On February 11, 2025 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Adaptive Biotechnologies, FEB 11, 2025, View Source [SID1234650164]).

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"2024 was a year of strong execution, marked by key catalysts achieved in our MRD business and advancements in our Immune Medicine programs. Our MRD revenue grew by 42%, with a 35% increase in clonoSEQ test volume, and we nominated a lead autoimmune indication within our Immune Medicine business," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "With strong momentum heading into 2025, we are focused on achieving profitability in MRD, advancing our therapeutics pipeline in Immune Medicine, and maintaining a durable cash position to support sustainable, long-term growth."

Recent Highlights

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Revenue for the fourth quarter and full year 2024 was $47.5 million and $179.0 million, respectively. The MRD business, which contributed 85% of revenue in the fourth quarter and 81% of revenue in the full year, grew 31% and 42% over the corresponding periods a year ago.
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clonoSEQ test volume increased 34% to 20,945 tests delivered in the fourth quarter of 2024, compared to the fourth quarter 2023 and ended the year with 76,105 tests delivered, up 35% versus 2023.
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Obtained updated Medicare Clinical Laboratory Fee Schedule (CLFS) Gapfill Determination for clonoSEQ of $2,007 per test, a 17% increase from the previous implied rate under the episode structure.
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The FDA’s Oncologic Drug Advisory Committee (ODAC) voted unanimously in favor of the use of MRD as a primary endpoint to support the accelerated approval of new therapies for patients with multiple myeloma.
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Received expanded Medicare coverage of clonoSEQ for assessing measurable residual disease in Mantle Cell Lymphoma (MCL), enabling initiation of MCL promotional efforts.
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Signed an exclusive strategic commercial partnership with NeoGenomics to cross-promote our clonoSEQ test along with NeoGenomics’ COMPASS and CHART hematopathology services.
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Completed multiple antibody mouse immunization campaigns in prioritized autoimmune indications and functionally tested a subset of selected antibodies to a number of disease-causing targets in these indications.
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Nominated a lead autoimmune indication to further advance on the preclinical development of antibody therapeutic candidates in this first autoimmune indication.

Fourth Quarter 2024 Financial Results

Revenue was $47.5 million for the quarter ended December 31, 2024, representing a 4% increase from the fourth quarter in the prior year. MRD revenue was $40.1 million for the quarter, representing a 31% increase from the fourth quarter in the prior year. Immune Medicine revenue was $7.3 million for the quarter, representing a 51% decrease from the fourth quarter in the prior year.

Operating expenses for the fourth quarter of 2024 were $81.3 million, compared to $116.9 million in the fourth quarter of the prior year, which included a $25.4 million lease impairment charge, representing a decrease of 30%. Excluding the impact of the lease impairment charge, operating expenses for the fourth quarter of 2024 decreased 11% compared to the fourth quarter of the prior year.

Interest and other income, net was $3.1 million for the fourth quarter of 2024, compared to $4.6 million in the fourth quarter of the prior year. Interest expense from our revenue interest purchase agreement was $3.0 million in both the fourth quarter of 2024 and the fourth quarter of the prior year.

Net loss was $33.7 million for the fourth quarter of 2024, compared to $69.5 million for the same period in 2023.

Adjusted EBITDA (non-GAAP) was a loss of $16.4 million for the fourth quarter of 2024, compared to a loss of $24.7 million for the fourth quarter of the prior year.

Full Year 2024 Financial Results

Revenue was $179.0 million for the year ended December 31, 2024, representing a 5% increase from the prior year. MRD revenue was $145.5 million in 2024, representing a 42% increase from the prior year. Immune Medicine revenue was $33.4 million in 2024, representing a 51% decrease from 2023.

Operating expenses for 2024, which included restructuring and long-lived asset impairment charges of $9.2 million, were $341.5 million, compared to $397.3 million for 2023, which included a $25.4 million lease impairment charge, representing a decrease of 14%. Excluding the impact of restructuring and impairment charges, operating expenses for 2024 decreased 11% compared to the prior year.

