On November 9, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported the acceptance of an abstract at the upcoming 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia, and virtually at View Source (Press release, Antengene, NOV 9, 2021, View Source [SID1234594934]).

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Antengene will release preliminary results of this Company-sponsored open-label Phase 1b study with selinexor (ATG-010) for the treatment of peripheral T-cell lymphoma and NK/T-cell lymphoma, in an offline poster presentation (full text of the abstract available at: View Source). Meanwhile, another seventeen abstracts related to selinexor and eltanexor will be presented at the 2021 ASH (Free ASH Whitepaper) Annual Meeting as announced by Antengene’s partner, Karyopharm Therapeutics, Inc. (Karyopharm) (see below for details of these abstracts).

"We are very pleased that the poster related to Antengene’s selinexor (ATG-010) T-Cell Lymphoma program has been accepted at the 2021 ASH (Free ASH Whitepaper) Annual Meeting," said Jay Mei, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Antengene. "Selinexor is Antengene’s first commercial stage product. We look forward to sharing more about this program following the poster session."

Details of the abstract that has already been published on the ASH (Free ASH Whitepaper) website are as follows:

XPO1 Inhibitor (ATG-010) Plus Chemotherapy per Investigator’s Choice for Heavily Pretreated Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) and Extranodal NK/T-Cell Lymphoma (ENKTL)：Preliminary Results from a Multicenter, Single-Arm Phase Ib Study (TOUCH Trial) (Abstract# 2452)

Session:
624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster II
Abstract #: 2452
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET
Venue: Hall B5, Georgia World Congress Center

Details of these abstracts announced by Karyopharm in a press release dated November 4, 2021.

In total, 17 abstracts were selected for presentation at the meeting, including five oral presentations and 12 posters.

Oral Presentations

Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor in Patients with Myelofibrosis Refractory or Intolerant to JAK Inhibitors
Presenter: Srinivas Tantravahi, University of Utah
Abstract #: 143
Session Type: Oral Presentation
Session: Myeloproliferative Syndromes: Clinical and Epidemiological: Non-JAK Inhibitor Therapies for Myelofibrosis
Date and Time: Saturday, December 11, 2021 at 1:00 p.m. ET

Title: Transcriptomic Correlates of Response to Selinexor in Multiple Myeloma Reveal a Predictive Signature
Presenter: Paula Restrepo, Icahn School of Medicine at Mount Sinai
Abstract #: 457
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Multiple Myeloma and Waldenstrom Macroglobulinemia: Exploring Biomarkers in the Era of Personalized Medicine
Date and Time: Sunday, December 12, 2021 at 12:00 p.m. ET

Title: Enhanced p53 Activation by Dual Inhibition of MDM2 and XPO1 Disrupts MYC Transcriptional Program and Restores Sensitivity to BCL-2 Inhibition in Ven/HMA Resistant AML
Presenter: Yuki Nishida, Saga University
Abstract #: 505
Session Type: Oral Presentation
Session: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel Strategies to Overcome Resistance to BCL-2 Inhibition
Date and Time: Sunday, December 12, 2021 at 4:30 p.m. ET

Title: Rationale for Selinexor Treatment in Daratumumab-Refractory MM Patients Identified by Paired Ex Vivo Drug Sensitivity and RNA-Seq
Presenter: Suresh Kumar Balasubramanian, Wayne State University
Abstract #: 683
Session Type: Oral Presentation
Session: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Targeting
Mitochondrial Survival Pathways
Date and Time: Monday, December 13, 2021 at 3:45 p.m. ET

Title: Comparison of Salvage Autologous Hematopoietic Cell Transplantation with Outcomes Following Selinexor Combinations Among Double/Triple Refractory Myeloma Patients
Presenter: Praneeth Sudalagunta, H Lee Moffitt Cancer Ctr
Abstract #: 893
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Myeloma Pathogenesis and Novel Targets
Date and Time: Monday, December 13, 2021 at 7:15 p.m. ET

