On August 2, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2023, and recent business highlights (Press release, Coherus Biosciences, AUG 2, 2023, View Source [SID1234633645]):

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RECENT BUSINESS HIGHLIGHTS

CIMERLI

CIMERLI (ranibizumab-eqrn) net product sales more than quadrupled to $26.7 million compared to the prior quarter following the April 1, 2023 implementation of the permanent, product-specific Q-code.
UDENYCA

Coherus launched a single-dose, prefilled autoinjector (AI) presentation of UDENYCA (pegfilgrastim-cbqv) on May 22, representing the first pegfilgrastim presentation innovation in eight years.
The U.S. Food and Drug Administration (FDA) review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA On-body Injector (OBI), is ongoing. Coherus plans to launch UDENYCA OBI directly upon potential approval later this year.
Toripalimab

The FDA completed inspection of the toripalimab manufacturing site in China in May, and has scheduled the clinical site inspections in China to begin in the second half of August 2023. Coherus anticipates potential FDA approval and U.S. commercial launch of toripalimab in the second half of 2023.
The final analysis of the JUPITER-02 clinical trial (NCT03581786) presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for nasopharyngeal carcinoma (NPC) patients who were treated with toripalimab in combination with chemotherapy versus chemotherapy alone. Median OS was 33.7 months in the chemotherapy-only treatment arm, and median OS was not reached in the toripalimab arm, with a hazard ratio of 0.63, representing a 37% reduction in risk of death (95% CI 0.45-0.89; p=0.0083).
YUSIMRY

Coherus launched YUSIMRY, a Humira biosimilar, with a citrate-free and sting-free formulation delivered via a state-of-the-art autoinjector on July 3rd. YUSIMRY is now available for sale nationwide through retail, mail order and specialty pharmacy channels.
Surface Oncology Merger and Novel Immuno-oncology Pipeline

Coherus announced that it had entered into a definitive agreement and plan of merger on June 16, 2023 that would result in the acquisition of Surface Oncology, Inc. ("Surface Oncology"), if completed. The merger is expected to significantly advance Coherus’ next-generation immuno-oncology pipeline focused on the tumor micro-environment with clinical stage anti-IL-27 and anti-CCR8 development programs. The merger is expected to close following the Surface Oncology special meeting of stockholders scheduled on September 7, 2023.
Patient enrollment continues in the U.S.-based Phase 1/2a dose expansion clinical trial evaluating CHS-006, a TIGIT-targeted antibody, in combination with toripalimab in patients with advanced solid tumors (NCT05757492).
Coherus plans to file an Investigational New Drug ("IND") application by year end for CHS-1000, a novel ILT4-targeted antibody.
"In the second quarter, we had strong execution on our strategy to build an innovative immuno-oncology company funded by revenues from FDA-approved products, and we made good progress across all areas of our business. Compared to the prior quarter, net revenues increased by 81% to $58.7 million, and we expect continued revenue growth in the second half of this year driven by continued success with CIMERLI, the UDENYCA autoinjector and YUSIMRY new product launches, as well as the launches of UDENYCA On-body Injector and of toripalimab for the treatment of NPC later this year, if approved," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "Coherus is successfully diversifying into a multi-product commercial organization with growing revenues supporting the development of our next-generation immuno-oncology franchise."

Mr. Lanfear added, "We look forward to closing the merger with Surface Oncology in the third quarter, reprioritizing our portfolio, and ultimately advancing a highly competitive, next-generation immuno-oncology clinical pipeline of innovative therapeutics focused on the tumor microenvironment. We will be well positioned to deliver the next step change in cancer treatment, with the goal of driving enhanced therapeutic benefit to patients beyond the outcomes achieved with checkpoint inhibitors alone."

SECOND QUARTER 2023 FINANCIAL RESULTS

Net revenue was $58.7 million during the three months ended June 30, 2023 and included $31.7 million of net sales of UDENYCA and $26.7 million of net sales of CIMERLI, which was launched in October 2022. Net revenue for the three months ended June 30, 2022, consisting primarily of UDENYCA net sales, was $60.2 million. Net revenue was $91.2 million and $120.3 million for the six months ended June 30, 2023 and 2022, respectively. Net revenue in the first half of 2023 was reduced by a $1.7 million charge for a contingent liability related to resolving a dispute regarding certain UDENYCA sales from October 2020 through December 2021. The declines were primarily due to a reduction in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition. These factors were partially offset by increasing revenue from CIMERLI sales during the first two quarters of 2023.

