On March 25, 2020 Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, reported financial results and provided program highlights for the fourth quarter and full year ended December 31, 2019 (Press release, Viela Bio, MAR 25, 2020, View Source [SID1234555828]).

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"2019 was a pivotal year for Viela as we achieved many important financial, clinical and regulatory milestones. Supported by our recently completed initial public offering, we ended the year with a strong cash position, enabling continued pipeline growth and expansion," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "With a Biologics License Application (BLA) under review by the U.S. Food and Drug Administration (FDA) for our lead product candidate inebilizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), we have hired and trained a talented and experienced commercial team in anticipation of its potential approval. Based on strong efficacy and safety results, we believe that inebilizumab has the potential to be an important new treatment option for patients who suffer from NMOSD, a devastating, rare neuroinflammatory disease.

"While our top priority remains preparing to launch inebilizumab, we continue to make strong progress throughout our entire pipeline. We recently dosed the first patient in our Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome and expect to report interim results from a cohort of patients with cutaneous lupus erythematosus in our ongoing Phase 1b trial of VIB7734 in the second quarter of 2020."

PROGRAM HIGHLIGHTS

Inebilizumab

BLA for the Treatment of NMOSD Under FDA Review

In August 2019, the FDA accepted for review Viela’s BLA for inebilizumab and set a Prescription Drug User Fee Act, or PDUFA, action date of June 11, 2020. Inebilizumab, which was studied as a potential first-line monotherapy in patients with NMOSD, previously received Orphan Drug and Breakthrough Therapy designations from the FDA. The safety and efficacy data from the pivotal N-MOmentum trial—which formed the basis of the BLA filing—were recently published in the peer-reviewed journal, The Lancet.

Commercial Planning Activities On Track

In anticipation of the potential FDA approval of inebilizumab for the treatment of NMOSD under the Company’s first BLA, Viela has hired and trained a seasoned sales force with extensive experience leading neurology or rare disease product launches. Commercial efforts will focus on community and top centers of excellence. There are an estimated 10,000 NMOSD patients in the U.S.

Viela Planning to Initiate Additional Clinical Trials, Including a Pivotal Trial

Viela Bio recently submitted two Investigational New Drug (IND) applications to the FDA to begin human studies of inebilizumab in myasthenia gravis and IgG4-related disease, and plans to initiate phase 3 pivotal and Phase 2b trials, respectively, in mid-year 2020.

VIB4920

Phase 2b Trial in Patients with Sjögren’s Syndrome

In 2019, Viela initiated a Phase 2b trial for VIB4920 in patients with Sjögren’s syndrome— a common rheumatic disease for which there are currently no approved disease-modifying therapies. Patients with Sjögren’s syndrome suffer from debilitating fatigue and mouth and eye dryness, and in some cases, lung and kidney disease as well as an increased risk of lymphoma. Based on earlier clinical data, Viela believes that treatment with VIB4920—a fusion protein designed to bind to CD40L—could address immune overactivation in T and B cell-driven diseases such as Sjögren’s syndrome.

Additional Ongoing and Potential VIB4920 Clinical Trials

In 2019, Viela initiated a Phase 2 trial in patients with kidney transplant rejection. The Company is also exploring other potential indications associated with the CD40/CD40L co-stimulatory pathway in which to pursue additional clinical studies with VIB4920.

VIB7734

Interim Results Anticipated from Phase 1b Trial

Viela plans to report interim results from a cohort of patients with cutaneous lupus erythematosus from the ongoing Phase 1b trial of VIB7734 in the second quarter of 2020. The drug candidate is designed to target and bind to ILT7, a cell surface molecule specific to plasmacytoid dendritic cells (pDCs), leading to their depletion. Assuming the trial is able to establish proof of concept, Viela plans to progress VIB7734 to Phase 2 clinical trials in other autoimmune diseases that are also driven by the overproduction of type I interferons, cytokines and other chemokines secreted by pDCs.

CORPORATE UPDATES

Viela Raised Over $172 Million in Successful Initial Public Offering (IPO)

In October 2019, Viela closed its IPO of 9,085,000 shares of common stock, which included 1,185,000 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares, at a price to the public of $19.00 per share, for gross proceeds of approximately $172.6 million, before deducting the underwriting discounts and commissions and estimated offering expenses.

