On November 8, 2022 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Protagonist, NOV 8, 2022, View Source [SID1234623411]).

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"Continued execution of the Phase 3 VERIFY global clinical development program of rusfertide in polycythemia vera remains our top corporate priority," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Rusfertide has the potential to transform the current treatment paradigm for PV, dramatically improving patients’ lives. The enthusiasm we have observed around rusfertide, among patients and physicians alike, reinforces our commitment to advancing this important drug candidate as rapidly as possible."

Dr. Patel continued, "We are pleased to have recently announced a new Chief Medical Officer, Dr. Arturo Molina, a renowned hematologist-oncologist and a successful drug developer. Dr. Molina will focus on providing medical and operational leadership to our rusfertide clinical development program.

"Our Janssen-partnered asset, PN-235 (JNJ-77242113), an oral peptide interleukin 23 receptor (IL-23R) antagonist, is currently in multiple Phase 2 clinical studies to assess safety and efficacy in moderate-to-severe plaque psoriasis. We look forward to decision-driving results from these studies in the first half of next year. With important pending readouts for both rusfertide and PN-235, we expect the first half of 2023 to be a period of potential transformational value creation for Protagonist."

Third Quarter 2022 and Recent Developments

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Potential Indications

While significant efforts have been undertaken toward the goal of full enrollment of the Phase 3 VERIFY study, and a high degree of interest has been observed from physician and patient communities, operational challenges including site staff shortages have continued to delay initial recruitment activities. The Company expects enrollment completion in the second half of 2023.
Protagonist will have three poster presentations at the 2022 ASH (Free ASH Whitepaper) Annual Meeting & Exposition, taking place December 10-13 in New Orleans, Louisiana. Details are as follows:
Poster Presentation 1:
Title: VERIFY: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I
Session Date: Saturday, December 10, 2022
Presentation Time: 5:30 PM – 7:30 PM CT.
Poster Presentation 2:
Title: Subgroup Analysis of Adverse Events Following Rusfertide Dosing in REVIVE: A Phase 2 Study of Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM – 8:00 PM CT.
Poster Presentation 3:
Title: Rusfertide Analog-PN23114 as a Hepcidin Mimetic Provides Efficacy Benefits in Conjunction with Phlebotomy in Mouse Model for Hereditary Hemochromatosis
Session Name: 102. Iron Homeostasis and Biology: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM – 8:00 PM CT.
In keeping with the Company’s organizational prioritization of rusfertide in PV, plans to initiate studies of rusfertide in additional disease indications have been paused. This decision was influenced in part by enactment of the Inflation Reduction Act in the U.S. and includes previously planned studies of rusfertide in the subset of hereditary hemochromatosis (HH) patients with chronic arthropathy.
PN-235: Oral IL-23 Receptor Antagonist

Four clinical studies of PN-235 (JNJ-77242113), a drug candidate discovered by Protagonist and further developed in collaboration with Janssen, are underway and led by Janssen:
FRONTIER 1, a Phase 2b multicenter, randomized, placebo controlled, 240-patient dose-ranging study commenced in early 2022 to evaluate the safety and efficacy of PN-235 for the treatment of moderate-to-severe plaque psoriasis;
FRONTIER 2, a long-term extension study in moderate-to-severe plaque psoriasis;
SUMMIT, a study of an oral tablet formulation of PN-235 for the treatment of moderate-to-severe plaque psoriasis; and
A separate Phase 1 study of PN-235 in healthy Japanese and Chinese participants. More information on these studies can be found at View Source
Protagonist expects the results of these studies to inform the next steps for PN-235 development. To date, $112.5 million in development milestones have been received and the Company remains eligible for up to approximately $855.0 million in future development and sales milestones. In the near term, the Company is eligible for a $10 million milestone payment in connection with the start of a second indication-based Phase 2 study, and a $50 million milestone upon dosing of a third patient in a Phase 3 study of PN-235.
PN-943: Oral, Gut-Restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)

With the exception of completing the 40-week extended treatment period for eligible patients in the Phase 2 IDEAL study, expected to be completed in Q1 2023, the Company intends to dedicate no further internal resources to clinical development or CMC activities for PN-943. The Company will continue to explore out-licensing opportunities globally.
Management and Operational Updates

