On November 2, 2023 Cerus Corporation (Nasdaq: CERS) reported its financial results for the third quarter ended September 30, 2023 (Press release, Cerus, NOV 2, 2023, View Source [SID1234636748]).

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Recent highlights include:

Third quarter 2023 total revenue of $47.3 million was comprised of total product revenue of $39.8 million and government contract revenue of $7.5 million.
Completed Phase 3 ReCePI study enrollment in cardiovascular surgery patients, with top-line data readout on track for Q1 2024.
Attended first in-person AABB Annual Meeting since 2019, where presentations from transfusion medicine leaders highlighted the growing experience with the benefits of INTERCEPT-treated products, including INTERCEPT platelets and INTERCEPT Fibrinogen Complex (IFC).
Cash, cash equivalents, and short-term investments were $79.0 million at September 30, 2023.
Reaffirming commitment to achieve non-GAAP adjusted EBITDA breakeven in the fourth quarter of 2023.
"We continued to make progress on multiple fronts in the third quarter," said William "Obi" Greenman, Cerus’ president and chief executive officer. "We completed patient enrollment in our U.S. Phase 3 ReCePI study and continue to plan for a top-line data readout from the study in the first quarter of next year."

"On the top line, product revenues in the quarter returned to prior year levels, and we expect continued growth from here through the end of the year, with the near-term growth trajectory influenced by the system-wide roll-out of INTERCEPT platelets at Canadian Blood Services," continued Greenman. "Due primarily to the timing of our recent execution of an IFC sales agreement with one of the largest U.S. producers of cryoprecipitate, we are adjusting our full-year 2023 product revenue guidance to a range of $155 million to $158 million. The growth we are expecting in the second half of this year reflects the ongoing global demand for INTERCEPT-treated blood components and the growing use of IFC by blood center and hospital customers, as evidenced at the recent AABB Annual Meeting."

Revenue

Product revenue during the third quarter of 2023 was $39.8 million, compared to $39.6 million during the prior year period.

Third-quarter 2023 government contract revenue was $7.5 million, compared to $6.8 million during the prior year period. Reported government contract revenue in the third quarter 2023 increased versus the prior year period primarily due to funding associated with development of LyoIFC as well as research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells. In addition to this funding, the Company’s government contract revenue was comprised of funding associated with efforts related to the development of next-generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit for the third quarter of 2023 was $21.8 million, which is consistent with the prior year period. Product gross margin for the third quarter of 2023 was 54.9% compared to 55.4% for the third quarter of 2022. The Company continues to expect stability in gross margin percentage for the balance of the year. The Company’s margin expansion efforts are ongoing with the goal of realizing further margin expansion in the future.

Operating Expenses

Total operating expenses for the third quarter of 2023 were $34.5 million compared to $36.1 million for the same period of the prior year, reflecting a year-over-year decrease of 4%.

Selling, general, and administrative (SG&A) expenses for the third quarter of 2023 totaled $16.2 million, compared to $19.9 million for the third quarter of 2022. The year-over-year decrease in SG&A expenses for the third quarter was tied to decreased headcount and decreased non-cash stock-based compensation.

R&D expenses for the third quarter of 2023 were $16.8 million, compared to $16.2 million for the third quarter of 2022. The small year-over-year increase in R&D expenses in the third quarter was tied to the development of our next-generation illuminator and increased clinical research activities.

As previously described, the Company entered into a plan to restructure certain functions and reduce its real estate footprint during the second quarter of 2023. For the third quarter of 2023, the plan resulted in an additional $1.6 million restructuring charge. Of the $1.6 million, $1.1 million primarily relates to the write off of operating lease assets* which will be paid down over the course of the operating lease, and $0.5 million relates to non-cash charges associated with leasehold improvements which were written off. 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 third quarter of 2023 was $7.3 million, or $0.04 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $8.5 million, or $0.05 per basic and diluted share, for the third quarter of 2022.

