Center in Singapore Expanding Access to Radiation Therapy Technology in the Fight Against Cancer

On May 7, 2020 Varian (NYSE: VAR) and the National University Cancer Institute, Singapore (NCIS), reported that are partnering to expand access to cancer solutions in Singapore in the fight against cancer (Press release, Varian Medical Systems, MAY 7, 2020, View Source [SID1234557329]). In 2018, 26,164 cases of cancer were diagnosed in Singapore, and it is expected to more than double to 57,319 cases over the next 20 years .1

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Two Varian VitalBeam medical linear accelerators, together with an Edge radiosurgery system with HyperArc technology, will be installed at NCIS, thereby expanding radiation therapy treatment options for cancer patients in Singapore.

Dr Francis Ho, head of the Department of Radiation Oncology at NCIS said: "We are proud to continue bringing in innovative therapy treatments, such as HyperArc, to help treat patients with cancer. We are committed to providing quality patient care to the people in Singapore. With this technology, we hope to reduce inefficiencies in plan creation and treatment delivery, leading to reduced treatment times for patients."

Kenneth Tan, president, Varian Asia Pacific said: "With an ever-rising number of patients being diagnosed with cancer and an increasingly aging population, it is now more important than ever to help patients and clinicians in Singapore in the fight against cancer. Through this partnership with the National University Cancer Institute, Singapore, and by bringing in high-quality radiation therapy combined with connected cancer care solutions, we are working towards our vision of living in a world without fear of cancer."

HyperArc technology is designed to automate and simplify sophisticated treatments such as stereotactic radiosurgery (SRS) and make them available to more cancer patients around the world. VitalBeam offers high-quality, high-throughput radiation therapy, which enables healthcare professionals to expand clinical capabilities and serve more patients with advanced treatment technology over time.

Momenta Pharmaceuticals Reports First Quarter 2020 Financial and Operating Results

On May 7, 2020 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, reported its financial results for the first quarter ended March 31, 2020 (Press release, Momenta Pharmaceuticals, MAY 7, 2020, View Source [SID1234557328]).

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"Despite the turbulence imposed by the COVID-19 pandemic, Momenta has remained focused on advancing our development pipeline for rare, immune-mediated diseases," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We are targeting key readouts from our lead programs by the end of the third quarter. These readouts will include interim proof-of-concept data from nipocalimab in MG and data from Part B of our Phase 1/2 study of M254 in ITP. We expect data from both programs will further demonstrate the potential of these programs, each with franchise opportunities across a range of large market auto- and alloimmune diseases. Finally, we remain in a strong corporate position, with cash to fund operations through at least the third quarter 2021, as we continue to leverage our platform for growth."

First Quarter 2020 Highlights, Recent Events and Anticipated Upcoming Milestones

Novel Therapeutics Pipeline:

Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

•We announced in February that Vivacity-MG, the Company’s Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), achieved its target enrollment. Momenta remains on track to report top-line interim data from this study by the third quarter of 2020.

•Unity, the Company’s global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), continues to enroll patients at sites where they can be safely accommodated.

•Momenta continues to activate sites globally for its Energy Study, the Company’s adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA), however it has temporarily suspended patient enrollment due to the COVID-19 pandemic.

M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)

•The Company’s multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) is progressing through Part B, which is evaluating M254 in a single ascending dose (SAD) cohort of ITP patients, followed by 1,000mg/kg of IVIg. Enrollment is ongoing, however it has slowed due to the COVID-19 pandemic. The Company plans to complete and report data from Part B in the third quarter of 2020 and expects to initiate Part C of the study in the fourth quarter of 2020.

•The Company’s planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to initiate in 2021, following completion of Parts C and D from its ongoing Phase 1/2 trial of M254 in ITP.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

•A Phase 1 clinical trial to evaluate the safety and tolerability of M230 in healthy volunteers is ongoing. Momenta’s partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program in 2020.

Momenta’s SIFbody platform combines multiple Fc’s with antibody Fabs to optimally activate Fc effector function, and to effectively deplete target cells.