Interest and other income, net was $14.5 million in 2024, compared to $15.5 million in 2023. Interest expense from our revenue interest purchase agreement was $11.6 million in 2024, compared to $13.8 million in 2023.

Net loss was $159.6 million in 2024, compared to $225.3 million in 2023.

Adjusted EBITDA (non-GAAP) was a loss of $80.4 million for 2024, compared to a loss of $116.4 million in the prior year.

Cash, cash equivalents and marketable securities was $256.0 million as of December 31, 2024.

2025 Financial Guidance

Adaptive Biotechnologies expects full year revenue for the MRD business to be between $175 million and $185 million. No revenue guidance is provided for the Immune Medicine business.

We expect full year total company operating expenses, including cost of revenue, to be between $340 million and $350 million.

We expect full year total company cash burn to be between $60 million and $70 million.

Management will provide further details on the outlook during the conference call.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its fourth quarter and full year 2024 financial results after market close on Tuesday, February 11, 2025 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On February 11, 2025 Specialised therapeutics reported that a new breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand (Press release, Specialised Therapeutics Asia, FEB 11, 2025, View Source [SID1234650180]).

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NERLYNX (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."

In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.

In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.

NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc.

ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company.

"We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease."

Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7]

Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025.

"We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible.

"As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them."

About NERLYNX

NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12]

NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong.

About HER2-Positive (HER2+) Breast Cancer

Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14]

While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14]

About the ExteNET Study

The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer.

The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation.

The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab.

The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

About the NALA Study

The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia.

The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086).

The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

On February 11, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 434,784 shares of its common stock at a purchase price of $2.415 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Lixte Biotechnology, FEB 11, 2025, View Source [SID1234650254]). In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to an aggregate of 434,784 shares of common stock. The warrants will have an exercise price of $2.29 per share and will be exercisable for five years from the date of issuance. The closing of the offering is expected to occur on or about February 12, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $1.05 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278874) originally filed with the Securities and Exchange Commission ("SEC") on April 23, 2024 and became effective on May 2, 2024. The registered direct offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On February 11, 2025 Alloy Therapeutics Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting edge drug discovery technologies reported its latest strategic collaboration with Pfizer Inc., to develop a new platform that could enhance Pfizer’s ability to discover potent, specific, and effective antibodies against targets that are difficult to address with existing antibody discovery technologies (Press release, Alloy Therapeutics, FEB 11, 2025, View Source [SID1234650165]). Under the terms of the collaboration, Alloy will receive an upfront payment from Pfizer and will be eligible for pre-specified preclinical to commercial milestones on products originating from the newly developed platform.

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"Pfizer has leveraged our industry-leading ATX-GxTM platform for several years, and we collaborated closely with them to develop the common light chain ATX-CLC strains. This collaboration exemplifies how pharma can leverage Alloy’s technology and expertise broadly in antibody discovery and technological innovation by participating in the creation of pre-competitive tools," said Heather Schwoebel, Chief Business Officer, Antibodies and Head of Strategic Collaborations at Alloy. "We will now apply this expertise to jointly create a new platform that enhances Pfizer’s ability to develop antibodies against challenging high-value targets. We are proud to expand our collaboration with Pfizer in the fight against disease."

Alloy’s ATX-Gx platform has rapidly become the industry standard for fully humanized transgenic mice, being used by over 170 partners and in turn enabling many therapeutic discovery programs. Alloy is dedicated to reinvesting its revenue into innovation and has continuously expanded its murine platforms, adding new strains such as ATX-GLTM with the full human lambda repertoire, as well as ATX-GKHTM hyperimmune strain for increased generation of antigen-specific B-cells and enhanced IgG class switching.

Pfizer and Alloy have collaborated on various antibody discovery efforts, including the use of Alloy’s ATX-CLC platform. Launched in 2023 and accessible through Alloy’s Antibody Discovery Services unit, the ATX-CLC platform enables the expression of common light chain antibodies with full heavy chain diversity, thereby facilitating efficient and modular bispecific antibody discovery.