On November 2, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that preliminary results of the Phase I NATHALI-01 clinical trial evaluating UCART20x22 in patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL) and updated results of the Phase I BALLI-01 clinical trial evaluating UCART22 in patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia, (r/r B-ALL) will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 65th Annual Meeting (ASH 2023), that will take place on December 9-12, 2023 in San Diego (CA) and online (Press release, Cellectis, NOV 2, 2023, View Source [SID1234636747]).

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These data will be presented in two poster sessions:

Poster Presentation (P2110)

Title: Preliminary Results of Nathali-01: A First-in-Human Phase I/IIa Study of UCART20x22, a Dual Allogeneic CAR-T Cell Product Targeting CD20 and CD22, in Relapsed or Refractory (R/R) Non-Hodgkin Lymphoma (NHL)

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I

Presenter: Dr. Jeremy Abramson (Massachusetts General Hospital Cancer Center)

Date/Time: Saturday, December 9, 2023 at 5:30 – 7:30 PM PT at San Diego Convention Center, Halls G-H

The poster presentation highlights the following data:

as of July 1, 2023, 3 patients were enrolled and treated at dose level 1 (50 million cells) with product manufactured in-house by Cellectis. Cytokine release syndrome (CRS) Grade 1 or 2 occurred in all patients, and all CRS resolved with treatment.
No immune effector cell associated neurotoxicity (ICANS) or graft versus host disease (GvHD) was observed. There were no UCART20x22 dose limiting toxicities (DLTs), and there was 1 DLT in connection with CLLS52 (alemtuzumab).
All patients responded at Day 28, with 1 partial metabolic response and 2 complete metabolic responses in patients who had failed prior autologous CD19 CAR T-cell therapies.
UCART20x22 expansion correlated with increases in serum cytokine and inflammatory marker levels as well as with CRS.
These initial data support the continued clinical trial evaluating UCART20x22 in R/R NHL.
Poster Presentation (P4847)

Title: Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III

Presenter: Dr. Nitin Jain (University of Texas MD Anderson Cancer Center)

Date/Time: Monday, December 11, 2023 at 6:00 – 8:00 PM PT at San Diego Convention Center, Halls G-H

The poster presentation highlights the following data:

in vitro comparability studies suggested that UCART22 Process 2 (P2) (manufactured in-house by Cellectis) is more potent than UCART22 Process 1 (P1) (manufactured by an external CDMO), and as of July 1, 2023, 3 patients were enrolled into the first UCART22 P2 cohort at dose level 2 (1 million cells/kg).
UCART22 P2 was administered after fludarabine, cyclophosphamide, and alemtuzumab (FCA) lymphodepletion regimen and was well tolerated. No DLTs or ICANS was observed, and the CRS observed was Grade 1 or 2.
There was a higher preliminary response rate (67%) at dose level 2 (1 million cells/kg) with UCART22 P2 (manufactured in-house by Cellectis) compared to 50% at dose level 3 (5 million cells/kg) with UCART22 P1 (manufactured by an external CDMO).
UCART22 expansion was observed in the responding patients and correlated with increases in serum cytokines and inflammatory markers.
The study continues to enroll patients at dose level 2i (2.5 million cells/kg) with UCART22 P2.

On November 2, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported that top-line data from the pivotal trial in Waldenstrom’s macroglobulinemia (WM) will be released during the JP Morgan Healthcare conference the week of January 8, 2024 (Press release, Cellectar Biosciences, NOV 2, 2023, View Source [SID1234636746]).

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Third Quarter and Recent Corporate Highlights

· Closed a securities purchase agreement with certain institutional investors for a private placement financing that, based on potential milestone payments, is expected to result in gross proceeds of up to $102.9 million, including an initial funding of $24.5 million. The PIPE was priced at the company’s common stock closing price on September 1, 2023, of $1.82 per share. The financing was led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC and other new and existing institutional investors.

