On November 6, 2023 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that Ryan Rhodes, Chief Executive Officer, is scheduled to deliver a presentation and host 1×1 investor meetings at the Jefferies London Healthcare Conference, which is being held November 14-16, 2023, in London (Press release, EDAP TMS, NOV 6, 2023, View Source [SID1234637064]).

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Presentation details:

Date: Tuesday, November 14
Time: 9:00 – 9:25 AM GMT
Webcast: Link

The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website here.

On November 6, 2023 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported financial results for the three months ended September 30, 2023 (Press release, Quanterix, NOV 6, 2023, View Source [SID1234637059]).

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Third Quarter Financial Highlights

● Revenue was $31.3 million, an 18% increase from $26.6 million for the corresponding prior year period.
● GAAP gross margin was 56.8% as compared to 41.1% for the corresponding prior year period. Non-GAAP gross margin was 48.6% as compared to 34.9% for the corresponding prior year period.
● Net loss was $7.8 million as compared to $35.1 million for the corresponding prior year period.
● Net cash use was approximately $1.9 million. Cash, cash equivalents, marketable securities, and restricted cash were $330.4 million as of September 30, 2023, as compared to $332.2 million as of June 30, 2023.
"We’re on track to achieve the six-quarter transformation plan we laid out by year end," said Masoud Toloue, President and Chief Executive Officer of Quanterix. "This will not only yield highly scaled production lines, but serve as the foundation for an accelerated innovation rate going into next year. Last month’s launch of our LucentAD p-Tau 217 blood-based test puts us in a leading position to address broad-based non-invasive patient testing for Alzheimer’s disease. We expect a faster release pace of pioneering, high sensitivity Simoa products going into 2024."

Operational and Business Highlights

● In October, the Company launched LucentAD p-Tau 217, a new blood-based biomarker laboratory developed test (LDT) using well-validated Johnson & Johnson Innovative Medicine (Janssen) antibodies to assist in the evaluation of patients suspected of having or developing Alzheimer’s disease. p-Tau 217 is the only blood-based biomarker recognized in the new draft NIA-AA Revised Criteria for Diagnosis and Staging of Alzheimer’s Disease capable of meeting a stringent 90% accuracy criterion necessary to diagnose Alzheimer’s.

● In data presented by Eli Lilly at the CTAD conference, the Simoa platform was used for analytical validation and initial clinical evaluation of Eli Lilly’s plasma p-Tau 217 immunoassay for a new blood-based diagnostic for Alzheimer’s disease. The study of over 1,000 patients from TRAILBLAZER-ALZ 2 demonstrated high positive and negative agreement to amyloid PET, with an AUC of 0.92 and the assay could prove to be a useful diagnostic test to identify the presence or absence of amyloid pathology.

Full Year Business Outlook

Management has increased full-year revenue expectations to be in the range of $118 to $120 million versus the prior range of $110 to $116 million. GAAP gross margin percentage is expected to be in the high 50’s, and non-GAAP gross margin percentage is expected to be approximately 50%. Both measures increased from prior guidance of low 50’s and high 40’s, respectively. The Company now anticipates 2023 cash usage in the range of $20 to $25 million, compared to prior guidance of $30 to $35 million.

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below.

Conference Call

In conjunction with this announcement, the Company will host a conference call on November 7, 2023 at 8:30 a.m. E.T. Click here to pre-register for the conference call and obtain your dial-in number and passcode.

Interested investors can also access the live webcast from the News & Events page within the Investors section of the Quanterix website at View Source An archived webcast replay will be available on the Company’s website for one year.

On November 6, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the third quarter ended September 30, 2023 (Press release, NanoString Technologies, NOV 6, 2023, View Source [SID1234637058]). The Company also announced it had reached agreement with holders to exchange approximately $216 million, or 94%, principal amount of its Convertible Notes for new Senior Secured Notes due September 1, 2026 and common stock warrants.

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"The last few months have been extraordinarily productive for our team. During the third quarter, we delivered record revenue while reducing our cash burn by nearly 50% sequentially," said Brad Gray, President and CEO of NanoString. "In the early weeks of Q4, we took critical steps to transform our financial profile through a reorganization that helps support our march to breakeven, and sets us up to achieve our goal of a first full year of profitability in 2025."

"We were pleased to complete the exchange transaction with the largest holders of our Convertible Notes, with these major investors showing their conviction in our business opportunity," said Thomas Bailey, Chief Financial Officer of NanoString. "The longer-dated notes provide the window needed for us to achieve profitability prior to maturity, which we believe will support improved terms and availability of any new financing that may be required. In addition to the maturity date extension, updated terms allow for payment-in-kind interest for the first year as we work to optimize our cash burn and profitability profile."

