On May 7, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended March 31, 2020 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 7, 2020, View Source [SID1234557356]).

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"While COVID-19 has created tremendous uncertainty across the globe, it has also reminded us of the critical importance of medical innovation," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Over the last few months, we have focused on ensuring the safety and well-being of our employees and our community, while continuing to advance our ongoing clinical trials and critical earlier-stage research. There is no playbook for what we are going through, and I am extremely proud of the dedication, creativity and flexibility our team has shown during this time. Thanks to their efforts, we recently completed enrollment in our Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory AML patients. We remain on track to report data from this cohort and mature data on SY-1425 from our cohort in newly diagnosed AML patients, as well as initial dose-escalation data from the Phase 1 trial of SY-5609, all in the fourth quarter. While these are difficult times, we have a strong foundation and a strong team, and I am confident we will adapt to the challenges ahead as we pursue our mission of delivering medicines that provide a profound benefit for patients."

Anticipated Milestones:

SY-1425

Report potential proof-of-concept data in the fourth quarter of 2020 from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in the fourth quarter of 2020 from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-5609

Present new preclinical data on the anti-tumor activity of SY-5609 in models of colorectal cancer, as well as details on the design of its ongoing Phase 1 trial, at the Virtual 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Report initial safety, tolerability, pharmacokinetic and pharmacodynamic data in the fourth quarter of 2020 from the dose-escalation portion of the ongoing Phase 1 trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology that harbor Rb pathway alterations.
Report additional dose-escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline

Nominate next development candidate by the end of 2021.
First Quarter 2020 Financial Results:

Cash, cash equivalents and marketable securities as of March 31, 2020 were $121.9 million, compared with $91.4 million on December 31, 2019. This increase reflects the $20 million upfront payment received in connection with Syros’ entry into a collaboration with Global Blood Therapeutics, Inc. (GBT) in December 2019, the $20 million that Syros drew down from its senior secured loan facility with Oxford Finance, LLC in February 2020, and $12.3 million from the sale of common stock under Syros’ at-the-market sales facility in the first quarter.

For the first quarter of 2020, Syros reported a net loss of $17.2 million, or $0.39 per share, compared to a net loss of $16.5 million, or $0.49 per share, for the same period in 2019.

Revenues were $2.4 million for the first quarter of 2020, compared to $0.5 million for the same period in 2019. In the first quarter of 2020 $2.2 million in revenue was recognized under Syros’ collaboration with GBT and $0.2 million was recognized under its collaboration with Incyte Corporation (Incyte). All revenues recognized in the first quarter of 2019 were under Syros’ collaboration with Incyte.
Research and development (R&D) expenses were $14.6 million for the first quarter of 2020, as compared to $12.6 million for the same period in 2019. This increase was primarily attributable to continued advancement of Syros’ existing clinical trials and preclinical programs, including its sickle cell disease program.
General and administrative (G&A) expenses $5.1 million for the first quarter of 2020, as compared to $4.9 million for the same period in 2019. This increase was primarily attributable to an increase in employee-related costs, including salary, benefits and stock-based compensation due to our increased headcount.
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 expenditures requirements into 2022, beyond key milestones expected for both SY-1425 and SY-5609.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these first quarter 2020 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 1585949. 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 May 7, 2020 Strata Oncology, a precision oncology company advancing molecular indications for cancer therapies, reported three studies highlighting data featuring its comprehensive genomic profiling (CGP) assay StrataNGSTM will be presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place digitally from May 29 – May 31 (Press release, Strata Oncology, MAY 7, 2020, View Source [SID1234557400]).

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All abstracts are available online May 13.

