On May 11, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the first quarter ended March 31, 2021 and provided an update on clinical and corporate developments (FilingPress release, Fusion Pharmaceuticals, MAY 11, 2021, View Source [SID1234579685]).

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"We continue to advance our Phase 1 study of FPI-1434," said Chief Executive Officer John Valliant, Ph.D. "In anticipation of data and determination of a recommended Phase 2 dose in the first half of 2022, we are amending the study protocol to define tumor-specific cohorts based upon IGF-1R expression and tumor uptake as seen to date in the Phase 1 study."

Dr. Valliant continued, "In parallel, we are building a diverse pipeline of alpha-emitting radiopharmaceuticals. We expect to file our investigational new drug (IND) application for FPI-1966 in the second quarter of this year. In addition, we recently completed the acquisition of IPN-1087, a first-in-class small molecule beta-emitting radiopharmaceutical targeting neurotensin receptor 1 (NTSR1), which is expressed on multiple solid tumors and which we plan to convert into alpha-emitting FPI-2059. These programs demonstrate the depth and versatility of Fusion’s radiopharmaceutical platform and our potential to treat a broad array of solid tumors with high unmet medical need.

"Evidenced by our recent presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, we are excited about the potential to evaluate Fusion’s TATs in combination with the latest generation of cancer therapies, including checkpoint inhibitors and DNA damage response inhibitors (DDRis). Our recently announced collaborations with Merck and AstraZeneca enable us to explore these combination therapies and highlight the growing interest in TAT therapies."

Recent Highlights and Future Milestones

Corporate Updates

On May 6, Fusion announced that it has entered a clinical trial collaboration with a subsidiary of Merck to evaluate FPI-1434 in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R). The planned Phase 1 combination trial will evaluate safety, tolerability and pharmacokinetics of the combination and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.
On April 10, Fusion announced the presentation of preclinical data at the 2021 AACR (Free AACR Whitepaper) Virtual Annual Meeting. The posters, titled "Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts" and "Combination of IGF-1R Targeted Alpha Therapy with Checkpoint Inhibitors Results in Synergistic Efficacy in Colorectal Cancer Syngeneic Model," highlight the potential of Fusion’s targeted alpha therapies (TATs) as both monotherapies and combination therapies.
On April 1, Fusion announced the closing of its acquisition of Ipsen’s assets and intellectual property related to IPN-1087. IPN-1087, previously studied in a Phase 1 trial, is a small molecule targeting NTSR1, a protein expressed on multiple solid tumor types. Fusion is using IPN-1087 to create a first-in-class alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an IND application in the first half of 2022.
FPI-1434 Monotherapy

Fusion continues to advance the multi-dose portion of its Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The dose-finding study is enrolling patients at sites in Canada, the United States and Australia.
Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose and schedule, in the first half of 2022.
FPI-1434 Combination Therapy

Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
As noted above, Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-1966

FPI-1966 is designed to target and deliver actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021.
First Quarter 2021 Financial Results

Cash and Investments: As of March 31, 2021, Fusion held cash, cash equivalents and investments of $278.2 million, compared to cash of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of March 31, 2021 will enable the Company to fund its operations through the end of 2023.
R&D Expenses: Research and development expenses for the first quarter of 2021 were $10.7 million, compared to $4.4 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, and preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the first quarter of 2021 were $7.0 million, compared to $4.3 million for the same period in 2020. The increase was primarily related to general corporate expenses, including increased professional and consulting fees as a result of public company activities, as well as increased salaries, benefits and stock compensation costs due to hiring.
Net Loss: For the first quarter of 2021, Fusion reported a net loss of $17.5 million, or $0.42 per share, compared with a net loss attributable to common shareholders of $11.6 million, or $6.01 per share, for the same period in 2020. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability and warrant liability, net loss was $8.8 million for the first quarter of 2020.
Impact of COVID-19

While Fusion continues to progress the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced moderate delays in patient recruitment and enrollment as a result of COVID-19.

