On May 7, 2024 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2024 (Press release, Veracyte, MAY 7, 2024, View Source [SID1234642802]).

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"We had a strong start to 2024, driven by robust growth from our market-leading Decipher Prostate and Afirma tests. We executed upon our strategies to further penetrate these markets by expanding our clinical evidence, and, for Decipher, securing enhanced status in guidelines while also achieving a key commercial reimbursement milestone," said Marc Stapley, Veracyte’s chief executive officer. "We also expanded our capabilities into minimal residual disease (MRD) testing by completing our acquisition of C2i Genomics and initiating development of our first test using their novel, whole-genome approach."

Key Business Highlights

Increased first quarter total revenue by 17% to $96.8 million, compared to the first quarter of 2023.
Grew total test volume to 33,424, an increase of 16% compared to the first quarter of 2023.
Received the highest-level rating among gene expression tests for the Decipher Prostate Genomic Classifier in updated NCCN* prostate cancer guidelines.
Expanded clinical evidence for the Decipher Prostate test with a study published in JCO Precision Oncology showing that it is prognostic for progression in prostate cancer patients undergoing Active Surveillance.
Demonstrated the power of the Veracyte Diagnostic Platform to expand evidence with the presentation of 14 abstracts at the American Urological Association’s 2024 Annual Meeting, including podium presentations for our research-use-only Decipher GRID offerings in prostate cancer and bladder cancer.
Contracted with one of the largest commercial payers in the U.S., making the Decipher Prostate test an in-network offering for its close to 30 million members.
Received Medicare coverage for our Afirma TERT promoter gene mutation test, following publication of analytical validity data for the test in the Journal of Endocrinology & Metabolism.
Completed the acquisition of C2i Genomics and initiated development of an MRD test for muscle-invasive bladder cancer.
Ended the first quarter with $209.2 million of cash and cash equivalents.
* National Comprehensive Cancer Network. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

First Quarter 2024 Financial Results

Total revenue for the first quarter of 2024 was $96.8 million, an increase of 17% compared to $82.4 million reported in the first quarter of 2023. Testing revenue was $90.3 million, an increase of 25% compared to $72.4 million in the first quarter of 2023, driven primarily by the strong performance of our Decipher Prostate and Afirma tests. Product revenue was $3.5 million, a decrease of 9% compared to $3.9 million in the first quarter of 2023. Biopharmaceutical and other revenue was $3.0 million, a decrease of 51% compared to $6.1 million in the first quarter of 2023.

Total gross margin for the first quarter of 2024, including the amortization of acquired intangible assets, was 65%, compared to 62% in the first quarter of 2023. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 68%, compared to 68% in the first quarter of 2023.

Operating expenses, excluding cost of revenue, were $67.1 million. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, grew 6% to $61.6 million compared to $58.1 million in the first quarter of 2023.

Net loss for the first quarter of 2024 was $1.9 million, an improvement of 77% compared to the first quarter of 2023. Basic and diluted net loss per common share was $0.02, an improvement of $0.09 compared to the first quarter of 2023. Net cash used in operating activities in the first three months of 2024 was $9.0 million inclusive of the typical annual bonus payments and payroll tax reset in the first quarter, as well as C2i acquisition-related expenses, an increase of $6.8 million compared to the same period in 2023.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2024 Financial Outlook

The company is raising full-year 2024 total revenue guidance to $402 million to $410 million, representing year-over-year growth of 11% to 14% and testing growth of 15% to 18%. This guidance range represents an increase compared to prior guidance of $394 million to $402 million. In addition, the company now expects cash, cash equivalents and short-term investments at the end of the year to be $236 million to $240 million compared to prior guidance of $230 million to $234 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BI5ccb6c3c55e34500b5c9256eb8e1a7f4

On May 7, 2024 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter ended March 31, 2024 (Press release, Y-mAbs Therapeutics, MAY 7, 2024, View Source [SID1234642803]).

