On November 6, 2024 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the third quarter of 2024. For the quarter, revenue was $1.01 billion, a decrease of 1.6% from $1.03 billion in the third quarter of 2023 (Press release, Charles River Laboratories, NOV 6, 2024, View Source [SID1234647807]).

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The impact of foreign currency translation benefited reported revenue by 0.4%, and an acquisition contributed 0.9% to consolidated third-quarter revenue. A divestiture of a small Safety Assessment site reduced reported revenue by 0.2%. Excluding the effect of these items, revenue declined 2.7% on an organic basis. On a segment basis, organic revenue growth in the Manufacturing Solutions (Manufacturing) and Research Models and Services (RMS) segments were more than offset by lower revenue in the Discovery and Safety Assessment (DSA) segment.
In the third quarter of 2024, the GAAP operating margin decreased to 11.6% from 14.8% in the third quarter of 2023. This GAAP decrease was primarily driven by costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, the operating margin improved in all three segments; however, the improvements were more than offset by higher unallocated corporate costs, which resulted in the third-quarter operating margin decreasing to 19.9% from 20.5%.

On a GAAP basis, third-quarter net income attributable to common shareholders was $68.7 million, a decrease of 21.4% from $87.4 million for the same period in 2023. Third-quarter diluted earnings per share on a GAAP basis were $1.33, a decrease of 21.3% from $1.69 for the third quarter of 2023. The GAAP net income and earnings per share decreases were driven primarily by lower revenue and operating income, which included higher costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, net income was $133.7 million for the third quarter of 2024, a decrease of 4.8% from $140.5 million for the same period in 2023. Third-quarter diluted earnings per share on a non-GAAP basis were $2.59, a decrease of 4.8% from $2.72 per share for the third quarter of 2023. The decreases in non-GAAP net income and earnings per share were driven primarily by lower revenue and operating income.

James C. Foster, Chair, President and Chief Executive Officer, said, "Forward-looking demand indicators were relatively stable in the third quarter, contributing to third-quarter financial performance which exceeded our prior outlook. We are continuing to navigate through a challenging period as global biopharmaceutical clients reduce spending in conjunction with major restructuring and pipeline reprioritization activities, but overall demand trends do not appear to have deteriorated further. In addition, biotech funding has improved in 2024, and demand appears to be demonstrating early signs of stabilization. These factors resulted in a slight, sequential improvement in net book-to-bill and the cancellation rate in the Safety Assessment business."

"We remain laser focused during this period on our strategy, which includes aggressively managing our cost structure, enhancing our clients’ experiences to gain additional share, and protecting shareholder value. We will continue to distinguish ourselves through our exceptional science and preclinical focus, in order to extend our leading position as our clients’ preferred, global, non-clinical drug development partner. We expect to emerge from this period as a stronger, leaner, and more profitable company, and an even more responsive partner for our clients," Mr. Foster concluded.
Third-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $197.8 million in the third quarter of 2024, an increase of 5.9% from $186.8 million in the third quarter of 2023. The Noveprim acquisition in November 2023 contributed 4.9% to third-quarter RMS reported revenue, and the impact of foreign currency translation increased revenue by 0.4%. Organic revenue increased by 0.6%, due primarily to higher sales of small research models in all geographic regions, principally driven by higher pricing. This was largely offset by a revenue decline for research model services, particularly in the Insourcing Solutions business.

In the third quarter of 2024, the RMS segment’s GAAP operating margin decreased to 13.9% from 15.2% in the third quarter of 2023. The GAAP operating margin decline was driven primarily by higher amortization expense related to the Noveprim acquisition coupled with higher costs associated with the Company’s restructuring initiatives, including severance and site consolidation costs. On a non-GAAP basis, the operating margin increased to 21.0% from 18.9%. The non-GAAP operating margin increase was primarily driven by higher pricing for small research models, a favorable revenue mix related to the Noveprim acquisition, and the benefit of cost savings associated with the Company’s restructuring initiatives.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $615.1 million in the third quarter of 2024, a decrease of 7.4% from $664.0 million in the third quarter of 2023. The divestiture of a small Safety Assessment site reduced reported revenue by 0.3% and the impact of foreign currency translation increased DSA revenue by 0.3%. Organic revenue decreased by 7.4%, driven primarily by lower sales volume in both the Discovery Services and Safety Assessment businesses.

