On May 15, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported that it will present a corporate update at the UBS Global Healthcare Conference in New York on Tuesday, May 22 at 8:30 a.m. ET (Press release, Aeglea BioTherapeutics, MAY 15, 2018, View Source [SID1234526608]).

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To access the live and archived webcast of the presentation, please visit the Presentations & Events section of the Aeglea BioTherapeutics investor relations website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary. The replay of the webcast will be available for 30 days thereafter.

On May 15, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported financial and operating results for the first quarter ended March 31, 2018 (Press release, Oncocyte, MAY 15, 2018, View Source [SID1234526638]).

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"We have completed initial sample testing and begun analyzing the data collected in the confirmation study of our DetermaVu lung cancer diagnostic test. This study is being conducted on alternative diagnostic testing platforms using newly discovered biomarkers and seeks to confirm previous results," said William Annett, President and Chief Executive Officer. "We are on track to meet our mid-year timeline for the results of this study. If the remaining DetermaVu studies are successful, our goal remains to complete the final Clinical Validation study in 2018."

As recently reported, OncoCyte discovered and filed patent applications for an additional 190 novel lung cancer biomarkers that may enable DetermaVu to provide better differentiation between malignant and benign lung nodules for improved lung cancer diagnosis. Our current study is analyzing a combination of the biomarkers OncoCyte used in earlier studies and newly discovered biomarkers. All 160 study samples have now been run on two established commercial diagnostic testing platforms and the data are being analyzed.

The outcome of the study will determine whether the 190 novel biomarkers will further increase the accuracy of DetermaVu and whether the diagnostic testing platforms being tested will provide consistent and robust support for the further clinical development studies that are necessary for commercialization.

Timeline and Upcoming Milestones

Data analysis from all 160 samples is expected to be completed by mid-year, at which time a decision will be made as to the diagnostic testing platform the Company will use going forward. Once the appropriate platform is selected, OncoCyte will work to optimize and lock a new algorithm based on the diagnostic testing platform and the new panel of biomarkers selected for the test, and then conduct an R&D Validation Study which will include an Analytic Validation Study. All samples necessary for carrying out these studies are in-house, enabling rapid advancement through each study. If these studies are successful, the Company will conduct a Clinical Validation study, which it expects to complete in 2018.

Other Recent Developments

Bolstered the balance sheet through a $10 million private placement of common stock with two current investors.

Discovered and filed patent applications for 190 novel lung cancer biomarkers that may enhance OncoCyte’s lung cancer test and enable better differentiation of malignant from benign lung nodules for improved lung cancer diagnosis.

Enhanced abilities to rapidly prototype, evaluate, and develop lung cancer diagnostic products through the continued growth of our well-characterized lung cancer clinical sample bank.

Strengthened the Board of Directors by adding Ronald Andrews, Jr., an executive with over 30 years’ experience in the molecular diagnostics and genomics industries. In addition, Cavan Redmond, a Director since 2015, was appointed Chairman of the Board.
First Quarter 2018 Financial Results

For the first quarter ended March 31, 2018, OncoCyte incurred a net loss of $3.8 million, or $0.12 per share, compared to a net loss of $4.7 million, or $0.16 per share, in the first quarter of 2017.

Operating expenses for the three months ended March 31, 2018 were $3.9 million, and were $3.4 million on an as adjusted basis.

Research and development expenses for the quarter ended March 31, 2018 were $1.5 million compared to $1.8 million for the same period in 2017, a decrease of $0.3 million. This decrease is primarily attributable to decreases in compensation and related expenses, including stock-based compensation expenses.

General and administrative expenses for the three months ended March 31, 2018 were $1.8 million compared to $2.0 million for the same period in 2017, a decrease of $0.2 million. This decrease is mainly attributable to a $1.1 million shareholder noncash expense for the issuance of certain warrants during the three months ended March 31, 2017. The decrease was partially offset by increases in legal, compliance and business development costs, and compensation related expenses, including noncash stock-based compensation expense primarily related to stock options granted to an executive hired in the fourth quarter of 2017.

