1stOncology™: Cancer Intelligence Service – Page 3752 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Clarity’s theranostic prostate cancer trial advances to highest dose level

On August 9, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the successful completion of cohort 2 and advancement to cohort 3 in the dose escalation phase of its Phase I/II theranostic trial, SECuRE, evaluating 64Cu/67Cu SAR-bisPSMA in patients with mCRPC (Press release, Clarity Pharmaceuticals, AUG 9, 2023, View Source [SID1234634058]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using 64Cu/67Cu SAR-bisPSMA. 64Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation trial with a cohort expansion involving up to 44 patients in the US. The aim of the trial is to determine the safety and efficacy of 67Cu SAR-bisPSMA for the treatment of prostate cancer.

The second cohort of the dose escalation, where 3 participants received a single administration of 8GBq of 67Cu SAR-bisPSMA, has been completed. No DLTs have been reported in any of the patients dosed to date. The SRC, responsible for assessing safety of participants and overseeing the general progress of the trial, has assessed the data and recommended progressing the trial to cohort 3, increasing the dose to 12GBq. The third cohort will be the last to assess single doses of 67Cu SAR-bisPSMA and will be followed by a multi-dose cohort, pending safety evaluation. The 3 participants in cohort 2 have been monitored by their physicians for safety and treatment response as per the trial protocol. All 3 participants in cohort 2 remain on the trial following their recent administration of 8GBq of 67Cu SAR-bisPSMA and are demonstrating a PSA reduction, with 2 of the 3 participants exhibiting an initial PSA reduction of ~90%. A PSA decline of 50% or greater is one of the primary endpoints of the SECuRE trial and a commonly used surrogate endpoint for efficacy in this patient population.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center / XCancer Omaha, NE, commented, "We are excited by the remarkable PSA declines seen in all three patients in cohort 2 with just a single dose of 8GBq of 67Cu SAR-bisPSMA. I have not observed PSA responses like this after a single dose of any agent and, considering the excellent safety profile we have seen to date in the first two cohorts of this study, we really look forward to progressing the development of this promising therapy. While in the VISION trial2 with 177Lu PSMA-617 we did see a >80% reduction in PSA in roughly 33% of patients, this was after up to six 7.4GBq doses of 177Lu PSMA-617 spaced out over a period of up to 30 weeks. If a single 8GBq dose of 67Cu SAR-bisPSMA can deliver so much benefit to the patients, we are excited to see how a single 12GBq dose will benefit patients in cohort 3 and to explore the effect of multiple dosing. If similar responses can be replicated in larger patient numbers, 67Cu SAR-bisPSMA may become the gold standard therapeutic agent for patients with mCRPC once approved."

Additional therapy cycles of 67Cu SAR-bisPSMA have been requested by clinicians under the FDA EAP for patients who participated in the SECuRE trial. SPECT-CT images depicted below were collected 48 hours after the first, third and fourth administrations of 4GBq of 67Cu SAR-bisPSMA in a patient from cohort 1 who received additional cycles under the EAP.

SPECT-CT images collected following the third and fourth therapy cycle demonstrate a reduction in the intensity of therapeutic 67Cu SAR-bisPSMA product uptake at the tumour sites. A reduction of greater than 50% in PSA levels was observed in this patient following the first administration of 4GBq of therapeutic 67Cu-SAR-bisPSMA and a drop of greater than 90% in PSA was observed after the fourth administration of 4GBq of 67Cu-SAR-bisPSMA.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to observe such a dramatic response in prostate cancer patients from cohort 2 following a single dose of 8GBq of 67Cu SAR-bisPSMA. SAR-bisPSMA aims to be a best-in-class PSMA product due to its differentiation from all other PSMA-targeted products in the market and in development that only have a single PSMA-targeting agent. We purposely designed and optimised SAR-bisPSMA to have two PSMA-targeting agents to address the challenges of low uptake and retention that the first generation of PSMA products suffer from. In pre-clinical and clinical development to date, we have observed two to three times the uptake of SAR-bisPSMA in tumours, followed by retention in tumours out to at least 96 hours. Although our data is early, the higher uptake and retention of product, coupled with the advantageous properties of copper-67, has shown quite impressive responses from single doses and we look forward to exploring the clinical benefits of 67Cu SAR-bisPSMA at the higher 12GBq level and over multiple treatment cycles. With commercial quantities of the 67Cu radioisotope now being routinely produced domestically in the US by our exclusive supplier, NorthStar, we see a clear path to commercialisation as we continue to push forward through clinical trials for 67Cu SAR-bisPSMA and bringing this product to the greater prostate cancer patient population.

