On November 5, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that 11 company-sponsored abstracts, in addition to two abstracts from collaboration trials with The University of Texas MD Anderson Cancer Center (MD Anderson), one abstract from a cooperative group trial and four abstracts from investigator-sponsored trials, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held December 5-8, 2020 as a virtual event (Press release, Jazz Pharmaceuticals, NOV 5, 2020, View Source [SID1234570240]).

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"This year, we submitted and had more Jazz abstracts accepted for presentation at ASH (Free ASH Whitepaper) than ever before, further demonstrating our commitment to research and innovation in hematology and oncology," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "There continues to be an urgent need for new therapeutics and regimens for people with blood cancers who have limited treatment options or who have a goal to obtain a transplant, and we remain committed to these patients through our ongoing research."

Oral presentations selected to be presented at ASH (Free ASH Whitepaper) include:

Long-term outcomes and five-year results from the Phase 3 study of Vyxeos (daunorubicin and cytarabine), also known as CPX-351, in older adults with newly diagnosed, high-risk/secondary acute myeloid leukemia (AML)
Analysis from a multinational, observational registry study evaluating treatment duration, VOD/SOS resolution and survival in patients with veno-occlusive disease/sinusoidal obstruction syndrome treated with Defitelio (defibrotide sodium) following hematopoietic cell transplantation
Results from a Phase 2 study in collaboration with MD Anderson investigating the safety and efficacy of Vyxeos in combination with venetoclax in patients with relapsed or refractory AML
The ASH (Free ASH Whitepaper) abstracts are available online at View Source

A full list of Jazz-sponsored oral and ePoster presentations follows below:

Vyxeos Oral and ePoster Presentations

Presentation Topic

Author

Date / Time (PST) /
Session Title /
Presentation Number

Five-Year Final Results of a Phase 3 Study of CPX-351 versus 7+3 in Older Adults with Newly Diagnosed High-Risk/Secondary Acute Myeloid Leukemia (AML): Outcomes by Age Subgroup and Among Responders

Lancet, et al.

Oral Presentation:

Monday, December 7

12:15 p.m.

Session Title: 615.

Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Commercially Available Therapy, Excluding Transplantation II

Presentation Number: 635

CPX-351 Population Pharmacokinetics in Pediatric and Adult Patients with Acute Myeloid Leukemia (AML)

Wang, et al.

ePoster Presentation:

Monday, December 7

7:00 a.m. – 3:30 p.m.

Session Title: 615.

Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster III

Poster Number: 2848

Quality-Adjusted Time without Symptoms of Disease and Toxicity (Q-TWiST) Analysis of CPX-351 versus 7+3 in Older Adults with Newly Diagnosed High-Risk/Secondary Acute Myeloid Leukemia (AML)

Cortes, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 615.

Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster II

Poster Number: 1946

CPX-351 Exposure-Response Analyses for Efficacy and Safety in Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Wang, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 615. Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster II

Poster Number: 1950

Long-term Outcomes of Allogeneic Hematopoietic Cell Transplantation in Patients Enrolled in CPX-351-301, a Randomized Phase 3 Study of CPX-351 versus 7+3 in Older Adults with Newly Diagnosed, High-Risk and/or Secondary AML

Uy, et al.

ePoster Presentation:

Monday, December 7

7:00 a.m. – 3:30 p.m.

Session Title: 732. Clinical Allogeneic Transplantation: Results: Poster III

Poster Number: 3346

Analysis of Treatments and Outcomes for Patients with De Novo AML, Therapy-Related AML, and Secondary AML (Prior MDS and CMML) Diagnosed in England between 2011 and 2016 Using Hospital Episode Statistics

Legg, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 613.

Acute Myeloid Leukemia: Clinical Studies: Poster II

Poster Number: 1929

Patient Experiences with Liposomal Daunorubicin and Cytarabine (CPX-351) versus Conventional Induction Regimens: An Analysis of Patient-Reported Outcomes Data from a Prospective Trial

LeBlanc, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 906.

Outcomes Research –Malignant Conditions (Myeloid Disease): Poster II

Poster Number: 2572

V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined with Various Targeted Agents in Patients with Previously Untreated Acute Myeloid Leukemia

Lin, et al.

ePoster Presentation:

Saturday, December 5

7:00 a.m. – 3:30 p.m.