•The Company has initiated IND-enabling studies for M267, a SIFbody candidate targeting CD38. Pre-clinical data suggest this candidate has the potential to be a best-in-class therapeutic to target CD38-expressing cells, which are prevalent in plasmacyte-mediated diseases such as multiple myeloma, AL amyloidosis and other rare, autoantibody-mediated diseases.

Legacy Products:

GLATOPA 20 mg and 40 mg: U.S. Food and Drug Administration (FDA) approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz

•In the first quarter of 2020, Momenta recorded $8.7 million in product revenue from Sandoz’s sales of GLATOPA products.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

•Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA. Mylan expects to target U.S. submission in 2021, while monitoring and navigating potential COVID-19 issues.

Corporate:

•In April 2020, Momenta provided an update on clinical trial activities and business operations amid the COVID-19 pandemic, including measures implemented to protect the health and safety of its personnel, as well as patients and healthcare professionals involved with its clinical studies; to ensure its clinical studies were able to continue unimpeded for patients already enrolled; and to preserve the integrity of its clinical data, in line with updated guidance from the FDA. These business continuity measures currently remain in place, as the Company continues to closely monitor the situation and guidance from public health authorities. Momenta expects to resume activities for affected studies when conditions permit.

First Quarter 2020 Financial Results

Revenue:

In the first quarter of 2020, the Company recorded $8.7 million in product revenue from Sandoz’s sales of GLATOPA, compared to $2.4 million for the same period in 2019. The increase in product revenue from the prior year period was primarily due to higher net sales of GLATOPA, driven by volume increases.

Research and development revenue for the first quarter of 2020 was $0.2 million, compared to $1.8 million for the same period in 2019. The decrease in research and development revenue of $1.6 million, or 89%, was primarily due to lower reimbursement revenue for GLATOPA expenses and lower revenue recognized from Mylan’s upfront payment associated with the biosimilar collaboration.

Total revenue for the first quarter of 2020 was $8.9 million compared to $4.1 million for the same period in 2019.

Operating Expenses:

Research and development expenses for the first quarter of 2020 were $34.2 million, compared to $28.0 million for the same period in 2019. The increase of $6.2 million, or 22%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254 and increased spending on M710, offset in part by lower lease costs.

General and administrative expenses for the first quarter of 2020 were $14.6 million, compared with $24.2 million for the same period in 2019. The decrease of $9.6 million, or 40%, was primarily due to lower depreciation and rent costs due to the modification of the Bent St. lease and lower legal costs.

Total GAAP operating expenses were $49.6 million in the first quarter of 2020. First quarter 2020 non-GAAP operating expense was $44.7 million. Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Loss:

The Company reported a net loss of $39.6 million, or $0.34 per share for the first quarter of 2020 compared to a net loss of $44.8 million, or $0.46 per share for the same period in 2019.

Liquidity:

At March 31, 2020, Momenta had $487.9 million in cash, cash equivalents, and marketable securities. This compares to $545.1 million at December 31, 2019 in cash, cash equivalents, and marketable securities.

2020 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenues. Due to lower clinical trial enrollment trends as a result of the COVID-19 pandemic, Momenta anticipates its full-year non-GAAP operating expenses will be lower than $220 – $240 million, as previously guided for 2020. The Company anticipates providing an update on expected non-GAAP operating expense for 2020 as part of its second quarter 2020 financial results.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense, restructuring expense and collaborative reimbursement revenue. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company does not expect restructuring expense and collaboration reimbursement revenue to be material.

Conference Call Information

Management will host a conference call and webcast today at 8:30 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call, you may also dial (866) 209-9686 (domestic) or (825) 312-2288 (international) prior to the scheduled conference call time and provide the access code 9178486.

Pacira BioSciences Reports First Quarter 2020 Financial Results and Business Update

On May 7, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX), a leading provider of innovative non-opioid pain management options, reported financial results for the first quarter of 2020 (Press release, Pacira Pharmaceuticals, MAY 7, 2020, View Source;991.htm [SID1234557327]).

