On September 24, 2019 Neogen Corporation (Nasdaq: NEOG) reported that revenues for the first quarter of its 2020 fiscal year, which ended Aug. 31, were $101,424,000, compared to the previous year’s first quarter revenues of $99,626,000 (Press release, Neogen, SEP 24, 2019, View Source [SID1234539757]).

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The first quarter was the 110th of the past 115 quarters that Neogen reported revenue increases compared with the previous year — including all consecutive quarters in the last 14 years.

Net income for the first quarter of Neogen’s 2020 fiscal year was $14,652,000, or $0.28 per share, compared to $15,237,000, or $0.29 per share, in the previous year’s first quarter. In the prior year’s first quarter, Neogen benefitted from higher tax deductions relating to employee stock option exercises, which contributed to an effective tax rate of 11% for the quarter. In the first quarter of the current year, Neogen’s effective tax rate was 17%.

"Our first quarter did not meet the overall performance expectations that we have for ourselves. Even considering the difficult international business climate created by the continuing strong U.S. dollar and the U.S. trade issues with China and elsewhere, we must work to produce better results," said John Adent, Neogen’s president and chief executive officer. "We were, however, pleased with the continued strength of our genomics business, and we are continuing to build upon our core strengths to return to our historic growth rates, while also expanding our capabilities.

"In August, we announced a licensing agreement with Corvium, a leading producer of risk management software for the food safety industry, that will complement our diagnostics business by efficiently providing our customers with the information they need to make rapid data-driven decisions to protect their consumers and businesses," Adent continued. "We have also continued our genomics laboratory expansions in China, Brazil Canada and the United Kingdom, and are in the beginning stages of an expansion at our flagship operation in Lincoln, Neb., as we work to satisfy the accelerating demand for our genomics services."

Neogen’s gross margin was 47.5% of sales in the first quarter of the current fiscal year, compared to 46.9% recorded in the same period a year ago, driven by improved gross margins in the domestic genomics business, and a favorable mix shift in Food Safety towards higher margin products. Operating income for the quarter was $16,264,000, or 16.0% of sales, compared to $16,479,000, or 16.5%, a year ago, with the decline largely the result of increased spending in new product development.

"The first quarter saw a continuation of the adverse currency environment that we experienced in each of the four quarters of our previous fiscal year. In the current quarter, we would have recorded approximately $1.2 million more in revenues in a neutral currency environment," said Steve Quinlan, Neogen’s chief financial officer. "At the bottom line, we knew we faced a difficult comparison with the prior year quarter’s exceptionally low effective tax rate, which was impacted by the exercise of stock options by company employees. The timing and amount of these exercises will continue to impact the company’s effective rate going forward. But, as shown on our balance sheet, our strong cash position provides great flexibility to continue to invest in our businesses going forward."

Revenues for the company’s Food Safety segment were $51,021,000 in the current quarter, compared to $52,183,000 in the prior year’s first three months. The decrease was due primarily to lower sales internationally, caused in part by the continued strong U.S. dollar. As the majority of Neogen’s international locations report through the company’s Food Safety segment, adverse currency translations are primarily reflected in this segment’s revenue results.

Revenues at the company’s Brazilian operations decreased 16% in the current quarter compared to the prior year in U.S. dollars, as losses in sales of biosecurity products and forensic test kits were offset only partially by increases in sales of mycotoxin test kits, dairy residue test kits and culture media. The decrease in biosecurity sales was the result of a non-recurring government tender in Brazil in the prior year first quarter, while the decline in forensic test kits revenues was due to the loss of a large commercial lab customer that performs drug testing of truck and bus drivers in that country.

Mexico-based Neogen Latinoamerica’s sales increased 5% in U.S. dollars, due to strong increases in sales of mycotoxin and pathogen test kits, and dehydrated culture media; these increases were somewhat offset by lower sales of rodenticides and disinfectants. Revenues at our European operations rose 1% in local currency, as increases in cleaners and disinfectants were partially offset by lower sales in the culture media, spoilage organism and foodborne pathogen product lines, but decreased 4% when converted to U.S. dollars. In China, the African swine fever outbreak in that country resulted in lower genomic testing to the pork markets, and contributed to an 18% decline in revenues.

Global sales of Neogen’s natural toxin test kits increased 9% in the current quarter, led by a 23% increase in sales to detect aflatoxin. The quarterly increase in aflatoxin test kit sales was largely driven by increased market share gains in Brazil and Mexico during the corn harvest. Because of a relatively wet spring in the U.S., testing of domestic grain crops has largely been delayed.

Sales of Neogen’s rapid tests to detect the foodborne pathogen Listeria, including the innovative Listeria Right Now test system, increased 20% in the quarter compared to the prior year. Listeria Right Now detects the pathogen in less than an hour — without the otherwise necessary incubation time of 24 to 48 hours. Sales of Neogen’s sanitation test systems, which includes its AccuPoint Advanced ATP Sanitation Monitoring System, increased 12% in the current quarter when compared to the prior year, and the company’s test kits to detect foodborne allergens increased 8% compared to the previous year’s first quarter.

Neogen’s Animal Safety segment reported revenues of $50,403,000 for the first quarter of the 2020 fiscal year, compared to $47,443,000 in the prior year first quarter, an increase of 6%. The segment’s highlights in the quarter included strong growth in the domestic genomics testing business, a 10% increase in sales of the company’s animal care products, and a 9% increase in veterinary instruments. These increases were partially offset by lower sales of certain rodenticides.

Revenues from Neogen’s worldwide animal genomics business increased 17% in the first quarter of fiscal 2020 compared to the prior year. This growth was primarily the result of continued strength in the company’s bovine business, which includes commercial beef and dairy product lines. The increase was also the result of Neogen’s accelerating growth in companion animal genetic testing, including tests for dog and cat parentage, breed verification, and genetic health.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

Certain portions of this news release that do not relate to historical financial information constitute forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties. Actual future results and trends may differ materially from historical results or those expected depending on a variety of factors listed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s most recently filed Form 10-K.

On September 24, 2019 SkylineDx reported at the 32nd Biennial Dermatology Symposium: The O’Leary Meeting 2019 in Rochester (MN, US) the launch of a pilot study it will conduct with the Mayo Clinic to evaluate and optimize its diagnostic services focused on primary cutaneous melanoma (skin cancer) (Press release, SkylineDx, SEP 24, 2019, View Source [SID1234539756]). SkylineDx’ proprietary diagnostic test combines genetic information from a patient’s tumor cells (taken during a diagnostic biopsy) with tumor – and patient specific characteristics. Put together, the test can accurately predict the risk of regional metastasis at the time of melanoma diagnosis. Currently, based on tumor characteristics alone, too many patients are predicted to have metastasis at diagnosis which results in many unneeded surgical interventions, so-called sentinel lymph node biopsies. The SkylineDx diagnostic test identifies patients who can safely forgo this surgical intervention. This pilot study with Mayo Clinic is an usability evaluation and the final step before starting a national trial in the United States in 2020.

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This announcement follows the joint development agreement that SkylineDx and Mayo Clinic signed in 2018. "In the last 18 months we have been working with the research group of Alexander Meves M.D., a dermatologist of Mayo Clinic, to fully optimize and develop the test", says Dharminder Chahal, CEO SkylineDx. This extensive collaboration has been part of the Falcon Research & Development Program. As the falcon is known as an intelligent creature with unprecedented senses and skills, this R&D program is uniquely equipped to unveil new, detailed insights in the genomic, pathologic and clinical nature of melanoma. "With melanoma being the deadliest form of skin cancer, the launch of this Falcon Research & Development Program will make an important and much needed contribution to improving patient outcomes in this field," continues Dharminder Chahal.

Under the wings of the Falcon R&D Program, a series of specific studies and projects are initiated to demonstrate clinical utility, aimed at developing and introducing an array of diagnostic utilities, ready for the patient. The first focus area is called the Merlin Study Initiative, which covers clinical research and validation studies for the test that predicts if a patient can safely avoid sentinel lymph node surgery. Furthermore, under the Peregrine Study Initiative, SkylineDx is in advanced stages of research to develop a test that predicts a patient’s prognosis and identifies patients that are likely to progress faster and might benefit from early adjuvant therapy.

Dr. Meves and Mayo Clinic have financial interest in the test referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

On September 24, 2019 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held, clinical-stage biopharmaceutical company focused on the development and commercialization of novel, small molecule oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for LNS8801, a small molecule agonist of the G protein-coupled estrogen receptor (GPER) (Press release, Linnaeus Therapeutics, SEP 24, 2019, View Source [SID1234539755]). Linnaeus is developing LNS8801 for the treatment of solid and hematologic cancers.

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"The FDA clearance of the IND allows Linnaeus to begin human testing of LNS8801 and represents the culmination of a tremendous effort by our research and development team," commented Patrick Mooney, MD, chief executive officer of Linnaeus. "LNS8801 is a potent and highly selective small molecule agonist of GPER. Based on the epidemiological evidence and the strong preclinical data, we believe that LNS8801 has very real potential to provide meaningful and lasting clinical benefit for patients with cancer. We are excited to enroll our first patient in the coming weeks."

FDA allowance of the IND enables Linnaeus to initiate its planned phase 1/2 clinical trial in patients with advanced cancers. The phase 1 dose-escalation portion of the trial will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of LNS8801. After a recommended phase 2 dose is established, dose expansion cohorts are anticipated. Linnaeus expects the first patient to be enrolled in the trial in October 2019.

About LNS8801
LNS8801 is an orally bioavailable, highly specific, agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has significant antitumor activity, including complete responses that are immune to rechallenge. LNS8801 also has combinatorial effects with targeted therapies and immunotherapies. Preclinical toxicology studies have established a wide safety margin.

On September 24, 2019 Amgen (NASDAQ:AMGN) reported that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met (Press release, Amgen, SEP 24, 2019, View Source [SID1234539754]). The study evaluated the efficacy, safety and tolerability of BLINCYTO (blinatumomab) compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia (ALL) at first relapse. Enrollment was terminated early due to encouraging efficacy in the BLINCYTO arm and was based on a recommendation from the Independent Data Monitoring Committee (DMC). Follow up will continue as prescribed per protocol.

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In addition, a randomized, Phase 3 trial (AALL1331) conducted by the Children’s Oncology Group (COG) using BLINCYTO in pediatric B-cell ALL patients at first relapse has closed to accrual for the high-risk and intermediate risk-arm based on the recommendation of the COG DMC. The DMC closure decision was based on a strong trend towards improved disease-free survival and improved overall survival, markedly lower toxicity, and better minimal residual disease (MRD) clearance for BLINCYTO compared to chemotherapy. The COG DMC recommended that the AALL1331 low-risk group continue to enroll and randomize patients until enrollment goals are reached. AALL1331 is sponsored by the Cancer Therapy Evaulation Program of the National Cancer Institute (NCI), part of the National Institutes of Health, and is conducted by the NCI-funded COG. Amgen provided BLINCYTO for AALL1331 under a Collaborative Research and Development Agreement between the NCI and Amgen.

"Considered together, the results of these studies are remarkable. Children and adolescents who relapse with acute lymphoblastic leukemia face a poor prognosis and there remains a need for additional treatment options, particularly for those that are identified as high-risk. These data have the potential to be practice-changing and may provide a treatment approach to prevent further relapse that is superior to chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to discussing these data with regulatory authorities."

The BLINCYTO adverse events observed in the Phase 3 20120215 and the COG AALL1331 studies were consistent with the known safety profile of BLINCYTO. These interim data will be submitted to a future medical conference and for publication.

