On February 13, 2025 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported financial results for its first quarter of fiscal 2025 ended December 31, 2024 (Press release, Applied DNA Sciences, FEB 13, 2025, View Source [SID1234650241]). The Company’s Form 10-Q, once filed, can be viewed on the SEC Filings page of its Investor Relations website.

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Recent Corporate and Operational Updates:

Corporate:

In December 2024, the Company announced a strategic restructuring of its business operations, including the potential divestiture of its DNA Tagging and Security Products and Services ("DNA Tagging") business segment.
Today, the Company announced its exit from its DNA Tagging business segment and completion of a workforce reduction of approximately 20% of its total headcount related primarily to employees within its DNA Tagging segment. The workforce reduction will result in an approximate 13% reduction in annual payroll costs, offset by one-time separation costs totaling approximately $300,000, which are expected to be recorded in the quarter ending March 31, 2025. The Company will continue to service certain of its existing DNA Tagging customer contracts.
LineaRx (Therapeutic DNA Production and Services subsidiary)

The buildout of the Company’s initial GMP facility located in Stony Brook, New York ("Site 1"), was completed on January 31, 2025, and certified for commercial operation with ISO 7-compliant with ISO 5-compliant workspaces. As currently configured, Site 1 enables the enzymatic manufacture of Linea DNA IVT templates used in the production of mRNA clinical trial materials:
The initial projected manufacturing capacity of Site 1 is approximately ten grams per annum, which supports potential annual revenues in the range of $10 million to $30 million, depending on product mix[1].
Site 1 gives the Company the new ability to service clients across all customer product stages with relevant grades of DNA: RUO for research and development; GLP for discovery and early pre-clinical studies; GMP for late pre-clinical studies and clinical phases.
The Company is in the late stage of process development with a U.S.-based therapeutics developer. If development is completed successfully, the Company anticipates its receipt of a first GMP order for IVT templates in the quarter ending June 30, 2025.
The Company’s Linea DNA platform secured its first-in-human clinical validation with Linea DNA used as a critical component in the manufacture of a CAR-T therapy under a Czech Republic State Institute for Drug Control-approved Phase I clinical trial sponsored by the Institute of Hematology and Blood Transfusion (UHKT). The trial represents the first instance of regulatory consent of Linea DNA’s use in a clinical setting and demonstrates Linea DNA’s ability to empower faster manufacturing timelines than conventional plasmid DNA-based therapy development.
Applied DNA Clinical Labs (MDx Testing Services subsidiary)

Completed certifications necessary to expand the TR8 PGx testing service to all S. States that recognize New York’s CLEP/CLIA certification for genetic testing. Samples collected from outside of New York State will be tested at Applied DNA’s diagnostic laboratory in Stony Brook.
Management Commentary
"Our first quarter performance reflects the implementation of a strategic restructuring to support our growth through our synthetic DNA manufacturing strategy," stated Dr. James A. Hayward, Chairman and CEO of Applied DNA. "We are taking difficult but necessary steps to optimize our corporate structure to lower our cash burn rate and stabilize our financial position to ensure our ability to execute against near-term operational goals."

"As we move through fiscal 2025, we are focused on commercializing the DNA production capacity of our recently certified GMP Site 1 facility," concluded Dr. Hayward. "We are preparing for initial orders of clinical grade materials, the acquisition of which we believe will validate the economics of our proprietary low-CAPEX approach to enzymatic DNA production in front of an industry that is actively seeking cell-free, synthetic alternatives to traditional pDNA production processes. We believe our capacity for the GMP production of DNA in an economical, fast, and scalable manner to advance the rapid development of genetic medicines is a unique competitive advantage in the marketplace and is the lynchpin to our future success."

