On May 9, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported financial results and provided a business update for the first quarter ended March 31, 2019 (Press release, argenx, MAY 9, 2019, View Source [SID1234536080]).

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"During the first quarter, we advanced our broad clinical development plan of efgartigimod across four autoimmune indications in both our IV and subcutaneous formulations. Enrollment of our Phase 3 ADAPT clinical trial in generalized myasthenia gravis is on track, and we intend to launch a second Phase 3 program in primary immune thrombocytopenia in the second half of 2019 that will encompass both formulations. There remains a gap in autoimmune disease innovation for therapies that are specific and well-tolerated, and it is this need that drives us in our goal to deliver our FcRn antagonist to patients quickly," commented Tim Van Hauwermeiren, chief executive officer of argenx. "We also closed on our global collaboration with Janssen this quarter, receiving $500 million in upfront payments, to evaluate cusatuzumab for acute myeloid leukemia, myelodysplastic syndromes and other potential hematological indications."

"We look forward to our upcoming R&D Day where we will showcase our formula for translating immunology breakthroughs into first-in-class medicines and unveil two new antibody assets in our wholly-owned pipeline."

FIRST QUARTER 2019 AND RECENT HIGHLIGHTS

Pipeline Updates:

Efgartigimod (ARGX-113) Program

Phase 3 ADAPT clinical trial, including one-year open-label extension study, is ongoing for treatment of generalized myasthenia gravis with topline data expected in 2020.

argenx on track to launch global development program in primary immune thrombocytopenia (ITP) in second half 2019; update expected to be provided in third quarter 2019 on development strategy and regulatory feedback, including planned registration path and plan to bridge between intravenous (IV) and subcutaneous (SC) formulations.

Orphan drug designation granted in February 2019 by U.S. Food and Drug Administration (FDA) for treatment of primary ITP.

Ongoing open-label extension study from completed Phase 2 proof-of-concept clinical trial in ITP expected to close in mid-2019 in preparation for start of Phase 3 development program.

Phase 2 proof-of-concept clinical trial ongoing for treatment of pemphigus vulgaris; data expected in 2020.

Phase 2 clinical trial for treatment of chronic inflammatory demyelinating polyneuropathy expected to start in second half of 2019.

Phase 1 clinical trial in healthy volunteers planned with ENHANZE SC formulation of efgartigimod as part of collaboration with Halozyme announced in February 2019; data expected before end of 2019.

Collaboration provides argenx access to ENHANZE subcutaneous delivery technology for up to three targets, including exclusive rights to develop therapeutic products targeting human neonatal Fc receptor FcRn.

Upfront payment of $30 million paid to Halozyme with potential future payments up to $160 million per selected target subject to achievement of specified development, regulatory and sales-based milestones.

Cusatuzumab (ARGX-110) Program

Announced closing of exclusive global collaboration and license agreement with Janssen for cusatuzumab.

Received $300 million upfront cash payment, and Johnson & Johnson Innovation made equity investment of €176.7 million ($200.0 million based on exchange rate on date of signing) in argenx.

argenx retains right to co-promote cusatuzumab in United States and share such royalties with Janssen on 50-50 basis.

Orphan drug designation granted by FDA in January 2019 for treatment of acute myeloid leukemia.
Received first clinical milestone payment of $30 million for initiation of first-in-human clinical trial with antibody product candidate ABBV-151 (ARGX-115) as part of option agreement with AbbVie.

Corporate Updates

Torsten Dreier will resign from his function as chief development officer of argenx to focus on new role as chief development officer of AgomAb, a company founded through collaboration with argenx to advance ARGX-114, an HFG-mimetic SIMPLE Antibody directed against the MET receptor. Mr. Dreier will continue to serve as a consultant to argenx.

argenx Japan KK is being established as a wholly-owned subsidiary, and Hermann Strenger was appointed as General Manager of argenx Japan. In this role, Mr. Strenger will be responsible for all aspects of early commercial planning for efgartigimod in Japan. He has served in executive positions in the pharmaceutical industry in Japan for the last 23 years.

argenx R&D Day

argenx to host its second R&D Day on Thursday, May 22, 2019, to present new pipeline programs
ARGX-117 and ARGX-118.