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"Prior to headwinds from the COVID-19 pandemic, which began in mid-March, we saw growing demand for EXPAREL continue with year-over-year growth rates of over 20 percent in January and February. Specifically, we saw demand continue to expand within the anesthesia community with EXPAREL-based nerve and field blocks continuing to take hold as institutional protocol for a variety of surgical procedures," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "We remain steadfast in our long-term strategy to solidify our role as a leading provider of innovative non-opioid pain management and regenerative health solutions and believe the fundamentals of our business will continue to fuel our long-term expansion. Importantly, we are ready to quickly ramp up as elective surgery restrictions lift across the states and ambulatory centers address the backlog of patients who require surgery with increased resources and hours of operation."

First Quarter 2020 Financial Results
•Total revenues were $105.7 million in the first quarter of 2020, a 16% increase over the $91.3 million reported for the first quarter of 2019.
•EXPAREL net product sales were $101.3 million in the first quarter of 2020, a 12% increase over the $90.6 million reported for the first quarter of 2019.
•First quarter iovera° net product sales were $2.3 million. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.
•Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.2 million in the first quarter of 2020, compared to $0.3 million in 2019.
•First quarter royalty revenue was $0.9 million compared to $0.4 million in 2019.
•Total operating expenses were $88.6 million in the first quarter of 2020, compared to $90.2 million in the first quarter of 2019.

•Research and development (R&D) expenses were $15.8 million in the first quarter of 2020, compared to $14.4 million in the first quarter of 2019. R&D expenses include $6.6 million and $6.4 million of product development and manufacturing capacity expansion costs in the first quarters of 2020 and 2019, respectively.
•Selling, general and administrative (SG&A) expenses were $44.8 million in the first quarter of 2020, compared to $47.3 million in the first quarter of 2019.
•GAAP net income was $8.2 million, or $0.19 per share (basic and diluted) in the first quarter of 2020, compared to a GAAP net loss of $2.8 million, or $0.07 per share (basic and diluted), in the first quarter of 2019.
•Non-GAAP net income was $22.8 million, or $0.54 per share (basic) and $0.53 per share (diluted), in the first quarter of 2020, compared to non-GAAP net income of $9.3 million, or $0.22 per share (basic and diluted), in the first quarter of 2019.
•Pacira ended the first quarter of 2020 with cash, cash equivalents, short-term and long-term investments ("cash") of $353.6 million. Cash provided by operations was $6.2 million in the first quarter of 2020, compared to $3.5 million in the first quarter of 2019.
•Pacira had 42.0 million basic weighted average shares of common stock outstanding in the first quarter of 2020.
•Pacira had 42.8 million diluted weighted average shares of common stock outstanding in the first quarter of 2020.
See "Non-GAAP Financial Information" below.

2020 Financial Guidance
Prior to March 16, 2020, EXPAREL net product sales were tracking ahead of plan. Given the rapidly changing variables related to the COVID-19 pandemic, the company does not have sufficient visibility to accurately forecast the impact of this pandemic and, consequently, is temporarily withdrawing all full-year 2020 financial guidance. The company believes expense reductions resulting from COVID-19 will partially mitigate the negative revenue impact of the pandemic.

Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, May 7, 2020, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8568879. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8568879. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

X4 Pharmaceuticals Provides Corporate Update, Including Expected Impact of COVID-19, and Reports First Quarter 2020 Financial Results

On May 7, 2020 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases resulting from dysfunction of the CXCR4 pathway, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update, including commentary related to the impact of the COVID-19 pandemic on the company (Press release, X4 Pharmaceuticals, MAY 7, 2020, View Source [SID1234557326]).

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"During these challenging and unprecedented times, our thoughts are with everyone affected by the COVID-19 pandemic," said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. "Here at X4, we continue our efforts to advance our lead product candidate, mavorixafor, through clinical development. As presented at our analyst day in April, we recently completed market research that enabled us to update and increase our estimates on the U.S. prevalence of Warts, Hypogammaglobulinemia, Infections, and Myelokathexis, or WHIM, syndrome, our lead indication for mavorixafor."

