On July 24, 2019 TScan Therapeutics, dedicated to unleashing the power of the immune system through life-changing T cell therapies, reported its Series B financing, with over $48 million raised since the company’s inception (Press release, TScan Therapeutics, JUL 24, 2019, View Source [SID1234537709]). An experienced executive team has been built consisting of David P. Southwell, Chief Executive Officer; Gavin MacBeath PhD, Chief Scientific Officer; Henry Rath, Chief Business Officer; and Robert Crane, Chief Financial Officer. TScan is dedicated to realizing the true potential of T-cell receptor (TCR) therapy for patients suffering from a broad range of cancers.

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"TScan is committed to unleashing the immune system in patients with the only genome-wide, high-throughput and unbiased system to discover the natural targets of TCRs. Through the pioneering work of Dr. Elledge, TScan’s technology platform has the potential to uncover new targets in a variety of diseases, including cancer, autoimmunity, and infectious disease. We have made significant progress in discovering novel targets which are shared across cancers and look forward to bringing TCR therapies to patient suffering from both liquid and solid tumors," commented David Southwell, Chief Executive Officer of TScan.

"Further, I am proud that we have assembled an outstanding team of executives, including Gavin, Henry and Bob, and scientists from leading cell therapy companies – along with top-tier investors – to drive development of these products internally and to work externally with corporate partners," continued Southwell. "We are pleased to welcome Novartis Institutes for BioMedical Research to our Series B financing, as they join the strong core of investors from our Series A round of financing."

Dr. Stephen Elledge, Professor of Genetics and of Medicine at Harvard Medical School and Brigham and Women’s Hospital, spearheaded the development of the TScan system utilizing ground-breaking technology developed in his lab. Dr. Elledge is internationally recognized for his pioneering work in DNA damage repair and was the recipient of the 2015 Lasker Prize in Basic Medicine and the 2017 Breakthrough Prize in the life sciences.

TScan’s approach is comprehensive, unbiased, and relies on natural processes in both T cells and cancer cells to identify physiologically relevant targets and to develop effective T cell therapies for patients.

"Within the tumors of cancer patients are T cells with the potential to recognize and eliminate those cancer cells," said Gavin MacBeath, PhD, Chief Scientific Officer of TScan. "We are identifying tumor-reactive T cells in patients that are winning their fight against cancer in order to discover the targets of their T cells and develop innovative, cell-based therapies for the many patients that are not so fortunate. Importantly, we believe the TScan technology will enable us to expand the currently limited range of targets for T cell therapy."

About the TScan Leadership Team

David Southwell, Chief Executive Officer
David Southwell is the Chief Executive Officer of TScan and also serves as a member of the Company’s Board of Directors. Previously, David served as President and Chief Executive Officer of Inotek Pharmaceuticals through Inotek’s merger with Rocket Pharmaceuticals, a gene therapy-based biotechnology company. Previously, Mr. Southwell served as Executive Vice President, Chief Financial Officer of Human Genome Sciences, until its merger with GlaxoSmithKline plc. and as Executive Vice President and Chief Financial Officer of Sepracor Inc., sold to Dainippon Sumitomo. Mr. Southwell is a member of the Board of Directors of Rocket Pharmaceuticals and PTC Therapeutics, and has also served on the Boards of Directors of Human Genome Sciences, THL Credit Inc., Inventiv Health, Biosphere Medical, Inotek Pharmaceuticals and Spero Therapeutics. In addition, Mr. Southwell serves on the Board of Advisers at the Tuck School at Dartmouth College, from which he received an MBA, and has a BA from Rice University.