· Received European Medicines Agency Priority Medicines (PRIME) Designation for iopofosine I 131 for Waldenstrom’s macroglobulinemia in patients who have received two or more prior treatment regimens. The PRIME designation was awarded based upon data from a pre-planned interim assessment in the pivotal study and six patients from the Phase 2a. PRIME designation is accorded to new therapies that demonstrate the potential to significantly address an unmet medical need in clinical trials. Also, it allows companies to optimize development plans and accelerate evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.

· Continued engagement with the U.S. Food and Drug Administration (FDA) providing additional regulatory clarity on the pivotal clinical trial and planned new drug application (NDA) submission in 2024. This includes direct feedback on key sections of the NDA and input around the design of a confirmatory study to support the accelerated approval strategy.

· Expanded the company’s global intellectual property portfolio with the addition of four patent grants. The patents, which are valid across key global regions of Europe, Australia, and Canada, cover iopofosine I 131 and the company’s proprietary Phospholipid Drug ConjugateTM (PDC) delivery platform.

· Enhanced the company’s commercial leadership team with the appointment of two new seasoned executives, William Yoon as vice president, medical affairs and Aaditya Nanduri as vice president, business strategy and analytics.

"We continue to collect and evaluate patient data from our pivotal trial and expect to announce top-line data the week of January 8, 2024. We view this data announcement as a potentially transformational event for Cellectar and as such merits optimal market and industry awareness, which the JP Morgan conference provides. As we prepare to announce trial data, we continue to work with the FDA and progress the NDA submission while advancing our commercialization readiness," said James Caruso, president and CEO of Cellectar. "With the recent financing providing up to $102.9 million in funding, we believe the company is well positioned for success with a clearly differentiated lead asset poised to establish a new standard of care for patients with relapsed or refractory WM."

Preliminary Third Quarter 2023 Financial Highlights

· Cash and Cash Equivalents: As of September 30, 2023, the company had cash and cash equivalents of $19.0 million, compared to $19.9 million as of December 31, 2022. During the third quarter, the company entered into a securities purchase agreement with certain institutional investors for a private placement financing that is expected to result in gross proceeds of up to $102.9 million, based upon achievement of certain milestones. Current cash includes an initial funding of $22.2 million from the transaction, net of commissions and fees. The company believes its cash on hand is adequate to fund budgeted operations into the second quarter of 2024.

· Research and Development Expense: R&D expense for the three months ended September 30, 2023 was approximately $7.3 million, compared to approximately $5.4 million for the three months ended September 30, 2022. The overall increase in research and development expense was primarily a result of an increase in WM pivotal trial patient enrollment and expansion of the central nervous system lymphoma cohort of the company’s Phase 2a basket trial in blood-borne malignancies as well as initiating its pediatric study in high-grade gliomas.

· General and Administrative Expense: G&A expense for the three months ended September 30, 2023, was $2.1 million, compared to $2.4 million for the same period in 2022. The overall decrease in G&A costs was primarily driven by reduced professional fees.

Conference Call & Webcast Details

Cellectar management will host a conference call for investors today, November 2, 2023, beginning at 8:30 am Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-888-886-7786 (in the U.S.) or 1-416-764-8658 (outside the U.S.). The call will be available via webcast by clicking HERE or on the Events page of the company’s website.

On November 2, 2023 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Celldex Therapeutics, NOV 2, 2023, View Source [SID1234636745]).

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"During the third quarter, we were pleased to complete enrollment of our Phase 2 chronic spontaneous urticaria study well ahead of schedule. We look forward to presenting topline data from this study by end of year as we also plan for the potential advancement of barzolvolimab into registrational studies in 2024," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "Our Phase 1b study results in prurigo nodularis met our internal hurdle for advancement and we are actively planning for the initiation of a Phase 2 study early next year. We are excited to discuss these data next week in an oral presentation at the World Congress on itch and continue to deepen our leadership role in furthering the science of mast cell biology."