Cost of goods sold (COGS) for the three months ended June 30, 2023 and 2022 was $24.8 million and $11.3 million, respectively, and $41.7 million and $20.6 million during the six months ended June 30, 2023 and 2022, respectively. The increases compared to prior year periods primarily result from COGS associated with CIMERLI which was launched in October 2022. UDENYCA COGS includes a mid-single digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid 50% royalty on gross profits. COGS for the first half of 2023 also includes $3.0 million in contract modification fees with one of our manufacturers and $2.3 million in write-offs of inventory that was damaged during processing at one of our manufacturers. In addition, gross margins were unfavorably impacted due to product mix resulting from increased volumes of CIMERLI sold following the product specific Q-code implementation on April 1st and the launch of UDENYCA AI in May 2023.

Research and development (R&D) expense for the three months ended June 30, 2023 and 2022 was $23.3 million and $41.6 million, respectively. For the six months ended June 30, 2023 and 2022, R&D expense was $57.4 million and $124.5 million, respectively. The decline in R&D expense compared to the prior year periods primarily resulted from the reduction in scope of the toripalimab collaboration agreement and from the recognition in the first quarter of 2022 of the $35.0 million option exercise fee paid to Junshi Biosciences to license CHS-006.

Selling, general and administrative (SG&A) expense was $45.1 million and $51.3 million during the three months ended June 30, 2023 and 2022, respectively, and $94.3 million and $100.0 million during the six months ended June 30, 2023 and 2022, respectively. The decline in SG&A expense compared to the prior year periods primarily reflects lower headcount.

Net loss for the second quarter of 2023 was $42.9 million, or $(0.49) per share on a diluted basis, compared to a net loss of $50.2 million, or $(0.65) per share on a diluted basis for the same period in 2022. Net loss for the first half of 2023 was $118.6 million, or $(1.42) per share on a diluted basis, compared to a net loss of $146.2 million, or $(1.89) per share on a diluted basis for the first half of 2022.

Non-GAAP net loss for the second quarter of 2023 was $32.8 million, or $(0.38) per share on a diluted basis, compared to non-GAAP net loss of $36.3 million, or $(0.47) per share on a diluted basis for the same period in 2022. Non-GAAP net loss for the first half of 2023 was $92.3 million, or $(1.11) per share on a diluted basis, compared to non-GAAP net loss of $113.3 million, or $(1.46) per share on a diluted basis for the first half of 2022. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $144.7 million as of June 30, 2023, compared to $191.7 million at December 31, 2022.

2023 Revenue and R&D and SG&A Expense Guidance

Coherus expects its 2023 net product revenue will exceed $275 million, including at least $100 million of CIMERLI net revenue.

Coherus projects combined R&D and SG&A expenses for 2023 to be in the range of $315 to $335 million. This guidance range includes stock-based compensation expense and excludes the Surface Oncology acquisition cost as well as any potential collaboration upfront payments to Klinge Pharma for the in-license of its Eylea biosimilar program or milestones payments to Junshi Biosciences due upon U.S. approval of toripalimab.

This financial guidance also excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information
When: Wednesday, August 2nd, 2023, starting at 5:00 p.m. Eastern Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI3fdbdc05783442f89d11db6b94e74a28

Please dial-in 15 minutes early to ensure a timely connection to the call.

Webcast Link: View Source

A replay of the webcast will be archived on the "Investors" section of the Coherus website at View Source

On August 2, 2023 ChromaDex Corp. (NASDAQ:CDXC), a global bioscience company dedicated to healthy aging, reported that it will hold a conference call on Wednesday, August 9, 2023 at 4:30 p.m. ET to discuss its financial results for the second quarter, which ended on June 30, 2023 (Press release, ChromaDex, AUG 2, 2023, View Source [SID1234633644]). The financial results will be reported in a press release after the close of regular stock market trading hours on the same day as the conference call.

