On November 12, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported third quarter financial results and operational highlights (Press release, Oncolytics Biotech, NOV 12, 2024, View Source [SID1234649454]).

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Wayne Pisano, Chair of Oncolytics’ Board of Directors and Interim CEO, stated, "With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep’s potential in HR+/HER2- metastatic breast cancer. After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep." Pisano continued, "We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort. Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I’ve never been more confident in the potential pelareorep can deliver to cancer patients in need."

Third Quarter Highlights

BRACELET-1 data exceeds expectations, providing clear evidence of pelareorep’s ability to improve outcomes in patients with advanced HR+/HER2- breast cancer (link to press release), demonstrating progression-free survival of 12.1 months for pelareorep + paclitaxel compared to 6.4 months for paclitaxel alone, yielding a benefit of 5.7 months. Additionally, 64% of patients treated with pelareorep + paclitaxel lived at least two years compared to only 33% of patients treated with paclitaxel alone. Overall survival could not be calculated as more than half of the pelareorep + paclitaxel patients were alive at the end of the study. Assuming the remaining patients survived only until their next planned follow-up visit, the median overall survival would have been 32.1 months, which compares favorably to the 18.2 months recorded for patients who received paclitaxel monotherapy.

Financial Highlights

As of September 30, 2024, the Company reported $19.6 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into 2025.
The net loss for the third quarter of 2024 was $9.5 million, compared to a net loss of $9.9 million for the third quarter of 2023. The basic and diluted loss per share was $0.12 in the third quarter of 2024, compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023.
Research and development expenses for the third quarter of 2024 were $6.8 million, compared to $5.8 million for the third quarter of 2023. The increase was primarily due to higher manufacturing expenses and clinical trial expenses.
General and administrative expenses for the third quarter of 2024 were $3.1 million, compared with $5.2 million for the third quarter of 2023. The decrease was primarily due to lower investor relations activities and transaction costs as part of our public offering in 2023.
Net cash used in operating activities for the nine months ended September 30, 2024 was $19.1 million, compared to $22.3 million for the nine months ended September 30, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.
Recent and Anticipated Milestones

H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA
H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer
H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer
Mid 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer
H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer

On November 12, 2024 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended September 30, 2024, and provided a business update (Press release, Bolt Biotherapeutics, NOV 12, 2024, View Source [SID1234648159]).

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"During the third quarter, we continued to make progress with our two proprietary programs, BDC-3042 and BDC-4182," said Willie Quinn, Chief Executive Officer. "We have now completed the sixth dose level in the first-in-human clinical trial of BDC-3042, have opened the final cohort which will study a dose level of 10 mg/kg, and expect to provide a data update in the first half of 2025. We are particularly excited about our next-generation ISAC BDC-4182, which builds on the lessons we learned from our clinical experience with BDC-1001. We believe that BDC-4182’s dramatic increase in potency and activity will potentially enable the treatment of patients whose tumors have lower claudin 18.2 expression and may provide even better anti-tumor activity than conventional ADCs. We presented some of the data that underlies this excitement at SITC (Free SITC Whitepaper), and the team is hard at work preparing for a clinical trial initiation of BDC-4182 in the second quarter next year."

Recent Highlights and Anticipated Milestones

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Presented updated clinical activity of BDC-4182 at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). BDC-4182 is a next-generation BoltbodyTMISAC clinical candidate targeting claudin 18.2, a novel, clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models, with clinical trial initiation expected in 2025. BDC-4182 was well tolerated in non-human primates at the highest dose tested (12mg/kg) with an acceptable safety profile. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs in syngeneic models and BDC-4182’s favorable toxicology profile enables a variety of potential future combinations.

