On February 11, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, CRISPR Therapeutics, FEB 11, 2025, View Source [SID1234650168]).

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"With continued advancements across our commercial and clinical portfolio, CRISPR Therapeutics is poised to make meaningful strides in transforming the landscape of medicine. As we continue to expand our portfolio and deliver on our mission to bring life-changing treatments to patients, 2025 stands as a milestone-rich year for CRISPR Therapeutics. In addition to the continued launch progress of CASGEVY, we expect several key milestones across our pipeline, including updates on our lead in vivo, cardiovascular programs in the first half of 2025. We also anticipate a broad update on CTX112 in oncology and autoimmune diseases in mid-2025, and additional updates across our pipeline. We remain deeply committed to advancing our technology platform to tackle some of the most challenging diseases and improving patient lives."

Recent Highlights and Outlook

Hemoglobinopathies and CASGEVY (exagamglogene autotemcel [exa-cel])
CASGEVY is approved in the U.S., Great Britain, the EU, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain (Bahrain), Canada, Switzerland and the United Arab Emirates (UAE) for the treatment of both SCD and TDT, and launches are ongoing. Building on the strong foundational launch in 2024, significant strides are being made to bring this transformative therapy to patients worldwide.
Vertex recently announced a reimbursement agreement with NHS England for SCD patients to access CASGEVY, consistent with the reimbursement agreement reached in August 2024 with NHS England for eligible TDT patients to access CASGEVY.

As of the end of 2024, more than 50 authorized treatment centers (ATCs) have been activated globally, including centers in all regions where CASGEVY is approved, and more than 50 patients have already had at least one cell collection across all regions. The number of new patients initiating cell collection is expected to grow significantly throughout 2025.
Enrollment has been completed in two global Phase 3 studies of CASGEVY in children 5 to 11 years of age with SCD or TDT, and dosing of this age group is expected to be completed in 2025.
CRISPR Therapeutics has two next-generation approaches with the potential to significantly expand the addressable population with SCD and TDT. The Company continues to advance its internally developed targeted conditioning program, an anti-CD117 (c-Kit) antibody-drug conjugate (ADC), through preclinical studies. Additionally, the Company is conducting ongoing research to enable in vivo editing of hematopoietic stem cells. This work could eliminate the need for conditioning altogether, expand geographic reach, and enable the treatment of additional other diseases beyond SCD and TDT.

Immuno-Oncology and Autoimmune Diseases

Clinical trials are ongoing for the Company’s next-generation CAR T product candidates, CTX112 and CTX131, targeting CD19 and CD70, respectively, across multiple indications. CTX112 and CTX131 both contain novel potency edits which can lead to significantly higher CAR T cell expansion and cytotoxicity, potentially representing best-in-class allogeneic CAR T products for these targets. CRISPR Therapeutics is advancing CTX112 for both hematologic malignancies and autoimmune indications, with an emerging best-in-class profile. The company’s next-generation allogeneic CAR T candidates reflect its commitment to continuous innovation, aiming to deliver potentially transformative medicines to patients as quickly as possible.

In December, CRISPR Therapeutics presented positive data from its ongoing Phase 1/2 trial of CTX112 in relapsed or refractory B-cell malignancies at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data demonstrated strong efficacy comparable to autologous therapies, a tolerable safety profile and robust cell expansion. The latest data, presented in January, highlight responses in patients who have received prior T-cell engager-based therapies (TCEs), with responses observed in all 6 patients, including 3 with large B-cell lymphoma (LBCL), who either relapsed post-TCE treatment or were refractory to TCEs. Based on these compelling preliminary data, CTX112 was awarded Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma. The Company plans to engage with regulatory authorities to align on the path forward for CTX112 in B-cell malignancies, with an update expected in mid-2025.

CRISPR Therapeutics has formed a strategic partnership with Nkure Therapeutics Private Limited ("NKure") to co-develop and co-commercialize CTX112 in India. This alliance aims to accelerate the global development of CTX112 in countries with significant unmet medical needs, while also highlighting the potential for lower costs associated with allogeneic cell therapy platform.