In the third quarter of 2024, the DSA segment’s GAAP operating margin decreased to 20.6% from 22.1% in the third quarter of 2023 primarily driven by lower revenue and higher severance costs related to restructuring initiatives. On a non-GAAP basis, the operating margin increased to 27.4% from 27.2% in the third quarter of 2023. The non-GAAP operating margin increase was primarily driven by the benefit of cost savings associated with restructuring initiatives.
Manufacturing Solutions (Manufacturing)
Revenue for the Manufacturing segment was $196.9 million in the third quarter of 2024, an increase of 12.0% from $175.7 million in the third quarter of 2023. The impact of foreign currency translation increased Manufacturing revenue by 0.2%. Organic revenue growth of 11.8% reflected higher revenue across each of the segment’s businesses.
In the third quarter of 2024, the Manufacturing segment’s GAAP operating margin increased to 20.4% from 15.0% in the third quarter of 2023, and on a non-GAAP basis, the operating margin increased to 28.7%, from 24.5% in the third quarter of 2023. The GAAP and non-GAAP operating margin increases were driven primarily by improved operating leverage from higher revenue in each of segment’s businesses, as well as the benefit of cost savings associated with restructuring initiatives.
Stock Repurchase Update
On August 2, 2024, the Company’s Board of Directors approved a new stock repurchase authorization of $1.0 billion. Following the new authorization, the Company repurchased 500,000 shares during the third quarter of 2024 for a total of $100.7 million. As of September 28, 2024, the Company has $899.3 million remaining on its $1.0 billion stock repurchase authorization.
Updates 2024 Guidance
The Company is updating its financial guidance for 2024, which was previously revised on August 7, 2024. Revenue and non-GAAP earnings per share guidance have been narrowed and slightly raised from the midpoint of the previous ranges to principally reflect the third-quarter financial performance, which exceeded the Company’s prior outlook. In addition, GAAP earnings per share guidance has been reduced due primarily to increased charges related to the Company’s additional restructuring actions.

On November 6, 2024 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the third quarter ended September 30, 2024 and provided a corporate update (Press release, Celldex Therapeutics, NOV 6, 2024, View Source [SID1234647805]).

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"Celldex recently presented best-in-disease data across both our Phase 2 studies of barzolvolimab in CSU and CIndU," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "The data demonstrated barzolvolimab’s unique potential to provide a rapid, durable treatment option and complete disease control for patients suffering from these severe, debilitating diseases. These are transformative results for patients with CSU, many whom do not see meaningful benefit from the current standard of care, and CIndU, where there are currently no approved therapies other than antihistamines. We continue to make strong progress across our entire pipeline, with enrollment ongoing in global Phase 3 CSU trials and our Phase 2 PN and EOE studies. As we look to the end of this year, we remain excited for our Phase 2 study in AD to initiate and our first bispecific for inflammatory diseases, CDX-622, to enter the clinic."

Recent Program Highlights

Barzolvolimab – KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

Chronic Urticarias

Phase 3 Development

A global Phase 3 program in chronic spontaneous urticaria (CSU) was initiated in July, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics. The studies will enroll approximately 915 patients each across 40 countries and 500 sites and are actively enrolling patients.
The Company is currently planning a global Phase 3 program in chronic inducible urticaria (CIndU), which is expected to initiate in 2025.
Phase 2 Development

Barzolvolimab met all primary and secondary endpoints at 12 weeks across the Company’s Phase 2 studies in CSU and CIndU. Results were highly statistically significant and clinically meaningful. Patients continue to be followed on both studies.

