On August 1, 2019 Mettler-Toledo International Inc. (NYSE: MTD) reported second quarter results for 2019. Provided below are the highlights (Press release, Mettler-Toledo, AUG 1, 2019, View Source [SID1234538049]):

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Reported sales increased 1% compared with the prior year. In local currency, sales increased 5% in the quarter as currency reduced sales growth by 4%.
Net earnings per diluted share as reported (EPS) were $5.06, compared with $4.31 in the prior-year period. Adjusted EPS was $5.16, an increase of 11% over the prior-year amount of $4.65. Adjusted EPS is a non-GAAP measure, and we have included a reconciliation to EPS on the last page of the attached schedules.
Second Quarter Results

Olivier Filliol, President and Chief Executive Officer, stated, "Sales growth was solid in the quarter with excellent growth in our Laboratory product lines and good growth in our Core Industrial business. Sales growth in the Americas and China was particularly strong while sales growth in Europe was impacted by strong prior-year comparisons. With the benefit of our margin initiatives, and despite significant challenges from the adverse impact of currency and tariff costs, we achieved strong growth in earnings in the quarter."

GAAP Results
EPS in the quarter was $5.06, compared with the prior-year amount of $4.31.

Compared with the prior year, total reported sales increased 1% to $731.4 million. By region, reported sales increased 7% in the Americas and 2% in Asia/Rest of World. Reported sales in Europe declined by 6%. Earnings before taxes amounted to $155.2 million, compared with $143.6 million in the prior year.

Non-GAAP Results
Adjusted EPS was $5.16, an increase of 11% over the prior-year amount of $4.65.

Compared with the prior year, total sales in local currency increased 5% as currency reduced reported sales growth by 4%. By region, local currency sales increased 7% in the Americas and 7% in Asia/Rest of World. Local currency sales declined 1% in Europe. Adjusted Operating Profit amounted to $177.7 million, a 5% increase from the prior-year amount of $169.3 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Six Month Results

GAAP Results
EPS was $9.48, compared with the prior-year amount of $7.88.

Compared with the prior year, total reported sales increased 2% to $1.411 billion. By region, reported sales increased 5% in the Americas and 3% in Asia/Rest of World. Reported sales in Europe declined 2%. Earnings before taxes amounted to $280.9 million, compared with $261.0 million in the prior year.

Non-GAAP Results
Adjusted EPS was $9.26, an increase of 11% over the prior-year amount of $8.38.

Compared with the prior year, total sales in local currency increased 6% as currency reduced reported sales growth by 4%. By region, local currency sales increased 5% in the Americas, 4% in Europe and 8% in Asia/Rest of World. Adjusted Operating Profit amounted to $325.6 million, a 5% increase from the prior-year amount of $308.8 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Outlook

The Company said that based on its assessment of market conditions today, management anticipates local currency sales growth in 2019 will be approximately 5%. This sales growth is expected to result in Adjusted EPS in the range of $22.60 to $22.75, a growth rate of 11% to 12%. This compares with previous Adjusted EPS guidance of $22.55 to $22.75.

Based on today’s assessment of market conditions, management anticipates that local currency sales growth in the third quarter 2019 will be in the range of 4% to 5%, and Adjusted EPS is forecasted to be in the range of $5.65 to $5.75, an increase of 10% to 12%.

While the Company has provided an outlook for local currency sales growth and Adjusted EPS, it has not provided an outlook for reported sales growth or EPS as it would require an estimate of currency exchange fluctuations and non-recurring items, which are not yet known. The Company noted in making its outlook that economic uncertainty remains in certain regions of the world and market conditions are subject to change.

Conclusion

Filliol concluded, "With the exception of our Food Retail business, demand in our markets is favorable and our growth initiatives continue to generate tangible results. We assume market conditions will remain unchanged and our outlook for the third quarter is positive. As we look to the later part of the year, we acknowledge there is more uncertainty due to macroeconomic data. We remain focused on our growth strategy and believe we can continue to gain market share regardless of the economy. Based on market conditions today, we believe we can deliver strong results in 2019."

Other Matters

The Company will host a conference call to discuss its quarterly results today (Thursday, August 1) at 5:00 p.m. Eastern Time. To hear a live webcast or replay of the call, visit the investor relations page on the Company’s website at www.mt.com/investors. The presentation referenced in the conference call will be located on the website prior to the call.

On August 1, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2019, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 1, 2019, View Source [SID1234538098]).

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"This is an exciting time for Syros as we continue to advance our clinical-stage programs toward multiple data readouts this year and next that have the potential to validate our fundamental approach to drug development and catalyze change in the treatment landscape for cancers with high unmet needs," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We plan to report updated clinical data for SY-1425 and SY-1365 in the fourth quarter, which we expect will provide additional insights into the safety and clinical activity of both drug candidates and further inform our development plans. We are particularly pleased to announce that we recently began enrolling relapsed or refractory AML patients in a new cohort in our Phase 2 trial of SY-1425 in combination with azacitidine. With this accomplishment, we now have three ongoing trial cohorts with potential for proof-of-concept data in 2020 that, if positive, bring us closer to our vision of providing much-needed therapies for patients."