"Enrollment continues as planned to our Phase 2 studies in chronic inducible urticaria and eosinophilic esophagitis where we anticipate important data read outs in 2024 and beyond. In closing, we look forward to a data rich end of the year and remain focused on successfully executing across our ongoing studies as we also make plans to broaden barzolvolimab into other mast cell mediated diseases," concluded Marucci.

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.

Celldex is conducting Phase 2 clinical studies of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU) and the two most common forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD). These randomized, double-blind, placebo-controlled Phase 2 studies are evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategies.

In July 2023, Celldex announced that enrollment to the CSU study (n=208) had been completed and that topline data is anticipated by the end of 2023.

In October 2023, data on quality of life outcomes from the Phase 1b CSU study were presented at the European Academy of Dermatology & Venereology (EADV) Congress. The Dermatology Life Quality Index (DLQI) assesses patients’ perceptions of the impact of their disease across different aspects of their health-related quality of life and includes questions on symptoms and feelings, daily activities, leisure, work and school performance, personal relationships and treatment. A rapid improvement in the DLQI was noted within 4 weeks in all barzolvolimab treated patients. DLQI improvement was sustained at doses ≥1.5mg/kg. Physician Global Assessment (PhysGA) for the treated cohorts also improved by week 1 and was sustained through week 24. DLQI and PhysGA trended closely with the dose-dependent improvement in UAS7 (Urticaria Activity Score over 7 days) and UCT (Urticaria Control Test), tryptase suppression, and increases in SCF.

Enrollment to the Phase 2 CIndU study is ongoing.

Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024. Data from the Phase 1b randomized, double-blind, placebo-controlled study in patients with prurigo nodularis have been accepted for oral presentation at the 12th World Congress on Itch (WCI), being held in Miami, November 5-7, 2023 and will be presented by Martin Metz, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin.

In July, the first patient was dosed in the Phase 2 randomized, double-blind, placebo-controlled study in eosinophilic esophagitis (EoE); enrollment is ongoing.
Bispecific Antibody Platform

CDX-585 – Bispecific ILT4 & PD-1

CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells.

In May 2023 the first patient was dosed in the Phase 1 study of CDX-585. This open-label, multi-center study of CDX-585 is evaluating patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy. Enrollment is ongoing in the dose-escalation portion of the study.
Third Quarter 2023 Financial Highlights and 2023 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2023 were $235.3 million compared to $252.7 million as of June 30, 2023. The decrease was primarily driven by third quarter cash used in operating activities of $19.0 million for the three months ended September 30, 2023. At September 30, 2023, Celldex had 47.3 million shares outstanding.

Revenues: Total revenue was $1.5 million in the third quarter of 2023 and $2.8 million for the nine months ended September 30, 2023, compared to $0.4 million and $0.7 million for the comparable periods in 2022. 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 $34.5 million in the third quarter of 2023 and $87.6 million for the nine months ended September 30, 2023, compared to $21.6 million and $59.4 million for the comparable periods in 2022. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, barzolvolimab contract manufacturing, and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $8.2 million in the third quarter of 2023 and $22.1 million for the nine months ended September 30, 2023, compared to $6.5 million and $20.6 million for the comparable periods in 2022. The increase in G&A expenses was primarily due to an increase in stock-based compensation and recruiting expenses, partially offset by a decrease in legal expenses.

Changes in Fair Value Remeasurement of Contingent Consideration: The gain on fair value remeasurement of contingent consideration was $6.9 million for the nine months ended September 30, 2022, primarily due to the Company’s decision to deprioritize the CDX-1140 program in the second quarter of 2022.

Net Loss: Net loss was $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, compared to a net loss of $26.8 million, or ($0.57) per share, for the third quarter of 2022, and $85.8 million, or ($1.83) per share, for the nine months ended September 30, 2022.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2023 are sufficient to meet estimated working capital requirements and fund planned operations through 2025, which include our ongoing and planned Phase 2 studies in CSU, CIndU, EoE, and PN.

