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Sierra Oncology to Report Momelotinib Long-term Overall Survival Data in Oral Presentation at ASH 2020

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

Heska Corporation Reports Third Quarter 2020 Results

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.

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.

Ardelyx Reports Third Quarter 2020 Financial Results and Business Highlights

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]).

"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.

ThermoGenesis Holdings to Announce Financial Results for the Third Quarter Ended September 30, 2020 and Provide a Corporate Strategic Update

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.

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.

Aeglea BioTherapeutics Reports Third Quarter 2020 Financial Results and Corporate Highlights

On November 5, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported its third quarter 2020 financial results, and provided recent corporate and program highlights (Press release, Aeglea BioTherapeutics, NOV 5, 2020, View Source [SID1234570233]).

"Although it’s been a challenging environment for biotech with the global pandemic, we have continued to be productive in our Arginase 1 Deficiency patient identification and engagement efforts. I am pleased with the progress we are making overall as well as specifically at our PEACE trial sites," said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "I am also excited by the momentum we are building in our Homocystinuria program with the recent granting of U.S. Orphan Drug Designation and a positive opinion for EU Orphan Drug Designation for ACN00177."

Recent Highlights and Updates

Pegzilarginase in Arginase 1 Deficiency

In September, Aeglea announced the PEACE Phase 3 pivotal trial was more than 50% enrolled with nearly twice the number of patients needed to complete enrollment identified at active trial sites. Enrollment for the trial is anticipated to be completed in January 2021.
As of September, Aeglea has identified over 250 Arginase 1 Deficiency patients in addressable markets, a 25% increase relative to the prior year. The number of currently identified patients represents more than 50% and 30% of the estimated genetic prevalence populations in the U.S. and EU5, respectively.
ACN00177 in Homocystinuria

In October, Aeglea announced the U.S. Food and Drug Administration granted Orphan Drug Designation to ACN00177 for the treatment of Homocystinuria.
Additionally, the European Medicines Agency Committee for Orphan Medicinal Products issued a positive opinion recommending Orphan Drug Designation for ACN00177 for the treatment of Homocystinuria in the European Union.
Corporate

In October, the Company strengthened its financial position with proceeds from shares of common stock sold under its ATM program, resulting in gross proceeds of $25 million, extending its cash runway into 2023.
Upcoming Events

Aeglea will be attending the following virtual investor conferences in the fourth quarter:

Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3
3rd Annual Evercore ISI HealthCONx Conference, December 1-3
Third Quarter 2020 Financial Results

As of September 30, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $141.5 million. In addition, in October 2020 the Company raised approximately $24.6 million in net proceeds from shares of common stock sold under its ATM program. Based on Aeglea’s current operating plan, and taking into account the net offering proceeds, management believes it has sufficient capital resources to fund anticipated operations into 2023.

Research and development expenses totaled $12.5 million for the third quarter of 2020 and $17.8 million for the third quarter of 2019. The decrease was primarily associated with completing certain manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase, completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing cancer trials; offset by a ramp-up in manufacturing for ACN00177 in Homocystinuria and higher personnel-related expenses.

General and administrative expenses totaled $5.7 million for the third quarter of 2020 and $4.3 million for the third quarter of 2019. This increase was primarily due to ramping-up commercial capabilities and additional facilities to support company growth.

Net loss totaled $18.0 million and $21.6 million for the third quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.7 million and $1.4 million for the third quarter of 2020 and 2019, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically lowers levels of the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating, progressive disease presenting in childhood with persistent hyperargininemia, spasticity, developmental delay, intellectual disability, seizures and early mortality. Pegzilarginase is intended for use as an enzyme therapy to reduce elevated blood arginine levels in patients with ARG1-D. Aeglea’s Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company’s single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.

About ACN00177 in Homocystinuria

Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness. ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. With this mechanism, ACN00177 is intended to lower the abnormally high blood levels of homocysteine in patients with Homocystinuria. Preclinical data demonstrated that ACN00177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. The Company initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities. The timing of first patient dosing in this Phase 1/2 trial will depend on determinations by individual sites as they adjust to impacts from COVID-19. ACN00177 has been granted Orphan Drug Designation by the U.S. FDA and received a positive opinion on Orphan Drug Designation from the European Medicines Agency.