First Quarter Fiscal 2025 Financial Highlights

Total revenues: $1.2 million, an increase of 34% compared to $891 thousand for the first quarter of fiscal 2024.
Operating loss: $3.0 million, compared to an operating loss of $3.8 million for the first quarter of fiscal 2024.
Net loss: $2.7 million, compared to a net loss of $1.1 million for the first quarter of fiscal 2024.
Adjusted EBITDA: improved to negative $2.9 million, compared to negative $3.2 million for the first quarter of fiscal 2024.
Cash and cash equivalents as of December 31, 2024: $9.3 million, which includes $5.7 million of net proceeds (after deducting placement agent fees and other offering expenses) from the registered direct offering that closed on October 31, 2024.
February 13 Investor Update Conference Call Information

The Company will hold a conference call and webcast to update investors on its restructuring and GMP roadmap on February 13, 2025, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To participate, please ask to be joined to the ‘Applied DNA Sciences’ call:

Domestic callers (toll free): 844-887-9402
International callers: 412-317-6798
Canadian callers (toll free): 866-605-3852
Live and replay of webcast: link
Telephonic replay (available 1 hour following the conclusion of the live call through February 20, 2025):

Domestic callers (toll free): 1-877-344-7529
Canadian callers (toll free): 1-855-669-9658
Participant Passcode: 7896562
An accompanying slide presentation that will be embedded in the webcast can be accessed under ‘News & Events’ tab and ‘Company Events’ section of the Applied DNA investor relations website at View Source

On February 13, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported the publication of data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) as a Rapid Communication in the Journal of Clinical Oncology (Press release, Allogene, FEB 13, 2025, View Source [SID1234650240]). These results represent the largest dataset of LBCL patients treated with an allogeneic CAR T product and, with a minimum of two years of follow-up, the longest follow-up to date.

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"Publication of the Phase 1 ALPHA/ALPHA2 trials in R/R LBCL mark a landmark moment for the field. These findings represent the most robust allogeneic CAR T experience yet presented and show, for the first time, that an "off-the-shelf" CAR T can induce durable complete remissions in a large fraction of patients with heavily pretreated LBCL," said Frederick L. Locke, MD, Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center and Research Institute (Tampa, FL). "These peer-reviewed results highlight how cema-cel development is on the cutting edge of lymphoma care, particularly with the ALPHA3 trial targeting only those patients who are MRD positive at the end of first-line treatment. If successful, ALPHA3 and cema-cel could transform the treatment paradigm for newly diagnosed patients."

"With multiple patients in ongoing complete remissions beyond four years, the lingering question of whether an allogeneic CAR T could deliver durable responses has now been answered," said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer of Allogene. "Furthermore, these results provide potent evidence supporting the use of CAR T in patients with low disease burden and the unique opportunity for the ALPHA3 trial to achieve something novel in this disease – predict and intervene before relapse. Opportunities to redefine the standard of care in oncology are rare, but if successful, ALPHA3 has the potential to achieve precisely that."

Key Findings from the Publication
The ALPHA/ALPHA2 studies were single-arm, multicenter, open-label, Phase 1 trials. As of the data cutoff date (September 26, 2024), 87 heavily pretreated patients with R/R non-Hodgkin lymphoma (NHL) were treated in the ALPHA/ALPHA2 studies between May 2019 and September 2022. In total, 33 CD19 CAR T-naive patients with R/R LBCL received cema-cel/ALLO-501 manufactured with the process selected for use in pivotal studies and were the focus of this publication.