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Presented key learnings from Phase 1 dose-escalation trial of BDC-1001 at SITC (Free SITC Whitepaper). First-generation ISAC BDC-1001 demonstrated immunological activity in this first-in-human trial, particularly in patients with high HER2 antigen expression. Greater immune activation appeared to be associated with clinical benefit. Pharmacodynamic changes were observed in patients whose tumors had higher levels of HER2 and were statistically significant in patients with HER2 IHC 3+ tumors. Data supports the hypothesis that an ISAC with enhanced immune activation could offer greater efficacy, warranting further testing in next-generation ISACs.
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Advanced to cohort 7 (10 mg/kg) in the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer (NSCLC), ovarian cancer, or melanoma.
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Collaborations with Genmab and Toray continue to progress. The Company continues to work with its collaborators to discover and develop ISACs for the treatment of cancer.
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Cash, cash equivalents, and marketable securities were $84.4 million as of September 30, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Third Quarter 2024 Financial Results

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Collaboration Revenue – Collaboration revenue was $1.1 million for the quarter ended September 30, 2024, compared to $2.5 million for the same quarter in 2023. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $13.8 million for the quarter ended September 30, 2024, compared to $15.0 million for the same quarter in 2023. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring partially offset by an increase in contract manufacturing expenses.

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General and Administrative (G&A) Expenses – G&A expenses were $3.8 million for the quarter ended September 30, 2024, compared to $5.8 million for the same quarter in 2023. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

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Loss from Operations – Loss from operations was $16.4 million for the quarter ended September 30, 2024, compared to $18.2 million for the same quarter in 2023.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On November 12, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, reported financial results for the third quarter ended September 30, 2024, and recent corporate highlights (Press release, In8bio, NOV 12, 2024, View Source [SID1234648175]).

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"This past quarter marked a critical moment for IN8bio. We streamlined our operations and refined our pipeline to focus our resources. This strategic realignment enhances our capacity to deliver on the potential of gamma-delta T cell therapies, which are increasingly gaining recognition for their significant contributions to immunity." said William Ho, CEO and co-founder of IN8bio. "INB-100 is our allogeneic therapy in development for the treatment of patients with leukemias. The FDA’s guidance received in a Type B meeting over the summer provides a clear path forward for a potential registrational trial. We’ve secured additional funding to advance INB-100 through the ongoing expansion cohort in the Phase 1 study that will provide additional data to further de-risk the program. With a leaner, more focused organization, we are advancing INB-100 and seeking opportunities to potentially partner assets in our pipeline."

Corporate Highlights and Recent Developments

IN8bio will present updated clinical trial results from INB-200 in a Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) in November 2024.
A poster presentation updating patient data from the INB-100 trial will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2024.
Secured net proceeds of $11.6 million from a private placement that is expected to provide cash runway into the first quarter of 2026.
Funding is expected to be used to continue to advance development of INB-100, future product candidates and for working capital and other general corporate purposes.
Focusing on continued enrollment in the Phase 1 expansion cohort of up to approximately 25 patients at the RP2D of INB-100, with plans to potentially add additional centers and include a parallel observational arm to provide control data.
Received FDA guidance in a Type B meeting, on the registrational path for INB-100 in AML, an allogeneic gamma-delta T cell therapy demonstrating early signs of activity in high-risk leukemia patients.
All AML patients treated with INB-100 have remained in CR as of August 31, 2024.
Older, high-risk leukemia patients receiving non-myeloablative, reduced intensity conditioning (RIC), have exceeded the expected one-year progression-free survival (PFS) rate of approximately 40-50% post-haploidentical transplantation.
These data continue to demonstrate the broad clinical potential of gamma-delta T cells for difficult-to-treat cancers and provides support for the advancement of these therapies into pivotal trials.
Significant dose-dependent in vivo expansion and long-term persistence of circulating gamma-delta T cells has been observed up to 365 days.
IN8bio implemented a plan to optimize resource allocation through pipeline prioritization and a strategic workforce reduction that was completed in the third quarter of 2024. IN8bio also suspended enrollment in its Phase 2 clinical trial of INB-400 for newly diagnosed glioblastoma (GBM) but will continue monitoring previously treated GBM patients in both the Phase 2 INB-400 and the Phase 1 INB-200 clinical trials to assess progression-free and overall survival. Updated data to be presented at future medical meetings.
Third Quarter 2024 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $3.3 million, compared to $3.8 million for the comparable prior year period. The decrease of $0.5 million was primarily due to a decrease of $0.6 million in personnel expenses, including salaries and stock-based compensation (SBC) as a result of our workforce reduction and a decrease of $0.1 million in facility-related and other expenses primarily due to decreases in R&D activities in connection with our pipeline prioritization, partially offset by an increase of $0.2 million in direct costs related to our clinical trials, primarily related to the INB-400 program. As part of the Company’s pipeline prioritization announced in September 2024, further clinical development on INB-400 has been suspended.