Details of Financial Results

Cash, cash equivalents and current financial assets totaled €961.6 million on March 31, 2019, compared to €564.6 million on December 31, 2018 and €346.6 million on March 31, 2018. The increase in the cash balance on March 31, 2019 resulted primarily from the closing of the exclusive global collaboration and license agreement for cusatuzumab with Janssen triggering a $300 million upfront payment and a $200 million equity investment in January 2019.

Operating income increased by €33.1 million for the three months ended March 31, 2019 to reach €40.0 million, compared to €6.9 million for the three months ended March 31, 2018. The increase of €30.9 million in revenue was primarily related to the recognition of a $30.0 million development milestone under the AbbVie collaboration agreement and the partial recognition of the upfront payment received under the Janssen collaboration agreement. Other operating income increased by €2.2 million, resulting mainly from an increase in payroll tax rebates for employing certain research and development personnel.

Research and development expenses increased by €19.6 million for the three months ended March 31, 2019 to €34.8 million, compared to €15.1 million for the three months ended March 31, 2018. The increase in 2019 resulted primarily from (i) an increase of €11.1 million in external research and development expenses, reflecting higher clinical trials costs and manufacturing expenses related to the development of the late-stage argenx product candidate portfolio, (ii) an increase of €4.3 million in license fee costs payable to one of argenx’ licensors following the achievement of a development milestone under the AbbVie collaboration agreement and (iii) a €2.6 million increase in share-based compensation expenses linked to the grant of stock options to its research and development employees.

Selling, general and administrative expenses totaled €11.3 million and €5.9 million for the three months ended March 31, 2019 and 2018, respectively. The increase of €5.4 million in selling, general and administrative expenses for the three months ended March 31, 2019 primarily resulted from (i) an increase of €2.1 million in share-based compensation expenses linked to the grant of stock options to its selling, general and administrative employees and board members and (ii) higher personnel expenses and consulting fees related to the preparation of potential future commercialization of the lead product candidate efgartigimod.

For the three months ended March 31, 2019, financial income amounted to €3.5 million, compared to €0.5 million for the three months ended March 31, 2018. The increase of €3.0 million in 2019 related primarily to an increase in the interest received on cash, cash equivalents and current financial assets.

Exchange gains totaled €9.5 million for the three months ended March 31, 2019, compared to the €4.0 million exchange losses incurred for the three months ended March 31, 2018. The increase was mainly attributable to unrealized exchange rate gains on the cash, cash equivalents and current financial assets position in U.S. dollars due to the favorable fluctuation of the EUR/USD exchange rate in the first three months of 2019.

The company generated a total comprehensive profit of €6.7 million for the three months ended March 31, 2019, compared to a total comprehensive loss of €17.7 million for the three months ended March 31, 2018. The total comprehensive profit in the first quarter of 2019 mainly resulted from the recognition of a $30.0 million development milestone under the AbbVie collaboration agreement and the unrealized exchange rate gains accounted during the period.

EXPECTED 2019 FINANCIAL CALENDAR:

August 1, 2019: HY 2019 business update and financial results

October 24, 2019: Q3 2019 business update and financial results

On May 9, 2019 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported an update on operational developments for the first quarter ended March 31, 2019 (Press release, Celyad, MAY 9, 2019, View Source [SID1234536079]).

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"We began the year with the announcement that treatment with CYAD-01 demonstrated a 40% complete response rate in patients with relapsed/refractory acute myeloid leukemia. As we continue to advance the development of our pipeline of CAR-T cells therapies, we are scheduled to provide an update on our allogeneic and autologous NKG2D-based CAR-T candidates for the treatment of refractory metastatic colorectal cancer at the ESMO (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer in July", stated Filippo Petti, CEO of Celyad.

"As I stepped into the CEO role at the beginning of the second quarter of 2019, my strategy for Celyad is to keep our focus on the optimization of our NKG2D-based programs while leveraging our shRNA platform to develop a deep pipeline of next-generation NKG2D-based and off-the-shelf non-gene edited CAR-T candidates. We anticipate that the shRNA platform will enable Celyad to continue to deliver innovative CAR-T therapeutics and potentially surpass the competition in the allogeneic CAR-T landscape."