Poster Presentations

Title: Efficacy and Safety of Selinexor-Containing Regimens in Patients with Multiple Myeloma Previously Treated with Anti-CD38 Monoclonal Antibodies (αCD38 mAb)
Presenter: Suzanne Lentzsch, Columbia University Irving Medical Center
Abstract #: 1651
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Effects of Cytogenetic Risk on Outcomes in Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd)
Presenter: Nizar Bahlis, University of Calgary
Abstract #: 1634
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Selinexor in Combination with Daratumumab-Bortezomib and Dexamethasone for the Treatment of Relapse or Refractory Multiple Myeloma: Initial Results of the Phase 2, Open-label, Multicenter GEM-SELIBORDARA Study
Presenter: Paula Rodríguez- Otero, Clínica Universidad de Navarra
Abstract #: 1677
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Once Weekly Oral Selinexor, Pomalidomide, and Dexamethasone in Relapsed Refractory Multiple Myeloma
Presenter: Darrell White, QEII Health Sciences Center, Dalhousie University
Abstract #: 2748
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor-Based Regimens in Patients with Multiple Myeloma after Prior Anti-B-Cell Maturation Antigen Treatment
Presenter: Muhamed Baljevic, University of Nebraska Medical Center
Abstract #: 2751
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Single Cell RNA Sequencing of a Selinexor Clinical Trial Reveals Overexpression of Alternative Nuclear Export Pathways Associated with Resistance to Selinexor in RRMM Patients
Presenter: Yael Cohen, Tel Aviv Sourasky Medical Center
Abstract #: 2725
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor Enhances NK Cell Activation Against Lymphoma Cells Via Downregulation of HLA
Presenter: Matthew Blunt, University of Southampton
Abstract #: 2411
Session Type: Poster Presentation
Session: Lymphomas: Translational—Non-Genetic: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Molecular Response Patterns in Relapsed/Refractory AML Patients Treated with Selinexor and Chemotherapy
Presenter: Piroska Klement, Hannover Medical School
Abstract #: 2369
Session Type: Poster Presentation
Session: Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Updated Efficacy of Eltanexor Monotherapy in Patients with Higher Risk Hypomethylating Myelodysplastic Syndrome Primary Refractory to Hypomethylating Agents
Presenter: Sangmin Lee, Weill Cornell Medical College
Abstract #: 3676
Session Type: Poster Presentation
Session: Myelodysplastic Syndromes — Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021 at 6:00 – 8:00 p.m. ET

Title: Clinical Outcomes in Patients with Dose Reduction of Selinexor in Combination with Bortezomib, and Dexamethasone (XVd) in Previously Treated Multiple Myeloma from the BOSTON Study
Presenter: Sundar Jagannath, Mount Sinai School of Medicine
Abstract #: 3793
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor in Combination with R-GDP for Patients with Relapsed/Refractory B-Cell Lymphoma: SELINDA Phase Ib LYSA Study
Presenter: Marie Maerevoet, Jules Bordet Institute
Abstract #: 1411
Session Type: Poster Presentation
Session: Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
Presenter: Seung Tae Lee, University of Maryland School of Medicine
Abstract #: 1420
Session Type: Poster Presentation
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021, 5:30-7:30 p.m. ET

About Selinexor (ATG-010)

Selinexor is so far the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) and the first drug approved for the treatment of both multiple myeloma and diffuse large B-cell lymphoma. By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins, thus induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor can be used in multiple combination regimens to improve treatment efficacy.

On November 9, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16, 2021 at 10:00 a.m. EDT (Press release, Bio-Techne, NOV 9, 2021, View Source [SID1234594933]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On November 9, 2021 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, reported that Mahesh Karande, President and Chief Executive Officer, and Thomas McCauley, Ph.D., Chief Scientific Officer, will present at the Jefferies London Healthcare Conference on Wednesday, November 17, 2021 at 8:00 a.m. GMT (Press release, Omega Therapeutics, NOV 9, 2021, View Source [SID1234594932]).

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A live webcast of the presentation will be available on the Investors & Media section of the Company’s website at www.omegatherapeutics.com. An archived replay of the presentation will be available on the same website for approximately 90 days.