Overall Response Rate (ORR) and Complete Response (CR) Rate: ORR and CR rates in the ALPHA/ALPHA2 trials were consistent with those observed with approved autologous CD19 CAR T cell products for patients with R/R LBCL after two or more lines of systemic therapy. All treatment regimens studied demonstrated clinical benefit. The selected Phase 2 regimen (fludarabine/cyclophosphamide lymphodepletion with 90 mg of ALLO-647 (FCA90) followed by a single dose of CAR+ cells) yielded the highest ORR and CR of 67% and 58%, respectively.
Durability of Response (DOR): Patients who achieved a CR had excellent outcomes with a median DOR, PFS (progression free survival) and OS of 23.1 months, 24 months, and not reached, respectively. For patients receiving the selected Phase 2 regimen, median DOR was 23.1 months and median OS was not reached.
Safety Profile: The overall safety profile, including incidence of cytopenias and infections, was manageable and consistent with that of approved autologous CD19 CAR T cell therapies. There were no dose-limiting toxicities, graft-versus-host disease (GvHD), immune effector cell-associated neurotoxicity syndrome (ICANS), or high-grade cytokine release syndrome (CRS). The most common any-grade treatment emergent adverse events (TEAE) (≥25%) were neutropenia (85%), anemia (67%), thrombocytopenia (58%), infusion-related reactions (IRRs; 58%), fatigue (52%), and pyrexia (49%), nausea (39%), lymphopenia (36%), hypotension (36%), peripheral edema (33%), decreased white blood cell count (30%), CMV reactivation (30%), decreased appetite (30%), chills (30%), and hypoxia (27%).
Time to Treatment: The median time to start of treatment was two days from study enrollment. In contrast, autologous CAR T cell products require wait times often longer than 1 month despite incremental advancements in manufacturing and supply chains.
Potential in Low Disease Burden Settings
A growing body of evidence indicates that treatment with CAR T at times when the disease burden is low leads to improved safety and efficacy outcomes and this study reported similar findings. Among patients with baseline tumor burden <1000 mm² or normal lactate dehydrogenase (LDH) levels prior to treatment, a blood test that indicates low disease activity, the CR rate was 100% (6/6) and 82% (9/11), respectively. These CR rates in this subpopulation support cema-cel as a promising therapeutic option in patients with minimum residual disease (MRD), the population currently being studied in the ALPHA3 trial.

Foundation for the ALPHA3 Trial
These results serve as a foundation for the ongoing ALPHA3 trial, which is evaluating cema-cel as a consolidation therapy in LBCL patients who are in remission following 1L treatment but remain positive for minimal residual disease (MRD) as detected by an ultrasensitive ctDNA based blood test, using Foresight Diagnostics’ investigational CLARITY powered by PhasED-Seq. These patients have extremely low disease burden, a key subgroup who demonstrated excellent disease outcomes in the ALPHA/ALPHA2 trials.

The groundbreaking randomized controlled ALPHA3 trial, initiated in June 2024, is the first to evaluate CAR T treatment as part of 1L consolidation treatment regimen for LBCL patients who achieve remission but test positive for MRD following initial therapy. The ALPHA3 trial is designed to predict and intervene before relapse. Cema-cel is administered only to patients at high risk for relapse as a one-time consolidation dose before disease recurs.

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

On February 13, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2024 (Press release, Agios Pharmaceuticals, FEB 13, 2025, View Source [SID1234650239]).

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"Agios had a transformative year in 2024, continuing to successfully deliver on all priorities. Our PYRUKYND franchise is poised for multi-billion-dollar potential, driven by the key milestones we achieved last year, including filing for regulatory approval in thalassemia across four markets and completing enrollment in our Phase 3 RISE UP study for sickle cell disease," said Brian Goff, chief executive officer at Agios. "Backed by a strong balance sheet and a highly experienced team, Agios is focused on maximizing the potential PYRUKYND launches in thalassemia and sickle cell disease in 2025 and 2026, respectively, while advancing and diversifying our key pipeline programs and strategically deploying our capital to drive long-term growth. We are well positioned to bring significant value for shareholders, healthcare professionals and patients, as we build towards a breakout year in 2025."

