On November 8, 2024 Infinitopes, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, reported that it will be presenting three posters on its pioneering cancer vaccine discovery and development, including one that has been recognised as a ‘top 100’ poster presentation, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024, held in Houston, US, from 6-10th November (Press release, Infinitopes, NOV 8, 2024, View Source [SID1234648048]).

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A spinout from Oxford University, supported by Cancer Research UK (CRUK), Infinitopes announced its oversubscribed £12.8 million seed financing in April 2024, to advance its AI/ML Precision ImmunomicsTM antigen discovery platform. The Company exploits this technology to accurately design ‘best-in-class’ therapeutics for multiple cancer indications. Led by an exceptional Scientific Advisory Board (SAB) and world-class team of clinicians, scientists, and regulatory leaders, Infinitopes is poised to commence its lead vaccine candidate ITOP1 in a highly anticipated, double-blind, randomised, placebo-controlled phase I/IIa clinical trial, starting H1’25 at four UK NHS university cancer centres, to treat patients with oesophageal cancer (OC).

Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, said: "Using our integrated ‘right targets, right vectors, right patients, right time’ approach, we aim to address the unmet clinical need for durably effective, accessible therapies, to save lives by preventing or significantly delaying disease recurrence for cancer patients. We combine our deep knowledge of the field of immunology with our uniquely sensitive AI/ML Precision ImmunomicsTM platform to identify and select optimal synergistic tumour targets, alongside engineering safe and effective proprietary vector delivery systems, designed to reliably stimulate lasting T-cell protection. With our expert capabilities and highly experienced team, our strategy to win an Innovation & Licensing Access Pathway (ILAP) innovation passport from the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has unlocked rapid entry into an ambitious clinical development programme for our lead vaccine candidate, ITOP1. The VISTA study, commencing H1’25, will open to oesophageal cancer patients most likely to positively respond, at the moment of their cancer journey where long-term protection is anticipated to be most likely."

Abstract One, number 635 is titled ‘A randomised, placebo-controlled, multi-centre Phase I/IIa study evaluating the safety and clinical activity of a novel viral vector cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study)’. It details the overall design and purpose of the Oxford University-led VISTA study, to test Infinitopes’ ITOP1 vaccine in HLA-matched patients undergoing surgery to remove their oesophageal cancers (OC). ITOP1 is an "off-the-shelf" vaccine administered as a prime-boost regimen before and after surgery, to prevent recurrence for patients with OC. OC is the 12th most common type of cancer in the UK, with about 10,000 cases a year. Due to its poor prognosis OC is the UK’s sixth most common cause of cancer deaths, claiming around 8,500 lives annually. Surgical resection plus neoadjuvant/adjuvant chemotherapy is the current best standard of care. Nearly half of those patients undergoing this ‘curative’ surgery suffer recurrence even after best standard of care; with a median disease-free survival of 11 months.

Abstract Two, number 1039 recognised as a ‘top 100’ SITC (Free SITC Whitepaper) poster, is titled ‘Vaccination with a single dose of a novel delivery platform confers durable >8 month immune responses, with lasting protection against tumour and metastases in preclinical models’. It details how Infinitopes has developed a foundational, proprietary vector delivery system and confirmed the success of this approach in industry-standard preclinical models. Immunisation with a single priming dose reliably generated durable, antigen-specific immune T-cell protection, capable of halting or significantly delaying tumour progression, without checkpoint inhibitor co-treatment. Up to 80% of mice survived tumour challenge, versus control animals dying within three weeks. Metastases were completely suppressed in multiple models.

Abstract Three, number 1427 is titled ‘Precision ImmunomicsTM: Identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platform’. It details how Infinitopes has used its unique AI/ML Precision ImmunomicsTM antigen discovery platform to identify hundreds of novel cancer-specific antigens from primary tumour samples. The abstract explains how this best-in-class pool of therapeutic combination targets could be used to accurately treat tumours, forming the basis for a suite of "off-the-shelf" therapies for many different cancer types. Infinitopes has begun discussions with potential Big Pharma collaboration partners to licence these for use in T-cell, TCR and other modalities, and is excited to progress its own vaccine programme.