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Investor Conference Call:

ChromaDex management will host an investor conference call to discuss second quarter 2023 results and provide a general business update on Wednesday, August 9, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior. The dial-in information is as follows:

Date: Wednesday, August 9, 2023
Time: 4:30 p.m. ET (1:30 p.m. PT)
Toll-free dial-in number: 1-888-330-2446
Conference ID: 4126168
Webcast link: ChromaDex Second Quarter 2023 Earnings Conference Call

The conference call will be broadcast live and will be available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available from 7:30 p.m. ET on Wednesday, August 9, 2023, to 11:59 p.m. ET on Wednesday, August 16, 2023.

Toll-free replay number: 1-800-770-2030
Replay ID: 4126168

On August 2, 2023 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2023 (Press release, Cerus, AUG 2, 2023, View Source [SID1234633643]).

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Recent highlights include:

Second quarter 2023 total revenue of $47.7 million was comprised of total product revenue of $38.9 million and government contract revenue of $8.9 million.
Received positive feedback for INTERCEPT Red Blood Cells CE Mark submission in clarification meeting with EU competent authority, the Dutch Medicines Evaluation Board (CBG), supporting possible CE Mark approval decision under the EU Medical Device Regulation (MDR) in the second half of 2024.
Planned completion of Phase 3 ReCePI study enrollment in cardiovascular surgery patients this year, with top-line data readout expected in Q1 2024.
Awarded an additional $8.7 million in funding from the U.S. Department of Defense for continued development of lyophilized INTERCEPT Fibrinogen Complex (LyoIFC), increasing total contract value to $17.8 million.
Adjusting full-year 2023 annual product revenue guidance to the range of $160 million to $165 million from the prior range of $165 million to $170 million given the expected impact of a temporary reduction in U.S. platelet kit shelf life on customer ordering patterns, reduced platelet collections in key regions of EMEA, and new Russia sanctions.
Cash, cash equivalents, and short-term investments were $84.5 million at June 30, 2023.
"We are pleased with our recent progress for the INTERCEPT Red Blood Cell program in both the EU and U.S.," said William "Obi" Greenman, Cerus’ president and chief executive officer. "During the second quarter, we gained additional clarity to a potential CE Mark approval decision in the second half of 2024 and a top-line data readout from our U.S. Phase 3 ReCePI study expected in the first quarter of next year. Given ongoing enrollment in RedeS, our second U.S. Phase 3 study, we plan to begin a modular premarket approval (PMA) application submission to FDA in the second half of 2025, with a final PMA module submission planned for the second half of 2026."

"On the commercial front, with many of the challenges of the first half of the year behind us, we remain confident in our expectations for growth during the rest of this year and into 2024. We also continue to be committed to achieving adjusted EBITDA breakeven this year," continued Greenman. "Given some recent ordering pattern modifications related to a temporary INTERCEPT kit shelf-life change in the U.S. and platelet collection dynamics in parts of Europe, along with the impact of recent Russia sanctions, we are adjusting our full-year 2023 product revenue guidance down to a range of $160 million to $165 million. Despite the adjustment, we are not seeing a change in market share, and we believe new customers and new geographies will fuel growth going forward."

Revenue

Product revenue during the second quarter of 2023 was $38.9 million, compared to $41.0 million during the prior year period. While the Company did not see a decline in market penetration in the U.S., it did continue to see some inventory management at U.S. customer sites during the second quarter. In addition, reduced platelet collections in certain regions of Europe and new sanctions in Russia provided headwinds during the second quarter.

Second-quarter 2023 government contract revenue was $8.9 million, compared to $6.6 million during the prior year period. Reported government contract revenue in the second quarter 2023 increased versus the prior year period primarily due to funding associated with development of LyoIFC. In addition to this funding, the Company’s government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells as well as efforts related to the development of next-generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit for the second quarter of 2023 was $21.3 million, which is consistent with the prior year period. Product gross margin for the second quarter of 2023 was 54.9% compared to 51.9% for the second quarter of 2022 and continues to represent the expected benefit of the Company’s growth and efforts over the past several years.

Operating Expenses

Total operating expenses for the second quarter of 2023 were $41.9 million compared to $34.7 million for the same period of the prior year, reflecting a year-over-year increase of 21%.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2023 totaled $20.5 million, compared to $19.5 million for the second quarter of 2022. The year-over-year increase in SG&A expenses for the second quarter was tied to increased sales personnel hired to accelerate adoption of INTERCEPT Fibrinogen Complex and, to a lesser extent, inflation.