First Quarter 2019 and Recent Business Highlights

Appointment of Filippo Petti as Chief Executive Officer and Anne Moore, PhD as Vice President Corporate Strategy as part of a strategic evolution of the management team;
Research & Development Day in NYC showcased the Company’s preclinical candidates based on its shRNA platform including next-generation NKG2D-based CAR-T candidates and the novel, non-gene edited allogeneic CYAD-200 series;
Scheduled to present an update on autologous and allogeneic NKG2D-based CAR-T candidates, CYAD-01 and CYAD-101, for the treatment of refractory metastatic colorectal cancer (mCRC) at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) on July 3-6, 2019 in Barcelona, Spain.

First Quarter 2019 Financial Review

The Company ended the quarter with €40.5 million ($45.4 million) in cash, cash equivalents and short-term bank deposits. Net cash burn over the first quarter of 2019 amounted to €8.6 million, in line with expectations. The Company confirms its previous guidance that its treasury position should be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until mid-2020.

Update on Clinical Programs

CYAD-01 – Autologous NKG2D-based CAR-T
The Company’s lead asset CYAD-01 continues to advance in clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Additional dosing and schedule optimization are under evaluation in the THINK Phase 1 trial. Interim data from the DEPLETHINK Phase 1 trial evaluating CYAD-01 following preconditioning chemotherapy showed the CAR-T cell therapy is well-tolerated at the initial dose levels following preconditioning chemotherapy.

CYAD-101 – Allogeneic NKG2D-based CAR-T
Celyad’s non-gene edited clincial candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial assessing the ‘off-the-shelf’ NKG2D-based therapy administered concurrently with FOLFOX chemotherapy in patients with refractory metastatic colorectal cancer.

Update on Preclinical Programs

In March, the Company announced that utilization of the shRNA platform allowed the Company to develop the next generation of autologous, NKG2D-based CAR-T candidate, CYAD-02, and the novel, non-gene edited allogeneic CYAD-200 series of CAR-T candidates.

CYAD-02 incorporates shRNA technology to target NKG2D ligands MICA/MICB. In preclinical AML models, CYAD-02 shows an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity.

In the CYAD-200 series, shRNA technology is used to target the CD3ζ component of the T-cell receptor (TCR) to knockdown the expression of the TCR/CD3 complex on the surface of the T-cell. In vivo data demonstrate that shRNA targeting of CD3ζ effectively protects against Graft-versus-Host Disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out. Furthermore, results from preclinical tests show significant increase in persistence of allogeneic T-cells using shRNA targeting when compared to gene editing technologies, such as CRISPR-Cas9.

Expected milestones for 2019

Clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology 21st World Congress on Gastrointestinal Cancer to be held on July 3-6, 2019, in Barcelona, Spain;
Clinical updates from the Phase 1 THINK and DEPLETHINK trials are anticipated by mid-2019;
Advancement towards an IND application with the preclinical development of next-generation NKG2D-based CAR-T, CYAD-02 ; and
Further pursue the development of the proprietary non-gene edited allogeneic shRNA platform and progress towards IND applications for the CYAD-200 series of shRNA-based CAR-T candidates.

On May 9, 2019 Cardinal Health (NYSE: CAH) reported third quarter fiscal year 2019 revenues of $35.2 billion, an increase of 5 percent (Press release, Cardinal Health, MAY 9, 2019, View Source [SID1234536078]). The company also reported a decrease in GAAP operating earnings of 21 percent to $432 million and a decrease in non-GAAP operating earnings of 15 percent to $667 million. GAAP diluted earnings per share (EPS) were $0.99, an increase of 22 percent. Non-GAAP diluted EPS increased 14 percent to $1.59.

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"We are pleased that Cardinal Health again delivered overall operating results that were consistent with our expectations for the quarter," said Mike Kaufmann, CEO. "Solid progress on our strategic initiatives, the recent renewal of our largest customer and our ability to navigate evolving market dynamics give us confidence over the long term."

Tax rate

During the third quarters of fiscal 2019 and 2018, GAAP effective tax rates were 20.0 percent and 45.1 percent, respectively, and non-GAAP effective tax rates were 21.6 percent and 37.5 percent, respectively.

This quarter’s lower effective tax rates included net favorable discrete items of $0.06 per share and a lower U.S. federal income tax rate. During the same quarter last year, the tax rate included unfavorable discrete items and a significant negative impact from Cordis.

