On October 22, 2019 A-Alpha Bio, a biotechnology startup that helps pharmaceutical companies characterize protein interactions for accelerated drug development, reported that it has raised $2.8M from leading science-focused venture capital firms and angel investors (Press release, A-Alpha Bio, OCT 22, 2019, View Source [SID1234636897]). The round was led by OS Fund and also includes AME Cloud Ventures, Boom Capital, Madrona Venture Group, Sahsen Ventures, Washington Research Foundation, and leading biotech angel investors. Since 2017, A-Alpha Bio has been supported by CoMotion, the University of Washington’s collaborative innovation hub, the National Science Foundation, and the Bill and Melinda Gates Foundation.

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A-Alpha Bio has developed a genetically engineered platform technology, called AlphaSeq, for measuring interactions between proteins that can be used to discover and optimize life-saving drugs. AlphaSeq was invented and developed by A-Alpha Bio’s founders Drs. David Younger and Randolph Lopez, and Scientific Advisors, Drs. David Baker and Eric Klavins, at the University of Washington (UW). AlphaSeq enables the measurement of millions of interactions between proteins with high quantitative accuracy.

"While there are many methods available for screening large biomolecular libraries for a particular binding activity, there are few approaches for assessing in parallel the very large number of possible interactions between biomolecules in two large libraries," said David Baker, who serves as Head of the Institute for Protein Design at the University of Washington and Scientific Advisor to A-Alpha Bio. "A-Alpha Bio’s exciting technology now provides a way to not only quantitatively measure the interactions between all pairs of molecules in two libraries, but also the effect of small molecules and other perturbations on these interactions."

Pharmaceutical companies are pursuing increasingly challenging targets, which often require binding to multiple proteins or specificity between closely related proteins. Drug development currently requires iterative screening against one target at a time. This approach is slow, costly, and often ineffective at producing successful therapeutics. AlphaSeq will allow drug developers and researchers to radically accelerate their screening against thousands of disease targets in a single experimental step.

"A-Alpha Bio’s platform is plug-and-play for partners, facilitating read-outs on drug potency and effectiveness in a much shorter time-frame, solving an important challenge for pharma companies," said Jeff Klunzinger, Co-Founder and General Partner of OS Fund. "We are confident David Younger, Randolph Lopez and the A-Alpha Bio team will be able to accelerate discovery of multi-target protein drugs, such as multi-target antibodies, and small-molecule protein interaction modulators."

The seed financing announced today will support research operations to validate AlphaSeq with many high-impact disease targets, including those for oncology and infectious diseases, and allow A-Alpha Bio to begin drug discovery and optimization partnerships with pharmaceutical companies.

"We are thrilled to have the backing of synthetic biology experts, pharmaceutical industry veterans, and seasoned company builders who will add a tremendous amount of value," said Dr. David Younger, Co-Founder and CEO of A-Alpha Bio. "We have assembled a powerful group of investors, led by OS Fund, who share our passion for disrupting the pharmaceutical industry with breakthrough innovations in synthetic biology."

This funding comes following an announcement earlier this year that A-Alpha Bio was awarded a Bill & Melinda Gates Foundation grant to support a feasibility study for the discovery and optimization of therapeutics to protect developing world infants from intestinal pathogens.

On October 22, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported financial results and business progress for the third quarter ended September 30, 2019. For the third quarter of 2019, revenue was $31.0 million, an increase of 32% over the third quarter of 2018 (Press release, Veracyte, OCT 22, 2019, View Source [SID1234542412]). Net cash used in operating activities in the third quarter of 2019 was $1.6 million, an improvement of 13% compared with the third quarter of 2018.

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"We had a solid third quarter in which we continued to drive volume and revenue growth across our products and grew biopharmaceutical services revenue through key milestone achievements," said Bonnie H. Anderson, chairman and chief executive officer of Veracyte. "We are particularly excited by the new, preliminary data for our noninvasive nasal swab test for early lung cancer detection, which we believe has significant potential to improve care among the millions of patients with suspicious lung nodules detected each year. Importantly, as we grow our business and advance our pipeline, we remain on track to achieve our goal of reaching cashflow breakeven status before the end of the year."