Expanded Partnerships for Global Development and Commercialization of Inebilizumab

In October 2019, Viela announced a partnership with Mitsubishi Tanabe Pharma Corporation to develop and commercialize inebilizumab in Japan and eight additional Asian countries for NMOSD and other potential indications. Viela received an upfront licensing fee of $30 million and will receive development and commercialization milestones and payments based, in part, on sales revenue.

Viela is also partnered with Hansoh Pharmaceuticals Group Company Limited for the development and commercialization of inebilizumab for autoimmune diseases and hematologic cancers in China, Hong Kong and Macau. Viela received a $20 million upfront payment and is eligible to receive milestone payments of up to an aggregate of $203 million, plus royalties on sales revenue.

FINANCIAL RESULTS

For the fourth quarter of 2019, Viela reported a net loss of $11.6 million, compared to a net loss of $15.1 million for the fourth quarter of 2018. For the full-year 2019, Viela Bio reported a net loss of $86.4 million, compared to a net loss of $190.3 million for the full year 2018.

As of December 31, 2019, Viela had $346.2 million in cash, cash equivalents, and investments and no outstanding debt. Viela received $30.0 million in cash for the upfront licensing fee from Mitsubishi Tanabe Pharma Corporation in 1Q 2020.

Research and development expenses were $32.5 million for the fourth quarter of 2019, which include $0.7 million of non-cash stock-based compensation expenses. For the full year of 2019, research and development expenses were $104.6 million. Research and development expenses for the year include $1.8 million of non-cash stock-based compensation expenses.

General and administrative expenses were $10.5 million for the fourth quarter of 2019, which include $0.7 million of non-cash stock-based compensation expenses. For the full year of 2019, general and administrative expenses were $35.1 million, which include $1.8 million of non-cash stock-based compensation expenses.

Total operating expenses for the fourth quarter of 2019 totaled $43.0 million, compared to $15.7 million for the fourth quarter of 2018. Non-cash share-based compensation expenses totaled $1.4 million for the fourth quarter of 2019, compared to $0.6 million for the fourth quarter of 2018.

Total operating expenses for the full-year 2019 totaled $139.7 million, compared to $192.3 million for the full-year 2018. Non-cash share-based compensation expense totaled $3.6 million for the full-year 2019, compared to $1.9 million for the full-year 2018.

2020 Financial Guidance

Viela Bio expects that its cash, cash equivalents and investments will fund its operating plans through 2022.

Conference Call and Webcast

The Company will host a live webcast and conference call to discuss its fourth quarter and full year financial results for 2019 and provide an update on recent corporate activities today at 5:00 p.m. ET.

The webcast will be accessible on the Events & Presentations page of Viela Bio’s website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 5057166.

The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.(i) General. This section must describe clinically significant adverse reactions (including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the drug), other potential safety hazards (including those that are expected for the pharmacological class or those resulting from drug/drug interactions), limitations in use imposed by them (eg, avoiding certain concomitant therapy), and steps that should be taken if they occur (eg, dosage modification). The frequency of all clinically significant adverse reactions and the approximate mortality and morbidity rates for patients experiencing the reaction, if known and necessary for the safe and effective use of the drug, must be expressed as provided under paragraph ©(7) of this section. In accordance with § 314.70 and § 601.12 of this chapter, the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established. A specific warning relating to a use not provided for under the "Indications and Usage" section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.(ii) Other special care precautions. This section must contain information regarding any special care to be exercised by the practitioner for safe and effective use of the drug (eg, precautions not required under any other specific section or subsection).

(iii) Monitoring: Laboratory tests. This section must identify any laboratory tests helpful in following the patient’s response or in identifying possible adverse reactions. If appropriate, information must be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.

(iv) Interference with laboratory tests. This section must briefly note information on any known interference by the product with laboratory tests and reference the section where the detailed information is presented (eg, "Drug Interactions" section

On March 25, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Personalis, MAR 25, 2020, View Source [SID1234555827]).

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Fourth Quarter and Full Year 2019 Highlights

Reported record revenues of $18.2 million in the fourth quarter and $65.2 million for the full year of 2019, representing a 38% and 73% increase versus $13.2 million in the fourth quarter and $37.8 million for the full year 2018

A total of 19 different customers placed orders for NeXT during 2019, with 9 of those customers placing their orders in the fourth quarter of 2019

Launched NeXT Dx Test, a diagnostic test for biopharmaceutical customers to utilize in clinical trials

"We are encouraged by the customer adoption and ramp of new orders for our NeXT platform, with orders exceeding revenues once again this quarter," said John West, Chief Executive Officer. "With the recent uptick in orders, as well as our broadening product offerings, which now includes diagnostic capabilities and with our liquid biopsy to be launched with customers this year, we expect revenues from biopharmaceutical customers to grow increasingly through the latter half of 2020."

