On May 15, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the company will present at the 2018 UBS Global Healthcare Conference in New York, NY (Press release, BeiGene, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349232 [SID1234526636]). The presentation is scheduled for 10:30 AM ET on Wednesday, May 23, 2018.

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

On May 15, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic) reported its unaudited financial results for the first quarter ended March 31, 2018 (Press release, ProMetic Life Sciences, MAY 15, 2018, View Source [SID1234526654]).

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"Our number one goal for 2018 is to close the gap between the fundamental value created over the last few years and the current share price as it does not reflect, in our view, all the clinical and operational milestones achieved. We have streamlined our clinical development programs to ensure that our most promising clinical assets and their respective indications are prioritized," said Pierre Laurin, President and Chief Executive Officer of Prometic. "We are committed to bringing to market our lead drug candidates for patients, as well as for shareholders. We are working diligently to improve our financial position and time-to-market, by partnering some of our lead drug candidates, in an effort to accelerate and facilitate access to markets."

Commenting on the first quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer said, "As I outlined at our recent Annual Shareholders’ Meeting, our priorities for the balance of 2018 are clearly established. Our commitment to tightly manage the cash resources is already paying off with less cash used in our operations during the first quarter of 2018, compared to the first quarter of 2017, with the goal of using approximately $15 million less in total for 2018. Our commitment to increase our cash runway is also underway, following the sale of $14 million worth of plasma inventory, early in the second quarter of 2018. We have also completed the review of our clinical and product development programs, concentrating on PBI-4050 in idiopathic pulmonary fibrosis and Alström syndrome, as well as on plasminogen. This allows us to focus our resources, save costs, and work toward partnership activities to increase our cash runway further."

Small Molecule Therapeutics Highlights

PBI-4050 – Mechanism of action and the discovery of a new antifibrotic pathway was published in the American Journal of Pathology
PBI-4050 – Clearance by the US Food and Drug Administration (FDA) for pivotal Phase 3 trial in patients with idiopathic pulmonary fibrosis (IPF), prioritizing IPF as one of our top indications along with Alström syndrome
PBI-4050 – Clinical activity sustained over 52 weeks with reversal of heart and liver fibrosis in Alström syndrome subjects
PBI-4547 – To be advanced in the clinic with a focus on liver fibrosis and metabolic diseases
Plasma Derived Therapeutics Highlights

RyplazimTM (plasminogen) – Comprehensive plan developed to address BLA chemistry, manufacturing and controls (CMC) changes requested by FDA
Inter-Alpha Inhibitor Proteins (IaIp) – Orphan drug and rare pediatric designations secured from the FDA
2018 First Quarter Financial Results

Revenues

Total revenues for the first quarter ended March 31, 2018 were $4.3 million compared to $4.9 million for the first quarter ended March 31, 2017. Revenues from the sale of goods amounted to $3.8 million for the first quarter ended March 31, 2018, compared to $4.4 million for the quarter ended March 31, 2017.

Net Loss

The Corporation incurred a net loss of $34.6 million for the quarter ended March 31, 2018 compared to a net loss for the quarter ended March 31, 2017 of $29.1 million. The increase in net loss year over year is mainly due to the increased finance costs of $2.9 million, the plasma inventory write-down of $1.5 million included in the cost of sales and other production expenses, the reduced margin contribution on the sale of bioseparations products, and the increase in administration, selling and marketing expenses. This was partially offset by the decrease in R&D expenses of $2.0 million during the quarter ended March 31, 2018 compared to the corresponding period in 2017.

Research and Development (R&D)

The Corporation incurred total R&D costs of $22.4 million for the quarter ended March 31, 2018 compared to $24.4 million for the first quarter ended March 31, 2017. R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics to be used in clinical trials and for the development of our production processes. The plasma-derived therapeutics are produced at the Laval plant and the Winnipeg Contract Manufacturing Organization (CMO) where as the small molecule therapeutics are manufactured by a third party pharmaceutical contract manufacturing organization for Prometic. The manufacturing and purchase cost of these therapeutics was $6.3 million during the quarter ended March 31, 2018 compared to $9.2 million during the quarter ended March 31, 2017. The decrease is mainly due to a reduction in production activities during the quarter ended March 31, 2018 compared to the same period in 2017.

Other R&D expenses were $16.1 million during the quarter ended March 31, 2018 compared to $15.2 million for the corresponding period in 2017. The increase of $1.0 million is partially due to an increase in employees working on the clinical trials and at our research centers and in pre-clinical studies of $0.8 million. These increases were partially offset by a decrease in Contract Research Organizations ("CRO") and investigator expenses by $0.4 million.

Administration, Sales & Marketing

Administration, selling and marketing expenses amounted to $7.7 million during the first quarter ended March 31, 2018 compared to $6.9 million during the first quarter ended March 31, 2017. The increase as compared to the first quarter of 2017 was due to the increase in salaries and benefits resulting from an overall increase in headcount, reflecting the build-up of the infrastructure in order to support the eventual sale of commercial product.

Finance Costs

Finance costs were $4.2 million for the quarter ended March 31, 2018 compared to $1.4 million during the corresponding period of 2017, representing an increase of $2.9 million. This increase reflects the higher level of debt during the quarter ended March 31, 2018 compared to the same period of 2017, reflecting the increase in the OID loans and the amounts drawn on the non-revolving credit facility agreement. Total long-term debt on the consolidated statement of financial position was $110.0 million at March 31, 2018 compared to $48.4 million at March 31, 2017.

Additional Information in Respect to the First Quarter Ended March 31, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended March 31, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

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