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.

On May 7, 2024 Rigel Pharmaceuticals, Inc. reported financial results for the first quarter ended March 31, 2024, including sales of TAVALISSE (fostamatinib disodium hexahydrate) tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and sales of REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (Press release, Rigel, MAY 7, 2024, View Source [SID1234642797]).

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"Results for the first quarter of 2024 continued to demonstrate strong commercial demand with the highest number of TAVALISSE and REZLIDHIA bottles sold in a quarter since launch. We are also excited about the recent acquisition of GAVRETO and are on track to include this product in our commercial portfolio in July of this year," said Raul Rodriguez, Rigel’s president and CEO. "At the same time, we are progressing the development of olutasidenib with our strategic collaborators, MD Anderson and CONNECT, and driving forward our other pipeline programs."

Business Update

In the first quarter of 2024, a total of 2,193 TAVALISSE bottles were sold in the U.S. driven by 2,483 bottles shipped to patients and clinics, the highest number in a quarter since launch. Bottles remaining in distribution channels decreased by 290 bottles during the quarter.
In the first quarter of 2024, a total of 390 REZLIDHIA bottles were sold in the U.S., significantly accelerating sales growth over last year. This growth was driven by increased demand, with 326 bottles shipped to patients and clinics.
In April 2024, Rigel announced a peer-reviewed publication in Leukemia & Lymphoma on data from an analysis of the Phase 2 study evaluating REZLIDHIA in patients with mIDH1 AML who were R/R to prior venetoclax-based regimens. The findings from these analyses suggest that REZLIDHIA may provide an effective treatment for patients with recurrent AML following venetoclax combination therapy. REZLIDHIA induced durable remissions consistent with those observed in the pivotal trial and had a favorable tolerability profile.
In March 2024, Rigel appointed Lisa Rojkjaer, M.D. as Executive Vice President and Chief Medical Officer. Dr. Rojkjaer is an industry veteran with over 20 years of clinical development, regulatory, and medical affairs experience with a focus on hematology and oncology. She is a board-certified hematologist with an international clinical practice background.
In February 2024, Rigel announced the acquisition of the U.S. rights to GAVRETO (pralsetinib). GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions. GAVRETO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer. The acquisition of this product further expands Rigel’s portfolio and leverages Rigel’s existing infrastructure in both the institutional and community settings. Rigel expects to complete the transition of the asset and start recognizing product sales in July 2024.
In January 2024, Rigel and CONNECT announced a strategic development collaboration to evaluate REZLIDHIA (olutasidenib) in combination with temozolomide in patients with high-grade glioma (HGG) harboring an IDH1 mutation. Under the collaboration, CONNECT will include olutasidenib in CONNECT’s TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. In the Rigel-sponsored arm, adolescents and young adult patients (≤39 years old) with newly diagnosed IDH1-mutation positive HGG will receive maintenance therapy with olutasidenib in combination with temozolomide for the first year after radiotherapy, followed by olutasidenib monotherapy for the second year. Rigel will provide CONNECT funding up to $3 million and study material over the four-year collaboration.
Rigel continues to advance its Phase 1b clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective IRAK1/4 inhibitor, in patients with relapsed/refractory lower-risk myelodysplastic syndrome (LR-MDS). Enrollment in the third cohort of the trial has been completed and the company is planning to include two additional cohorts with twice daily dosing regimens. Preliminary data are expected by the end of 2024.
Financial Update
For the first quarter of 2024, total revenues were $29.5 million, consisting of $21.1 million in TAVALISSE net product sales, $4.9 million in REZLIDHIA net product sales, and $3.5 million in contract revenue from collaborations. Although TAVALISSE bottles shipped to patients and clinics reached the highest quarterly number of bottles since launch, net product sales were $21.1 million compared to $22.3 million in the same period of 2023, primarily due to a decrease in the number of bottles remaining in distribution channels. REZLIDHIA net product sales were $4.9 million compared to $1.5 million in the same period of 2023. Contract revenue from collaborations consisted of $2.3 million from Kissei Pharmaceutical Co., Ltd. related to delivery of drug supplies, $1.1 million from Grifols S.A. related to earned royalties, and $0.1 million from Medison Pharma Trading AG related to delivery of drug supplies and earned royalties.

For the first quarter of 2024, total costs and expenses were $36.5 million compared to $38.8 million for the same period of 2023. The decrease in costs and expenses was partly due to decreased research and development costs due to the timing of clinical trial activities related to the IRAK 1/4 inhibitor program, as well as the timing of trial completion activities related to two Phase 3 clinical trials of fostamatinib in patients with COVID-19 and wAIHA. In addition, the decrease was due to lower consulting and third-party services as well as lower facility-related costs. These decreases were partially offset by higher stock-based compensation expenses, mainly from performance-based awards.

For the first quarter of 2024, Rigel reported a net loss of $8.2 million, or $0.05 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted share, for the same period of 2023.

As of March 31, 2024, Rigel had cash, cash equivalents and short-term investments of $49.6 million, compared to $56.9 million as of December 31, 2023. In April 2024, Rigel entered into an amendment to the Credit Agreement with MidCap Financial Trust. As part of the amendment, Rigel extended the maturity date and interest only period by one year.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.