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"We continued to make meaningful progress across our commercial and clinical development initiatives during the first quarter of this year," said Mike Rossi, President and Chief Executive Officer. "On the commercial front, the first quarter of 2024 marked the highest quarter of U.S. demand for DANYELZA (naxitamab-gqgk) since its initial launch. Our recorded net product revenues in the first quarter were primarily driven by heightened demand across both new and existing U.S. accounts. DANYELZA remains a leading anti-GD2 therapy, and we continue to believe in its potential to serve patients beyond the high-risk relapse/refractory neuroblastoma market. In addition, we are highly encouraged by the clinical advancement of our Self-Assembly DisAssembly ("SADA") Pretargeted Radioimmunotherapy ("PRIT") Technology platform. With the potential to deliver optimal therapy with minimal toxicity, increase physician participation in the patient treatment journey, and leverage existing infrastructure as a potentially isotope-agnostic platform, we believe SADA PRIT has the potential to make a positive and lasting impact on patient care."

First Quarter 2024 and Recent Corporate Developments

● In April 2024, Y-mAbs’ distribution partner in Latin America, Adium, initiated the commercial launch of DANYELZA in Brazil and Mexico.
● On April 25, 2024, Y-mAbs announced several abstracts to be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting taking place May 31 through June 4, 2024, in Chicago, IL. The Company will be available to comment at booth #35151 on the Exhibition Floor of McCormick Place.
● On March 8, 2024, Bo Kruse, Executive Vice President, Chief Financial Officer, Secretary and Treasurer of Y-mAbs informed the Company of his intention to resign from such offices effective as of the date the Company appoints his successor and such successor commences employment with the Company and to resign from employment with the Company effective July 31, 2024. A search firm has been retained to assist in the recruitment of a new Chief Financial Officer.
● On February 29, 2024, the Board of Directors of Y-mAbs increased the size of the Board from eight to nine directors and elected Mary A. Tagliaferri, M.D., to serve as a Class I director of the Company. Dr. Tagliaferri’s term as a Class I director continues until the Company’s 2025 annual meeting of stockholders.

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Financial Results

Revenues

DANYELZA total net product revenues were $19.4 million for the quarter ended March 31, 2024, which represented a decrease of 4% over $20.3 million in the comparable period of 2023. Y-mAbs’ U.S. DANYELZA net product revenues were $18.6 million for the quarter ended March 31, 2024, an increase of 11% over $16.8 million in the comparable period of 2023. The Company had international DANYELZA net product revenues of $0.8 million and $3.4 million in the quarters ended March 31, 2024 and 2023, respectively. The decrease in the quarter ended March 31, 2024, compared to the quarter ended March 31, 2023, was a result of a 2023 initial product stocking shipment of $2.5 million to Y-mAbs’ distribution partner, WEP, in connection with an early access program for DANYELZA in Europe. The Company did not have a shipment to WEP in the quarter ended March 31, 2024. Volumes for international shipments can vary from quarter to quarter, and the Company expects a higher volume to resume in future quarters in 2024.

U.S. DANYELZA net product revenues increased 3% compared to the quarter ended December 31, 2023, when excluding the $0.3 million and $1.3 million impact of a Medicaid accrual change in estimate recognized as increases in net product revenues in the quarters ended March 31, 2024 and December 31, 2023, respectively. DANYELZA total net product revenues of $19.4 million in the first quarter of 2024, represented a 17% decrease compared to the fourth quarter of 2023, primarily driven by decreased international revenues.

As of March 31, 2024, Y-mAbs has delivered DANYELZA to 63 centers across the U.S. since initial launch, with five new accounts added in the first quarter of 2024. During the quarter ended March 31, 2024, approximately 60% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center ("MSK"), compared to 55% in the fourth quarter ended December 31, 2023.

The Company had license revenues of $0.5 million for the quarter ended March 31, 2024. License revenue for the quarter ended March 31, 2024 arose from the January 2024 acceptance of the Brazilian Medicines Market Regulation Chamber ("CMED") price for DANYELZA. The Company did not have license revenue for the quarter ended March 31, 2023.

Operating Costs and Expenses

Cost of Goods Sold

Cost of goods sold was $2.1 million for the quarters ended March 31, 2024 and 2023, respectively.

The Company’s gross margin in the quarters ended March 31, 2024 and 2023 remained approximately constant at 89% and 90%, respectively. The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues.