Abstract # 3574, "PCR-based Comprehensive Genomic Profiling: Feasibility From >20,000 Tumor Tissues Specimens and Predicted Impact on Actionable Biomarker Identification Versus Hybrid Capture and Plasma" presented by Scott Tomlins, M.D., Ph.D., Strata Oncology
Abstract # 312647, "The Impact of Tumor NGS Testing on Hereditary Cancer Risk Assessment and Population Management in an Integrated Community Health Care System" presented by Sachdev Thomas, M.D., Kaiser Permanente Northern California
Abstract # e19185, "Implementing a Genomic Oncology Program in an Integrated Health Care Network with Large Scale Genomic Next Generation Sequencing (NGS) Testing of Advanced Cancers in a Community Setting" presented by Marie Suga, M.D., Kaiser Permanente Northern California
About StrataNGS
StrataNGS is a comprehensive genomic profiling assay that assesses DNA and RNA in solid tumors. The assay requires industry-low tumor tissue requirements (0.5mm2). StrataNGS is performed on co-isolated RNA and DNA and detects all classes of genomic alterations, including SNVs, small insertions and deletions, gene fusions, exon skipping mutations and copy number changes. Results include MSI and TMB to help inform immunotherapy decisions.

On May 7, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from clinical trials of 19 approved and investigational medicines across 21 cancer types, will be presented at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program organised by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which will be held 29-31 May, 2020 (Press release, Hoffmann-La Roche, MAY 7, 2020, View Source [SID1234557204]). A total of 120 abstracts that include a Roche medicine will be presented at this year’s meeting.

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"At ASCO (Free ASCO Whitepaper), we will present new data from many investigational and approved medicines across our broad oncology portfolio," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "These efforts exemplify our long-standing commitment to improving outcomes for people with cancer, even during these unprecedented times. By integrating our medicines and diagnostics together with advanced insights and novel platforms, Roche is uniquely positioned to deliver the healthcare solutions of the future."

Together with its partners, Roche is pioneering a comprehensive approach to cancer care, combining new diagnostics and treatments with innovative, integrated data and access solutions for approved medicines that will both personalise and transform the outcomes of people affected by this deadly disease.

Key presentations
First results of tiragolumab, Roche’s novel cancer immunotherapy designed to bind to TIGIT, will be shared. These results, from the phase II CITYSCAPE study, examine tiragolumab in combination with Tecentriq (atezolizumab) compared with Tecentriq alone as an initial treatment for people with PD-L1-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). In addition, updated five-year overall survival rates with Alecensa (alectinib) in people living with treatment-naive anaplastic lymphoma kinase (ALK)-positive metastatic/advanced NSCLC will be presented. With five approved lung cancer medicines and an extensive pipeline across multiple subtypes, Roche’s ultimate aim is to provide an effective treatment option for each person diagnosed with the disease, tailored to the unique characteristics of their tumours.

Studies featured from partnerships with Flatiron Health and Foundation Medicine demonstrate how the use of next-generation sequencing (NGS) may help inform treatment decisions, optimise testing and enable personalised therapy, including an ongoing additional study designed to prospectively link longitudinal, real-world clinical data with genomic, imaging and outcomes data for patients with advanced lung cancers. The study is monitoring circulating tumour DNA (ctDNA) using FoundationOne Liquid, and tumour tissue samples will be genomically profiled using FoundationOne CDx.

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2020 scientific programme, as well as the latest innovations and developments in Roche’s approach to accelerating progress in cancer care, will be featured during the Roche virtual analyst event from 5:00 – 6:15 pm CEST on Friday,29 May. Further details are available here

To access Roche’s ASCO (Free ASCO Whitepaper) virtual newsroom, please register via this link: View Source

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) news and updates by using the hashtag #ASCO20.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2020

Medicine Abstract title Abstract number
Lung cancer
Tiragolumab Primary analysis of a randomized, double-blind, phase II study of the anti-TIGIT antibody tiragolumab (tira) plus atezolizumab (atezo) versus placebo plus atezo as first-line (1L) treatment in patients with PD-L1-selected NSCLC (CITYSCAPE) #9503
Oral abstract session

Alecensa (alectinib) Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC #9518
Poster: 284
Poster discussion session
Tecentriq (atezolizumab) Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC #9594
Poster: 360
Poster session
Tecentriq IMpower150: exploratory analysis of brain metastases development #9587
Poster: 353
Poster session
Tecentriq IMpower150: exploratory efficacy analysis in patients (pts) with bulky disease N/A
e-publication
Flatiron Health data in lung cancer
Real World Data A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer #TPS2087
Poster: 79
Poster session
Real World Data Genomic testing among patients (pts) with newly diagnosed advanced non-small cell lung cancer (aNSCLC) in the United States: a contemporary clinical practice patterns study #9592
Poster: 358
Poster session
Solid tumours
Rozlytrek (entrectinib) Updated entrectinib data in children and adolescents with recurrent or refractory solid tumors, including primary CNS tumor #107
Clinical science symposium
Rozlytrek Efficacy and safety of entrectinib in patients (pts) with NTRK-Fusion-Positive (NTRK-fp) solid tumors: An updated integrated analysis #3605
Poster: 335
Poster session
Genitourinary and gastrointestinal cancers
Tecentriq IMvigor010: primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC) #5000
Oral abstract session

