On October 31, 2019 Hansa Biopharma reported Positive results from a pooled analysis of Phase 2 trials with imlifidase for desensitization in highly sensitized kidney transplant patients were presented for the first time at the European Society of Organ Transplantation’s (ESOT) Congress on September 17 (Press release, Hansa Biopharma, OCT 31, 2019, View Source [SID1234550164]). Imlifidase enabled kidney transplantation in 46 sensitized patients. The data presented was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

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– Hansa Biopharma continued to advance imlifidase towards a potential marketing approval in the EU. A Marketing Authorization Application (MAA) for imlifidase for enabling kidney transplantation in highly sensitized patients is currently under review by the European Medicines Agency, EMA. An opinion from the Committee for Medicinal Products for Human Use is expected during the first half of 2020.

– In the United States, a follow-up meeting with the U.S. Food and Drug Administration (FDA) has been scheduled. At the meeting, the Company intends to continue the discussion from the December 2018 meeting regarding the path forward for a regulatory filing for imlifidase in kidney transplantation of highly sensitized patients in the U.S. The meeting will take place on November 20th, 2019. Minutes from the FDA meeting expected by end-of-December 2019.

– Our pipeline has advanced with the first patient treated within our Phase 2 study in acute Antibody Mediated Rejection (AMR). In the Anti-GBM study we enrolled 11 patients at the end of the third quarter.

– Hansa Biopharma continued building its’ medical and commercial organization to support a potential commercial launch of imlifidase in 2020: Investments in R&D and SG&A increased in the third quarter to SEK 47m (Q3’18: SEK 36m) and SEK 46m (SEK 24m) respectively.

– Cash flow from operating activities for the third quarter ended at SEK -80m (SEK -54m); the Company’s cash position was SEK 680m at the end of September 2019.

Søren Tulstrup, President and CEO, comments

"Hansa Biopharma’s evolution into a fully integrated, commercial biopharmaceutical company continues according to plan. During the first nine months of 2019 we made solid progress across the organization with the expansion of our global footprint, advancements in our pipeline and continued engagements with the healthcare community in transplantation, autoimmune diseases and beyond.

Our top priority is advancing our lead candidate, imlifidase, through market authorization to enable kidney transplants for highly sensitized patients. At the same time, we continue to develop our proprietary enzyme technology platform in rare autoimmune diseases, where there is a significant unmet medical need.

In September, Hansa Biopharma presented positive imlifidase data at the ESOT Congress in Copenhagen, Denmark. The data was based on a pooled analysis of highly sensitized kidney transplant patients from four single arm, 6-month, open label, Phase 2 trials of imlifidase treatment prior to deceased and living donor transplantation in sensitized patients. The analysis included 46 patients, of which 50% had a cPRA of 100%, 85% were crossmatch positive and 70% were re-transplanted. Following the treatment of imlifidase, the donor specific antibodies (DSA) levels rapidly decreased and all positive crossmatches were converted to negative, thus enabling transplantation of all patients. The data was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

In Europe, the regulatory review process for imlifidase is progressing as planned, following the acceptance of our Marketing Authorization Application end of February. We expect to receive an opinion from the committee for medical products of European Medicines Agency in the first half of 2020.

In the U.S., we recently confirmed a follow-up meeting with the FDA. The purpose of the meeting will be to continue the discussion from our December 2018 meeting regarding the path forward for a regulatory filing of imlifidase in kidney transplantation of highly sensitized patients in the U.S.

Talking about the U.S., we welcome the initiative by the current administration in the United States, who recently issued an executive order to improve the care of people with end stage renal disease (ESRD). Following the executive order, the U.S. Department of Health and Human Services (HHS) set out three specific goals for ESRD:

1) Reducing the number of Americans developing ESRD by 25 percent by 2030

2) Having 80 percent of new ESRD patients in 2025 either receiving a transplant or homecare dialysis

3) Doubling the number of kidneys available for transplant by 2030

In the U.S., approximately 37 million people have chronic kidney disease and more than 700,000 have ESRD. There are nearly 100,000 Americans waiting to receive a kidney transplant, and approximately 20% of the money spent on traditional Medicare in the U.S. are related to kidney disease. If approved, imlifidase may have the potential to help highly sensitized patients getting off dialysis by enabling transplantation.