R&D expenses for the second quarter of 2023 were $19.2 million, compared to $15.2 million for the second quarter of 2022. The year-over-year increase in R&D expenses in the second quarter was tied to increased activity for our government reimbursed programs. In addition, we realized increased costs associated with development of our next-generation illumination device and in conjunction with producing data, and regulatory interactions with respect to our existing products.

In order to align operating expenses with the operating environment and priority initiatives, the Company entered into a plan to restructure certain functions and reduce its real estate footprint during the most recently completed quarter. The plan resulted in a $2.1 million restructuring charge for the second quarter of 2023. As part of the plan, the Company expects to take an additional future charge at the time it ceases use of leased real estate contemplated under the plan. The Company estimates that the cumulative actions taken will result in annualized operating expense savings of approximately $10 million per year. The Company excludes the restructuring charge from its non-GAAP adjusted EBITDA measure presented below.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2023 was $13.3 million, or $0.07 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $8.4 million, or $0.05 per basic and diluted share, for the second quarter of 2022.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the second quarter of 2023 was negative $4.7 million, compared to non-GAAP Adjusted EBITDA of negative $2.4 million for the second quarter of 2022. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Use

At June 30, 2023, the Company had cash, cash equivalents and short-term investments of $84.5 million, compared to $102.2 million at December 31, 2022.

As of June 30, 2023, the Company had $55 million outstanding on its term loan and $16.5 million drawn on its revolving credit facility. The Company has access to another $20 million of term debt and $18.5 million under its revolving line of credit.

For the second quarter of 2023, net cash used in operating activities totaled $7.6 million as compared to $0.3 million during the prior year period. The increase in operating cash use was primarily related to increased operating expenses, including the Company’s restructuring plan and increases in net production of inventory. The Company expects to moderate production of inventory in the second half of 2023 and sell down or reduce the net amount of inventory it has on hand.

2023 Product Revenue Guidance

The Company is adjusting its previously stated product revenue guidance range. The Company expects full-year 2023 product revenue to be in the range of $160 million to $165 million, compared to its previous range of $165 million to $170 million, due to a temporary reduction in the U.S. platelet kit shelf life, a reduction in platelet collections in parts of Europe, and new Russia sanctions instituted during the quarter.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through August 16, 2023.

On August 2, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter and six months ended June 30, 2023 (Press release, Castle Biosciences, AUG 2, 2023, View Source [SID1234633642]).

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"Castle delivered an outstanding second quarter, with strength across our entire test portfolio," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Building on our first quarter momentum and driven by consistent execution across the entire Castle team, we delivered strong test report volume and revenue growth. Based on strong first half 2023 execution and confidence in our business, we are raising our 2023 revenue guidance to at least $180 million.

"In addition, we expanded our body of evidence, further demonstrating the clinical value of our innovative tests and supporting adoption by clinicians and payers. Specifically, two patient outcome studies on our DecisionDx-Melanoma test were published in the second quarter. The first study was from our collaboration with the National Cancer Institute’s SEER Program Registries. Data from this study showed that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. A similar study was published by Dhillon, et al. This independent, multi-center study found that sentinel lymph node negative patients whose follow-up treatment pathway was directed by the DecisionDx-Melanoma test for use of routine imaging in patients with high-risk DecisionDx-Melanoma results led to earlier detection of recurrences, when the tumor burden was lower. At study end, 76% of patients in the tested group who had a melanoma recurrence were alive compared to 50% in the untested group.

"Additionally, during open comment periods, we had the opportunity to present data to a number of Medicare contractors related to one of the treatments that our DecisionDx-SCC test has been shown to inform, adjuvant radiation therapy (ART). These data from a matched control analysis compare patients with high-risk squamous cell carcinoma (SCC) with one or more risk factors who received ART and those who did not. When evaluating this cohort, we observed that the DecisionDx-SCC Class 2B result could identify a group of patients with a significant reduction in metastasis rate after having received ART and that the DecisionDx-SCC Class 1 patients did not receive a benefit from ART.

