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.

On November 8., 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its financial results for the third quarter ended September 30, 2022 and highlighted recent corporate progress (Press release, CohBar, NOV 8, 2022, View Source [SID1234623406]).

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"I’m pleased with the team’s performance during the third quarter of 2022 in advancing our top priorities, including improving the formulation of CB5138-3, our product candidate for IPF," stated Dr. Joseph Sarret, Chief Executive Officer. "We continue to operate the company in a prudent financial manner, and we completed a reverse stock split, which was a necessary step to regain compliance with Nasdaq and enable potential access to institutional capital. Looking ahead, we are prioritizing activities that will support the planned clinical development of our IPF program and we look forward to communicating additional progress in the near future."

Recent Updates and Third Quarter 2022 Highlights

Formulation Work for CB5138-3 Ongoing: The company continues to advance CB5138-3, its lead program for IPF, through IND-enabling studies and formulation activities. In the second half of 2023, CohBar plans to submit an Investigational New Drug Application (IND) for CB5138-3 to the U.S. Food and Drug Administration pending a suitable formulation.

Strengthened Board with Appointment of Effie Tozzo, Ph.D: CohBar announced the appointment of Dr. Effie Tozzo as an independent director to the company’s board of directors. Dr. Tozzo brings 26 years of research and development expertise at both established pharmaceutical and innovative biotechnology companies, including extensive experience in mitochondria research.

Executed Reverse Stock Split: CohBar implemented a 1-for-30 reverse stock split effective on September 23, 2022. The company utilized this corporate action to regain compliance with Nasdaq’s $1.00 minimum bid price requirement. The company has since received a letter from Nasdaq confirming that it has achieved compliance with the listing requirements.
Third Quarter 2022 Financial Highlights

Cash, Cash Equivalents and Investments: The company had cash, cash equivalents and investments of $18.3 million as of September 30, 2022, compared to $26.2 million as of December 31, 2021. The cash burn for the quarter ended September 30, 2022 was approximately $1.9 million.

R&D Expenses: Research and development expenses were $1.0 million for the three months ended September 30, 2022, compared to $1.6 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower program costs due to the timing of those expenses.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended September 30, 2022, compared to $1.8 million in the prior year quarter. The decrease in general and administrative expenses was due to lower stock-based compensation costs.

Net Loss: For the three months ended September 30, 2022, net loss, which included $0.4 million of non-cash expenses, was $2.4 million, or $0.82 per basic and diluted share on a post-split basis. For the three months ended September 30, 2021, net loss, which included $0.7 million of non-cash expenses, was $3.4 million, or $1.61 per basic and diluted share on a post-split basis.
Details for the Conference Call:

A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 8, 2022, through 11:59 p.m. Eastern Time on November 29, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 10171343. The audio recording will also be available at www.cohbar.com during the same period.