We have also continued advancing our pipeline during the first 9 months of 2019, with the initiation of two Phase 2 studies in Guillain-Barré Syndrome (GBS) and acute Antibody Mediated Rejection (AMR) in kidney transplantation. In AMR, the first patient has now been treated with imlifidase. Our Anti-Glomerular Basement Membrane (Anti-GBM) program is also progressing as expected, with 11 patients enrolled so far and it’s our aim to complete enrollment in this study by year-end.

With the continued progress across the organization and significant progress for our lead candidate and pipeline activities, we are well-positioned to become a global biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generate value to society at large. I look forward to updating you on our continued progress."

Søren Tulstrup

President and CEO of Hansa Biopharma

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on October 31, 2019.

On October 31, 2019 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported revenues of $605 million for the third quarter of 2019, an increase of 11% on a reported basis, and 12% on an organic basis, including over 1% in growth benefit related to equivalent business day effects (Press release, IDEXX Laboratories, OCT 31, 2019, View Source [SID1234550163]).

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Third quarter results were driven by CAG Diagnostics recurring revenue growth of 13% reported and 14% organic, including a nearly 2% growth benefit related to equivalent business day effects. CAG Diagnostics recurring revenue results reflected strong 13% reported and organic revenue growth in the U.S. and international revenue growth of 12% reported and 16% organic. Global results reflected strong double-digit growth in IDEXX VetLab consumables, reference laboratory diagnostic and consulting services revenues, and high single-digit growth in rapid assay products revenues. IDEXX VetLab consumables revenue growth was supported by an 18% year-over-year increase in the Catalyst chemistry analyzer installed base, benefiting from 1,270 placements at new and competitive accounts globally, a 23% year-over-year increase. Overall organic revenue growth results in the third quarter were also supported by high single-digit organic growth in Water and livestock, poultry and dairy ("LPD") revenues.

Earnings per diluted share ("EPS") was $1.24 for the third quarter, representing reported EPS growth of 18% and comparable constant currency EPS growth of 21%. These results reflected benefits from strong CAG Diagnostics recurring revenue gains, which supported a higher than projected 160 basis point improvement in operating margins on a reported basis and 130 basis points on a constant currency basis.

The Company is updating its full year 2019 revenue growth outlook to 8% – 8.5% on a reported basis and 10% – 10.5% on an organic basis. This results in an increase of $5 million at midpoint, reflecting expectations for overall organic growth and CAG Diagnostics recurring organic revenue growth at the high end of previous estimates, incorporating strong third quarter results. This outlook is supported by expectations for CAG Diagnostics recurring reported revenue growth of 9.5% – 10% and organic revenue growth of 11.5% – 12%, consistent with strong year-to-date trends. The Company is lowering its 2019 EPS guidance range by $0.12 per share at mid-point to $4.72 – $4.78, as benefits from strong operating performance are offset by a projected $0.18 negative impact from CEO transition charges in the fourth quarter of 2019. Our updated 2019 EPS guidance is for 11% – 12% in reported EPS growth, or 15% – 16% on a comparable constant currency basis. Our EPS outlook reflects expectations for full year operating margin improvement of 55 – 70 basis points on a constant currency basis, including 55 basis points of unfavorable impact related to CEO transition charges in the fourth quarter of 2019.

The Company is providing preliminary 2020 guidance for reported and organic revenue growth of 9% – 10.5%, supported by sustained high growth CAG Diagnostics recurring revenues, and EPS of $5.30 – $5.46, supported by expectations of 100 – 150 basis points of constant currency operating margin expansion, including 50 basis points of benefit related to favorable comparisons to 2019 CEO transition charges. Reported 2020 EPS growth of 12% – 15% incorporates $0.11 of negative projected year-over-year impact from foreign exchange effects and a $0.12 year-over-year reduction in projected benefits from share-based compensation tax benefits. Adjusting for these impacts, the 2020 EPS guidance reflects projected year-over-year EPS growth of 17% – 20% on a comparable constant currency basis.