Session Title: 615

Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster I

Poster Number: 1025

Exploratory Analysis of the Efficacy and Safety of CPX-351 versus 7+3 by European LeukemiaNet (ELN) 2017 Risk Groups in a Phase 3 Study of Older Adults with High-Risk/Secondary Acute Myeloid Leukemia

Prebet, et al.

ePoster Presentation:

Monday, December 7

7:00 a.m. – 3:30 p.m.

Session Title: 615.

Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster III

Poster Number: 2844

Post-Marketing Observational Study to Assess the Incidence of Infusion-Related Reactions in Adult Patients with Therapy-Related Acute Myeloid Leukemia (AML) or AML with Myelodysplasia-Related Changes Who Were Treated with CPX-351

Jacoby, et al.

Accepted for publication only

Defitelio Oral and ePoster Presentations

Presentation Topic

Author

Date / Time (PST) /
Session Title /
Presentation Number

Treatment Duration, Symptom Resolution, and Survival in Defibrotide-Treated Patients with Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation: Analysis of a Multinational, Prospective, Observational Registry Study

Locatelli, et al.

Oral Presentation:

Saturday, December 5

10:15 a.m.

Session Title: 721.

Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Presentation Number: 138

Final Primary Results from the DEFIFrance Registry Study: Effectiveness and Safety of

Defibrotide in the Treatment of Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction

Syndrome after Hematopoietic Cell Transplantation

Mohty, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 721.

Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster II

Poster Number: 2386

Additionally, data from the following collaboration and investigator-sponsored trials on Vyxeos and Defitelio will be presented:

Presentation Topic

Author

Date / Time (PST) /
Session Title /
Presentation Number

Phase II Study of CPX–351 Plus Venetoclax in Patients with Acute Myeloid Leukemia (AML)

Kadia, et al.

Oral Presentation:

Saturday, December 5

8:30 a.m.

Session Title: 616.

Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Novel Combination Therapies in Treatment of Newly Diagnosed AML

Presentation Number: 28

Liposomal Cytarabine and Daunorubicin (CPX–351) in Combination with Gemtuzumab Ozogamicin (GO) in Relapsed Refractory (R/R) Patients with Acute Myeloid Leukemia (AML) and Post–Hypomethylating Agent (Post–HMA) Failure High–Risk Myelodysplastic Syndrome (HR–MDS)

Perez, et al.

ePoster Presentation:

Saturday, December 5

7:00 a.m. – 3:30 p.m.

Session Title: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I

Poster Number: 987

Initial Results of a Phase 1 Dose Escalation Study of CPX-351 for Patients with Int-2 or High risk IPSS Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) After Failure to Hypomethylating Agents

Montalban Bravo, et al.

Accepted for publication only

Higher Dose of CPX-351 is Associated With Prolonged Hematologic Recovery:

Results from an Interim Safety Analysis of the Randomized, Phase III AMLSG 30-18 Trial

Gaidzik, et al.

ePoster Presentation:

Saturday, December 5

7:00 a.m. – 3:30 p.m.

Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Poster Number: 1043

Outpatient Vyxeos Induction without Planned Admission for Select Patients with

Secondary Acute Myeloid Leukemia (sAML) Is Safe and Yields Healthcare Resource Savings

Keiffer, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster II

Poster Number: 1949

A Phase I/II Trial of CPX-351 + Palbociclib in Patients with Acute Myeloid Leukemia

Nazha, et al.

ePoster Presentation:

Sunday, December 6

7:00 a.m. – 3:30 p.m.

Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Poster Number: 1962

A Phase II Study of CPX-351 as a Novel Therapeutic Approach for Patients with Myelodysplastic Syndromes (MDS) after Hypomethylating Agent Failure

Nazha, et al.

Accepted for publication only

Preliminary Results of a Phase II Study to Determine the Safety of Defibrotide in Children

and Adolescents with Sickle Cell Disease-Associated Acute Chest Syndrome (IND 127812)

Milner, et al.

ePoster Presentation:

Saturday, December 5

7:00 a.m. – 3:30 p.m.

Session Title: 114.

Hemoglobinopathies, Excluding Thalassemia – Clinical: Poster I

Poster Number: 805

A Pilot Trial of Pre-Transplant Risk Stratification and Prophylactic Defibrotide to Prevent Serious

Thrombotic Microangiopathy in High-Risk Pediatric Hematopoietic Stem Cell Transplant Patients

Higham, et al.

ePoster Presentation:

Monday, December 7

7:00 a.m. – 3:30 p.m.

Session Title: 721.

Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster III

Poster Number: 3307

Defibrotide for the Treatment of Endotheliitis Complicating Sars-Cov-2 Infection: Rationale and Ongoing Studies as Part of the International Defacovid Study Group

Moraleda, et al.

Accepted for publication only

About Vyxeos (daunorubicin and cytarabine)
In the U.S., Vyxeos (daunorubicin and cytarabine) is a liposomal formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion that represents the first, only and most proven chemotherapy treatment option specifically for two types of high-risk, secondary acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). In Europe, Vyxeos Liposomal (daunorubicin/cytarabine) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Backed by a robust clinical development program including Phase 3 data, Vyxeos is currently approved in more than 30 countries, and Jazz continues to work with regulatory authorities worldwide to bring this innovative therapy to appropriate patients.

Important Safety Information for Vyxeos Liposomal
Vyxeos Liposomal has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos Liposomal for other daunorubicin- and/or cytarabine- containing products.

Vyxeos Liposomal should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos Liposomal can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos Liposomal. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos Liposomal can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles or legs
unusual tiredness
Vyxeos Liposomal may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
Vyxeos Liposomal contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

Vyxeos Liposomal can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

Vyxeos Liposomal can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos Liposomal. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos Liposomal.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Please see full Prescribing Information for Vyxeos Liposomal including BOXED Warning, and visit www.Vyxeos.com for additional information.

About Defitelio (defibrotide sodium)
In the U.S., Defitelio (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication. Defitelio is not approved for the prevention of VOD.

Please see full Prescribing Information for Defitelio.

In Europe, defibrotide is marketed under the name Defitelio ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients undergoing HSCT therapy. It is the first and only approved treatment in Europe for severe VOD. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC.

(View Source)

Defibrotide is currently being investigated in two Phase 2 trials for the prevention of acute Graft-versus-Host-Disease (aGvHD) and the prevention of neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving CAR T-cell therapy.

Important Safety Information for Defitelio
Defitelio should not be given to patients who are:

Currently taking anticoagulants or fibrinolytics
Allergic to Defitelio or any of its ingredients
Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.

Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.

The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

On November 5, 2020 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company focused on the Phase 3 execution, registration and potential commercialization of momelotinib, a novel drug that may address serious unmet needs in myelofibrosis, reported two abstracts have been selected for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 5-8, 2020 (Press release, Sierra Oncology, NOV 5, 2020, View Source [SID1234570239]).

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"Data presented at this year’s ASH (Free ASH Whitepaper) annual meeting may support the potential of momelotinib as a unique treatment option for myelofibrosis patients, capable of improving all three hallmarks of disease: anemia, symptoms and spleen," said Barbara Klencke, M.D., Chief Development Officer at Sierra Oncology. "Further, activity is demonstrated in thrombocytopenic patients, regardless of previous treatment with a JAK inhibitor. Collectively, the additional data presented from the SIMPLIFY-1 and SIMPLIFY-2 clinical trials may demonstrate potential long-term survival, and the possibility that more patients may become transfusion independent. A similar clinical profile has not been seen with other agents at this time."

Robust Overall Survival and Sustained Efficacy Outcomes During Long Term Exposure to Momelotinib in JAK Inhibitor Naïve and Previously JAK Inhibitor Treated Intermediate/High Risk Myelofibrosis Patients

Long-term overall survival data from the previously completed SIMPLIFY-1 and SIMPLIFY-2 Phase 3 trials will be reported in an oral presentation by Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas. The trials evaluated JAK inhibitor-naïve and previously JAK inhibitor-treated patients with myelofibrosis who were either randomized to receive momelotinib or were dosed initially with ruxolitinib or best available therapy followed by momelotinib.

Presentation Details

Abstract: 54
Title: Robust Overall Survival and Sustained Efficacy Outcomes During Long Term Exposure to Momelotinib in JAK Inhibitor Naïve and Previously JAK Inhibitor Treated Intermediate/High Risk Myelofibrosis Patients
Presenter: Srdan Verstovsek, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical: New Therapies and JAKi-based Combinations for Myelofibrosis
Session Information: Saturday, December 5, 2020; 7:30 AM – 9:00 AM PT
Presentation Time: 8:15 AM PT

Momelotinib’s Spleen, Symptom and Anemia Efficacy is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia

Comparative efficacy data for momelotinib and ruxolitinib in patients with low platelets from SIMPLIFY-1 and SIMPLIFY-2 will be presented in a poster presentation by Jean-Jacques Kiladjian, MD, PhD, Professor of Clinical Pharmacology, Paris Diderot University; Consultant Hematologist, Head, Clinical Investigation Center, Saint Louis Hospital, Paris, France. The presentation will include post-hoc comparative efficacy analyses for momelotinib and ruxolitinib for spleen, symptom and transfusion independence response in patients with baseline platelet counts of <150 x 109/L versus the ITT populations from the two previously completed global Phase 3 SIMPLIFY studies. A baseline platelet limit of ≥50 × 109/L was required in SIMPLIFY-1 while there was no lower platelet limit for SIMPLIFY-2. In SIMPLIFY-2, most patients randomized to best available therapy (88%) received ruxolitinib during the randomization period.

Presentation Details

Abstract: 3086
Title: Momelotinib’s Spleen, Symptom and Anemia Efficacy is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia
Presenter: Jean-Jacques Kiladjian, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical: Poster III
Session Information: Monday, December 7, 2020; 7:00 AM – 3:30 PM PT

On November 5, 2020 Heska Corporation (NASDAQ: HSKA; "Heska" or "Company"), a leading provider of advanced veterinary diagnostic and specialty products, reported financial results in two segments (North America and International) for its third quarter ended September 30, 2020 (Press release, Heska, NOV 5, 2020, View Source [SID1234570236]). Point of Care is "POC" and scil animal care company GmbH is "scil" in this release.

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Third Quarter 2020 Highlights

Record quarterly revenue growth led by strong POC Lab Consumables and recent scil acquisition. North America POC Lab Consumables sales up 15.2% in period and up 9.7% year to date.
As anticipated, consolidated gross margin was impacted by acquired lower scil margin. Year-over-year, North America quarterly sales rose 16.4% at 48.3% gross margin (+430 bps compared to prior year) and International sales and gross margin met the Company’s targets.
Net loss and diluted EPS impacted by income tax, stock-based compensation, one-time transaction costs, interest associated with convertible debt, and other expenses relating primarily to the acquisition of scil. Non-GAAP diluted EPS impacted by income tax expense and cash interest charge in the current period.
Research, development, and commercial launch of key strategic initiatives advanced in-line with previously stated timelines.
Heska management to present strategic plan, new product demonstration and launch roadmap, multi-year financial targets, and other key considerations at the Company’s virtual Investor Day on November 18 at 9:00 a.m. MT.
Kevin Wilson, Heska’s Chief Executive Officer and President, commented, "Heska’s third quarter followed through on a solid 2020 first half. Our teams delivered record revenue and near-universal outperformance across key metrics that lead us to believe that we will perform at the top of the ranges for most, if not all, of the full-year targets we shared in our second quarter earnings release. In the third quarter, Heska’s North America POC Lab Consumables sales accelerated nicely, our International segment performed wonderfully, and our margins, cost discipline, cash management, and other key areas were all excellent. Heska and the animal health industry continue to reaffirm a decades-long resiliency. Pet visits and veterinary trends have generally outpaced most forecasted estimates. Heska end-user demand remains strong, our current subscribers continue to increase utilization of key tests, and our teams, logistics, and supply chain continue to meet demand well, even from a partial work-from-home posture."

"In addition to Heska’s strong financial results," continued Mr. Wilson, "we met and advanced key non-financial objectives. Research and development initiatives progressed in-line with previously stated timelines, and commercial launch plans further solidified across several projects. Integration with our recent international acquisitions progressed in-line with our expectations and we are confident in our ability to meaningfully grow and improve the profitability of these businesses over time. We remain convinced we will succeed in the core tenets of our five year strategic plan (2018-2023) to: (1) double the geographies and customers we serve, (2) double the products and revenue lines we offer, and (3) continue to grow our core business. We are grateful for our industry, customers, employees, and investors, and we are humbly thankful for our good fortune as we continue to accomplish our plans, which we will share with you in more detail at our Investor Day on November 18th. We hope to ‘see’ you there (virtually)," concluded Mr. Wilson.

Third Quarter Financial Results

Operating Expenses

Total operating expenses in the third quarter of 2020 were $23.2 million, compared to $13.5 million in the third quarter of the prior year. The increase is driven primarily by the impact related to the consolidation of our acquisitions’ operations of approximately $6.5 million, an increase in stock-based compensation of $2.9 million, and one-time acquisition costs of $0.8 million.