At March 31, 2018, OncoCyte had cash and cash equivalents of $12.6 million and marketable securities valued at $0.95 million. An additional $2 million was received on May 10, 2018 as the final installment of a stock purchase commitment in a private placement of common stock during March 2018. The Company believes its resources, coupled with prudent expense management, are sufficient to execute its near-term strategies.

Cash used in operations was approximately $2.75 million for the first quarter of 2018, as reported, or just over $900,000 per month, which represents a reduced annualized cash used in operations compared to 2017.

Conference Call

OncoCyte will host a conference call today, May 15, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.

The dial-in number in the U.S./Canada is 800-263-0877; for international participants, the number is +1-323-794-2094. For all callers, please refer to Conference ID 6365614. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial +1-719-457-0820. Use the Conference ID 6365614. Additionally, the archived webcast will be available at View Source

On May 15, 2018 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant") reported that Paul S. Herendeen, executive vice president, Finance and chief financial officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Barclays High Yield Bond and Syndicated Loan Conference in Colorado Springs, Colo. on May 22, 2018 at 10:10 a.m. MDT (12:10 p.m. EDT) (Press release, Valeant, MAY 15, 2018, http://ir.valeant.com/news-releases/2018/05-15-2018-130406481 [SID1234526655]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Valeant web site at: http://ir.valeant.com/events-and-presentations/2018

On May 15, 2018 Eos Biosciences reported it will attend the 2018 Biotechnology Innovation Organization (BIO) International Convention being held June 2-5, 2018, in Boston (Press release, Eos Biosciences, MAY 15, 2018, View Source [SID1234526906]). Eos Biosciences’ Chief Executive Officer, Omar Haffar, Ph.D. and Chief Financial Officer, Thomas Plotts will attend the BIO International Convention.

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On May 15, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported financial and operating results for the first quarter ended March 31, 2018 as well as an update on its strategic direction and key organizational initiatives (Press release, Cancer Genetics, MAY 15, 2018, View Source [SID1234526639]).

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John A. Roberts, Chief Executive Officer of Cancer Genetics said, "Our progress during the first quarter aligned with our transformation strategy for 2018, which focuses on leveraging our core competencies and market-leading portfolio of diagnostics to accelerate the path to profitability and improve our competitive position.

"We are particularly pleased with the expansion of our Biopharma and Discovery Services businesses, where we are continuing to capitalize on the significant synergies that exist to add new clients and expand revenue among existing clients. Our oncology-focused testing, genomic services and biomarker insight capabilities are among the strongest in the industry, and add substantive value to our partners’ development efforts. We are currently supporting over 300 clinical trial and discovery projects, including 101 clinical trials that are focused on the growing trends associated with immuno-oncology product development, and are continuing to add more as we expand our capabilities and further establish ourselves as a major player in this space.

Mr. Roberts added, "In addition to expanding Biopharma and Discovery Services activities, there are two other keys to executing this strategy, which we believe will drive revenue growth and operating cost reductions. These were the divestiture of certain non-strategic assets and the reduction of our geographic footprint. We advanced both of these initiatives since the beginning of 2018."

"In an effort to further optimize efficiency across the organization, we recently completed the sale of our India operation to REPROCELL Incorporated and made the strategic decision to consolidate our Los Angeles laboratory operations, relocating our comprehensive solid tumor test portfolio and capabilities to our New Jersey and North Carolina facilities during the second and third quarters of 2018. These actions represent an important step in focusing our business, simplifying our operating structure and generating monetary value for the Company, and are consistent with the execution of the transformation strategy."

Mr. Roberts concluded, "Overall, we are pleased with the advancements we have made since the beginning of 2018. We are continuing to leverage synergies and implement strategies aimed at accelerating growth, while reducing expenses associated with non-core activities. We remain committed to optimizing our proprietary and unique test and service offerings to drive a leadership position in precision oncology."