Prof. David Curiel, Professor of Radiation Oncology and Director of the Biologic Therapeutic Centre at Washington University St Louis., commented: "Infinitopes’ systematic approach to cancer vaccine development is making rapid and substantive progress. This week’s findings support acceleration towards clinical development. Infinitopes’ lead candidate ITOP1 represents a significant milestone for the Company, and is a potential treatment paradigm change for the early and effective treatment of future patients with cancerous tumours, beginning with oesophageal cancer."

Details of the poster presentations are as follows:

Poster Title: A randomised, placebo-controlled, multi-centre Phase I/IIa study evaluating the safety and clinical activity of a novel viral vector cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study)
Abstract Number: 635
Primary Category: Clinical Trials in Progress
Presenting Author: Michael Grant, Executive Medical Director at Infinitopes
Date & Time: Friday 8 November 2024, 9am – 7pm CDT
Abstract Authors: Michael Grant¹, Jonathan Kwok¹, Paul Smith¹, Lian Ni Lee¹, Senthil Chinnakannan¹, Orion Tong¹, David Thompson², Paul Klenerman², Nicola Ternette² and Mark Middleton²

¹ Infinitopes, Oxford, UK, ² University of Oxford, Oxford, UK

Poster Title: Vaccination with a single dose of a novel delivery platform confers durable >8 month immune responses, with lasting protection against tumour and metastases in preclinical models
Abstract Number: 1039
Primary Category: Immune-Stimulants and Immune Modulators
Presenting Author: Lian Lee, VP Preclinical & Co-Founder at Infinitopes
Date & Time: Friday 8 November 2024, 9am – 7pm CDT
Abstract Authors: Lian Ni Lee1, Jonathan Kwok1, Anna Maria Theresa Kroon2, Senthil Chinnakannan1, Spyridoula Marinou1, Annemieke Kok1, Callum Beach1, Steve John1, Tim Davies1, Andrew Highton2, Catherine de Lara2, Claire Hutchings2, Robert Parker1, Silvia Salatino2, Orion Tong1, Nicola Ternette2, Uzi Gileadi2, Paul Klenerman2

¹ Infinitopes, Oxford, UK, ² University of Oxford, Oxford, UK

Poster Title: Precision ImmunomicsTM: Identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platform
Abstract Number: 1427
Primary Category: Antigen Presentation
Presenting Author: Georges Bedran, Senior Scientist & Computational Immunomics Lead at Infinitopes
Date & Time: Friday 8 November 2024, 9am – 7pm CDT
Abstract Authors: Yuxin Sun¹, Nil Adell Mill¹, Tiffany Ma¹, Yves du Toit¹, Ava Van Ess¹, Chloe Hyun-Jung Lee¹, Spyridoula Marinou¹, Annemieke ten Bokum¹, May Ke¹, Oliver Turnbull¹, Luke Heirene¹, Lian Ni Lee¹, Alexey I. Nesvizhskii², Pouya Faridi³, Paul Klenerman⁴, Jonathan Kwok¹, Orion Tong¹, Robert Parker¹ and Georges Bedran

On November 8, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the third quarter 2024 (Press release, Sana Biotechnology, NOV 8, 2024, View Source [SID1234648033]).

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"Early clinical data with our hypoimmune technology suggest HIP-modified cells evade immune detection, and we look forward to sharing data in 2024 and 2025 across multiple clinical settings, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology," said Steve Harr, Sana’s President and Chief Executive Officer. "This past quarter was an important one for the company, as we enhanced our leadership team with the addition of Dhaval Patel as our new Chief Scientific Officer, made progress with our clinical programs, and focused our pipeline. We are optimistic that our recent strategic repositioning to increase focus on immunologic diseases, particularly type 1 diabetes and B-cell mediated autoimmune diseases, will help accelerate development and prolong the capital runway for the company. We look forward to multiple clinical data readouts with our current balance sheet with our cash runway into 2026."