Fiscal year 2019 outlook
The company does not provide GAAP EPS outlook because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.
The company is raising the lower end of its fiscal 2019 non-GAAP EPS guidance to the range of $5.02 to $5.17 from the range of $4.97 to $5.17.

Segment results

Pharmaceutical segment

Third quarter revenue for the Pharmaceutical segment increased 6 percent to $31.4 billion due to sales growth from Pharmaceutical Distribution and Specialty Solutions customers.

Segment profit for the quarter decreased 10 percent to $536 million, which reflects the negative impact from the company’s generics program performance, partially offset by Specialty Solutions performance.

Medical segment

Third quarter revenue for the Medical segment was down 1 percent due to the divestitures of the China distribution and naviHealth businesses, offset by growth from existing customers.

Medical segment profit decreased 22 percent to $155 million driven by performance of Cardinal Health Brand products.

Additional third quarter and recent highlights

Cardinal Health extended its agreements with CVS Health to distribute pharmaceuticals to retail pharmacies and distribution centers through June 30, 2023.

Cardinal Health board of directors approved a 1 percent increase in the company’s quarterly dividend from $0.4763 per share to $0.4811 per share, or $1.92 on an annualized basis. The dividend will be payable on July 15, 2019 to shareholders of record on July 1, 2019.

Cardinal Health announced the acquisition of mscripts, a company that delivers patient adherence and engagement solutions through an innovative, easy-to-use mobile and web-based health management platform.

Cardinal Health Specialty Solutions announced a collaboration with PANTHERx Specialty Pharmacy designed to meet the growing needs of the market and strengthen its cell and gene therapy capability.

Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss third quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Cardinal Health website at ir.cardinalhealth.com until May 8, 2020.

On May 9, 2019 AVEO Oncology (NASDAQ: AVEO) reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, AVEO, MAY 9, 2019, View Source [SID1234536077]).

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"With a successful recent equity offering, together with the triggering of a FOTIVDA (tivozanib) milestone from EUSA, AVEO’s strengthened balance sheet provides us with a cash runway that we expect will take us into the fourth quarter of 2020," said Michael Bailey, president and chief executive officer of AVEO. "We remain committed to our goal of improving outcomes and patient experience in renal cell carcinoma (RCC), and look forward to reporting more mature interim OS results from our TIVO-3 study in advanced or metastatic RCC, which we expect will occur in the fourth quarter of 2019, as well as the subsequent decision regarding a potential NDA filing in the U.S. We also continue to make progress with the balance of our programs and pipeline, most notably the ongoing clinical collaborations combining FOTIVDA with Bristol Myers Squibb’s OPDIVO (nivolumab) for the TiNivo study in RCC and with AstraZeneca’s IMFINZI (durvalumab) in first-line hepatocellular carcinoma, ongoing studies of ficlatuzumab in multiple oncology indications, and the emerging potential of a new ocular formulation of tivozanib for the treatment of age-related macular degeneration."

Recent Highlights

$2 Million Milestone Payment from EUSA Pharma Triggered. In April 2019, AVEO announced the triggering of a $2 million milestone payment from EUSA Pharma related to the February 2019 reimbursement approval and subsequent commercial launch of FOTIVDA (tivozanib) in Spain as a first-line treatment of adult patients with RCC.

Closing of Public Offering of Common Stock and Warrants. In April 2019, AVEO completed an underwritten public offering of 21,739,131 shares of common stock and 25,000,000 warrants to purchase common stock at the public offering price of $1.14 per share and $0.01 per warrant. The warrants have a two-year term and a strike price of $1.25 per share. Gross proceeds of the offering were approximately $25.0 million and are expected to be used for ongoing clinical and preclinical development of AVEO’s product candidates, as well as for working capital and other general corporate purposes.

Announced Positive Results from Phase 1b Ficlatuzumab-Cytarabine Trial (CyFi) in Patients with Relapsed and Refractory AML. In April 2019, AVEO announced the presentation of positive data from an investigator-sponsored Phase 1b expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 – Apr 3, 2019 in Atlanta. Of 18 AML patients enrolled in the study, all had disease that was refractory to initial treatment, 17 were evaluable and 9 achieved a complete response. The most frequent grade 3/4 treatment emergent adverse events observed were febrile neutropenia, LFT abnormalities, and electrolyte disturbance.