Liquidity

We continue to demonstrate a strong liquidity position with cash of $84.5 million.

2020 Investor Day

The Company plans to host a virtual Investor Day on November 18, 2020 at 9:00 a.m. MT (11:00 a.m. ET) to present the Company’s strategic growth plan, new product demonstration and launch roadmap, multi-year financial targets, and other key considerations. To register for the event, please visit View Source

Investor Conference Call

Management will conduct a conference call on November 5, 2020 at 9:00 a.m. MT (11:00 a.m. ET) to discuss the third quarter 2020 financial results. To participate, dial 1-866-548-4713 (US) or 1-323-794-2093 (international) and reference conference call access number 9707717. The conference call will also be broadcast live over the Internet at www.heska.com. To listen, simply log on to the web at this address at least ten minutes prior to the start of the call to register and download and install any necessary audio software. Telephone replays of the conference call will be available for playback until November 19, 2020. The telephone replay may be accessed by dialing 1-844-512-2921 (US) or 1-412-317-6671 (international). The replay access number is 9707717. The webcast will also be archived on www.heska.com for 90 days.

On November 5, 2020 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, reported business highlights and financial results for the third quarter ended September 30, 2020 (Press release, Ardelyx, NOV 5, 2020, View Source [SID1234570235]).

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"The FDA’s acceptance of our New Drug Application for tenapanor is a major milestone that continues our progress toward the potential launch of this novel therapeutic for the many dialysis patients who struggle with controlling hyperphosphatemia," said Mike Raab, president and chief executive officer of Ardelyx. "Our commitment to this field was further highlighted in clinical data presented at ASN Kidney Week 2020 generated by Ardelyx and our Japanese partner KKC, supporting the clinical safety and efficacy of tenapanor and reinforcing its potential to transform the treatment landscape for patients."

Recent Business and Pipeline Updates

The United States Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for tenapanor to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis with a Prescription Drug User Fee Act ("PDUFA") goal date of April 29, 2021. The filing was supported by three successful Phase 3 studies demonstrating tenapanor’s ability to reduce phosphate levels, with two trials evaluating tenapanor as a monotherapy and the third evaluating tenapanor as part of a dual mechanism approach with phosphate binders.

Presented new clinical data supporting the clinical safety and efficacy of tenapanor at ASN Kidney Week 2020. Three poster presentations highlighted data from Phase 3 trials conducted by Ardelyx, including the BLOCK, AMPLIFY and PHREEDOM studies. Additionally, the company’s partner for tenapanor in Japan, Kyowa Kirin Co., Ltd., presented the results from two Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis.
Third Quarter 2020 Financial Results

Cash Position: As of September 30, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $185.5 million, as compared to total cash, cash equivalents and short-term investments of $247.5 million as of December 31, 2019.

Revenue: The company generated $2.7 million in revenue during the three months ended September 30, 2020, which primarily represents collaborative development revenue and sales of tenapanor for clinical supply to KKC.

R&D Expenses: Research and development expenses were $12.2 million for the three months ended September 30, 2020, a decrease of approximately $5.4 million, or 30 percent, compared to $17.6 million for the three months ended September 30, 2019. The decrease was primarily due to the completion of the Phase 3 PHREEDOM and AMPLIFY clinical trials evaluating tenapanor for the control of hyperphosphatemia.

G&A Expenses: General and administrative expenses were $7.6 million for the three months ended September 30, 2020, an increase of $0.7 million, or approximately 10 percent, compared to $6.9 million for the three months September 30, 2019. The increase was primarily due to an increase in costs associated with building and staffing our commercial infrastructure and teams as we prepare for the anticipated U.S. launch of tenapanor for the control of serum phosphorus in CKD patients on dialysis.

Net Loss: Net loss for the quarter ended September 30, 2020 was $18.1 million, or ($0.20) per common share, as compared to $23.5 million, or ($0.37) per common share, for the quarter ended September 30, 2019.

On November 5, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported that the Company will release its financial results for the third quarter ended September 30, 2020 and provide a corporate strategic update on Thursday, November 12, 2020 after the close of trading (Press release, Thermogenesis, NOV 5, 2020, View Source [SID1234570234]). A conference call and webcast will follow at 1:30 p.m. PT/ 4:30 p.m. ET.

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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!

A webcast replay will be available on ThermoGenesis’ website for three months by visiting the Investor page of the Company’s website at www.thermogenesis.com.