Upcoming Milestones:

SY-1425

Syros plans to complete enrollment in the second half of 2019 in the Phase 2 trial cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed AML who are not suitable candidates for standard chemotherapy.
Syros plans to report updated data on SY-1425 in combination with azacitidine in the fourth quarter of 2019 in newly diagnosed patients with AML who are not suitable candidates for standard chemotherapy.
Syros plans to report potential proof-of-concept data from the ongoing cohort evaluating SY-1425 in combination with azacitidine in biomarker-positive patients with relapsed or refractory (R/R) AML in 2020.
SY-1365

Syros plans to report initial clinical data in the fourth quarter of 2019 from the expansion portion of its Phase 1 trial, including: initial efficacy and safety assessments from the cohort evaluating SY-1365 as a single agent in high-grade serous ovarian cancer patients who have had three or more prior lines of therapy; initial safety and pharmacokinetic data from the cohort evaluating SY-1365 in combination with carboplatin in high-grade serous ovarian cancer patients who have had one or more prior lines of therapy; and initial safety, efficacy and mechanistic data from the cohort evaluating SY-1365 as a single agent in patients with advanced solid tumors accessible for biopsy.
Syros plans to report additional data from these cohorts, including potential proof-of-concept data from the ongoing cohort in high-grade serous ovarian cancer patients who have had three or more prior lines of therapy, in 2020.
Syros also plans to report potential proof-of-concept data from an ongoing cohort evaluating SY-1365 as a single agent in patients with relapsed ovarian clear cell cancer and initial data from an ongoing cohort in hormone receptor (HR)-positive CDK4/6 inhibitor-resistant breast cancer patients in 2020.
SY-5609

Syros plans to present new preclinical data on SY-5609, including pharmacokinetic and pharmacodynamic data and assessments of anti-tumor activity in patient-derived xenograft models of multiple cancers, in the fourth quarter.
Syros plans to complete investigational new drug (IND)-enabling studies of SY-5609 in 2019 to support the initiation of a Phase 1 oncology trial in early 2020.
Recent Pipeline Highlights:

In May 2019, Syros opened for enrollment the new Phase 2 trial cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with R/R AML.
In May 2019, Syros published a new manuscript, Discovery and Characterization of SY-1365, a Selective, Covalent Inhibitor of CDK7, in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s journal Cancer Research. The publication highlighted the discovery, mechanism of action and promise of SY-1365 as a new targeted approach to treat a range of difficult-to-treat cancers.
Recent Corporate Highlights:

In June 2019, Syros appointed Alice Shaw, M.D., Ph.D., Director of the Center for Thoracic Cancers at Massachusetts General Hospital and a Professor of Medicine at Harvard Medical School, to its Board of Directors. Dr. Shaw is a highly respected oncologist and recognized leader in translational medicine and the development of targeted cancer therapies.
Second Quarter 2019 Financial Results:

Syros had cash, cash equivalents and marketable securities of $121.7 million as of June 30, 2019, as compared with $99.7 million in December 31, 2018. This increase in cash reflects aggregate net proceeds of approximately $65.0 million from Syros’ two concurrent underwritten public offerings, which closed in April 2019.

For the second quarter of 2019, Syros reported a net loss of $19.5 million, or $0.47 per share, compared to a net loss of $14.0 million, or $0.43 per share, for the same period in 2018.

Revenues were $0.5 million for the second quarter of 2019, as compared to $0.4 million for the second quarter of 2018. Revenues in both the second quarter of 2019 and the second quarter of 2018 were earned under Syros’ collaboration with Incyte Corporation.
Research and development (R&D) expenses were $15.5 million for the second quarter of 2019, as compared to $11.1 million for the same period in 2018. This increase was primarily attributable to continued advancement of the Company’s existing clinical trials and advancement of its preclinical programs, including SY-5609 into IND-enabling studies.
General and administrative (G&A) expenses were $5.2 million for the second quarter of 2019, as compared to $3.8 million for the same period in 2018. This increase was primarily attributable to an increase in employee-related expenses.
Financial Guidance:
Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements to the end of the first quarter of 2021.

Conference Call and Webcast:
Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2019 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international), and refer to conference ID 7254685. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.

On August 1, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the potential of the microbiome organ to treat disease and improve human health, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Kaleido Biosciences, AUG 1, 2019, View Source [SID1234540067]).

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"In the second quarter we made important progress with our pipeline and now have five clinical studies underway with our Microbiome Metabolic Therapy (MMT) candidates," said Alison Lawton, President and Chief Executive Officer of Kaleido. "We initiated Kaleido’s first Phase 2 clinical trial with the advancement of KB195 for urea cycle disorders (UCD) under an IND. For our KB174 program, we completed enrollment in a dosing study in healthy subjects and continued to progress our clinical study in patients with cirrhosis. We also advanced a third MMT, KB109, into a clinical study in patients colonized with multi-drug resistant pathogens. We look forward to a number of key milestones expected during the second half of the year, including data from three clinical studies in two different patient populations."