"IDEXX delivered outstanding operating results in the third quarter, supported by continued strong growth in CAG Diagnostics recurring revenues. Our high-return investments in our global commercial capability are driving the global adoption of our innovative products and services, including the rapid expansion of our Catalyst installed base and increased utilization of IDEXX’s proprietary Fecal Dx Antigen Panel and IDEXX SDMA test," said Jay Mazelsky, the Company’s President and Chief Executive Officer. Mazelsky continued," It is clear that our customers are benefiting from increased interaction and support from IDEXX engagement as we work together to advance the standard of companion animal healthcare. We are building on this momentum with an eight percent expansion of our U.S. field commercial capability in the fourth quarter of this year, which will position us well to continue delivering strong financial results aligned with our long-term goals."

Third Quarter Performance Highlights

Companion Animal Group

The Companion Animal Group generated 12% reported and 13% organic revenue growth for the quarter, supported by CAG Diagnostics recurring revenue growth of 13% reported and 14% organic, which included nearly 2% of growth benefit related to equivalent business day effects.

IDEXX VetLab consumables generated 16% reported and 18% organic revenue growth, including an estimated 3% of growth benefit related to equivalent business day effects. IDEXX VetLab consumables growth was supported by ongoing expansion of our global premium instrument installed base, continued strong customer retention, increases in testing utilization and moderate net price gains.
Reference laboratory diagnostic and consulting services generated 11% reported and 12% organic revenue growth. These results were driven by continued strong double-digit organic growth in the U.S., reflecting volume gains with existing customers, moderate net price realization and benefits from net customer additions. Global organic revenue growth rates were supported by improved high single-digit revenue gains in international markets.
Rapid assay products generated 9% reported and 10% organic revenue growth, including an estimated 3% of growth benefit related to equivalent business day effects. Rapid assay revenue growth was supported by volume gains across our SNAP portfolio of products, including 4Dx Plus, high customer retention rates and moderate net price gains.
Veterinary software, services and diagnostic imaging systems revenue grew 6% on a reported and organic basis, driven by growth in subscription-based service revenues, including continued expansion of our practice management platforms. Overall segment growth was constrained by comparisons to very strong prior year digital imaging system placement levels.

Water

Water achieved revenue growth of 5% on a reported basis and 7% on an organic basis in the third quarter, supported by solid volume growth across all regions.

Livestock, Poultry and Dairy ("LPD")

LPD generated revenue growth of 7% on a reported basis and 10% on an organic basis for the third quarter. These results reflected revenue gains across the product portfolio including increases in diagnostic testing in Asia from new testing programs and from testing associated with alternative food sources, such as poultry. Third quarter results also benefited from favorable comparisons to soft prior year revenue levels in the Asia region. These gains were partially offset by moderate declines in herd health screening, compared to strong prior year levels, and continued impacts on swine testing from the prolonged outbreak of African swine fever in China.

Gross Profit and Operating Profit

Gross profits increased 13% year-over-year, and gross margin was 57%, an increase of 100 basis points compared to prior year period results on a reported basis and 60 basis points on a constant currency basis. Gross margin improvement was supported by mix benefits from strong growth in IDEXX VetLab consumables revenue, reference laboratory productivity gains and continued moderate CAG Diagnostics recurring revenue net price gains.

Operating margin was 23.1% in the quarter, 160 basis points higher than the prior year period results on a reported basis and 130 basis points on a constant currency basis, supported by gross margin gains and operating expense leverage on high revenue growth. Operating expenses increased 9% on a reported basis and 10% on a constant currency basis, driven by increases in our CAG segment’s sales and marketing costs and research and development spending.