Fourth Quarter 2019 Financial Results

Revenues were $18.2 million in the three months ended December 31, 2019, up 38% from $13.2 million in the same period of the prior year. Fourth quarter revenue growth was driven by an increase in volume for testing and analytical services provided to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In the fourth quarter, the VA MVP accounted for $13.8 million, or 76%, of revenues and the remaining $4.4 million, or 24%, was from biopharmaceutical and all other customers.

Gross margin was 36.2% for the three months ended December 31, 2019, compared with 36.7% in the same period of the prior year.

Operating expenses were $13.8 million for the three months ended December 31, 2019, compared with $8.0 million in the same period of the prior year.

Net loss was $6.6 million for the three months ended December 31, 2019 and net loss per share was $0.21 based on a weighted-average basic and diluted share count of 31.2 million, compared with a net loss of $3.6 million and a net loss per share of $1.16 on a weighted-average basic and diluted share count of 3.1 million in the same period of the prior year.

Cash, cash equivalents, and short-term investments were $128.3 million as of December 31, 2019.

Full Year 2019 Financial Results

Revenues were $65.2 million in the year ended December 31, 2019, up 73% from $37.8 million in 2018. Revenue growth was driven by an increase in volume for testing and analytical services provided to the VA MVP. In 2019, the VA MVP accounted for $43.5 million, or 67%, of revenues and the remaining $21.7 million, or 33%, was from biopharmaceutical and all other customers.

Gross margin was 33.9% for the year ended December 31, 2019, compared with 31.3% in 2018.

Operating expenses were $44.5 million for the year ended December 31, 2019, compared with $25.6 million in 2018.

Net loss was $25.1 million for the year ended December 31, 2019 and net loss per share was $1.39 based on a weighted-average basic and diluted share count of 18.0 million, compared with a net loss of $19.9 million and a net loss per share of $6.49 on a weighted-average basic and diluted share count of 3.1 million in 2018.

Outlook and COVID-19

Due to uncertainty surrounding the COVID-19 pandemic, Personalis is withdrawing previous 2020 guidance and will provide an updated outlook for 2020 during its first quarter earnings announcement and press release, to the extent practicable, based on available information at that time.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter financial results after market close on Wednesday, March 25, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 3623198. The live webinar can be accessed at View Source

On March 25 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported financial and operating results for the fourth quarter and year ended December 31, 2019, and provided a corporate update (Press release, Oncocyte, MAR 25, 2020, View Source [SID1234555826]).

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"We started 2020 in a strong position with significant accomplishments that support our strategy to provide actionable answers to physicians and their patients with the goal of improving outcomes and survival," said Ron Andrews, Chief Executive Officer of Oncocyte. "I am incredibly proud to have officially transitioned to a commercial stage company with the launch of DetermaRxTM, the first test for chemotherapy benefit prediction in patients with NSCLC. We have successfully onboarded all 7 of our early access partners and they have started sending patient samples to our lab and, notably, all physicians have re-ordered the test, a very important indicator of future utilization. To date, we have identified 7 "high-risk" patients and believe we are already saving lives by identifying high-risk patients whose treatment course will now include adjuvant chemotherapy instead of surgical resection alone. This is a remarkable advancement for early NSCLC patients, and we are honored to be able to provide clarity for these patients and their physicians when making critical decisions after surgery. We look forward to receiving our final coverage decision from CMS and our continued progress in widespread adoption of this important test."