52 week long term follow up data from the Phase 2 study in CSU (n=208) were presented in a late breaking oral presentation at the EADV Congress 2024 in September. A deepening of response was observed over the 52 week treatment period and barzolvolimab demonstrated the highest rate of complete response observed in a well controlled study in CSU with 71% of patients (150 mg Q4W) achieving a complete response at Week 52. Importantly, barzolvolimab was also well tolerated through 52 weeks.

12 week primary endpoint data from the Phase 2 study in CIndU (n=196) were presented in a late breaking oral presentation at ACAAI 2024 in October. Barzolvolimab is the first drug to demonstrate clinical benefit in patients with cold urticaria (ColdU) in a large, randomized, placebo-controlled study. Per provocation test, up to 53.1% of patients with ColdU and 57.6% of patients with symptomatic dermographism (SD) treated with barzolvolimab experienced a complete response compared to placebo rates of only 12.5% (p=0.0011) in ColdU and 3.2% (p<0.0001) in SD—the primary endpoint of the study. Secondary and exploratory endpoints were highly supportive of the primary endpoint. Patients on study continued to receive barzolvolimab or placebo for up 20 weeks and are being followed for an additional 24 weeks. The study also includes an Open Label Extension that allows patients with symptoms during the follow-up phase (including patients who were on placebo) to receive active study drug.
Additional Indications

A Phase 2 study in eosinophilic esophagitis (EoE) was initiated in July 2023 and enrollment is ongoing. This randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety profile of barzolvolimab in approximately 75 patients with active EoE. Data from this study is expected in the second half of 2025.
A Phase 2 study in prurigo nodularis (PN) was initiated in early 2024 and enrollment is ongoing. This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in approximately 120 patients with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications are medically inadvisable, including patients who received prior biologics.
In May 2024, Celldex announced that atopic dermatitis (AD) has been selected as the fifth indication for the development of barzolvolimab. Barzolvolimab’s novel mast cell depleting mechanism could play an important role in addressing patients with moderate to severe AD who do not achieve complete disease control on currently available systemic therapies. Celldex plans to initiate a Phase 2 study in AD by year end.
Bispecific Antibody Platform

CDX-622 – Bispecific SCF & TSLP

CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders.

Celldex has completed preclinical, manufacturing and IND-enabling activities for CDX-622 and plans to initiate a Phase 1 study in healthy volunteers by the end of 2024. In preclinical studies, CDX-622 inhibits TSLP and SCF with similar potency to both its respective parental mAbs and comparator mAbs in vitro. CDX-622 was well tolerated in a multi-dose 8 week toxicology study in non-human primates and the No Adverse Event Level (NOAEL) was established to be 75 mg/kg, the highest dose level tested. In inflammatory and fibrotic disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells drive or contribute to the pathophysiology of many of these disorders and CDX-622 contains a unique SCF neutralizing function that is expected to inhibit and deplete mast cells.
CDX-585 – Bispecific ILT4 & PD-1

The dose-escalation portion of this open-label, multi-center Phase 1 study of CDX-585 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy has been completed. We are prioritizing our expanding clinical development program in the inflammatory space and will not advance CDX-585.
Third Quarter 2024 Financial Highlights and 2024 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2024 were $756.0 million compared to $802.3 million as of June 30, 2024. The decrease was primarily driven by third quarter cash used in operating activities of $55.3 million. From June 30, 2024 to September 30, 2024, prepaid and other current assets increased $13.9 million and other assets increased $9.6 million as a result of non-recurring advance payments related to our Phase 3 studies in CSU and late-stage barzolvolimab commercial manufacturing batches. At September 30, 2024, Celldex had 66.3 million shares outstanding.