Recent Highlights

Received approval from regulatory authorities in the United Kingdom and Belgium for the Company’s clinical trial application (CTA) for its Phase 2 clinical trial of KB195 in UCD

Initiated the Phase 2 clinical trial evaluating KB195 in patients with UCD

Initiated a non-IND clinical study of KB109 in patients colonized with multi-drug resistant pathogens

Expanded Kaleido’s Scientific Advisory Board to include six leading experts in microbiology, chemistry and microbiome research across a variety of therapeutic areas:

Laurie H. Glimcher, M.D., President and CEO, Dana-Farber Cancer Institute, Director, Dana-Farber/Harvard Cancer Center, and Richard and Susan Smith Professor of Medicine, Harvard Medical School;

Robert Jenq, M.D., Assistant Professor in the Department of Genomic Medicine, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center;

C. Ronald Kahn, M.D., Head of the Section on Integrative Physiology and Metabolism, Past President & CEO, Joslin Diabetes Center, and Mary K. Iacocca Professor of Medicine, Harvard Medical School;

Laura L. Kiessling, Ph.D., Novartis Professor of Chemistry, Massachusetts Institute of Technology;

Max Nieuwdorp, M.D., Professor of Internal Medicine and endocrinologist, University of Amsterdam’s Faculty of Medicine (AMC-UvA); and

Peter J. Turnbaugh, Ph.D., Associate Professor, Department of Microbiology and Immunology, G.W. Hooper Research Foundation, and Investigator, Chan Zuckerberg Biohub, University of California, San Francisco.

Appointed Jerald Korn as General Counsel and Corporate Secretary

Members of Kaleido’s leadership team were featured speakers at the 4th Microbiome Movement – Drug Development Summit held June 26-28, 2019 in Boston

Anticipated Key Milestones
Safety and tolerability data from a non-IND clinical study of KB195 in patients with UCD accepted for presentation at the annual Society for the Study of Inborn Errors of Metabolism Symposium, Sept 3-6, 2019

Data from a non-IND clinical study of KB174 in healthy subjects to explore dosing expected in Q4 2019

Data from a non-IND clinical study of KB174 in patients with well-compensated cirrhosis expected in Q4 2019
Second Quarter 2019 Financial Results
For the second quarter ended June 30, 2019, Kaleido reported a net loss of approximately $24.6 million, or $0.83 per share, basic and diluted, compared to a net loss for the quarter ended June 30, 2018 of $12.3 million, or $2.57 per share, basic and diluted.
Total operating expenses for the quarter ended June 30, 2019 were $25.0 million compared to $12.4 million for the quarter ended June 30, 2018.
Research and development expenses for the quarter ended June 30, 2019 were $18.8 million, compared to $9.1 million for the quarter ended June 30, 2018. The increase in expense for the quarter was driven by an increase in external manufacturing and research costs to support the production of study material used in preclinical studies, human clinical studies, and clinical trials as well as clinical research organizations costs associated with MMT candidates for 2019.
General and administrative expenses were $6.2 million for the quarter ended June 30, 2019, compared to $3.2 million for the quarter ended June 30, 2018. The increase in general and administrative expenses compared to the same quarter last year was driven by increased professional services and employee-related costs as the Company continues to expand its infrastructure to support its growth.
Total operating expenses for the quarter ended June 30, 2019 include non-cash stock-based compensation expense of $2.4 million compared to $0.5 million of non-cash stock-based compensation expense for the quarter ended June 30, 2018.
Cash and cash equivalents were $100.0 million as of June 30, 2019.

About Microbiome Metabolic Therapies (MMT)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted glycans that are orally administered, have limited systemic exposure, and are selectively-metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples from healthy subjects and patients in an ex vivo setting, followed by advancing MMT candidates rapidly into non-Investigational New Drug (non-IND) clinical studies in healthy subjects and patients. These non-IND human clinical studies are conducted under regulations supporting research with food, measuring safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an IND or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On August 1, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that members of Aura’s executive team will participate in the following upcoming investor conferences (Press release, Aura Biosciences, AUG 1, 2019, View Source [SID1234538002]):

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Canaccord Genuity’s 39th Annual Growth Conference on August 8, 2019 in Boston, MA and will present at 2:00 p.m. Eastern Time

BTIG Biotechnology Conference on August 12, 2019 in New York, NY

On August 1, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that it plans to issue its second quarter 2019 financial results before the open of the U.S. financial markets on Thursday, August 08, 2019 (Press release, Selecta Biosciences, AUG 1, 2019, View Source [SID1234538018]).

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At 8:30 a.m. ET that day, Selecta will host a conference call and live audio webcast to discuss second quarter 2019 financial results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10127459.