Mr. Andrews continued, "While we are doing our part to minimize the COVID-19 situation in our local communities, we have been able to continue lab operations in compliance with applicable orders and mandates, and have made great strides in expanding our suite of important tests with the acquisition of Insight Genetics which includes DetermaIOTM, our immunotherapy response prediction test. With the recently announced CLIA validation of DetermaIOTM, and the subsequent commercial launch for research use in academic and biopharma settings, we are poised to provide a valuable and potentially transformative test that we believe, based on recently published clinical data, outperforms currently available PD-L1 and TMB immunotherapy response prediction tests. We also have continued our progress in advancing DetermaDxTM , and we were pleased to announce the completion of CLIA validation in early January, consistent with our previous guidance, and believe we are now are on track with clinical validation and preparations for commercial availability. Taken together, it is clear that Oncocyte is transforming into a leader for early lung content. While cancer surgeries are being impacted by the current COVID-19 situation, our discussions with surgeons indicate that these patients will still be getting treated and surgeries will restart soon, so our focus is on being ready when that moment happens. We look forward to continued execution across our commercialization and development efforts for a milestone rich 2020."

Recent Corporate Highlights

●Successfully completed acquisition of Insight Genetics

oAcquisition broadens Oncocyte’s portfolio of molecular diagnostic tests with addition of DetermaIOTM, a potentially transformative immunotherapy response prediction test demonstrated to outperform PD-L1 and TMB tests

oCompleted CLIA validation of DetermaIOTM, enabling research use launch of the test as a reliable and robust option for academic research and biopharma companies

oUnlocks significant pharma services opportunity including immunotherapy trials and development of companion diagnostics in lung cancer and other solid tumors

oAcquisition significantly expands Oncocyte’s suite of proprietary tests to manage key decision points potentially across multiple stages and types of cancer, as immunotherapies are currently approved for thirteen solid tumor types

●Transformed into a commercial stage company with launch of DetermaRxTM

oAnnounced commercial availability of DetermaRxTM in early January, transforming Oncocyte to a commercial stage company. With multiple sites already onboarded and testing beginning, the commercial team is focused on driving rapid adoption across specialty physicians

oDetermaRxTM, a CLIA-validated lung cancer treatment stratification test, broadens Oncocyte’s capabilities with an extensively validated and published molecular test that enables the identification of early-stage lung cancer patients at high risk for recurrence that are likely to benefit from chemotherapy. OncoCyte acquired the rights to commercialize this test from Razor Genomics in September 2019

oReceived regulatory approval to begin distribution of DetermaRxTM in Canada

oProvided an educational grant in support of an accredited Continuing Medical Education (CME) Activity: Advances in Diagnostic Testing: Assessing Your Patient’s Risk of Recurrence to Inform Treatment Decisions in Early-Stage NSCLC

●Successful Completion of CLIA Validation Study of DetermaDxTM

oDemonstrates the successful transfer of the research assay to the rigorous environment of Oncocyte’s commercial CLIA laboratory

oOncocyte has commenced Clinical Validation, which is expected to be completed in Q2 2020. Upon successful completion of Clinical Validation and establishment of performance parameters, Oncocyte will begin preparations for commercial availability

●Presented data at the CHEST Annual Meeting 2019 on the Immune Response for Nodule Evaluation (IRENE) clinical cohort used for the development and validation of DetermaDxTM. IRENE is one of the largest reported clinical study cohorts in lung nodule management with 62 sites in the U.S. and over 3,000 enrolled patients. IRENE is uniquely representative across clinical settings with a focus on community practices, where most lung cancer patients are diagnosed and treated

●Successfully completed a $7.6 million registered offering of common shares, priced at the market, directly with fundamentally driven, healthcare focused institutional investors. The proceeds strengthened Oncocyte’s balance sheet, which will support the strategic commercial launch of the DetermaRxTM lung cancer stratification test and the continued development of DetermaDxTM

●Moved Oncocyte’s administrative and executive headquarters to Orange County, California, in January 2020. Plans to construct a clinical diagnostic laboratory and a research laboratory at the new location are being implemented. The move best suited Oncocyte’s need to find talented individuals to join its growing team and provides opportunities to engage with oncology patients in the community setting, as well as potentially reduce overall operating costs associated with our CLIA Lab Service

Fourth Quarter and Annual 2019 Financial Highlights

At December 31, 2019, Oncocyte had cash, cash equivalents, and marketable securities of $22.5 million as compared to $8.5 million at December 31, 2018. On March 20, 2020 Oncocyte put in place an at-the-market (ATM) offering for access to additional working capital.

For the fourth quarter ended December 31, 2019, Oncocyte reported a net loss of $8.0 million, or $(0.15) per share, as compared to $4.5 million, or $(0.11) per share, for the fourth quarter ended December 31, 2018.

For 2019, Oncocyte reported a net loss of $22.4 million, or $(0.44) per share, compared to $15.8 million, or $(0.42) per share for 2018.