Payments related to ongoing activities combined with the strategic repositioning may increase the 2024 operating cash burn above prior guidance of less than $200 million.

Recent Corporate Highlights

Advancing three clinical programs across five indications, including a gene-modified primary islet cell therapy in type 1 diabetes, an allogeneic CAR T program for B-cell mediated autoimmune diseases, and an allogeneic CAR T program for cancer patients that have failed a CD19-targeted therapy:

Type 1 Diabetes – UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells in type 1 diabetics without any immunosuppression. Sana expects to share initial data in 2024 and/or 2025. Sana is also making progress with the pre-clinical development of SC451, a HIP-modified, stem cell-derived pancreatic islet cell program.
B-cell Mediated Autoimmune Diseases – The GLEAM trial evaluates SC291, a HIP-modified CD19-directed allogeneic CAR T therapy, in patients with B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Sana is enrolling patients in this study and expects to share initial data in 2024 and/or 2025.
Oncology – The VIVID trial evaluates SC262, a HIP-modified CD22-directed allogeneic CAR T therapy, in patients with relapsed or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy. Sana is enrolling patients and expects to share data in 2025.
Strengthened Research and Development leadership with the appointment of new Chief Scientific Officer

Appointed Dhaval Patel, M.D., Ph.D., as Executive Vice President and Chief Scientific Officer. Dr. Patel has decades of experience in research, drug discovery, drug development, and clinical care – including roles at UCB, Novartis, University of North Carolina, and the Duke University School of Medicine – and over the course of his career has participated in the development of 10 approved drugs in multiple indications.
Third Quarter 2024 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2024 were $199.0 million compared to $205.2 million as of December 31, 2023. The decrease of $6.2 million was primarily driven by cash used in operations of $176.0 million and cash used for the purchase of property and equipment of $33.0 million, partially offset by net proceeds from equity financings of $181.0 million, proceeds from stock option exercises and the employee stock purchase plan of $10.3 million, and net proceeds of $7.8 million from a loan to fund tenant improvements for our manufacturing facility in Bothell, Washington during the nine months ended September 30, 2024.

Research and Development Expenses: For the three and nine months ended September 30, 2024, research and development expenses, inclusive of non-cash expenses, were $53.2 million and $170.5 million, respectively, compared to $65.6 million and $205.8 million for the same periods in 2023. The decreases of $12.4 million and $35.3 million for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023 were primarily due to lower personnel-related and laboratory costs due to a decrease in headcount and decreased research costs related to the strategic repositioning in the fourth quarter of 2023, lower costs for third-party manufacturing at contract development and manufacturing organizations, and a decline in facility and other allocated costs. These decreases were partially offset by increased clinical development costs. Research and development expenses include non-cash stock-based compensation of $6.5 million and $19.5 million, respectively, for the three and nine months ended September 30, 2024 and $5.7 million and $18.4 million, for the same periods in 2023.

Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2024, Sana recognized a non-cash gain of $5.5 million and a non-cash expense of $4.6 million, respectively, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to non-cash gains of $82.6 million and $55.8 million for the same periods in 2023. The value of these potential liabilities fluctuate significantly with changes in Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2024, inclusive of non-cash expenses, were $14.1 million and $46.8 million, respectively, compared to $19.2 million and $52.5 million for the same periods in 2023. The decreases of $5.1 million and $5.8 million for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023 were primarily due to a decrease in costs related to Sana’s previously planned manufacturing facility in Fremont, California, a decrease in legal and consulting fees, and lower personnel-related costs due to a decrease in headcount. These decreases were partially offset by an increase in non-cash stock-based compensation.

Net Loss: Net loss for the three and nine months ended September 30, 2024 was $59.9 million, or $0.25 per share, and $217.7 million, or $0.95 per share, respectively. Net income for the three months ended September 30, 2023 was $1.0 million, or $0.00 per share, and net loss for the nine months ended September 30, 2023 was $195.1 million, or $1.01 per share.

Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the nine months ended September 30, 2024 was $153.1 million compared to $187.2 million for the same period in 2023. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development, non-recurring items, and the purchase of property and equipment.
Non-GAAP General and Administrative Expenses: Non-GAAP general and administrative expenses for the three and nine months ended September 30, 2024 were $14.1 million and $46.8 million, respectively, compared to $16.5 million and $49.8 million for the same periods in 2023. Non-GAAP general and administrative expenses for the three and nine months ended September 30, 2023 excludes the loss on termination of the Fremont lease.
Non-GAAP Net Loss: Non-GAAP net loss for the three and nine months ended September 30, 2024 was $64.7 million, or $0.27 per share, and $208.3 million, or $0.91 per share, respectively, compared to $79.0 million, or $0.41 per share, and $248.3 million, or $1.28 per share, for the same periods in 2023. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, the impairment of other assets, and, for the three and nine months ended September 30, 2023, the loss on termination of the Fremont lease.

On November 8, 2024 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported an oral presentation at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2024 annual meeting, occurring November 6 – 10, 2024, in Houston, Texas (Press release, Myeloid Therapeutics, NOV 8, 2024, View Source [SID1234648049]). Dr. Matthew Maurer, Myeloid’s Chief Medical Officer, will present on Myeloid’s discovery and development of MT-303. MT-303 is the Company’s second in vivo mRNA CAR program to enter the clinic from its pipeline of in vivo immune cell programming therapies.

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MT-303 is a first-in-class Glypican-3 (GPC3) targeting CAR encoded from mRNA and encapsulated in lipid nanoparticles. It is currently in a first-in-human Phase 1 clinical trial of advanced hepatocellular carcinoma (HCC). There are limited treatment options to combat HCC.

GPC3 is a target of growing therapeutic interest given its overexpression in many cancers, including the majority of hepatocellular carcinomas, coupled with limited expression in normal tissues. GPC3 expression has been linked to aggressive tumor behavior and poor prognosis.

Myeloid’s treatment approach focuses on selective in vivo programming of immune cell subsets with innovative off-the-shelf mRNA-encoded CAR technologies. These candidates are administered without the need for preconditioning. MT-303 arms myeloid cells with a proprietary chimeric antigen receptor that expresses specifically within myeloid cells. This approach directs and enables myeloid cells to kill GPC3 expressing cancers while orchestrating a coordinated adaptive immune anti-tumor response marked by expansion of new T cell clones.

"Myeloid has rapidly advanced MT-303 into first-in-human testing as our second in vivo CAR clinical program. Dose escalation of MT-303 and MT-302 continues, and we are encouraged by the ongoing biologic indications of proof-of-mechanism, as well as the early observed safety and efficacy experience," said Dr. Matthew Maurer, Chief Medical Officer of Myeloid. "The clinical observations extend the earlier preclinical results, that also demonstrated selective activation of CAR myeloid cells and robust anti-tumor activity in mouse hepatocellular tumor models."

Oral presentation details are as follows:

Abstract #: 1125
Title: "Preclinical Development of MT-303, a Novel LNP-Formulated GPC3-Specific CAR mRNA, for in vivo Programming of Monocytes to Treat Hepatocellular Carcinoma"
Session Title: Protein and Cellular Engineering Strategies
Session Date and Time: Friday, November 8, 2024, 5:10 pm
Presenting Author: Matthew Maurer – Myeloid Therapeutics

For more information, please visit the SITC (Free SITC Whitepaper) 2024 website.

Myeloid’s in vivo programming candidates are designed with proprietary insights to deliver personalized therapy, providing benefits to patients while reducing time and costs through the elimination of ex vivo handling of patient cells and complex neoantigen sequencing. The Myeloid platform integrates validated antibody/antigen binding with novel combinations of myeloid signaling domains, coded within a simple mRNA that can be delivered repeatedly using lipid nanoparticles (LNPs). The platform’s versatility provides a range of signaling domains and immune cell types useful for combination approaches.