Third Quarter 2019 Financial Results

For the third quarter of 2019 as compared with the third quarter of 2018:

Revenue was $31.0 million, an increase of 32%; excluding $4.3 million of biopharmaceutical services revenue, revenue was $26.7 million, an increase of 15%.
Gross Margin was 71%, an increase of six percentage points; excluding biopharmaceutical services revenue, gross margin was 66%, an increase of two percentage points.
Operating Expenses, Excluding Cost of Revenue were $23.6 million, an increase of 21%.
Net Loss was $0.7 million, an improvement of 84%.
Net Loss Per Share was $0.02, an improvement of 83%.
Net Cash Used in Operating Activities was $1.6 million, an improvement of 13%.
Cash and Cash Equivalents were $195.7 million at September 30, 2019.
For the nine-month period ended September 30, 2019, as compared with the prior year period of 2018:

Revenue was $90.6 million, an increase of 37%; excluding $11.8 million of biopharmaceutical services revenue, revenue was $78.8 million, an increase of 20%.
Gross Margin was 71%, an increase of eight percentage points; excluding biopharmaceutical services revenue, gross margin was 66%, an increase of three percentage points.
Operating Expenses, Excluding Cost of Revenue were $71.2 million, an increase of 17%.
Net Loss was $5.1 million, an improvement of 74%.
Net Loss Per Share was $0.11, an improvement of 80%.
Net Cash Used in Operating Activities was $5.0 million, an improvement of 59%.
Third Quarter 2019 and Recent Business Highlights

Commercial Growth and Reimbursement Expansion:

Grew total genomic test volume in the third quarter of 2019 to 9,941, an increase of 24% over the third quarter of 2018.
– Increased Percepta Genomic Sequencing Classifier (GSC) volume to 793 tests, an increase of 112% compared to the third quarter of 2018.

– Expanded Envisia Genomic Classifier volume to 223 tests, a Q3 2019 growth sequentially over Q2 2019 of 72%.

– Grew Afirma test volume to 8,925 tests, an increase of 17%, compared to the third quarter of last year.

Strengthened Library of Clinical Evidence:

Published a clinical and analytical validation paper in Frontiers in Endocrinology demonstrating the Afirma Xpression Atlas’s ability to help inform surgery and treatment decisions in patients with thyroid nodules deemed suspicious for cancer by the Afirma Genomic Sequencing Classifier. A separate paper published in Thyroid reinforced the test’s potential value in clinical practice.
Five studies are being presented at the annual meeting of the American College of Chest Physicians (CHEST 2019), including:
– Three abstracts showing that the Envisia classifier enhances physicians’ ability to confidently distinguish idiopathic pulmonary fibrosis from other interstitial lung diseases when used with high-resolution CT imaging.

– Two abstracts demonstrating the clinical validity and utility, respectively, of the Percepta classifier in lung cancer diagnosis when bronchoscopy findings are inconclusive.

Advanced Pipeline:

Presented data at CHEST 2019 demonstrating the ability of the company’s preliminary nasal swab test to enable early lung cancer detection and diagnosis. The findings show that the test can accurately classify lung cancer risk in patients with lung nodules so that they may be directed to prompt diagnosis and treatment or may be monitored noninvasively.
Updated 2019 Financial Outlook

Veracyte is re-affirming its 2019 annual revenue guidance of $119 million to $122 million and net cash used in operating activities of $2 million to $4 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time today.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source webcast should be accessed 10 minutes prior to the conference call start time.