Third Quarter Financial Highlights

•Total revenue of $48.1 million
•Spatial biology revenue of $28.9 million
•nCounter revenue, inclusive of all service and other revenue, of $19.2 million
•Cash, cash equivalents and short-term investments balance of $97.1 million as of September 30, 2023
Spatial Biology
•Accelerated CosMx SMI shipments during Q3, resulting in Q3 spatial biology instrument revenue growth of 350% year-over-year
•Successfully defended sizeable CosMx instrument order book, fulfilling or retaining approximately 95% of cumulative orders as of September 30, 2023
•Recorded spatial biology consumables revenue growth of 70% year-over-year, and approximately $70,000 of annualized pull-through driven by a steady GeoMx consumables pull-through over a larger installed base supplemented by growing shipments of CosMx consumables
•Announced the launch of the GeoMx IO Proteome Atlas (IPA) assay, which enables spatial profiling of more than 500 immuno-oncology relevant protein targets from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue sections with commercial availability expected in Q4 2023
•Grew total spatial biology system installed base to approximately 510 systems, an increase of approximately 55% year-over-year
•Total peer-reviewed publications featuring our spatial biology platforms were approximately 340 as of September 30, 2023, representing an increase of approximately 180 publications in the last 12 months
nCounter
•Recorded nCounter revenue, inclusive of all service and other revenue, of $19.2 million and approximately $37,000 of annualized pull-through
•Total installed base of our nCounter platforms of approximately 1,140, an increase of approximately 3% year-over-year
•Total peer-reviewed publications featuring nCounter were approximately 7,315 as of September 30, 2023, representing an increase of approximately 1,215 publications in the last 12 months
Financial
•Completed exchange with holders of approximately $216 million principal amount of the Company’s Convertible Senior Notes due March 1, 2025 for new Senior Secured Notes, with key updated terms as follows:
◦Maturity extended to September 1, 2026
◦Interest rate of 6.95% per year, with interest payable quarterly
◦Interest payable in-kind in the form of additional notes in the first year, at the Company’s election
◦Issuance of warrants to purchase 16 million shares of common stock, with an exercise price of $1.69, replacing approximately 4.5 million shares of common stock potentially issuable under the old Convertible Senior Notes
◦Secured by substantially all of the assets of the Company
2023 Outlook
Management updated its financial outlook for 2023 with results now expected as follows:
•Total revenue of $175 to $180 million, as compared to the previous range of $175 to $185 million
◦Spatial biology revenue of $96 to $100 million, as compared to the previous range of $100 to $105 million
◦nCounter revenue, inclusive of all service and other revenue, of $79 to $80 million, as compared to the previous range of $75 to $80 million
•Adjusted EBITDA loss of approximately $80 to $85 million, as compared to the previous range of $65 to $75 million

Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the tables at the end of this press release.

On November 6, 2023 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that it has received agreement from the U.S. Food and Drug Administration (FDA) under an SPA for the design and planned analysis of CoMpass, the Company’s global Phase 3 clinical trial of bel-sar for the first-line treatment of adult patients with early-stage Choroidal Melanoma (CM) (Press release, Aura Biosciences, NOV 6, 2023, View Source [SID1234637054]). The Company also announced the presentation of positive Phase 2 safety and efficacy data of bel-sar with 90% of patients at twelve months of follow-up evaluating two key clinical endpoints: tumor control and visual acuity preservation using suprachoroidal (SC) route of administration for the first-line treatment of adult patients with early-stage CM. The results were presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, in San Francisco, California.

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"This written agreement from the FDA is consistent with our regulatory strategy and reaffirms that the design and planned analysis of the CoMpass Phase 3 Clinical Trial, if successful, adequately address the objectives necessary to support a biologics license application submission for bel-sar for the treatment of early-stage CM," said Dr. Jill Hopkins, Chief Medical Officer and President of R&D of Aura Biosciences. "We are excited with the momentum in the ocular oncology community to participate in what would be the first ever registration-enabling clinical trial for early-stage CM."