"Prostate cancer is one of the largest oncology indications worldwide and, based on our estimates, represents a US$5-10 billion therapy market for PSMA targeting radiopharmaceuticals. Radiopharmaceuticals are expected to play an increasingly important role in the management of patients with prostate cancer, however, challenges associated with the current generation of products prevail. Clarity’s Targeted Copper Theranostic (TCT) platform represents the next-generation platform in radiopharmaceuticals to improve treatment outcomes for children and adults with cancer as well as resolve the supply and manufacturing issues associated with the first generation of products. Because of these characteristics, TCTs are ideally positioned to enable the field to expand into the oncology market, addressing large indications such as prostate cancer and beyond.

"We look forward to sharing more data on 67Cu SAR-bisPSMA as the SECuRE trial continues to progress and any further updates from patients who may receive single or multiple doses of 67Cu SAR-bisPSMA in our programs," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

ChromaDex Corporation Reports Second Quarter 2023 Financial Results

On August 9, 2023 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2023 (Press release, ChromaDex, AUG 9, 2023, View Source [SID1234634056]).

Second Quarter 2023 and Recent Highlights

Total net sales were $20.3 million, with $16.9 million from Tru Niagen, up 21% and 16% from the prior year quarter, respectively.
Strong gross margin of 60.8% and a $1.8 million reduction in operating expenses.
Sales and marketing expense as a percentage of net sales was 29.6%, an improvement of 1,830 basis points, compared to 47.9% from the prior year quarter.
Net loss was $2.2 million or $(0.03) per share, an improvement of $4.2 million, or $0.06 per share, from the prior year quarter.
Adjusted EBITDA, a non-GAAP measure, was a positive $0.2 million, a $4.9 million improvement from the prior year quarter.
Two published abstracts, originally presented in April 2023, highlighted the significance of NAD+ in glaucoma patients and that supplementation with nicotinamide riboside, NR, shows promising effects.(1)
ChromaDex External Research Program (CERP) celebrated its 10th anniversary, signing more than 275 global research agreements with over 235 independent, expert investigators to uncover the full potential of NAD+ with Niagen. This research has shown that the health benefits of Niagen translate from preclinical models to human clinical studies for brain, heart and muscle health with remarkable consistency. Looking to the next 10 years, there is great anticipation for emerging benefits in sensory, infant, maternal and reproductive health to be translated from preclinical to human studies.
"This was another excellent quarter, delivering 21% year-over-year revenue growth, positive Adjusted EBITDA of $0.2 million and positive operating cash flows for the second consecutive quarter," said ChromaDex Chief Executive Officer, Rob Fried. "We are again raising our 2023 revenue outlook by 2.5% to at least 15% growth, underscoring our commitment to consistent profitable growth."

(1) Refers to two independent clinical study abstracts originally presented in April 2023 at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting and recently published in the peer-reviewed ARVO journal, Investigative Ophthalmology & Visual Science.

Results of operations for the three months ended June 30, 2023 compared to the prior year quarter

ChromaDex reported a net sales increase of 21%, or $3.6 million, to $20.3 million. The increase in net sales was fueled by growth in sales of Tru Niagen and growth in Niagen ingredient sales.