About Liver Cancer

With limited treatment options, and over 850,000 new cases diagnosed globally each year, liver cancer has become the third leading cause of cancer death. After initial treatment success with small molecule therapies, the development of new treatment approaches in the field of liver cancer has been limited. Today, patients with liver cancer who are refractory to first line treatment are left with few treatment options, creating a substantial unmet medical need. Myeloid sees an opportunity to make a significant contribution to address this need, by providing a new CAR for these patients who are living with liver cancer. The CARs are capable of providing a coordinated and durable immune response to counter advanced disease. The CARs are combinable and will expand the treatment options for physicians.

About the Phase 1 Study of MT-303

The MT-303 Phase 1 study (NCT06478693) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adults with advanced or metastatic hepatocellular carcinoma that overexpresses GPC3. This study will also define the recommended Phase 2 dose (RP2D) of MT-303.

About MT-303

MT-303 represents the first candidate in a new therapeutic modality targeting hepatocellular carcinoma (HCC). This clinical candidate is a first-in-class, GPC3-FcA-LNP, with a strong preclinical profile supporting its advance into this first-in-human trial. GPC3 is overexpressed in most human hepatocellular carcinomas, with limited expression in corresponding normal tissues. Increased GPC3 expression has been linked to tumor growth.

Treatment with MT-303 as a monotherapy demonstrates activity in a GPC3/HCC preclinical model, confirming the tumor-fighting potency of programmed myeloid cells even in the model’s absence of T cells. MT-303 has demonstrated strong expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-303 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells.

MT-303 represents Myeloid’s second in vivo CAR clinical program, building on the company’s innovative approach to cancer treatment through immune cell programming.

On November 8, 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 third quarter ended September 30, 2024 (Press release, Y-mAbs Therapeutics, NOV 8, 2024, View Source [SID1234648034]).

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"The third quarter of this year was one of continued focus and execution across our DANYELZA commercial business and our novel SADA PRIT radiopharmaceutical platform development pipeline," said Michael Rossi, President and Chief Executive Officer. "Physician usage of DANYELZA in the U.S. continues to remain very strong for patients with relapsed/refractory high-risk neuroblastoma. In addition, we continue to drive ex-U.S. market expansion with our new exclusive license and distribution agreement with Nobelpharma in Japan and the launch of our named patient program in Turkey. From a SADA PRIT pipeline standpoint, we expect to complete Part A of our GD2-SADA Phase 1 trial this year and present that data in the first quarter of next year."

Third Quarter 2024 and Recent Corporate Highlights

● Effective October 29, 2024, Y-mAbs entered into an exclusive license and distribution agreement with Nobelpharma for the development and commercialization of DANYELZA in Japan. Pursuant to the agreement, the Company recognized an upfront payment of $2.0 million in the fourth quarter of 2024. Y-mAbs is entitled to receive up to $31.0 million in product and commercial milestone payments in addition to profit sharing on the commercial sales of DANYELZA, if successfully approved and commercialized in Japan.
● Y-mAbs received notification of the accepted patent extension for DANYELZA, US 9,315,585, through February 2034.
● The Company’s named patient program for DANYELZA launched in Turkey with partner TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC.
● Y-mAbs presented new clinical and preclinical data from studies evaluating anti-GD2 therapy naxitamab and the Company’s first program from its Self-Assembly DisAssembly Radioimmunotherapy Technology Platform ("SADA PRIT"), GD2-SADA, respectively, in neuroblastoma in poster presentations at the American Academy of Cancer Research Special Conference in the Advanced in Pediatric Cancer Research on September 6-7, 2024 in Toronto, Canada.
● The Company entered into a lease agreement for a term of ten years and nine months for office space in Princeton, New Jersey, where the Company plans to transition its headquarters in the first half of 2025 upon being provided access to the location.