A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

8767084

On October 22, 2019 Revolution Medicines, Inc., a clinical-stage oncology company focused on developing targeted therapies to inhibit elusive frontier targets within notorious cancer pathways, reported that preclinical in vivo data on the company’s novel inhibitors of oncogenic RAS(ON) mutants will be presented at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Revolution Medicines, OCT 22, 2019, View Source [SID1234542428]). Presented findings will highlight the ability of the company’s inhibitors to overcome adaptive resistance mechanisms and drive xenograft regressions in in vivo models. The 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) is being held October 26-30, 2019 in Boston, MA.

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Leveraging its proprietary tri-complex technology platform, Revolution Medicines is developing a portfolio of targeted RAS compounds that it believes are the first potent, mutant-selective, cell-active inhibitors of the active, GTP-bound form of RAS, or RAS(ON). Initially, the company is prioritizing four mutant RAS(ON) targets, KRASG12C, KRASG13C, KRASG12D and NRASG12C.

The data on the company’s active RAS(ON) inhibitors will be reported in podium and poster presentations entitled, "Tri-complex inhibitors of the oncogenic, GTP-bound form of KRASG12C overcome RTK-mediated escape mechanisms and drive tumor regressions in vivo." Details of the presentations are as follows:

Podium Presentation #PR10:

Session: Spotlight on Proffered Papers 3
Presenting Author: Christopher Schulze, Ph.D., senior scientist at Revolution Medicines
Date/Time: Tuesday, October 29, 2019, 12:20 – 12:30 p.m. Eastern
Location: Level 3 Ballroom AB Lobby
Poster Presentation #B077:

Session: Poster Session B: MAPK Pathways 1
Presenting Author: Christopher Schulze, Ph.D., senior scientist at Revolution Medicines
Date/Time: Monday, October 28, 2019, 12:30 – 4:00 p.m. Eastern
Location: Level 2 – Hall D
In addition to the presentations on its mutant RAS inhibitors, Revolution Medicines will also report preclinical data from its 4EBP1/mTORC1 program in a poster presentation at the conference. The presented findings will highlight results of the company’s work in identifying a potential biomarker of response to selective mTORC1 inhibitors. Details of that presentation are as follows:

Poster Presentation #B108:

Title: 4EBP3 mRNA as a biomarker of therapeutic response to treatment with mTORC1 inhibitors
Presenting Author: Bianca Lee, Ph.D., scientist at Revolution Medicines
Session: Poster Session B: mTOR/PI3-Kinase
Date/Time: Monday, October 28, 2019, 12:30 – 4:00 p.m. Eastern
Location: Level 2 – Hall D

On October 22, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the third quarter ended September 30, 2019 (Press release, Quest Diagnostics, OCT 22, 2019, View Source [SID1234542395]).

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"We had a solid quarter of top and bottom-line growth," said Steve Rusckowski, Chairman, CEO and President. "While PAMA reimbursement pressures persist throughout the industry, our expanded network access and laser focus on driving operational excellence are enabling growth. Based on our progress to date we have updated our outlook and are well-positioned to meet our commitments for the rest of the year."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, income from continuing operations attributable to Quest Diagnostics, and diluted EPS from continuing operations, see note 2 of the financial tables attached below.

Beginning in 2019, the company has changed how it presents adjusted income measures to additionally exclude amortization expense for all periods presented. We believe this presentation provides investors with additional insight to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business.

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: Investor; or via live webcast on the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 888-566-0408 for domestic callers or 402-998-0597 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 22, 2019 until midnight Eastern Time on November 5, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On October 22, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported preliminary clinical data showing that the company’s noninvasive nasal swab test – the first of its kind – can enable early lung cancer detection and diagnosis so that more lives can be saved (Press release, Veracyte, OCT 22, 2019, View Source [SID1234542397]). The new findings specifically show that the novel genomic test can accurately classify lung cancer risk in patients with lung nodules so that these patients can obtain the prompt diagnosis and potential treatment they need or may be monitored noninvasively. The findings will be presented today at the annual meeting of the American College of Chest Physicians (CHEST) in New Orleans.