"The Phase 2 data presented today, with 90% of patients at twelve months follow-up, show results that are highly consistent with and strongly support the assumptions for the design of the CoMpass trial. We have observed 80% tumor control and 90% visual acuity preservation for patients that have been treated with the therapeutic regimen of bel-sar and meet the Phase 3 enrollment criteria. The safety profile continues to be favorable with no treatment-related Serious Adverse Events or significant Adverse Events. This is very encouraging as most of these patients had tumors close to the fovea or optic disk and would have likely experienced severe and irreversible vision loss with the current standard of care with radiotherapy," said Dr. Carol Shields, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University (USA). "We are excited for the possibility to have for the first time a vision preserving therapy, expanding the possibility to treat patients earlier than we do today."

The presentation can be accessed on the Company’s website here.

Agreement from the FDA Under an SPA for the Global Phase 3 CoMpass Trial:

The Company received written agreement from the FDA under an SPA for the design and planned analysis of the Global Phase 3 CoMpass trial indicating concurrence by the FDA with the adequacy of the study, if successful, to address the objectives necessary to support the Company’s planned biologics license application submission. The Phase 3 trial is designed as a superiority trial comparing bel-sar versus sham. The trial is a global, multi-center, masked study, and it is intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose regimen of bel-sar with SC administration, low dose regimen of bel-sar with SC administration, or a sham control. The primary endpoint is time to tumor progression, and the first key secondary endpoint is a composite time to event analysis that will compare the tumor control and visual acuity of the bel-sar high dose regimen to sham when the last patient completes their 15 months of follow up. The trial is powered at greater than 90%. The Company is on track to dose the first patient in Q4 2023.

Updated Safety and Efficacy Data from the Phase 2 Trial with SC Administration

The Phase 2 trial (NCT04417530) is assessing the safety and preliminary efficacy of single- and multiple ascending-doses of bel-sar up to three cycles of treatment via SC administration for the first-line treatment of early-stage CM. A total of 22 adult patients have been enrolled in the trial including the single dose Cohorts 1-3 (n=6) and multiple dose escalation Cohorts 4-6 (n=16). Cohorts 5 and 6 (n=13) received up to three cycles of therapy, which was considered the therapeutic regimen for evaluation. One patient in Cohort 5 (n=3) received two cycles of therapy and two patients in Cohort 5 received three cycles of therapy (40 µg/dose). All patients from Cohort 6 (n=10) were assigned to receive three cycles of therapy at the highest dose (80 µg/dose). One patient from Cohort 6, who discontinued after one cycle due to unrelated serious adverse events (SAEs), is not included in the analysis. All patients in Cohorts 5 and 6 had active tumor growth at study entry, as an enrichment strategy to evaluate preliminary efficacy. This group of patients with active growth treated at the therapeutic regimen of three cycles was evaluated for tumor control, visual acuity preservation and tumor growth rate as the defined clinical endpoints to evaluate preliminary efficacy. The results, with 90% of patients at twelve months of follow-up who received three cycles of therapy in Cohorts 5 and 6, and who match the criteria for the global Phase 3 trial, showed a tumor control rate of 80% (8/10) and the visual acuity preservation rate was 90% (9/10). The majority of patients being at high-risk for vision loss with tumors close to the fovea or optic disk. For the 80% of patients that responded, data showed a statistically significant reduction in tumor growth rate (-0.382 mm/yr, p = <0.0001) compared to each patient’s documented growth rate at study entry. The overall tolerability profile of bel-sar was favorable, with no dose-limiting toxicities, treatment-related SAEs or significant AEs reported as of August 3, 2023. There was no posterior inflammation and only mild anterior inflammation (Grade 1) in ~18% of the patients which was self-limited or resolved with a short course of topical steroids. Treatment-related AEs were predominantly mild and resolved without sequalae. We believe these updated results indicate that bel-sar may offer a targeted, vision preserving therapy for the first-line treatment of primary CM, where 80% of patients are diagnosed at an early stage and have no approved therapies to date.

Preliminary Data from Phase 1 Trial in Bladder Cancer

The trial has completed enrollment of the cohort that received bel-sar injection without light activation. Protocol mandated safety review found no safety issues and the study has proceeded to the bel-sar injection plus light activation cohorts. Preliminary data from the first patient in the light activated cohort of the trial, utilizing a single dose of bel-sar with light activation, demonstrated a clinical complete response demonstrated by absence of cancer cells on histopathology with evidence of extensive necrosis and immune activation.

Bel-sar is a novel investigational agent designed with a dual mechanism of action that includes targeted cytotoxicity and immune activation. The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 19 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The trial will provide histopathological evaluation after the local treatment to assess bel-sar’s biological activity. In addition, the FDA has allowed an amendment to the protocol of the Company’s ongoing Phase 1 trial evaluating bel-sar, allowing the inclusion of adult patients with muscle invasive bladder cancer in addition to non-muscle invasive bladder cancer. The Company expects to provide more data mid-2024.