Operating expenses, as reported, for the three months ended December 31, 201,9 were $7.5 million, an increase of $3.5 million as compared to the same period in 2018. Operating expenses, as adjusted, for the three months ended December 31, 2019, were $6.7 million, an increase of $3.1 million as compared to the same period in 2018.

Operating expenses, as reported, for the year ended December 31, 2019, were $22.2 million, an increase of $7.0 million as compared to the same period 2018. Operating expenses, as adjusted, for the year ended December 31, 2019, were $18.6 million, an increase of $6.1 million as compared in 2018.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for fourth quarter of 2019 were $2.3 million as compared to $1.2 million for the same period in 2018, an increase of $1.1 million. The increase was primarily attributable to personnel and laboratory related expenses for the completion of CLIA validation of DetermaDxTM. Research and development expenses for 2019 were $6.8 million as compared to $6.5 million for 2018, remained relatively unchanged.

General and administrative expenses for the fourth quarter of 2019 were $4.2 million, as compared to $2.6 million for the same period in 2018, an increase of $1.6 million. General and administrative expenses for the year ended December 31, 2019, were $13.3 million, as compared to $7.0 million for 2018, an increase of $6.3 million. The increases were primarily attributable to personnel and related expenses, including management transition costs; investment banking expenses; legal, business development, investor relations, recruiting, audit and accounting related expenses; and noncash stock-based compensation expense due to additional equity grants. As Oncocyte transitioned from Lineage Cell Therapeutics ("Lineage" formerly BioTime, Inc.) Shared Services by the second half of 2019, Oncocyte hired its own administrative, human resources, legal, finance and accounting functions and teams. This transition also included the termination of the Shared Facilities agreement with Lineage as of December 31, 2019, in which Oncocyte leased its own facilities and laboratories and moved into its Irvine, California, headquarters in January 2020.

Sales and marketing expenses for the three months ended December 31, 2019, were $1.0 million, as compared to $0.3 million for the same period in 2018, an increase of $0.7 million. Sales and marketing expenses for 2019 were $2.2 million, as compared to $1.7 million for 2018, an increase of $0.5 million. The increases were primarily due to sales and marketing efforts, including key hires and ramp-up in activities for commercialization of DetermaRxTM.

Conference Call

The Company will host a conference call today, March 25, 2020, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13700598. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: View Source

On March 25, 2020 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that it will hold a conference call and webcast on Wednesday, March 31, 2020 at 8:00 a.m. Eastern Time to discuss the company’s 2019 fourth quarter and full year financial and operational results (Press release, IMV, MAR 25, 2020, View Source [SID1234555824]).

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Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID: 7482187.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On March 25, 2020 Abbisko Therapeutics, an innovative biopharmaceutical company based in Shanghai Zhangjiang High Tech Park, reported the completion of a $70 million Series C financing (Press release, Abbisko Therapeutics, MAR 25, 2020, View Source;article_id=140 [SID1234555823]). The investment was led by Temasek, joined by existing investors including Qiming Venture Partners, Jianxin Capital, GIC, Lilly Asia Ventures, CICC Capital, Loyal Valley Capital. This financing brings the total equity capital that the company has raised since its inception in 2016 to $140 million.

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The proceeds from this financing will be used to advance the company’s four clinical programs and further expand its discovery pipeline consisting of multiple programs in IND enabling and discovery stages in oncology targeted therapy and immuno-oncology areas.

In the last twelve months, Abbisko advanced two internally discovered and developed pre-clinical candidates into the clinical stage with IND approvals in the US, mainland China and Taiwan. Phase I clinical trials have either been initiated or in active preparation in these countries and region. Abbisko also completed two strategic collaborations to strengthen its portfolios by in-licensing two clinical stage assets from X4 Pharmaceuticals and AstraZeneca PLC.

Dr. Yao-Chang Xu, founder and CEO of Abbisko Therapeutics commented on the successful completion of series C financing, "We’re very pleased that internationally well-known investment company Temasek has led this series of financing. We are equally pleased to get continued funding support from our previous investors including Qiming Venture Partners, Jianxin Capital, GIC, Lilly Asia Ventures, CICC Capital, and Loyal Valley Capital. The fund raised in Series C will allow us to rapidly advance our clinical programs and continue to move forward the portfolio of novel cancer therapies in the discovery and early development stages".