2019 and 2020 Financial Outlook

The following guidance for 2019 and 2020 reflects the assumptions that for the remainder of 2019 and the full year 2020, the value of foreign currencies will remain at the following rates in U.S. dollars:

the euro at $1.09;
the British pound at $1.26;
the Canadian dollar at $0.75; and
the Australian dollar at $0.67;
and relative to the U.S. dollar:

the Japanese yen at ¥110.00;
the Chinese renminbi at RMB 7.22; and
the Brazilian real at R$4.21.
Outlook for 2019

We are updating our 2019 revenue outlook to $2,395 million – $2,405 million, reflecting expectations for reported revenue growth of 8% – 8.5% and organic revenue growth of 10% – 10.5%. At mid-point, the updated revenue outlook is $5 million above our previous guidance reflecting projected organic revenue growth at the higher end of our previous guidance range. Our outlook now reflects expectations for CAG Diagnostics recurring reported revenue growth of 9.5% – 10% and organic revenue growth of 11.5% – 12%. Modest benefits from a recently completed acquisition are offset by refinements to our foreign exchange rate assumptions. At the foreign exchange rate assumptions in 2019 noted above, we estimate that the effect of the stronger U.S. dollar will reduce full year 2019 reported revenue growth by approximately 2%.

We are updating our 2019 EPS outlook to $4.72 – $4.78 per share, reflecting a decrease of $0.12 per share at mid-point, incorporating a projected $0.18 negative impact from CEO transition charges in the fourth quarter of 2019 and a negative $0.02 per share impact related to updated foreign exchange assumptions. These impacts are partially offset by $0.06 in operational improvement related to strong third quarter performance and lower projections for net interest costs, as well as $0.02 per share of improvement related to updated estimates for share-based compensation tax benefits. For the full year, we now expect a foreign exchange headwind of $0.06 per share, net of projected hedge gains of approximately $11.5 million in 2019. The updated outlook represents EPS growth of 11% – 12% on a reported basis, and 15% – 16% on a comparable constant currency growth basis.

The Company continues to project free cash flow at approximately 60% – 65% of net income in 2019 and capital spending of approximately $160 million – $175 million, including an estimated $70 million of capital spending related to the completion of our Westbrook, Maine headquarters expansion and the relocation and expansion of our core laboratory in Germany.

The Company provides the following updated guidance for 2019:

We now expect an effective tax rate of approximately 20%, including approximately 1% of impact related to CEO transition charges. The effective tax rate outlook incorporates expectations for share-based compensation tax benefits of $15 million or approximately 300 basis points, resulting in EPS benefits of $0.17 per share. We continue to project a reduction in weighted average shares outstanding of approximately 1%, and now expect interest expense, net of interest income, of approximately $31.5 million reflecting current and projected borrowings.

Preliminary Outlook for 2020

The Company provides the following preliminary guidance for 2020:

Amounts in millions except per share data and percentage

The Company’s 2020 outlook is for continued strong overall organic revenue growth, supported by sustained high growth in CAG Diagnostics recurring revenues.

At the foreign exchange rates assumed in this earnings release, we estimate that foreign exchange impacts will decrease 2020 reported revenue growth by approximately 0.5%, and EPS by approximately $0.11 per share, including impacts from comparisons to approximately $11.5 million of projected foreign exchange hedge gains in 2019.

Our 2020 EPS outlook includes approximately $0.04 – $0.06 per share of projected benefit from share-based compensation tax benefits, $0.12 per share below higher than expected 2019 levels at midpoint. Our preliminary outlook for our effective tax rate is 21% – 22% and for a reduction in weighted average shares outstanding from continued stock repurchases of approximately 1%. We are projecting interest expense, net of interest income, of approximately $36 million, reflecting current and projected borrowings and the assumed continuation of current floating interest rate costs.