There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleed, determined to be likely ficlatuzumab related. A copy of the presentation is currently available in the Publications & Presentation section of AVEO’s website.

Based on these results, the Company is evaluating potential next steps for this program in collaboration with its ficlatuzumab development and commercialization partner, Biodesix, Inc.

Appointed Gregory T. Mayes to Board of Directors. In February 2019, the Company announced the appointment of Gregory T. Mayes to its Board of Directors. Mr. Mayes brings to the AVEO Board over 20 years of experience as a biopharmaceutical executive with deep expertise in public company governance, business strategy and the commercialization of life sciences products.

Presented Topline Results from TIVO-3 in an Oral Presentation at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium and Announced Updated NDA Timing. In February 2019, AVEO presented topline results from the TIVO-3 trial, AVEO’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in 350 subjects with refractory advanced or metastatic RCC at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium held February 14-16, 2019 in San Francisco. The results were presented during an oral presentation titled "TIVO-3: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma (RCC)." A copy of the presentation is currently available in the Publications & Presentation section of AVEO’s website.

The presentation noted that the TIVO-3 trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS) versus sorafenib. There was also a significant PFS improvement demonstrated for tivozanib both in the subgroups of patients who received prior PD-1 therapy and those who received two prior VEGF TKI therapies. The secondary endpoint of overall response rate demonstrated a statistically significant improvement for patients receiving tivozanib compared to sorafenib. The analysis of the secondary endpoint of overall survival (OS) was not mature at the time of the final PFS analysis, but the hazard ratio at the time of the analysis favored sorafenib. Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.

AVEO intends to initiate an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019 and would be the first planned update since the prior OS analysis was initiated in the fourth quarter of 2018. At the recommendation of the U.S. Food and Drug Administration, AVEO plans to make a

New Drug Application (NDA) filing decision following the availability of more mature OS results.

First Quarter 2019 Financial Results

AVEO ended Q1 2019 with $23.5 million in cash, cash equivalents and marketable securities as compared with $24.4 million at December 31, 2018.

Total revenue for Q1 2019 was approximately $1.6 million compared with $1.0 million for Q1 2018.

Research and development expense for Q1 2019 was $6.9 million compared with $5.4 million for Q1 2018.

General and administrative expense for Q1 2019 was $2.5 million compared with $2.6 million for Q1 2018.

Net income for Q1 2019 was $0.6 million, or net income of $0.01 and net loss of $0.06 per basic and diluted share, respectively, compared with a net loss of $9.0 million for Q1 2018, or net loss of $0.08 per basic and diluted share.

The Q1 2019 net income was driven by an approximate $8.8 million non-cash gain attributable to the decrease in the fair value of the 2016 PIPE warrant liability that principally resulted from the decrease in the stock price that occurred during the fiscal quarter. In Q1 2018, the non-cash loss attributable to the increase in the fair value of such warrant liability was $1.5 million.

Financial Guidance

AVEO believes that our approximate $23.5 million in cash, cash equivalents and marketable securities at March 31, 2019, along with approximately $24.2 million in additional net funding received in the second quarter of 2019 to-date, as described above, would allow us to fund our planned operations into the fourth quarter of 2020. This estimate excludes possible additional clinical trials we may sponsor and, subject to our decision whether to submit an NDA for tivozanib to the FDA following the availability of more mature OS results, remaining costs to prepare and filing fees in connection with a possible NDA submission, any related drug manufacturing and drug supply distribution, and pre-commercialization activities that we may undertake. This estimate also assumes no receipt of additional milestone payments from our partners, no funding from new partnership agreements, no additional equity financings, no debt financings, no additional sales of equity under our Leerink Sales Agreement and no additional sales of equity through the exercise of our outstanding warrants. Accordingly, the timing and nature of activities contemplated for the remainder of 2019 and thereafter will be conducted subject to the availability of sufficient financial resources.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF

receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers. In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma of the head and neck (HNSCC), metastatic pancreatic ductal cancer (PDAC), and acute myeloid leukemia (AML).