Dr. Ragan continued, "Our first priority is the safety and wellbeing of our patients. During the pandemic, we have been regularly assessing the impact of COVID-19 on our current clinical development activities and timelines while taking measures to ensure the health and safety of our employees, patients, and healthcare providers. Our Phase 1b clinical trial of mavorixafor in patients with Waldenström’s macroglobulinemia remains on track, with initial data expected in the second half of 2020. Based on our current assessment of the impact of COVID-19 on our clinical trial sites and the pace of enrollment at certain sites, we now expect top-line Phase 3 results from our clinical trial in patients with WHIM syndrome to be delayed into 2022. Based on a similar assessment, we now expect initial data from our Phase 1b clinical trial in patients with Severe Congenital Neutropenia, or SCN, to be delayed into 2021. We will continue to work on minimizing further impact of COVID-19 on our ongoing clinical trials. We plan to provide further updates, including narrowing our guidance regarding upcoming clinical milestones, as we gain greater clarity."

Current Impact of COVID-19 on X4 Operations and Clinical Trials

In March 2020, X4 enacted a mandatory "work from home" policy for employees with non-laboratory based work and maintained a small number of lab-based employees, compliantly working in shifts, in its Vienna, Austria research facility in order to mitigate the risk of coronavirus spreading among its personnel.

•Operations: To date, the company believes that COVID-19 has had minimal effect on its ongoing business operations.
◦Since March 16, 2020, X4 has continued its business operations using technology and communications tools to effectively execute plans while working remotely and in virtual settings. X4 teams have continued to virtually attend meetings with investigators, regulatory authorities, partners, contractors, and investors.
◦Notably, X4 hosted a well-attended Virtual Analyst Day in early April, including a key opinion leader (KOL) presentation and a fireside chat. Additionally, representatives of X4 continue to attend virtual investor conferences and engage with the investment community.

•Clinical Trials: To date, the company believes that the COVID-19 pandemic has had the following impact on its clinical programs:
◦Phase 1b Waldenström’s Trial. X4’s Phase 1b clinical trial of mavorixafor in patients with Waldenström’s macroglobulinemia remains on track, with the initial data readout still expected in the second half of 2020. The Phase 1b multi-center, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of mavorixafor in combination with ibrutinib, as well as to obtain certain efficacy signals in patients with Waldenström’s macroglobulinemia, a rare form of non-Hodgkin’s lymphoma.
◦Phase 1b SCN Trial. X4 is updating its guidance regarding the timing of initial data from its Phase 1b clinical trial of mavorixafor in patients with SCN. The Phase 1b clinical trial is a 14-day, proof-of-concept trial designed to assess the safety and tolerability of daily, oral mavorixafor in up to 45 patients with SCN and other selected congenital neutropenia disorders. The company expects a delay into 2021 to report initial data, which were previously expected in the second half of 2020.
◦Phase 3 WHIM Trial. X4 is updating its guidance on the timing of top-line data from its pivotal Phase 3 clinical trial in patients with WHIM syndrome, a rare, inherited, primary immunodeficiency disease. The 4WHIM trial is a global, 52-week, randomized, double-blind, placebo-controlled clinical trial of mavorixafor for the treatment of WHIM. Following an assessment of and input from many of its clinical trial sites, the company expects a delay into 2022 to report top-line data, which were previously expected in the second half of 2021.

First Quarter / Recent Highlights

•Increased Guidance on Prevalence of WHIM at Virtual Analyst Day. X4 conducted a broad online survey of U.S. physicians to validate current prevalence estimates, and conducted additional research using artificial intelligence (AI), interrogating a database of more than 300 million anonymized patient records that spanned 10 years of insurance claims, to help identify additional likely but unconfirmed WHIM patients.
◦Data from the quantitative market research support an estimate of between 1,000 and 1,300 diagnosed WHIM patients in the United States today.