Arturo Molina, M.D., M.S. has joined Protagonist as its Chief Medical Officer (CMO). Dr. Molina’s responsibilities will include strategic and execution leadership across the Company’s clinical development programs, with a primary focus on the Phase 3 VERIFY study of rusfertide in PV.
Dr. Molina comes most recently from Sutro Biopharma, where he was Chief Medical Officer for more than six years. Previously, from 2013 to 2016, Dr. Molina was Vice President, Oncology Scientific Innovation, at Johnson & Johnson.
De-prioritization of the PN-943 program and streamlining of certain discovery programs is part of Company’s ongoing commitment to optimize and focus resources toward the rusfertide program in PV.
Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2022 were $267.4 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the end of 2024.
License and Collaboration Revenue: License and collaboration revenue was zero and $26.6 million for the three and nine months ended September 30, 2022, respectively, as compared to $10.3 million and $18.7 million, respectively, for the same periods in 2021. The decrease in revenue from prior year quarter was primarily due to a decrease in the level of services the Company provided under the Janssen license and collaboration agreement. The Company completed its performance obligation pursuant to the collaboration as of June 30, 2022. The revenue increase from prior year-to-date included the $25.0 million milestone that the Company became eligible to receive in March 2022 upon the dosing of the third patient in the Janssen Phase 2b FRONTIER 1 study of PN-235.
Research and Development ("R&D") Expenses: R&D expenses were $25.4 million and $96.3 million for the three and nine months ended September 30, 2022 as compared to $37.0 million and $87.6 million for the same periods in 2021. The decrease in R&D expense from prior year quarter was primarily due to lower PN-943 expenses related to the suspension of further program expenditures and the impact of $4.0 million recorded during the third quarter of 2021 related to the resolution of the Company’s collaboration agreement dispute with Zealand Pharma. The increase in R&D expense from prior year to date was primarily due to costs associated with rusfertide and PN-943, including current and planned Phase 3 clinical trials, partially offset by a decrease in costs related to the completion of PN-235 and PN-232 Phase 1 trials and the impact of $4.0 million recorded during the third quarter of 2021 related to the resolution of the Company’s collaboration agreement dispute with Zealand Pharma.
General and Administrative ("G&A") Expenses: G&A expenses were $6.9 million and $25.1 million for the three and nine months ended September 30, 2022 as compared to $7.3 million and $19.9 million for the same periods in 2021. The decrease from prior year quarter was primarily due to decreases in consulting, legal and other expenses. The increase from prior year to date was primarily due to increases in personnel related and other expenses to support Company growth.
Net Loss: Net loss was $31.2 million, or $0.64 per share, for the three months ended September 30, 2022 as compared to a net loss of $33.8 million, or $0.70 per share, for the three months ended September 30, 2021. Net loss was $93.2 million, or $1.90 per share, for the nine months ended September 30, 2022 as compared to a net loss of $88.6 million, or $1.94 per share for the nine months ended September 30, 2021.

On November 8, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology and innate immuno-oncology, reported third quarter 2022 financial results and recent portfolio and business updates (Press release, Alector, NOV 8, 2022, View Source [SID1234623410]). As of September 30, 2022, Alector’s cash, cash equivalents and investments totaled $758.3 million.

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Commentary on the Quarter:

"In the third quarter, we expanded our first-in-class clinical immuno-neurology pipeline with AL044, a biologic targeting MS4A, a brain immune checkpoint molecule and a genetic risk factor for Alzheimer’s disease. We also continued to advance our INFRONT-3 Phase 3 pivotal study of latozinemab for frontotemporal dementia with progranulin mutations, or FTD-GRN, and our INVOKE-2 Phase 2 Alzheimer’s disease study with AL002, which activates TREM2 receptor signaling," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We will be reporting new data from the Phase 1 study of AL101 later this year at CTAD in addition to follow-up data from the INFRONT-2 Phase 2 trial in patients with symptomatic FTD-C9orf72 in 2023."