Gross marginpercentageimproved 80 basis points to 60.8%. The improvement in gross margin percentage is primarily driven by economies of scale and supply chain management optimization efforts, partly offset by changes in business mix.

Operating expensedecreased 11%, or $1.8 million, to $14.7 million driven by a $2.0 million reduction in sales and marketing expense slightly offset by higher research and development expense and general and administrative expense.

Net loss was $2.2 million, or $0.03 loss per share, compared to a net loss of $6.4 million or $0.09 loss per share for the second quarter of 2022. Adjusted EBITDA, a non-GAAP measure, was a positive $0.2 million, a $4.9 million improvement from Q2 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net loss, the most directly comparable GAAP measure.

Net cash inflow from operating activities was $6.1 million for the six months ended June 30, 2023, showing a significant improvement compared to a net cash outflow of $11.0 million in the prior year. This improvement can be attributed to a $10.0 million reduction in net loss, a positive impact of $4.9 million from inventory management, as well as other favorable changes in working capital.

2023 Full Year Outlook

Looking forward, for the full year, the Company expects at least 15.0% revenue growth year-over-year. The projected growth considers only recurring, steady revenue growth from the e-commerce business and established partnerships, as well as upside from newer partnerships realized in the first half of the year. However, potential upside which is not reflected in this growth, lies within new partnerships, channels, and products. The Company projects that gross margin will remain stable year over year as cost savings initiatives and benefits from economies of scale are expected to largely offset continued inflationary pressures. Moreover, further optimization, coupled with new and focused customer acquisition strategies are expected to result in reduced selling and marketing expense as a percentage of net sales. The Company plans to increase investments in research and development, mainly during the latter half of the year, to drive innovation and expects general and administrative expense to be flat to down $1 million year over year.

Investor Conference Call

A live webcast will be held Wednesday, August 9, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 9, 2023 through 11:59 p.m. Eastern time on August 16, 2023. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

Charles River Laboratories Announces Second-Quarter 2023 Results

On August 9, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter of 2023 (Press release, Charles River Laboratories, AUG 9, 2023, View Source [SID1234634054]). For the quarter, revenue was $1.06 billion, an increase of 8.9% from $973.1 million in the second quarter of 2022.

Acquisitions contributed 0.2% to consolidated second-quarter revenue growth. The divestiture of the Avian Vaccine business in December 2022 reduced reported revenue growth by 2.3%, and the impact of foreign currency translation reduced reported revenue growth by 0.2% for the quarter. Excluding the effect of these items, organic revenue growth of 11.2% was driven primarily by the Research Models and Services (RMS) and Discovery and Safety Assessment (DSA) business segments.

On a GAAP basis, second-quarter net income attributable to common shareholders was $97.0 million, a decrease of 11.3% from $109.3 million for the same period in 2022. Second-quarter diluted earnings per share on a GAAP basis were $1.89, a decrease of 11.3% from $2.13 for the second quarter of 2022. GAAP earnings per share included a loss from the Company’s venture capital and other strategic investments of $0.03 per share in the second quarter of 2023, compared to a loss of $0.14 per share for the same period in 2022. Certain venture capital and other strategic investment performance has been excluded from the Company’s non-GAAP results.

On a non-GAAP basis, net income was $138.3 million for the second quarter of 2023, a decrease of 2.5% from $141.9 million for the same period in 2022. Second-quarter diluted earnings per share on a non-GAAP basis were $2.69, a decrease of 2.9% from $2.77 per share for the second quarter of 2022.

The lower GAAP and non-GAAP net income and earnings per share were driven primarily by non-operating items, including increased interest expense and a higher tax rate, as well as the impact of the Avian Vaccine divestiture.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We were pleased with our second-quarter financial results, highlighted by another strong quarter for the DSA segment and the expected improvement in the RMS and Manufacturing segments. We believe our significant scientific breadth and experience, as well as the substantial scale and duration of our DSA backlog, are important differentiators during times of macroeconomic or funding uncertainty."