Fourth Quarter 2024 and Recent Highlights

•PYRUKYND Revenues: Generated $10.7 million in net revenue for the fourth quarter of 2024, a 20 percent increase from the third quarter of 2024, primarily driven by year-end stocking and adjustments to certain revenue reserves. A total of 223 unique patients have completed prescription enrollment forms, representing an increase of 6 percent over the third quarter of 2024. A total of 130 patients are on PYRUKYND therapy, inclusive of new prescriptions and continued therapy.
•Thalassemia:
◦Presented positive results from the ENERGIZE-T Phase 3 randomized clinical trial evaluating mitapivat versus placebo in adults with transfusion-dependent alpha- or beta-thalassemia at the 66ᵗʰ American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2024) in December 2024.
◦Based on the favorable benefit-risk profile observed in both the ENERGIZE and ENERGIZE-T Phase 3 studies, filed regulatory applications for mitapivat (PYRUKYND) for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia with the U.S., European Union, Kingdom of Saudi Arabia and United Arab Emirates health authorities.
◦The U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The review classification for this application is Standard and the Prescription Drug User Fee Act (PDUFA) goal date is September 7, 2025.
•Sickle Cell Disease:
◦Completed enrollment of the Phase 3 RISE UP study evaluating mitapivat for the treatment of sickle cell disease patients who are 16 years of age or older. This Phase 3 study enrolled more than 200 patients worldwide.
◦European Commission adopted a positive decision for the designation of mitapivat as an orphan medicinal product for the treatment of sickle cell disease.
◦Presented Phase 1 clinical results on tebapivat (AG-946) in patients with sickle cell disease at ASH (Free ASH Whitepaper) 2024.
•Pediatric Pyruvate Kinase (PK) Deficiency:
◦Reported in a separate press release today, positive topline results from the ACTIVATE-Kids Phase 3 study of mitapivat in children aged 1 to <18 years with PK deficiency who are not regularly transfused.
•Lower-risk myelodysplastic syndromes (LR-MDS):
◦Initiated patient enrollment in the Phase 2b study of tebapivat in LR-MDS.
◦FDA granted orphan drug designation to tebapivat for the treatment of MDS.
•Medical Congresses: Presented 16 abstracts highlighting new data on mitapivat and tebapivat at ASH (Free ASH Whitepaper) 2024.
•Corporate: David Schenkein, M.D., has informed the company that he will step down from Agios’ Board of Directors, effective February 28, 2025, to devote more time to his other commitments. He will continue to serve as a strategic advisor to Agios’ Leadership Team, concentrating on advancing the company’s clinical development programs.

Key Upcoming Milestones & Priorities

Agios expects to achieve the following key milestones in 2025:
•Thalassemia: Receive FDA regulatory decision for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia (PDUFA goal date is September 7, 2025).
•Sickle Cell Disease: Announce topline results from the Phase 3 RISE UP study of mitapivat in sickle cell disease in late 2025, with a potential U.S. commercial launch in 2026. Additionally, begin patient enrollment for the Phase 2 study of tebapivat in sickle cell disease in mid-2025.
•LR-MDS: Complete patient enrollment in the Phase 2b study of tebapivat for LR-MDS in late 2025.
•Early-Stage Pipeline: File an Investigational New Drug Application for AG-236, a siRNA targeting TMPRSS6 intended for the treatment of polycythemia vera, in mid-2025.

Fourth Quarter 2024 Financial Results

Revenue: Net product revenue from sales of PYRUKYND for the fourth quarter of 2024 was $10.7 million, compared to $7.1 million for the fourth quarter of 2023, and $36.5 million for the year ended December 31, 2024, compared to $26.8 million for the year ended December 31, 2023.

Cost of Sales: Cost of sales for the fourth quarter of 2024 was $1.3 million and $4.2 million for the full year ended December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses were $82.8 million for the fourth quarter of 2024, compared to $77.5 million for the fourth quarter of 2023, and $301.3 million for the full year ended December 31, 2024, compared to $295.5 million for the full year ended December 31, 2023.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $51.7 million for the fourth quarter of 2024 compared to $35.3 million for the fourth quarter of 2023, and $156.8 million for the full year ended December 31, 2024, compared to $119.9 million for the full year ended December 31, 2023. The year-over-year increase was primarily attributable to an increase in commercial-related activities as the company prepares for the potential approval of PYRUKYND in thalassemia.