"We anticipate biomarker data from the AL044 healthy volunteer study and completion of enrollment in our INVOKE-2 study in 2023. We believe that our immuno-neurology drug candidates, which are designed to regulate key aspects of microglial proliferation, survival, migration, lysosomal function and immune response, could prove important in effectively treating neurodegeneration either as stand-alone therapies or potentially in combination with anti-beta amyloid drugs."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "Our immuno-oncology pipeline continues to advance as well. We remain on track to submit an IND for AL009, Alector’s first-in-class multi-Siglec inhibitor, by the end of the year."

"We are also thrilled to have expanded our talented leadership team over the past quarter as we welcomed Peter Heutink, Ph.D., as Chief Scientific Officer," said Dr. Kenkare-Mitra. "Peter’s expertise in the human genetics of neurodegenerative disease is important to our efforts at Alector."

Immuno-Neurology Portfolio

Progranulin Assets (Latozinemab, AL101)

Enrollment is ongoing globally in the INFRONT-3 randomized, placebo-controlled, pivotal Phase 3 trial evaluating the efficacy and safety of latozinemab (AL001) in at-risk and symptomatic patients with FTD-GRN. The first patient has been enrolled in the open-label extension study.

The company expects to report follow-up data from the INFRONT-2 Phase 2 clinical trial of latozinemab in frontotemporal dementia patients with a C9orf72 genetic mutation (FTD-C9orf72) in 2023.

Alector will present a poster, Repeat IV and SC dosing of the Anti-Sortilin Antibody AL101, with data from the Phase 1 trial of AL101 in healthy volunteers at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held in San Francisco, California from November 29 to December 2, 2022. AL101 is intended to elevate progranulin levels in a manner similar to latozinemab, and the company plans to investigate AL101 for the treatment of Alzheimer’s disease (AD) and Parkinson’s disease (PD).

Latozinemab and AL101 are being developed in collaboration with GSK.

TREM2 Asset (AL002)

Enrollment in the INVOKE-2 Phase 2 study of AL002 continues. The INVOKE-2 Phase 2 clinical trial is designed to evaluate the efficacy and safety of AL002 in slowing disease progression in individuals with early AD. AL002 is being developed in collaboration with AbbVie and targets Triggering Receptor Expressed on Myeloid cells 2 (TREM2) to increase TREM2 signaling and the functionality of microglia, which are brain-specific immune cells.

Novel MS4A Asset (AL044)

The company commenced its first-in-human Phase 1 trial of AL044, the first clinical-stage drug candidate to target MS4A, a major genetic risk factor for AD and an immune checkpoint expressed on microglia. The study, initiated in September of this year, is investigating the safety profile, pharmacokinetics (PK), pharmacodynamics (PD) and target engagement of AL044 in healthy adults. Safety and biomarker data from this study are anticipated in 2023. The company views MS4A as a master inhibitory checkpoint for the brain’s immune system and believes its inhibition will activate microglia in a disease-selective manner to broadly counteract Alzheimer’s disease and potentially orphan neurodegenerative indications.

Alector Reports Third Quarter 2022 Financial Results

Immuno-Oncology Portfolio

Multi-Siglec and SIRPα Assets (AL009, AL008)
anticipates submitting an IND for its AL009 innate immuno-oncology program before the end of the year. The company will present a poster, Characterization of suppressive myeloid cells in solid tumors to refine disease selection in a Phase 1 study of the multi-Siglec inhibitor AL009, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held in Boston, Massachusetts and virtually from November 8 to 12, 2022. AL009 is a dual function biologic that inhibits multiple Siglec receptors on myeloid cells and simultaneously activates a stimulating receptor on the same cells. The company plans to prioritize tumor types that have immunosuppressive phenotypes and expects to study AL009 as a monotherapy and in combination with standard of care.

The company plans to utilize data and documentation from a regulatory filing previously submitted by Innovent to Chinese authorities for AL008 to support a potential IND submission in the U.S. AL008 is a novel innate immuno-oncology candidate with a dual mechanism of action, targeting SIRP-alpha (SIRPa) to inhibit the CD47- SIRPα pathway and activating Fc receptors to promote immuno-stimulatory pathways that drive anti-tumor immunity.

Recent Corporate Updates

Peter Heutink, Ph.D., began his role as Alector’s Chief Scientific Officer in October. Leveraging nearly 30 years of experience in the neurodegenerative disease space, Dr. Heutink provides scientific oversight of the company’s significant research pipeline and helps drive business strategy.