General and Administrative (G&A) expenses: G&A expenses were $2.7 million, compared to $3.4 million for the comparable prior year period. The decrease of $0.7 million was primarily due to a decrease in salaries and bonus expense in connection with our workforce reduction and cost savings related to directors’ and officers’ insurance premiums, partially offset by an increase in professional services.

Severance and related charges: Severance and related charges were $1.1 million for the three months ended September 30, 2024, compared to zero for the comparable prior year period. The increase of $1.1 million was due to one-time costs related to the September 2024 workforce reduction, including SBC expense of $0.8 million resulting from acceleration in full of outstanding unvested stock options at the separation date for the impacted employees, and $0.3 million related to severance payments.

Net loss: Net loss was $7.1 million, or $0.15 per basic and diluted common share, compared to a net loss of $7.2 million, or $0.23 per basic and diluted common share, for the comparable prior year period.

Cash position: As of September 30, 2024, the Company had cash of $4.0 million, compared to $10.2 million, as of June 30, 2024. Subsequently in October 2024 closed a Private Placement of $11.6 Million in net proceeds.

On November 12, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended September 30, 2024 (Press release, ORIC Pharmaceuticals, NOV 12, 2024, View Source [SID1234648203]).

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"We are encouraged by the growing evidence supporting the potential best-in-class profiles of ORIC-114 and ORIC-944, and we continue to steadily advance both programs towards the initiation of registrational studies next year," said Jacob M. Chacko, M.D., president and chief executive officer. "Preclinical data presented at the ENA conference highlighted ORIC-114’s potential for superior potency and selectivity in targeting EGFR exon 20 insertions and other atypical mutations, building on previously reported clinical data in NSCLC patients. For ORIC-944, the clinical trial collaboration and supply agreements we secured with Bayer and Johnson and Johnson have helped us further advance our combination studies in prostate cancer. We remain laser-focused on execution across our clinical and preclinical pipeline and look forward to reporting updated data in 2025."

Third Quarter 2024 and Other Recent Highlights:

ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

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Presented preclinical data demonstrating potential best-in-class properties, including potency and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics.
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Expect to report updated Phase 1b data in the first half of 2025.

ORIC-944: a potent and selective allosteric inhibitor of PRC2

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Initiated dosing of ORIC-944 in combination with NUBEQA (darolutamide) and in combination with ERLEADA (apalutamide) in the ongoing Phase 1b trial for prostate cancer in first half of 2024.
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Entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson to support the ongoing Phase 1b trial of ORIC-944 in combinations with AR inhibitors for the treatment of prostate cancer.

Corporate Highlights:

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Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs.

Third Quarter 2024 Financial Results

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Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $282.4 million as of September 30, 2024, which the company expects will be sufficient to fund its operating plan into late 2026.

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R&D Expenses: Research and development (R&D) expenses were $31.2 million for the three months ended September 30, 2024, compared to $22.4 million for the three months ended September 30, 2023, an increase of $8.8 million. For the nine months ended September 30, 2024, R&D expenses were $82.1 million, compared to $60.7 million for the nine months ended September 30, 2023, an increase of $21.4 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs, including additional non-cash-stock-based compensation.

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G&A Expenses: General and administrative (G&A) expenses were $7.1 million for the three months ended September 30, 2024, compared to $6.3 million for the three months ended September 30, 2023, an increase of $0.8 million. For the nine months ended September 30, 2024, G&A expenses were $21.2 million, compared to $18.7 million for the nine months ended September 30, 2023, an increase of $2.6 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation.

On November 12, 2024 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, reported financial results for the third quarter ended September 30, 2024, and provided corporate updates (Press release, Terns Pharmaceuticals, NOV 12, 2024, View Source [SID1234648218]).