Net Income (Loss): Net loss was $96.5 million for the fourth quarter of 2024 compared to a net loss of $95.9 million for the fourth quarter of 2023 and net income was $673.7 million for the year ended December 31, 2024, compared to a net loss of $352.1 million for the year ended December 31, 2023.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of December 31, 2024, were $1.5 billion compared to $806.4 million as of December 31, 2023. This increase reflects payments from the royalty monetization for vorasidenib and a milestone payment from Servier for vorasidenib approval received in the third quarter of 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND launches in thalassemia and sickle cell disease, advance existing programs, and to opportunistically expand its pipeline through both internally and externally discovered assets.

Conference Call Information

Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s fourth quarter 2024 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

On February 13, 2025 DAAN Biotherapeutics, a leading innovative drug development company specializing in T-cell receptor (TCR)- based therapies, reported that it has signed an exclusive licensing agreement with LigaChem Biosciences for a novel tumor-targeting antibody to advance the development and commercialization of Antibody-Drug Conjugates (ADC) (Press release, DAAN Bio Therapeutics, FEB 13, 2025, View Source [SID1234650225]).

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By leveraging DAAN Biotherapeutics’ next-generation antibody technology, built upon its exceptional target discovery and antibody development capabilities, LigaChem Biosciences is now positioned to take a significant step forward in ADC development for solid tumor patients.

DAAN Biotherapeutics has successfully established a proprietary pipeline for efficiently developing antibodies targeting overexpressed tumor targets in solid cancers through a strategic partnership with OmniAb.

Byoung Chul Cho, MD, the CEO of DAAN Biotherapeutics, stated, "We will continue to develop state-of-the-art antibodies targeting solid tumors and collaborate with global pharmaceutical companies in the ADC field. Beyond ADCs, we also aim to become a global leader in solid tumor-targeting T-cell engagers using our proprietary TACTIC (Tumor Targeting Conditionally Activated T Cell Engager) platform."

On February 12, 2025 MimiVax, Inc., a leader in clinical-stage pharmaceutical research, reported that its now fully enrolled Phase 2b clinical trial of SurVaxM in glioblastoma, [SURVIVE] (NCT05163080), has successfully progressed following the first interim analysis of trial data (Press release, MimiVax, FEB 12, 2025, View Source;utm_medium=rss&utm_campaign=mimivax-survaxm-interim-analysis [SID1234650255]). The analysis, conducted as part of the company’s rigorous clinical development program, has provided valuable insights that support the continued advancement of the trial. The purpose of this study is to determine whether adding SurVaxM to standard-of-care (resection, radiation/chemotherapy) is better than standard treatment alone for patients with newly diagnosed glioblastoma.

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While the company is unable to disclose specific details about the interim analysis due to regulatory requirements set forth by the U.S. Food and Drug Administration (FDA), MimiVax remains confident in the potential of SurVaxM and is committed to advancing the study as planned.

"We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program," said Dr. Michael Ciesielski, CEO of MimiVax. "We are working closely with the FDA to ensure compliance with regulatory guidelines as we move forward with the trial."

Based on the results of the recent interim futility analysis, and ongoing review by the study’s Independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed without modification.

The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM at 11 participating major Cancer Centers in the United States. The company will provide updates at appropriate milestones, in accordance with regulatory requirements.

MimiVax thanks all participants, healthcare professionals, clinical support teams and investigators involved in the study for their continued support and commitment to the advancement of SurVaxM.

About SurVaxM:

SurVaxM is a peptide mimic immunogen that targets ‘survivin’, a cell-survival protein present in most glioblastomas and in many other cancers. SurVaxM stimulates a patients’ own immune response to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in many other forms of cancer.