Conference Call and Webcast Information

IDEXX Laboratories, Inc. will be hosting a conference call today at 8:30 a.m. (Eastern) to discuss its third quarter 2019 results and management’s outlook. To participate in the conference call, dial 1-800-230-1096 or 1-612-332-0335 and reference confirmation code 472946. Replay of the conference call will be available through Thursday, November 7, 2019 by dialing 1-800-475-6701 or 1-320-365-3844 and referencing replay code 472946. Individuals can access a live webcast of the conference call through a link on the IDEXX website, www.idexx.com/investors. An archived edition of the webcast will be available after 1:00 p.m. (Eastern) on that day via the same link and will remain available for one year.

On October 31, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and nine months ended September 30, 2019 (Press release, Nuvo Pharmaceuticals, OCT 31, 2019, View Source [SID1234550162]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

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Third Quarter Financial Summary

Adjusted total revenue(1) was $18.9 million for the three months ended September 30, 2019 compared to $5.1 million for the three months ended September 30, 2018.

Adjusted EBITDA(1) was $7.8 million for the three months ended September 30, 2019 compared to $(1.3) million for the three months ended September 30, 2018.

Gross profit on total revenue was $11.3 million or 60% for the three months ended September 30, 2019 compared to a gross profit of $2.9 million or 57% for the three months ended September 30, 2018.

Cash and short-term investments were $18.5 million as at September 30, 2019 compared to $28.1 million as at December 31, 2018. The decrease was primarily related to the settlement of transaction costs and indebtedness acquired by Nuvo upon close of the Aralez Transaction. In November 2019, the Company will make a US$2.5 million payment towards its Bridge Loan.
(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Third Quarter and 2019 Business Update

Canadian prescriptions of Blexten increased by 56% for the three months ended September 30, 2019 compared to the three months ended September 30, 2018.

Canadian prescriptions of Cambia increased by 30% for the three months ended September 30, 2019 compared to the three months ended September 30, 2018.

In October 2019, the United States Court of Appeals for the Federal Circuit (Court of Appeals) issued a ruling affirming the New Jersey court’s decision upholding the validity of a certain claim of U.S. Patent No. 9,066,913 (the ‘913 Patent) which covers Pennsaid 2%. Pursuant to this decision, but subject to any appeal rights, Actavis Laboratories UT, Inc., formerly known as Watson Laboratories, Inc., Actavis, Inc. and Actavis plc (collectively Actavis) is blocked from launching its generic version of Pennsaid 2% in the United States until the ‘913 Patent expires on October 17, 2027. Nuvo is the exclusive manufacturer of Pennsaid 2% for our licensing partner, who owns the Pennsaid 2% intellectual property (IP) rights in the U.S.

In September 2019, the Company received notice from Sayre Therapeutics PVT Ltd. (Sayre Therapeutics), that the Drug Controller General of India had approved the sale of Pennsaid 2% in India. Sayre Therapeutics has the exclusive rights to distribute, market and sell Pennsaid 2% in India, Sri Lanka, Bangladesh and Nepal. The Company anticipates the commercial launch of Pennsaid 2% in India during the first quarter of 2020.

On July 30, 2019, the Court of Appeals denied the en banc request to the Court of Appeals to have the court reconsider the May 2019 decision involving U.S. Patent Nos. 6,926,907 (the ‘907 Patent) and 8,557,285 (the ‘285 Patent) which cover Vimovo. However, U.S. Patents Nos. 8,858,996 and 9,161,920 were unaffected by the Court of Appeals decision and remain valid and enforceable. A generic version of Vimovo did not launch in the U.S. during the three months ended September 30, 2019. As a result, the Company has accrued $1.7 million of license revenue related to its U.S. Vimovo royalty stream for the three months ended September 30, 2019. The Company anticipates that a generic version of Vimovo could launch in the U.S. during the fourth quarter of 2019. Nuvo and its U.S. partner will continue to consider every possible legal strategy to protect Vimovo’s market exclusivity in the U.S.