"We are also closely monitoring the near-term demand trends that show more cautious spending by biopharmaceutical clients. In this environment, we believe clients will look for scientific partners who can provide even more efficiency and speed to market, and that they will continue to choose Charles River in order to derive additional value through our flexible and efficient outsourcing solutions. We believe these factors will enable us to effectively manage the business and give us confidence in our revenue growth and non-GAAP earnings per share guidance for the year, which we are narrowing to the upper ends of the previous ranges," Mr. Foster concluded.

Second-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $209.9 million in the second quarter of 2023, an increase of 12.6% from $186.4 million in the second quarter of 2022. The impact of foreign currency translation reduced revenue by 1.3% in the quarter. Organic revenue growth of 13.9% was driven by broad-based growth for research models in all geographies, particularly in China, as well as for research model services, primarily the Insourcing Solutions (IS) business.

In the second quarter of 2023, the RMS segment’s GAAP operating margin increased to 23.3% from 21.2% in the second quarter of 2022, and on a non-GAAP basis, the operating margin increased to 26.4% from 24.9%. The GAAP and non-GAAP operating margin increases were driven primarily by the timing of large model shipments in China.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $663.5 million in the second quarter of 2023, an increase of 12.1% from $591.9 million in the second quarter of 2022. The SAMDI Tech acquisition contributed 0.3% to reported DSA revenue growth, and the impact of foreign currency translation was negligible in the quarter. Organic revenue growth of 11.7% was driven by the Safety Assessment business, as a result of higher pricing and study volume.

In the second quarter of 2023, the DSA segment’s GAAP operating margin increased to 24.3% from 21.8% in the second quarter of 2022, and on a non-GAAP basis, the operating margin increased to 27.6% from 25.3%. The GAAP and non-GAAP operating margin increases were driven by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $186.5 million in the second quarter of 2023, a decrease of 4.2% from $194.8 million in the second quarter of 2022. The impact of the Avian Vaccine divestiture reduced revenue by 10.8%, and the impact of foreign currency translation was negligible. Organic revenue growth of 6.6% for the quarter was driven primarily by the CDMO and Microbial Solutions businesses.

In the second quarter of 2023, the Manufacturing segment’s GAAP operating margin decreased to 13.1% from 32.1% in the second quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 22.9% from 28.6% in the second quarter of 2022. The GAAP and non-GAAP operating margin declines were primarily the result of lower operating margins in the Biologics Testing and CDMO businesses. The GAAP operating margin decline was also driven by an acquisition-related adjustment in the CDMO business that benefited second-quarter 2022 results.

Updates 2023 Guidance

The Company is updating its 2023 financial guidance, which was previously provided on May 11, 2023. The Company is narrowing its revenue growth and non-GAAP earnings per share outlooks to largely reflect its solid first-half financial performance and the successful implementation of mitigation efforts around NHP supply constraints. These benefits are anticipated to be partially offset by near-term demand trends as biopharmaceutical clients appear to be reprioritizing their pipelines and tightening R&D budgets.

The Company’s 2023 guidance for revenue growth and earnings per share is as follows:

2023 GUIDANCE

CURRENT

PRIOR

Revenue growth, reported

2.5% – 4.5%

2.0% – 4.5%

Impact of divestitures/(acquisitions), net

~1.5%

Impact of 53rd week in 2022

~1.5%

Unfavorable/(favorable) impact of foreign exchange

0.0% – (0.5)%

Revenue growth, organic (1)

5.5% – 7.5%

5.0% – 7.5%

GAAP EPS estimate

$7.60 – $8.20

$7.45 – $8.45

Acquisition-related amortization

~$2.00

Acquisition and integration-related adjustments (2)

$0.20 – $0.25

~$0.10

Venture capital and other strategic investment losses/(gains), net (3)

$0.06

$0.03

Other items (4)

~$0.40

$0.30 – $0.35

Non-GAAP EPS estimate

$10.30 – $10.90

$9.90 – $10.90

Footnotes to Guidance Table:

(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.