CTX112 is also in an ongoing Phase 1 clinical trial in systemic lupus erythematosus (SLE), systemic sclerosis and inflammatory myositis. Preliminary safety, pharmacokinetic, and pharmacodynamic data from oncology trials highlight the potential of CTX112 in autoimmune indications. Based on favorable oncology data, CRISPR Therapeutics expanded the CTX112 trial in SLE to include patients with systemic sclerosis and inflammatory myositis in a basket study, with updates expected in mid-2025.
Clinical trials are ongoing for CTX131 in both solid tumors and hematologic malignancies, with updates expected in 2025. Additionally, we are advancing an autologous, gene-edited CAR T therapy targeting glypican-3 (GPC3) for the potential treatment of solid tumors and expect to initiate a clinical trial in the first half of 2025.
In Vivo
CRISPR Therapeutics continues to make significant progress in advancing its proprietary LNP delivery technologies for gene editing in the liver, with ongoing development in both clinical and preclinical stages. The first two in vivo programs utilizing this proprietary platform, CTX310 and CTX320, are directed towards validated therapeutic targets associated with cardiovascular disease.
CTX310 is in an ongoing Phase 1 clinical trial targeting ANGPTL3 in patients with homozygous familial hypercholesterolemia (HoFH), severe hypertriglyceridemia (SHTG), heterozygous familial hypercholesterolemia (HeFH), or mixed dyslipidemias. ANGPTL3 loss-of-function mutations are linked to reduced LDL-C, triglycerides, and a lower risk of atherosclerotic cardiovascular disease (ASCVD), without adverse effects on overall health. This program has the potential for approval based on validated biomarkers, pending regulatory discussions. Dose escalation is ongoing, with an update expected in the first half of 2025.
CTX320 is in an ongoing Phase 1 clinical trial targeting LPA in patients with elevated lipoprotein(a) [Lp(a)], a genetically determined cardiovascular risk factor linked to major adverse cardiovascular events (MACE). Elevated Lp(a) affects up to 20% of the global population. Dose escalation is ongoing, with an update expected in the first half of 2025.
CRISPR Therapeutics continues to advance two preclinical programs: CTX340, targeting angiotensinogen (AGT) for the treatment of refractory hypertension, and CTX450, targeting 5’ aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias (AHP). Both programs are currently in IND/CTA-enabling studies, with clinical trials expected to begin in the second half of 2025.
Regenerative Medicine
Progress in regenerative medicine continues with the ongoing clinical trial for CTX211 in Type 1 diabetes (T1D), along with the development of next-generation programs. These initiatives focus on allogeneic, gene-edited, stem cell-derived beta islet cell precursors, which have the potential to make T1D patients insulin-independent without the need for chronic immunosuppression. The Company expects to provide an update in 2025.
Other Corporate Matters
In January, CRISPR Therapeutics announced its proposal to elect Briggs Morrison, M.D., to its Board of Directors at the Company’s upcoming 2025 annual general meeting. With his extensive experience in the pharmaceutical industry and deep expertise in clinical development, Dr. Morrison will be an invaluable asset as CRISPR Therapeutics continues advancing its innovative platform and pipeline, aiming to develop transformative therapies for patients with serious diseases.