FIRST QUARTER 2018 AND RECENT OPERATIONAL HIGHLIGHTS

Received special 510(k) clearance from the FDA for the Tissue of Origin (TOO) test to identify tumor origin and differentiate between metastatic, poorly differentiated, or undifferentiated cancers.
Completed sale of wholly-owned subsidiary BioServe Biotechnologies (India) Private Limited to REPROCELL for $1.9 million in April 2018.
As part of 2018 transformation strategy, began the consolidation of the west coast molecular profiling laboratory and relocation of most of these activities to New Jersey and North Carolina laboratories. The consolidation of this facility is expected to reduce operating expenses by over $4 million annually once completed, with completion planned for September 2018.
FIRST QUARTER 2018 FINANCIAL RESULTS

On January 1, 2018 the Company adopted the FASB Accounting Standards Codification Topic 606 "Revenue from Contracts with Customers" ("ASC 606"). The Company also adopted several FASB Accounting Standards Updates ("ASUs"). Financial information for the three months ended March 31, 2017 has not been restated and continues to be reported under the accounting standards in effect for that period. Additional information on the recently adopted accounting standards is included in the Company’s quarterly report on Form 10-Q for the period ended March 31, 2018.

The Company reported total revenue of $7.7 million for the first quarter of 2018 compared to revenue of $7.0 million in the first quarter of 2017, an increase of 10% or $0.7 million.

Biopharma services revenue totaled $3.7 million in the first quarter, flat compared to $3.7 million during the first quarter 2017. Biopharma projects are dependent on the timing, size and duration of our contracts with pharmaceutical and biotech companies and clinical research organizations, and can fluctuate in comparable periods. The Company increased the number of clinical studies and trials it is supporting to 241, up from 140 in Q1 2017. The Company’s book-to-bill ratio moved from 1.2 in Q1 2017 to 1.3 in Q1 2018.

​Clinical Services revenue decreased by approximately $0.7 million in the first quarter of 2018 compared to the same period in 2017, from $3.0 million to $2.3 million. The decrease in revenue was primarily related to the adoption of ASC 606, and a 16% decline in test volume in the NJ lab.

The Company’s Discovery Services contributed $1.7 million in revenue for the first quarter of 2018, an increase of approximately $1.4 million compared to $0.3 million in the first quarter of 2017. The increase was driven by a full quarter of vivoPharm revenue following its acquisition in August 2017, as well as growing demand for the Company’s early-stage discovery and bioinformatics analysis capabilities.

Gross profit margin was 33.7% or $2.6 million in Q1 2018, compared to 40% or $2.8 million in the first quarter 2017. Gross profit and gross margin percentage were impacted by a reduction in the number of non-revenue generating test validations, an increased focus among clinical and medical staff on customer-driven initiatives, and the continued rationalization of the Company’s cost structure from prior acquisitions and efforts to introduce greater efficiency in its laboratory operations.

Total operating expenses for the first quarter of 2018 were approximately $7.5 million, an increase of 35.5% compared to $5.6 million during the first quarter of 2017. The increase in total operating expenses is primarily related to the addition of SG&A expenses from the vivoPharm acquisition of $0.9 million, increases in sales and marketing costs of $0.4 million in the comparable periods as the Company ramped up clinical sales during the second half of 2017, non-cash charges associated with severance related payroll and benefit costs of $0.5 million in Q1 2018 and an increase in bad debt reserve of $0.5 million related to its Clinical Services business.

Net loss was $(4.5) million or $(0.16) per share for the first quarter of 2018, compared to a net loss of $(9.6) million or $(0.51) per share for the first quarter of 2017.

Cash and cash equivalents, excluding restricted cash of $0.4 million as of March 31, 2018 totaled $4.0 million, compared to $9.9 million as of December 31, 2017.

As announced on April 2, 2018, the Company engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership.