On November 4, 2020 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that twenty-one abstracts have been selected for virtual presentation, including two oral presentations, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting taking place December 5-8, 2020 (Press release, Karyopharm, NOV 4, 2020, View Source [SID1234569899]). Key abstracts to be presented at the meeting will feature clinical data for XPOVIO (selinexor), the Company’s first in class, oral SINE compound, including: (i) updated data from the Pomalyst (pomalidomide), Kyprolis (carfilzomib) and Revlimid (lenalidomide) arms of the Phase 1b/2 STOMP study evaluating XPOVIO in combination with backbone therapies in patients with relapsed or refractory multiple myeloma; (ii) several new subgroup analyses from the pivotal Phase 3 BOSTON study evaluating once weekly XPOVIO in combination with once weekly Velcade (bortezomib) and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received one to three prior lines of therapy; and (iii) new subgroup analyses from the Phase 2b SADAL study evaluating XPOVIO in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our tradition of having a strong presence at the ASH (Free ASH Whitepaper) annual meeting continues this year and we are excited to share important clinical data from a variety of our XPOVIO clinical studies," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "In total, twenty-one abstracts have been selected, including an oral presentation highlighting the all-oral regimen of XPOVIO and Pomalyst from the ongoing STOMP study. Additionally, updated data from two other arms of the STOMP study will also be presented, including the arm investigating XPOVIO and Kyprolis as well as the arm investigating XPOVIO and Revlimid. In all three arms, the response rates and safety profile continue to be encouraging. In addition, we look forward to several poster presentations describing a variety of subanalyses from the Phase 3 BOSTON study in important subgroups such as older, frail patients, patients previously treated with proteasome inhibitors, and patients with high risk cytogenetics, among others."

Karyopharm plans to host a virtual investor and analyst event to discuss the Company’s pipeline of clinical programs and highlights from the ASH (Free ASH Whitepaper) 2020 data presentations. Details for this event, including date, time, and log-in information will be announced in the coming weeks. A live webcast of the presentation will be accessed under "Events & Presentations" in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the event.

Details for the ASH (Free ASH Whitepaper) 2020 presentations are as follows:

XPOVIO (selinexor) – Company-Sponsored Studies – Oral Presentation – Multiple Myeloma

Title: Selinexor in combination with pomalidomide and dexamethasone (SPd) for treatment of patients with relapsed refractory multiple myeloma (RRMM).
Presenter: Christine Chen, Princess Margaret Cancer Centre
Abstract #: 726
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation; Novel Approaches for Relapsed/Refractory Myeloma and Amyloidosis
Date and Time: Monday, December 7, 2020, 1:30 p.m. to 3:00 p.m. ET
Location: Channel 10 (Virtual Meeting)

XPOVIO (selinexor) – Company-Sponsored Studies – Poster Presentations – Multiple Myeloma

Title: Selinexor in combination with carfilzomib and dexamethasone, all once weekly (SKd), for patients with relapsed/refractory multiple myeloma
Presenter: Cristina Gasparetto, Duke University Medical Center
Abstract #: 1366
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 5, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Selinexor, lenalidomide and dexamethasone (SRd) for patients with relapsed/refractory and newly diagnosed multiple myeloma
Presenter: Darrell White, Dalhousie University
Abstract #: 1393
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 5, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Effect of prior treatment with proteasome inhibitors on the efficacy and safety of once-weekly selinexor, bortezomib, and dexamethasone in comparison with twice weekly bortezomib and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis from the BOSTON study
Presenter: Maria Mateos, University Hospital of Salamanca
Abstract #: 2297
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 6, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Impact of prior therapies on the safety and efficacy of once-weekly selinexor, bortezomib, and dexamethasone compared with twice-weekly bortezomib and dexamethasone in relapsed ore refractory multiple myeloma: results from the BOSTON study
Presenter: Maria Mateos, University Hospital of Salamanca
Abstract #: 3245
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Once weekly selinexor, bortezomib, and dexamethasone versus twice weekly bortezomib and dexamethasone in relapsed ore refractory multiple myeloma: age and frailty subgroup analyses from the phase 3 BOSTON study
Presenter: Harold Auner, Imperial College London
Abstract #: 3215
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Once weekly selinexor, bortezomib, and dexamethasone (SVd) versus twice weekly bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma: high-risk cytogenetic risk planned subgroup analyses from the phase 3 BOSTON study
Presenter: Shambavi Richard, Mount Sanai Hospital
Abstract #: 1385
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 5, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Peripheral neuropathy symptoms, pain and functioning in relapsed or refractory MM patients treated with selinexor, bortezomib, and dexamethasone
Presenter: Larysa Sanchez, Icahn School of Medicine at Mount Sinai
Abstract #: 3489
Session: 906. Outcomes Research—Malignant Conditions (Myeloid Disease): Poster III
Date and Time: Monday, December 7, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

XPOVIO (selinexor) – Company-Sponsored – Poster Presentations – Lymphoma

Title: Effect of age on the efficacy and safety of single agent oral selinexor in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a post-hoc analysis from the SADAL pivotal study
Presenter: Marie Maerevoet, Institut Jules Bordet
Abstract #: 1201
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster I
Date and Time: Saturday, December 5, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Selinexor efficacy and safety are independent of renal function in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a post-hoc analysis from the pivotal phase 2b SADAL study
Presenter: Jason Westin, The University of Texas MD Anderson Cancer Center
Abstract #: 1384
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 5, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: A six-protein activity signature defines favorable response to selinexor treatment for patients with diffuse large B-cell lymphoma (DLBCL)
Presenter: Christopher Walker, Karyopharm Therapeutics
Abstract #: 2125
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Retrospective/Observational Studies: Poster II
Date and Time: Sunday, December 6, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

XPOVIO (selinexor) – Investigator-Sponsored – Oral Presentations – Lymphoma

Title: Inhibiting the Nuclear Exporter XPO1 and the Antiapoptotic Factor BCL2 Is Synergistic in XPO1 Mutant and Wildtype Lymphoma
Presenter: Justin Taylor, University of Miami
Abstract #: 526
Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Molecular pharmacology and drug resistance mechanisms in lymphoproliferative disorders
Date and Time: Monday, December 7, 2020 ; 7:00 a.m. to 8:30 a.m.
Location: Channel 8 (Virtual Meeting)

XPOVIO (selinexor) – Investigator-Sponsored – Poster Presentations – Lymphoma

Title: Selinexor in combination with R-CHOP for frontline treatment of non-Hodgkin lymphoma: results of a phase 1b study
Presenter: Erlene Seymour, Wayne State University
Abstract #: 2109
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster II
Date and Time: Sunday, December 6, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: A Phase I Investigator Sponsored Trial of Selinexor (KPT-330) and Rituximab, Ifosfamide, Carboplatin and Etoposide in Patients with Relapsed or Refractory Aggressive B-Cell Lymphomas
Presenter: Sarah Rutherford, Weill Cornell Medicine
Abstract #: 2104
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster II
Date and Time: Sunday, December 6, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: XPO1 Relieves MYC-Induced Replication Stress Limiting the Immunogenicity of DLBCL Cells
Presenter: Rossella Marullo, Weill Cornell Medicine
Abstract #: 2018
Session: 621. Lymphoma—Genetic/Epigenetic Biology: Poster II
Date and Time: Sunday, December 6, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: The Expression of Chromosome Region Maintenance Protein 1 (CRM1) in Large Cell Lymphoma
Presenter: Jithma Abeykoon, Mayo Clinic
Abstract #: 2132
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Retrospective/Observational Studies: Poster II
Date and Time: Sunday, December 6, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

XPOVIO (selinexor) – Investigator-Sponsored – Poster Presentations – Leukemia

Title: Frontline selinexor and chemotherapy is highly active in older adults with AML
Presenter: Timothy Pardee, Wake Forest School of Medicine
Abstract #: 633
Session: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Commercially Available Therapy, excluding Transplantation II
Date and Time: Monday, December 7, 2020, 11:45 a.m. ET
Location: Channel 12 (Virtual Meeting)

Title: Exportin-1 (XPO1) Inhibition Sequesters p53 from MDM2 and MDM4 and Is Highly Synergistic with MDM2 Inhibition in Inducing Apoptosis in Wild-Type p53 Acute Myeloid Leukemias
Presenter: Yuki Nishida, MD Anderson Cancer Center
Abstract #: 2775
Session: 603. Oncogenes and Tumor Suppressors: Poster III
Date and Time: Monday, December 7, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

XPOVIO (selinexor) – Investigator-Sponsored – Poster Presentations – Other

Title: CRISPR/Cas9 Chemogenetic Profiling Identifies Candidate Biomarker Genes That Modulate Sensitivity to Selinexor
Presenter: Bert Kwanten, KU Leuven
Abstract #: 965
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I
Date and Time: Saturday, December 5, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

Title: Salicylates Potentiate and Broaden CRM1 Inhibitor Anti-Tumor Activity Via S-Phase Arrest and Impaired DNA-Damage Repair
Presenter: Jithma Abeykoon, Mayo Clinic
Abstract #: 171
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Novel Approaches to Overcome Resistance
Date and Time: Saturday, December 5, 2020, 12:00 p.m. ET
Location: Channel 7 (Virtual Meeting)

KPT-9274 – Investigator-Sponsored – Poster Presentations – Other

Title: Nicotinamide Phosphoribosyltransferase Inhibitors Induce Apoptosis of AML Stem Cells through Dysregulation of Lipid Metabolism
Presenter: Amit Subedi, Princess Margaret Cancer Center
Abstract #: 2777
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster III
Date and Time: Monday, December 7, 2020, 7:00 a.m. to 3:30 p.m. ET
Location: Poster Hall (Virtual Meeting)

About XPOVIO (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

IMPORTANT SAFETY INFORMATION

Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection. Neutropenia and febrile neutropenia occurred in patients with MM and in patients with DLBCL.

Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction (AR).

Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients with MM and DLBCL.

Nausea/Vomiting: Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

Diarrhea: Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration, and replace electrolytes as clinically indicated.

Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia. Hyponatremia developed in patients with MM and in patients with DLBCL.

Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first 2 months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose, or permanently discontinue based on severity of the AR.

Serious Infection: XPOVIO can cause serious and fatal infections. Most infections were not associated with Grade 3 or higher neutropenia. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.

Monitor for signs and symptoms of infection, and evaluate and treat promptly.

Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.

Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.

Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (ARs) in ≥20% of patients with MM are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The most common ARs, excluding laboratory abnormalities, in ≥20% of patients with DLBCL are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities in ≥15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia, lymphopenia, and neutropenia.

In patients with MM, fatal ARs occurred in 9% of patients. Serious ARs occurred in 58% of patients. Treatment discontinuation rate due to ARs was 27%. The most frequent ARs requiring permanent discontinuation in ≥4% of patients included fatigue, nausea, and thrombocytopenia.

In patients with DLBCL, fatal ARs occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal AR was infection (4.5% of patients). Serious ARs occurred in 46% of patients; the most frequent serious AR was infection. Discontinuation due to ARs occurred in 17% of patients.

USE IN SPECIFIC POPULATIONS

In MM, no overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥75 years old had a higher incidence of discontinuation due to an AR than younger patients, a higher incidence of serious ARs, and a higher incidence of fatal ARs.

Clinical studies in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.

On November 4, 2020 TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, reported financial results for the quarter ended September 30, 2020 (Press release, TransMedics, NOV 4, 2020, View Source [SID1234569898]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Highlights

Net revenue of $7.1 million in the third quarter of 2020, representing a 2% decrease compared to the third quarter of 2019
Completed enrollment in OCS Heart DCD U.S. clinical program
Received FDA approval for OCS Heart DCD continued access protocol
"Our sequential growth in the third quarter was driven by the ongoing recovery in transplant activities in the United States in addition to the rapid enrollment and completion of our OCS Heart DCD U.S. trial," said Waleed Hassanein, MD, President and Chief Executive Officer. "We are actively engaged with FDA to complete the review of the additional OCS Heart EXPAND CAP data and the rescheduling of our OCS Heart FDA Advisory Committee meeting. We remain confident in our ability to have all three of our OCS products approved and commercially available in the second half of 2021."

Third Quarter 2020 Financial Results
Net revenue for the third quarter of 2020 was $7.1 million, a 2% decrease compared to $7.2 million in the third quarter of 2019. The slight decrease in revenue was predominantly a result of the lingering impact of the global COVID-19 pandemic through the third quarter.

Gross margin for the third quarter of 2020 was 71% as compared to 59% in the third quarter of 2019.

Operating expenses for the third quarter of 2020 were $9.6 million compared to $11.5 million in the third quarter of 2019. The decrease in operating expenses was due primarily to our cash preservation measures enacted earlier this year in response to the COVID-19 pandemic.

Net loss for the third quarter of 2020 was $5.1 million compared to $8.3 million in the third quarter of 2019.

Cash, cash equivalents and marketable securities were $132.7 million as of September 30, 2020.

2020 Financial Outlook
As previously announced, TransMedics is not providing annual guidance for 2020 due to the unpredictability of the duration and the magnitude of the impact of the COVID-19 pandemic.

Webcast and Conference Call Details
The TransMedics management team will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT on Wednesday, November 4, 2020. Investors interested in listening to the conference call may do so by dialing (833) 378-1026 for domestic callers or (236) 712-2344 for international callers, followed by Conference ID: 1716957. A live and archived webcast of the event will be available on the "Investors" section of the TransMedics website at www.transmedics.com.

On November 4, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported its financial results for the third quarter ended September 30, 2020 (Press release, CryoLife, NOV 4, 2020, View Source [SID1234569897]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our performance in the third quarter further validated our belief that the majority of products in our portfolio are used in procedures that cannot be postponed or delayed for long. We believe our business is weathering the pandemic well and we continue to progress on our strategic initiatives," commented Pat Mackin, Chairman, President, and Chief Executive Officer. "We saw an improvement in procedure volumes sequentially month to month from July to September with a corresponding increase in revenue growth over those months. Our manufacturing facilities continue to run at near capacity and our supply chain remains largely intact. We have continued to fund R&D programs related to products that we believe will deliver revenue in 2021 and 2022, including our regulatory approvals for U.S. PerClot PMA, BioGlue China and PROACT Mitral. Lastly, we completed the acquisition of Ascyrus Medical LLC, further strengthening our innovative portfolio of products focused on aortic repair and increasing our total addressable market opportunity to over $6 billion, providing us adequate opportunity to drive our financial performance for years to come. Given these achievements in the third quarter, we remain optimistic that we will deliver on our growth strategy and remain in a position of strength through 2021."

Third Quarter Financial Results
Total revenues for the third quarter of 2020 were $65.1 million, reflecting a decrease of (4%) on a GAAP and non-GAAP constant currency basis, both compared to the third quarter of 2019. Revenue performance across all product lines reflected the impact of the COVID-19 pandemic on the number of procedures using our products.

Net loss for the third quarter of 2020 was ($2.9) million, or ($0.08) per fully diluted common share, compared to net loss of ($134,000), or less than $0.01 per fully diluted common share for the third quarter of 2019. Non-GAAP net income for the third quarter of 2020 was $4.9 million, or $0.13 per fully diluted common share, compared to non-GAAP net income of $2.5 million, or $0.07 per fully diluted common share for the third quarter of 2019.

2020 Financial Outlook
Due to continued uncertainties resulting from the COVID-19 pandemic, the Company is not issuing 2020 financial guidance at this time.

The Company’s financial performance for 2020 is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company’s non-GAAP net income and non-GAAP EBITDA results exclude (as applicable) business development, integration, and severance expense, amortization expense, non-cash interest expense, loss on foreign currency revaluation, stock-based compensation expense, and corporate rebranding expense. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions; the operating expense structure of the Company’s existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has excluded the impact of changes in currency exchange from certain revenues to evaluate growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, November 4, 2020 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through November 11, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13712302.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

On November 4, 2020 Triple-S Management Corporation (NYSE: GTS) reported that President and Chief Executive Officer Roberto García-Rodríguez, and EVP and Chief Financial Officer Juan José Román-Jiménez, will present at the 29th Annual Credit Suisse Virtual Healthcare Conference on Wednesday, November 11, 2020 via live webcast (Press release, Triple-S Management, NOV 4, 2020, https://www.prnewswire.com/news-releases/triple-s-management-corporation-to-present-at-the-29th-annual-credit-suisse-virtual-healthcare-conference-301166594.html [SID1234569896]). The presentation will begin at 1:15 PM Eastern Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors and interested parties may listen to the webcast of the presentation by visiting the Company’s investor relations website at www.triplesmanagement.com under the "News and Events" section at the appropriate time. A replay of the presentation will be available on the website following the conference.

On November 4, 2020 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported its full financial and operational results for the quarter ending September 30, 2020 (Press release, Cytosorbents, NOV 4, 2020, View Source [SID1234569895]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third Quarter 2020 Financial Results:

Total revenue for Q3 2020 was approximately $10.5 million, a 73% increase from $6.1 million in Q3 2019
Q3 2020 product revenues were approximately $10.2 million, an increase of 79% from $5.7 million for Q3 2019
Trailing twelve months product sales for the period ending September 30, 2020 were approximately $34.5 million
Gross margin on total revenues grew to $7.7 million in Q3 2020, an increase of $3.3 million or 74% from Q3 2019
Product gross margins for Q3 2020 were approximately 74%, compared to 77% for Q3 2019, but up from 70% from Q2 2020, primarily as a result of the increase in the percentage contribution of lower margin distributor sales as well as additional costs related to COVID-19 incentive payments to employees as a result of the continued rapid ramp-up of production during Q3 2020
Cash balances at September 30, 2020 were approximately $88.0 million, compared to approximately $35.1 million at June 30, 2020 as a result of the July 24, 2020 equity financing
Third Quarter 2020 Operational Highlights:

More than 110,000 cumulative CytoSorb treatments have been delivered to date, up approximately 51% from a year ago
Completed a $57.5 million equity financing, including the underwriter’s overallotment, in July 2020 led by Cowen and SVB Leerink, with co-manager, B. Riley FBR, netting approximately $53.8 million in cash after fees
Initiation of healthcare analyst coverage by SVB Leerink analyst Danielle Antalffy and Jefferies analyst Anthony Petrone
Undertook multiple activities in preparation to resume the REFRESH 2-AKI Trial, following the recommendation of the Data Monitoring Committee after a favorable review of safety data
Awarded a $4.4 million contract by the U.S. Department of Defense to complete HemoDefend-BGA adsorber pre-clinical development to enable "Universal Plasma" and safer whole blood transfusions
Established U.S. collaborations with Terumo Cardiovascular, InvoSurg Inc., and Surgical Partners to commercialize CytoSorb in a total of 25 states under the FDA Emergency Use Authorization allowing the use of CytoSorb in adult, critically-ill COVID-19 patients with imminent or confirmed respiratory failure
Began actively enrolling patients in the "CytoSorb Therapy in COVID-19 ICU Patient" (CTC) Registry
Hosted the webinar, "The Use of CytoSorb for Antithrombotic Drug Removal" with presentations by Dr. C. Michael Gibson, Dr. Robert Storey, and Dr. Michael Schmoeckel.
In recognition of World Sepsis Day 2020 and Sepsis Awareness Month that highlight the need to prevent the 11 million lives lost each year due to sepsis, including the 1.2 million lives lost to COVID-19 related sepsis in this year alone, we sponsored the World Sepsis Meeting, the Sepsis Alliance’s SEPSIS HEROES Gala and Sepsis Alliance Summit, and multiple COVID-19 webinars
Achieved registration of CytoSorb in Brazil and expanded usage of CytoSorb throughout many countries in Latin America for COVID-19 and other critical illnesses
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "We believe we are in an excellent position for continued growth and success, with another outstanding quarter of record sales and cumulative treatments delivered. These results were driven by steady growth in our core markets of critical care and cardiac surgery, and robust global sales to help treat critically-ill patients stricken with COVID-19. Product gross margins also improved sequentially from Q2 2020 to 74%, reflecting our improved manufacturing efficiencies and a reduction in ramp-up costs related to COVID-19."

"With our strong financial performance and solid cash position, coupled with strong current and anticipated demand for CytoSorb, we are aggressively executing upon our clinical trial and sales growth strategy to continue our momentum into 2021 and beyond. These include the following multiple initiatives:

Clinical Strategy:

Company Sponsored Clinical Trials: We have consolidated and expanded our U.S. and E.U. Clinical Development group under the leadership of Chief Medical Officer Dr. Efthymios Deliargyris to support a multi-year international clinical trial strategy (to be discussed further on today’s earnings call) that is intended to drive data generation and usage in key clinical applications with large market opportunities. These include company-sponsored clinical studies that are either underway, or will be initiated over the next 12 months in:
Critical care: Septic shock (PROCYSS), U.S. shock trial, and acute liver disease (HepOnFire)
Cardiac surgery: REFRESH 2-AKI pivotal trial, and anti-thrombotic, or "blood thinner" removal including ticagrelor (Brilinta, Brilique, AstraZeneca) under the U.K. TISORB and German CyTATION studies, to be extended with the international STAR (Safe and Timely Antithrombotic Removal) registry and U.S. STAR trials for removal of novel oral anticoagulants (NOACs) such as rivaroxaban (Xarelto, Janssen and Bayer) and apixaban (Eliquis, BMS and Pfizer)
FDA Breakthrough Designation: We believe we are very close to a regulatory path forward that is consistent with Breakthrough Designation status. In a recent meeting with FDA, we closely aligned around the pressing unmet medical need to remove ticagrelor during urgent and emergent cardiothoracic surgery, and discussed additional data that we believe support the very positive benefit-to-risk profile of CytoSorb for this application. This collaborative discussion was supplemented with the perspectives of invited experts in the field of cardiac surgery and antithrombotics, highlighting the clinical dilemma and serious consequences of blood thinners in cardiac surgery, with FDA assurances of a rapid review of some additional requested data that is being submitted
REFRESH 2-AKI Trial: As mentioned, we are actively working to resume this study, pending a resolution of COVID-19 restrictions, with multiple activities, including for example, site re-training and a renewal of materials and certain documents. Our target is to resume patient enrollment in Q1 2021
REMOVE Endocarditis Trial: Based upon recent discussions with the study investigators of this completed 250-patient, German government-funded, investigator initiated randomized controlled trial (RCT) in patients undergoing valve replacement surgery for infective endocarditis, they are working to have topline data from the study available before the end of this year, despite delays in data monitoring and analysis caused by COVID-19 at a number of trial sites. Full analysis of the study is expected in 1H-2021 with a publication submitted by mid-2021. If positive, we believe this can be a significant catalyst for growth
CTC COVID-19 Registry: The CTC registry is actively enrolling patients, primarily from U.S. centers, with an initial analysis planned for the end of this year. The registry is being opened up internationally, with the goal of consolidating data from the more than 30 countries worldwide where an estimated 2,800 COVID-19 patients have been treated to date with CytoSorb
Commercialization

Maximizing the COVID-19 opportunity: To date, there have been more than 48 million cases of COVID-19 worldwide, with 1.2 million deaths. New global cases have been rising rapidly, with approximately a half million new cases a day. COVID-19 cases are surging throughout Europe – with far more new daily cases than seen earlier in the pandemic, the Midwest United States, Russia, and many other countries. Unlike in the early pandemic, a greater percentage of patients are young, resulting in less severe disease and lower rates of hospitalization and deaths, for now. For example, mortality rates for critically-ill COVID-19 patients have been declining from a peak of approximately 42% in the early pandemic, where lack of resources such as mechanical ventilators, personnel, and anti-viral therapies, and a predominantly older, high-risk patient population, contributed to poor outcomes. The use of dexamethasone in mechanically ventilated patients has reduced mortality to about 29%, though the risk of death remains high, as is the need for more effective therapies. However, as the numbers of new cases grow, hospital and ICU bed occupancy has been steadily rising across Europe and in newly hit U.S. states in the Midwest, with the expectation that death rates could spike significantly. That said, new case series data received from multiple institutions on the use of CytoSorb in critically-ill COVID-19 patients on mechanical ventilation with or without extracorporeal membrane oxygenation, suggest positive outcomes in treated patients with hyperinflammation, with survival rates exceeding 80%. We believe we are well-positioned in Europe to help with the current COVID-19 crisis. Meanwhile, in the U.S., we have already established a commercialization network for CytoSorb in half of the United States and are actively establishing a network in many of the currently hard-hit areas of the Midwest. All of these activities are in preparation for what is expected to be a difficult and busy winter season for COVID-19 infection throughout the U.S. and around the world. We believe COVID-19 will continue to be a significant contributor to revenue in Q4 2020 and potentially in Q1 2021
Returning to the Pre-COVID-19 Growth Strategy: Prior to COVID-19, we were already executing on an ambitious plan for growth. As COVID-19 declines in importance in 2021 with the expected approval of multiple vaccines early in the year, we plan to return to this growth strategy
Focus on Driving both Direct and Distributor Sales: We believe 2020 product sales to date have demonstrated the power of this dual engine for growth in our underlying business of critical care and cardiac surgery. However, we believe there is substantial room for growth. COVID-19 has opened doors and accelerated usage of CytoSorb in our international distributor and strategic partner network. We believe this momentum will continue post-COVID-19. In our direct territories, COVID-19 has been a significant driver of growth, but has also slowed our normal business due to fewer surgical procedures, hospital restrictions on sales representative access to physicians, and decreased effectiveness of major scientific conferences. We believe the significant investments made in our direct sales force has only begun to reflect in our overall product sales and will become much more apparent in a post-COVID world
Maximizing the Ticagrelor and Rivaroxaban E.U. approvals: We believe these applications can be significant drivers of sales growth for CytoSorb in 2021 and beyond. Due to the recent approvals earlier this year, and COVID-19 restrictions on access to hospitals and physicians, we have only begun to see a glimpse of what we can potentially achieve in this field. Our goal is for CytoSorb to rapidly become a de facto standard of care for this application worldwide
Expand in New Applications: CytoSorb has the potential to be a leader in many different fields, including cardiac surgery, with pending results from the REMOVE endocarditis trial, the blood thinner applications, and management of vasoplegic shock, as well as new applications in acute-on-chronic liver disease, and many other indications. We are committed to driving the data to support usage in many of these areas
Expansion of the International Team: We have continued to invest in our organization, increasing headcount to approximately 175 full-time and part-time employees, up from 153 earlier this year, focused primarily in commercialization, manufacturing, clinical development, and R&D. This reflects our confidence in our growth potential
Plant Expansion: We are evaluating potential options for plant expansion to achieve the next scale, capable of supporting $300-400M in sales of CytoSorb each year, which once operational is expected to expand blended product gross margins to well beyond 80%
Preparing for U.S. commercialization: We are in the process of recruiting a Vice President of U.S. Sales to help develop the strategy and lay the groundwork to commercialize CytoSorb in the U.S. for potential applications such as ticagrelor removal and to support COVID-19 sales in the interim
Streamlining the Balance Sheet: We believe we are in a strong financial position. After the expiration of our interest-only period, we have begun both interest and principal payments this month on our $15 million term loan with Bridge Bank, a division of Western Alliance Bank. We are finalizing an extensive evaluation of different options amongst an excellent network of lenders, exploring either refinancing or retiring the debt."
Dr. Chan concluded, "I am extremely proud of our CytoSorbents team, executing very well in a challenging healthcare environment dominated by COVID-19, and am grateful to the medical community for continuing to embrace CytoSorb for many different applications. We are very excited about the potential for continued growth in 2021."

"Please join us on our earnings conference call today, details for which are below."

Conference Call Details:

Date: Wednesday, November 4, 2020

Time: 4:45 PM Eastern Time

Participant Dial-In: 877-451-6152

Conference ID: 13705996

Live Presentation Webcast: View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

Results of Operations

Comparison for the three months ended September 30, 2020 and 2019:

Revenues:

Revenue from product sales was approximately $10,246,000 in the three months ended September 30, 2020, as compared to approximately $5,728,000 in the three months ended September 30, 2019, an increase of approximately $4,518,000, or 79%. This increase was driven by an increase in direct sales of approximately $2,063,000 resulting from sales to both new customers and repeat orders from existing customers and an increase in distributor sales of approximately $2,455,000. Sales to hospitals in the United States under the EUA granted by the FDA amounted to approximately $262,000 for the three months ended September 30, 2020. Though difficult to quantitate, we estimate that approximately $2.7 million of total product sales in the third quarter of 2020 was due to the demand for CytoSorb to treat COVID-19 patients. In addition, as a result of the increase in the average exchange rate of the Euro to the U.S. dollar, sales were positively impacted by approximately $428,000. For the three months ended September 30, 2020, the average exchange rate of the Euro to the U.S. dollar was $1.17 as compared to an average exchange rate of $1.11 for the three months ended September 30, 2019.

Grant income was approximately $301,000 for the three months ended September 30, 2020 as compared to approximately $367,000 for the three months ended September 30, 2019, a decrease of approximately $66,000 or 18%. This decrease was a result of delays in grant related work caused by the COVID-19 pandemic as our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of CytoSorb.

Total revenues were approximately $10,547,000 for the three months ended September 30, 2020, as compared to total revenues of approximately $6,095,000 for the three months ended September 30, 2019, an increase of approximately $4,452,000, or 73%.

Cost of Revenues:

For the three months ended September 30, 2020 and 2019, cost of revenue was approximately $2,890,000 and $1,696,000, respectively, an increase of approximately $1,194,000. Product cost of revenues increased approximately $1,279,000 during the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 primarily as a result of increased sales. Product gross margins were approximately 74% for the three months ended September 30, 2020 and approximately 77% for the three months ended September 30, 2019. The decrease in gross margin in 2020 was due to an increase in percent contribution of lower margin distributor sales as well as additional costs primarily related to COVID-19 incentive payments to employees as a result of the continued rapid ramp-up of production during the three months ended September 30, 2020.

Research and Development Expenses:

For the three months ended September 30, 2020, research and development expenses were approximately $1,753,000 as compared to research and development expenses of approximately $3,185,000 for the three months ended September 30, 2019. The decrease of approximately $1,432,000 was due to a decrease in our clinical trial costs of approximately $1,045,000 which is due primarily to the pause in our Company-sponsored clinical trials as a result of hospital restrictions due to the COVID-19 pandemic, a decrease in non-clinical research and development salary related costs of approximately $337,000, a decrease in new product development costs of approximately $49,000 and a decrease in non-grant related research and development costs of approximately $86,000. These decreases were offset by a decrease in direct labor and other costs being deployed toward grant-funded activities of approximately $85,000, which had the effect of increasing the amount of our non-reimbursable research and development costs.

Legal, Financial and Other Consulting Expenses:

Legal, financial and other consulting expenses were approximately $580,000 for the three months ended September 30, 2020, as compared to approximately $733,000 for the three months ended September 30, 2019. The decrease of approximately $153,000 was due to a decrease in employment agency fees of approximately $34,000 and a decrease in legal fees of approximately $193,000. These increases were offset by an increase in consulting fees of approximately $35,000 and an increase in accounting fees of approximately $39,000.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were approximately $7,282,000 for the three months ended September 30, 2020, as compared to approximately $6,108,000 for the three months ending September 30, 2019, an increase of $1,174,000. This increase is related to an increase in salaries, commissions and other employee-related costs of approximately $1,345,000, an increase in royalty expenses of approximately $646,000 due to the increase in product sales, and an increase in non-cash stock compensation expense of approximately $286,000. These increases were offset by a decrease in travel and entertainment expenses of approximately $127,000, a decrease in sales and marketing expenses, which include advertising and conference attendance of approximately $546,000, a decrease in non-cash restricted stock expense of approximately $307,000 related to restricted stock units granted to the Company’s executive officers and a decrease in other general and administrative costs of approximately $123,000.

Interest Expense, net:

For the three months ended September 30, 2020, net interest expense was approximately $261,000, as compared to net interest expense of approximately $302,000 for the three months ended September 30, 2019. This decrease in net interest expense of approximately $41,000 was primarily a result of the interest income earned on our increased cash balances as a result of equity raised during 2020.

Gain (Loss) on Foreign Currency Transactions:

For the three months ended September 30, 2020, the gain on foreign currency transactions was approximately $1,380,000 as compared to a loss of approximately $956,000 for the three months ended September 30, 2019. The 2020 gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar at September 30, 2020 as compared to June 30, 2020. The spot exchange rate of the Euro to the U.S. dollar was $1.17 per Euro at September 30, 2020, as compared to $1.12 per Euro at June 30, 2020. The 2019 loss was directly related to the decrease in the spot exchange rate of the Euro at September 30, 2019 as compared to June 30, 2019. The spot exchange rate of the Euro to the U.S. dollar was $1.09 per Euro at September 30, 2019, as compared to $1.14 per Euro at June 30, 2019.

Comparison for the nine months ended September 30, 2020 and 2019:

Revenues:

Revenue from product sales was approximately $27,922,000 in the nine months ended September 30, 2020, as compared to approximately $16,155,000 in the nine months ended September 30, 2019, an increase of approximately $11,767,000, or 73%. This increase was driven by an increase in direct sales of approximately $6,204,000 resulting from sales to both new customers and repeat orders from existing customers and an increase in distributor sales of approximately $5,563,000. Sales to hospitals in the United States under the EUA granted by the FDA amounted to approximately $928,000 for the nine months ended September 30, 2020. Though difficult to quantitate, we estimate that approximately $6.9 million of total product sales in the nine months ended September 30, 2020 was due to the demand for CytoSorb to treat COVID-19 patients. The change in the Euro to U.S. dollar exchange rate did not have a significant impact on sales for the nine months ended September 30, 2020 as compared to the nine months ended September 30, 2019.

Grant income was approximately $1,127,000 for the nine months ended September 30, 2020 as compared to approximately $1,364,000 for the nine months ended September 30, 2019, a decrease of approximately $237,000 or 17%. This decrease was a result of delays in grant related work caused by the COVID-19 pandemic as our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing production of CytoSorb.

Total revenues were approximately $29,049,000 for the nine months ended September 30, 2020, as compared to total revenues of approximately $17,519,000 for the nine months ended September 30, 2019, an increase of approximately $11,530,000, or 66%.

Cost of Revenues:

For the nine months ended September 30, 2020 and 2019, cost of revenue was approximately $8,525,000 and $5,269,000, respectively, an increase of approximately $3,256,000, primarily as a result of increased sales. Product gross margins were approximately 73% for the nine months ended September 30, 2020 and approximately 76% for the nine months ended September 30, 2019. The decrease in gross margin was due to an increase in percent contribution of lower margin distributor sales as well as certain costs associated with the rapid ramp-up of production during the nine months ended September 30, 2020.

Research and Development Expenses:

For the nine months ended September 30, 2020, research and development expenses were approximately $6,125,000 as compared to research and development expenses of approximately $8,533,000 for the nine months ended September 30, 2019. The decrease of approximately $2,408,000 was due to a decrease in our clinical trial costs of approximately $2,067,000, which was due primarily to the pause in our Company-sponsored clinical trials as a result of hospital restrictions due to the COVID-19 pandemic, a decrease in non-clinical research and development salary related costs of approximately $563,000 and a decrease in non-grant related research and development costs of approximately $112,000. These decreases were offset by a decrease in direct labor and other costs being deployed toward grant-funded activities of approximately $296,000, which had the effect of increasing the amount of our non-reimbursable research and development costs, and an increase in new product development costs of approximately $38,000.

Legal, Financial and Other Consulting Expenses:

Legal, financial and other consulting expenses were approximately $1,945,000 for the nine months ended September 30, 2020, as compared to approximately $1,887,000 for the nine months ending September 30, 2019. The increase of approximately $58,000 was due to an increase in employment agency fees of approximately $68,000 related to the hiring of senior level personnel, and increase in accounting and auditing fees of approximately $96,000 and an increase in consulting fees of approximately $7,000. These increases were offset by a decrease in legal fees of approximately $113,000.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were approximately $20,190,000 for the nine months ended September 30, 2020, as compared to $15,372,000 for the nine months ended September 30, 2019, an increase of $4,818,000. This increase is related to an increase in salaries, commissions and other employee-related costs of approximately $3,351,000, an increase in royalty expenses of approximately $934,000 due to the increase in product sales, an increase in non-cash stock compensation expense of approximately $1,677,000 and an increase in other general and administrative expenses of approximately $204,000. These increases were offset by a decrease in travel and entertainment expenses of approximately $365,000, a decrease in sales and marketing expenses, which include advertising and conference attendance of approximately $983,000.

Interest Expense, net:

For the nine months ended September 30, 2020, interest expense was approximately $840,000, as compared to interest expense of approximately $722,000 for the nine months ended September 30, 2019. This increase in interest expense of approximately $118,000 was primarily a result of the additional interest incurred related to the draw down of the $5,000,000 Term B Loan with Bridge Bank on July 31, 2019.

Gain (Loss) on Foreign Currency Transactions:

For the nine months ended September 30, 2020, the gain on foreign currency transactions was approximately $1,417,000 as compared to a loss of approximately $1,052,000 for the three months ended September 30, 2019. The 2020 gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar at September 30, 2020 as compared to December 31, 2019. The spot exchange rate of the Euro to the U.S. dollar was $1.17 per Euro at September 30, 2020, as compared to $1.12 per Euro at December 31, 2019. The 2019 loss was directly related to the decrease in the spot exchange rate of the Euro at September 30, 2019 as compared to December 31, 2018. The spot exchange rate of the Euro to the U.S. dollar was $1.09 per Euro at September 30, 2019, as compared to $1.15 per Euro at December 31, 2018.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. At September 30, 2020, we had current assets of approximately $96,803,000 including cash on hand of approximately $87,978,000 and current liabilities of approximately $17,356,000. On July 24, 2020, the Company closed the sale of approximately 6,052,631 shares of its Common Stock and received gross proceeds of approximately $57.5 million and, after deducting the underwriting discounts and commissions and expenses related to the offering, received total net proceeds of approximately $53.8 million. In early July 2020, the Company received approximately $2,414,000 in proceeds related to the sale of shares pursuant to the Open Market Sale Agreement with Jefferies LLC and B. Riley FBR, Inc.

On July 31, 2019, the Company executed an Amendment to its Loan Agreement with Bridge Bank and, simultaneous with this Amendment, received $5 million in proceeds from an additional term loan. In addition, the Amendment extended the interest-only period of the loan through October 2020. Monthly principal payments of approximately $833,000 commence in November 2020.

We believe that we have sufficient cash to fund our operations well into the future.

COVID-19 Impact on Financial Results

The COVID-19 pandemic has, on the whole, been a positive driver for the Company’s financial performance during the past several quarters. Though difficult to quantitate, we estimate that approximately $2.7 million of our third quarter 2020 revenues and $6.9 million of our year-to-date revenues at September 30, 2020 were directly or indirectly related to COVID-19. Given the order patterns we are currently experiencing, we expect that the COVID-19 pandemic will continue to have a positive impact on product revenues in the fourth quarter of 2020 and potentially into the first quarter of 2021. These expectations may change depending on the severity of the illness associated with COVID-19, or containment of the pandemic.

For a more detailed discussion on the impact of the COVID-19 pandemic on our financial results, please see the Company’s Q3 2020 Form 10-Q, filed today with the Securities Exchange Commission.

Fourth Quarter 2020 Revenue Guidance

CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, notwithstanding uncertainty related to the COVID-19 pandemic, based upon current order patterns, we expect that Q4 2020 will be one of the Company’s strongest quarters to date in terms of product sales.

For additional information, please see the Company’s Form 10-Q for the period ended September 30, 2020 filed with the Securities Exchange Commission on November 4, 2020 and available at View Source