In June 2019, the Company announced its intention to reduce annual operating expenses by approximately $7.0 million due to synergies identified and organizational changes implemented. The Company began to realize these synergies during the three months ended September 30, 2019.
"Our third quarter financial performance was in-line with our expectations, with Blexten and Cambia maintaining strong year-over-year growth. In spite of the July 30, 2019 U.S. Court of Appeals decision that found that two of our Vimovo patents were invalid, we continue to enjoy market exclusivity in the U.S. and to receive the benefit of the U.S. Vimovo royalty stream. We have additional patents that were unaffected by this decision that remain valid and enforceable, which means any generic company launching a generic would do so "at risk" of having to later pay patent infringement damages should our additional patents survive validity challenges in pending patent infringement proceedings," said Jesse Ledger, Nuvo’s President & CEO. "We made advances in our pipeline with Pennsaid 2% receiving approval in India in the third quarter with the commercial launch anticipated early in 2020. The marketing authorization applications for Pennsaid 2% in Europe and Suvexx in Canada have moved beyond the initial screening phase and are now in full review with the respective government agencies. Finally, we are committed to reducing Nuvo’s financial leverage and will make a US$2.5 million payment on our Deerfield loans in November."

Third Quarter 2019 Financial Results

Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $18.8 million for the three months ended September 30, 2019 compared to $5.1 million for the three months ended September 30, 2018. The significant increase in total revenue for the current three and nine-month periods was primarily attributable to the addition of revenue as a result of the Aralez Transaction. Total revenue for the nine months ended September 30, 2019 was $50.0 million compared to $15.4 million for the comparative nine-month period.

Adjusted total revenue increased to $18.9 million for the three months ended September 30, 2019 compared to $5.1 million for the three months ended September 30, 2018. The $13.8 million increase in adjusted total revenue in the current quarter was primarily attributable to the addition of revenue related to the Aralez Transaction, which provided an incremental $9.6 million of total revenue contributed from the Commercial Business segment and $4.0 million attributable to the Vimovo royalties related to earned Vimovo royalties. Adjusted total revenue increased to $55.1 million for the nine months ended September 30, 2019 compared to $15.7 for the nine months ended September 30, 2018.

Adjusted EBITDA increased to $7.8 million for the three months ended September 30, 2019 compared to $(1.3) million for the three months ended September 30, 2018. The increase in adjusted EBITDA for the current quarter was primarily attributable to the increase in gross profit as a result of the Aralez Transaction, as well as a reduction in general and administrative (G&A) expenses of $0.9 million, partially offset by an increase in sales and marketing of $2.0 million. Adjusted EBITDA increased to $18.7 million for the nine months ended September 30, 2019 compared to $1.4 million for the nine months ended September 30, 2018.

Gross profit on total revenue was $11.3 million or 60% for the three months ended September 30, 2019 compared to a gross profit of $2.9 million or 57% for the three months ended September 30, 2018. The increase in gross profit for the current quarter was primarily attributable to an increase in gross margin on product sales and an increase in license revenue as a result of the Aralez Transaction. Gross profit on total revenue was $30.0 million or 60% for the nine months ended September 30, 2019 compared to a gross profit of $9.0 million or 58% for the nine months ended September 30, 2018.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure from which to determine the Company’s ability to generate cash from its customer contracts that is used to fund its operations.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expense, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure from which to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Thursday, October 31, 2019) at 8:30 a.m. ET. To participate in the conference call, please dial 1 888 390 0546 or 416 764 8688. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on November 7, 2019 by calling 1 888 390 0541 or 416 764 8677 playback passcode 072242#.

A live audio webcast of the conference call will be available through www.nuvopharmaceuticals.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

On October 31, 2019 Thermo Fisher Scientific reported that it will host a series of customer presentations during its corporate workshops featuring the latest clinical research data on emerging biomarkers in cancer at the Association for Molecular Pathology (AMP) 2019 annual meeting on Nov. 6 (Press release, Thermo Fisher Scientific, OCT 31, 2019, View Source [SID1234550161]). The workshops will highlight details from studies in non-small cell lung cancer, immuno-oncology and hematology, and include the introduction of Thermo Fisher’s newest next generation sequencing (NGS) assay, Oncomine Comprehensive Assay Plus.*

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As the oncology biomarker landscape continues to evolve, greater clarity is needed to understand the prevalence and proper utilization of targeted and immuno-oncology biomarkers in tumor evaluation. Drs. Alain Mita, co-director of Experimental Therapeutics, and Eric Vail, director of Molecular Pathology at Cedars Sinai, will present data on RET fusions, the value of simultaneous assessment of comprehensive molecular results and the impact of faster turnaround times.