About the 20120215 Study

Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial to evaluate event-free survival after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first relapsed B-cell ALL. Key secondary endpoints included incidence of overall survival and MRD response, AEs, 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. This is a global study that is being conducted as part of the PIP (Pediatric Investigation Plan) agreed to between Amgen and the EMA. The study is being conducted in Australia and various countries in EU and Latin America. Click here to read about the trial on ClinicalTrials.gov.

About the COG AALL1331 Study

The COG AALL1331 study is a risk-stratified, randomized, Phase 3 trial of blinatumomab in first relapse of pediatric B-ALL to evaluate disease-free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapsed B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab. It also compares the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab. Key secondary endpoints include overall survival of HR, IR, and LR relapsed B-ALL patients. This is a global study that is being conducted in Australia, Canada, New Zealand and United States. Click here to read about the trial on ClinicalTrials.gov.

About BLINCYTO (blinatumomab)

BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

BiTE antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:

relapsed or refractory B-cell precursor ALL in adults and children.
B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.
This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
In the EU, BLINCYTO is indicated as monotherapy for the treatment of:

adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
About BiTE Technology

Bispecific T cell engager (BiTE) technology is a targeted immuno-oncology platform designed to engage patients’ own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended.
Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
Contraindications

BLINCYTO is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and Precautions

Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in 15% of patients with R/R ALL and in 7% of patients with MRD-positive ALL. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO overlap with those of infusion reactions, capillary leak syndrome, and hemophagocytic histiocytosis/macrophage activation syndrome. If severe CRS occurs, interrupt BLINCYTO until CRS resolves. Discontinue BLINCYTO permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
Neurological Toxicities: Approximately 65% of patients receiving BLINCYTO in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life‐threatening, or fatal neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO as outlined in the PI.
Infections: Approximately 25% of patients receiving BLINCYTO in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO as needed.
Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO as needed to manage these events.
Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO infusion and interrupt BLINCYTO if prolonged neutropenia occurs.
Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered.
Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO treatment with a median time to onset of 3 days. In patients receiving BLINCYTO, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and TBILI prior to the start of and during BLINCYTO treatment. BLINCYTO treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO and dexamethasone as needed.
Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
Preparation and administration errors have occurred with BLINCYTO treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO treatment, during treatment, and until immune recovery following last cycle of BLINCYTO.
Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including "gasping syndrome," which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO (with preservative). When prescribing BLINCYTO (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing < 22 kg.
Adverse Reactions

The most common adverse reactions (≥ 20%) in clinical trial experience of patients with MRD-positive B-cell precursor ALL (BLAST Study) treated with BLINCYTO were pyrexia (91%), infusion-related reactions (77%), headache (39%), infections (pathogen unspecified [39%]), tremor (31%), and chills (28%). Serious adverse reactions were reported in 61% of patients. The most common serious adverse reactions (≥ 2%) included pyrexia, tremor, encephalopathy, aphasia, lymphopenia, neutropenia, overdose, device related infection, seizure, and staphylococcal infection.
The most common adverse reactions (≥ 20%) in clinical trial experience of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL (TOWER Study) treated with BLINCYTO were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, CRS, bacterial sepsis, device related infection, and bacteremia.
Adverse reactions that were observed more frequently (≥ 10%) in the pediatric population compared to the adults with relapsed or refractory B-cell precursor ALL were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%).
Dosage and Administration Guidelines

BLINCYTO is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.

About Amgen Oncology

Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

For more information, follow us on www.twitter.com/amgenoncology.

On September 24, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its third quarter 2019 financial results after the market close on Monday, October 28, 2019 (Press release, Medpace, SEP 24, 2019, View Source [SID1234539753]). The Company will host a conference call the following morning, Tuesday, October 29, 2019, at 9:00 a.m. ET to discuss these results.

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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 7668623.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, October 29, 2019 until 12:00 p.m. ET on Tuesday, November 12, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 7668623.