On May 9, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the first quarter of 2019 (Press release, Immunomedics, MAY 9, 2019, View Source [SID1234536076]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

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"We have made meaningful progress in all business areas during the past three months. Significantly, we have received clarity from the FDA on the CRL and plan to resubmit the BLA in early fourth quarter of 2019. In the meantime, our salesforce is working closely with Janssen Biotech Inc. to co-promote Balversa, allowing our team to further build on its extensive experience in the oncology community. To enhance shareholder value and to continue on our path to becoming a global biopharmaceutical company, we are partnering with China-based Everest Medicines to develop and commercialize sacituzumab govitecan in Greater China, the world’s fastest growing pharmaceutical market. Finally, we have launched the registrational Phase 3 TROPICS-02 study in late-line HR+/HER2 metastatic breast cancer to potentially address a large unmet market," said Behzad Aghazadeh, Executive Chairman of Immunomedics.

The randomized global TROPICS-02 study is expected to enroll approximately 400 patients with hormonal receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC) who have failed at least two prior chemotherapy regimens for metastatic disease. Patients are randomized to receive either sacituzumab govitecan or physician’s choice of eribulin, capecitabine, gemcitabine or vinorelbine.

The primary endpoint will be progression-free survival with overall survival serving as secondary endpoint. The protocol also allows for an interim analysis of overall response rate (ORR) and duration of response (DoR), the results of which could support a potential accelerated approval submission.

Recent Company Highlights

Phase 2 data with sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) were published in the New England Journal of Medicine.1

The Company’s sales force is co-promoting Balversa (erdafitinib) in the U.S. with Janssen Biotech Inc. until the end of March 2020. Should sacituzumab govitecan be approved for mTNBC in the U.S. before that time, Immunomedics is only required to support Balversa in second position detail.

The Company entered into an exclusive license agreement with Everest Medicines, the largest single-asset in-licensing deal for regional China to-date, to support development, registration, and commercialization of sacituzumab govitecan for key cancer indications in Greater China, South Korea and certain Southeast Asian countries. The Company will receive a $65 million upfront payment and an additional $60 million based on the FDA approval of sacituzumab govitecan in mTNBC in the U.S., and has the potential to receive an additional $710 million, if certain milestones are achieved.

The Company met with the FDA to discuss issues raised in the Complete Response Letter (CRL) it received in January 2019. After receiving clarity from the regulatory agency, the Company plans to resubmit its Biologics License Application in early fourth quarter of 2019 seeking the approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received two prior therapies for metastatic disease.

A registrational Phase 3 TROPICS-02 study of sacituzumab govitecan was launched in late-line HR+/HER2‒ mBC. This study could support a potential accelerated approval submission with interim results of ORR and DoR.
Results for the First Quarter of 2019
The Company had no revenues for the three months ended March 31, 2019, due primarily to the discontinued sale of LeukoScan during the quarter ended March 31, 2018 in order for the Company to focus on its ADC business. Revenues in the comparable quarter ended March 31, 2018, were approximately $0.5 million.

Total costs and expenses were $79.6 million for the three months ended March 31, 2019, compared to $38.1 million for the comparable quarter ended March 31, 2018, due primarily to a $29.3 million increase in research and development expenses, a $6.7 million increase in general and administrative expenses, and a $5.5 million increase in sales and marketing expenses. Most of these increases were attributable to activities related to preparations for the potential approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States, and to expanded clinical development of sacituzumab govitecan into other indications.

The Company had no non-cash income or expense for the three months ending March 31, 2019, compared to a $9.8 million non-cash gain for the comparable quarter ended March 31, 2018, due to a decrease in the fair value of outstanding warrants. There were no warrants outstanding as of March 31, 2019.

Interest expense was $10.0 million for the three months ended March 31, 2019, compared to $10.9 million for the comparable quarter March 31, 2018. The decrease was due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $87.3 million, or $0.46 per share, for the three months ended March 31, 2019, compared to $35.5 million, or $0.21 per share, for the comparable quarter ended March 31, 2018.

As of March 31, 2019, the Company had $442.7 million in cash, cash equivalents, and marketable securities, which it believes is adequate to support its clinical development plan for sacituzumab govitecan; further build its clinical and manufacturing infrastructure and fund its operations through 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 8:00 a.m. Eastern Time to discuss first quarter 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 5357619. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

Reference

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