On November 6, 2023 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the quarter ended September 30, 2023, and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, NOV 6, 2023, View Source [SID1234637049]).

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"We are executing on our fast-to-market strategy for our potentially first-in-class and best-in-class WEE1 inhibitor, azenosertib, while also laying the groundwork for the franchise opportunity we see for azenosertib across multiple tumor types," said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "Azenosertib continues to show very encouraging monotherapy anti-tumor activity, safety and tolerability in both ovarian cancer and uterine serous carcinoma. We are executing our clinical strategy to advance this high-potential asset to patients with ovarian cancer and uterine serous carcinoma as quickly as possible and expand into additional indications where WEE1 inhibition has the potential to improve outcomes for patients. By focusing our team and resources on the advancement of azenosertib, Zentalis is targeting the submission of the first NDA for azenosertib in a gynecologic malignancy in 2026."

"This quarter we are also executing on our succession plan for Chief Scientific Officer, which will see our Chief Translational Officer, Mark Lackner, succeed our co-founder, Kevin Bunker, at the end of the year" said Dr. Blackwell. "Kevin’s passion for discovering promising oncology drugs is a cornerstone of our culture and led to four of our product candidates advancing into the clinic, including azenosertib. I want to thank Kevin for his immense contributions to Zentalis and to the cancer patients we serve."

"Since joining Zentalis last year, Mark has put together a talented translational team and has spearheaded our biomarker enrichment strategies for azenosertib," continued Dr. Blackwell. "Mark’s appointment as Chief Scientific Officer sees our translational and discovery efforts brought under a single umbrella, which puts us in a strong position as we continue to advance azenosertib through the clinic while supporting robust preclinical drug discovery efforts."

Program Updates and Highlights

•Azenosertib monotherapy program. Today, the Company announced an updated analysis of the ongoing Phase 1 clinical trial of azenosertib as a monotherapy in solid tumors (ZN-c3-001), which continued to show anti-tumor activity with intermittent dosing. In the same population of 19 platinum resistant or refractory ovarian cancer and uterine serous carcinoma (USC) patients that were included in the data reported on June 6, 2023, the objective response rate (ORR) was 37%.

Median follow-up has increased by nearly 5 months and the median progression free survival (mPFS) has increased to 6.5 months. With additional safety-evaluable patients and follow-up since June, azenosertib continues to demonstrate a favorable safety and tolerability profile that is similar to or better than approved ovarian cancer products, supporting its continued advancement

•Azenosertib development strategy. Azenosertib is currently being evaluated in more than 10 ongoing and planned clinical trials as a monotherapy and in combinations with compelling scientific rationales across a broad array of tumor types. The Company is on track to submit its first New Drug Application (NDA) for azenosertib in a gynecologic malignancy in 2026. The Company has revised its strategy in platinum sensitive ovarian cancer (PSOC) and plans to evaluate azenosertib in PSOC in the first-line (1L) maintenance setting in the clinic. This strategy allows for the opportunity to benefit a larger segment of patients with ovarian cancer and fill a gap in the treatment paradigm since the standard of care in the 1L maintenance setting is evolving and fewer options are available. The Company plans to provide additional details on this trial in the second half of 2024, and anticipates initiating enrollment in 2025.

•Presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Ovarian Cancer. In October, the Company presented a poster presentation titled "Cyclin E1 Positive Staining Is Frequent and Independent of Prior Platinum Treatment in High Grade Serous Ovarian Cancer" at the AACR (Free AACR Whitepaper) Special Conference: Ovarian Cancer in Boston. To review the data in more detail, click here.

•ZN-d5 + azenosertib in relapsed or refractory acute myeloid leukemia (R/R AML). Zentalis is the only company known to have both a WEE1 inhibitor, azenosertib, and a BCL-2 inhibitor, ZN-d5, in clinical development. The Company is evaluating the combination of these promising product candidates in a Phase 1/2 trial in heavily pretreated patients with R/R AML based on strong preclinical data demonstrating highly synergistic anti-leukemia activity of this combination. The Company updated guidance for sharing initial data from this trial to the second half of 2024.