On November 9, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2021 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 9, 2021, View Source [SID1234594931]).

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Clinical Update

FPI-1434

Fusion now expects to provide multi-dose safety and imaging data, and recommended Phase 2 dose, in the second half of 2022 rather than in the first half of 2022. The shift in timelines is primarily associated with a decrease in patient enrollment rates attributable to the impact of the COVID-19 pandemic.

Chief Executive Officer John Valliant, Ph.D. commented, "Despite our efforts to mitigate the impacts of the COVID-19 pandemic, including the addition of new trial sites in multiple geographic regions, we have seen patient enrollment rates decline largely due to resourcing and reduced staffing issues at trial sites. Longer timelines to enroll patients have persisted and therefore we are shifting our expectation for multi-dose data to the second half of 2022. We continue to make patient recruitment a top priority, are working closely with our trial sites to support their efforts and believe that with increased vaccination rates recruitment will return to previous levels."

Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy. In addition, the study arm exploring the impact on biodistribution and tumor uptake of administration of a dose of naked ("cold") IGF-1R antibody prior to each dose of FPI-1434 is ongoing.

Dr. Valliant continued, "Although the Phase 1 study of FPI-1434 is experiencing delays during these unprecedented times, we continue to believe in the significant opportunity we have to address a broad array of tumor types with high unmet need and we are working diligently to optimize the development program and progress the study for the benefit of patients."

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated with the first study site open to recruitment. Fusion expects to dose the first patient in the first quarter of 2022 and expects interim data from the first patient cohort in the first quarter of 2023.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in multiple solid tumors. FPI-2059 combines Ipsen’s IPN-1087, which Fusion acquired in 2021, with actinium-225. Fusion continues to anticipate submitting an IND application for FPI-2059 in the first half of 2022.

Recent News and Highlights

In August, Fusion and TRIUMF, Canada’s particle accelerator centre, announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225. Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.
Fusion recently expanded its executive leadership team with the appointments of Mohit Rawat as president and chief business officer, and Christopher Leamon, Ph.D. as chief scientific officer, and Eric S. Hoffman, Ph.D. as senior vice president, business development.
In October, Fusion announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1.
Dr. Valliant said, "We are building a fully integrated radiopharmaceutical company based upon our platform, reflecting a diverse pipeline of TATs in development. We are also making strategic investments in critical areas of manufacturing and supply chain to support the growth of our business, and we are attracting top industry leaders to join Fusion in our mission to impact the cancer therapy landscape with this new generation of targeted radiopharmaceuticals."

Third Quarter 2021 Financial Results

Cash and Investments: As of September 30, 2021, Fusion held cash, cash equivalents and investments of $238.2 million, compared to cash, cash equivalents and investments of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of September 30, 2021 will enable the Company to fund its operations through the end of 2023.
Collaboration Revenue: For the third quarter of 2021, Fusion recorded $0.3 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the third quarter of 2021 were $12.7 million, compared to $4.5 million for the same period in 2020. The increase was primarily related to costs associated with the FPI-1434 Phase 1 clinical trial, as well as preclinical research and manufacturing costs, platform development and personnel-related costs.
G&A Expenses: General and administrative expenses for the third quarter of 2021 were $7.2 million, compared to $5.8 million for the same period in 2020. The increase was primarily related to personnel-related costs and general corporate costs, partially offset by a decrease in professional fees.
Net Loss: For the third quarter of 2021, Fusion reported a net loss of $19.4 million, or $0.45 per share, compared with a net loss of $10.0 million, or $0.24 per share, for the same period in 2020.
Impact of COVID-19

Fusion is experiencing material delays in patient recruitment and enrollment as a result of continued resourcing issues related to COVID-19 at trial sites.

There also remains uncertainty relating to the trajectory of the pandemic, hospital staffing and resource issues, and whether they may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in further difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

On November 9, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases including rare disorders, reported financial results for the third quarter ended September 30, 2021, and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, Biohaven Pharmaceutical, NOV 9, 2021, View Source [SID1234594930]).