Fusion is closely monitoring how the spread of COVID-19 is affecting the Company’s employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion’s research labs are operating but with reduced capacity.

At this time, there is significant uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

On May 11, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI), a pharmaceutical company developing novel immunotherapies against cancer, reported its first quarter 2021 results today (Press release, Ultimovacs, MAY 11, 2021, View Source [SID1234579701]). A presentation by the Company’s management team will take place today on a webcast at 09:00 CEST. The presentation can be followed as a live webcast, which will also be available on our website.

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Highlights for the first quarter of 2021:

In the INITIUM trial, 40 patients have been enrolled as per the reporting date as compared to 24 patients reported in the previous quarterly report.
In the NIPU trial, 29 patients have been enrolled as per the reporting date compared to 18 patients reported in the previous quarterly report.
As a natural consequence of the COVID-19 pandemic, the activation of hospitals is progressing slower than initially planned in both the INITIUM and NIPU trials. The Company continues to implement activities to minimize the impact on patient recruitment. The effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain and dependent on the speed of return to a more normal situation.
Ultimovacs provided details on the DOVACC trial in January 2021. Ultimovacs will participate in this randomized Phase II collaboration study, together with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer. The trial will include 184 patients in approximately 10 European countries at more than 40 sites. (Announced in Q4-20 report).
Preparations are ongoing for the initiation of the DOVACC and FOCUS trials, with the first patients expected to be included in both trials around mid-year 2021.
On 18 February 2021, Ultimovacs started clinical evaluation of the novel TET-Platform, with the treatment of the first patient in the Phase I TENDU study investigating a prostate cancer-specific therapeutic vaccine. The first cohort of three patients has been enrolled as per the reporting date.
On 28 April 2021, Ultimovacs announced that an abstract on the Company’s Phase I trial evaluating its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab in patients with metastatic malignant melanoma has been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting to be held virtually from June 4 to 8, 2021. (post period event).
Total operating expenses amounted to MNOK 31.2 in Q1-21.
Cash flow from operations was MNOK -29.5 in Q1-21. Total cash and cash equivalents amounted to MNOK 409.3 as per 31 March 2021.

On May 11, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter for the period ended March 31, 2021 (Press release, Navidea Biopharmaceuticals, MAY 11, 2021, View Source [SID1234579718]).

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"We are continuing a positive dialogue with the FDA and are moving as quickly as we can to fully document all the data from Arm 3 of NAV3-31," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are also excited to begin patient enrollment for NAV3-32 both here in the U.S. and in the UK."

First Quarter 2021 Highlights and Subsequent Events

Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration ("FDA"). The FDA granted the Type B Meeting and reviewed the formal briefing documents Navidea submitted containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol. Following the feedback received from the FDA at the end of March 2021, the Company continues to work toward completing the analysis of the full trial dataset in preparation for the standard End of Phase 2 Type B meeting and in preparation for the Phase 3 study.
Achieved last patient, last visit in the Company’s NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
Opened the first US site, Northwestern University, as well as the primary UK site, Queen Mary University of London, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active rheumatoid arthritis ("RA").
Opened the NAV3-35 trial to establish a normative database of healthy controls for Tc99m tilmanocept imaging in rheumatoid arthritis.
Continued enrollment in the Investigator-Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Received a notice of allowance from the United States Patent and Trademark Office for the patent application: "Compounds and methods for diagnosis and treatment of viral infections" (U.S. Patent Application 15/729,635).
Announced that the results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science’s ("NYAS") Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the "Series E Preferred Stock") for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.
Appointed Amit Bhalla to the Company’s Board of Directors. Mr. Bhalla brings a wealth of financial experience to the board.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We are completing the analysis of the full dataset from the NAV3-31 Phase 2B trial as well as planning for the Phase 3 trial. We continue to prepare for initiation of this trial and have opened up key sites for enrollment into the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, some of which will be presented this month at the NYAS conference, and we expect to continue to advance these towards the clinic."