Research and Development

Research and development expenses were $13.3 million for the quarter ended March 31, 2024, a decrease of 1% compared to $13.4 million for the quarter ended March 31, 2023. The $0.1 million decrease was mainly due to decreased personnel related costs of $2.6 million, inclusive of the impact of the Company’s restructuring charge recorded in the quarter ended March 31, 2023, partially offset by a $2.5 million increase in clinical trial expenses related to the Company’s investments in SADA PRIT Technology in 2024.

Selling, General, and Administration

Selling, general, and administrative expenses were $11.4 million for the quarter ended March 31, 2024, which was a $0.8 million decrease compared to $12.2 million for the quarter ended March 31, 2023. The $0.8 million decrease in selling, general, and administrative expenses was primarily attributable to a decrease in personnel related costs related to the Company’s $1.1 million restructuring charge recorded in the quarter ended March 31, 2023.

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Interest and Other Income

Interest and other income was $0.4 million for the quarter ended March 31, 2024, as compared to $1.1 million for the quarter ended March 31, 2023. The decrease of $0.7 million was primarily due to a $0.6 million decrease in foreign currency transaction income.

Net Loss

Y-mAbs reported a net loss for the quarter ended March 31, 2024, of $(6.6) million, or $(0.15) per basic and diluted share, which was relatively flat compared to net loss of $(6.4) million, or $(0.15) per basic and diluted share, for the quarter ended March 31, 2023.

Cash and Cash Equivalents

As of March 31, 2024, Y-mAbs had approximately $75.7 million in cash and cash equivalents which, together with anticipated DANYELZA product revenues, is expected to support operations as currently planned into 2027. This estimate reflects the Company’s current business plan that is supported by assumptions that may prove to be inaccurate, such that Y-mAbs could use its available capital resources sooner than it currently expects. The cash burn for the first quarter of 2024 was $2.9 million.

2024 Financial Guidance

Management reiterates its full year 2024 guidance:

● Anticipated total DANYELZA net product revenues of between $95 million and $100 million;
● Anticipated operating expenses of between $115 million and $120 million;
● Anticipated total annual cash burn of between $15 million and $20 million; and
● Cash and cash equivalents anticipated to continue to support operations as currently planned into 2027.

On May 7, 2024 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received an issue notification from the U.S. Patent and Trademark Office for a new patent which covers extended-release oral formulations of MN-166 (ibudilast) (Press release, MediciNova, MAY 7, 2024, https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-issue-notification-new-patent-covering [SID1234642806]). This new patent is expected to expire no earlier than September 2040. The allowed claims cover a formulation in the form of a tablet or capsule and cover a range of doses of MN-166 (ibudilast).

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Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased to receive the issue notification for this new patent and we believe it could increase the potential value of MN-166. New extended-release formulations are more convenient for patients which may lead to improve compliance with the dosing schedule and to reduce undesirable side effect."

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy- induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

On May 7, 2024 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the quarter ended March 31, 2024, and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAY 7, 2024, View Source [SID1234642804]).

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"Zentalis continues to advance towards a catalyst-rich period during the second half of 2024 and into 2025, with a clear path to demonstrating the clinical profile of azenosertib, our potentially first-in-class and best-in-class WEE1 inhibitor, across various tumor types," said Kimberly Blackwell, M.D., Chief Executive Officer. "We believe that the data emerging this year and next have the potential to establish azenosertib’s monotherapy activity, differentiated safety and efficacy profile, and its ability to address significant unmet need for patients with serious gynecological cancers. Our clinical development plan remains on track as we work to bring azenosertib to patients living with gynecological cancers and other solid tumors."

Program Updates and Highlights
•Phase 1 azenosertib clinical data in osteosarcoma to be presented at ASCO (Free ASCO Whitepaper). In accordance with the Company’s guidance, Phase 1 results of azenosertib in combination with gemcitabine in adult and pediatric patients with relapsed or refractory (R/R) osteosarcoma will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
•Azenosertib preclinical data at AACR (Free AACR Whitepaper). On April 9, 2024, Zentalis presented preclinical data demonstrating that azenosertib exerts synergistic anti-tumor activity with KRASG12C inhibitors at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. This research supports azenosertib’s potential to be highly synergistic in combination with KRAS targeted cancer therapeutics, creating an additional large opportunity to combine with other standard of care targeted agents.
•Azenosertib development continues to progress on track across gynecological and other tumor types. Azenosertib is being evaluated in more than 10 ongoing and planned clinical trials as a monotherapy and in combinations supported by compelling scientific rationales across a broad array of tumor types, including platinum resistant ovarian cancer (PROC), platinum sensitive ovarian cancer (PSOC), uterine serous carcinoma (USC), BRAF mutant metastatic colorectal cancer, and other solid tumors. In addition, the Company is evaluating azenosertib and its BCL-2 inhibitor (ZN-d5) in patients with R/R acute myeloid leukemia (AML).