•ZN-d5 in relapsed or refractory light chain amyloidosis (R/R AL amyloidosis). Dose escalation is complete in the Phase 1 trial of ZN-d5 as a monotherapy in R/R AL amyloidosis. A preliminary efficacy signal was observed in patients with R/R AL amyloidosis with a hematologic response rate of 40% in patients treated with at least 400 mg daily of ZN-d5. ZN-d5 was well tolerated with few treatment-related adverse events. The proposed monotherapy dose has been identified as 800 mg daily. The Company does not plan to develop ZN-d5 further for this indication in order to focus its resources on the azenosertib franchise opportunity, including the azenosertib + ZN-d5 combination.

Corporate Highlight

•Today, the Company announced that Mark Lackner, Ph.D., Chief Translational Officer, Head of Biomarker Strategy, will succeed co-founder, Kevin Bunker, Ph.D., as Chief Scientific Officer at the end of the year. Dr. Bunker will continue his service to the Company as an advisor following the transition. Dr. Lackner joined Zentalis in October 2022. Prior to Zentalis, Dr. Lackner served as Senior Vice President, Head of Biology and Translational Sciences at IDEAYA Biosciences, where he successfully led biology efforts contributing to three small molecule development candidates and established a strong translational team that led to the discovery of a novel combination biomarker strategy. Previously, Dr. Lackner worked at Genentech for over a decade, holding multiple roles of increasing responsibility that culminated in serving as the Head of Genentech Oncology Early Stage Biomarker Group. During this tenure, he led multiple

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research teams in developing and incorporating predictive biomarker strategies across all phases of clinical trials and managed a diverse biomarker portfolio spanning targeted therapies, immuno-oncology agents and antibody drug conjugates.

Anticipated Upcoming Milestones

•1H 2024
◦Final results of Phase 1 azenosertib + chemotherapy (gemcitabine) trial in osteosarcoma (ZN-c3-003)
•2H 2024
◦Final results of Phase 1b azenosertib monotherapy trial in solid tumors (ZN-c3-001)
◦Topline data from Phase 1/2 azenosertib + PARP inhibitor (niraparib) and azenosertib monotherapy trial in platinum resistant ovarian cancer in partnership with GSK (MAMMOTH, ZN-c3-006)
◦Initial data from Phase 1 azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer (ZN-c3-016)
◦Initial data from Phase 1 of azenosertib + ZN-d5 trial in R/R AML (ZN-d5-004C)
◦Additional details on planned clinical trial of azenosertib in PSOC in the 1L maintenance setting
•1H 2025
◦Topline data from Phase 2 azenosertib monotherapy trial in platinum resistant high-grade serous ovarian cancer (DENALI, ZN-c3-005)
•2H 2025
◦Topline data from Phase 2 azenosertib monotherapy trial in recurrent or persistent USC (TETON, ZN-c3-004)
•2025
◦Initiate clinical trial of azenosertib in PSOC in the 1L maintenance setting.
•2026
◦First NDA for azenosertib in a gynecologic malignancy

Third Quarter 2023 Financial Results

•Cash and Marketable Securities Position: As of September 30, 2023, Zentalis had cash, cash equivalents and marketable securities of $516.6 million. The Company believes that its existing cash, cash equivalents and marketable securities as of September 30, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements into 2026.

•Research and Development Expenses: Research and development (R&D) expenses for the quarter ended September 30, 2023 were $46.8 million, compared to $42.2 million for the quarter ended September 30, 2022. The increase of $4.6 million was primarily attributable to $3.2 million of costs shared with Zentera in the prior period, a $2.6 million increase related to personnel expenses, of which $1.4 million related to non-cash stock-based compensation expense, and $0.8 million related to consulting costs. These increases were partially offset by decreases of $1.3 million and $0.7 million in facility expenses and clinical expenses, respectively.

•General and Administrative Expenses: General and administrative (G&A) expenses for the quarter ended September 30, 2023 were $16.0 million, compared to $12.0 million during the quarter ended September 30, 2022. This increase of $4.0 million was primarily attributable to a $2.9 million increase in personnel expenses, of which $2.2 million related to non-cash stock-based compensation expense, and a $1.1 million increase related to facilities and outside services.

About Azenosertib
Azenosertib is a potentially first-in-class and best-in-class small molecule WEE1 inhibitor in development for the treatment of cancer. Inhibition of WEE1, a DNA damage response kinase, drives cancer cells into mitosis without being able to repair damaged DNA, resulting in cell death. Currently, there are no FDA-approved WEE1 inhibitors, and azenosertib has been designed for superior selectivity and pharmacokinetic properties. Azenosertib is being developed in therapeutic areas of high unmet need and is being evaluated as a monotherapy, in combination with chemotherapy, and in combination with molecularly targeted agents.