Third Quarter 2022 Financial Results

Revenue. Collaboration revenue for the quarter ended September 30, 2022, was $14.9 million, compared to $182.4 million for the same period in 2021. The decrease of $167.6 million was due to $173.4 million collaboration revenue recognized from AL001 FTD-GRN license provided as part of the GSK Agreement in 2021.

R&D Expenses. Total research and development expenses for the quarter ended September 30, 2022, were $48.3 million, compared to $43.1 million for the quarter ended September 30, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses as well as an increase in AL002 expenses.

G&A Expenses. Total general and administrative expenses for the quarter ended September 30, 2022, were $14.3 million, compared to $13.0 million for the same period in 2021. The increase is primarily due to personnel-related expenses.

Net Income (Loss). For the quarter ended September 30, 2022, Alector reported net loss of $46.1 million, or $0.56 net loss per share, compared to a net income of $126.6 million, or $1.56 net income per share, for the same period in 2021.

Alector Reports Third Quarter 2022 Financial Results

Cash Position. Cash, cash equivalents, and investments were $758.3 million as of September 30, 2022. Management anticipates that this will be sufficient to fund current operations through 2024.

On November 8, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported for the third quarter of 2022, during which the Company made significant progress on its oral vaccine candidates (Press release, Vaxart, NOV 8, 2022, View Source [SID1234623409]).

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"We are encouraged by the growing body of clinical evidence that supports the transformational potential of Vaxart’s oral pill vaccine platform with positive data from both our leading programs, COVID-19 and norovirus," said Andrei Floroiu, Vaxart’s Chief Executive Officer.

Dr. James Cummings, Vaxart’s Chief Medical Officer, said, "During the third quarter, we announced positive top-line Phase II clinical study results for our Wuhan S-only COVID-19 pill vaccine candidate. These data are very encouraging, showing that Vaxart’s vaccine candidate can trigger both serum and mucosal immunity and can boost responses in those having previously received mRNA vaccines. These results highlight the potential of mucosal immunity through remarkable cross-reactive responses. Our Wuhan vaccine candidate showed equally strong activity towards Omicron, something not seen with injectable vaccines. Additionally, we remain confident in our norovirus program, with encouraging recent data from our trial in elderly adults, which suggests similar activity as seen in younger adults. This is not often expected with vaccines and offers another potential source of differentiation for our oral pill vaccine candidate."

"Norovirus is a significant opportunity for Vaxart – with a $10 billion economic burden of disease in the U.S. alone and no approved vaccine against a disease that disproportionately affects older and pediatric populations. Vaxart has generated compelling clinical data across five norovirus trials. We are eagerly anticipating the upcoming results of our norovirus human challenge study at the end of the first quarter or at the start of the second quarter of 2023. We are increasing our focus on the norovirus program, with two additional clinical trials planned to start in the next six months," Mr. Floroiu added.

Vaxart’s oral vaccine platform has the potential to transform the vaccination paradigm globally, by providing significant advantages compared to injectable vaccines. One of the Company’s vaccine candidates was shown to be as protective as a leading injectable against a pandemic respiratory virus in a human flu challenge study. In addition, data from multiple programs suggest that by triggering mucosal immunity the platform could provide cross-reactivity against variants, reduce viral transmission, offer long duration of protection and offer a more tolerable safety profile.

"These potential advantages are in addition to those offered by the oral pill format, which could allow more people to be vaccinated painlessly, easily and faster all around the world. We are in a position to aggressively pursue our two leading clinical programs and are very excited looking into 2023 at the significant milestones for both programs – the readouts of two human challenge studies for norovirus and COVID-19," Mr. Floroiu concluded.