On November 2, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the third quarter and nine months ended September 30, 2023 (Press release, Castle Biosciences, NOV 2, 2023, View Source [SID1234636744]).

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"Our third quarter results were exceptional, demonstrating the strength of our business fundamentals and the innovative test portfolio we’ve built to provide patients and clinicians with actionable information to guide patient care," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We delivered another quarter of significant test volume growth and revenue growth, which helped drive positive earnings and positive operating cash flow. Given our consistent performance year-to-date and confidence in our business, we are raising our 2023 revenue guidance to at least $200 million, up from at least $180 million.

"We continue to invest in our strategic growth initiatives across our entire test portfolio, while maintaining our firm focus on financial discipline. We believe our investments will continue to support our long-term value creation plans and the improvement of patient care. Our success is not possible without the continued dedication and efforts of our Castle team, and I would like to express my sincere appreciation for their contributions."
Third Quarter Ended September 30, 2023, Financial and Operational Highlights
•Revenues were $61.5 million, a 66% increase compared to $37.0 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 September 30, 2023, were $0.9 million of net positive 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 $60.6 million, a 63% increase compared to $37.3 million for the same period in 2022.
•Delivered 18,409 total test reports in the third quarter of 2023, an increase of 52% compared to 12,114 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the quarter were 8,559, compared to 7,354 in the third quarter of 2022, an increase of 16%.
◦DecisionDx-SCC test reports delivered in the quarter were 2,820, compared to 1,636 in the third quarter of 2022, an increase of 72%.
◦MyPath Melanoma test reports delivered in the quarter were 1,011, compared to 834 MyPath Melanoma and DiffDx-Melanoma aggregate test reports in the third quarter of 2022, an increase of 21%.
◦DecisionDx-UM test reports delivered in the quarter were 399, compared to 392 in the third quarter of 2022, an increase of 2%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 2,829, compared to 690 in the third quarter of 2022, an increase of 310%.
◦IDgenetix test reports delivered in the quarter were 2,791, compared to 1,208 in the third quarter of 2022, an increase of 131%.
•Gross margin for the quarter ended September 30, 2023, was 78%, and adjusted gross margin was 81%.

•Net cash provided by operations was $5.0 million, compared to net cash used in operations of $5.2 million for the same period in 2022.
•Net loss for the third quarter, which includes non-cash stock-based compensation expense of $13.0 million, was $(6.9) million, compared to a net loss of $(20.2) million for the same period in 2022.
•Adjusted EBITDA for the third quarter was $6.6 million, compared to $(9.6) million for the same period in 2022.

Nine Months Ended September 30, 2023, Financial and Operational Highlights
•Revenues were $153.7 million, a 56% increase compared to $98.7 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 nine months ended September 30, 2023, were $(3.1) million of net negative revenue adjustments, compared to $(1.9) 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 $156.8 million, a 56% increase compared to $100.6 million for the same period in 2022.
•Delivered 50,145 total test reports in the nine months ended September 30, 2023, an increase of 58% compared to 31,775 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the nine months ended September 30, 2023, were 24,739, compared to 20,502 for the same period in 2022, an increase of 21%.
◦DecisionDx-SCC test reports delivered in the nine months ended September 30, 2023, were 7,912, compared to 4,122 for the same period in 2022, an increase of 92%.
◦MyPath Melanoma test reports delivered in the nine months ended September 30, 2023, were 2,944, compared to 2,739 MyPath Melanoma and DiffDx-Melanoma aggregate test reports for the same period in 2022, an increase of 7%.
◦DecisionDx-UM test reports delivered in the nine months ended September 30, 2023, were 1,269, compared to 1,279 for the same period in 2022, a decrease of 1%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the nine months ended September 30, 2023, were 5,659, compared to 1,098 for the same period in 2022, following our initial offering of the test beginning in December 2021.
◦IDgenetix test reports delivered in the nine months ended September 30, 2023, were 7,622, compared to 2,035 for the same period in 2022, following our initial offering of the test beginning in April 2022.
•Gross margin for the nine months ended September 30, 2023, was 74%, and adjusted gross margin was 79%.
•Net cash used in operations was $24.2 million, compared to $35.7 million for the same period in 2022.
•Net loss for the nine months ended September 30, 2023, which includes non-cash stock-based compensation expense of $39.4 million, was $(54.9) million, compared to $(46.5) million for the same period in 2022.
•Adjusted EBITDA for the nine months ended September 30, 2023, was $(13.8) million, compared to $(32.2) million for the same period in 2022.
Cash, Cash Equivalents and Marketable Investment Securities
As of September 30, 2023, the Company’s cash, cash equivalents and marketable investment securities totaled $229.8 million.
2023 Outlook
Castle Biosciences is increasing its guidance for anticipated total revenue in 2023. The Company now anticipates generating at least $200 million in total revenue in 2023 compared to the previously provided guidance of at least $180 million.
Third Quarter and Recent Accomplishments and Highlights
Dermatology
•DecisionDx-Melanoma: In October 2023, the Company announced a new study demonstrating DecisionDx-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer

Center in predicting the risk of sentinel lymph node positivity in patients with cutaneous melanoma. The study can be found here.
•DecisionDx-SCC: In October 2023, the Company shared new data demonstrating the ability of its DecisionDx-SCC test to identify localized high-risk cutaneous squamous cell carcinoma patients at a higher risk of metastasis who may benefit from adjuvant radiation therapy. See the Company’s news release from October 3, 2023, for more information.
Gastroenterology
•In October, the Company announced new data demonstrating the significant clinical utility of its TissueCypher Barrett’s Esophagus test in guiding risk-aligned upstaging of care for patients with non-dysplastic Barrett’s esophagus (BE) at a higher risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) than indicated by their clinicopathologic risk factors. See the Company’s news release from October 2, 2023, for more information.
•In September, the Company announced the publication of data demonstrating that the TissueCypher Barrett’s Esophagus test outperformed standard of care pathology review in predicting malignant progression to HGD and EAC in BE patients with an initial diagnosis of low-grade dysplasia (LGD).The study can be found here.
•In September, the Company announced new data demonstrating its TissueCypher Barrett’s Esophagus test can identify patients at a higher or lower risk of developing esophageal cancer than indicated by pathologic diagnoses and clinical risk factors to guide escalated or de-escalated patient management. See the Company’s news release from September 8, 2023, for more information.
•In August, the Company announced a new study published in The American Journal of Gastroenterology showing how use of TissueCypher Barrett’s Esophagus test results can significantly improve management decisions for BE patients with LGD to improve health outcomes. The study can be found here.
Mental Health
•In September, the Company announced data from a study showing the addition of drug-drug interactions and lifestyle factors to drug-gene interactions provided by its IDgenetix test significantly impacted the number of drug recommendations and contributed to improved remission rates for patients with moderate to severe depression. See the Company’s new release from September 9, 2023, for more information.
Corporate
•In September, the Company announced that it had earned a Top Workplaces National Industry Award, ranking third among 84 Top Workplaces in the healthcare industry. Castle has earned several additional Top Workplace awards this year, including Top Workplaces USA and Arizona Top Workplace awards, both for the second consecutive year, as well as the Culture Excellence Awards for Innovation, Work-Life Flexibility, Compensation & Benefits, Leadership and Purpose & Values. See the Company’s news release from September 19, 2023, for more information.
•In September, the Company announced that it had received its Clinical Laboratory Permit from the New York State Department of Health for its laboratory in Pittsburgh. Castle operates clinical laboratories in Pittsburgh and Phoenix. With the recent successful inspection in Pittsburgh, both laboratories are now permitted to provide test services to patients and physicians in the state of New York. Castle’s Phoenix laboratory received its permit in early 2018. See the Company’s news release from September 12, 2023, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, Nov. 2, 2023, at 4:30 p.m. Eastern time to discuss its third 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 Nov. 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 925738.