"Our continued success is a testament to the ongoing dedication of our team to our patient-centric mission. With a track record of delivering on our short- and long-term strategies, combined with a healthy balance sheet and multi-year plan to deliver revenue growth and positive net operating cash flow by year-ending 2025, we are managing the business with a goal of driving near- and long-term shareholder value."
Second Quarter Ended June 30, 2023, Financial and Operational Highlights
•Revenues were $50.1 million, a 44% increase compared to $34.8 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the quarter ended June 30, 2023, were $0.1 million of net negative revenue adjustments, compared to $0.6 million of net positive revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $50.2 million, a 47% increase compared to $34.3 million for the same period in 2022.
•Delivered 16,820 total test reports in the second quarter of 2023, an increase of 52% compared to 11,034 in the same period of 2022:

◦DecisionDx-Melanoma test reports delivered in the quarter were 8,597, compared to 7,125 in the second quarter of 2022, an increase of 21%.
◦DecisionDx-SCC test reports delivered in the quarter were 2,681, compared to 1,344 in the second quarter of 2022, an increase of 99%.
◦MyPath Melanoma test reports delivered in the quarter were 953, compared to 955 MyPath Melanoma and DiffDx-Melanoma aggregate test reports in the second quarter of 2022.
◦DecisionDx-UM test reports delivered in the quarter were 461, compared to 431 in the second quarter of 2022, an increase of 7%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 1,447, compared to 352 in the second quarter of 2022, an increase of 311%.
◦IDgenetix test reports delivered in the quarter were 2,681, compared to 827 in the second quarter of 2022, an increase of 224%.
•Gross margin for the quarter ended June 30, 2023, was 73%, and adjusted gross margin was 78%.
•Net cash used in operations was $3.8 million, compared to $9.0 million for the same period in 2022.
•Net loss for the second quarter, which includes non-cash stock-based compensation expense of $12.8 million, was $(18.8) million, compared to $(1.6) million for the same period in 2022.
•Adjusted EBITDA for the second quarter was $(5.3) million, compared to $(11.2) million for the same period in 2022.

Six Months Ended June 30, 2023, Selected Results
•Revenues were $92.2 million, a 49% increase compared to $61.7 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the six months ended June 30, 2023, were $1.7 million of net negative revenue adjustments, compared to $0.3 million of net negative revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $93.9 million, a 51% increase compared to $62.0 million for the same period in 2022.
•Delivered 31,736 total test reports in the six months ended June 30, 2023, an increase of 61% compared to 19,661 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2023, were 16,180, compared to 13,148 for the same period in 2022, an increase of 23%.
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2023, were 5,092, compared to 2,486 for the same period in 2022, an increase of 105%.
◦MyPath Melanoma and DiffDx-Melanoma test reports delivered in the six months ended June 30, 2023, were 1,933, compared to 1,905 MyPath Melanoma and DiffDx-Melanoma aggregate test reports for the same period in 2022, an increase of 1%.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2023, were 870, compared to 887 for the same period in 2022, a decrease of 2%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2023, were 2,830, compared to 408 for the same period in 2022, following our initial offering of the test beginning in December 2021.
◦IDgenetix test reports delivered in the six months ended June 30, 2023, were 4,831, compared to 827 for the same period in 2022, following our initial offering of the test beginning in April 2022.
•Gross margin for the six months ended June 30, 2023, was 72%, and adjusted gross margin was 77%.
•Net cash used in operations was $29.2 million, compared to $30.4 million for the same period in 2022.
•Net loss for the six months ended June 30, 2023, which includes non-cash stock-based compensation expense of $26.4 million, was $(48.0) million, compared to $(26.3) million for the same period in 2022.
•Adjusted EBITDA for the six months ended June 30, 2023, was $(20.4) million, compared to $(22.6) million for the same period in 2022.
Cash, Cash Equivalents and Marketable Investment Securities
As of June 30, 2023, the Company’s cash, cash equivalents and marketable investment securities totaled $225.5 million.