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"Early lung cancer detection is key to saving lives. However, today when a potentially malignant lung nodule is found, physicians lack accurate and reliable tools to determine which patients require more invasive diagnostic evaluation and those who can be managed with noninvasive surveillance," said Carla R. Lamb, M.D., interventional pulmonologist at Lahey Hospital & Medical Center, in Burlington, Mass., who was a primary investigator on the nasal classifier study and will present the findings. "Given the nasal classifier’s ability to more accurately classify cancer risk in patients with lung nodules, the test can help address this diagnostic gap, potentially helping to save more lives while also enabling patients to avoid unnecessary invasive procedures and reducing costs."

To develop and evaluate the test, Veracyte utilized nasal samples from over 700 patients with lung nodules found on computed tomography (CT) scans who were prospectively recruited and whose cancer status was subsequently determined. The researchers evaluated the test’s performance on an independent blinded subset of 261 patients. The researchers determined the genomic test’s ability to identify patients as high risk and low risk for cancer and then modeled its impact on patient care when the cancer prevalence is 25 percent. This aligns with the anticipated cancer prevalence among the people on whom the test will eventually be used.

Among patients whose nodules were benign, the genomic test classified over 40 percent as low risk for cancer, with a sensitivity of over 95 percent, meaning that these patients could be monitored noninvasively with a very low chance of missing a cancer. Among patients whose nodules were malignant, the test classified over 40 percent as high risk for cancer, with a specificity of over 94 percent, meaning these patients could be directed to more invasive diagnostic procedures and treatment, with a low rate of false positive results. The test’s performance was consistent regardless of lung nodule size or location, as well as cancer subtype or stage.

Currently, physicians use clinical factors to calculate the risk of cancer when a lung nodule is found. However, these calculators vary widely in how they measure risk, produce differing results and have in some cases been shown to be less accurate than physician judgment alone. Researchers in the current study determined that the nasal swab test would identify over 70 percent more patients as "low risk" and 18 percent more patients as "high risk," as compared to one of the most widely used clinical risk calculators.

"Lung cancer is the leading cancer killer worldwide," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "We are very encouraged by these preliminary data, which suggest that our nasal swab test has the potential to transform how this disease is diagnosed, enabling lung cancer patients to get the treatment they need sooner, while helping patients with benign nodules avoid unnecessary and costly invasive procedures. These data also mark the latest milestone in our long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson.* We look forward to finalizing and making our test available to physicians and their patients by early 2021."

Veracyte is collaborating with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration, announced in January 2019, was formed to accelerate two key lung cancer programs for Veracyte: the commercialization of its Percepta Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson have combined clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte has contributed bronchial and nasal samples from its clinical trials, which are part of the company’s extensive lung cancer-focused biorepository.

Veracyte’s nasal swab test utilizes novel and proven "field of injury" science, which identifies genomic damage associated with lung cancer in current or former smokers using a simple brushing of the person’s nasal passage. The company is developing the test on its RNA whole-transcriptome sequencing and machine learning platform, which leverages highly granular genomic information to answer specific clinical questions.

Veracyte estimates that the market opportunity for its nasal swab test, when used to assess lung cancer risk in patients with lung nodules identified by imaging is approximately $1.9 billion in the United States and $3.9 billion for both the U.S. and European Union. Veracyte also plans to explore opportunities to deploy its "field of injury" technology at other points along the lung cancer care continuum. The company believes the overall global lung cancer diagnostic market is approximately $30 billion.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year. Early detection is key, with a five-year survival rate of over 60 percent when the cancer is found early, compared to five percent when it is found at a later stage. Lung nodules are typically the first sign of lung cancer. Approximately two million lung nodules are detected each year in the U.S. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss the company’s third quarter 2019 financial results and provide a general business update, including details on the new nasal swab test data for early lung cancer detection. The conference call will be webcast live from the company’s website and will be available via the following link: View Source

The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:
U.S./Canada participant dial-in number (toll-free): (855) 541-0980
International participant dial-in number: (970) 315-0440
Conference I.D.: 8767084