Financial Results

Total net revenues for the first quarter of 2021 were $124,000, compared to $156,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by the partial recovery in the first quarter of 2021 of debts previously written off in 2015.
Research and development expenses for the first quarter of 2021 were $1.2 million, compared to $999,000 in the same period in 2020. The increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic and therapeutic development costs and increased Tc99m development costs, offset by decreased employee compensation.
Selling, general and administrative expenses for the first quarter of 2021 were $2.2 million, compared to $1.8 million in the same period in 2020. The net increase was primarily due to increased legal and professional services, insurance, investor relations services, and employee compensation, offset by decreased franchise taxes.
Navidea’s net loss attributable to common stockholders for the first quarter of 2021 was $3.0 million, or $0.11 per share, compared to $2.7 million, or $0.13 per share, for the same period in 2020.
Navidea ended the first quarter of 2021 with $7.5 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.D:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On May 11, 2021 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported that its shareholders have voted to adopt and approve the previously announced agreement to be acquired by AstraZeneca at a special meeting of shareholders held today (Press release, Alexion, MAY 11, 2021, View Source [SID1234579655]).

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Ludwig Hantson, Ph.D., Chief Executive Officer, Alexion, said: "We’re very pleased with today’s affirmative shareholder vote, which brings us one step closer to completing a transaction that will accelerate the combined company’s ability to develop and provide access to life-changing medicines for patients with rare and devastating diseases around the world."

Subject to receipt of additional regulatory clearances, the acquisition is expected to close in the third quarter of 2021.

On May 11, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2021 (Press release, VolitionRX, MAY 11, 2021, View Source [SID1234579670]). Volition management will host a conference call tomorrow, May 12 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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"We have made significant progress on many fronts during 2021 on all four of the Company’s key pillars: Nu.Q, Nu.Q Vet, Nu.Q NETs and Nu.Q Capture," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We have also significantly strengthened our balance sheet, our intellectual property portfolio, and our executive team to drive commercial focus."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer and Terig Hughes, Chief Financial Officer.

Mr. Reynolds continued, "Silver One, our manufacturing facility and service lab, is proving to have been an excellent addition to Volition’s commercialization efforts and is now producing finished product and components at commercial scale for our anticipated product launches. I am delighted that the Nu.Q Vet beta launch has not only provided revenue but also invaluable real-world learnings allowing us to move ahead soon with our expected national U.S. and international launches. We are also seeing a high level of interest in both the licensing and distribution of our products and are actively negotiating multiple agreements."

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2021 totaled approximately $33.1 million compared with $19.4 million as of December 31, 2020.
During the first quarter of 2021, added an aggregate of approximately $20.3 million in cash mostly through an underwritten public offering of our common stock that closed in February, as well as through periodic sales of common stock under Volition’s at-the-market equity distribution program.
Secured a further $4 million in non-dilutive funding consisting of a cash grant of $1.3 million and loans totalling $2.7 million from the Walloon Regional Government and associated agencies.
Continued to manage expenditures carefully with a cash burn rate of approximately $2 million per month.
Personnel

As Volition transitions from a research and development company to a commercial company, it strengthened the leadership team with the appointment of a new Chief Financial Officer, Mr. Terig Hughes, as well as the appointment of Mr. Gael Forterre as Chief Commercial Officer. In addition, Volition promoted Dr. Gaetan Michel to Chief Operating Officer and Dr. Mark Eccleston to Chief Technology Officer.
Volition announced the appointment of two Independent Directors to its main Board – Kim Nguyen, an HR executive with global expertise at Google, and Richard Brudnick, a pharmaceutical business executive with extensive commercial know-how.
As of May 1, Dr. Tom Butera, a seasoned veterinary executive with an extensive commercial track record, joined the team as Chief Executive Officer of Volition’s Veterinary subsidiary to drive its product launches.
Intellectual Property