Revenues: Total revenue was $3.2 million in the third quarter of 2024 and $5.8 million for the nine months ended September 30, 2024, compared to $1.5 million and $2.8 million for the comparable periods in 2023. The increase in revenue was primarily due to an increase in services performed under our manufacturing and research and development agreements with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $45.3 million in the third quarter of 2024 and $116.6 million for the nine months ended September 30, 2024, compared to $34.5 million and $87.6 million for the comparable periods in 2023. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and personnel expenses, partially offset by a decrease in barzolvolimab contract manufacturing expenses.

G&A Expenses: General and administrative (G&A) expenses were $10.1 million in the third quarter of 2024 and $28.3 million for the nine months ended September 30, 2024, compared to $8.2 million and $22.1 million for the comparable periods in 2023. The increase in G&A expenses was primarily due to an increase in stock-based compensation and barzolvolimab commercial planning expenses.

Net Loss: Net loss was $42.1 million, or ($0.64) per share, for the third quarter of 2024, and $110.8 million, or ($1.74) per share, for the nine months ended September 30, 2024, compared to a net loss of $38.3 million, or ($0.81) per share, for the third quarter of 2023, and $98.1 million, or ($2.08) per share, for the nine months ended September 30, 2023.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2024 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.

On November 6, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported it will showcase its market-leading portfolio to advance cancer research from target discovery to personalized medicine and cell therapy development at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, taking place November 6-10, 2024, in Houston, Texas (Press release, Bio-Techne, NOV 6, 2024, View Source [SID1234647804]).

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Bio-Techne’s spatial biology brands, Advanced Cell Diagnostics (ACD) and Lunaphore, are revolutionizing spatial biology research with their pioneering innovations that are advancing the development of tailored immunotherapies to improve patient outcomes.

At booth #613, ACD will present its wide range of spatial multiomics products. These products leverage the precise RNAscope technology and an advanced protease-free workflow for same-section RNA and protein detection assays. In combination, these capabilities empower drug discovery research, accelerate cell and gene therapy workflows, enable the characterization of key soluble factors and the immune landscape, and support the development of improved diagnostic tools for an accelerated path from translational research to clinical applications.

At booth #701, Lunaphore will showcase its fully-automated, end-to-end COMET suite, designed to provide innovative solutions in spatial biology for the translational research community. The complete portfolio will be showcased through product demonstrations. Furthermore, attendees can test the HORIZON image analysis software, tailored for COMET hyperplex images, offering new features for intuitive multiomics data and neighborhood analysis.

"Bio-Techne’s spatial biology solutions lead the way in developing groundbreaking innovations, shaping the future of scientific discovery," said Dr. Matt McManus, President of Bio-Techne’s Diagnostics & Spatial Biology Segment. "Our mission is to empower scientists with cutting-edge technologies to accelerate research and develop the next-generation therapies. We are excited to feature our spatial portfolio at this prestigious conference."

Several scientists from the company and its partners will present posters at the conference highlighting how the industry-leading capabilities of Bio-Techne’s solutions enable key research and clinical applications.

Bio-Techne poster presentations:

Multiomic mapping of the brain: same-section, fully-automated spatial RNA and protein detection on mouse frozen tissues
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Alice Comberlato, Ph.D., Lunaphore, a Bio-Techne Brand
Poster number: #81

Novel fully-automated multiomics assay for profiling immune cell landscape and activation states
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Anushka Dikshit, Ph.D, Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #85

Qualification of immune checkpoint biomarker antibodies in glioblastoma with multiplex immunofluorescence
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Ruha Adelkar, Bio-Techne
Poster number: #69

High throughput spatial mulitomic assay for assessing immune cell phenotype and function in the tumor microenvironment
Saturday, November 9 at 12:15- 13:45 & 19:00 – 20:30
Presenter: Anushka Dikshit, Ph.D., Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #86

Fully automated, novel protease-free workflow for co-detection of protein-protein interaction, individual proteins and mRNA using RNAscope Multiomic LS assay
Saturday, November 9 at 12:15 -13:45 & 19:10 – 20:30
Presenters: Ge-Ah Kim, Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #106

