER-301 is being evaluated in a Phase 1b study in adults with mild-to-moderate ulcerative colitis. The study is being conducted in Australia and New Zealand and is designed to enroll approximately 65 subjects. The study objectives are to evaluate drug safety and pharmacokinetics and to evaluate clinical remission and other measures of efficacy as secondary endpoints.

The consortia of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract and modulate pathways linked to gastrointestinal inflammation and epithelial barrier integrity in patients with ulcerative colitis. SER-301 was designed using Seres’ reverse translation discovery and development platforms. The design incorporated learnings from the SER-287 Phase 1b study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy. Additionally, the design incorporated insights on the engraftment dynamics of different bacteria and also the association of specific bacteria with the modulation of inflammatory and immune pathways in human subjects that have been observed across our broader clinical portfolio and confirmed using our nonclinical human-cell based assays and in vivo models.

In December 2020, Seres received a $10 million milestone payment associated with the Phase 1b SER-301 clinical study initiation from Nestlé Health Science, the Company’s ex-North American collaborative partner for this program.

SER-155 Phase 1b clinical study activities: SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to prevent or reduce mortality due to gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is a consortium of bacterial species selected using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models. The composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD.

The SER-155 program is supported by a CARB-X grant that provides financial and operational support through Phase 1b clinical development. Seres continues to advance SER-155 toward a Phase 1b clinical study in collaboration with Memorial Sloan Kettering Cancer Center.

SER-401 Phase 1b study in metastatic melanoma: SER-401 is an orally-administered, live microbiome therapeutic candidate comprising bacteria that reflect the bacterial signature in the gastrointestinal microbiome associated with patient response to checkpoint inhibitor immunotherapy. SER-401 Phase 1b study enrollment has been impacted by COVID-19-related operation disruptions and enrollment has been slower than anticipated. Further development plans for SER-401 are being assessed by Seres and its study collaborators, the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center.

Financial Results

Seres reported a net loss of $89.1 million for the full year of 2020, as compared to a net loss of $70.3 million for the prior year. Seres reported a net loss of $18.3 million for the fourth quarter of 2020, as compared to a net loss of $18.8 million for the same period in 2019.

Research and development expenses for the fourth quarter of 2020 were $24.9 million, as compared to $21.0 million for the same period in 2019. The research and development expenses were primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as well as the Company’s immuno-oncology efforts.

General and administrative expenses for the fourth quarter were $10.6 million, as compared to $5.8 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, including costs related to infrastructure supporting commercialization, professional fees and facility costs.

Seres ended the 2020 year with approximately $303.4 million in cash, cash equivalents and short and long-term investments.

Conference Call Information

Seres’ management team will host a conference call today, March 2, 2021, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 7338026. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On March 2, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Barclays Global Healthcare Conference on Thursday, March 11, 2021 at 9:10 a.m. EST (Press release, Bio-Techne, MAR 2, 2021, View Source [SID1234575944]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On March 2, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will take part in a fireside chat at Barclays’ Virtual Global Healthcare Conference, which will be webcast on Tuesday, March 9, 2021. David Elkins, Executive Vice President, Chief Financial Officer will answer questions about the company at 3 p.m. ET (Press release, Bristol-Myers Squibb, MAR 2, 2021, View Source [SID1234575943]).

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Investors and the general public are invited to listen to a live webcast of the session at View Source Material related to the company’s presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.