(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives.

(3) Venture capital and other strategic investment performance only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments.

(4) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) investigations by the U.S. government into the NHP supply chain related to our Safety Assessment business; and (c) severance and other costs related to the Company’s efficiency initiatives.

Webcast

Charles River has scheduled a live webcast on Wednesday, August 9th, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Investor Day

Charles River will host a virtual Meeting with Management on Thursday, September 21st, beginning at 8:30 a.m. ET. Investors will have the opportunity to listen to a webcast of the virtual event through the Investor Relations section of the Company’s website at ir.criver.com. A replay will be accessible through the same website.

Century Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Updates

On August 9, 2023 Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the second quarter ended June 30, 2023 (Press release, Century Therapeutics, AUG 9, 2023, View Source [SID1234634053]).

"Here at Century we have continued to focus on the further advancement of our pipeline, specifically our ELiPSE-1 Phase 1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas, for which we expect to report initial data from Schedule A by year end," said Greg Russotti, Ph.D., Interim Chief Executive Officer, Century Therapeutics. "We remain confident in our differentiated scientific approach and are looking forward to spending the second half of this year working towards solidifying our position as an innovative leader in the cell therapy space."

Business Highlights & Upcoming Milestones

● The first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas is ongoing. The Company remains on track to report preliminary data from Schedule A of the trial, including pharmacokinetics, pharmacodynamics, and safety, by year end.

● At the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023, the Company presented a Trials in Progress poster related to its Phase 1 ELiPSE-1 trial. A copy of the poster, titled, "The ELiPSE-1 Study: A Phase 1 Multicenter Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B Cell Malignancies", is available on the Posters section of Century’s website at View Source

Second Quarter 2023 Financial Results

● Cash Position: Cash, cash equivalents, and marketable securities were $301.0 million as of June 30, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $48.5 million for the six months ended June 30, 2023, compared to net cash provided by operations of $61.2 million for the six months ended June 30, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $120.7 million).

● Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option and license agreement with BMS was $0.1 million for the three months ended June 30, 2023, compared to $1.4 million for the same period in 2022.

● Research and Development (R&D) expenses: R&D expenses were $22.7 million for the three months ended June 30, 2023, compared to $24.5 million for the same period in 2022. The decrease in R&D expenses was primarily due to the reduction in force in January of 2023.

● General and Administrative (G&A) expenses: G&A expenses were $8.2 million for the three months ended June 30, 2023, compared to $8.3 million for the same period in 2022. The decrease in G&A expenses was primarily due to a reduction in headcount.

● Impairment of long lived assets: A one-time impairment charge of $4.2 million was recorded in connection with the strategic decision to consolidate two of the Company’s existing leased facilities in Philadelphia.

● Net loss: Net loss was $33.3 million for the three months ended June 30, 2023, compared to $31.0 million for the three months ended June 30, 2022.

Financial Guidance

● The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million, including non-cash stock-based compensation expense of $12 million to $17 million.

● The Company estimates its cash, cash equivalents, and investments will support operations into 2026.

Aura Biosciences Reports Second Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

On August 9, 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 financial results for the second quarter ended June 30, 2023, and provided clinical development and operational highlights (Press release, Aura Biosciences, AUG 9, 2023, View Source [SID1234634050]).