Graphic

Financial Results

Revenues

Total net revenues for the quarter ended September 30, 2024 were $18.5 million, a 10% decline over total net revenues for the quarter ended September 30, 2023 of $20.5 million, which included $0.5 million in license revenue, primarily driven by decreased net product revenues in both U.S. and ex-U.S. markets.

Total net revenues for the nine months ended September 30, 2024 were relatively flat compared to the nine months ended September 30, 2023, at $61.2 million and $61.5 million, respectively. The slight decrease was driven by a $0.7 million decrease in ex-U.S. DANYELZA net product revenues in the nine months ended September 30, 2024, which was partially offset by increased net product revenues in the U.S.

The Company’s U.S. DANYELZA net product revenues were $15.3 million and $16.1 million for the three months ended September 30, 2024 and 2023, respectively, representing a 5% decline, primarily due to an unfavorable price mix, partially offset by increased volume of 5% vial growth over the same time period.

Y-mAbs’ ex-U.S. DANYELZA net product revenues for the quarter ended September 30, 2024 were $3.1 million, a 19% decline from $3.9 million in the comparable period in 2023, primarily driven by decreased volume from Western Europe partially offset by volume increases in the remaining ex-U.S. territories.

As of September 30, 2024, Y-mAbs had delivered DANYELZA to 68 centers across the U.S. since initial launch, with three new accounts added in the U.S. in the third quarter of 2024. During the quarter ended September 30, 2024, approximately 65% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center ("MSK"), compared to 67% in the second quarter ended June 30, 2024.

The Company did not have license revenue for the quarter ended September 30, 2024. The Company had license revenues of $0.5 million for the nine months ended September 30, 2024, from its Latin America distribution partner, Adium, related to price approval for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber. The Company had license revenues of $0.5 million for the quarter and nine months ended September 30, 2023 from Adium, recognized upon the September 2023 achievement of marketing authorization for DANYELZA in Mexico.

Operating Costs and Expenses

Cost of Goods Sold

Cost of goods sold were $2.3 million and $2.6 million for the quarter ended September 30, 2024 and 2023, respectively. Cost of goods sold were $7.4 million and $9.3 million for the nine months ended September 30, 2024 and 2023, respectively. Cost of goods sold included lower vial volumes of 1% and 37% in the three and nine months ended September 30, 2024, compared to the same periods in 2023, respectively. Cost of goods sold also included $0.4 million and $0.8 million inventory write-downs in the three and nine months ended September 30, 2023, respectively.

The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues. The Company’s gross margins was relatively unchanged in the quarter ended September 30, 2024, compared to the comparable periods in 2023. The Company’s gross margins increased in the nine months ended September 30, 2024, compared to the comparable period in 2023, due to a favorable gross profit mix from revenue in international regions, particularly Eastern Asia that had an inventory stocking order in the nine months ended September 30, 2024, and inventory write-downs during the comparable periods in 2023, as noted above.

Research and Development

Research and development expenses were $11.2 million for the quarter ended September 30, 2024, a decrease of $4.2 million when compared with the same period in 2023. The decrease in research and development expenses was primarily attributable to the recognition of $4.1 million of milestone and license acquisition costs related to the Company’s SADA license agreement during the three months ended September 30, 2023, as certain time-based clinical milestones within the agreement were determined to be probable based on the availability of necessary data and the assessment of clinical progress in the third quarter of 2023.

For the nine months ended September 30, 2024, research and development expenses were $36.8 million, a decrease of $4.0 million when compared with the same period in 2023. The decrease in the research and development expenses was primarily attributable to recognition of $4.1 million of milestone and license acquisition costs related to the Company’s SADA license agreement during the nine months ended September 30, 2023, as noted above.

Selling, General, and Administrative

Selling, general, and administrative expenses were $13.6 million and $10.2 million for the quarters ended September 30, 2024 and 2023, respectively. The $3.4 million increase in the selling, general and administrative expenses was primarily attributable to a $1.2 million increase related to the Company’s former Chief Financial Officer’s separation and consulting agreements, $1.1 million increase in personnel cost, inclusive of stock-based compensation and $0.5 million in professional and consulting fees.