2023 Outlook
Castle Biosciences is increasing its guidance for anticipated total revenue in 2023. The Company now anticipates generating at least $180 million in total revenue in 2023 compared to the previously provided guidance of $170-180 million.
Second Quarter and Recent Accomplishments and Highlights
Dermatology
•DecisionDx-Melanoma: In June, the Company announced the initial publication of its collaboration with the National Cancer Institute’s SEER Program Registries. This large study of real-world, unselected patients confirmed prior prospective and retrospective studies showing DecisionDx-Melanoma provided clinically meaningful and significant, independent risk stratification of patients with cutaneous melanoma (CM), beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage. Additionally, the study showed that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. The publication can be found here.
•DecisionDx-Melanoma: In May, the Company announced an independent, multi-center study providing a direct chain of evidence that use of DecisionDx-Melanoma test results to guide radiological surveillance could lead to improved patient outcomes. Specifically, this study directly compared the impact of management changes in sentinel lymph node negative patients whose follow-up pathway was directed by the DecisionDx-Melanoma test to patients in the same institution who were not tested and, therefore, did not have their follow-up pathway changed from the institution’s traditional follow-up pathway. The results showed that metastasis was detected earlier, when the tumor burden was smaller, and at study end, 76% of patients in the tested group who had a metastasis were alive compared to 50% in the untested group. The study, authored by Dhillon et al., can be found here.
•DecisionDx-SCC: In June, the Company announced new data demonstrating the ability of the DecisionDx-SCC test to identify cutaneous squamous cell carcinoma (cSCC) tumors at a biologically high risk of metastasis in a subset of patients considered to be at a low risk of metastasis by traditional staging. In the study, the DecisionDx-SCC test was able to significantly stratify three-year metastasis free survival rates within the AJCC8 and Brigham and Women’s Hospital T1 populations of the cSCC cohort. See the Company’s news release from June 12, 2023, for more information.
•DecisionDx-SCC: In June, the Company announced the publication of a paper highlighting a clinician-derived, real-world algorithm that provides a framework to incorporate DecisionDx-SCC test results into clinical practice within National Comprehensive Cancer Network (NCCN) guideline recommendations. This framework for stratifying patients with advanced cSCC includes a treatment algorithm that demonstrates how use of DecisionDx-SCC test results can assist clinicians in identifying personalized, risk-aligned treatment pathway improvements for patients with high-risk cSCC, based on the patient’s tumor biology, which may help improve their disease outcome. The publication can be found here.
Gastroenterology
•In May, the Company announced that its three posters at the recent Digestive Disease Week Annual Meeting were honored as "Posters of Distinction" by the American Gastroenterological Association Institute Council, ranking among the top 10% of the more than 3,100 abstracts showcased during the meeting. See the Company’s news release from May 26, 2023, for more information.
•In May, the Company announced that it had been selected as the winner of the "Best Use of Artificial Intelligence in Healthcare" award in the seventh annual MedTech Breakthrough Awards program for its innovative TissueCypher Barrett’s Esophagus (BE) test. The TissueCypher test provides clinicians with important information about a patient’s individual risk of progression to esophageal cancer based on advanced analysis of biopsied tissue to guide more informed and risk-aligned management of BE patients. See the Company’s news release from May 15, 2023, for more information.
Mental Health
•In June, ECRI, an independent, nonprofit organization improving the safety, quality and cost-effectiveness of care across all healthcare settings, concluded its genetic test assessment of Castle’s

IDgenetix test with a four out of five, or "Somewhat Favorable," rating. Commercial payers utilize ECRI evaluations to assist in making coverage decisions.
•In May, the Company announced real-world study data demonstrating that use of IDgenetix to guide medication management can significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression, compared to current standard-of-care treatment. The study abstract can be found here.
Corporate
•In July, the Company announced that it had earned a second consecutive Arizona Top Workplace award from AZ Central, the digital home of The Arizona Republic newspaper. See the Company’s news release from July 17, 2023, for more information.
•In May, the Company announced that it opened a new state-of-the-art laboratory facility in Pittsburgh. The new 20,000-square-foot facility doubles the size of its previous Pittsburgh laboratory and is expected to have the capacity and ability to process each of its proprietary tests. Additionally, the Company anticipates doubling its workforce in Pittsburgh, creating approximately 35 new jobs by the end of 2023. See the Company’s news release from May 22, 2023, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Wednesday, August 2, 2023, at 4:30 p.m. Eastern time to discuss its second quarter 2023 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 23, 2023.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 967509.

There will be a brief Question & Answer session following management commentary.

On August 2, 2023 Eterna Therapeutics presented its investor presentation (Presentation, Brooklyn ImmunoTherapeutics, AUG 2, 2023, View Source [SID1234633641]).

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