Fourth Quarter and Full Year 2024 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $1,903.8 million as of December 31, 2024, compared to $1,695.7 million as of December 31, 2023. The increase in cash was primarily driven by proceeds from the $280.0 million February 2024 registered direct offering, milestone payments received from Vertex Pharmaceuticals in connection with our license and collaboration agreements, proceeds from ATM activity and employee option exercises, as well as interest income, offset by operating expenses.
R&D Expenses: R&D expenses were $82.2 million for the fourth quarter of 2024, compared to $95.1 million for the fourth quarter of 2023. The decrease in R&D expense was primarily driven by reduced variable external research and manufacturing costs.
G&A Expenses: General and administrative expenses were $18.1 million for the fourth quarter of 2024, compared to $16.5 million for the fourth quarter of 2023.
Collaboration Expense: There was no collaboration expense, net for the fourth quarter of 2024 due to reaching the deferral limit on costs related to the CASGEVY program in the third quarter of 2024. Collaboration expense for the fourth quarter of 2023 was $20.0 million.
Net Loss: Net loss was $37.3 million for the fourth quarter of 2024, compared to net income of $89.3 million for the fourth quarter of 2023.

About CASGEVY (exagamglogene autotemcel [exa-cel])
CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate recurrent vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved for certain indications in multiple jurisdictions for eligible patients.

On February 11, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update (Press release, Arvinas, FEB 11, 2025, View Source [SID1234650167]).

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"We made significant progress across our pipeline in 2024, all of which we believe supports our mission to improve the lives of patients with debilitating and life-threatening diseases," said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. "Looking ahead, we are on the cusp of a number of firsts, including results from VERITAC-2, the first ever Phase 3 clinical trial of a PROTAC. In addition, we plan to present the first-in-human data for our most advanced neuroscience program, ARV-102, which we believe will highlight the potential value our PROTAC degraders can offer to patients with neurodegenerative diseases. In the coming months, we look forward to sharing additional updates emerging from our pipeline and PROTAC platform."

4Q 2024 Business Highlights and Recent Developments

Vepdegestrant: Oral PROTAC ER degrader

Announced that the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in ER+/HER2- metastatic breast cancer remains on track, with topline data anticipated in 1Q25 (ClinicalTrials.gov Identifier: NCT05654623).
Announced plans to initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC (pending emerging data and regulatory feedback) in 2025:
First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib.
Second-line Phase 3 combination trial with a CDK4/6 inhibitor.
Presented initial Phase 1b safety and pharmacokinetic data from the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib at the San Antonio Breast Cancer Symposium (SABCS) in December 2024 (ClinicalTrials.gov Identifier: NCT05548127).
Presented data from the Phase 1 clinical pharmacology study of vepdegestrant in combination with midazolam at SABCS in December 2024 (ClinicalTrials.gov Identifier: NCT06256510).
Continued enrollment globally in multiple additional clinical studies of vepdegestrant in ER+/HER2- metastatic breast cancer.
TACTIVE-K: Phase 1b/2 clinical trial with vepdegestrant in combination with Pfizer’s novel investigational CDK4 inhibitor atirmociclib (ClinicalTrials.gov Identifier: NCT06206837).
TACTIVE-U: Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (ClinicalTrials.gov Identifiers: NCT05573555, and NCT06125522).
ARV-393: Oral PROTAC BCL6 degrader

Continued recruiting patients in the first-in-human Phase 1 clinical trial in patients with non-Hodgkin lymphoma (NHL) (ClinicalTrials.gov Identifier: NCT06393738).
ARV-102: Oral PROTAC LRRK2 degrader

Completed enrollment in the multiple ascending (MAD) dose cohort of the Phase 1 clinical trial in healthy volunteers in 1Q25.
Initiated dosing of the first patients with Parkinson’s disease (PD) in the single ascending dose (SAD) cohort of a Phase 1 clinical trial.
Corporate

Completed the Investigational New Drug application (IND) transition of luxdegalutamide (ARV-766) to Novartis as part of global license agreement executed in April 2024.
Announced Alex Santini, Arvinas’ Senior Vice President, Global and U.S. Market Access, has been appointed interim Chief Commercial Officer effective January 17, 2025.
Anticipated Upcoming Milestones and Expectations

Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas global collaboration with Pfizer, the companies plan to:

Announce topline data for the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in patients with ER+/HER2- metastatic breast cancer (mBC) in a topline press release 1Q25 and present full results of the trial at a medical conference in 2025.
Initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC (pending emerging data and regulatory feedback) in 2025:
First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib.
Second-line Phase 3 combination trial with a CDK4/6 inhibitor.
With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 Phase 3 clinical trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in.
Continue to collect safety and efficacy data from ongoing TACTIVE-U sub-studies evaluating combination of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522) and submit key data for presentation at medical conference.
Continue enrollment in the Phase 2 TACTIVE-K clinical trial (atirmociclib + vepdegestrant) and submit initial Phase 1b data for presentation at a medical conference.
ARV-393: Oral PROTAC BCL6 degrader

Present preclinical data of ARV-393 in combination with standard of care biologic agents and small molecule inhibitors in high grade and aggressive diffuse large B-cell lymphoma in vivo models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (April 25-30, 2025).
Disclose preliminary data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) in 2025.
ARV-102: Oral PROTAC LRRK2 degrader

Present SAD data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease (AD/PD) conference in Vienna, Austria (April 1-4, 2025) demonstrating:
Bioavailability and brain penetration with dose dependent exposure in cerebral spinal fluid (CSF)
Degradation of LRRK2 in the periphery and CSF of healthy volunteers
Complete enrollment and present initial data from the ongoing SAD Phase 1 clinical trial in patients with PD in 2025; initiate MAD cohort in patients with PD in 2025.
Novel PROTAC KRAS G12D degrader

File an Investigational New Drug (IND) application in 2025.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of December 31, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027.

Full Year and Fourth Quarter Financial Results

Cash, Cash Equivalents, and Marketable Securities Position: As of December 31, 2024, cash, cash equivalents and marketable securities were $1,039.4 million as compared with cash, cash equivalents, restricted cash and marketable securities of $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents and marketable securities of $227.1 million for the 12 months ended December 31, 2024 was primarily related to cash used in operations of $237.4 million (net of $150.0 million received from the Novartis agreements), inclusive of a one-time cash termination fee in the amount of $41.5 million related to the termination of our laboratory and office space lease with 101 College Street LLC in August 2024, the purchase of lab equipment and leasehold improvements of $1.8 million and $0.4 million of long term debt repayments, partially offset by proceeds from the exercise of stock options of $8.3 million, unrealized gains on marketable securities of $4.1 million and proceeds from disposal of equipment of $0.1 million.

Research and Development Expenses: Research and development expenses were $348.2 million and $83.3 million for the year and quarter ended December 31, 2024, respectively, as compared with $379.7 million and $95.2 million for the year and quarter ended December 31, 2023, respectively. The decrease in research and development expenses of $31.5 million for the year was primarily due to a decrease in external expenses of $41.7 million, partially offset by an increase in compensation and related personnel expenses of $11.2 million, which are not allocated by program. External expenses include program-specific expenses, which decreased by $32.1 million, driven by decreases in our vepdegestrant and bavdegalutamide (ARV-110) programs of $27.9 million and $18.1 million, respectively, partially offset by increases in our ARV-102 and ARV-393 programs of $10.7 million and $5.4 million, respectively, and our non-program specific expenses, which decreased by $9.6 million. The decrease in research and development expenses of $11.9 million for the quarter was primarily due to a decrease in external expenses of $9.9 million, compensation and related personnel expenses of $0.5 million, which are not allocated by program, and other expenses of $1.5 million. External expenses include program-specific expenses, which decreased by $14.2 million, primarily driven by decreases in our vepdegestrant, luxdegalutamide (ARV-766) and bavdegalutamide (ARV-110) programs of $13.6 million, $6.0 million and $2.6 million, respectively, partially offset by increases in our ARV-102 and ARV-393 programs of $5.5 million and $1.3 million, respectively, and our non-program specific expenses of $4.3 million.