◦The research that used AI identified between 800 and 2,400 additional potential WHIM patients in the United States, which the company believes are likely to be unconfirmed and undiagnosed.
◦Based on this research, X4 updated guidance on its estimated range of diagnosed and undiagnosed WHIM patients in the United States to be between 1,800 and 3,700, a significant increase from its prior estimate of approximately 1,000 WHIM patients.

•Results of Open-Label Extension of Phase 2 WHIM Trial to Be Presented at EHA (Free EHA Whitepaper) 2020. The Phase 2 trial was an open-label, multi-center trial of mavorixafor in patients with WHIM syndrome. The trial had an initial 24-week treatment period followed by an extension phase. With its abstract accepted as a poster presentation, X4 plans to present updated data from patients participating in the extension phase of the Phase 2 trial at the Virtual Edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, which will be held June 11-14, 2020.

•Granted Two New U.S. Patents for Mavorixafor Composition of Matter and Method of Use. In February 2020, X4 was issued patents that are expected to provide exclusivity through 2038 for mavorixafor, the company’s lead therapeutic candidate, with additional protection for WHIM.

•Expansion of Debt Facility. In March 2020, X4 amended its credit agreement with Hercules Capital, Inc. to increase X4’s potential borrowing capacity to $50 million, of which $25 million remains potentially available.

•Milestone Payment from Abbisko Therapeutics. In April 2020, X4 received its first milestone payment of $3.0 million from Abbisko Therapeutics, X4’s solid tumor oncology partner for the Greater China region. This payment, tied to the closing of a financing by Abbisko, represented the first milestone stemming from the companies’ collaboration arrangement and was recognized by X4 as license revenue in the first quarter ended March 31, 2020.

First Quarter 2020 Financial Results

•Cash, Cash Equivalents & Restricted Cash: X4 had $117.0 million in cash, cash equivalents and restricted cash, as of March 31, 2020. X4 continues to expect that its cash and cash equivalents will fund company operations into early 2022. In addition, X4 has $25 million of potential borrowing capacity under its amended credit agreement with Hercules. X4 continues to monitor the impact of the COVID-19 pandemic and to manage cash and working capital accordingly in case of potential changes to its business plans.
•License Revenues were $3.0 million for the first quarter of 2020 related to X4’s strategic agreement with Abbisko. Cash related to this revenue was collected in April 2020 and is therefore not reflected in the $117.0 million of cash, cash equivalents and restricted cash shown above. There were no license revenues recorded in the comparable period in 2019.
•Research and Development Expenses were $8.9 million for the first quarter ended March 31, 2020, as compared to $5.7 million for the comparable period in 2019.
•General and Administrative Expenses were $4.7 million for the first quarter ended March 31, 2020, as compared to $4.8 million for the comparable period in 2019.
•Net Loss: X4 reported a net loss of $11.1 million for the first quarter ended March 31, 2020 as compared to a net loss of $10.9 million for the comparable period in 2019.

Conference Call and Webcast

The company will host a webcast and conference call to discuss its first quarter 2020 results and provide an update on recent corporate activities today at 8:30 a.m. Eastern Time. The webcast will be accessible under "Events & Presentations" on the Investors page of the company’s website at www.x4pharma.com. The conference call can be accessed by dialing (866) 721-7655 from the United States or (409) 216-0009 internationally, followed by the conference ID: 5573325. Following the completion of the call, a webcast replay of the conference call will be available on the company website.

Halozyme To Present At The Bank Of America Securities 2020 Healthcare Conference

On May 7, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO), reported that it will participate in the Bank of America Securities 2020 Healthcare Conference (Press release, Halozyme, MAY 7, 2020, View Source [SID1234557325]. This conference is being hosted virtually . Dr. Helen Torley, president and chief executive officer, will provide an overview of the company on Thursday, May 14 at 5:00 p.m. ET / 2:00 p.m. PT).

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.