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"Our progress in the third quarter was highlighted by the compelling topline results from our Phase 1 study of TERN-601, which demonstrated class-leading potential as a differentiated, once-daily, oral GLP-1R agonist for the treatment of obesity and supports its rapid advancement into Phase 2 studies," stated Amy Burroughs, chief executive officer of Terns. "We are looking forward to sharing interim dose escalation data from the Phase 1 CARDINAL trial of TERN-701 as a treatment for chronic myeloid leukemia (CML) and expect this early look at safety, tolerability and signals of efficacy to reinforce its potential as a best-in-class allosteric for the treatment of CML. Importantly, our successful equity raise underscores the strong support for our promising pipeline of differentiated small molecules, funds Terns through multiple catalysts across our clinical development programs and extends our cash runway into 2028."

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

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Interim data from initial dose escalation cohorts in Terns’ ongoing Phase 1 CARDINAL study of TERN-701 in CML expected in early December 2024
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CARDINAL is a global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, pharmacokinetics (PK) and efficacy of TERN-701 in patients with previously treated CML
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The Company expects to share interim dose escalation data from the CARDINAL study, including safety, tolerability and early signals of efficacy
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In August, Terns hosted a TERN-701 webinar event focused on interpreting early datasets in CML

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

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Terns plans to initiate a Phase 2 clinical trial in early second quarter of 2025 with initial 12-week data expected in the second half of 2025
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The trial will begin with a 12-week portion to optimize dose titration and inform subsequent cohorts
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In September, Terns announced positive safety and 28-day weight loss data from the Phase 1 first-in-human clinical trial of TERN-601 in obese and overweight participants
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The results showed TERN-601 was well tolerated and demonstrated dose-dependent, statistically significant mean weight loss up to 5.5% (4.9% placebo adjusted) over 28 days
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67% of study participants lost 5% or more of their baseline body weight at the highest dose of 740 mg once-daily (QD)
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TERN-601 exhibited distinct properties for an oral GLP-1R agonist

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Low solubility and high gut permeability allowed for prolonged absorption and sustained target coverage and a flat PK curve, while high drug levels in the gut wall may lead to robust GLP-1R activation in the gut triggering satiety centers in the brain
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Low free fraction in circulation, combined with the flat PK curve, may contribute to TERN-601’s tolerability profile at higher target doses than other oral GLP-1R agonists
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TERN-601 was well-tolerated with no treatment-related dose interruptions, reductions, or discontinuations even with rapid dose titration
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

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In June, Terns presented new preclinical data at the American Diabetes Association (ADA) 84th Scientific Sessions supporting TERN-501 in combination with a GLP-1 receptor agonist for obesity
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Preclinical findings demonstrated TERN-501 in combination with semaglutide significantly enhanced weight loss and showed proportionally greater loss of fat mass relative to lean mass compared to semaglutide alone
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Supports the potential for TERN-501 as a combination partner for injectable and oral GLP-1 agonists for use in obesity and other metabolic disorders
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The full poster is available on Terns’ scientific publications website
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Terns continues to evaluate opportunities for TERN-501 in metabolic diseases
TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist

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Discovery efforts are ongoing for small molecule GIPR modulators for obesity, which have the potential for combination with GLP-1 receptor agonists, such as TERN-601
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Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity
Corporate Updates

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In September, Terns completed an upsized public offering of 14,064,048 shares of its common stock and 2,380,952 pre-funded warrants, generating gross proceeds of approximately $172.7 million before deducting underwriting discounts and commissions and other offering expenses, which extends the Company’s cash runway into 2028
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In July, Terns appointed Elona Kogan as Chief Legal Officer

Third Quarter 2024 Financial Results

Cash Position: As of September 30, 2024, cash, cash equivalents and marketable securities were $372.8 million, as compared with $263.4 million as of December 31, 2023. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $15.2 million for the quarter ended September 30, 2024, as compared with $14.8 million for the quarter ended September 30, 2023.

General and Administrative (G&A) Expenses: G&A expenses were $9.8 million for the quarter ended September 30, 2024, as compared with $18.4 million for the quarter ended September 30, 2023.

Net Loss: Net loss was $21.9 million for the quarter ended September 30, 2024, as compared with $29.8 million for the quarter ended September 30, 2023.