General and Administrative Expenses: General and administrative expenses were $165.4 million and $34.1 million for the year and quarter ended of December 31, 2024, respectively, as compared with $100.3 million and $27.0 million for the year and quarter ended of December 31, 2023, respectively. The increase in general and administrative expenses of $65.1 million for the year was primarily due to a loss on the termination of our laboratory and office space lease with 101 College Street LLC in August 2024 of $43.4 million as well as increases in personnel and infrastructure related costs of $9.0 million, professional fees of $8.1 million and in developing our commercial operations of $4.2 million. The increase in general and administrative expenses of $7.1 million for the quarter was primarily due to increases in developing our commercial operations of $2.6 million, personnel and infrastructure related costs of $2.2 million and professional fees of $1.8 million.

Revenue: Revenue was $263.4 million and $59.2 million for the year and quarter ended December 31, 2024, respectively, as compared with $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023, respectively. The increase in revenue of $184.9 million for the year was primarily due to revenue from the Novartis agreements of $162.4 million, an increase in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $21.7 million related in part to adjustments to revenue in 2023 from changes in contract estimates and year over year increases in revenue of $2.8 million and $2.2 million from the Bayer Collaboration Agreement and the Pfizer Research Collaboration Agreement, respectively, primarily due to changes in estimates in 2023 of the performance period duration under the agreements resulting from updated research timelines, offset by a decrease of $2.5 million of previously constrained deferred revenue related to our Oerth Bio joint venture, and a decrease of $1.8 million of revenue under the Restated Genentech Agreement as the performance period had concluded in 2023. The increase in revenue of $102.3 million for the quarter was primarily related to an increase in revenue from the Pfizer ARV-471 Collaboration Agreement totaling $63.8 million, primarily due to adjustments in 2023 to revenue from changes in contract estimates, as well as revenue from the Novartis agreements of $40.3 million, offset by a decrease in revenue from Bayer of $1.6 million related to the termination of the Bayer Collaboration Agreement in August 2024.

Investor Call & Webcast Details

Arvinas will host a conference call and webcast today, February 11, 2025, at 8:00 a.m. ET to review its fourth quarter and full year 2024 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.

The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.

On February 11, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Mike Catelani, President and CFO of Anixa, will be participating in the 18th Annual European Life Sciences CEO Forum taking place February 26-27, 2025, at the Hilton Zurich Airport Hotel in Zurich, Switzerland (Press release, Anixa Biosciences, FEB 11, 2025, View Source [SID1234650166]).

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The conference brings together leading executives, investors, and industry experts from the global life sciences sector to discuss the latest innovations, investment trends, and partnership opportunities. Mr. Catelani will provide an update on Anixa’s pipeline, highlighting its groundbreaking CAR-T therapy for ovarian cancer in collaboration with Moffitt Cancer Center, its breast cancer vaccine developed in partnership with Cleveland Clinic, and its expanding portfolio of cancer vaccine programs aimed at addressing multiple hard-to-treat cancers.

Presentation Details:

Event: 18th Annual European Life Sciences CEO Forum
Location: Hilton Zurich Airport Hotel
Date: February 27, 2025
Time: 10:40 AM CET
The presentation will highlight recent clinical advancements and strategic initiatives aimed at accelerating the development of Anixa’s innovative therapies. Additionally, Mr. Catelani will engage in one-on-one meetings with potential partners and investors.

"We are excited to participate in this prestigious event and share updates on our cutting-edge programs," said Mike Catelani, President and CFO of Anixa Biosciences. "As we continue to advance our pipeline, we look forward to collaborating with investors and industry leaders who share our dedication to developing innovative and life-changing oncology therapies."

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 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

•
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.
•
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.
•
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.
•
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.
•
Received expanded Medicare coverage of clonoSEQ for assessing measurable residual disease in Mantle Cell Lymphoma (MCL), enabling initiation of MCL promotional efforts.
•
Signed an exclusive strategic commercial partnership with NeoGenomics to cross-promote our clonoSEQ test along with NeoGenomics’ COMPASS and CHART hematopathology services.
•
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.
•
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.