"Our Cambridge, UK research team has developed a cutting-edge workflow for generating transgenic animal models, strengthening Alloy’s position as a leader in this area of drug discovery," said Davide Schiavone, Head of Genetically Engineered Organisms at Alloy Therapeutics. "By collaborating with industry leaders like Pfizer, we help to ensure our platforms are built for what scientists truly need—solutions that streamline the drug discovery process. Our commitment to continuous innovation is rooted in collaboration, and we firmly believe the best way to build technologies of the future is to create them hand-in-hand with our partners when possible."

On February 11, 2025 Lion TCR reported that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial (Press release, Lion TCR, FEB 11, 2025, View Source [SID1234650181]). This significant progress further solidifies Lion TCR’s leading position in the mRNA-based TCR-T field and brings new hope to patients with hepatocellular carcinoma (HCC).

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Hepatitis B and liver cancer are significant global public health challenges. Hepatitis B virus (HBV) infection is a leading risk factor for liver cancer, particularly HCC. Globally, an estimated 296 million people live with chronic HBV infection. Liver cancer is the sixth most common cancer worldwide. In 2020 alone, there were approximately 905,000 new cases and 830,000 deaths from liver cancer globally. Liocyx-M004 is the world’s first mRNA-encoded TCR-T cell therapy targeting HBV-related hepatocellular carcinoma. The FDA-approved international multicenter Phase 2 clinical trial will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib. Lenvatinib, a well-established first-line treatment for advanced hepatocellular carcinoma, demonstrates the ability to reprogram the immunosuppressive tumour microenvironment into an immune-supportive state, thereby enhancing tumour-killing efficacy. When combined with Liocyx-M004, this therapy is anticipated to create synergistic effects, further amplifying its anti-tumour potential and improving patient outcomes.

Dr. Tina Wang, Chief Medical Officer and Chief Operating Officer of Lion TCR, explained: "In patients with HBV-related hepatocellular carcinoma, HBV-specific T cells are often functionally exhausted, leading to a significant impairment in their ability to eliminate liver cancer cells and HBV-infected liver cells with HBV-DNA integration. Our research has shown that HBV-specific TCR-T cells can effectively target and destroy these cancerous cells. This makes the adoptive transfer and supplementation of autologous HBV-specific TCR-T cells a promising therapeutic strategy, with the potential to restore the HBV-specific T cell pool in patients. This approach enables targeted killing of liver cancer cells and infected liver cells expressing HBV antigens, providing a novel treatment option for HBV-related hepatocellular carcinoma. While systemic therapies for advanced hepatocellular carcinoma have made significant strides in recent years, including the development of targeted combination immunotherapies, precision treatments for HBV-related hepatocellular carcinoma remain limited. By investigating the combination of Liocyx-M004 with lenvatinib, we aim to further improve response rates and survival outcomes for these patients. The FDA’s approval of this international multicenter Phase 2 clinical trial is a major milestone that strengthens our confidence and commitment to advancing mRNA-encoded TCR-T therapies for hepatocellular carcinoma. Moving forward, we will accelerate the trial’s progress and gather clinical data to bring this innovative treatment to patients as soon as possible."

Dr. Xiaoming Peng, CEO of Lion TCR, remarked: "Liocyx-M004 is the first TCR-T therapy targeting HBV viral antigens to receive IND approval from the U.S. FDA and the first of its kind to be granted Fast Track designation. This approval for Liocyx-M004 to proceed with international multicenter Phase 2 clinical trials underscores its significance as an innovative therapy for liver cancer and represents a major milestone for Lion TCR. It also signifies a critical step in Lion TCR’s transition from the clinical stage to commercialization. While advancing our lead product through these critical trials, we are simultaneously accelerating the development of an ‘off-the-shelf’ (or ‘universal’) in vivo TCR-T product platform, leveraging mRNA-LNP delivery technology to significantly reduce production costs. In parallel, we are enhancing our AI-powered TCR discovery platform to expand our pipeline into treatments for various solid tumors with high unmet needs, including lung cancer, breast cancer, and gastrointestinal cancers."

Liocyx-M004 has already demonstrated promising outcomes in earlier clinical trials, achieving a median overall survival of 33.1 months in patients with HBV-related hepatocellular carcinoma.