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"We are ecstatic with the success that our platform continued to achieve over the quarter, with NURTEC ODT impressively surpassing revenue expectations, and becoming the market leader in oral CGRP targeting migraine therapies," said Vlad Coric, M.D., Chief Executive Officer of Biohaven. "We are further encouraged by the overwhelmingly positive patient experience to date, recognizing the value of providing a solution that will further improve the quality of life of those who are now able to prevent the debilitating effects of migraine. While there remains significant upside for NURTEC ODT across new geographies and patient demographics given the expanded preventive treatment use, we also look forward to the continuous progress made outside of our CGRP franchise and within our broad pipeline."

Dr. Coric continued, "We are also excited to have announced a strategic collaboration with pharmaceutical powerhouse Pfizer for the global commercialization ex-US of NURTEC ODT, validating the medicine’s dual therapy potential and highlighting our commitment to the more than 1 billion patients worldwide suffering with migraine."

Link to Pfizer Press Release Here.

Third Quarter and Recent Business Highlights

Continued strong uptake of NURTEC ODT – Following the landmark approval of NURTEC ODT for the preventive treatment of migraine in May, we believe NURTEC ODT will continue its impressive growth as the first and only medication approved to both treat and prevent migraine attacks. NURTEC ODT has now achieved over 1,100,000 prescriptions, and over 53,000 unique prescribers to date, an increase of 15,000 prescribers from the second quarter signaling traction with physicians. The $136 million in net product revenues for the quarter represents a 46% increase from net product revenues over the second quarter, significantly exceeding expectations. We saw a continuation of the improvement in net price realization in the third quarter 2021, as compared to the first quarter of 2021.

We believe there continues to be a significant market opportunity for oral CGRP targeting agents ahead, with a potential $4-5 billion annual market in the US alone. We will continue to invest in NURTEC’s long term success, driving its growth outside of the U.S. and continuing to expand commercial payer coverage.

Entered into second amendment to term loan financing facility – In September 2021, the Company, Biohaven Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company (together with the Company, the "Borrowers"), and certain other of the Company’s subsidiaries entered into an Amendment No. 2 (the "Second Amendment") to its Financing Agreement dated as of August 7, 2020 with Sixth Street Specialty Lending, Inc. Pursuant to the Second Amendment, the parties agreed, among other things, to increase the total size of the credit facility by $250.0 million to $750.0 million, and reduce the interest rate margin (as defined in the Sixth Street Financing Agreement) by 0.75% on the amounts made available under the amendment and the remaining $100.0 million not previously drawn on the August 2020 agreement. On closing of the amendment, the Company drew $125.0 million made available from the amendment, and the $100.0 million remaining under the August 2020 agreement. The remaining $125.0 million available under the facility remains available at the Company’s discretion until December 31, 2021.

Presented expanded NURTEC ODT and intranasal zavegepant data at the International Headache Society – European Headache Federation Joint Congress – In September, the Company presented 17 abstracts, including three late-breaking abstracts and four oral presentations, highlighting the efficacy and safety of NURTEC ODT as both an acute and preventive treatment of migraine. Within the Phase 2/3 study, preventive effects of rimegepant were evident as early as the first week of treatment and sustained after 12 weeks. Results from an open label safety study of rimegepant demonstrated its preventive benefits when dosed on an as needed basis to treat migraine attacks, expressed as median time to 30% and 50% reduction in monthly migraine days observed to decrease at 12 weeks and 32 weeks respectively. Within the Phase 2/3 dose-ranging study evaluating the safety, efficacy and tolerability of intranasal zavegepant, it was found that both 10 mg and 20 mg doses were superior to placebo on the coprimary endpoints of pain freedom. Lastly, health economics and outcomes research posters highlighted the association between migraine-related absenteeism, healthcare utilization and cost of care.

Phase 3 clinical trial of verdiperstat in MSA did not statistically differentiate from placebo on the study’s prespecified primary or secondary efficacy measures – In September, the Company announced that verdiperstat did not demonstrate efficacy for the treatment of multiple system atrophy (MSA). Although the mechanism of action for verdiperstat, myeloperoxidase inhibition, was shown not to be effective for MSA, Biohaven maintains that there remains a strong rationale of targeting brain inflammation in other disease states. An ongoing clinical trial evaluating the efficacy of verdiperstat in amyotrophic lateral sclerosis (ALS) is being conducted in collaboration with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and is expected to complete enrollment in the fourth quarter of 2021.