Tecentriq Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study #5011
Clinical science symposium
Tecentriq Phase Ib/II open-label, randomized evaluation of 2L atezolizumab + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC) #4540
Poster: 148
Poster session
Tecentriq, Avastin (bevacizumab) Complete responses (CR) in patients receiving atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) in IMbrave150: a phase III clinical trial for unresectable hepatocellular carcinoma (HCC) #4596
Poster: 204
Poster session
Ipatasertib Circulating tumor DNA (ctDNA) dynamics associate with treatment response and radiological progression-free survival (rPFS): Analyses from a randomized phase II trial in metastatic castration-resistant prostate cancer (mCRPC) #5508
Oral abstract session

Blood cancer
Venclexta (venetoclax)

Impact of premature venetoclax (Ven) discontinuation/interruption on outcomes in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Phase III MURANO study results #8028
Poster: 361
Poster session
Venclexta, Gazyva (obinutuzumab) Fixed-duration venetoclax-obinutuzumab for previously untreated patients with chronic lymphocytic leukemia: follow-up of efficacy and safety results from the multicenter, open-label, randomized, phase III CLL14 trial #8027
Poster: 360
Poster session
Gazyva Comparison of efficacy and safety with obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma – Updated results from the phase III Gallium Study #8023
Poster: 356
Poster session
Breast cancer
Kadcyla (trastuzumab emtansine), Perjeta (pertuzumab) Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC) #500
Oral abstract session

Kadcyla Biomarker data from KATHERINE: A phase III study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab (H) in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer #502
Oral abstract session

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Polivy (polatuzumab vedotin-piiq); Tarceva (erlotinib); RozlytrekTM (entrectinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.

About Roche in Personalised Healthcare
For more than 20 years, Roche has helped lay the scientific groundwork for personalised healthcare with treatments that target the underlying biology of cancer and other diseases. Now, with profound changes in data and technology transforming how medicines are discovered, developed and delivered to patients, we are uniquely positioned to extend this approach across all of healthcare. With our ability to integrate research and development, personalised diagnosis, disease monitoring and treatment access, we are advancing personalised healthcare for every aspect of the patient experience.

Our strategy is rooted in groundbreaking science that can accelerate drug discovery and development. We are also leveraging technologies such as real-world datasets, artificial intelligence, genomic profiling and digital health across our therapeutic portfolio, with an initial emphasis on oncology, neurology, ophthalmology and diagnostics. Through collaborations with academic institutions, industry partners, patients, physicians and regulatory agencies, our goal is to dramatically improve the performance of the entire healthcare ecosystem and the lives of every patient.

On May 7, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported financial and operating results for the first quarter ended March 31, 2020 (Press release, Lineage Cell Therapeutics, MAY 7, 2020, View Source [SID1234557267]). Lineage management will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2020 financial and operating results and to provide a business update.

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"Lineage has adapted quickly to an unprecedented business environment. We ensured the safety of our teams while maintaining the continuity of our global operations and advancing our programs with meaningful clinical data and contractual arrangements," stated Brian M. Culley, Lineage CEO. "Looking ahead, we believe we are well positioned to achieve many of our 2020 objectives. Most notably, a clinical update recently presented at the ARVO meeting provided a more comprehensive picture of treatment with OpRegen, where certain patients were able to see better, have less growth to their area of geographic atrophy, and read faster, representing important enhancements to vision and quality of life metrics. We also are excited about exercising our option to regain control of the VAC platform for immuno-oncology and expand it to the development of a vaccine for coronaviruses such as SARS-CoV-2, the virus which causes COVID-19."