A new automated RNAscopeTM assay for the fluorescent co-detection of multiple RNA and protein biomarkers on Roche DISCOVERY ULTRA
Saturday, November 9 at 12:15- 13:45 & 19:10 – 20:30
Presenters: Renzo Adilardi, Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #206

Poster presentations, in collaboration

Application of a novel multiplex imaging-based immunotherapy panel and AI-powered analysis solution for spatial biomarker identification on immunotherapy-treated melanoma patients [research conducted in collaboration with Prof. Paolo Ascierto, National Tumor Institute Fondazione G. Pascale and Nucleai]
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Ettai Markovits, Ph.D., Nucleai
Poster number: #117

Enhanced analysis of tumor microenvironment and immune regulation via an automated adjustable signal amplification technique for multiplex immunofluorescence [research conducted in collaboration with Prof. Janis Taube, Johns Hopkins University School of Medicine]
Saturday, November 9 at13:45 & 19:10 – 20:30
Presenter: François Rivest, Ph.D., Lunaphore, a Bio-Techne Brand
Poster number: #124

On November 6, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will participate in the Jefferies London Healthcare Conference on November 20, 2024, with a fireside chat at 2:30 p.m. GMT (Press release, BeiGene, NOV 6, 2024, View Source [SID1234647803]).

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The live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source An archived replay will be available for 90 days following the event.

On November 6, 2024 Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, reported an overview of business updates and announced financial results for the third quarter of 2024 (Press release, Barinthus Biotherapeutics, NOV 6, 2024, View Source [SID1234647802]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We continue our strong execution on our clinical trials, completing enrollment in the HBV003 trial of VTP-300 in chronic hepatitis B, and advancing VTP-1000 in celiac disease into the clinic with the first in human study of the novel SNAP-TI platform," said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio. "We expect a data rich fourth quarter from the VTP-300 chronic hepatitis B program, with updated interim readouts from both the HBV003 and IM-PROVE II trials accepted as late-breaking abstracts at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2024. These updates will provide more mature data than previously disclosed as participants progress and move towards a potential functional cure."

Third Quarter 2024 and Recent Corporate Developments

VTP-300 (Chronic hepatitis B)
In September 2024, enrollment was completed in the HBV003 trial of VTP-300 in 121 adult participants with chronic hepatitis B. The Phase 2b trial is designed to obtain critical dosing information for a potential functional cure regimen for chronic hepatitis B, with participants receiving VTP-300 and low-dose (LD) nivolumab.
Earlier this year, interim data from the HBV003 trial was presented at the European Association for the Study of the Liver (EASL) Congress and demonstrated that treatment with VTP-300 and LD nivolumab was generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Seventy-six percent of participants (n=16/21) assessed for nucleos(t)ide analogue (NUC) therapy discontinuation met the criteria. Sixty-seven percent of participants (n=14/21) assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later. Nineteen percent of the eligible participants (n=4/21) reached undetectable levels of HBsAg, with 2 of these patients maintaining undetectable levels for over 16 weeks.

VTP-1000 (Celiac Disease)
In September 2024, we initiated the first-in-human Phase 1 AVALON trial of VTP-1000 in adults with celiac disease. The randomized, placebo-controlled clinical trial, which includes a controlled gluten challenge, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.

VTP-850 (Prostate Cancer)
In October 2024, we announced that the PCA001 trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence) had completed patient enrollment of 22 participants. The Phase 1 trial is designed to evaluate safety and efficacy, as measured by PSA and T cell response. We expect to have data from the Phase 1 trial in the first half of 2025.

Financial Update
In October 2024, we were informed that an additional $15.0 million of revenue was due to the Company from Oxford University Innovation (OUI) in relation to the Company’s share of royalties received by OUI, as a result of prior commercial sales of Vaxzevria by AstraZeneca. We expect that this additional cash, when received, will enable us to fund our research and development plans further into the second quarter of 2026.