Recent Business Highlights

COVID-19 Vaccine Developments

In September 2022, Vaxart reported positive top-line data from its Phase II COVID-19 trial supporting broad potential of the Company’s COVID-19 vaccine candidates to tackle the challenges of an evolving virus that continues to overcome the immune protection provided by approved vaccines.
Vaxart is the only company with a mucosal vaccine candidate for COVID-19 that has produced Phase II clinical data that shows it stimulates mucosal immunity.
In July 2022, the Company updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal samples from human subjects and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2.
Norovirus Vaccine Developments

In June 2022, Vaxart reported positive top-line data about its norovirus vaccine candidate.
The data from Vaxart’s Phase Ib trial in subjects aged 55-80 demonstrated that Vaxart’s oral norovirus vaccine candidate stimulated a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells.
Results were consistent with previous studies conducted in younger populations, which is typically not the case, as the immune system often weakens with age, and older people tend to have less robust responses to vaccination than younger people.
No vaccine exists in the United States to treat norovirus, a virus that causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States.
Corporate Updates

Bolstered management and Board with three significant additions:
In August, named Ray Stapleton, Ph.D. as Chief Technology Officer.
Dr. Stapleton joins Vaxart from Genocea, where he served as CTO and Executive Vice President, working to develop next generation personalized immunotherapies in the forms of vaccines and cell therapies. His prior experience includes senior manufacturing and technical operations roles at a number of biotech companies after spending 15 years in positions of increasing responsibility in Merck and Company’s manufacturing organization.
Also in August, appointed Elaine J. Heron, Ph.D. and W. Mark Watson to the Company’s Board of Directors.
Dr. Heron currently serves on the boards of BioMarin Pharmaceutical, Inc., Palvella Therapeutics, Inc., Visgenx, Inc., and Watershed Medical, Inc. She also serves as an advisor to Kyto Technology and Life Science, Inc. Dr. Heron has over 35 years of experience in the life science research and biotech development sectors.
Mr. Watson is a Certified Public Accountant with more than 40 years of experience in public accounting and auditing, having spent his entire career from January 1973 to June 2013 at Deloitte Touche Tohmatsu and its predecessor, most recently as Central Florida Marketplace Leader.
Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines

Vaxart continues to make progress on its expected milestones:

Start of Phase II trial of Vaxart’s bivalent norovirus vaccine candidate in Q4 2022 or Q1 2023.
Top-line data from ongoing Phase II norovirus challenge study expected at the end of Q1 2023 or early Q2 2023.
Selection of COVID-19 vaccine construct to be used in the UK human challenge study expected in Q4 2022.
After determining which COVID-19 vaccine candidate to advance, Vaxart anticipates updating its plans for its India trials.
Omicron Human Challenge Trial in the UK starting in 2H 2023 using selected vaccine construct.
Financial Results for the Three Months Ended September 30, 2022

Vaxart ended the third quarter with cash, cash equivalents and available-for-sale debt securities of $114.8 million, compared to $131.5 million as of June 30, 2022. The decrease was primarily due to $14.6 million of cash used in operations.
The Company reported a net loss of $29.3 million for the third quarter of 2022, compared to $17.6 million for the third quarter of 2021. Net loss per share for the third quarter of 2022 was $0.23, compared to a net loss of $0.14 per share in the third quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development costs.
Research and development expenses were $22.5 million for the third quarter of 2022, compared to $12.4 million for the third quarter of 2021. The increase was mainly due to increases in headcount and related costs, and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
General and administrative expenses were $7.0 million for the third quarter of 2022, compared to $5.0 million for the third quarter of 2021. The increase was mainly due to increases in headcount and related costs and in legal and professional costs.
Conference Call
The Vaxart senior management team will host a conference call to discuss the business update and financial results for the third quarter of 2022 today, beginning at 4:30 p.m. ET.

On November 8, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the third quarter ended September 30, 2022 and provided pipeline updates (Press release, AnaptysBio, NOV 8, 2022, View Source [SID1234623408]).