Gavin MacBeath, PhD, Chief Scientific Officer
Gavin MacBeath joined TScan from AbPro where he served as the Chief Scientific Officer. Gavin has two decades of experience in academia and industry, founding companies and driving research from early-stage discovery through drug approval. Previously, Dr. MacBeath served as Co-founder and SVP of Discovery at Merrimack Pharmaceuticals. Dr. MacBeath began his career in academia, where he served as the first fellow at Harvard’s Bauer Center for Genomics Research, as an Assistant and later Associate Professor in the Department of Chemistry & Chemical Biology at Harvard University, and as a Lecturer and Principal Investigator at Harvard Medical School. Dr. MacBeath received his undergraduate degree from the University of Manitoba, his Ph.D. from The Scripps Research Institute, and postdoctoral training with Dr. Stuart Schreiber at Harvard University.

Henry Rath, Chief Business Officer
Henry Rath joined TScan from Seres Therapeutics where he served as Senior Vice President of Corporate Development. Henry has over 25 years of experience in the biotechnology industry with roles spanning corporate finance, strategy, and business development. Prior to joining Seres, Henry served in various leadership roles at Amgen, Catabasis Pharmaceuticals, and Baxter BioScience Mr. Rath began his career with roles in the banking and consulting industries focusing on biotechnology with Oppenheimer & Co. Inc. and LEK Consulting. Mr. Rath earned his undergraduate degree from Harvard College and his M.B.A. from the Wharton School of the University of Pennsylvania.

Robert Crane, Chief Financial Officer
Robert Crane has served as Chief Financial Officer from company formation in April 2018. Mr. Crane has served as Chief Financial Officer and other senior roles in over 30 companies including Sirtris (acquired by GSK); I-STAT (acquired by Abbott); InKine (acquired by Salix); Seragen (acquired by Ligand), deCODE (acquired by Amgen) and Circe (acquired by ICN Pharmaceuticals). Mr. Crane was previously a partner at venture capital firm Montgomery Ventures and chairman of the American Bicycle Group. Mr. Crane holds a Bachelor of Science from MIT and an MBA from Stanford.

On July 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended June 29, 2019 (Press release, Thermo Fisher Scientific, JUL 24, 2019, View Source [SID1234537693]).

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Second Quarter 2019 Highlights

Second quarter revenue increased 4% to $6.32 billion.
Second quarter GAAP diluted earnings per share (EPS) increased 50% to $2.77.
Second quarter adjusted EPS increased 11% to $3.04.
Strengthened our mass spectrometry leadership with new instruments, workflows and software, highlighted by two new-generation Thermo Scientific Orbitrap systems – the Exploris 480 and Eclipse Tribrid – and a new workflow to advance biotherapeutics, called the HR Multi-Attribute Method. In genetic analysis, we launched the Applied Biosystems QuantStudio 6 and 7 Pro Real-Time PCR systems to automate qPCR workflows.
Continued to expand our bioproduction capabilities to meet customer demand for biologics, committing $50 million to add manufacturing capacity for single-use technologies at our facilities in the U.S. and Europe, and establishing a Bioprocessing Collaboration Center at our Pharma Services site in St. Louis, Missouri.
Opened Customer Experience Center in Seoul, South Korea, to showcase our depth of capabilities for life sciences applications and create a hub for customers to work with our experts and facilitate strategic partnerships within Korea’s scientific community.
Significantly expanded our CDMO capabilities for pharma and biotech customers, completing the acquisition of Brammer Bio, a leader in viral vector manufacturing for gene and cell therapy, for $1.7 billion and announcing our intent to acquire a GlaxoSmithKline site in Cork, Ireland, for the production of complex Active Pharmaceutical Ingredients (APIs).
Completed our previously announced divestiture of the Anatomical Pathology business for $1.14 billion.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We’re pleased to deliver very strong second-quarter results," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our team executed well in the quarter and we made great progress with our growth strategy to set our company up for an even stronger future.

"It was an outstanding quarter for technology innovation, and we are especially excited about the launch of two new Orbitrap systems – the Exploris 480 and Eclipse Tribrid – that extend our legacy of breakthrough mass spectrometry. In Asia-Pacific and emerging markets, we continued to capitalize on our leading position, highlighted by strong performance in China.