Upcoming Milestones:

Biohaven is continuing to support the launch of NURTEC ODT for the acute and preventive treatment of migraine, as well as develop our product candidates through clinical and preclinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones with its CGRP receptor antagonists, glutamate modulators, and myeloperoxidase inhibitors in the coming quarters.

Biohaven expects to:

Continue to advance the commercialization of NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine outside of the U.S.
Report topline of intranasal zavegepant in the acute treatment of migraine in the fourth quarter of 2021.
Complete enrollment of verdiperstat for the treatment of ALS in the fourth quarter of 2021.
Marketing Authorization Application for rimegepant dual activity, inclusive of acute and prevention of migraine expected regulatory approval in the first half of 2022.
Report topline of NURTEC ODT for the acute treatment of migraine in China and Korea in the first half of 2022.
Report topline of troriluzole in Spinocerebellar Ataxia in the first half of 2022.
Report topline of troriluzole in OCD in the second half of 2022.
Third Quarter Financial Results

Product Revenues, Net: Net product revenue was $135.7 million for the three months ended September 30, 2021, compared to $17.7 million for the three months ended September 30, 2020. The increase of $118.1 million in net product revenues is due to both increased NURTEC ODT sales volume and improvements in net price realization due to decreases in sales allowances during the three months ended September 30, 2021, compared to the three months ended September 30, 2020. Sales allowances and accruals mostly consisted of patient affordability programs, distribution fees and rebates.

Cash, Restricted Cash, and Marketable Securities: Cash, restricted cash, and marketable securities as of September 30, 2021, was $523.9 million, compared to $368.0 million as of June 30, 2021. In addition, the Company has access to $125.0 million in available borrowing under our credit facility, and Series B preferred share forward contracts with quarterly cash proceeds totaling $147.2 million until the fourth quarter of 2024.

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $85.7 million for the three months ended September 30, 2021, compared to $57.0 million for the three months ended September 30, 2020. The increase of $28.6 million was primarily due to an increase in both late-stage product candidates and preclinical research. Non-cash share-based compensation expense was $13.1 million for the three months ended September 30, 2021, an increase of $7.9 million as compared to the same period in 2020.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses, including non-cash share-based compensation costs, were $164.5 million for the three months ended September 30, 2021, compared to $119.5 million for the three months ended September 30, 2020. The increase of $45.0 million was primarily due to increases in spending to support increased commercial sales of NURTEC ODT for the three months ended September 30, 2021, compared to the three months ended September 30, 2020. Less than half of the SG&A expense was for commercial organization personnel costs, excluding non-cash share-based compensation expense. Non-cash share-based compensation expense was $14.9 million for the three months ended September 30, 2021, an increase of $5.5 million as compared to the same period in 2020.

Net Loss: Biohaven reported a net loss attributable to common shareholders for the three months ended September 30, 2021, of $171.8 million, or $2.63 per share, compared to $195.2 million, or $3.27 per share for the same period in 2020. Non-GAAP adjusted net loss for the three months ended September 30, 2021 was $125.1 million, or $1.91 per share, compared to $159.5 million, or $2.67 per share for the same period in 2020. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, non-cash interest expense related to the accounting for mandatorily redeemable preferred shares and liability related to sale of future royalties, changes in the fair value of derivatives, gains or losses from equity method investment, collaboration and license upfront expenses, and accrued development milestone payments. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter 2021 results today at 8:00 a.m. EDT. To access the call, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast, and accompanying slide presentation, can be accessed through the "Investors" section of Biohaven’s website at www.biohavenpharma.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the call will be made available for two weeks following the conference call. To hear a replay of the call, dial 877-660-6853 (domestic) or 201-612-7415 (international) with conference ID 13723890. An archived webcast will be available on Biohaven’s website.