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"We are excited about the potential of our novel immune cell modulator pipeline, including our two checkpoint agonists in clinical-stage development, rosnilimab and ANB032. We believe their mechanisms of action, acting directly on cell types mediating disease pathology, have the potential to treat a broad range of autoimmune and inflammatory disorders" said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We’re well capitalized to execute with over $590 million in cash at the end of Q3 as we move forward in our strategic portfolio review."
Rosnilimab (Anti-PD-1 agonist) Program
•Rosnilimab, our investigational wholly owned anti-PD-1 agonist antibody, is in the ongoing AZURE Phase 2 clinical trial in moderate-to-severe alopecia areata, and we anticipate top-line data in Q1 2023.
ANB032 (Anti-BTLA agonist) Program
•ANB032, our investigational wholly owned anti-BTLA agonist antibody, will be advancing with a U.S. IND submission for an initial Phase 2 clinical trial in Q4 2022.
ANB033 (Anti-CD122 antagonist) Program
•ANB033, our investigational wholly owned anti-CD122 antagonist antibody, targets the common beta subunit shared by the IL-15 and IL-2 receptors. IL-15 signaling mediates the survival and maintenance of tissue resident memory T cells (TRM). The presence of long-lived and persistent TRM have been shown to drive tissue-specific immune-mediated inflammation. We anticipate submitting a U.S. IND in first half of 2024.
Imsidolimab (Anti-IL-36 receptor) Program
•Imsidolimab, our investigational wholly owned anti-IL-36R therapeutic antibody, is in Phase 3 trials in generalized pustular psoriasis (GPP), and we anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023 and plan to outlicense imsidolimab prior to potential FDA approval.
GSK Partnered Programs
•PERLA, a head-to head Phase 2 trial of JEMPERLI (dostarlimab) vs. Keytruda in patients with metastatic non-squamous non-small cell lung cancer met its primary endpoint of objective response rate (ORR) of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy as assessed by blinded independent central review per RECIST v1.1.
◦GSK will present full results, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Annual Congress on Friday, December 9th.
•COSTAR, a Phase 2 trial of dostarlimab plus cobolimab, an anti-TIM-3 antagonist antibody, achieved pre-specified efficacy and safety criteria, and GSK is advancing both arms of the COSTAR Lung clinical trial

from Phase 2 to Phase 3, testing both doublet and triplet combinations of dostarlimab plus chemotherapy, and cobolimab plus dostarlimab plus chemotherapy in advanced non-small cell lung cancer who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
◦Cobolimab was discovered at AnaptysBio and licensed to TESARO, Inc., (GSK) as part of the same collaboration agreement as dostarlimab.
◦AnaptysBio earned a $5 million milestone from GSK in October 2022 on initiation of the first Phase 3 trial with cobolimab.
•Sold our royalty interest on future global net sales of Zejula to a wholly-owned subsidiary of DRI Healthcare Trust for up to $45 million during Q3.
◦Received an upfront payment of $35 million and are eligible for a further $10 million from DRI upon FDA approval of Zejula for the treatment of endometrial cancer, for which the drug is currently in a fully-enrolled ongoing Phase 3 study, to the extent that such approval occurs on or before December 31, 2025.
Third Quarter Financial Results
•Cash, cash equivalents and investments totaled $590.5 million as of September 30, 2022, compared to $615.2 million as of December 31, 2021, for a decrease of $24.7 million. The decrease relates primarily to cash used for operating activities offset by cash received from the Zejula royalty sale and stock option exercises.
•Collaboration revenue was $1.3 million and $3.5 million for the three and nine months ended September 30, 2022, compared to $20.9 million and $62.2 million for the three months and nine months ended September 30, 2021. The decrease relates primarily to one development milestone achieved for JEMPERLI for the three months ended September 30, 2021, and four development milestones achieved for JEMPERLI for the nine months ended September 30, 2021, and no development milestones achieved during the nine months ended September 30, 2022.
•Research and development expenses were $22.1 million and $65.4 million for the three and nine months ended September 30, 2022, compared to $22.2 million and $71.7 million for the three and nine months ended September 30, 2021. The year-to-date decrease was due primarily to reduced clinical costs and manufacturing costs for the Company’s programs. The R&D non-cash, stock-based compensation expense was $1.5 million and $5.0 million for the three and nine months ended September 30, 2022, as compared to $1.8 million and $4.4 million in the same period in 2021.
•General and administrative expenses were $8.9 million and $27.2 million for the three and nine months ended September 30, 2022, compared to $5.4 million and $16.1 million for the three and nine months ended September 30, 2021. The increase was due primarily to $3.8 million of costs incurred from personnel changes in the first quarter of 2022 and non-cash stock compensation expense. The G&A non-cash, stock-based compensation expense was $4.7 million and $15.7 million for the three and nine months ended September 30, 2022, which includes $3.2 million of the $3.8 million one-time costs described earlier as compared to $2.6 million and $7.0 million in the same period in 2021.
•Net loss was $33.5 million and $102.3 million for the three and nine months ended September 30, 2022, or a net loss per share of $1.18 and $3.64, compared to a net loss of $6.7 million and $25.3 million for the three and nine months ended September 30, 2021, or a net loss per share of $0.24 and $0.92.