28 patent families covering both human and animal use of Volition’s Nucleosomics platform.
64 granted patents (ten in the U.S., 14 in Europe and 42 rest of world).
93 patents pending.
Continued focus on filings during the first quarter and expect portfolio to grow in the quarters and years ahead.
Publications

Volition’s list of publications and abstracts is growing.
Year to date data for Nu.Q has been presented at two international conferences and Volition has collaborated on three clinical paper publications.
These publications are another very important step forward for the Company.
Nu.Q Vet Cancer Screening Test Beta Launch

Beta launch of the Nu.Q Vet Cancer Screening Test in late November 2020 in Texas. This beta launch is facilitating real-world learnings to help shape the marketing mix before Volition’s planned launch nationally across the U.S. expected in the next few months.
Volition has received strong indications of interest in the whole Nu.Q Vet platform, from a range of small and very large companies, and it is progressing potential licensing discussions with several well-known major players in the veterinary space around the world.
In addition to the Texas beta launch, Volition is finalizing beta launch planning in both Asia and Europe.
Nu.Q Capture

The clinical paper published in Nature’s Scientific Reports in March highlighted for the first time that histone H2A1R3 citrulline is, in plasma, upregulated in colorectal cancer patients and so could be a biomarker Volition targets for future Nu.Q immunoassay development.
It showed that the use of Nu.Q Capture may open up the possibility of using mass spectrometry not only for biomarker discovery but also as a high throughput platform for screening and/or diagnostics.
Volition aims for Nu.Q Capture to be an important enabling technology in the liquid biopsy space and expects to launch its first product with this technology in 2022.
Clinical – NETosis including COVID-19

Volition believes that the versatility of the Nu.Q platform and the range of applications for which these assays can be leveraged may help increase diagnostic power and monitor disease progression and potentially treatment response across a broad range of diseases that involve the over production of NETs, such as COVID-19, pneumonia, influenza and sepsis.
From a sepsis product development perspective, to date Volition has completed animal studies in the monitoring of disease progress and treatment efficacy which have demonstrated the effective use of Nu.Q NETs.
Human studies in the monitoring of disease progress and treatment efficacy in sepsis are now underway at a leading UK hospital.
From a COVID-19 product development perspective, Volition has conducted studies of serial testing of COVID-19 patients at leading UK hospitals to determine the predictive value of its test, with further data due to be presented at upcoming conferences and potentially additional studies and collaborations as well.
Clinical – Cancer

As previously reported, due to the pandemic collection for the U.S. EDRN study for colorectal cancer has been paused, and collection for the blood cancer studies in the U.S. have been delayed with an updated timeline expected in the near future.
In Asia, Volition has reached its target patient cohorts for both colorectal cancer studies and the lung cancer study, all collected in conjunction with the National Taiwan University, notwithstanding the pandemic. Volition expects to run the assays and finalize the analysis over the coming months with data due to be reported at future conferences.
Volition has installed a Service Lab in Silver One, which will undertake sample processing for external parties such as pharmaceutical companies, biotech companies and academic researchers. This service, branded as Nu.Q Discover, has already generated interest, and Volition expects to see initial revenue from this during 2021.
Volition is producing recombinant nucleosomes in-house and at large-scale, building a library for sale through Nu.Q Discover and also for internal R&D use.
Volition is still in active discussions on its first potential licensing deal with a large healthcare company.
Upcoming Milestones

Volition expects to achieve the following milestones during 2021 and beyond, pandemic permitting:

National launch of the Nu.Q Vet Cancer Screening Test in the U.S.
Beta launches of the Nu.Q Vet Cancer Screening Test in Asia and Europe.
Continue to focus on driving revenue in the coming quarters in four key areas:
– Nu.Q Vet products,
– Disease monitoring tests (e.g. Nu.Q NETs for COVID-19, sepsis),
– Nu.Q Discover, and
– Licensing of its technology for others to commercialize in both humans and animals.

Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance its previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited First Quarter 2021 Financial Results and Business Update

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source

In addition, a telephone replay of the call will be available until May 26, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13719633.