Corporate Updates

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•On April 5, 2024, Cam Gallagher was appointed interim Chief Financial Officer while the Company conducts a search for a new Chief Financial Officer.

Anticipated Upcoming Milestones
•1H 2024
◦Presentation of final results of Phase 1 (ZN-c3-003) azenosertib + chemotherapy (gemcitabine) trial in R/R osteosarcoma at 2024 ASCO (Free ASCO Whitepaper) Annual Meeting
•2H 2024
◦Presentation of final results of Phase 1b (ZN-c3-001) azenosertib monotherapy trial in solid tumors
◦Topline data from Phase 1/2 MAMMOTH (ZN-c3-006) azenosertib + PARP inhibitor (niraparib) and azenosertib monotherapy trial in platinum resistant ovarian cancer in partnership with GSK
◦Presentation of initial data from Phase 1 (ZN-c3-016) azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer
◦Initial data from Phase 1 (ZN-d5-004C) azenosertib + ZN-d5 trial in R/R AML
◦Additional details on design of planned registration-enabling trial of azenosertib in PSOC in the 1L maintenance setting
•1H 2025
◦Topline data from registration-enabling Phase 2 DENALI study (ZN-c3-005) of azenosertib monotherapy in platinum resistant high-grade serous ovarian cancer
•2H 2025
◦Topline data from registration-enabling Phase 2 TETON study (ZN-c3-004) of azenosertib monotherapy in recurrent or persistent USC
•2025
◦Initiate registration-enabling trial of azenosertib in PSOC in the 1L maintenance setting
•2026
◦First NDA for azenosertib in a gynecologic malignancy

First Quarter 2024 Financial Results
•Cash, Cash Equivalents and Marketable Securities Position: As of March 31, 2024, Zentalis had cash, cash equivalents and marketable securities of $489.0 million, which includes $56.7 million representing the March 31, 2024 fair value of Immunome common stock received by the Company as part of its upfront payment for the out-licensing of its ROR1 antibody-drug conjugate (ADC) product candidate and ADC platform in January 2024. The Company believes that its existing cash, cash equivalents and marketable securities (excluding the Immunome

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stock) as of March 31, 2024 will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2026.
•Research and Development Expenses: Research and development (R&D) expenses for the three months ended March 31, 2024, were $49.6 million, compared to $48.6 million for the three months ended March 31, 2023. The increase of $1.0 million was primarily due to increases of $2.4 million and $2.2 million from drug product and clinical expense, respectively. We also saw increases of $0.7 million and $0.7 million from consulting and R&D cost sharing, respectively. These increases were partially offset by a decrease of $4.7 million in overhead allocations and a $0.3 million decrease of personnel expense.
•General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2024, were $15.7 million, compared to $16.4 million during the three months ended March 31, 2023. This decrease of $0.7 million was primarily attributable to $0.8 million and $0.7 million decreases in depreciation and other expenses, respectively. This was partially offset by $0.8 million increase related to personnel expense, of which $0.2 million is from non-cash stock-based compensation expense.

About Azenosertib
Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

On May 7, 2024 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that company management will participate in a fireside chat at two upcoming investor conferences (Press release, Syros Pharmaceuticals, MAY 7, 2024, View Source [SID1234642798]). Details are as follows:

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JMP Securities 2024 Life Sciences Conference
Date: Tuesday, May 14
Presentation Time: 11:00 a.m. ET
Location: New York Hilton Midtown, 1335 Sixth Avenue, New York, NY

TD Cowen’s 5th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)
Date: Wednesday, May 29
Presentation Time: 1:00 p.m. ET
Location: Virtual

To access the webcasts and subsequent archived recording of each event, please visit the Investors & Media section of the Syros website at www.syros.com. An archived replay of each webcast will be available for approximately 30 days following each presentation.