On November 8, 2022 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported operating results for the three months ended September 30, 2022 (Press release, Quanterix, NOV 8, 2022, View Source [SID1234623407]).

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Financial Highlights

Revenue of $26.6M for Q3 2022 was flat versus Q3 2021 with the prior year NIH RADx funding excluded, and increased 13% over Q2 2022.
Pro-forma gross margin of 35% for Q3 2022 was up 670 bps over Q2 2022 and down 1470 bps from Q3 2021.
For additional information on the pro-forma financial measures included in this press release, please see "Use of Pro-Forma Financial Measures" and "Reconciliation of GAAP to Pro-Forma" below.

Business Highlights

The Bio-Hermes trial we are participating in is nearing completion. This is a prospective trial in partnership with the Global Alzheimer’s Platform Foundation. This prospective validation trial for pTau-181 will generate data in support of our regulatory filing for FDA clearance of the test, which would be the first of its kind in the market.
Quanterix received funding from Alzheimer’s Drug Discovery Foundation (ADDF) to accelerate Alzheimer’s disease diagnostic plasma test development. This is a collaboration with Amsterdam University Medical Centers (Amsterdam UMC) on four phases of clinical trials to validate Quanterix’s multi-analyte test. We are approximately 50% through Phase 1 and showing promising results for Alzheimer’s detection and differential diagnosis of memory complaints, generating four abstracts and one presentation to date.
Published discoveries enabled through Quanterix’s SimoaÒ technology continue to be strong. The technology was highlighted in a record 159 new publications in the third quarter 2022, bringing total Simoa-specific inclusions to over 2,000.
"Our third quarter results were in line with expectations set last quarter when we launched a significant assay quality remediation program," said Masoud Toloue, President and Chief Executive Officer of Quanterix. "We are pleased with the quarter-over-quarter financial and business progress with both revenue and gross margin growing, the program is on track and proceeding to plan. While demand remains robust, we are managing our volume to ensure we deliver quality products to our customers while we focus our efforts to improve the quality and long-term scalability of our product offerings. Our team’s conviction is resolute and the urgency high as our Simoa technology remains the foundation for unlocking new discoveries and innovations in both research and clinical applications, every day."

Quanterix’s third quarter revenue was flat compared to prior year excluding RADx, with consumable revenue declining as the Company balanced demand with assay quality and process improvement initiatives. This shortfall was offset by strong services revenue driven by the Company’s collaboration agreement with Eli Lilly and Company.

Quanterix’s third quarter pro-forma gross margin of 35% declined 1470 bps from 49.8% in the third quarter of 2021. The decline is due primarily to increased inventory reserves (800 bps), the change in allocation of expenses between operating expense and cost of goods sold (500 bps) previously announced in Q2 of this year and a slight revenue decline. Third quarter pro-forma margin increased 670 bps from the prior quarter driven by expense reductions and product mix shift, which offset increased inventory reserves.

Strategic Business Re-Alignment Progress

In August of 2022, the Company announced a comprehensive restructuring and business re-alignment plan in order to fully realize the potential of its Simoa platforms and continue its leadership role in ultrasensitive translational biomarker detection. As a result of the restructuring and the corresponding impact to Quanterix’s stock price, the Company has incurred the following restructuring and related charges in Q3:

Goodwill impairment—$8.2 million;
Impairment of long-lived assets—$8.7 million;
Restructuring expenses—$3.4 million (mainly related to employee costs); and
Other lease costs—$0.6 million.
In addition, the assay redevelopment program designed to improve its ability to manufacture and deliver high-quality assays at scale is on target and moving forward aligned to the plan announced last quarter.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 8, 2022 at 4:30 p.m. EST. Individuals interested in listening to the conference call may do so by pre-registering here and obtaining a dial-in number and passcode.

A live webcast will also be available at: View Source You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.