For the nine months ended September 30, 2024, selling, general, and administrative expenses were $42.3 million, an increase of $8.5 million compared with the same period in 2023. The increase was primarily attributable to a net impact of $3.6 million related to the settlement of a shareholder class-action lawsuit in the nine months ended September 30, 2024, and an additional legal settlement of $0.2 million in the nine months ended September 30, 2024. The increase also includes a $1.2 million increase related to our former Chief Financial Officer’s separation and consulting agreements, $1.1 million increase in personnel cost inclusive of stock-based compensation and $0.8 million in professional and consulting fees.

Interest and Other Income

Interest and other income were $1.9 million for the quarter ended September 30, 2024, as compared to $0.2 million for the quarter ended September 30, 2023. The increase of $1.7 million was primarily due to a $1.9 million of foreign currency transactional gains in the three months ended September 30, 2024, partially offset by a $0.2 million decrease in interest earned on the Company’s cash and cash equivalents.

For the nine months ended September 30, 2024 and 2023, the interest and other income was $3.0 and $2.4 million, respectively. The increase of $0.6 million was primarily due to $1.1 million of foreign currency transactional gains, partially offset by a $0.3 million decrease in interest earned on the Company’s cash and cash equivalents.

Net Loss

Y-mAbs reported a net loss for the quarter ended September 30, 2024, of $7.0 million, or ($0.16) per basic and diluted share, compared to a net loss of $7.7 million, or ($0.18) per basic and diluted share, for the quarter ended September 30, 2023. The decrease in net loss for the quarter ended September 30, 2024 was primarily driven by decreased operating expenses and foreign currency transactional gains, partially offset by decreased net product revenue.

For the nine months ended September 30, 2024, the Company reported a net loss of $22.9 million, or ($0.52) per basic and diluted share, as compared to net loss of $20.4 million, or ($0.47) per basic and diluted share, for the nine months ended September 30, 2023. The increase in net loss for the nine months ended September 30, 2024 was primarily driven by the net $3.8 million in charges related to the Company’s two legal settlements, as described above.

Cash and Cash Equivalents

As of September 30, 2024, Y-mAbs had approximately $68.1 million in cash and cash equivalents. Cash utilized in the first three quarters of 2024 was $10.5 million, which was favorable relative to the Company’s internal forecasts, and is on track to meet its corporate guidance for the full year 2024.

2024 Financial Guidance

Management reiterates its full year 2024 guidance:

● Anticipated Total Net Revenues expected to be between $87 million and $95 million;
● Anticipated Operating Expenses expected to remain between $115 million and $120 million;
● Anticipated Total Annual Cash Investment expected to remain between $15 million and $20 million; and
● Cash and Cash Equivalents anticipated to continue to support operations as currently planned into 2027.

Webcast and Conference Call

Y-mAbs will host a conference call on Friday, November 8, 2024, at 8:00 a.m. ET. To participate in the call, please use the following dial-in information:

Investors (domestic):(877) 407-0792

Investors (international):(201) 689-8263

To access the live webcast, please use this link. Prior to the call and webcast, a slide presentation pertaining to the Company’s quarterly earnings will be made available on the Investor Relations section of the Y-mAbs website, www.ymabs.com, shortly before the call begins.

On November 8, 2024 SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology (Press release, SystImmune, NOV 8, 2024, View Source [SID1234648050]). The IND supports the initiation of a Phase 1 clinical trial, BL‑M17D1-ST-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 for the treatment of patients with advanced or metastatic solid tumors in the United States.

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‍The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Jie D’Elia, Chief Executive Officer of SystImmune, commented, "Our mission at SystImmune is to bring therapies that can provide transformative clinical benefit to patients. As BL-M17D1 is developed using our next generation linker and payload technology, the initiation of clinical development for BL-M17D1 demonstrates our ability to continue to innovate in the ADC space and bring potentially best-in-class products to patients."