2020 Plans and Objectives:

– Present new OpRegen data from the ongoing Phase 1/2a clinical trial as available throughout the year.

– Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

– Meet with the U.S. Food and Drug Administration (FDA) to discuss the further clinical development of OpRegen.

– Evaluate partnership opportunities for the OpRegen program and other development assets.

– Report VAC2 clinical data from the initial patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

– Enhance commercial utility of OPC1 program by introducing commercially enabling improvements to the manufacturing process in our GMP manufacturing facility.

– Continue engagement with the investment and medical communities with virtual participation at medical and healthcare industry conferences, ongoing throughout 2020.

– Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine and Cancer Research UK.

– Seek non-dilutive support for certain programs, as may be available, including for coronavirus vaccine development.

Balance Sheet and Cash Flow Highlights

Cash, cash equivalents, and marketable securities totaled $25.8 million as of March 31, 2020. Marketable securities include our remaining ownership of unrestricted securities in OncoCyte Corporation (OncoCyte), AgeX Therapeutics, Inc. (AgeX) and Hadasit Bio-Holdings Ltd (Hadasit).

We have continued to fund our operations primarily by selling a portion of our marketable securities. On January 2, 2020, we sold 2,383,090 shares of OncoCyte stock for net proceeds of approximately $5.0 million. On April 23, 2020, we sold an additional 1,672,689 shares of OncoCyte stock for net proceeds of approximately $3.7 million. We continue to hold approximately 4.3 million shares of OncoCyte stock that are valued at $11.3 million as of May 5, 2020, based on the closing price of its common stock on that date. All of our marketable securities are now in companies in which we hold less than 10% of the outstanding shares.

In conjunction with the sale of AgeX shares to Juvenescence Limited (Juvenescence) in 2018, we also hold a $21.6 million promissory note bearing 7% annual interest that matures on August 30, 2020. As of March 31, 2020, the outstanding principal and accrued interest on the note was $24.0 million. If, prior to August 30, 2020, Juvenescence completes an initial public offering resulting in gross proceeds of at least $50.0 million, the promissory note automatically converts into the Juvenescence securities.

Net cash used in operating activities for the three months ended March 31, 2020 was approximately $5.0 million, a decrease of $4.3 million as compared to $9.3 million in the same period of 2019. This level of quarterly activity was in line with our budgeted annual net operational spend of $16 million for 2020. As a result of incremental expenses we anticipate incurring during the remainder of the year related to the early exercise of our option with Cancer Research UK, our plans for the development of a prophylactic vaccine against SARS-CoV-2 and other coronaviruses, and delays caused by COVID-19 to our OpRegen clinical trial, we anticipate our net operational spend for 2020 will increase modestly.

First Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties and licensing fees. Total revenues for the three months ended March 31, 2020 were $0.5 million, a decrease of $0.4 million as compared to $0.9 million for the same period in 2019. The decrease was primarily related to a $0.4 million decrease in grant revenue due to the timing of grant related activities for OpRegen and other ophthalmic applications.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended March 31, 2020 were approximately $7.8 million, a decrease of $5.8 million as compared to $13.6 million for the same period in 2019.

R&D Expenses: R&D expenses for the three months ended March 31, 2020 were $3.3 million, an approximate decrease of $1.7 million as compared to $5.0 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.8 million in OpRegen and other ophthalmic application expenses and $0.4 million in Renevia expenses, offset by an increase of approximately $0.5 million in OPC1 expenses.

G&A Expenses: G&A expenses for the three months ended March 31, 2020 were $4.5 million, a decrease of $4.1 million as compared to approximately $8.6 million for the same period in 2019. The decrease was primarily attributable to a $3.3 million reduction in expenses related to our merger with Asterias Biotherapeutics, Inc. (Asterias), a $0.9 million decrease in salaries, benefits and severance costs primarily related to terminated personnel, a $0.4 million reduction in accounting expenses, a $0.1 million reduction in rent expenses and a $0.1 million reduction in consulting expenses, offset by a $0.5 million increase in legal and patent expenses and a $0.2 million increase related to the cessation of shared services reimbursements.

Loss from Operations: Loss from operations for the three months ended March 31, 2020 was $7.4 million, an approximate decrease of $5.4 million as compared to $12.8 million for the same period in 2019.