Ilaria Alborelli, Ph.D., scientist at the Institute of Pathology, University Hospital Basel, Switzerland, will deliver preliminary results from her assessment of Oncomine Comprehensive Assay Plus, a pan-cancer assay that covers more than 500 genes and enables simultaneous analysis of both DNA and RNA from just 10 ng in a single workflow. The new assay is designed to identify all classes of somatic variants, including SNVs, CNVs, fusions and splice variants, while also measuring tumor mutation burden (TMB) and microsatellite instability (MSI) – key biomarkers for emerging immunotherapies.

Dr. Yuri Fesko, medical director for oncology for Quest Diagnostics, will provide an overview of the limitations and best practices for TMB assessment results. The workshop will also feature comparison studies from Q2 Solutions which evaluated results from Oncomine TCR-Beta assays* with other on-market panels.

The rapid adoption of NGS to effectively assess driver mutations in hematology-oncology samples is providing many advantages and efficiencies over conventional molecular testing techniques. Speakers from the University of Nebraska Medical Center and Q2 Solutions will present their assessment of how to simplify analysis of myeloid and lymphoid samples using assays from Thermo Fisher’s portfolio of Oncomine panels, including Oncomine BCR IGH assays.*

For more information on the workshops taking place at the Baltimore Convention Center (9 a.m. E.T. Nov. 6, rooms 314-315) and other activities at AMP, please stop by Thermo Fisher’s booth (#2825), or visit the website.

* For Research use only. Not for use in diagnostic procedures

On October 31, 2019 RareCyte reported an addition to the RarePlex Staining Kit product line, enabling customers to evaluate HER2 and ER expression on circulating tumor cells (CTCs) in their own laboratory (Press release, RareCyte, OCT 31, 2019, View Source [SID1234550160]). HER2 and ER are biomarkers that direct treatment recommendations for invasive breast cancer, and liquid biopsy offers a blood-based method to evaluate biomarker expression for insight into receptor status, response to treatment, and potentially therapy selection in clinical research.

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The RarePlex HER2/ER CTC Panel Kit includes all the reagents necessary for immunofluorescent detection of CTCs along with HER2 and ER expression. When combined with the RareCyte platform for CTC analysis, the RarePlex HER2/ER CTC Panel Kit enables the first blood-to-result breast-specific CTC assay deployable in customer laboratories.

The HER2/ER Panel Kit was validated based on rigorous requirements set to clinical standards with guidance from CLIA and industry experts. Tad George, PhD, Sr. VP of Biology R&D at RareCyte noted "Our approach to CTC assay development and validation is centered on creating deployable products that combine the sensitivity, specificity, and precision required for multi-center trials, not only for CTC enumeration but also for classifying CTCs based on their biomarker phenotypes."

Dr. Minetta Liu, MD, Professor and Research Chair in the Department of Oncology at Mayo Clinic recently presented her work with the HER2/ER CTC Panel Kit at the Advances in Circulating Tumor Cells Conference in Corfu, Greece. "Our early work with this assay has revealed interesting patterns of HER2/ER expression that vary widely across patients. Efforts will now focus on defining thresholds for HER2 and ER positivity that are specific to CTCs. This platform will facilitate important investigations into the clinical significance of CTC heterogeneity relative to standard tissue-based definitions of HER2 positive and/or hormone receptor positive advanced breast cancer."

The HER2/ER Panel Kit is available for purchase and more information on the HER2/ER Panel Kit and the RareCyte platform is available at rarecyte.com.

RareCyte products are for research use only. Not for use in diagnostic procedures.