Upcoming Milestones
VTP-300 (Chronic hepatitis B)
In the fourth quarter of 2024, we expect to announce updated data from the VTP-300 program in ongoing clinical trials in chronic hepatitis B at AASLD – The Liver Meeting 2024 scheduled from November 15-19, 2024 in San Diego, CA:
•Updated interim data from HBV003, the Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, accepted as a late-breaking oral presentation.
•Updated interim data from the Phase 2a IM-PROVE II clinical trial evaluating the combination of VTP-300 and Arbutus Biopharma’s imdusiran, accepted as a late-breaking poster.

VTP-1000 (Celiac Disease)
In the first half of 2025, we expect to announce data from the single ascending dose part of the Phase 1 AVALON trial of VTP-1000 in adults with celiac disease.

VTP-850 (Prostate Cancer)

In the first half of 2025, we expect to announce results of the Phase 1 PCA001 trial of VTP-850 in men with rising PSA after definitive local therapy for prostate cancer (i.e., biochemical recurrence).

Third Quarter 2024 Financial Highlights

•Cash position: As of September 30, 2024, cash, cash equivalents and restricted cash were $106.1 million, compared to $117.8 million as of June 30, 2024. The net cash used in operating activities was $18.2 million in the third quarter of 2024, primarily resulting from the development of our pipeline and ongoing clinical trials, offset by $6.2 million due to the effect of foreign exchange rates on cash balances. Based on our current operating plans, we expect our available resources to fund operating expenses and capital expenditure requirements into the second quarter of 2026.

•Revenue: Revenue consisted of $15.0 million in the third quarter of 2024 compared to nil in the second quarter of 2024. Revenue was comprised of the Company’s share of royalties received by OUI as a result of prior commercial sales of Vaxzevria by AstraZeneca.There is no expectation of additional payments or that we will be notified of such payments in a timely manner.
•Research and development expenses: Research and development expenses were $11.1 million in the third quarter of 2024 compared to $11.7 million in the second quarter of 2024, with the decrease mainly attributable to a reduction in personnel-related costs as a result of the pipeline prioritization earlier in the year. The quarter-on-quarter R&D expense per program is outlined in the following table.

Period ended Three months ended September 30, 2024
Three months ended June 30, 2024
Change
$000 $000 $000
Direct research and development expenses by program:
VTP-200 HPV $ 246 $ 383 $ (137)
VTP-300 HBV 2,748 3,034 (286)
VTP-500 MERS1
40 304 (264)
VTP-600 NSCLC/ESCC2
108 24 84
VTP-850 Prostate cancer 914 414 500
VTP-1000 Celiac
1,751 1,371 380
Other and earlier stage programs 707 908 (201)
Total direct research and development expenses $ 6,514 $ 6,438 $ 76
Indirect research and development expenses:
Personnel-related (including share-based compensation)3
3,871 4,763 (892)
Facility related 214 342 (128)
Other indirect costs 540 119 421
Total indirect research and development expenses 4,625 5,224 (599)
Total research and development expense $ 11,139 $ 11,662 $ (523)

1The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
2The VTP-600 NSCLC/Esophageal Squamous-Cell Carcinoma (ESCC) Phase 1/2a trial is sponsored by Cancer Research UK.
3This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
•General and administrative expenses: General and administrative expenses were $13.4 million in the third quarter of 2024, compared to $7.2 million in the second quarter of 2024. The increase of $6.2 million relates primarily to a loss of $7.7 million on foreign exchange in the third quarter of 2024, compared to a loss of $0.1 million in the second quarter of 2024.
•Net loss: For the third quarter of 2024, we generated a net loss attributable to shareholders of $8.1 million, or $(0.21) per share on both basic and fully diluted bases, compared to a net loss attributable to shareholders of $16.9 million, or $(0.43) per share on both basic and fully diluted bases in the second quarter of 2024.