"As we build momentum across our portfolio, we are happy to welcome Drs. Bruce Brown and Anthony Daniels as our Therapeutic Area Heads in Urologic Oncology and Ocular Oncology, respectively, as well as Dr. Richard Mountfield as our new Senior Vice President of Regulatory Affairs and Quality. These key appointments are critical in supporting our corporate growth and expansion of our clinical programs in two important oncology therapeutic areas with high unmet medical needs for patients," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

Dr. de los Pinos added, "We are excited to announce that we have released our drug product manufactured using the commercial process to be used in the global Phase 3 trial and remain encouraged by the progress we have made with the start-up activities, with multiple sites ready to enroll patients in the United States. We remain focused on the execution of our clinical studies and plan to share 12-month data from the Phase 2 trial in choroidal melanoma in the second half of 2023."

Recent Pipeline Developments

•
Global Start up Activities for the Phase 3 trial ongoing.
•
The Phase 3 trial is designed as a superiority trial comparing belzupacap sarotalocan (bel-sar) versus sham. The trial is a global Phase 3, randomized, 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, low dose regimen of bel-sar with suprachoroidal (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 12 months of follow up.

•
Aura released the commercial process material for the global Phase 3 trial. The majority of sites are qualified globally, and multiple sites are ready to enroll patients in the United States.
•
The first patient is expected to be dosed in the second half of 2023.

•
Enrollment is complete in the Phase 2 trial evaluating SC administration of bel-sar for the first-line treatment of adult patients with early-stage choroidal melanoma (CM). Updated efficacy data with 12 months median follow up of patients treated with the therapeutic regimen intended to be used in the global Phase 3 trial is on track to be presented in the second half of 2023.

•
The Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) is currently ongoing, and Aura expects to report data in 2024. This represents an area of high unmet need with approximately 60,000 patients diagnosed in the United States every year. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.

•
The 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 primary endpoint of the Phase 1 trial is the incidence and severity of treatment-related adverse events, serious adverse events and/or the incidence of dose-limiting toxicities. The trial will provide histopathological evaluation after the local treatment to support bel-sar’s biological activity.

•
Beyond early-stage CM, Aura continues to build its ocular oncology franchise. Aura’s goal is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no approved therapies, as the second ocular oncology indication. Aura is on track to initiate the Phase 2 trial in 2024.

Recent Corporate Events

Strengthened the clinical leadership team with the following key appointments:

•
Dr. Bruce Brown joined Aura as Therapeutic Area Head Urologic Oncology. Dr. Brown is responsible for leading the bladder cancer program, including the current ongoing trial, as well as driving future strategy and development plans. Dr. Brown was previously VP, Clinical Development at Myovant Sciences. Dr. Brown is a board-certified urologist and joined the pharmaceutical industry after practicing urology for 17 years.

•
Dr. Anthony Daniels is joining Aura as the Therapeutic Area Head Ocular Oncology. Dr. Daniels will be responsible for leading the ocular oncology program and driving future strategy. Dr. Daniels is a board-certified ophthalmologist who has treated ocular oncology patients for 15 years, and most recently was Chief of the Division of Ocular Oncology at Vanderbilt University Medical Center.

•
Dr. Richard Mountfield joined Aura as SVP, Regulatory Affairs & Quality. Dr. Mountfield is responsible for overseeing regulatory affairs and quality activities for all programs. Dr. Mountfield was previously the SVP of Regulatory Affairs & Quality at Zenas BioPharma.

Second Quarter 2023 Financial Results

•
As of June 30, 2023, Aura had cash and cash equivalents and marketable securities totaling $162.0 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2025.

•
Research and development expenses increased to $15.1 million for the three months ended June 30, 2023 from $9.5 million for the three months ended June 30, 2022, primarily due to ongoing clinical costs associated with the progression of our Phase 2 study and CRO costs associated with the start of our Phase 3 global trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

•
General and administrative expenses increased to $5.2 million for the three months ended June 30, 2023 from $4.3 million for the three months ended June 30, 2022. General and administrative expenses include $1.2 million and $0.8 million of stock-based compensation for the three months ended June 30, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to growth of the Company.

•
Net loss for the three months ended June 30, 2023 was $18.3 million compared to $13.5 million for the three months ended June 30, 2022.