Other (Expense) Income, Net: Other income/(expenses), net for the three months ended March 31, 2020 reflected other expense, net of ($1.0) million, compared to other income, net of $47.7 million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage’s international subsidiaries. The value of Lineage’s OncoCyte shares increased by $37.7 million in the three months ended March 31, 2019, which contributed greatly to the overall balance in other income, net for that period.

Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2020 was $8.4 million, or $0.06 per share (basic and diluted), compared to a net income attributable to Lineage of $39.3 million, or $0.30 per share (basic and diluted), for the same period in 2019.

Conference Call and Webcast

Lineage will host a conference call and webcast today, at 1:30 pm PT/4:30 pm ET to discuss its first quarter 2020 financial results and to provide a business update. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7948501.

On May 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter 2020 (Press release, Y-mAbs Therapeutics, MAY 7, 2020, View Source [SID1234557283]).

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"We are very pleased with our first quarter 2020 financial results, especially seen in conjunction with the completion of our naxitamab BLA submission to the FDA and the notable progress we’ve made on our rolling BLA submission for omburtamab, as well as the continued commercial ramp-up for the potential launch of both compounds. After the balance sheet date, we entered into an exclusive licensing agreement with MSK and MIT for the SADA technology, which we believe may be a potential game changer in therapeutic and diagnostic use of Liquid RadiationTM," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We have worked hard to complete the submission of the naxitamab BLA in March, and were excited to see the application go in. The omburtamab BLA application process is well underway, and after our recent pre-BLA meeting with the FDA, we have made good progress on that submission. We expect to start submitting a rolling BLA in May, with anticipated completion in June."

First Quarter 2020 and Recent Corporate Developments

·Subsequent to the end of the first quarter, on April 24, 2020, Y-mAbs announced the appointment of Laura J. Hamill to its Board of Directors.

·Also, subsequent to the end of the first quarter, on April 15, 2020, Y-mAbs announced that it has entered into an agreement with Memorial Sloan Kettering Cancer Center and the Massachusetts Institute of Technology for a worldwide exclusive license and research collaboration for the SADA technology, a concept we refer to as Liquid RadiationTM.

·After the close of the first quarter, on April 1, 2020, Y-mAbs announced that the Company completed the submission of its rolling BLA submission to the FDA for naxitamab on March 31, 2020.

·On February 26, 2020, Y-mAbs announced a Pre-BLA meeting with the FDA for omburtamab.

Financial Results

Y-mAbs reported a net loss for the first quarter of 2020 of $26.2 million, or $0.66 per basic and diluted share, compared to a net loss of $15.9 million, or $0.47 per basic and diluted share, reported for the first quarter of 2019.

Operating Expenses

Research and Development

Research and development expenses were $18.6 million for the quarter ended March 31, 2020, compared to $12.5 million for the quarter ended March 31, 2019, an increase of $6.1 million. The increase in research and development expenses primarily reflects the following:

·$2.8 million increase in outsourced research and supplies to support the expansion of our product development activities;
·$2.1 million increase in personnel costs; and
·$0.9 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab.

General and Administration

General and administrative expenses were $8.1 million for the quarter ended March 31, 2020, compared to $3.7 million for the quarter ended March 31, 2019, an increase of $4.4 million. Such increase in general and administrative expenses primarily reflects the following:

·$1.6 million increase in personnel costs; and
·$1.6 million increase in commercial infrastructure costs.

Cash and Cash Equivalents

The Company had approximately $185.8 million in cash and cash equivalents as of March 31, 2020, compared to $207.1 million as of December 31, 2019. The decrease of $21.4 million was primarily attributable to the increased costs of operation as the Company completed its BLA submission for naxitamab and prepared the upcoming submission of the rolling BLA for omburtamab, as wells as build-up of the Company’s commercial infrastructure, and increased personnel costs related to thesse activities.

Webcast and Conference Call

The Company will host a conference call on Friday, May 8, 2020 at 9 am eastern time. To participate in the call, please dial 855-327-6838 (domestic) or 604-235-2082 (international) and reference the access code 10009507. A webcast will be available at: View Source