"We also further strengthened our value proposition for pharma and biotech customers, completing our acquisition of Brammer Bio and announcing our intent to acquire a site from GSK to expand our capacity for complex API manufacturing."

Casper added, "We’ve made excellent progress through the halfway point in the year, which positions us to achieve an outstanding 2019."

Second Quarter 2019

Revenue for the quarter grew 4% to $6.32 billion in 2019, versus $6.08 billion in 2018. Organic revenue growth was 5%; acquisitions increased revenue by 1% and currency translation decreased revenue by 2%.

As previously disclosed, in the final week of the quarter, the company experienced an outage in one of its data centers that caused delays in the processing of certain orders and shipments. This resulted in some second quarter activity shifting to the third quarter. Thermo Fisher estimates that the outage had a negative impact on total company organic revenue growth of approximately 1% in the second quarter, primarily affecting the Analytical Instruments Segment.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2019 increased 50% to $2.77, versus $1.85 in the same quarter last year. GAAP operating income for the second quarter of 2019 grew to $1.50 billion, compared with $0.94 billion in the year-ago quarter. GAAP operating margin increased to 23.7%, compared with 15.4% in the second quarter of 2018. GAAP results for the second quarter of 2019 reflect the gain on the sale of the company’s Anatomical Pathology business during the quarter.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2019 increased 11% to $3.04, versus $2.75 in the second quarter of 2018. Adjusted operating income for the second quarter of 2019 grew 6% compared with the year-ago quarter. Adjusted operating margin was 23.5%, compared with 23.1% in the second quarter of 2018.

2019 Guidance Update

Thermo Fisher is raising its 2019 revenue and earnings guidance primarily to reflect stronger operational performance. The company is raising its revenue guidance to a new range of $25.30 to $25.50 billion versus its previous guidance of $25.17 to $25.47 billion. This would result in 4 to 5% revenue growth over 2018. The company is raising its adjusted EPS guidance to a new range of $12.16 to $12.26, versus its previous guidance of $12.08 to $12.22, for 9 to 10% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the second quarter of 2019, Life Sciences Solutions Segment revenue grew 9% to $1.71 billion, compared with revenue of $1.57 billion in the second quarter of 2018. Segment adjusted operating margin increased to 35.6%, versus 33.3% in the 2018 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 1% to $1.32 billion in the second quarter of 2019, compared with revenue of $1.31 billion in the second quarter of 2018. Segment adjusted operating margin was 21.6%, versus 22.2% in the 2018 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue increased 1% to $0.94 billion in the second quarter of 2019, compared with revenue of $0.93 billion in the second quarter of 2018. Segment adjusted operating margin was 25.7%, versus 27.2% in the 2018 quarter.

Laboratory Products and Services Segment

In the second quarter of 2019, Laboratory Products and Services Segment revenue grew 3% to $2.63 billion, compared with revenue of $2.55 billion in the second quarter of 2018. Segment adjusted operating margin was 13.1%, versus 13.2% in the 2018 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. Based on acquisitions closed through the end of the second quarter of 2019, adjusted EPS will exclude approximately $3.30 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, July 24, 2019, at 8:30 a.m. Eastern time. To listen, dial (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, August 9, 2019.

On July 24, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported that the management team is scheduled to present at the 39th Annual Canaccord Genuity Growth Conference, and to conduct one-on-one meetings at the BTIG Biotechnology Conference 2019 (Press release, X4 Pharmaceuticals, JUL 24, 2019, View Source [SID1234537710]).

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Details related to the team’s participation are as follows:

Conference:

39th Annual Canaccord Genuity Growth Conference

Location:

Boston, MA

Presentation Date & Time:

August 7th at 3 pm EDT

Conference:

BTIG Biotechnology Conference 2019

Location:

New York, NY

Date:

August 12th

On July 24, 2019 Freenome, a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw, reported the close of its $160 million Series B financing, bringing its total financing to $238 million to date (Press release, Freenome, JUL 24, 2019, View Source [SID1234537711]). Freenome will use the proceeds to further the development of its early cancer detection blood test powered by its platform. The Company plans to conduct a pivotal validation study and submit to the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) under the Parallel Review Program the first application of its platform in colorectal cancer screening and expand its laboratory infrastructure and software to support its continued growth.

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"The only way to achieve meaningful progress against cancer is to interweave normally disparate fields towards a single mission. And the leadership team at Freenome has built a world-class, multi-disciplinary team of molecular biologists, computational biologists, machine learning scientists, and engineers"

The Series B financing was led by RA Capital Management and Polaris Partners. They were joined by other new investors including Perceptive Advisors, funds and accounts advised by T. Rowe Price Associates, Inc., Roche Venture Fund, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures. Freenome’s existing investors also participated in the financing including Andreessen Horowitz, GV (formerly Google Ventures), Data Collective Venture Capital, Section 32, and Verily Life Sciences (a subsidiary of Alphabet focused on life sciences and healthcare).

"We are fortunate to have an experienced and proven group of biotech and healthcare investors who share our mission of making early detection of cancer a routine part of patient care," said Gabe Otte, Chief Executive Officer of Freenome, "In addition, we are excited to welcome several strategic investors who are committed to our mission. Each brings insight, expertise, and partnership opportunities to accelerate our path to positively impacting patient care."

"Freenome’s work holds much promise and potential," said Bob Crutchfield, Managing Director of the American Cancer Society’s philanthropic impact fund, BrightEdge. "We hope our investment will help lead to accelerated patient access to this technology and better outcomes for cancer patients."

Mr. Otte added, "Since our founding in 2014, we have been focused on building a multi-disciplinary team to achieve our vision of a future where cancer mortality is significantly reduced through early detection matched with the right treatment informed by our blood test. We have already demonstrated promising clinical results at Digestive Disease Week this year, where our cell-free DNA (cfDNA) assay and machine learning approach enabled high sensitivity and specificity in a cohort of mostly early stage colorectal cancer patients. This funding will allow us to execute the necessary validation study for approval and reimbursement coverage of our colorectal cancer screening test, as well as expand our platform to other forms of cancer or immune-driven disease areas in the future."

Freenome’s multiomics platform detects key biological signals from a routine blood draw. The platform integrates assays for cell-free DNA, methylation, and proteins with advanced computational biology and machine learning techniques to identify additive signatures that improve the accuracy for early cancer detection given the molecular subtypes of cancer are heterogeneous in nature. This strategy incorporates a multidimensional view of both tumor- and immune-derived signatures that enables the early detection of cancer, instead of relying only on tumor-derived markers, which may miss the early signs of cancer. Freenome’s first cancer test is for the screening of colorectal cancer, the second deadliest form of cancer in the U.S. When identified early, colorectal cancer has a 90 percent five-year relative survival rate compared to 14 percent when detected at a more advanced stage according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program.

"The most affordable and effective treatment for metastatic cancer is to detect it early, when the tumor is still small and local, and we can cure it with surgery. It’s with that vision that we have invested in Freenome," said Peter Kolchinsky, Managing Partner of RA Capital. "Freenome’s multiomics platform is unlike anything we’ve seen, and we believe it can unlock the promise of using blood tests to detect and treat cancer early."

"The only way to achieve meaningful progress against cancer is to interweave normally disparate fields towards a single mission. And the leadership team at Freenome has built a world-class, multi-disciplinary team of molecular biologists, computational biologists, machine learning scientists, and engineers," said Amir Nashat, Managing Partner of Polaris Partners. "Having seen the tremendous progress Freenome has made in early cancer detection, we are excited to continue charting that path together."

On July 24, 2019 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the second quarter of 2019 before the market opens on Wednesday, August 7, 2019 (Press release, ArQule, JUL 24, 2019, View Source [SID1234537695]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

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The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."